# MedResin full grade data

> 391 medical-grade resin grades. Values are as stated by the cited public supplier source; "not stated" means the source is silent, not "no". Last checked 2026-10-16. Verify with the manufacturer before use.

## Lustran 348 (INEOS Styrolution, ABS)
- Page: https://medresin.com/grades/ineos-styrolution-lustran-348
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://www.ineos.com/contentassets/b97fc78f6a874895bf6506c5a8d97477/brochure_healthcare_global-emea_revaugust2026.pdf
- Note: INEOS Styrolution Full Service HD package: USP Class VI, ISO 10993 (-4/-5), food contact statements and DMF can be provided. Sterilization table: gamma, e-beam, EtO, NO2 (steam not ticked). INEOS regulatory table (rev. August 2026, p.28) lists the Lustran 348 DMF as "in progress" (Novodur HD 15: DMF 18858; HD M203FC: 15885), so FDA master file is left blank (checked 2026-10-20).

## Novodur HD 15 (INEOS Styrolution, ABS)
- Page: https://medresin.com/grades/ineos-styrolution-novodur-hd-15
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: DMF
- Source: https://www.ineos.com/contentassets/b97fc78f6a874895bf6506c5a8d97477/brochure_healthcare_global-emea_revaugust2026.pdf
- Note: INEOS Styrolution Full Service HD package: USP Class VI, ISO 10993 (-4/-5), food contact statements and DMF can be provided. Sterilization table: gamma, e-beam, EtO, NO2 (steam not ticked).

## Novodur HD M203FC (INEOS Styrolution, ABS)
- Page: https://medresin.com/grades/ineos-styrolution-novodur-hd-m203fc
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: DMF
- Source: https://www.ineos.com/contentassets/b97fc78f6a874895bf6506c5a8d97477/brochure_healthcare_global-emea_revaugust2026.pdf
- Note: INEOS Styrolution Full Service HD package: USP Class VI, ISO 10993 (-4/-5), food contact statements and DMF can be provided. Sterilization table: gamma, e-beam, EtO, NO2 (steam not ticked).

## OPTIX CA-1000IG (Plaskolite, Acrylic)
- Page: https://medresin.com/grades/plaskolite-optix-ca-1000ig
- USP VI: yes
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://plaskolite.com/docs/default-source/rds/pds283_oap_ca_1000_ig.pdf
- Data sheet: https://plaskolite.com/docs/default-source/rds/pds283_oap_ca_1000_ig.pdf
- Note: Plaskolite datasheet: USP Class VI; suitable for gamma or EtO sterilization (medical guide: dry EtO only; gamma yellowing is temporary).

## Marlex 9012 (Chevron Phillips Chemical, HDPE)
- Page: https://medresin.com/grades/chevron-phillips-chemical-marlex-9012
- USP VI: yes
- ISO 10993: not stated
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: DMF
- Source: https://www.cpchem.com/sites/default/files/2025-08/9012_PRO_FC_07182025_Rev_1.pdf
- Data sheet: https://www.cpchem.com/sites/default/files/2021-08/TDS%20-%20Marlex%C2%AE%209012%20Polyethylene.pdf
- Note: CPChem PRO: meets USP <87>, <88> Class VI (70 °C) and <661.1>; FDA Type III DMF 1646.

## Marlex 9018 (Chevron Phillips Chemical, HDPE)
- Page: https://medresin.com/grades/chevron-phillips-chemical-marlex-9018
- USP VI: yes
- ISO 10993: not stated
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: DMF
- Source: https://www.cpchem.com/sites/default/files/2025-08/9018_PRO_FC_07182025_Rev_1.pdf
- Data sheet: https://www.cpchem.com/sites/default/files/2021-08/TDS%20-%20Marlex%C2%AE%209018%20Polyethylene.pdf
- Note: CPChem PRO: meets USP <87>, <88> Class VI (70 °C) and <661.1>; FDA Type III DMF 1646.

## Purell PE5307 (LyondellBasell, HDPE)
- Page: https://medresin.com/grades/lyondellbasell-purell-pe5307
- USP VI: not stated
- ISO 10993: not stated
- Gamma: not stated
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: DMF
- Source: https://cdn.brandfolder.io/EZH48IU3/at/pv38vhjwthkb78rv8xm8tg2r/SM531_2026_May_OP_Purell_NA_Brochure.pdf
- Note: USP status listed as pending by LYB.

## Purell PE5618 (LyondellBasell, HDPE)
- Page: https://medresin.com/grades/lyondellbasell-purell-pe5618
- USP VI: not stated
- ISO 10993: not stated
- Gamma: not stated
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: DMF
- Source: https://cdn.brandfolder.io/EZH48IU3/at/pv38vhjwthkb78rv8xm8tg2r/SM531_2026_May_OP_Purell_NA_Brochure.pdf
- Note: USP status listed as pending by LYB.

## Purell 1840H (LyondellBasell, LDPE)
- Page: https://medresin.com/grades/lyondellbasell-purell-1840h
- USP VI: yes
- ISO 10993: not stated
- Gamma: not stated
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: DMF
- Source: https://cdn.brandfolder.io/EZH48IU3/at/pv38vhjwthkb78rv8xm8tg2r/SM531_2026_May_OP_Purell_NA_Brochure.pdf

## Purell 3020D (LyondellBasell, LDPE)
- Page: https://medresin.com/grades/lyondellbasell-purell-3020d
- USP VI: yes
- ISO 10993: not stated
- Gamma: not stated
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: DMF
- Source: https://cdn.brandfolder.io/EZH48IU3/at/pv38vhjwthkb78rv8xm8tg2r/SM531_2026_May_OP_Purell_NA_Brochure.pdf

## Purell 3220D (LyondellBasell, LDPE)
- Page: https://medresin.com/grades/lyondellbasell-purell-3220d
- USP VI: yes
- ISO 10993: not stated
- Gamma: not stated
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: DMF
- Source: https://cdn.brandfolder.io/EZH48IU3/at/pv38vhjwthkb78rv8xm8tg2r/SM531_2026_May_OP_Purell_NA_Brochure.pdf

## Terlux HD 2802/2822 (INEOS Styrolution, MABS)
- Page: https://medresin.com/grades/ineos-styrolution-terlux-hd-2802-2822
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: DMF
- Source: https://www.ineos.com/contentassets/b97fc78f6a874895bf6506c5a8d97477/brochure_healthcare_global-emea_revaugust2026.pdf
- Note: INEOS Styrolution Full Service HD package: USP Class VI, ISO 10993 (-4/-5), food contact statements and DMF can be provided. Sterilization table: gamma, e-beam, EtO, NO2 (steam not ticked). Manufacturer brochure lists Terlux HD 2802 only; 2822 not confirmed.

## Terlux HD 2812 (INEOS Styrolution, MABS)
- Page: https://medresin.com/grades/ineos-styrolution-terlux-hd-2812
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: DMF
- Source: https://www.ineos.com/contentassets/b97fc78f6a874895bf6506c5a8d97477/brochure_healthcare_global-emea_revaugust2026.pdf
- Note: INEOS Styrolution Full Service HD package: USP Class VI, ISO 10993 (-4/-5), food contact statements and DMF can be provided. Sterilization table: gamma, e-beam, EtO, NO2 (steam not ticked).

## Clearblend 145 (INEOS Styrolution, MBS)
- Page: https://medresin.com/grades/ineos-styrolution-clearblend-145
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: DMF
- Source: https://www.ineos.com/contentassets/b97fc78f6a874895bf6506c5a8d97477/brochure_healthcare_global-emea_revaugust2026.pdf
- Note: INEOS Styrolution Essential HD package: USP Class VI, ISO 10993 compliance and DMF can be provided. Sterilization table: gamma, e-beam, EtO, NO2 (steam not ticked).

## Clearblend 165 (INEOS Styrolution, MBS)
- Page: https://medresin.com/grades/ineos-styrolution-clearblend-165
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: DMF
- Source: https://www.ineos.com/contentassets/b97fc78f6a874895bf6506c5a8d97477/brochure_healthcare_global-emea_revaugust2026.pdf
- Note: INEOS Styrolution Essential HD package: USP Class VI, ISO 10993 compliance and DMF can be provided. Sterilization table: gamma, e-beam, EtO, NO2 (steam not ticked).

## Zylar 631 (INEOS Styrolution, MBS)
- Page: https://medresin.com/grades/ineos-styrolution-zylar-631
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: DMF
- Source: https://www.ineos.com/contentassets/b97fc78f6a874895bf6506c5a8d97477/brochure_healthcare_global-emea_revaugust2026.pdf
- Note: INEOS Styrolution Essential HD package: USP Class VI, ISO 10993 compliance and DMF can be provided. Sterilization table: gamma, e-beam, EtO, NO2 (steam not ticked).

## Zylar 960 (INEOS Styrolution, MBS)
- Page: https://medresin.com/grades/ineos-styrolution-zylar-960
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: DMF
- Source: https://www.ineos.com/contentassets/b97fc78f6a874895bf6506c5a8d97477/brochure_healthcare_global-emea_revaugust2026.pdf
- Note: INEOS Styrolution Essential HD package: USP Class VI, ISO 10993 compliance and DMF can be provided. Sterilization table: gamma, e-beam, EtO, NO2 (steam not ticked).

## Ultradur PRO B4521 (BASF, PBT)
- Page: https://medresin.com/grades/basf-ultradur-pro-b4521
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: limited
- VHP: not stated
- FDA master file: not stated
- Source: https://download.basf.com/p1/8a8081c57fd4b609018021fe1bcc1c95/en/Ultraform%C2%AE_PRO_%28POM%29_and_Ultradur%C2%AE_PRO_%28PBT%29_-_Engineering_Plastics_for_Medical_Solutions_Brochure_English.pdf?view=
- Autoclave/steam (as stated): 121 °C: limited resistance; 134/143 °C: no resistance (depends on conditions, duration and number of cycles)
- Note: BASF sterilization table: Ultradur PRO steam 121 °C limited, gamma/e-beam and EtO full resistance, plasma limited.

## Apec 1745 (Covestro, PC (high-heat))
- Page: https://medresin.com/grades/covestro-apec-1745
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://solutions.covestro.com/-/media/covestro/solution-center/story/brochures/covestro_healthcare-reference-guide_2025_new.pdf
- Gamma dose (as stated): 28 kGy assumed per sterilization; 10-20 sterilizations before appreciable strength loss (Makrolon/Apec, per Covestro)
- Autoclave/steam (as stated): steam up to 143 °C; Apec specimens kept comparatively good impact strength after 100 cycles at 120-125 °C
- Note: USP Class VI per Covestro portfolio statement (ISO 10993 and USP Class VI for contact of 30 days or less).

## Apec 2045 (Covestro, PC (high-heat))
- Page: https://medresin.com/grades/covestro-apec-2045
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://solutions.covestro.com/-/media/covestro/solution-center/story/brochures/covestro_healthcare-reference-guide_2025_new.pdf
- Gamma dose (as stated): 28 kGy assumed per sterilization; 10-20 sterilizations before appreciable strength loss (Makrolon/Apec, per Covestro)
- Autoclave/steam (as stated): steam up to 143 °C; Apec specimens kept comparatively good impact strength after 100 cycles at 120-125 °C
- Note: USP Class VI per Covestro portfolio statement (ISO 10993 and USP Class VI for contact of 30 days or less).

## Makrolon 2458 (Covestro, PC)
- Page: https://medresin.com/grades/covestro-makrolon-2458
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://solutions.covestro.com/-/media/covestro/solution-center/story/brochures/covestro_healthcare-reference-guide_2025_new.pdf
- Gamma dose (as stated): 28 kGy assumed per sterilization; 10-20 sterilizations before appreciable strength loss (Makrolon/Apec, per Covestro)
- Autoclave/steam (as stated): steam at 121 °C; Covestro says do not exceed 125 °C for Makrolon
- Note: USP Class VI per Covestro portfolio statement (ISO 10993 and USP Class VI for contact of 30 days or less).

## Makrolon 2558 (Covestro, PC)
- Page: https://medresin.com/grades/covestro-makrolon-2558
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://solutions.covestro.com/-/media/covestro/solution-center/story/brochures/covestro_healthcare-reference-guide_2025_new.pdf
- Gamma dose (as stated): 28 kGy assumed per sterilization; 10-20 sterilizations before appreciable strength loss (Makrolon/Apec, per Covestro)
- Autoclave/steam (as stated): steam at 121 °C; Covestro says do not exceed 125 °C for Makrolon
- Note: USP Class VI per Covestro portfolio statement (ISO 10993 and USP Class VI for contact of 30 days or less).

## Makrolon Rx1805 (Covestro, PC)
- Page: https://medresin.com/grades/covestro-makrolon-rx1805
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://solutions.covestro.com/-/media/covestro/solution-center/story/brochures/covestro_healthcare-reference-guide_2025_new.pdf
- Gamma dose (as stated): 28 kGy assumed per sterilization; 10-20 sterilizations before appreciable strength loss (Makrolon/Apec, per Covestro)
- Autoclave/steam (as stated): steam at 121 °C; Covestro says do not exceed 125 °C for Makrolon
- Note: USP Class VI per Covestro portfolio statement (ISO 10993 and USP Class VI for contact of 30 days or less). Radiation-stabilized grade.

## Makrolon Rx2235 (Covestro, PC)
- Page: https://medresin.com/grades/covestro-makrolon-rx2235
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://solutions.covestro.com/-/media/covestro/solution-center/story/brochures/covestro_healthcare-reference-guide_2025_new.pdf
- Gamma dose (as stated): 28 kGy assumed per sterilization; 10-20 sterilizations before appreciable strength loss (Makrolon/Apec, per Covestro)
- Autoclave/steam (as stated): steam at 121 °C; Covestro says do not exceed 125 °C for Makrolon
- Note: USP Class VI per Covestro portfolio statement (ISO 10993 and USP Class VI for contact of 30 days or less). Radiation-stabilized grade.

## Makrolon Rx2435 (Covestro, PC)
- Page: https://medresin.com/grades/covestro-makrolon-rx2435
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://solutions.covestro.com/-/media/covestro/solution-center/story/brochures/covestro_healthcare-reference-guide_2025_new.pdf
- Gamma dose (as stated): 28 kGy assumed per sterilization; 10-20 sterilizations before appreciable strength loss (Makrolon/Apec, per Covestro)
- Autoclave/steam (as stated): steam at 121 °C; Covestro says do not exceed 125 °C for Makrolon
- Note: USP Class VI per Covestro portfolio statement (ISO 10993 and USP Class VI for contact of 30 days or less). Radiation-stabilized grade.

## Makrolon Rx2530 (Covestro, PC)
- Page: https://medresin.com/grades/covestro-makrolon-rx2530
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://solutions.covestro.com/-/media/covestro/solution-center/story/brochures/covestro_healthcare-reference-guide_2025_new.pdf
- Gamma dose (as stated): 28 kGy assumed per sterilization; 10-20 sterilizations before appreciable strength loss (Makrolon/Apec, per Covestro)
- Autoclave/steam (as stated): steam at 121 °C; Covestro says do not exceed 125 °C for Makrolon
- Note: USP Class VI per Covestro portfolio statement (ISO 10993 and USP Class VI for contact of 30 days or less). Radiation-stabilized grade.

## Makrolon Rx3440 (Covestro, PC)
- Page: https://medresin.com/grades/covestro-makrolon-rx3440
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://solutions.covestro.com/-/media/covestro/solution-center/story/brochures/covestro_healthcare-reference-guide_2025_new.pdf
- Gamma dose (as stated): 28 kGy assumed per sterilization; 10-20 sterilizations before appreciable strength loss (Makrolon/Apec, per Covestro)
- Autoclave/steam (as stated): steam at 121 °C; Covestro says do not exceed 125 °C for Makrolon
- Note: USP Class VI per Covestro portfolio statement (ISO 10993 and USP Class VI for contact of 30 days or less). Radiation-stabilized grade.

## Makrolon M410 GF (Covestro, PC/GF)
- Page: https://medresin.com/grades/covestro-makrolon-m410-gf
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://solutions.covestro.com/-/media/covestro/solution-center/story/brochures/covestro_healthcare-reference-guide_2025_new.pdf
- Gamma dose (as stated): 28 kGy assumed per sterilization; 10-20 sterilizations before appreciable strength loss (Makrolon/Apec, per Covestro)
- Autoclave/steam (as stated): steam at 121 °C
- Note: USP Class VI per Covestro portfolio statement (ISO 10993 and USP Class VI for contact of 30 days or less).

## Bayblend M750 (Covestro, PC/ABS)
- Page: https://medresin.com/grades/covestro-bayblend-m750
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: no
- VHP: not stated
- FDA master file: not stated
- Source: https://solutions.covestro.com/-/media/covestro/solution-center/story/brochures/covestro_healthcare-reference-guide_2025_new.pdf
- Note: USP Class VI per Covestro portfolio statement (ISO 10993 and USP Class VI for contact of 30 days or less).

## ZEONEX 690R (Zeon, COP)
- Page: https://medresin.com/grades/zeon-zeonex-690r
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: yes
- FDA master file: DMF
- Source: https://zeonsmi.com/uploads/downloads/Medical-grade-overview-data-sheet_V2026_09_29.pdf
- Data sheet: https://zeonsmi.com/uploads/downloads/ZEONEX_690R_V2026_09_29.pdf
- Additional source: https://www.zeonsmi.com/resources/downloads/

## ZEONEX 790R (Zeon, COP)
- Page: https://medresin.com/grades/zeon-zeonex-790r
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: yes
- FDA master file: DMF
- Source: https://zeonsmi.com/uploads/downloads/Medical-grade-overview-data-sheet_V2026_09_29.pdf
- Data sheet: https://zeonsmi.com/uploads/downloads/ZEONEX_790R_V2026_09_29.pdf
- Additional source: https://www.zeonsmi.com/resources/downloads/

## ZEONOR 1020R (Zeon, COP)
- Page: https://medresin.com/grades/zeon-zeonor-1020r
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: DMF
- Source: https://zeonsmi.com/uploads/downloads/Medical-grade-overview-data-sheet_V2026_09_29.pdf
- Data sheet: https://zeonsmi.com/uploads/downloads/ZEONOR_1020R_V2026_09_29.pdf
- Additional source: https://www.zeonsmi.com/resources/downloads/

## ZEONEX 5000 (Zeon, COP)
- Page: https://medresin.com/grades/zeon-zeonex-5000
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: DMF
- Source: https://zeonsmi.com/uploads/downloads/Medical-grade-overview-data-sheet_V2026_09_29.pdf
- Data sheet: https://zeonsmi.com/uploads/downloads/ZEONEX_5000_V2026_09_29.pdf
- Additional source: https://www.zeonsmi.com/resources/downloads/

## Ultraform N2320 003 PRO AT (BASF, POM)
- Page: https://medresin.com/grades/basf-ultraform-n2320-003-pro-at
- USP VI: not stated
- ISO 10993: not stated
- Gamma: limited
- EtO: yes
- Autoclave: limited
- VHP: not stated
- FDA master file: not stated
- Source: https://download.basf.com/p1/8a8081c57fd4b609018021fe1bcc1c95/en/Ultraform%C2%AE_PRO_%28POM%29_and_Ultradur%C2%AE_PRO_%28PBT%29_-_Engineering_Plastics_for_Medical_Solutions_Brochure_English.pdf?view=
- Autoclave/steam (as stated): 121 °C and 134 °C: limited resistance; 143 °C: no resistance (depends on conditions, duration and number of cycles)
- Data sheet: https://download.basf.com/p1/8a8082587fd4b608017fd64402e17397/en/ULTRAFORM%3Csup%3E%C2%AE%3Csup%3E_N2320_003_PRO_AT_Product_Data_Sheet_Europe_English.pdf?view=
- Note: BASF sterilization table: Ultraform PRO steam limited, gamma/e-beam limited, EtO and plasma full resistance. USP Class VI and ISO 10993-5 cytotoxicity: yes; DMF 34139 (BASF table).

## Ultraform S1320 003 PRO AT (BASF, POM)
- Page: https://medresin.com/grades/basf-ultraform-s1320-003-pro-at
- USP VI: not stated
- ISO 10993: not stated
- Gamma: limited
- EtO: yes
- Autoclave: limited
- VHP: not stated
- FDA master file: not stated
- Source: https://download.basf.com/p1/8a8081c57fd4b609018021fe1bcc1c95/en/Ultraform%C2%AE_PRO_%28POM%29_and_Ultradur%C2%AE_PRO_%28PBT%29_-_Engineering_Plastics_for_Medical_Solutions_Brochure_English.pdf?view=
- Autoclave/steam (as stated): 121 °C and 134 °C: limited resistance; 143 °C: no resistance (depends on conditions, duration and number of cycles)
- Note: BASF sterilization table: Ultraform PRO steam limited, gamma/e-beam limited, EtO and plasma full resistance. USP Class VI and ISO 10993-5 cytotoxicity: yes; DMF 33419 (BASF table).

## Ultraform S2320 003 PRO AT (BASF, POM)
- Page: https://medresin.com/grades/basf-ultraform-s2320-003-pro-at
- USP VI: not stated
- ISO 10993: not stated
- Gamma: limited
- EtO: yes
- Autoclave: limited
- VHP: not stated
- FDA master file: not stated
- Source: https://download.basf.com/p1/8a8081c57fd4b609018021fe1bcc1c95/en/Ultraform%C2%AE_PRO_%28POM%29_and_Ultradur%C2%AE_PRO_%28PBT%29_-_Engineering_Plastics_for_Medical_Solutions_Brochure_English.pdf?view=
- Autoclave/steam (as stated): 121 °C and 134 °C: limited resistance; 143 °C: no resistance (depends on conditions, duration and number of cycles)
- Note: BASF sterilization table: Ultraform PRO steam limited, gamma/e-beam limited, EtO and plasma full resistance.

## Ultraform W2320 003 PRO AT (BASF, POM)
- Page: https://medresin.com/grades/basf-ultraform-w2320-003-pro-at
- USP VI: not stated
- ISO 10993: not stated
- Gamma: limited
- EtO: yes
- Autoclave: limited
- VHP: not stated
- FDA master file: not stated
- Source: https://download.basf.com/p1/8a8081c57fd4b609018021fe1bcc1c95/en/Ultraform%C2%AE_PRO_%28POM%29_and_Ultradur%C2%AE_PRO_%28PBT%29_-_Engineering_Plastics_for_Medical_Solutions_Brochure_English.pdf?view=
- Autoclave/steam (as stated): 121 °C and 134 °C: limited resistance; 143 °C: no resistance (depends on conditions, duration and number of cycles)
- Note: BASF sterilization table: Ultraform PRO steam limited, gamma/e-beam limited, EtO and plasma full resistance.

## 23M2A (INVISTA, PP)
- Page: https://medresin.com/grades/invista-23m2a
- USP VI: yes
- ISO 10993: not stated
- Gamma: not stated
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://invista-pp.com/InvistaPolypropylene/media/PolypropyleneGeneral/25-INV-Polypropylene-Medical-Brochure-V4.pdf
- Note: INVISTA: biocompatibility results incl. USP <88> Class VI and ISO 10993-5 (cytotoxicity) for all MedSelect grades; "Radiation" sterilization listed as gamma.

## 23R2A (INVISTA, PP)
- Page: https://medresin.com/grades/invista-23r2a
- USP VI: yes
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://invista-pp.com/InvistaPolypropylene/media/PolypropyleneGeneral/25-INV-Polypropylene-Medical-Brochure-V4.pdf
- Note: INVISTA: biocompatibility results incl. USP <88> Class VI and ISO 10993-5 (cytotoxicity) for all MedSelect grades; "Radiation" sterilization listed as gamma.

## H0500HN (INVISTA, PP)
- Page: https://medresin.com/grades/invista-h0500hn
- USP VI: yes
- ISO 10993: not stated
- Gamma: not stated
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://invista-pp.com/InvistaPolypropylene/media/PolypropyleneGeneral/25-INV-Polypropylene-Medical-Brochure-V4.pdf
- Note: INVISTA: biocompatibility results incl. USP <88> Class VI and ISO 10993-5 (cytotoxicity) for all MedSelect grades; "Radiation" sterilization listed as gamma.

## 13R9A (INVISTA, PP)
- Page: https://medresin.com/grades/invista-13r9a
- USP VI: yes
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://invista-pp.com/InvistaPolypropylene/media/PolypropyleneGeneral/25-INV-Polypropylene-Medical-Brochure-V4.pdf
- Note: INVISTA: biocompatibility results incl. USP <88> Class VI and ISO 10993-5 (cytotoxicity) for all MedSelect grades; "Radiation" sterilization listed as gamma.

## 23N10A (INVISTA, PP)
- Page: https://medresin.com/grades/invista-23n10a
- USP VI: yes
- ISO 10993: not stated
- Gamma: not stated
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://invista-pp.com/InvistaPolypropylene/media/PolypropyleneGeneral/25-INV-Polypropylene-Medical-Brochure-V4.pdf
- Note: INVISTA: biocompatibility results incl. USP <88> Class VI and ISO 10993-5 (cytotoxicity) for all MedSelect grades; "Radiation" sterilization listed as gamma.

## 11R12A (INVISTA, PP)
- Page: https://medresin.com/grades/invista-11r12a
- USP VI: yes
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://invista-pp.com/InvistaPolypropylene/media/PolypropyleneGeneral/25-INV-Polypropylene-Medical-Brochure-V4.pdf
- Note: INVISTA: biocompatibility results incl. USP <88> Class VI and ISO 10993-5 (cytotoxicity) for all MedSelect grades; "Radiation" sterilization listed as gamma.

## P4C5N-046 (INVISTA, PP)
- Page: https://medresin.com/grades/invista-p4c5n-046
- USP VI: yes
- ISO 10993: not stated
- Gamma: not stated
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://invista-pp.com/InvistaPolypropylene/media/PolypropyleneGeneral/25-INV-Polypropylene-Medical-Brochure-V4.pdf
- Note: INVISTA: biocompatibility results incl. USP <88> Class VI and ISO 10993-5 (cytotoxicity) for all MedSelect grades; "Radiation" sterilization listed as gamma.

## 11M35V (INVISTA, PP)
- Page: https://medresin.com/grades/invista-11m35v
- USP VI: yes
- ISO 10993: not stated
- Gamma: not stated
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://invista-pp.com/InvistaPolypropylene/media/PolypropyleneGeneral/25-INV-Polypropylene-Medical-Brochure-V4.pdf
- Note: INVISTA: biocompatibility results incl. USP <88> Class VI and ISO 10993-5 (cytotoxicity) for all MedSelect grades; "Radiation" sterilization listed as gamma.

## 13T25A (INVISTA, PP)
- Page: https://medresin.com/grades/invista-13t25a
- USP VI: yes
- ISO 10993: not stated
- Gamma: not stated
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://invista-pp.com/InvistaPolypropylene/media/PolypropyleneGeneral/25-INV-Polypropylene-Medical-Brochure-V4.pdf
- Note: INVISTA: biocompatibility results incl. USP <88> Class VI and ISO 10993-5 (cytotoxicity) for all MedSelect grades; "Radiation" sterilization listed as gamma.

## P5M6K-080 (INVISTA, PP)
- Page: https://medresin.com/grades/invista-p5m6k-080
- USP VI: yes
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://invista-pp.com/InvistaPolypropylene/media/PolypropyleneGeneral/25-INV-Polypropylene-Medical-Brochure-V4.pdf
- Note: INVISTA: biocompatibility results incl. USP <88> Class VI and ISO 10993-5 (cytotoxicity) for all MedSelect grades; "Radiation" sterilization listed as gamma.

## P9M7R-056 (INVISTA, PP)
- Page: https://medresin.com/grades/invista-p9m7r-056
- USP VI: yes
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://invista-pp.com/InvistaPolypropylene/media/PolypropyleneGeneral/25-INV-Polypropylene-Medical-Brochure-V4.pdf
- Note: INVISTA: biocompatibility results incl. USP <88> Class VI and ISO 10993-5 (cytotoxicity) for all MedSelect grades; "Radiation" sterilization listed as gamma.

## Purell HP6331 (LyondellBasell, PP)
- Page: https://medresin.com/grades/lyondellbasell-purell-hp6331
- USP VI: not stated
- ISO 10993: not stated
- Gamma: not stated
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: DMF
- Source: https://cdn.brandfolder.io/EZH48IU3/at/pv38vhjwthkb78rv8xm8tg2r/SM531_2026_May_OP_Purell_NA_Brochure.pdf
- Note: USP status listed as pending by LYB.

## Purell PF511 (LyondellBasell, PP)
- Page: https://medresin.com/grades/lyondellbasell-purell-pf511
- USP VI: yes
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: DMF
- Source: https://cdn.brandfolder.io/EZH48IU3/at/pv38vhjwthkb78rv8xm8tg2r/SM531_2026_May_OP_Purell_NA_Brochure.pdf

## Purell PF531 (LyondellBasell, PP)
- Page: https://medresin.com/grades/lyondellbasell-purell-pf531
- USP VI: yes
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: DMF
- Source: https://cdn.brandfolder.io/EZH48IU3/at/pv38vhjwthkb78rv8xm8tg2r/SM531_2026_May_OP_Purell_NA_Brochure.pdf

## Purell RP491S (LyondellBasell, PP)
- Page: https://medresin.com/grades/lyondellbasell-purell-rp491s
- USP VI: not stated
- ISO 10993: not stated
- Gamma: not stated
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: DMF
- Source: https://cdn.brandfolder.io/EZH48IU3/at/pv38vhjwthkb78rv8xm8tg2r/SM531_2026_May_OP_Purell_NA_Brochure.pdf
- Note: USP status listed as pending by LYB.

## 3740WR (TotalEnergies, PP)
- Page: https://medresin.com/grades/totalenergies-3740wr
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://polymers.totalenergies.com/sites/g/files/wompnd5016/files/site_collection_documents/Technical%20Datasheets/3740WR-US.pdf
- Gamma dose (as stated): good gamma radiation stability up to 50 kGy
- Data sheet: https://polymers.totalenergies.com/sites/g/files/wompnd5016/files/site_collection_documents/Technical%20Datasheets/3740WR-US.pdf
- Note: TotalEnergies TDS: recommended for injection-molded medical applications.

## 3847MR (TotalEnergies, PP)
- Page: https://medresin.com/grades/totalenergies-3847mr
- USP VI: yes
- ISO 10993: not stated
- Gamma: yes
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://polymers.totalenergies.com/sites/g/files/wompnd5016/files/site_collection_documents/Technical%20Datasheets/3847MR-US.pdf
- Data sheet: https://polymers.totalenergies.com/sites/g/files/wompnd5016/files/site_collection_documents/Technical%20Datasheets/3847MR-US.pdf
- Note: TotalEnergies TDS: passed USP Class VI; resists typical gamma sterilization levels.

## 3944MR (TotalEnergies, PP)
- Page: https://medresin.com/grades/totalenergies-3944mr
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://polymers.totalenergies.com/sites/g/files/wompnd5016/files/site_collection_documents/Technical%20Datasheets/3944MR-US.pdf
- Data sheet: https://polymers.totalenergies.com/sites/g/files/wompnd5016/files/site_collection_documents/Technical%20Datasheets/3944MR-US.pdf
- Note: TotalEnergies TDS: resists typical gamma sterilization levels; USP Class VI not stated on the TDS.

## Ultrason E 2010 (BASF, PESU)
- Page: https://medresin.com/grades/basf-ultrason-e-2010
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: not stated
- Autoclave: limited
- VHP: not stated
- FDA master file: not stated
- Source: https://download.basf.com/p1/8a8082587fd4b608017fd654898f0d1e/en/Ultrason%3Csup%3E%C2%AE%3Csup%3E_E_S_P_%28PESU_PSU_PPSU%29_%E2%80%92_Product_Brochure_Brochure_English.pdf?view=
- Gamma dose (as stated): noticeable property decline only above 2 MGy (Ultrason E)
- Autoclave/steam (as stated): up to 100 superheated-steam cycles at 134 °C (avoid mechanical stress)
- Note: BASF brochure: Ultrason S/E steam (134 °C) up to 100 cycles if mechanical stress is avoided; very resistant to gamma/beta/X-rays. BASF family used.

## Ultrason E 3010 (BASF, PESU)
- Page: https://medresin.com/grades/basf-ultrason-e-3010
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: not stated
- Autoclave: limited
- VHP: not stated
- FDA master file: not stated
- Source: https://download.basf.com/p1/8a8082587fd4b608017fd654898f0d1e/en/Ultrason%3Csup%3E%C2%AE%3Csup%3E_E_S_P_%28PESU_PSU_PPSU%29_%E2%80%92_Product_Brochure_Brochure_English.pdf?view=
- Gamma dose (as stated): noticeable property decline only above 2 MGy (Ultrason E)
- Autoclave/steam (as stated): up to 100 superheated-steam cycles at 134 °C (avoid mechanical stress)
- Note: BASF brochure: Ultrason S/E steam (134 °C) up to 100 cycles if mechanical stress is avoided; very resistant to gamma/beta/X-rays. BASF family used.

## Ultrason S 2010 (BASF, PSU)
- Page: https://medresin.com/grades/basf-ultrason-s-2010
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: not stated
- Autoclave: limited
- VHP: not stated
- FDA master file: not stated
- Source: https://download.basf.com/p1/8a8082587fd4b608017fd654898f0d1e/en/Ultrason%3Csup%3E%C2%AE%3Csup%3E_E_S_P_%28PESU_PSU_PPSU%29_%E2%80%92_Product_Brochure_Brochure_English.pdf?view=
- Autoclave/steam (as stated): up to 100 superheated-steam cycles at 134 °C (avoid mechanical stress)
- Note: BASF brochure: Ultrason S/E steam (134 °C) up to 100 cycles if mechanical stress is avoided; very resistant to gamma/beta/X-rays.

## APEX 32043RV-NT1 (Teknor Apex, PVC)
- Page: https://medresin.com/grades/teknor-apex-apex-32043rv-nt1
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://www.teknorapex.com/en-us/teknor-apexs-extensive-product-portfolio-of-vinyl-thermoplastic-elastomers-nylon-and-colorants/vinyl/flexible-pvc-compounds/apex-flexible-pvc/apex-flexible-pvc-medical
- Note: Teknor Apex medical PVC page (family-level): "Biocompatibility backed by USP Class VI & ISO 10993 testing", including ISO 10993-5 cytotoxicity test data; holds color after gamma and e-beam.

## APEX 33043RV-NT1 (Teknor Apex, PVC)
- Page: https://medresin.com/grades/teknor-apex-apex-33043rv-nt1
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://www.teknorapex.com/en-us/teknor-apexs-extensive-product-portfolio-of-vinyl-thermoplastic-elastomers-nylon-and-colorants/vinyl/flexible-pvc-compounds/apex-flexible-pvc/apex-flexible-pvc-medical
- Note: Teknor Apex medical PVC page (family-level): "Biocompatibility backed by USP Class VI & ISO 10993 testing", including ISO 10993-5 cytotoxicity test data; holds color after gamma and e-beam.

## Styroflex 2G66 (INEOS Styrolution, S-TPE)
- Page: https://medresin.com/grades/ineos-styrolution-styroflex-2g66
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: DMF
- Source: https://www.ineos.com/contentassets/b97fc78f6a874895bf6506c5a8d97477/brochure_healthcare_global-emea_revaugust2026.pdf
- Note: INEOS Styrolution Essential HD package: USP Class VI, ISO 10993 compliance and DMF can be provided. Sterilization table: gamma, e-beam, EtO, NO2 (steam not ticked).

## Luran HD 20 TR64000 (INEOS Styrolution, SAN)
- Page: https://medresin.com/grades/ineos-styrolution-luran-hd-20-tr64000
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: DMF
- Source: https://www.ineos.com/contentassets/b97fc78f6a874895bf6506c5a8d97477/brochure_healthcare_global-emea_revaugust2026.pdf
- Note: INEOS Styrolution Full Service HD package: USP Class VI, ISO 10993 (-4/-5), food contact statements and DMF can be provided. Sterilization table: gamma, e-beam, EtO, NO2 (steam not ticked).

## K-Resin KR01 (INEOS Styrolution, SBC)
- Page: https://medresin.com/grades/ineos-styrolution-k-resin-kr01
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: DMF
- Source: https://www.ineos.com/contentassets/b97fc78f6a874895bf6506c5a8d97477/brochure_healthcare_global-emea_revaugust2026.pdf
- Note: INEOS Styrolution Essential HD package: USP Class VI, ISO 10993 compliance and DMF can be provided. Sterilization table: gamma, e-beam, EtO, NO2 (steam not ticked).

## Styrolux 656C (INEOS Styrolution, SBC)
- Page: https://medresin.com/grades/ineos-styrolution-styrolux-656c
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: DMF
- Source: https://www.ineos.com/contentassets/b97fc78f6a874895bf6506c5a8d97477/brochure_healthcare_global-emea_revaugust2026.pdf
- Note: INEOS Styrolution Essential HD package: USP Class VI, ISO 10993 compliance and DMF can be provided. Sterilization table: gamma, e-beam, EtO, NO2 (steam not ticked).

## NAS 21 (INEOS Styrolution, SMMA)
- Page: https://medresin.com/grades/ineos-styrolution-nas-21
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: DMF
- Source: https://www.ineos.com/contentassets/b97fc78f6a874895bf6506c5a8d97477/brochure_healthcare_global-emea_revaugust2026.pdf
- Note: INEOS Styrolution Essential HD package: USP Class VI, ISO 10993 compliance and DMF can be provided. Sterilization table: gamma, e-beam, EtO, NO2 (steam not ticked).

## NAS 30 (INEOS Styrolution, SMMA)
- Page: https://medresin.com/grades/ineos-styrolution-nas-30
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: DMF
- Source: https://www.ineos.com/contentassets/b97fc78f6a874895bf6506c5a8d97477/brochure_healthcare_global-emea_revaugust2026.pdf
- Note: INEOS Styrolution Essential HD package: USP Class VI, ISO 10993 compliance and DMF can be provided. Sterilization table: gamma, e-beam, EtO, NO2 (steam not ticked).

## Texin RxS285 (Covestro, TPU)
- Page: https://medresin.com/grades/covestro-texin-rxs285
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: no
- VHP: not stated
- FDA master file: not stated
- Source: https://solutions.covestro.com/-/media/covestro/solution-center/story/brochures/covestro_healthcare-reference-guide_2025_new.pdf
- Note: Covestro: Texin Rx can be sterilized with EtO, gamma and e-beam; do not steam autoclave.

## Texin RxT50D (Covestro, TPU)
- Page: https://medresin.com/grades/covestro-texin-rxt50d
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: no
- VHP: not stated
- FDA master file: not stated
- Source: https://solutions.covestro.com/-/media/covestro/solution-center/story/brochures/covestro_healthcare-reference-guide_2025_new.pdf
- Note: Covestro: Texin Rx can be sterilized with EtO, gamma and e-beam; do not steam autoclave.

## Texin RxT65D (Covestro, TPU)
- Page: https://medresin.com/grades/covestro-texin-rxt65d
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: no
- VHP: not stated
- FDA master file: not stated
- Source: https://solutions.covestro.com/-/media/covestro/solution-center/story/brochures/covestro_healthcare-reference-guide_2025_new.pdf
- Note: Covestro: Texin Rx can be sterilized with EtO, gamma and e-beam; do not steam autoclave.

## Texin RxT70A (Covestro, TPU)
- Page: https://medresin.com/grades/covestro-texin-rxt70a
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: no
- VHP: not stated
- FDA master file: not stated
- Source: https://solutions.covestro.com/-/media/covestro/solution-center/story/brochures/covestro_healthcare-reference-guide_2025_new.pdf
- Note: Covestro: Texin Rx can be sterilized with EtO, gamma and e-beam; do not steam autoclave.

## Texin RxT85A (Covestro, TPU)
- Page: https://medresin.com/grades/covestro-texin-rxt85a
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: no
- VHP: not stated
- FDA master file: not stated
- Source: https://solutions.covestro.com/-/media/covestro/solution-center/story/brochures/covestro_healthcare-reference-guide_2025_new.pdf
- Note: Covestro: Texin Rx can be sterilized with EtO, gamma and e-beam; do not steam autoclave.

## Texin RxT90A (Covestro, TPU)
- Page: https://medresin.com/grades/covestro-texin-rxt90a
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: no
- VHP: not stated
- FDA master file: not stated
- Source: https://solutions.covestro.com/-/media/covestro/solution-center/story/brochures/covestro_healthcare-reference-guide_2025_new.pdf
- Note: Covestro: Texin Rx can be sterilized with EtO, gamma and e-beam; do not steam autoclave.

## TOPAS 8007S-04 (TOPAS Advanced Polymers, COC)
- Page: https://medresin.com/grades/topas-advanced-polymers-topas-8007s-04
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://topas.com/wp-content/uploads/2023/05/TOPAS-Medical-Brochure.pdf
- Data sheet: https://topas.com/wp-content/uploads/2023/05/TDS_8007S-04_e_US.pdf
- Additional source: https://topas.com/wp-content/uploads/2023/05/TDS_8007S-04_e_US.pdf
- Note: TOPAS brochure: studied grades meet USP Class VI & ISO 10993; 8007 rated EtO + gamma, not steam. DMF/MAF numbers cited only by SpecialChem (secondary), removed.

## TOPAS 6017S-04 (TOPAS Advanced Polymers, COC)
- Page: https://medresin.com/grades/topas-advanced-polymers-topas-6017s-04
- USP VI: not stated
- ISO 10993: not stated
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://topas.com/tech-center/datasheets/6017s-04/
- Note: TOPAS datasheet does not state compliance or sterilization; previous values came from SpecialChem (secondary) and were removed pending a TOPAS source.

## TOPAS 6013M-07 (TOPAS Advanced Polymers, COC)
- Page: https://medresin.com/grades/topas-advanced-polymers-topas-6013m-07
- USP VI: yes
- ISO 10993: yes
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://topas.com/company/news/new-topas-6013m-07-blow-molding-injection-molding/
- Data sheet: https://topas.com/wp-content/uploads/2023/05/TDS-6013M-07_e_US.pdf

## Radel R-5000 (Syensqo (Solvay), PPSU)
- Page: https://medresin.com/grades/syensqo-solvay-radel-r-5000
- USP VI: not stated
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: yes
- FDA master file: MAF
- Source: https://www.syensqo.com/en/brands/radel-ppsu/healthcare

## Zeniva ZA-600 (Syensqo (Solvay), PEEK)
- Page: https://medresin.com/grades/syensqo-solvay-zeniva-za-600
- USP VI: not stated
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: MAF
- Source: https://www.syensqo.com/en/solutions-market/healthcare/medical-devices-equipment/implantable-devices

## Silopren LSR 4060 (Momentive, LSR)
- Page: https://medresin.com/grades/momentive-silopren-lsr-4060
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://dev.momentive.com/content/dam/momentive/global/docs/default-source/tds/silopren/silopren-lsr-4060.pdf

## Silopren LSR 4080 (Momentive, LSR)
- Page: https://medresin.com/grades/momentive-silopren-lsr-4080
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://dev.momentive.com/content/dam/momentive/global/docs/default-source/tds/silopren/silopren-lsr-4080.pdf

## Silopren LSR 4660 (Momentive, LSR)
- Page: https://medresin.com/grades/momentive-silopren-lsr-4660
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://www.momentive.com/content/dam/momentive/en-us/products/tds/silopren/Silopren%20LSR%204660.pdf
- Note: Momentive TDS: biocompatible USP Class VI and ISO 10993 (parts 5, 6, 10, 11); sterilizable with EtO, steam and gamma. Regulatory section: tests were run on "a representative sample of an analogous product" (USP Class VI, max. 29 days tissue contact) (checked 2026-10-20).

## VESTAMID Care ML16 (Evonik, PA12)
- Page: https://medresin.com/grades/evonik-vestamid-care-ml16
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: limited
- VHP: not stated
- FDA master file: not stated
- Source: https://products.evonik.com/assets/34/33/Evonik_Medical_Care_brochure_1124_EN_243433.pdf
- Gamma dose (as stated): up to 50 kGy (all Evonik Care grades)
- Autoclave/steam (as stated): 5-25 steam sterilization cycles

## VESTAMID Care ML17 (Evonik, PA12)
- Page: https://medresin.com/grades/evonik-vestamid-care-ml17
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: limited
- VHP: not stated
- FDA master file: not stated
- Source: https://products.evonik.com/assets/34/33/Evonik_Medical_Care_brochure_1124_EN_243433.pdf
- Gamma dose (as stated): up to 50 kGy (all Evonik Care grades)
- Autoclave/steam (as stated): 5-25 steam sterilization cycles

## VESTAMID Care ML18 (Evonik, PA12)
- Page: https://medresin.com/grades/evonik-vestamid-care-ml18
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: limited
- VHP: not stated
- FDA master file: not stated
- Source: https://products.evonik.com/assets/34/33/Evonik_Medical_Care_brochure_1124_EN_243433.pdf
- Gamma dose (as stated): up to 50 kGy (all Evonik Care grades)
- Autoclave/steam (as stated): 5-25 steam sterilization cycles

## VESTAMID Care ML19 (Evonik, PA12)
- Page: https://medresin.com/grades/evonik-vestamid-care-ml19
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: limited
- VHP: not stated
- FDA master file: not stated
- Source: https://products.evonik.com/assets/34/33/Evonik_Medical_Care_brochure_1124_EN_243433.pdf
- Gamma dose (as stated): up to 50 kGy (all Evonik Care grades)
- Autoclave/steam (as stated): 5-25 steam sterilization cycles

## VESTAMID Care ML21 (Evonik, PA12)
- Page: https://medresin.com/grades/evonik-vestamid-care-ml21
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: limited
- VHP: not stated
- FDA master file: not stated
- Source: https://products.evonik.com/assets/34/33/Evonik_Medical_Care_brochure_1124_EN_243433.pdf
- Gamma dose (as stated): up to 50 kGy (all Evonik Care grades)
- Autoclave/steam (as stated): 25-50 steam sterilization cycles

## PEEK-OPTIMA (family) (Invibio (Victrex), PEEK)
- Page: https://medresin.com/grades/invibio-victrex-peek-optima-family
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: MF (type not stated)
- Source: https://invibio.com/-/media/downloads/invibio/fact-sheets/peek-optima-polymers-fact-sheet_final-08-2020.pdf
- Note: Invibio fact sheet (current download on invibio.com, dated 8/2020): PEEK-OPTIMA polymers can be repeatedly sterilized using steam, EtO or gamma; biocompatibility is supported by comprehensive master files (type not stated). USP Class VI and ISO 10993 are not named in the fact sheet.

## SILPURAN 6000/10 A/B (Wacker, LSR)
- Page: https://medresin.com/grades/wacker-silpuran-6000-10-a-b
- USP VI: yes
- ISO 10993: yes
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://www.wacker.com/h/en-us/silicone-rubber/liquid-silicone-rubber-lsr/silpuran-600010-ab/p/000011067

## SILPURAN 6000/30 A/B (Wacker, LSR)
- Page: https://medresin.com/grades/wacker-silpuran-6000-30-a-b
- USP VI: yes
- ISO 10993: yes
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: MF (type not stated)
- Source: https://www.wacker.com/h/en-us/silicone-rubber/liquid-silicone-rubber-lsr/silpuran-600030-ab/p/000011069

## SILPURAN 6000/50 A/B (Wacker, LSR)
- Page: https://medresin.com/grades/wacker-silpuran-6000-50-a-b
- USP VI: yes
- ISO 10993: yes
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://www.wacker.com/h/en-us/silicone-rubber/liquid-silicone-rubber-lsr/silpuran-600050-ab/p/000011071

## SILPURAN 6000/60 A/B (Wacker, LSR)
- Page: https://medresin.com/grades/wacker-silpuran-6000-60-a-b
- USP VI: yes
- ISO 10993: yes
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: MF (type not stated)
- Source: https://www.wacker.com/h/en-us/silicone-rubber/liquid-silicone-rubber-lsr/silpuran-600060-ab/p/000011072

## Pellethane 2363 Series (Lubrizol, TPU (aromatic polyether))
- Page: https://medresin.com/grades/lubrizol-pellethane-2363-series
- USP VI: not stated
- ISO 10993: not stated
- Gamma: limited
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Gamma dose (as stated): 25 and 50 kGy: may cause discoloration (performance not affected)
- Note: FDA master file removed 2026-10-20: no current public Lubrizol document states an MAF for this series (Lubrizol 2025 Medical Device Solutions guide 25-0004408 mentions only generic master-file support).

## Pellethane 2363-75D (Lubrizol, TPU (aromatic polyether))
- Page: https://medresin.com/grades/lubrizol-pellethane-2363-75d
- USP VI: yes
- ISO 10993: not stated
- Gamma: limited
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Health/Documents/TDS/Pellethane-2363-75D.pdf
- Gamma dose (as stated): 25 and 50 kGy: may cause discoloration (performance not affected)
- Data sheet: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Health/Documents/TDS/Pellethane-2363-75D.pdf
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/medical-device-tpu-product-guide.pdf
- Note: Sterilization from Lubrizol family-level guidance: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf

## Tecoflex (aliphatic series) (Lubrizol, TPU (aliphatic polyether))
- Page: https://medresin.com/grades/lubrizol-tecoflex-aliphatic-series
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Gamma dose (as stated): 25 and 50 kGy recommended (single cycle tested)
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/medical-device-tpu-product-guide.pdf

## Carbothane (aliphatic series) (Lubrizol, TPU (aliphatic polycarbonate))
- Page: https://medresin.com/grades/lubrizol-carbothane-aliphatic-series
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Gamma dose (as stated): 25 and 50 kGy recommended (single cycle tested)
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/medical-device-tpu-product-guide.pdf

## ULTEM HU1004 (SABIC, PEI blend)
- Page: https://medresin.com/grades/sabic-ultem-hu1004
- USP VI: not stated
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: yes
- FDA master file: not stated
- Source: https://materialfinder.sabic-specialties.com/explore-applications/ultemhu1004
- Data sheet: https://materialfinder.sabic-specialties.com/material/ultem-resin-hu1004
- Note: SABIC Material Finder (re-checked): steam, gamma, EtO and e-beam sterilizable; biocompatible (ISO 10993 or USP Class VI).

## Veradel HC PESU (Syensqo (Solvay), PESU)
- Page: https://medresin.com/grades/syensqo-solvay-veradel-hc-pesu
- USP VI: not stated
- ISO 10993: not stated
- Gamma: limited
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://www.syensqo.com/en/solutions-market/healthcare/medical-devices-equipment/implantable-devices/usages

## Makrolon 2258 (Covestro, PC)
- Page: https://medresin.com/grades/covestro-makrolon-2258
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://solutions.covestro.com/-/media/covestro/solution-center/story/brochures/covestro_healthcare-reference-guide_2025_new.pdf
- Gamma dose (as stated): 28 kGy assumed per sterilization; 10-20 sterilizations before appreciable strength loss (Makrolon/Apec, per Covestro)
- Autoclave/steam (as stated): steam at 121 °C; Covestro says do not exceed 125 °C for Makrolon
- Note: USP Class VI per Covestro portfolio statement (ISO 10993 and USP Class VI for contact of 30 days or less).

## Makrolon Rx1452 (Covestro, PC)
- Page: https://medresin.com/grades/covestro-makrolon-rx1452
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://solutions.covestro.com/-/media/covestro/solution-center/story/brochures/covestro_healthcare-reference-guide_2025_new.pdf
- Gamma dose (as stated): 28 kGy assumed per sterilization; 10-20 sterilizations before appreciable strength loss (Makrolon/Apec, per Covestro)
- Autoclave/steam (as stated): steam at 121 °C; Covestro says do not exceed 125 °C for Makrolon
- Note: USP Class VI per Covestro portfolio statement (ISO 10993 and USP Class VI for contact of 30 days or less).

## Makrolon Rx1851 (Covestro, PC)
- Page: https://medresin.com/grades/covestro-makrolon-rx1851
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://solutions.covestro.com/-/media/covestro/solution-center/story/brochures/covestro_healthcare-reference-guide_2025_new.pdf
- Gamma dose (as stated): 28 kGy assumed per sterilization; 10-20 sterilizations before appreciable strength loss (Makrolon/Apec, per Covestro)
- Autoclave/steam (as stated): steam at 121 °C; Covestro says do not exceed 125 °C for Makrolon
- Note: USP Class VI per Covestro portfolio statement (ISO 10993 and USP Class VI for contact of 30 days or less).

## Makrolon 2658 (Covestro, PC)
- Page: https://medresin.com/grades/covestro-makrolon-2658
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://solutions.covestro.com/-/media/covestro/solution-center/story/brochures/covestro_healthcare-reference-guide_2025_new.pdf
- Gamma dose (as stated): 28 kGy assumed per sterilization; 10-20 sterilizations before appreciable strength loss (Makrolon/Apec, per Covestro)
- Autoclave/steam (as stated): steam at 121 °C; Covestro says do not exceed 125 °C for Makrolon
- Note: USP Class VI per Covestro portfolio statement (ISO 10993 and USP Class VI for contact of 30 days or less).

## Makrolon 2858 (Covestro, PC)
- Page: https://medresin.com/grades/covestro-makrolon-2858
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://solutions.covestro.com/-/media/covestro/solution-center/story/brochures/covestro_healthcare-reference-guide_2025_new.pdf
- Gamma dose (as stated): 28 kGy assumed per sterilization; 10-20 sterilizations before appreciable strength loss (Makrolon/Apec, per Covestro)
- Autoclave/steam (as stated): steam at 121 °C; Covestro says do not exceed 125 °C for Makrolon
- Note: USP Class VI per Covestro portfolio statement (ISO 10993 and USP Class VI for contact of 30 days or less).

## Makrolon 3158 (Covestro, PC)
- Page: https://medresin.com/grades/covestro-makrolon-3158
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://solutions.covestro.com/-/media/covestro/solution-center/story/brochures/covestro_healthcare-reference-guide_2025_new.pdf
- Gamma dose (as stated): 28 kGy assumed per sterilization; 10-20 sterilizations before appreciable strength loss (Makrolon/Apec, per Covestro)
- Autoclave/steam (as stated): steam at 121 °C; Covestro says do not exceed 125 °C for Makrolon
- Note: USP Class VI per Covestro portfolio statement (ISO 10993 and USP Class VI for contact of 30 days or less).

## Makrolon 3258 (Covestro, PC)
- Page: https://medresin.com/grades/covestro-makrolon-3258
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://solutions.covestro.com/-/media/covestro/solution-center/story/brochures/covestro_healthcare-reference-guide_2025_new.pdf
- Gamma dose (as stated): 28 kGy assumed per sterilization; 10-20 sterilizations before appreciable strength loss (Makrolon/Apec, per Covestro)
- Autoclave/steam (as stated): steam at 121 °C; Covestro says do not exceed 125 °C for Makrolon
- Note: USP Class VI per Covestro portfolio statement (ISO 10993 and USP Class VI for contact of 30 days or less).

## Makrolon 3638 (Covestro, PC)
- Page: https://medresin.com/grades/covestro-makrolon-3638
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://solutions.covestro.com/-/media/covestro/solution-center/story/brochures/covestro_healthcare-reference-guide_2025_new.pdf
- Gamma dose (as stated): 28 kGy assumed per sterilization; 10-20 sterilizations before appreciable strength loss (Makrolon/Apec, per Covestro)
- Autoclave/steam (as stated): steam at 121 °C; Covestro says do not exceed 125 °C for Makrolon
- Note: USP Class VI per Covestro portfolio statement (ISO 10993 and USP Class VI for contact of 30 days or less). Covestro grade text: suitable for EtO, radiation and steam sterilization at 121 °C.

## Makrolon Rx2430 (Covestro, PC)
- Page: https://medresin.com/grades/covestro-makrolon-rx2430
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://solutions.covestro.com/-/media/covestro/solution-center/story/brochures/covestro_healthcare-reference-guide_2025_new.pdf
- Gamma dose (as stated): 28 kGy assumed per sterilization; 10-20 sterilizations before appreciable strength loss (Makrolon/Apec, per Covestro)
- Autoclave/steam (as stated): steam at 121 °C; Covestro says do not exceed 125 °C for Makrolon
- Note: USP Class VI per Covestro portfolio statement (ISO 10993 and USP Class VI for contact of 30 days or less). Radiation-stabilized grade.

## Makrolon Rx2440 (Covestro, PC)
- Page: https://medresin.com/grades/covestro-makrolon-rx2440
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://solutions.covestro.com/-/media/covestro/solution-center/story/brochures/covestro_healthcare-reference-guide_2025_new.pdf
- Gamma dose (as stated): 28 kGy assumed per sterilization; 10-20 sterilizations before appreciable strength loss (Makrolon/Apec, per Covestro)
- Autoclave/steam (as stated): steam at 121 °C; Covestro says do not exceed 125 °C for Makrolon
- Note: USP Class VI per Covestro portfolio statement (ISO 10993 and USP Class VI for contact of 30 days or less). Radiation-stabilized grade.

## Makrolon Rx2635 (Covestro, PC)
- Page: https://medresin.com/grades/covestro-makrolon-rx2635
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://solutions.covestro.com/-/media/covestro/solution-center/story/brochures/covestro_healthcare-reference-guide_2025_new.pdf
- Gamma dose (as stated): 28 kGy assumed per sterilization; 10-20 sterilizations before appreciable strength loss (Makrolon/Apec, per Covestro)
- Autoclave/steam (as stated): steam at 121 °C; Covestro says do not exceed 125 °C for Makrolon
- Note: USP Class VI per Covestro portfolio statement (ISO 10993 and USP Class VI for contact of 30 days or less). Radiation-stabilized grade.

## Makrolon M420 GF (Covestro, PC/GF)
- Page: https://medresin.com/grades/covestro-makrolon-m420-gf
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://solutions.covestro.com/-/media/covestro/solution-center/story/brochures/covestro_healthcare-reference-guide_2025_new.pdf
- Gamma dose (as stated): 28 kGy assumed per sterilization; 10-20 sterilizations before appreciable strength loss (Makrolon/Apec, per Covestro)
- Autoclave/steam (as stated): steam at 121 °C
- Note: USP Class VI per Covestro portfolio statement (ISO 10993 and USP Class VI for contact of 30 days or less).

## Makrolon M430 GF (Covestro, PC/GF)
- Page: https://medresin.com/grades/covestro-makrolon-m430-gf
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://solutions.covestro.com/-/media/covestro/solution-center/story/brochures/covestro_healthcare-reference-guide_2025_new.pdf
- Gamma dose (as stated): 28 kGy assumed per sterilization; 10-20 sterilizations before appreciable strength loss (Makrolon/Apec, per Covestro)
- Autoclave/steam (as stated): steam at 121 °C
- Note: USP Class VI per Covestro portfolio statement (ISO 10993 and USP Class VI for contact of 30 days or less).

## Makrolon M810 GF (Covestro, PC/GF)
- Page: https://medresin.com/grades/covestro-makrolon-m810-gf
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://solutions.covestro.com/-/media/covestro/solution-center/story/brochures/covestro_healthcare-reference-guide_2025_new.pdf
- Gamma dose (as stated): 28 kGy assumed per sterilization; 10-20 sterilizations before appreciable strength loss (Makrolon/Apec, per Covestro)
- Autoclave/steam (as stated): steam at 121 °C
- Note: USP Class VI per Covestro portfolio statement (ISO 10993 and USP Class VI for contact of 30 days or less).

## Makrolon M820 GF (Covestro, PC/GF)
- Page: https://medresin.com/grades/covestro-makrolon-m820-gf
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://solutions.covestro.com/-/media/covestro/solution-center/story/brochures/covestro_healthcare-reference-guide_2025_new.pdf
- Gamma dose (as stated): 28 kGy assumed per sterilization; 10-20 sterilizations before appreciable strength loss (Makrolon/Apec, per Covestro)
- Autoclave/steam (as stated): steam at 121 °C
- Note: USP Class VI per Covestro portfolio statement (ISO 10993 and USP Class VI for contact of 30 days or less).

## Makrolon M830 GF (Covestro, PC/GF)
- Page: https://medresin.com/grades/covestro-makrolon-m830-gf
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://solutions.covestro.com/-/media/covestro/solution-center/story/brochures/covestro_healthcare-reference-guide_2025_new.pdf
- Gamma dose (as stated): 28 kGy assumed per sterilization; 10-20 sterilizations before appreciable strength loss (Makrolon/Apec, per Covestro)
- Autoclave/steam (as stated): steam at 121 °C
- Note: USP Class VI per Covestro portfolio statement (ISO 10993 and USP Class VI for contact of 30 days or less).

## Makrolon M204 LF (Covestro, PC (low friction))
- Page: https://medresin.com/grades/covestro-makrolon-m204-lf
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: limited
- VHP: not stated
- FDA master file: not stated
- Source: https://solutions.covestro.com/-/media/covestro/solution-center/story/brochures/covestro_healthcare-reference-guide_2025_new.pdf
- Gamma dose (as stated): 28 kGy assumed per sterilization; 10-20 sterilizations before appreciable strength loss (Makrolon/Apec, per Covestro)
- Autoclave/steam (as stated): single sterilization cycle only (steam 121 °C)
- Note: USP Class VI per Covestro portfolio statement (ISO 10993 and USP Class VI for contact of 30 days or less).

## Makrolon M402 LF (Covestro, PC (low friction))
- Page: https://medresin.com/grades/covestro-makrolon-m402-lf
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: limited
- VHP: not stated
- FDA master file: not stated
- Source: https://solutions.covestro.com/-/media/covestro/solution-center/story/brochures/covestro_healthcare-reference-guide_2025_new.pdf
- Gamma dose (as stated): 28 kGy assumed per sterilization; 10-20 sterilizations before appreciable strength loss (Makrolon/Apec, per Covestro)
- Autoclave/steam (as stated): single sterilization cycle only (steam 121 °C)
- Note: USP Class VI per Covestro portfolio statement (ISO 10993 and USP Class VI for contact of 30 days or less).

## Makrolon M404 LF (Covestro, PC (low friction))
- Page: https://medresin.com/grades/covestro-makrolon-m404-lf
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: limited
- VHP: not stated
- FDA master file: not stated
- Source: https://solutions.covestro.com/-/media/covestro/solution-center/story/brochures/covestro_healthcare-reference-guide_2025_new.pdf
- Gamma dose (as stated): 28 kGy assumed per sterilization; 10-20 sterilizations before appreciable strength loss (Makrolon/Apec, per Covestro)
- Autoclave/steam (as stated): single sterilization cycle only (steam 121 °C)
- Note: USP Class VI per Covestro portfolio statement (ISO 10993 and USP Class VI for contact of 30 days or less).

## Bayblend M850 XF (Covestro, PC/ABS)
- Page: https://medresin.com/grades/covestro-bayblend-m850-xf
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: no
- VHP: not stated
- FDA master file: not stated
- Source: https://solutions.covestro.com/-/media/covestro/solution-center/story/brochures/covestro_healthcare-reference-guide_2025_new.pdf
- Note: USP Class VI per Covestro portfolio statement (ISO 10993 and USP Class VI for contact of 30 days or less).

## Makroblend M525 (Covestro, PC/PBT)
- Page: https://medresin.com/grades/covestro-makroblend-m525
- USP VI: not stated
- ISO 10993: limited
- Gamma: yes
- EtO: yes
- Autoclave: no
- VHP: not stated
- FDA master file: not stated
- Source: https://solutions.covestro.com/-/media/covestro/solution-center/story/brochures/covestro_healthcare-reference-guide_2025_new.pdf
- Note: Biocompatibility limited to contact with uncompromised skin (ISO 10993).

## Makrolon M6011 FR (Covestro, PC (flame retardant))
- Page: https://medresin.com/grades/covestro-makrolon-m6011-fr
- USP VI: not stated
- ISO 10993: limited
- Gamma: not stated
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://solutions.covestro.com/-/media/covestro/solution-center/story/brochures/covestro_healthcare-reference-guide_2025_new.pdf
- Autoclave/steam (as stated): steam at 121 °C
- Note: Flame retardant (UL94 V-0 at 1.5 mm). Biocompatibility limited to contact with uncompromised skin.

## Bayblend M301 FR (Covestro, PC/ABS (flame retardant))
- Page: https://medresin.com/grades/covestro-bayblend-m301-fr
- USP VI: not stated
- ISO 10993: limited
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://solutions.covestro.com/-/media/covestro/solution-center/story/brochures/covestro_healthcare-reference-guide_2025_new.pdf
- Note: Flame retardant. Biocompatibility limited to contact with uncompromised skin (ISO 10993). Sterilization not stated for this grade.

## Bayblend M303 FR (Covestro, PC/ABS (flame retardant))
- Page: https://medresin.com/grades/covestro-bayblend-m303-fr
- USP VI: not stated
- ISO 10993: limited
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://solutions.covestro.com/-/media/covestro/solution-center/story/brochures/covestro_healthcare-reference-guide_2025_new.pdf
- Note: Flame retardant. Biocompatibility limited to contact with uncompromised skin (ISO 10993). Sterilization not stated for this grade.

## Makroblend M4000 FR (Covestro, PC/PBT (flame retardant))
- Page: https://medresin.com/grades/covestro-makroblend-m4000-fr
- USP VI: not stated
- ISO 10993: limited
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://solutions.covestro.com/-/media/covestro/solution-center/story/brochures/covestro_healthcare-reference-guide_2025_new.pdf
- Note: Flame retardant. Biocompatibility limited to contact with uncompromised skin (ISO 10993). Sterilization not stated for this grade.

## Makroblend M5005 FR (Covestro, PC/PBT (flame retardant))
- Page: https://medresin.com/grades/covestro-makroblend-m5005-fr
- USP VI: not stated
- ISO 10993: limited
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://solutions.covestro.com/-/media/covestro/solution-center/story/brochures/covestro_healthcare-reference-guide_2025_new.pdf
- Note: Flame retardant. Biocompatibility limited to contact with uncompromised skin (ISO 10993). Sterilization not stated for this grade.

## Purell PD702 (LyondellBasell, PP)
- Page: https://medresin.com/grades/lyondellbasell-purell-pd702
- USP VI: yes
- ISO 10993: not stated
- Gamma: not stated
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: DMF
- Source: https://cdn.brandfolder.io/EZH48IU3/at/pv38vhjwthkb78rv8xm8tg2r/SM531_2026_May_OP_Purell_NA_Brochure.pdf

## Purell HP6523 (LyondellBasell, PP)
- Page: https://medresin.com/grades/lyondellbasell-purell-hp6523
- USP VI: not stated
- ISO 10993: not stated
- Gamma: not stated
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: DMF
- Source: https://cdn.brandfolder.io/EZH48IU3/at/pv38vhjwthkb78rv8xm8tg2r/SM531_2026_May_OP_Purell_NA_Brochure.pdf
- Note: USP status listed as pending by LYB.

## Purell EP494T (LyondellBasell, PP (impact copolymer))
- Page: https://medresin.com/grades/lyondellbasell-purell-ep494t
- USP VI: not stated
- ISO 10993: not stated
- Gamma: not stated
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: DMF
- Source: https://cdn.brandfolder.io/EZH48IU3/at/pv38vhjwthkb78rv8xm8tg2r/SM531_2026_May_OP_Purell_NA_Brochure.pdf
- Note: USP status listed as pending by LYB.

## Purell SR549M (LyondellBasell, PP (random copolymer))
- Page: https://medresin.com/grades/lyondellbasell-purell-sr549m
- USP VI: yes
- ISO 10993: not stated
- Gamma: not stated
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: DMF
- Source: https://cdn.brandfolder.io/EZH48IU3/at/pv38vhjwthkb78rv8xm8tg2r/SM531_2026_May_OP_Purell_NA_Brochure.pdf

## Purell PE53003 (LyondellBasell, HDPE)
- Page: https://medresin.com/grades/lyondellbasell-purell-pe53003
- USP VI: yes
- ISO 10993: not stated
- Gamma: not stated
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: DMF
- Source: https://cdn.brandfolder.io/EZH48IU3/at/pv38vhjwthkb78rv8xm8tg2r/SM531_2026_May_OP_Purell_NA_Brochure.pdf

## Purell PE53003Z (LyondellBasell, HDPE)
- Page: https://medresin.com/grades/lyondellbasell-purell-pe53003z
- USP VI: yes
- ISO 10993: not stated
- Gamma: not stated
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: DMF
- Source: https://cdn.brandfolder.io/EZH48IU3/at/pv38vhjwthkb78rv8xm8tg2r/SM531_2026_May_OP_Purell_NA_Brochure.pdf

## Tecothane TT-1074A (Lubrizol, TPU (aromatic polyether))
- Page: https://medresin.com/grades/lubrizol-tecothane-tt-1074a
- USP VI: not stated
- ISO 10993: not stated
- Gamma: limited
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy: may cause discoloration (performance not affected)
- Data sheet: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Health/Documents/TDS/Tecothane-TPU-Clear.pdf
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); gamma/e-beam may cause discoloration but performance is not affected; autoclave not recommended.

## Tecothane TT-1085A (Lubrizol, TPU (aromatic polyether))
- Page: https://medresin.com/grades/lubrizol-tecothane-tt-1085a
- USP VI: not stated
- ISO 10993: not stated
- Gamma: limited
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy: may cause discoloration (performance not affected)
- Data sheet: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Health/Documents/TDS/Tecothane-TPU-Clear.pdf
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); gamma/e-beam may cause discoloration but performance is not affected; autoclave not recommended.

## Tecothane TT-1095A (Lubrizol, TPU (aromatic polyether))
- Page: https://medresin.com/grades/lubrizol-tecothane-tt-1095a
- USP VI: not stated
- ISO 10993: not stated
- Gamma: limited
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy: may cause discoloration (performance not affected)
- Data sheet: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Health/Documents/TDS/Tecothane-TPU-Clear.pdf
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); gamma/e-beam may cause discoloration but performance is not affected; autoclave not recommended.

## Tecothane TT-1055D (Lubrizol, TPU (aromatic polyether))
- Page: https://medresin.com/grades/lubrizol-tecothane-tt-1055d
- USP VI: not stated
- ISO 10993: not stated
- Gamma: limited
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy: may cause discoloration (performance not affected)
- Data sheet: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Health/Documents/TDS/Tecothane-TPU-Clear.pdf
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); gamma/e-beam may cause discoloration but performance is not affected; autoclave not recommended.

## Tecothane TT-1065D (Lubrizol, TPU (aromatic polyether))
- Page: https://medresin.com/grades/lubrizol-tecothane-tt-1065d
- USP VI: not stated
- ISO 10993: not stated
- Gamma: limited
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy: may cause discoloration (performance not affected)
- Data sheet: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Health/Documents/TDS/Tecothane-TPU-Clear.pdf
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); gamma/e-beam may cause discoloration but performance is not affected; autoclave not recommended.

## Tecothane TT-1069D (Lubrizol, TPU (aromatic polyether))
- Page: https://medresin.com/grades/lubrizol-tecothane-tt-1069d
- USP VI: not stated
- ISO 10993: not stated
- Gamma: limited
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy: may cause discoloration (performance not affected)
- Data sheet: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Health/Documents/TDS/Tecothane-TPU-Clear.pdf
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); gamma/e-beam may cause discoloration but performance is not affected; autoclave not recommended.

## Tecothane TT-1072D (Lubrizol, TPU (aromatic polyether))
- Page: https://medresin.com/grades/lubrizol-tecothane-tt-1072d
- USP VI: not stated
- ISO 10993: not stated
- Gamma: limited
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy: may cause discoloration (performance not affected)
- Data sheet: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Health/Documents/TDS/Tecothane-TPU-Clear.pdf
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); gamma/e-beam may cause discoloration but performance is not affected; autoclave not recommended.

## Tecothane TT-1075D-M (Lubrizol, TPU (aromatic polyether))
- Page: https://medresin.com/grades/lubrizol-tecothane-tt-1075d-m
- USP VI: not stated
- ISO 10993: not stated
- Gamma: limited
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy: may cause discoloration (performance not affected)
- Data sheet: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Health/Documents/TDS/Tecothane-TPU-Clear.pdf
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); gamma/e-beam may cause discoloration but performance is not affected; autoclave not recommended.

## Pellethane 2363-80A (Lubrizol, TPU (aromatic polyether))
- Page: https://medresin.com/grades/lubrizol-pellethane-2363-80a
- USP VI: yes
- ISO 10993: not stated
- Gamma: limited
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy: may cause discoloration (performance not affected)
- Data sheet: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Health/Documents/TDS/Pellethane-2363-80A.pdf
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); gamma/e-beam may cause discoloration but performance is not affected; autoclave not recommended. Lubrizol TDS: USP Class VI biocompatibility testing (USP XXII guidelines).

## Pellethane 2363-80AE (Lubrizol, TPU (aromatic polyether))
- Page: https://medresin.com/grades/lubrizol-pellethane-2363-80ae
- USP VI: yes
- ISO 10993: not stated
- Gamma: limited
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy: may cause discoloration (performance not affected)
- Data sheet: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Health/Documents/TDS/Pellethane-2363-80AE.pdf
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); gamma/e-beam may cause discoloration but performance is not affected; autoclave not recommended. Lubrizol TDS: USP Class VI biocompatibility testing (USP XXII guidelines).

## Pellethane 5863-85A-R1 (Lubrizol, TPU (aromatic polyether))
- Page: https://medresin.com/grades/lubrizol-pellethane-5863-85a-r1
- USP VI: not stated
- ISO 10993: not stated
- Gamma: limited
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy: may cause discoloration (performance not affected)
- Data sheet: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Health/Documents/TDS/Pellethane-5863-85A-R1.pdf
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); gamma/e-beam may cause discoloration but performance is not affected; autoclave not recommended.

## Pellethane 5863-87A-R1 (Lubrizol, TPU (aromatic polyether))
- Page: https://medresin.com/grades/lubrizol-pellethane-5863-87a-r1
- USP VI: not stated
- ISO 10993: not stated
- Gamma: limited
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy: may cause discoloration (performance not affected)
- Data sheet: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Health/Documents/TDS/Pellethane-5863-87A-R1.pdf
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); gamma/e-beam may cause discoloration but performance is not affected; autoclave not recommended.

## Pellethane 2363-90A (Lubrizol, TPU (aromatic polyether))
- Page: https://medresin.com/grades/lubrizol-pellethane-2363-90a
- USP VI: yes
- ISO 10993: not stated
- Gamma: limited
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy: may cause discoloration (performance not affected)
- Data sheet: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Health/Documents/TDS/Pellethane-2363-90A.pdf
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); gamma/e-beam may cause discoloration but performance is not affected; autoclave not recommended. Lubrizol TDS: USP Class VI biocompatibility testing (USP XXII guidelines).

## Pellethane 2363-90AE (Lubrizol, TPU (aromatic polyether))
- Page: https://medresin.com/grades/lubrizol-pellethane-2363-90ae
- USP VI: yes
- ISO 10993: not stated
- Gamma: limited
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy: may cause discoloration (performance not affected)
- Data sheet: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Health/Documents/TDS/Pellethane-2363-90AE.pdf
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); gamma/e-beam may cause discoloration but performance is not affected; autoclave not recommended. Lubrizol TDS: USP Class VI biocompatibility testing (USP XXII guidelines).

## Pellethane 2363-55D (Lubrizol, TPU (aromatic polyether))
- Page: https://medresin.com/grades/lubrizol-pellethane-2363-55d
- USP VI: yes
- ISO 10993: not stated
- Gamma: limited
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy: may cause discoloration (performance not affected)
- Data sheet: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Health/Documents/TDS/Pellethane-2363-55D.pdf
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); gamma/e-beam may cause discoloration but performance is not affected; autoclave not recommended. Lubrizol TDS: USP Class VI biocompatibility testing (USP XXII guidelines).

## Pellethane 2363-55DE (Lubrizol, TPU (aromatic polyether))
- Page: https://medresin.com/grades/lubrizol-pellethane-2363-55de
- USP VI: yes
- ISO 10993: not stated
- Gamma: limited
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy: may cause discoloration (performance not affected)
- Data sheet: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Health/Documents/TDS/Pellethane-2363-55DE.pdf
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); gamma/e-beam may cause discoloration but performance is not affected; autoclave not recommended. Lubrizol TDS: USP Class VI biocompatibility testing (USP XXII guidelines).

## Pellethane 2363-65D (Lubrizol, TPU (aromatic polyether))
- Page: https://medresin.com/grades/lubrizol-pellethane-2363-65d
- USP VI: yes
- ISO 10993: not stated
- Gamma: limited
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy: may cause discoloration (performance not affected)
- Data sheet: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Health/Documents/TDS/Pellethane-2363-65D.pdf
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); gamma/e-beam may cause discoloration but performance is not affected; autoclave not recommended. Lubrizol TDS: USP Class VI biocompatibility testing (USP XXII guidelines).

## Pellethane 5855-92A (Lubrizol, TPU (aromatic polyester))
- Page: https://medresin.com/grades/lubrizol-pellethane-5855-92a
- USP VI: not stated
- ISO 10993: not stated
- Gamma: limited
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy: may cause discoloration (performance not affected)
- Data sheet: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Health/Documents/TDS/Pellethane-5855-92A.pdf
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); gamma/e-beam may cause discoloration but performance is not affected; autoclave not recommended.

## Pellethane 5855-70D-WF (Lubrizol, TPU (aromatic polyester))
- Page: https://medresin.com/grades/lubrizol-pellethane-5855-70d-wf
- USP VI: not stated
- ISO 10993: not stated
- Gamma: limited
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy: may cause discoloration (performance not affected)
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); gamma/e-beam may cause discoloration but performance is not affected; autoclave not recommended.

## Isoplast 2510 (Lubrizol, Rigid TPU (aromatic))
- Page: https://medresin.com/grades/lubrizol-isoplast-2510
- USP VI: not stated
- ISO 10993: not stated
- Gamma: limited
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy: may cause discoloration (performance not affected)
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); gamma/e-beam may cause discoloration but performance is not affected; autoclave not recommended.

## Isoplast 2530 R1 (Lubrizol, Rigid TPU (aromatic))
- Page: https://medresin.com/grades/lubrizol-isoplast-2530-r1
- USP VI: not stated
- ISO 10993: not stated
- Gamma: limited
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy: may cause discoloration (performance not affected)
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); gamma/e-beam may cause discoloration but performance is not affected; autoclave not recommended.

## Isoplast 2531 (Lubrizol, Rigid TPU (aromatic))
- Page: https://medresin.com/grades/lubrizol-isoplast-2531
- USP VI: not stated
- ISO 10993: not stated
- Gamma: limited
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy: may cause discoloration (performance not affected)
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); gamma/e-beam may cause discoloration but performance is not affected; autoclave not recommended.

## Isoplast 2540 (Lubrizol, Rigid TPU (aromatic))
- Page: https://medresin.com/grades/lubrizol-isoplast-2540
- USP VI: not stated
- ISO 10993: not stated
- Gamma: limited
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy: may cause discoloration (performance not affected)
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); gamma/e-beam may cause discoloration but performance is not affected; autoclave not recommended.

## Tecoplast TP-470 Clear (Lubrizol, Rigid TPU (aromatic))
- Page: https://medresin.com/grades/lubrizol-tecoplast-tp-470-clear
- USP VI: not stated
- ISO 10993: not stated
- Gamma: limited
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy: may cause discoloration (performance not affected)
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); gamma/e-beam may cause discoloration but performance is not affected; autoclave not recommended.

## Tecoplast OP-770 Opaque (Lubrizol, Rigid TPU (aromatic))
- Page: https://medresin.com/grades/lubrizol-tecoplast-op-770-opaque
- USP VI: not stated
- ISO 10993: not stated
- Gamma: limited
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy: may cause discoloration (performance not affected)
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); gamma/e-beam may cause discoloration but performance is not affected; autoclave not recommended.

## Carbothane PC-3575A (Lubrizol, TPU (aliphatic polycarbonate))
- Page: https://medresin.com/grades/lubrizol-carbothane-pc-3575a
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy recommended (single cycle tested)
- Data sheet: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Health/Documents/TDS/Carbothane-TPU-Clear-Aliphatic.pdf
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); dry heat and autoclave not recommended.

## Carbothane PC-3585A (Lubrizol, TPU (aliphatic polycarbonate))
- Page: https://medresin.com/grades/lubrizol-carbothane-pc-3585a
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy recommended (single cycle tested)
- Data sheet: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Health/Documents/TDS/Carbothane-TPU-Clear-Aliphatic.pdf
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); dry heat and autoclave not recommended.

## Carbothane PC-3595A (Lubrizol, TPU (aliphatic polycarbonate))
- Page: https://medresin.com/grades/lubrizol-carbothane-pc-3595a
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy recommended (single cycle tested)
- Data sheet: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Health/Documents/TDS/Carbothane-TPU-Clear-Aliphatic.pdf
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); dry heat and autoclave not recommended.

## Carbothane PC-3555D (Lubrizol, TPU (aliphatic polycarbonate))
- Page: https://medresin.com/grades/lubrizol-carbothane-pc-3555d
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy recommended (single cycle tested)
- Data sheet: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Health/Documents/TDS/Carbothane-TPU-Clear-Aliphatic.pdf
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); dry heat and autoclave not recommended.

## Carbothane PC-3572D (Lubrizol, TPU (aliphatic polycarbonate))
- Page: https://medresin.com/grades/lubrizol-carbothane-pc-3572d
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy recommended (single cycle tested)
- Data sheet: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Health/Documents/TDS/Carbothane-TPU-Clear-Aliphatic.pdf
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); dry heat and autoclave not recommended.

## Carbothane AC-4075A (Lubrizol, TPU (aromatic polycarbonate))
- Page: https://medresin.com/grades/lubrizol-carbothane-ac-4075a
- USP VI: not stated
- ISO 10993: not stated
- Gamma: limited
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy: may cause discoloration (performance not affected)
- Data sheet: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Health/Documents/TDS/Carbothane-TPU-Clear-Aromatic.pdf
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); gamma/e-beam may cause discoloration but performance is not affected; autoclave not recommended.

## Carbothane AC-4085A (Lubrizol, TPU (aromatic polycarbonate))
- Page: https://medresin.com/grades/lubrizol-carbothane-ac-4085a
- USP VI: not stated
- ISO 10993: not stated
- Gamma: limited
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy: may cause discoloration (performance not affected)
- Data sheet: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Health/Documents/TDS/Carbothane-TPU-Clear-Aromatic.pdf
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); gamma/e-beam may cause discoloration but performance is not affected; autoclave not recommended.

## Carbothane AC-4095A (Lubrizol, TPU (aromatic polycarbonate))
- Page: https://medresin.com/grades/lubrizol-carbothane-ac-4095a
- USP VI: not stated
- ISO 10993: not stated
- Gamma: limited
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy: may cause discoloration (performance not affected)
- Data sheet: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Health/Documents/TDS/Carbothane-TPU-Clear-Aromatic.pdf
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); gamma/e-beam may cause discoloration but performance is not affected; autoclave not recommended.

## Carbothane AC-4055D (Lubrizol, TPU (aromatic polycarbonate))
- Page: https://medresin.com/grades/lubrizol-carbothane-ac-4055d
- USP VI: not stated
- ISO 10993: not stated
- Gamma: limited
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy: may cause discoloration (performance not affected)
- Data sheet: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Health/Documents/TDS/Carbothane-TPU-Clear-Aromatic.pdf
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); gamma/e-beam may cause discoloration but performance is not affected; autoclave not recommended.

## Carbothane AC-4065D (Lubrizol, TPU (aromatic polycarbonate))
- Page: https://medresin.com/grades/lubrizol-carbothane-ac-4065d
- USP VI: not stated
- ISO 10993: not stated
- Gamma: limited
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy: may cause discoloration (performance not affected)
- Data sheet: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Health/Documents/TDS/Carbothane-TPU-Clear-Aromatic.pdf
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); gamma/e-beam may cause discoloration but performance is not affected; autoclave not recommended.

## Carbothane AC-4075D (Lubrizol, TPU (aromatic polycarbonate))
- Page: https://medresin.com/grades/lubrizol-carbothane-ac-4075d
- USP VI: not stated
- ISO 10993: not stated
- Gamma: limited
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy: may cause discoloration (performance not affected)
- Data sheet: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Health/Documents/TDS/Carbothane-TPU-Clear-Aromatic.pdf
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); gamma/e-beam may cause discoloration but performance is not affected; autoclave not recommended.

## Tecoflex EG-80A (Lubrizol, TPU (aliphatic polyether))
- Page: https://medresin.com/grades/lubrizol-tecoflex-eg-80a
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy recommended (single cycle tested)
- Data sheet: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Health/Documents/TDS/Tecoflex-TPU-Clear.pdf
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); dry heat and autoclave not recommended.

## Tecoflex EG-85A (Lubrizol, TPU (aliphatic polyether))
- Page: https://medresin.com/grades/lubrizol-tecoflex-eg-85a
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy recommended (single cycle tested)
- Data sheet: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Health/Documents/TDS/Tecoflex-TPU-Clear.pdf
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); dry heat and autoclave not recommended.

## Tecoflex EG-93A (Lubrizol, TPU (aliphatic polyether))
- Page: https://medresin.com/grades/lubrizol-tecoflex-eg-93a
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy recommended (single cycle tested)
- Data sheet: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Health/Documents/TDS/Tecoflex-TPU-Clear.pdf
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); dry heat and autoclave not recommended.

## Tecoflex EG-100A (Lubrizol, TPU (aliphatic polyether))
- Page: https://medresin.com/grades/lubrizol-tecoflex-eg-100a
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy recommended (single cycle tested)
- Data sheet: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Health/Documents/TDS/Tecoflex-TPU-Clear.pdf
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); dry heat and autoclave not recommended.

## Tecoflex EG-60D (Lubrizol, TPU (aliphatic polyether))
- Page: https://medresin.com/grades/lubrizol-tecoflex-eg-60d
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy recommended (single cycle tested)
- Data sheet: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Health/Documents/TDS/Tecoflex-TPU-Clear.pdf
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); dry heat and autoclave not recommended.

## Tecoflex EG-65D (Lubrizol, TPU (aliphatic polyether))
- Page: https://medresin.com/grades/lubrizol-tecoflex-eg-65d
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy recommended (single cycle tested)
- Data sheet: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Health/Documents/TDS/Tecoflex-TPU-Clear.pdf
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); dry heat and autoclave not recommended.

## Tecoflex EG-68D (Lubrizol, TPU (aliphatic polyether))
- Page: https://medresin.com/grades/lubrizol-tecoflex-eg-68d
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy recommended (single cycle tested)
- Data sheet: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Health/Documents/TDS/Tecoflex-TPU-Clear.pdf
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); dry heat and autoclave not recommended.

## Tecoflex EG-72D (Lubrizol, TPU (aliphatic polyether))
- Page: https://medresin.com/grades/lubrizol-tecoflex-eg-72d
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy recommended (single cycle tested)
- Data sheet: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Health/Documents/TDS/Tecoflex-TPU-Clear.pdf
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); dry heat and autoclave not recommended.

## Tecoflex MG-8020 (Lubrizol, TPU (aliphatic polyether))
- Page: https://medresin.com/grades/lubrizol-tecoflex-mg-8020
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy recommended (single cycle tested)
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); dry heat and autoclave not recommended.

## Tecoflex MG-8812 (Lubrizol, TPU (aliphatic polyether))
- Page: https://medresin.com/grades/lubrizol-tecoflex-mg-8812
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy recommended (single cycle tested)
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); dry heat and autoclave not recommended.

## Tecoflex SG-80A (Lubrizol, TPU (aliphatic polyether))
- Page: https://medresin.com/grades/lubrizol-tecoflex-sg-80a
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy recommended (single cycle tested)
- Data sheet: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Health/Documents/TDS/Tecoflex-Solution-Grade.pdf
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); dry heat and autoclave not recommended.

## Tecoflex SG-85A (Lubrizol, TPU (aliphatic polyether))
- Page: https://medresin.com/grades/lubrizol-tecoflex-sg-85a
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy recommended (single cycle tested)
- Data sheet: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Health/Documents/TDS/Tecoflex-Solution-Grade.pdf
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); dry heat and autoclave not recommended.

## Tecoflex SG-60D (Lubrizol, TPU (aliphatic polyether))
- Page: https://medresin.com/grades/lubrizol-tecoflex-sg-60d
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy recommended (single cycle tested)
- Data sheet: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Health/Documents/TDS/Tecoflex-Solution-Grade.pdf
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); dry heat and autoclave not recommended.

## Tecophilic HP-93A-100 (Lubrizol, TPU (hydrophilic aliphatic))
- Page: https://medresin.com/grades/lubrizol-tecophilic-hp-93a-100
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy recommended (single cycle tested)
- Data sheet: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Health/Documents/TDS/Tecophilic-TPU-Extrusion-Grade.pdf
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); dry heat and autoclave not recommended.

## Tecophilic HP-60D-20 (Lubrizol, TPU (hydrophilic aliphatic))
- Page: https://medresin.com/grades/lubrizol-tecophilic-hp-60d-20
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy recommended (single cycle tested)
- Data sheet: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Health/Documents/TDS/Tecophilic-TPU-Extrusion-Grade.pdf
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); dry heat and autoclave not recommended.

## Tecophilic HP-60D-35 (Lubrizol, TPU (hydrophilic aliphatic))
- Page: https://medresin.com/grades/lubrizol-tecophilic-hp-60d-35
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy recommended (single cycle tested)
- Data sheet: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Health/Documents/TDS/Tecophilic-TPU-Extrusion-Grade.pdf
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); dry heat and autoclave not recommended.

## Tecophilic HP-60D-60 (Lubrizol, TPU (hydrophilic aliphatic))
- Page: https://medresin.com/grades/lubrizol-tecophilic-hp-60d-60
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy recommended (single cycle tested)
- Data sheet: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Health/Documents/TDS/Tecophilic-TPU-Extrusion-Grade.pdf
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); dry heat and autoclave not recommended.

## Tecophilic SP-80A-150 (Lubrizol, TPU (hydrophilic aliphatic))
- Page: https://medresin.com/grades/lubrizol-tecophilic-sp-80a-150
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy recommended (single cycle tested)
- Data sheet: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Health/Documents/TDS/Tecophilic-Solution-Grade.pdf
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); dry heat and autoclave not recommended.

## Tecophilic SP-93A-100 (Lubrizol, TPU (hydrophilic aliphatic))
- Page: https://medresin.com/grades/lubrizol-tecophilic-sp-93a-100
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy recommended (single cycle tested)
- Data sheet: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Health/Documents/TDS/Tecophilic-Solution-Grade.pdf
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); dry heat and autoclave not recommended.

## Tecophilic SP-60D-60 (Lubrizol, TPU (hydrophilic aliphatic))
- Page: https://medresin.com/grades/lubrizol-tecophilic-sp-60d-60
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy recommended (single cycle tested)
- Data sheet: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Health/Documents/TDS/Tecophilic-Solution-Grade.pdf
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); dry heat and autoclave not recommended.

## Tecothane Soft AR-75A (Lubrizol, TPU (aromatic polyester))
- Page: https://medresin.com/grades/lubrizol-tecothane-soft-ar-75a
- USP VI: not stated
- ISO 10993: not stated
- Gamma: limited
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy: may cause discoloration (performance not affected)
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); gamma/e-beam may cause discoloration but performance is not affected; autoclave not recommended. Sterilization guidance is for Tecothane overall; Tecothane Soft is not listed separately.

## Tecothane Soft AR-85A (Lubrizol, TPU (aromatic polyester))
- Page: https://medresin.com/grades/lubrizol-tecothane-soft-ar-85a
- USP VI: not stated
- ISO 10993: not stated
- Gamma: limited
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy: may cause discoloration (performance not affected)
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); gamma/e-beam may cause discoloration but performance is not affected; autoclave not recommended. Sterilization guidance is for Tecothane overall; Tecothane Soft is not listed separately.

## Tecothane Soft AR-95A (Lubrizol, TPU (aromatic polyester))
- Page: https://medresin.com/grades/lubrizol-tecothane-soft-ar-95a
- USP VI: not stated
- ISO 10993: not stated
- Gamma: limited
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Solutions/Technologies/PDF/25-0004408-MedicalDeviceSolutions-US-LTR-ENGLISH.pdf
- Gamma dose (as stated): 25 and 50 kGy: may cause discoloration (performance not affected)
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); gamma/e-beam may cause discoloration but performance is not affected; autoclave not recommended. Sterilization guidance is for Tecothane overall; Tecothane Soft is not listed separately.

## Hostaform MT 8U01 (Celanese, POM)
- Page: https://medresin.com/grades/celanese-hostaform-mt-8u01
- USP VI: yes
- ISO 10993: yes
- Gamma: no
- EtO: yes
- Autoclave: limited
- VHP: not stated
- FDA master file: DMF, MAF
- Source: https://edm.industrysourcing.com/edm/2021/conf/vemd2021/celanese_brochure.pdf
- Autoclave/steam (as stated): steam 121/134 °C rated "possible"
- Data sheet: https://www.materialdatacenter.com/ms/en/Hostaform/Celanese/HOSTAFORM%C2%AE+MT%C2%AE8U01/941567ae/2434
- Note: Current Celanese grade datasheet (Material Data Center, checked 2026-10-17) states biocompatibility in tests corresponding to USP Class VI/ISO 10993 and lists DMF and MAF. Sterilization ratings are from the Celanese brochure "Medical and Pharmaceutical Materials" (MED-016, printed 2018, third-party hosted copy).

## Hostaform MT 12U01 (Celanese, POM)
- Page: https://medresin.com/grades/celanese-hostaform-mt-12u01
- USP VI: yes
- ISO 10993: yes
- Gamma: no
- EtO: yes
- Autoclave: limited
- VHP: not stated
- FDA master file: DMF, MAF
- Source: https://edm.industrysourcing.com/edm/2021/conf/vemd2021/celanese_brochure.pdf
- Autoclave/steam (as stated): steam 121/134 °C rated "possible"
- Data sheet: https://www.materialdatacenter.com/ms/en/Hostaform/Celanese/HOSTAFORM%C2%AE+MT%C2%AE12U01/a56fb4e6/2434
- Note: Current Celanese grade datasheet (Material Data Center, checked 2026-10-17) states biocompatibility in tests corresponding to USP Class VI/ISO 10993 and lists DMF and MAF. Sterilization ratings are from the Celanese brochure "Medical and Pharmaceutical Materials" (MED-016, printed 2018, third-party hosted copy).

## Hostaform MT 12U03 (Celanese, POM)
- Page: https://medresin.com/grades/celanese-hostaform-mt-12u03
- USP VI: yes
- ISO 10993: yes
- Gamma: no
- EtO: yes
- Autoclave: limited
- VHP: not stated
- FDA master file: DMF, MAF
- Source: https://edm.industrysourcing.com/edm/2021/conf/vemd2021/celanese_brochure.pdf
- Autoclave/steam (as stated): steam 121/134 °C rated "possible"
- Data sheet: https://www.materialdatacenter.com/ms/en/Hostaform/Celanese/HOSTAFORM%C2%AE+MT%C2%AE12U03/d07a19cb/2434
- Note: Current Celanese grade datasheet (Material Data Center, checked 2026-10-17) states biocompatibility in tests corresponding to USP Class VI/ISO 10993 and lists DMF and MAF. Sterilization ratings are from the Celanese brochure "Medical and Pharmaceutical Materials" (MED-016, printed 2018, third-party hosted copy).

## Hostaform MT 24U01 (Celanese, POM)
- Page: https://medresin.com/grades/celanese-hostaform-mt-24u01
- USP VI: yes
- ISO 10993: yes
- Gamma: no
- EtO: yes
- Autoclave: limited
- VHP: not stated
- FDA master file: DMF, MAF
- Source: https://edm.industrysourcing.com/edm/2021/conf/vemd2021/celanese_brochure.pdf
- Autoclave/steam (as stated): steam 121/134 °C rated "possible"
- Data sheet: https://www.materialdatacenter.com/ms/en/Hostaform/Celanese/HOSTAFORM+MT24U01/816727f4/2434
- Note: Current Celanese grade datasheet (Material Data Center, checked 2026-10-17) states biocompatibility in tests corresponding to USP Class VI/ISO 10993 and lists DMF and MAF. Sterilization ratings are from the Celanese brochure "Medical and Pharmaceutical Materials" (MED-016, printed 2018, third-party hosted copy).

## Hostaform MT 8R02 (Celanese, POM)
- Page: https://medresin.com/grades/celanese-hostaform-mt-8r02
- USP VI: yes
- ISO 10993: yes
- Gamma: no
- EtO: yes
- Autoclave: limited
- VHP: not stated
- FDA master file: DMF, MAF
- Source: https://edm.industrysourcing.com/edm/2021/conf/vemd2021/celanese_brochure.pdf
- Autoclave/steam (as stated): steam 121/134 °C rated "possible"
- Data sheet: https://www.materialdatacenter.com/ms/en/Hostaform/Celanese/HOSTAFORM%C2%AE+MT%C2%AE8R02/9fd66c2d/2434
- Note: Current Celanese grade datasheet (Material Data Center, checked 2026-10-17) states biocompatibility in tests corresponding to USP Class VI/ISO 10993 and lists DMF and MAF. Sterilization ratings are from the Celanese brochure "Medical and Pharmaceutical Materials" (MED-016, printed 2018, third-party hosted copy).

## Hostaform MT 12R01 (Celanese, POM)
- Page: https://medresin.com/grades/celanese-hostaform-mt-12r01
- USP VI: yes
- ISO 10993: yes
- Gamma: no
- EtO: yes
- Autoclave: limited
- VHP: not stated
- FDA master file: DMF, MAF
- Source: https://edm.industrysourcing.com/edm/2021/conf/vemd2021/celanese_brochure.pdf
- Autoclave/steam (as stated): steam 121/134 °C rated "possible"
- Data sheet: https://www.materialdatacenter.com/ms/en/Hostaform/Celanese/HOSTAFORM%C2%AE+MT%C2%AE12R01/fd2eb019/2434
- Note: Current Celanese grade datasheet (Material Data Center, checked 2026-10-17) states biocompatibility in tests corresponding to USP Class VI/ISO 10993 and lists DMF and MAF. Sterilization ratings are from the Celanese brochure "Medical and Pharmaceutical Materials" (MED-016, printed 2018, third-party hosted copy).

## Hostaform MT 8F01 (Celanese, POM)
- Page: https://medresin.com/grades/celanese-hostaform-mt-8f01
- USP VI: yes
- ISO 10993: yes
- Gamma: no
- EtO: yes
- Autoclave: limited
- VHP: not stated
- FDA master file: DMF, MAF
- Source: https://edm.industrysourcing.com/edm/2021/conf/vemd2021/celanese_brochure.pdf
- Autoclave/steam (as stated): steam 121/134 °C rated "possible"
- Data sheet: https://www.materialdatacenter.com/ms/en/Hostaform/Celanese/HOSTAFORM%C2%AE+MT%C2%AE8F01/0fdf181c/2434
- Note: Current Celanese grade datasheet (Material Data Center, checked 2026-10-17) states biocompatibility in tests corresponding to USP Class VI/ISO 10993 and lists DMF and MAF. Sterilization ratings are from the Celanese brochure "Medical and Pharmaceutical Materials" (MED-016, printed 2018, third-party hosted copy).

## Hostaform MT 8F02 (Celanese, POM)
- Page: https://medresin.com/grades/celanese-hostaform-mt-8f02
- USP VI: yes
- ISO 10993: not stated
- Gamma: no
- EtO: yes
- Autoclave: limited
- VHP: not stated
- FDA master file: DMF, MAF
- Source: https://edm.industrysourcing.com/edm/2021/conf/vemd2021/celanese_brochure.pdf
- Autoclave/steam (as stated): steam 121/134 °C rated "possible"
- Note: Source dated 2018: Celanese brochure "Medical and Pharmaceutical Materials" (MED-016, printed 2018, third-party hosted copy). It lists cytotoxicity testing for the grade; its only ISO 10993 mention is a general service-package line ("USP Class VI / ISO 10993, etc.") that doesn't name the grade or its product line, so the ISO 10993 column is left blank. Not found in Celanese's current datasheet listing on Material Data Center (checked 2026-10-17); it may be discontinued.

## Hostaform MT 24F01 (Celanese, POM)
- Page: https://medresin.com/grades/celanese-hostaform-mt-24f01
- USP VI: yes
- ISO 10993: yes
- Gamma: no
- EtO: yes
- Autoclave: limited
- VHP: not stated
- FDA master file: DMF, MAF
- Source: https://edm.industrysourcing.com/edm/2021/conf/vemd2021/celanese_brochure.pdf
- Autoclave/steam (as stated): steam 121/134 °C rated "possible"
- Data sheet: https://www.materialdatacenter.com/ms/en/Hostaform/Celanese/HOSTAFORM%C2%AE+MT%C2%AE24F01/6d538f6d/2434
- Note: Current Celanese grade datasheet (Material Data Center, checked 2026-10-17) states biocompatibility in tests corresponding to USP Class VI/ISO 10993 and lists DMF and MAF. Sterilization ratings are from the Celanese brochure "Medical and Pharmaceutical Materials" (MED-016, printed 2018, third-party hosted copy).

## Hostaform MT 8U05 (Celanese, POM)
- Page: https://medresin.com/grades/celanese-hostaform-mt-8u05
- USP VI: yes
- ISO 10993: yes
- Gamma: no
- EtO: yes
- Autoclave: limited
- VHP: not stated
- FDA master file: DMF, MAF
- Source: https://edm.industrysourcing.com/edm/2021/conf/vemd2021/celanese_brochure.pdf
- Autoclave/steam (as stated): steam 121/134 °C rated "possible"
- Data sheet: https://www.materialdatacenter.com/ms/en/Hostaform/Celanese/HOSTAFORM%C2%AE+MT%C2%AE8U05/6361fa65/2434
- Note: Current Celanese grade datasheet (Material Data Center, checked 2026-10-17) states biocompatibility in tests corresponding to USP Class VI/ISO 10993 and lists DMF and MAF. Sterilization ratings are from the Celanese brochure "Medical and Pharmaceutical Materials" (MED-016, printed 2018, third-party hosted copy).

## Hostaform MT SlideX 1203 (Celanese, POM)
- Page: https://medresin.com/grades/celanese-hostaform-mt-slidex-1203
- USP VI: yes
- ISO 10993: yes
- Gamma: no
- EtO: yes
- Autoclave: limited
- VHP: not stated
- FDA master file: DMF, MAF
- Source: https://edm.industrysourcing.com/edm/2021/conf/vemd2021/celanese_brochure.pdf
- Autoclave/steam (as stated): steam 121/134 °C rated "possible"
- Data sheet: https://www.materialdatacenter.com/ms/en/Hostaform/Celanese/HOSTAFORM%C2%AE+MT%C2%AE+SlideX%C2%AE+1203/c58cc4cd/2434
- Note: Current Celanese grade datasheet (Material Data Center, checked 2026-10-17) states biocompatibility in tests corresponding to USP Class VI/ISO 10993 and lists DMF and MAF. Sterilization ratings are from the Celanese brochure "Medical and Pharmaceutical Materials" (MED-016, printed 2018, third-party hosted copy).

## Hostaform MT SlideX 2404 (Celanese, POM)
- Page: https://medresin.com/grades/celanese-hostaform-mt-slidex-2404
- USP VI: yes
- ISO 10993: yes
- Gamma: no
- EtO: yes
- Autoclave: limited
- VHP: not stated
- FDA master file: DMF, MAF
- Source: https://edm.industrysourcing.com/edm/2021/conf/vemd2021/celanese_brochure.pdf
- Autoclave/steam (as stated): steam 121/134 °C rated "possible"
- Data sheet: https://www.materialdatacenter.com/ms/en/Hostaform/Celanese/HOSTAFORM%C2%AE+MT%C2%AE+SlideX%C2%AE+2404/8305977b/2434
- Note: Current Celanese grade datasheet (Material Data Center, checked 2026-10-17) states biocompatibility in tests corresponding to USP Class VI/ISO 10993 and lists DMF and MAF. Sterilization ratings are from the Celanese brochure "Medical and Pharmaceutical Materials" (MED-016, printed 2018, third-party hosted copy).

## Celanex 2401MT (Celanese, PBT)
- Page: https://medresin.com/grades/celanese-celanex-2401mt
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: limited
- VHP: not stated
- FDA master file: DMF, MAF
- Source: https://edm.industrysourcing.com/edm/2021/conf/vemd2021/celanese_brochure.pdf
- Autoclave/steam (as stated): steam 121/134 °C rated "possible"
- Data sheet: https://www.materialdatacenter.com/ms/en/Celanex/Celanese/CELANEX%C2%AE+2401MT/e7f5e114/2424
- Note: Current Celanese grade datasheet (Material Data Center, checked 2026-10-17) states biocompatibility in tests corresponding to USP Class VI/ISO 10993 and lists DMF and MAF. Sterilization ratings are from the Celanese brochure "Medical and Pharmaceutical Materials" (MED-016, printed 2018, third-party hosted copy).

## Celanex 2402MT (Celanese, PBT)
- Page: https://medresin.com/grades/celanese-celanex-2402mt
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: limited
- VHP: not stated
- FDA master file: DMF, MAF
- Source: https://edm.industrysourcing.com/edm/2021/conf/vemd2021/celanese_brochure.pdf
- Autoclave/steam (as stated): steam 121/134 °C rated "possible"
- Data sheet: https://www.materialdatacenter.com/ms/en/Celanex/Celanese/CELANEX%C2%AE+2402MT/8e38042e/2424
- Note: Current Celanese grade datasheet (Material Data Center, checked 2026-10-17) states biocompatibility in tests corresponding to USP Class VI/ISO 10993 and lists DMF and MAF. Sterilization ratings are from the Celanese brochure "Medical and Pharmaceutical Materials" (MED-016, printed 2018, third-party hosted copy).

## Celanex 2404MT (Celanese, PBT)
- Page: https://medresin.com/grades/celanese-celanex-2404mt
- USP VI: yes
- ISO 10993: yes
- Gamma: no
- EtO: yes
- Autoclave: limited
- VHP: not stated
- FDA master file: DMF, MAF
- Source: https://edm.industrysourcing.com/edm/2021/conf/vemd2021/celanese_brochure.pdf
- Autoclave/steam (as stated): steam 121/134 °C rated "possible"
- Data sheet: https://www.materialdatacenter.com/ms/en/Celanex/Celanese/CELANEX%C2%AE+2404MT/200a2589/2424
- Note: Current Celanese grade datasheet (Material Data Center, checked 2026-10-17) states biocompatibility in tests corresponding to USP Class VI/ISO 10993 and lists DMF and MAF. Sterilization ratings are from the Celanese brochure "Medical and Pharmaceutical Materials" (MED-016, printed 2018, third-party hosted copy).

## Celanex 2405MT (Celanese, PBT)
- Page: https://medresin.com/grades/celanese-celanex-2405mt
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: limited
- VHP: not stated
- FDA master file: DMF, MAF
- Source: https://edm.industrysourcing.com/edm/2021/conf/vemd2021/celanese_brochure.pdf
- Autoclave/steam (as stated): steam 121/134 °C rated "possible"
- Data sheet: https://www.materialdatacenter.com/ms/en/Celanex/Celanese/CELANEX%C2%AE+2405MT/85e9f333/2424
- Note: Current Celanese grade datasheet (Material Data Center, checked 2026-10-17) states biocompatibility in tests corresponding to USP Class VI/ISO 10993 and lists DMF and MAF. Sterilization ratings are from the Celanese brochure "Medical and Pharmaceutical Materials" (MED-016, printed 2018, third-party hosted copy).

## GUR 1020 (Celanese, UHMW-PE)
- Page: https://medresin.com/grades/celanese-gur-1020
- USP VI: yes
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: no
- VHP: not stated
- FDA master file: DMF, MAF
- Source: https://edm.industrysourcing.com/edm/2021/conf/vemd2021/celanese_brochure.pdf
- Note: Source dated 2018: Celanese brochure "Medical and Pharmaceutical Materials" (MED-016, printed 2018, third-party hosted copy). It lists cytotoxicity testing for the grade; its only ISO 10993 mention is a general service-package line ("USP Class VI / ISO 10993, etc.") that doesn't name the grade or its product line, so the ISO 10993 column is left blank. Celanese's GUR product manual (2016) states USP Class VI and FDA Master Files for the medical grades but no ISO 10993 statement; no current grade datasheet with an ISO 10993 statement was found (checked 2026-10-17).

## GUR 1050 (Celanese, UHMW-PE)
- Page: https://medresin.com/grades/celanese-gur-1050
- USP VI: yes
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: no
- VHP: not stated
- FDA master file: DMF, MAF
- Source: https://edm.industrysourcing.com/edm/2021/conf/vemd2021/celanese_brochure.pdf
- Note: Source dated 2018: Celanese brochure "Medical and Pharmaceutical Materials" (MED-016, printed 2018, third-party hosted copy). It lists cytotoxicity testing for the grade; its only ISO 10993 mention is a general service-package line ("USP Class VI / ISO 10993, etc.") that doesn't name the grade or its product line, so the ISO 10993 column is left blank. Celanese's GUR product manual (2016) states USP Class VI and FDA Master Files for the medical grades but no ISO 10993 statement; no current grade datasheet with an ISO 10993 statement was found (checked 2026-10-17).

## GUR 1020-E (Celanese, UHMW-PE)
- Page: https://medresin.com/grades/celanese-gur-1020-e
- USP VI: yes
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: no
- VHP: not stated
- FDA master file: DMF, MAF
- Source: https://edm.industrysourcing.com/edm/2021/conf/vemd2021/celanese_brochure.pdf
- Note: Source dated 2018: Celanese brochure "Medical and Pharmaceutical Materials" (MED-016, printed 2018, third-party hosted copy). It lists cytotoxicity testing for the grade; its only ISO 10993 mention is a general service-package line ("USP Class VI / ISO 10993, etc.") that doesn't name the grade or its product line, so the ISO 10993 column is left blank. Celanese's GUR product manual (2016) states USP Class VI and FDA Master Files for the medical grades but no ISO 10993 statement; no current grade datasheet with an ISO 10993 statement was found (checked 2026-10-17).

## GUR 1050-E (Celanese, UHMW-PE)
- Page: https://medresin.com/grades/celanese-gur-1050-e
- USP VI: yes
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: no
- VHP: not stated
- FDA master file: DMF, MAF
- Source: https://edm.industrysourcing.com/edm/2021/conf/vemd2021/celanese_brochure.pdf
- Note: Source dated 2018: Celanese brochure "Medical and Pharmaceutical Materials" (MED-016, printed 2018, third-party hosted copy). It lists cytotoxicity testing for the grade; its only ISO 10993 mention is a general service-package line ("USP Class VI / ISO 10993, etc.") that doesn't name the grade or its product line, so the ISO 10993 column is left blank. Celanese's GUR product manual (2016) states USP Class VI and FDA Master Files for the medical grades but no ISO 10993 statement; no current grade datasheet with an ISO 10993 statement was found (checked 2026-10-17).

## GUR 1001 (Celanese, UHMW-PE)
- Page: https://medresin.com/grades/celanese-gur-1001
- USP VI: yes
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: no
- VHP: not stated
- FDA master file: not stated
- Source: https://edm.industrysourcing.com/edm/2021/conf/vemd2021/celanese_brochure.pdf
- Note: Source dated 2018: Celanese brochure "Medical and Pharmaceutical Materials" (MED-016, printed 2018, third-party hosted copy). It lists cytotoxicity testing for the grade; its only ISO 10993 mention is a general service-package line ("USP Class VI / ISO 10993, etc.") that doesn't name the grade or its product line, so the ISO 10993 column is left blank. Celanese's GUR product manual (2016) states USP Class VI and FDA Master Files for the medical grades but no ISO 10993 statement; no current grade datasheet with an ISO 10993 statement was found (checked 2026-10-17). No DMF/MAF listed for this grade.

## Fortron MT 9140L4 (Celanese, PPS (40% GF))
- Page: https://medresin.com/grades/celanese-fortron-mt-9140l4
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: DMF, MAF
- Source: https://edm.industrysourcing.com/edm/2021/conf/vemd2021/celanese_brochure.pdf
- Data sheet: https://www.materialdatacenter.com/ms/en/Fortron/Celanese/FORTRON%C2%AE+MT9140L4/8a09bfb8/2431
- Note: Current Celanese grade datasheet (Material Data Center, checked 2026-10-17) states biocompatibility in tests corresponding to USP Class VI/ISO 10993 and lists DMF and MAF. Sterilization ratings are from the Celanese brochure "Medical and Pharmaceutical Materials" (MED-016, printed 2018, third-party hosted copy).

## Fortron MT 9140L6 (Celanese, PPS (40% GF))
- Page: https://medresin.com/grades/celanese-fortron-mt-9140l6
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: DMF, MAF
- Source: https://edm.industrysourcing.com/edm/2021/conf/vemd2021/celanese_brochure.pdf
- Data sheet: https://www.materialdatacenter.com/ms/en/Fortron/Celanese/FORTRON%C2%AE+MT9140L6/9830b5a8/2431
- Note: Current Celanese grade datasheet (Material Data Center, checked 2026-10-17) states biocompatibility in tests corresponding to USP Class VI/ISO 10993 and lists DMF and MAF. Sterilization ratings are from the Celanese brochure "Medical and Pharmaceutical Materials" (MED-016, printed 2018, third-party hosted copy).

## Vectra MT 1300 (Celanese, LCP)
- Page: https://medresin.com/grades/celanese-vectra-mt-1300
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: limited
- VHP: not stated
- FDA master file: DMF, MAF
- Source: https://edm.industrysourcing.com/edm/2021/conf/vemd2021/celanese_brochure.pdf
- Autoclave/steam (as stated): steam 121/134 °C rated "possible"
- Data sheet: https://www.materialdatacenter.com/ms/en/Vectra/Celanese/VECTRA+MT1300/bc2f2eba/2442
- Note: Current Celanese grade datasheet (Material Data Center, checked 2026-10-17) states biocompatibility in tests corresponding to USP Class VI/ISO 10993 and lists DMF and MAF. Sterilization ratings are from the Celanese brochure "Medical and Pharmaceutical Materials" (MED-016, printed 2018, third-party hosted copy).

## Vectra MT 1310 (Celanese, LCP (30% GF))
- Page: https://medresin.com/grades/celanese-vectra-mt-1310
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: limited
- VHP: not stated
- FDA master file: DMF, MAF
- Source: https://edm.industrysourcing.com/edm/2021/conf/vemd2021/celanese_brochure.pdf
- Autoclave/steam (as stated): steam 121/134 °C rated "possible"
- Data sheet: https://www.materialdatacenter.com/ms/en/Vectra/Celanese/VECTRA+MT1310/9536bf65/2442
- Note: Current Celanese grade datasheet (Material Data Center, checked 2026-10-17) states biocompatibility in tests corresponding to USP Class VI/ISO 10993 and lists DMF and MAF. Sterilization ratings are from the Celanese brochure "Medical and Pharmaceutical Materials" (MED-016, printed 2018, third-party hosted copy).

## Vectra MT 4310 (Celanese, LCP (30% GF))
- Page: https://medresin.com/grades/celanese-vectra-mt-4310
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: limited
- VHP: not stated
- FDA master file: DMF, MAF
- Source: https://edm.industrysourcing.com/edm/2021/conf/vemd2021/celanese_brochure.pdf
- Autoclave/steam (as stated): steam 121/134 °C rated "possible"
- Data sheet: https://www.materialdatacenter.com/ms/en/Vectra/Celanese/VECTRA%C2%AE+MT%C2%AE4310/f95ce26e/2442
- Note: Current Celanese grade datasheet (Material Data Center, checked 2026-10-17) states biocompatibility in tests corresponding to USP Class VI/ISO 10993 and lists DMF and MAF. Sterilization ratings are from the Celanese brochure "Medical and Pharmaceutical Materials" (MED-016, printed 2018, third-party hosted copy).

## Vectra MT 4350 (Celanese, LCP (40% mineral))
- Page: https://medresin.com/grades/celanese-vectra-mt-4350
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: limited
- VHP: not stated
- FDA master file: DMF, MAF
- Source: https://edm.industrysourcing.com/edm/2021/conf/vemd2021/celanese_brochure.pdf
- Autoclave/steam (as stated): steam 121/134 °C rated "possible"
- Data sheet: https://www.materialdatacenter.com/ms/en/Vectra/Celanese/VECTRA+MT4350/46e57144/2442
- Note: Current Celanese grade datasheet (Material Data Center, checked 2026-10-17) states biocompatibility in tests corresponding to USP Class VI/ISO 10993 and lists DMF and MAF. Sterilization ratings are from the Celanese brochure "Medical and Pharmaceutical Materials" (MED-016, printed 2018, third-party hosted copy).

## Vectra MT 1335 (Celanese, LCP (glass/PTFE))
- Page: https://medresin.com/grades/celanese-vectra-mt-1335
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: limited
- VHP: not stated
- FDA master file: DMF, MAF
- Source: https://edm.industrysourcing.com/edm/2021/conf/vemd2021/celanese_brochure.pdf
- Autoclave/steam (as stated): steam 121/134 °C rated "possible"
- Data sheet: https://www.materialdatacenter.com/ms/en/Vectra/Celanese/VECTRA%C2%AE+MT%C2%AE1335/c0468737/2442
- Note: Current Celanese grade datasheet (Material Data Center, checked 2026-10-17) states biocompatibility in tests corresponding to USP Class VI/ISO 10993 and lists DMF and MAF. Sterilization ratings are from the Celanese brochure "Medical and Pharmaceutical Materials" (MED-016, printed 2018, third-party hosted copy).

## VESTAMID Care ML67 (Evonik, PA12)
- Page: https://medresin.com/grades/evonik-vestamid-care-ml67
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: limited
- VHP: not stated
- FDA master file: not stated
- Source: https://products.evonik.com/assets/34/33/Evonik_Medical_Care_brochure_1124_EN_243433.pdf
- Gamma dose (as stated): up to 50 kGy (all Evonik Care grades)
- Autoclave/steam (as stated): 5-25 steam sterilization cycles

## VESTAMID Care ML94 (Evonik, PA12)
- Page: https://medresin.com/grades/evonik-vestamid-care-ml94
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: limited
- VHP: not stated
- FDA master file: not stated
- Source: https://products.evonik.com/assets/34/33/Evonik_Medical_Care_brochure_1124_EN_243433.pdf
- Gamma dose (as stated): up to 50 kGy (all Evonik Care grades)
- Autoclave/steam (as stated): 5-25 steam sterilization cycles

## VESTAMID Care ML24 (Evonik, PA12)
- Page: https://medresin.com/grades/evonik-vestamid-care-ml24
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: limited
- VHP: not stated
- FDA master file: not stated
- Source: https://products.evonik.com/assets/34/33/Evonik_Medical_Care_brochure_1124_EN_243433.pdf
- Gamma dose (as stated): up to 50 kGy (all Evonik Care grades)
- Autoclave/steam (as stated): 25-50 steam sterilization cycles

## VESTAMID Care MLGB30 (Evonik, PA12 (glass beads))
- Page: https://medresin.com/grades/evonik-vestamid-care-mlgb30
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: limited
- VHP: not stated
- FDA master file: not stated
- Source: https://products.evonik.com/assets/34/33/Evonik_Medical_Care_brochure_1124_EN_243433.pdf
- Gamma dose (as stated): up to 50 kGy (all Evonik Care grades)
- Autoclave/steam (as stated): 25-100 steam sterilization cycles

## VESTAMID Care ME26 (Evonik, PEBA)
- Page: https://medresin.com/grades/evonik-vestamid-care-me26
- USP VI: yes
- ISO 10993: limited
- Gamma: yes
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://products.evonik.com/assets/34/33/Evonik_Medical_Care_brochure_1124_EN_243433.pdf
- Gamma dose (as stated): up to 50 kGy (all Evonik Care grades)
- Note: Evonik: ME26 does not meet the ISO 10993-5 cytotoxicity requirement (53% viability) and is slightly hemolytic.

## VESTAMID Care ME40 (Evonik, PEBA)
- Page: https://medresin.com/grades/evonik-vestamid-care-me40
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: limited
- VHP: not stated
- FDA master file: not stated
- Source: https://products.evonik.com/assets/34/33/Evonik_Medical_Care_brochure_1124_EN_243433.pdf
- Gamma dose (as stated): up to 50 kGy (all Evonik Care grades)
- Autoclave/steam (as stated): <5 steam sterilization cycles

## VESTAMID Care ME47 (Evonik, PEBA)
- Page: https://medresin.com/grades/evonik-vestamid-care-me47
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: limited
- VHP: not stated
- FDA master file: not stated
- Source: https://products.evonik.com/assets/34/33/Evonik_Medical_Care_brochure_1124_EN_243433.pdf
- Gamma dose (as stated): up to 50 kGy (all Evonik Care grades)
- Autoclave/steam (as stated): 5-25 steam sterilization cycles

## VESTAMID Care ME55 (Evonik, PEBA)
- Page: https://medresin.com/grades/evonik-vestamid-care-me55
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: limited
- VHP: not stated
- FDA master file: not stated
- Source: https://products.evonik.com/assets/34/33/Evonik_Medical_Care_brochure_1124_EN_243433.pdf
- Gamma dose (as stated): up to 50 kGy (all Evonik Care grades)
- Autoclave/steam (as stated): 25-50 steam sterilization cycles

## VESTAMID Care ME62 (Evonik, PEBA)
- Page: https://medresin.com/grades/evonik-vestamid-care-me62
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: limited
- VHP: not stated
- FDA master file: not stated
- Source: https://products.evonik.com/assets/34/33/Evonik_Medical_Care_brochure_1124_EN_243433.pdf
- Gamma dose (as stated): up to 50 kGy (all Evonik Care grades)
- Autoclave/steam (as stated): 25-50 steam sterilization cycles

## VESTAMID Care ME71 (Evonik, PEBA)
- Page: https://medresin.com/grades/evonik-vestamid-care-me71
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: limited
- VHP: not stated
- FDA master file: not stated
- Source: https://products.evonik.com/assets/34/33/Evonik_Medical_Care_brochure_1124_EN_243433.pdf
- Gamma dose (as stated): up to 50 kGy (all Evonik Care grades)
- Autoclave/steam (as stated): 25-50 steam sterilization cycles

## TROGAMID Care MX73 (Evonik, PA (transparent microcrystalline))
- Page: https://medresin.com/grades/evonik-trogamid-care-mx73
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: limited
- VHP: not stated
- FDA master file: not stated
- Source: https://products.evonik.com/assets/34/33/Evonik_Medical_Care_brochure_1124_EN_243433.pdf
- Gamma dose (as stated): up to 50 kGy (all Evonik Care grades)
- Autoclave/steam (as stated): 5-25 steam sterilization cycles

## TROGAMID Care MX97 (Evonik, PA (transparent microcrystalline))
- Page: https://medresin.com/grades/evonik-trogamid-care-mx97
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: limited
- VHP: not stated
- FDA master file: not stated
- Source: https://products.evonik.com/assets/34/33/Evonik_Medical_Care_brochure_1124_EN_243433.pdf
- Gamma dose (as stated): up to 50 kGy (all Evonik Care grades)
- Autoclave/steam (as stated): 5-25 steam sterilization cycles

## VESTAKEEP Care M20 G (Evonik, PEEK)
- Page: https://medresin.com/grades/evonik-vestakeep-care-m20-g
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://products.evonik.com/assets/34/33/Evonik_Medical_Care_brochure_1124_EN_243433.pdf
- Gamma dose (as stated): up to 50 kGy (all Evonik Care grades)
- Autoclave/steam (as stated): > 500 autoclave cycles

## VESTAKEEP Care M33 G-HP (Evonik, PEEK)
- Page: https://medresin.com/grades/evonik-vestakeep-care-m33-g-hp
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://products.evonik.com/assets/34/33/Evonik_Medical_Care_brochure_1124_EN_243433.pdf
- Gamma dose (as stated): up to 50 kGy (all Evonik Care grades)
- Autoclave/steam (as stated): > 500 autoclave cycles

## VESTAKEEP Care M40 G (Evonik, PEEK)
- Page: https://medresin.com/grades/evonik-vestakeep-care-m40-g
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://products.evonik.com/assets/34/33/Evonik_Medical_Care_brochure_1124_EN_243433.pdf
- Gamma dose (as stated): up to 50 kGy (all Evonik Care grades)
- Autoclave/steam (as stated): > 500 autoclave cycles

## Tritan MX711 (Eastman, Copolyester)
- Page: https://medresin.com/grades/eastman-tritan-mx711
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://productcatalog.eastman.com/tds/ProdDatasheet.aspx?product=71070154
- Gamma dose (as stated): tested at 50 kGy (minimal color shift; Eastman)
- Data sheet: https://productcatalog.eastman.com/tds/ProdDatasheet.aspx?product=71070154
- Additional source: https://www.eastman.com/content/dam/eastman/corporate/en/literature/s/spmbs1164.pdf
- Note: Eastman: tested for FDA/ISO 10993 and USP Class VI biological evaluation after gamma and EtO sterilization.

## Tritan MX731 (Eastman, Copolyester)
- Page: https://medresin.com/grades/eastman-tritan-mx731
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://productcatalog.eastman.com/tds/ProdDatasheet.aspx?product=71070461
- Data sheet: https://productcatalog.eastman.com/tds/ProdDatasheet.aspx?product=71070461
- Note: Eastman: tested for FDA/ISO 10993 and USP Class VI biological evaluation after gamma and EtO sterilization.

## Tritan MX811 (Eastman, Copolyester)
- Page: https://medresin.com/grades/eastman-tritan-mx811
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://productcatalog.eastman.com/tds/ProdDatasheet.aspx?product=71072160
- Data sheet: https://productcatalog.eastman.com/tds/ProdDatasheet.aspx?product=71072160
- Note: Eastman: tested for FDA/ISO 10993 and USP Class VI biological evaluation after gamma and EtO sterilization.

## Tritan MX710 (Eastman, Copolyester)
- Page: https://medresin.com/grades/eastman-tritan-mx710
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://productcatalog.eastman.com/tds/ProdDatasheet.aspx?product=71070148
- Data sheet: https://productcatalog.eastman.com/tds/ProdDatasheet.aspx?product=71070148
- Note: Eastman TDS lists good color stability upon gamma and EtO sterilization; no biocompatibility statement on the TDS.

## Eastar MN006 (Eastman, Copolyester)
- Page: https://medresin.com/grades/eastman-eastar-mn006
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://productcatalog.eastman.com/tds/ProdDatasheet.aspx?product=71064561
- Data sheet: https://productcatalog.eastman.com/tds/ProdDatasheet.aspx?product=71064561
- Note: Eastman: tested for FDA/ISO 10993 and USP Class VI biological evaluation after gamma and EtO sterilization.

## Eastar MN005 (Eastman, Copolyester)
- Page: https://medresin.com/grades/eastman-eastar-mn005
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://productcatalog.eastman.com/tds/ProdDatasheet.aspx?product=71055564
- Data sheet: https://productcatalog.eastman.com/tds/ProdDatasheet.aspx?product=71055564
- Note: Eastman: tested for FDA/ISO 10993 and USP Class VI biological evaluation after gamma and EtO sterilization.

## Eastar MN052 (Eastman, Polyester)
- Page: https://medresin.com/grades/eastman-eastar-mn052
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://productcatalog.eastman.com/tds/ProdDatasheet.aspx?product=71059437
- Data sheet: https://productcatalog.eastman.com/tds/ProdDatasheet.aspx?product=71059437
- Note: Eastman: tested for FDA/ISO 10993 and USP Class VI biological evaluation after gamma and EtO sterilization.

## Eastar MN058 (Eastman, Copolyester)
- Page: https://medresin.com/grades/eastman-eastar-mn058
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://productcatalog.eastman.com/tds/ProdDatasheet.aspx?product=71068566
- Data sheet: https://productcatalog.eastman.com/tds/ProdDatasheet.aspx?product=71068566
- Note: Eastman TDS: "Meets ISO 10993 and/or USP Class VI biocompatibility requirements" (which one is not specified, so both left blank). TDS key attribute: gamma and e-beam color stability (listed as gamma). EtO and autoclave not stated.

## Eastar MN211 (Eastman, Copolyester)
- Page: https://medresin.com/grades/eastman-eastar-mn211
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://productcatalog.eastman.com/tds/ProdDatasheet.aspx?product=71017000
- Data sheet: https://productcatalog.eastman.com/tds/ProdDatasheet.aspx?product=71017000
- Note: Eastman TDS: "Meets ISO 10993 and/or USP Class VI biocompatibility requirements" (which one is not specified, so both left blank). TDS key attribute: gamma and e-beam color stability (listed as gamma). EtO and autoclave not stated.

## Medalist MD-36165 (Teknor Apex, TPE (medical tubing))
- Page: https://medresin.com/grades/teknor-apex-medalist-md-36165
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://www.teknorapex.com/content/dam/teknorapex/teknor-pardot-assets-/Medalist___Medical_Elastomers_for_Medical_Tubing.pdf
- Note: Teknor Apex: series "Biocompatible, ISO 10993-5 compliant" (cytotoxicity only, so ISO 10993 column left blank); sterilization by e-beam, gamma and EtO. Coded cytotoxicity-only 2026-10-20 per Teknor Apex Medalist tubing sell sheet ("Biocompatible, ISO 10993-5 compliant").

## Medalist MD-53253 (Teknor Apex, TPE (medical tubing))
- Page: https://medresin.com/grades/teknor-apex-medalist-md-53253
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://www.teknorapex.com/content/dam/teknorapex/teknor-pardot-assets-/Medalist___Medical_Elastomers_for_Medical_Tubing.pdf
- Note: Teknor Apex: series "Biocompatible, ISO 10993-5 compliant" (cytotoxicity only, so ISO 10993 column left blank); sterilization by e-beam, gamma and EtO. Coded cytotoxicity-only 2026-10-20 per Teknor Apex Medalist tubing sell sheet ("Biocompatible, ISO 10993-5 compliant").

## Medalist MD-53263 (Teknor Apex, TPE (medical tubing))
- Page: https://medresin.com/grades/teknor-apex-medalist-md-53263
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://www.teknorapex.com/content/dam/teknorapex/teknor-pardot-assets-/Medalist___Medical_Elastomers_for_Medical_Tubing.pdf
- Note: Teknor Apex: series "Biocompatible, ISO 10993-5 compliant" (cytotoxicity only, so ISO 10993 column left blank); sterilization by e-beam, gamma and EtO. Coded cytotoxicity-only 2026-10-20 per Teknor Apex Medalist tubing sell sheet ("Biocompatible, ISO 10993-5 compliant").

## Medalist MD-53268 (Teknor Apex, TPE (medical tubing))
- Page: https://medresin.com/grades/teknor-apex-medalist-md-53268
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://www.teknorapex.com/content/dam/teknorapex/teknor-pardot-assets-/Medalist___Medical_Elastomers_for_Medical_Tubing.pdf
- Note: Teknor Apex: series "Biocompatible, ISO 10993-5 compliant" (cytotoxicity only, so ISO 10993 column left blank); sterilization by e-beam, gamma and EtO. Coded cytotoxicity-only 2026-10-20 per Teknor Apex Medalist tubing sell sheet ("Biocompatible, ISO 10993-5 compliant").

## Medalist MD-53273 (Teknor Apex, TPE (medical tubing))
- Page: https://medresin.com/grades/teknor-apex-medalist-md-53273
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://www.teknorapex.com/content/dam/teknorapex/teknor-pardot-assets-/Medalist___Medical_Elastomers_for_Medical_Tubing.pdf
- Note: Teknor Apex: series "Biocompatible, ISO 10993-5 compliant" (cytotoxicity only, so ISO 10993 column left blank); sterilization by e-beam, gamma and EtO. Coded cytotoxicity-only 2026-10-20 per Teknor Apex Medalist tubing sell sheet ("Biocompatible, ISO 10993-5 compliant").

## Medalist MD-53278 (Teknor Apex, TPE (medical tubing))
- Page: https://medresin.com/grades/teknor-apex-medalist-md-53278
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://www.teknorapex.com/content/dam/teknorapex/teknor-pardot-assets-/Medalist___Medical_Elastomers_for_Medical_Tubing.pdf
- Note: Teknor Apex: series "Biocompatible, ISO 10993-5 compliant" (cytotoxicity only, so ISO 10993 column left blank); sterilization by e-beam, gamma and EtO. Coded cytotoxicity-only 2026-10-20 per Teknor Apex Medalist tubing sell sheet ("Biocompatible, ISO 10993-5 compliant").

## Medalist MD-53283 (Teknor Apex, TPE (medical tubing))
- Page: https://medresin.com/grades/teknor-apex-medalist-md-53283
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://www.teknorapex.com/content/dam/teknorapex/teknor-pardot-assets-/Medalist___Medical_Elastomers_for_Medical_Tubing.pdf
- Note: Teknor Apex: series "Biocompatible, ISO 10993-5 compliant" (cytotoxicity only, so ISO 10993 column left blank); sterilization by e-beam, gamma and EtO. Coded cytotoxicity-only 2026-10-20 per Teknor Apex Medalist tubing sell sheet ("Biocompatible, ISO 10993-5 compliant").

## Medalist MD-53288 (Teknor Apex, TPE (medical tubing))
- Page: https://medresin.com/grades/teknor-apex-medalist-md-53288
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://www.teknorapex.com/content/dam/teknorapex/teknor-pardot-assets-/Medalist___Medical_Elastomers_for_Medical_Tubing.pdf
- Note: Teknor Apex: series "Biocompatible, ISO 10993-5 compliant" (cytotoxicity only, so ISO 10993 column left blank); sterilization by e-beam, gamma and EtO. Coded cytotoxicity-only 2026-10-20 per Teknor Apex Medalist tubing sell sheet ("Biocompatible, ISO 10993-5 compliant").

## Medalist MD-53293 (Teknor Apex, TPE (medical tubing))
- Page: https://medresin.com/grades/teknor-apex-medalist-md-53293
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://www.teknorapex.com/content/dam/teknorapex/teknor-pardot-assets-/Medalist___Medical_Elastomers_for_Medical_Tubing.pdf
- Note: Teknor Apex: series "Biocompatible, ISO 10993-5 compliant" (cytotoxicity only, so ISO 10993 column left blank); sterilization by e-beam, gamma and EtO. Coded cytotoxicity-only 2026-10-20 per Teknor Apex Medalist tubing sell sheet ("Biocompatible, ISO 10993-5 compliant").

## Medalist MD-12337 (Teknor Apex, TPE (medical tubing))
- Page: https://medresin.com/grades/teknor-apex-medalist-md-12337
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://www.teknorapex.com/content/dam/teknorapex/teknor-pardot-assets-/Medalist___Medical_Elastomers_for_Medical_Tubing.pdf
- Note: Teknor Apex: series "Biocompatible, ISO 10993-5 compliant" (cytotoxicity only, so ISO 10993 column left blank); sterilization by e-beam, gamma and EtO. Coded cytotoxicity-only 2026-10-20 per Teknor Apex Medalist tubing sell sheet ("Biocompatible, ISO 10993-5 compliant").

## Medalist MD-12342 (Teknor Apex, TPE (medical tubing))
- Page: https://medresin.com/grades/teknor-apex-medalist-md-12342
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://www.teknorapex.com/content/dam/teknorapex/teknor-pardot-assets-/Medalist___Medical_Elastomers_for_Medical_Tubing.pdf
- Note: Teknor Apex: series "Biocompatible, ISO 10993-5 compliant" (cytotoxicity only, so ISO 10993 column left blank); sterilization by e-beam, gamma and EtO. Coded cytotoxicity-only 2026-10-20 per Teknor Apex Medalist tubing sell sheet ("Biocompatible, ISO 10993-5 compliant").

## Medalist MD-12352 (Teknor Apex, TPE (medical tubing))
- Page: https://medresin.com/grades/teknor-apex-medalist-md-12352
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://www.teknorapex.com/content/dam/teknorapex/teknor-pardot-assets-/Medalist___Medical_Elastomers_for_Medical_Tubing.pdf
- Note: Teknor Apex: series "Biocompatible, ISO 10993-5 compliant" (cytotoxicity only, so ISO 10993 column left blank); sterilization by e-beam, gamma and EtO. Coded cytotoxicity-only 2026-10-20 per Teknor Apex Medalist tubing sell sheet ("Biocompatible, ISO 10993-5 compliant").

## Medalist MD-12362 (Teknor Apex, TPE (medical tubing))
- Page: https://medresin.com/grades/teknor-apex-medalist-md-12362
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://www.teknorapex.com/content/dam/teknorapex/teknor-pardot-assets-/Medalist___Medical_Elastomers_for_Medical_Tubing.pdf
- Data sheet: https://www.teknorapex.com/datasheet/pdf/en/287329.pdf
- Note: Teknor Apex: series "Biocompatible, ISO 10993-5 compliant" (cytotoxicity only, so ISO 10993 column left blank); sterilization by e-beam, gamma and EtO. Datasheet lists autoclave and EtO sterilizable. Coded cytotoxicity-only 2026-10-20 per Teknor Apex Medalist tubing sell sheet ("Biocompatible, ISO 10993-5 compliant").

## Medalist MD-12368 (Teknor Apex, TPE (medical tubing))
- Page: https://medresin.com/grades/teknor-apex-medalist-md-12368
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://www.teknorapex.com/content/dam/teknorapex/teknor-pardot-assets-/Medalist___Medical_Elastomers_for_Medical_Tubing.pdf
- Data sheet: https://www.teknorapex.com/datasheet/pdf/en/211311.pdf
- Note: Teknor Apex: series "Biocompatible, ISO 10993-5 compliant" (cytotoxicity only, so ISO 10993 column left blank); sterilization by e-beam, gamma and EtO. Datasheet lists autoclave and EtO sterilizable. Coded cytotoxicity-only 2026-10-20 per Teknor Apex Medalist tubing sell sheet ("Biocompatible, ISO 10993-5 compliant").

## Medalist MD-12372 (Teknor Apex, TPE (medical tubing))
- Page: https://medresin.com/grades/teknor-apex-medalist-md-12372
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://www.teknorapex.com/content/dam/teknorapex/teknor-pardot-assets-/Medalist___Medical_Elastomers_for_Medical_Tubing.pdf
- Note: Teknor Apex: series "Biocompatible, ISO 10993-5 compliant" (cytotoxicity only, so ISO 10993 column left blank); sterilization by e-beam, gamma and EtO. Coded cytotoxicity-only 2026-10-20 per Teknor Apex Medalist tubing sell sheet ("Biocompatible, ISO 10993-5 compliant").

## Medalist MD-12382 (Teknor Apex, TPE (medical tubing))
- Page: https://medresin.com/grades/teknor-apex-medalist-md-12382
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://www.teknorapex.com/content/dam/teknorapex/teknor-pardot-assets-/Medalist___Medical_Elastomers_for_Medical_Tubing.pdf
- Note: Teknor Apex: series "Biocompatible, ISO 10993-5 compliant" (cytotoxicity only, so ISO 10993 column left blank); sterilization by e-beam, gamma and EtO. Coded cytotoxicity-only 2026-10-20 per Teknor Apex Medalist tubing sell sheet ("Biocompatible, ISO 10993-5 compliant").

## Medalist MD-91760 (Teknor Apex, TPE (biopharma tubing))
- Page: https://medresin.com/grades/teknor-apex-medalist-md-91760
- USP VI: yes
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://www.teknorapex.com/content/dam/teknorapex/en-us/pdf/technical-literature/Medalist_SellSheet_FINAL.pdf
- Note: Teknor Apex: MD-90000 series meets USP Class VI and ISO 10993-5 (cytotoxicity; ISO column left blank); sterilizable by EO, gamma, e-beam, X-ray and autoclaving.

## Medalist MD-91970 (Teknor Apex, TPE (biopharma tubing))
- Page: https://medresin.com/grades/teknor-apex-medalist-md-91970
- USP VI: yes
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://www.teknorapex.com/content/dam/teknorapex/en-us/pdf/technical-literature/Medalist_SellSheet_FINAL.pdf
- Note: Teknor Apex: MD-90000 series meets USP Class VI and ISO 10993-5 (cytotoxicity; ISO column left blank); sterilizable by EO, gamma, e-beam, X-ray and autoclaving.

## Medalist MD-96267 (Teknor Apex, TPE (biopharma tubing))
- Page: https://medresin.com/grades/teknor-apex-medalist-md-96267
- USP VI: yes
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://www.teknorapex.com/content/dam/teknorapex/en-us/pdf/technical-literature/Medalist_SellSheet_FINAL.pdf
- Note: Teknor Apex: MD-90000 series meets USP Class VI and ISO 10993-5 (cytotoxicity; ISO column left blank); sterilizable by EO, gamma, e-beam, X-ray and autoclaving.

## Medalist MD-92260 (Teknor Apex, TPE (biopharma tubing))
- Page: https://medresin.com/grades/teknor-apex-medalist-md-92260
- USP VI: yes
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://www.teknorapex.com/content/dam/teknorapex/en-us/pdf/technical-literature/Medalist_SellSheet_FINAL.pdf
- Note: Teknor Apex: MD-90000 series meets USP Class VI and ISO 10993-5 (cytotoxicity; ISO column left blank); sterilizable by EO, gamma, e-beam, X-ray and autoclaving.

## Texin RxT80A (Covestro, TPU)
- Page: https://medresin.com/grades/covestro-texin-rxt80a
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: no
- VHP: not stated
- FDA master file: not stated
- Source: https://solutions.covestro.com/-/media/covestro/solution-center/story/brochures/covestro_healthcare-reference-guide_2025_new.pdf
- Note: Covestro: Texin Rx biocompatible TPU; ISO 10993 and USP Class VI per portfolio statement; sterilize with EtO, gamma or e-beam; do not steam autoclave.

## Texin RxT76D (Covestro, TPU)
- Page: https://medresin.com/grades/covestro-texin-rxt76d
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: no
- VHP: not stated
- FDA master file: not stated
- Source: https://solutions.covestro.com/-/media/covestro/solution-center/story/brochures/covestro_healthcare-reference-guide_2025_new.pdf
- Note: Covestro: Texin Rx biocompatible TPU; ISO 10993 and USP Class VI per portfolio statement; sterilize with EtO, gamma or e-beam; do not steam autoclave.

## Texin RxS292 (Covestro, TPU)
- Page: https://medresin.com/grades/covestro-texin-rxs292
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: no
- VHP: not stated
- FDA master file: not stated
- Source: https://solutions.covestro.com/-/media/covestro/solution-center/story/brochures/covestro_healthcare-reference-guide_2025_new.pdf
- Note: Covestro: Texin Rx biocompatible TPU; ISO 10993 and USP Class VI per portfolio statement; sterilize with EtO, gamma or e-beam; do not steam autoclave.

## 23R2B (INVISTA, PP)
- Page: https://medresin.com/grades/invista-23r2b
- USP VI: yes
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://invista-pp.com/InvistaPolypropylene/media/PolypropyleneGeneral/25-INV-Polypropylene-Medical-Brochure-V4.pdf
- Note: INVISTA: biocompatibility results incl. USP <88> Class VI and ISO 10993-5 (cytotoxicity) for all MedSelect grades; "Radiation" sterilization listed as gamma.

## 12G50M (INVISTA, PP)
- Page: https://medresin.com/grades/invista-12g50m
- USP VI: yes
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://invista-pp.com/InvistaPolypropylene/media/PolypropyleneGeneral/25-INV-Polypropylene-Medical-Brochure-V4.pdf
- Note: INVISTA: biocompatibility results incl. USP <88> Class VI and ISO 10993-5 (cytotoxicity) for all MedSelect grades; "Radiation" sterilization listed as gamma.

## NAS 90 (INEOS Styrolution, SMMA)
- Page: https://medresin.com/grades/ineos-styrolution-nas-90
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: DMF
- Source: https://www.ineos.com/contentassets/b97fc78f6a874895bf6506c5a8d97477/brochure_healthcare_global-emea_revaugust2026.pdf
- Note: INEOS Styrolution Essential HD package: USP Class VI, ISO 10993 compliance and DMF can be provided. Sterilization table: gamma, e-beam, EtO, NO2 (steam not ticked).

## Zylar 245 (INEOS Styrolution, MBS)
- Page: https://medresin.com/grades/ineos-styrolution-zylar-245
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: DMF
- Source: https://www.ineos.com/contentassets/b97fc78f6a874895bf6506c5a8d97477/brochure_healthcare_global-emea_revaugust2026.pdf
- Note: INEOS Styrolution Essential HD package: USP Class VI, ISO 10993 compliance and DMF can be provided. Sterilization table: gamma, e-beam, EtO, NO2 (steam not ticked).

## Zylar 550 (INEOS Styrolution, MBS)
- Page: https://medresin.com/grades/ineos-styrolution-zylar-550
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: DMF
- Source: https://www.ineos.com/contentassets/b97fc78f6a874895bf6506c5a8d97477/brochure_healthcare_global-emea_revaugust2026.pdf
- Note: INEOS Styrolution Essential HD package: USP Class VI, ISO 10993 compliance and DMF can be provided. Sterilization table: gamma, e-beam, EtO, NO2 (steam not ticked).

## Zylar 650 (INEOS Styrolution, MBS)
- Page: https://medresin.com/grades/ineos-styrolution-zylar-650
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: DMF
- Source: https://www.ineos.com/contentassets/b97fc78f6a874895bf6506c5a8d97477/brochure_healthcare_global-emea_revaugust2026.pdf
- Note: INEOS Styrolution Essential HD package: USP Class VI, ISO 10993 compliance and DMF can be provided. Sterilization table: gamma, e-beam, EtO, NO2 (steam not ticked).

## Styroflex 4G80 (INEOS Styrolution, S-TPE)
- Page: https://medresin.com/grades/ineos-styrolution-styroflex-4g80
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: DMF
- Source: https://www.ineos.com/contentassets/b97fc78f6a874895bf6506c5a8d97477/brochure_healthcare_global-emea_revaugust2026.pdf
- Note: INEOS Styrolution Essential HD package: USP Class VI, ISO 10993 compliance and DMF can be provided. Sterilization table: gamma, e-beam, EtO, NO2 (steam not ticked).

## Styrolux 3G46 (INEOS Styrolution, SBC)
- Page: https://medresin.com/grades/ineos-styrolution-styrolux-3g46
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: DMF
- Source: https://www.ineos.com/contentassets/b97fc78f6a874895bf6506c5a8d97477/brochure_healthcare_global-emea_revaugust2026.pdf
- Note: INEOS Styrolution Essential HD package: USP Class VI, ISO 10993 compliance and DMF can be provided. Sterilization table: gamma, e-beam, EtO, NO2 (steam not ticked).

## Styrolux 684D (INEOS Styrolution, SBC)
- Page: https://medresin.com/grades/ineos-styrolution-styrolux-684d
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: DMF
- Source: https://www.ineos.com/contentassets/b97fc78f6a874895bf6506c5a8d97477/brochure_healthcare_global-emea_revaugust2026.pdf
- Note: INEOS Styrolution Essential HD package: USP Class VI, ISO 10993 compliance and DMF can be provided. Sterilization table: gamma, e-beam, EtO, NO2 (steam not ticked).

## K-Resin KR03/KR05/DK11 (INEOS Styrolution, SBC)
- Page: https://medresin.com/grades/ineos-styrolution-k-resin-kr03-kr05-dk11
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: DMF
- Source: https://www.ineos.com/contentassets/b97fc78f6a874895bf6506c5a8d97477/brochure_healthcare_global-emea_revaugust2026.pdf
- Note: INEOS Styrolution Essential HD package: USP Class VI, ISO 10993 compliance and DMF can be provided. Sterilization table: gamma, e-beam, EtO, NO2 (steam not ticked).

## Luran S MED 797S SPF30 (INEOS Styrolution, ASA)
- Page: https://medresin.com/grades/ineos-styrolution-luran-s-med-797s-spf30
- USP VI: not stated
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://www.ineos.com/contentassets/b97fc78f6a874895bf6506c5a8d97477/brochure_healthcare_global-emea_revaugust2026.pdf
- Note: INEOS Styrolution sterilization table lists Luran S Med for gamma, e-beam, EtO and NO2. INEOS regulatory table (rev. August 2026, p.31): biocompatibility tests ISO 10993-5 (cytotoxicity) and ISO 10993-10 (hypersensitivity); USP Class VI and DMF not listed (checked 2026-10-20).

## Luran S MED 797S FC (INEOS Styrolution, ASA)
- Page: https://medresin.com/grades/ineos-styrolution-luran-s-med-797s-fc
- USP VI: not stated
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://www.ineos.com/contentassets/b97fc78f6a874895bf6506c5a8d97477/brochure_healthcare_global-emea_revaugust2026.pdf
- Note: INEOS Styrolution sterilization table lists Luran S Med for gamma, e-beam, EtO and NO2. INEOS regulatory table (rev. August 2026, p.31): biocompatibility tests ISO 10993-5 (cytotoxicity) and ISO 10993-10 (hypersensitivity); USP Class VI and DMF not listed (checked 2026-10-20).

## Ultraform S2320 003 PRO TR AT (BASF, POM (tribologically modified))
- Page: https://medresin.com/grades/basf-ultraform-s2320-003-pro-tr-at
- USP VI: yes
- ISO 10993: yes
- Gamma: limited
- EtO: yes
- Autoclave: limited
- VHP: not stated
- FDA master file: DMF
- Source: https://download.basf.com/p1/8a8081c57fd4b609018021fe1bcc1c95/en/Ultraform%C2%AE_PRO_%28POM%29_and_Ultradur%C2%AE_PRO_%28PBT%29_-_Engineering_Plastics_for_Medical_Solutions_Brochure_English.pdf?view=
- Autoclave/steam (as stated): 121 °C and 134 °C: limited resistance; 143 °C: no resistance (depends on conditions, duration and number of cycles)
- Note: BASF sterilization table: Ultraform PRO steam limited, gamma/e-beam limited, EtO and plasma full resistance. BASF brochure p.11 compliance table: USP Class VI yes, cytotoxicity (ISO 10993-5) yes, DMF 34209 (checked 2026-10-20).

## Ultraform W2320 003 PRO TR AT (BASF, POM (tribologically modified))
- Page: https://medresin.com/grades/basf-ultraform-w2320-003-pro-tr-at
- USP VI: not stated
- ISO 10993: not stated
- Gamma: limited
- EtO: yes
- Autoclave: limited
- VHP: not stated
- FDA master file: not stated
- Source: https://download.basf.com/p1/8a8081c57fd4b609018021fe1bcc1c95/en/Ultraform%C2%AE_PRO_%28POM%29_and_Ultradur%C2%AE_PRO_%28PBT%29_-_Engineering_Plastics_for_Medical_Solutions_Brochure_English.pdf?view=
- Autoclave/steam (as stated): 121 °C and 134 °C: limited resistance; 143 °C: no resistance (depends on conditions, duration and number of cycles)
- Note: BASF sterilization table: Ultraform PRO steam limited, gamma/e-beam limited, EtO and plasma full resistance. BASF brochure p.11 compliance table shows "–" for USP Class VI, cytotoxicity and DMF for this TR grade (checked 2026-10-20), so biocompatibility is left blank.

## Delrin SC631 (Delrin (formerly DuPont), POM (homopolymer))
- Page: https://medresin.com/grades/delrin-formerly-dupont-delrin-sc631
- USP VI: not stated
- ISO 10993: not stated
- Gamma: not stated
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://www.delrin.com/wp-content/uploads/2024/02/Delrin-Healthcare-Brochure-NA-RevFNL.pdf
- Autoclave/steam (as stated): "a number of repeat autoclave cycles" (not quantified)
- Note: Delrin healthcare brochure: SC grades tested against relevant parts of ISO 10993 (-5, -11) and selected parts of USP Class VI (so both columns left blank); compatible with EtO and a number of repeat autoclave cycles.

## Delrin SC655 (Delrin (formerly DuPont), POM (homopolymer))
- Page: https://medresin.com/grades/delrin-formerly-dupont-delrin-sc655
- USP VI: not stated
- ISO 10993: not stated
- Gamma: not stated
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://www.delrin.com/wp-content/uploads/2024/02/Delrin-Healthcare-Brochure-NA-RevFNL.pdf
- Autoclave/steam (as stated): "a number of repeat autoclave cycles" (not quantified)
- Note: Delrin healthcare brochure: SC grades tested against relevant parts of ISO 10993 (-5, -11) and selected parts of USP Class VI (so both columns left blank); compatible with EtO and a number of repeat autoclave cycles.

## Delrin RASC655 (Delrin (formerly DuPont), POM (homopolymer))
- Page: https://medresin.com/grades/delrin-formerly-dupont-delrin-rasc655
- USP VI: not stated
- ISO 10993: not stated
- Gamma: not stated
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://www.delrin.com/wp-content/uploads/2024/02/Delrin-Healthcare-Brochure-NA-RevFNL.pdf
- Autoclave/steam (as stated): "a number of repeat autoclave cycles" (not quantified)
- Note: Delrin healthcare brochure: SC grades tested against relevant parts of ISO 10993 (-5, -11) and selected parts of USP Class VI (so both columns left blank); compatible with EtO and a number of repeat autoclave cycles.

## Delrin SC690 (Delrin (formerly DuPont), POM (homopolymer))
- Page: https://medresin.com/grades/delrin-formerly-dupont-delrin-sc690
- USP VI: not stated
- ISO 10993: not stated
- Gamma: not stated
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://www.delrin.com/wp-content/uploads/2024/02/Delrin-Healthcare-Brochure-NA-RevFNL.pdf
- Autoclave/steam (as stated): "a number of repeat autoclave cycles" (not quantified)
- Note: Delrin healthcare brochure: SC grades tested against relevant parts of ISO 10993 (-5, -11) and selected parts of USP Class VI (so both columns left blank); compatible with EtO and a number of repeat autoclave cycles. PC690 variant: FDA DMF available.

## Delrin SC698 (Delrin (formerly DuPont), POM (homopolymer))
- Page: https://medresin.com/grades/delrin-formerly-dupont-delrin-sc698
- USP VI: not stated
- ISO 10993: not stated
- Gamma: not stated
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://www.delrin.com/wp-content/uploads/2024/02/Delrin-Healthcare-Brochure-NA-RevFNL.pdf
- Autoclave/steam (as stated): "a number of repeat autoclave cycles" (not quantified)
- Note: Delrin healthcare brochure: SC grades tested against relevant parts of ISO 10993 (-5, -11) and selected parts of USP Class VI (so both columns left blank); compatible with EtO and a number of repeat autoclave cycles.

## Delrin RASC698 (Delrin (formerly DuPont), POM (homopolymer))
- Page: https://medresin.com/grades/delrin-formerly-dupont-delrin-rasc698
- USP VI: not stated
- ISO 10993: not stated
- Gamma: not stated
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://www.delrin.com/wp-content/uploads/2024/02/Delrin-Healthcare-Brochure-NA-RevFNL.pdf
- Autoclave/steam (as stated): "a number of repeat autoclave cycles" (not quantified)
- Note: Delrin healthcare brochure: SC grades tested against relevant parts of ISO 10993 (-5, -11) and selected parts of USP Class VI (so both columns left blank); compatible with EtO and a number of repeat autoclave cycles.

## TECAPEEK MT natural (Ensinger, PEEK (stock shapes))
- Page: https://medresin.com/grades/ensinger-tecapeek-mt-natural
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: not stated
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://www.ensingerplastics.com/en/shapes/medical-peek-tecapeek-mt-natural
- Data sheet: https://www.ensingerplastics.com/en/shapes/medical-peek-tecapeek-mt-natural
- Note: Ensinger: stock shapes tested to ISO 10993 and USP Class VI; resistant to repeated steam autoclaving; very good resistance to high-energy radiation (listed as gamma). Stock shapes, not molding resin.

## ULTEM HU1000 (SABIC, PEI)
- Page: https://medresin.com/grades/sabic-ultem-hu1000
- USP VI: not stated
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: yes
- FDA master file: not stated
- Source: https://materialfinder.sabic-specialties.com/material/ultem-resin-hu1000
- Data sheet: https://materialfinder.sabic-specialties.com/material/ultem-resin-hu1000
- Note: SABIC: "biocompatible (ISO 10993 or USP Class VI)" - feature list names ISO 10993, so USP column left blank. Healthcare management of change applies. SABIC: may offer steam, hydrogen peroxide, gamma, EtO, UV-C and e-beam resistance for repeated sterilization cycles.

## ULTEM HU1010 (SABIC, PEI)
- Page: https://medresin.com/grades/sabic-ultem-hu1010
- USP VI: not stated
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: yes
- FDA master file: not stated
- Source: https://materialfinder.sabic-specialties.com/material/ultem-resin-hu1010
- Data sheet: https://materialfinder.sabic-specialties.com/material/ultem-resin-hu1010
- Note: SABIC: "biocompatible (ISO 10993 or USP Class VI)" - feature list names ISO 10993, so USP column left blank. Healthcare management of change applies. SABIC: may offer steam, hydrogen peroxide, gamma, EtO, UV-C and e-beam resistance for repeated sterilization cycles.

## ULTEM HU2300 (SABIC, PEI (30% GF))
- Page: https://medresin.com/grades/sabic-ultem-hu2300
- USP VI: not stated
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: yes
- FDA master file: not stated
- Source: https://materialfinder.sabic-specialties.com/material/ultem-resin-hu2300
- Data sheet: https://materialfinder.sabic-specialties.com/material/ultem-resin-hu2300
- Note: SABIC: "biocompatible (ISO 10993 or USP Class VI)" - feature list names ISO 10993, so USP column left blank. Healthcare management of change applies. SABIC: may offer steam, hydrogen peroxide, gamma, EtO, UV-C and e-beam resistance for repeated sterilization cycles.

## ULTEM HU1100 (SABIC, PEI)
- Page: https://medresin.com/grades/sabic-ultem-hu1100
- USP VI: not stated
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://materialfinder.sabic-specialties.com/material/ultem-resin-hu1100
- Data sheet: https://materialfinder.sabic-specialties.com/material/ultem-resin-hu1100
- Note: SABIC: "biocompatible (ISO 10993 or USP Class VI)" - feature list names ISO 10993, so USP column left blank. Healthcare management of change applies. SABIC: steam, gamma, EtO and e-beam sterilizable.

## ULTEM HU2100 (SABIC, PEI (10% GF))
- Page: https://medresin.com/grades/sabic-ultem-hu2100
- USP VI: not stated
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://materialfinder.sabic-specialties.com/material/ultem-resin-hu2100
- Data sheet: https://materialfinder.sabic-specialties.com/material/ultem-resin-hu2100
- Note: SABIC: "biocompatible (ISO 10993 or USP Class VI)" - feature list names ISO 10993, so USP column left blank. Healthcare management of change applies. SABIC: steam, gamma, EtO and e-beam sterilizable.

## ULTEM HU2200 (SABIC, PEI (20% GF))
- Page: https://medresin.com/grades/sabic-ultem-hu2200
- USP VI: not stated
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://materialfinder.sabic-specialties.com/material/ultem-resin-hu2200
- Data sheet: https://materialfinder.sabic-specialties.com/material/ultem-resin-hu2200
- Note: SABIC: "biocompatible (ISO 10993 or USP Class VI)" - feature list names ISO 10993, so USP column left blank. Healthcare management of change applies. SABIC: steam, gamma, EtO and e-beam sterilizable.

## LEXAN HPX4 (SABIC, PC copolymer)
- Page: https://medresin.com/grades/sabic-lexan-hpx4
- USP VI: not stated
- ISO 10993: yes
- Gamma: not stated
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://materialfinder.sabic-specialties.com/material/lexan-copolymer-hpx4
- Data sheet: https://materialfinder.sabic-specialties.com/material/lexan-copolymer-hpx4
- Note: SABIC: "biocompatible (ISO 10993 or USP Class VI)" - feature list names ISO 10993, so USP column left blank. Healthcare management of change applies. SABIC: EtO and steam sterilizable; improved autoclavability.

## LEXAN HPX8R (SABIC, PC copolymer)
- Page: https://medresin.com/grades/sabic-lexan-hpx8r
- USP VI: not stated
- ISO 10993: yes
- Gamma: not stated
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://materialfinder.sabic-specialties.com/material/lexan-copolymer-hpx8r
- Data sheet: https://materialfinder.sabic-specialties.com/material/lexan-copolymer-hpx8r
- Note: SABIC: "biocompatible (ISO 10993 or USP Class VI)" - feature list names ISO 10993, so USP column left blank. Healthcare management of change applies. SABIC: EtO sterilizable; contains mold release.

## LEXAN HPX8REU (SABIC, PC copolymer)
- Page: https://medresin.com/grades/sabic-lexan-hpx8reu
- USP VI: not stated
- ISO 10993: yes
- Gamma: not stated
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://materialfinder.sabic-specialties.com/material/lexan-copolymer-hpx8reu
- Data sheet: https://materialfinder.sabic-specialties.com/material/lexan-copolymer-hpx8reu
- Note: SABIC: "biocompatible (ISO 10993 or USP Class VI)" - feature list names ISO 10993, so USP column left blank. Healthcare management of change applies. SABIC: EtO sterilizable; contains mold release (Europe).

## CYCOLOY HCX1640 (SABIC, PC/ABS)
- Page: https://medresin.com/grades/sabic-cycoloy-hcx1640
- USP VI: not stated
- ISO 10993: not stated
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://materialfinder.sabic-specialties.com/material/cycoloy-non-fr-resin-hcx1640
- Data sheet: https://materialfinder.sabic-specialties.com/material/cycoloy-non-fr-resin-hcx1640
- Note: SABIC: biocompatible grade for medical devices and pharmaceutical applications (standard not named); sterilization not stated.

## TOPAS 6015S-04 (TOPAS Advanced Polymers, COC)
- Page: https://medresin.com/grades/topas-advanced-polymers-topas-6015s-04
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://topas.com/wp-content/uploads/2023/05/TOPAS-Medical-Brochure.pdf
- Autoclave/steam (as stated): hot steam 121, 134 and 143 °C: + (base type 6015)
- Data sheet: https://topas.com/wp-content/uploads/2023/05/TDS_6015S-04_english-units.pdf
- Note: Sterilization from the TOPAS medical brochure table for the base type (6015); the grade datasheet does not state medical compliance. TOPAS states studied COC grades meet USP Class VI and ISO 10993 but does not list which grades, so those columns are blank.

## TOPAS 5013S-04 (TOPAS Advanced Polymers, COC)
- Page: https://medresin.com/grades/topas-advanced-polymers-topas-5013s-04
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: no
- VHP: not stated
- FDA master file: not stated
- Source: https://topas.com/wp-content/uploads/2023/05/TOPAS-Medical-Brochure.pdf
- Data sheet: https://topas.com/wp-content/uploads/2023/04/TDS-5013S-04_e_US.pdf
- Note: Sterilization from the TOPAS medical brochure table for the base type (5013); the grade datasheet does not state medical compliance. TOPAS states studied COC grades meet USP Class VI and ISO 10993 but does not list which grades, so those columns are blank.

## VICTREX PC (family) (Victrex, PEEK)
- Page: https://medresin.com/grades/victrex-victrex-pc-family
- USP VI: yes
- ISO 10993: not stated
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://www.victrex.com/en/pc
- Note: Victrex: VICTREX PC meets USP Class VI and USP <661> for non-implantable pharmaceutical contact applications. Individual grades and sterilization not listed on the page.

## Radel R-5100 (Syensqo (Solvay), PPSU)
- Page: https://medresin.com/grades/syensqo-solvay-radel-r-5100
- USP VI: not stated
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: yes
- FDA master file: MAF
- Source: https://www.syensqo.com/en/brands/radel-ppsu/healthcare
- Autoclave/steam (as stated): Over 1,000 steam cycles without significant loss of properties or appearance (Radel PPSU)
- Note: Radel PPSU healthcare page: ISO 10993 tested, limited exposure (<24 h); compatible with steam, EtO, gamma and VHP. R-5100 listed in Syensqo healthcare TDS library.

## Udel P-1700 (Syensqo (Solvay), PSU)
- Page: https://medresin.com/grades/syensqo-solvay-udel-p-1700
- USP VI: yes
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://www.syensqo.com/en/brands/udel-psu/faq
- Additional source: https://www.syensqo.com/en/solutions-market/healthcare/medical-devices-equipment/biopharma-processing
- Note: Udel FAQ: good resistance to steam, EtO, gamma, plasma and chemical sterilization (lower than Radel PPSU). Biopharma page: Udel PSU tested to USP Class VI before and after gamma.

## Pebax 1074 SA 01 MED (Arkema, PEBA)
- Page: https://medresin.com/grades/arkema-pebax-1074-sa-01-med
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://hpp.arkema.com/en/product-families/pebax-elastomer-family/regulatory-compliance/
- Additional source: https://hpp.arkema.com/en/markets-and-applications/healthcare/catherters-and-mediacl-tubing/
- Note: USP Class VI per Arkema Pebax regulatory table. All Pebax MED grades tested for ISO 10993-4 and -5 and are gamma, steam and ETO sterilizable (Arkema).

## Pebax 2533 SA 01 MED (Arkema, PEBA)
- Page: https://medresin.com/grades/arkema-pebax-2533-sa-01-med
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://hpp.arkema.com/en/product-families/pebax-elastomer-family/regulatory-compliance/
- Additional source: https://hpp.arkema.com/en/markets-and-applications/healthcare/catherters-and-mediacl-tubing/
- Note: USP Class VI per Arkema Pebax regulatory table. All Pebax MED grades tested for ISO 10993-4 and -5 and are gamma, steam and ETO sterilizable (Arkema).

## Pebax 3533 SA 01 MED (Arkema, PEBA)
- Page: https://medresin.com/grades/arkema-pebax-3533-sa-01-med
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://hpp.arkema.com/en/product-families/pebax-elastomer-family/regulatory-compliance/
- Additional source: https://hpp.arkema.com/en/markets-and-applications/healthcare/catherters-and-mediacl-tubing/
- Note: USP Class VI per Arkema Pebax regulatory table. All Pebax MED grades tested for ISO 10993-4 and -5 and are gamma, steam and ETO sterilizable (Arkema).

## Pebax 4033 SA 01 MED (Arkema, PEBA)
- Page: https://medresin.com/grades/arkema-pebax-4033-sa-01-med
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://hpp.arkema.com/en/product-families/pebax-elastomer-family/regulatory-compliance/
- Additional source: https://hpp.arkema.com/en/markets-and-applications/healthcare/catherters-and-mediacl-tubing/
- Note: USP Class VI per Arkema Pebax regulatory table. All Pebax MED grades tested for ISO 10993-4 and -5 and are gamma, steam and ETO sterilizable (Arkema).

## Pebax 4533 SA 01 MED (Arkema, PEBA)
- Page: https://medresin.com/grades/arkema-pebax-4533-sa-01-med
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://hpp.arkema.com/en/product-families/pebax-elastomer-family/regulatory-compliance/
- Additional source: https://hpp.arkema.com/en/markets-and-applications/healthcare/catherters-and-mediacl-tubing/
- Note: USP Class VI per Arkema Pebax regulatory table. All Pebax MED grades tested for ISO 10993-4 and -5 and are gamma, steam and ETO sterilizable (Arkema).

## Pebax 5533 SA 01 MED (Arkema, PEBA)
- Page: https://medresin.com/grades/arkema-pebax-5533-sa-01-med
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://hpp.arkema.com/en/product-families/pebax-elastomer-family/regulatory-compliance/
- Additional source: https://hpp.arkema.com/en/markets-and-applications/healthcare/catherters-and-mediacl-tubing/
- Note: USP Class VI per Arkema Pebax regulatory table. All Pebax MED grades tested for ISO 10993-4 and -5 and are gamma, steam and ETO sterilizable (Arkema).

## Pebax 6333 SA 01 MED (Arkema, PEBA)
- Page: https://medresin.com/grades/arkema-pebax-6333-sa-01-med
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://hpp.arkema.com/en/product-families/pebax-elastomer-family/regulatory-compliance/
- Additional source: https://hpp.arkema.com/en/markets-and-applications/healthcare/catherters-and-mediacl-tubing/
- Note: USP Class VI per Arkema Pebax regulatory table. All Pebax MED grades tested for ISO 10993-4 and -5 and are gamma, steam and ETO sterilizable (Arkema).

## Pebax 7033 SA 01 MED (Arkema, PEBA)
- Page: https://medresin.com/grades/arkema-pebax-7033-sa-01-med
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://hpp.arkema.com/en/product-families/pebax-elastomer-family/regulatory-compliance/
- Additional source: https://hpp.arkema.com/en/markets-and-applications/healthcare/catherters-and-mediacl-tubing/
- Note: USP Class VI per Arkema Pebax regulatory table. All Pebax MED grades tested for ISO 10993-4 and -5 and are gamma, steam and ETO sterilizable (Arkema).

## Pebax 7233 SA 01 MED (Arkema, PEBA)
- Page: https://medresin.com/grades/arkema-pebax-7233-sa-01-med
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://hpp.arkema.com/en/product-families/pebax-elastomer-family/regulatory-compliance/
- Additional source: https://hpp.arkema.com/en/markets-and-applications/healthcare/catherters-and-mediacl-tubing/
- Note: USP Class VI per Arkema Pebax regulatory table. All Pebax MED grades tested for ISO 10993-4 and -5 and are gamma, steam and ETO sterilizable (Arkema).

## Kynar 720 MED (Arkema, PVDF)
- Page: https://medresin.com/grades/arkema-kynar-720-med
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://hpp.arkema.com/en/products/product/f/flup_hpp_Kynar/p/kynar-720-med/
- Data sheet: https://hpp.arkema.com/assets/arkema/TDS_KYNAR%C2%AE%20720%20MED_en_WW.pdf
- Note: TDS: resistant to gamma, steam and ETO sterilization; USP Class VI and ISO 10993-4/-5 compliance letters on request.

## Bormed DM55pharm (Borealis, PP)
- Page: https://medresin.com/grades/borealis-bormed-dm55pharm
- USP VI: not stated
- ISO 10993: not stated
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: DMF 009146
- Source: https://www.borealisgroup.com/storage/Industries/Healthcare-literature/SummaryDataSheet_Healthcare_062025.pdf
- Note: US DMF number per Borealis Bormed summary data sheet; pharmacopeia/ISO 10993 status per grade medical statement.

## Bormed HD800CF (Borealis, PP)
- Page: https://medresin.com/grades/borealis-bormed-hd800cf
- USP VI: not stated
- ISO 10993: not stated
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: DMF 020240
- Source: https://www.borealisgroup.com/storage/Industries/Healthcare-literature/SummaryDataSheet_Healthcare_062025.pdf
- Note: US DMF number per Borealis Bormed summary data sheet; pharmacopeia/ISO 10993 status per grade medical statement.

## Bormed HD850MO (Borealis, PP)
- Page: https://medresin.com/grades/borealis-bormed-hd850mo
- USP VI: not stated
- ISO 10993: not stated
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: DMF 017929
- Source: https://www.borealisgroup.com/storage/Industries/Healthcare-literature/SummaryDataSheet_Healthcare_062025.pdf
- Note: US DMF number per Borealis Bormed summary data sheet; pharmacopeia/ISO 10993 status per grade medical statement.

## Bormed HD810MO (Borealis, PP)
- Page: https://medresin.com/grades/borealis-bormed-hd810mo
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: DMF 009040
- Source: https://www.borealisgroup.com/storage/Industries/Healthcare-literature/SummaryDataSheet_Healthcare_062025.pdf
- Additional source: https://www.borealisgroup.com/storage/Industries/Healthcare-literature/Brochure_BormedSolutionsHealthcare_032025.pdf
- Note: Radiation package; Borealis states it was specially developed for gamma irradiation. US DMF number per Borealis Bormed summary data sheet; pharmacopeia/ISO 10993 status per grade medical statement.

## Bormed HF840MO (Borealis, PP)
- Page: https://medresin.com/grades/borealis-bormed-hf840mo
- USP VI: not stated
- ISO 10993: not stated
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: DMF 009040
- Source: https://www.borealisgroup.com/storage/Industries/Healthcare-literature/SummaryDataSheet_Healthcare_062025.pdf
- Note: US DMF number per Borealis Bormed summary data sheet; pharmacopeia/ISO 10993 status per grade medical statement.

## Bormed HG820MO (Borealis, PP)
- Page: https://medresin.com/grades/borealis-bormed-hg820mo
- USP VI: not stated
- ISO 10993: not stated
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: DMF 027799
- Source: https://www.borealisgroup.com/storage/Industries/Healthcare-literature/SummaryDataSheet_Healthcare_062025.pdf
- Note: US DMF number per Borealis Bormed summary data sheet; pharmacopeia/ISO 10993 status per grade medical statement.

## Bormed RB801CF (Borealis, PP)
- Page: https://medresin.com/grades/borealis-bormed-rb801cf
- USP VI: not stated
- ISO 10993: not stated
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: DMF 028484
- Source: https://www.borealisgroup.com/storage/Industries/Healthcare-literature/SummaryDataSheet_Healthcare_062025.pdf
- Note: US DMF number per Borealis Bormed summary data sheet; pharmacopeia/ISO 10993 status per grade medical statement.

## Bormed RD804CF (Borealis, PP)
- Page: https://medresin.com/grades/borealis-bormed-rd804cf
- USP VI: not stated
- ISO 10993: not stated
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: DMF 028486
- Source: https://www.borealisgroup.com/storage/Industries/Healthcare-literature/SummaryDataSheet_Healthcare_062025.pdf
- Note: US DMF number per Borealis Bormed summary data sheet; pharmacopeia/ISO 10993 status per grade medical statement.

## Bormed RD808CF (Borealis, PP)
- Page: https://medresin.com/grades/borealis-bormed-rd808cf
- USP VI: not stated
- ISO 10993: not stated
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: DMF 028487
- Source: https://www.borealisgroup.com/storage/Industries/Healthcare-literature/SummaryDataSheet_Healthcare_062025.pdf
- Note: US DMF number per Borealis Bormed summary data sheet; pharmacopeia/ISO 10993 status per grade medical statement.

## Bormed RD834CF (Borealis, PP)
- Page: https://medresin.com/grades/borealis-bormed-rd834cf
- USP VI: not stated
- ISO 10993: not stated
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: DMF 031866
- Source: https://www.borealisgroup.com/storage/Industries/Healthcare-literature/SummaryDataSheet_Healthcare_062025.pdf
- Note: US DMF number per Borealis Bormed summary data sheet; pharmacopeia/ISO 10993 status per grade medical statement.

## Bormed RE816CF (Borealis, PP)
- Page: https://medresin.com/grades/borealis-bormed-re816cf
- USP VI: not stated
- ISO 10993: not stated
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: DMF 028485
- Source: https://www.borealisgroup.com/storage/Industries/Healthcare-literature/SummaryDataSheet_Healthcare_062025.pdf
- Note: US DMF number per Borealis Bormed summary data sheet; pharmacopeia/ISO 10993 status per grade medical statement.

## Bormed RF825MO (Borealis, PP)
- Page: https://medresin.com/grades/borealis-bormed-rf825mo
- USP VI: not stated
- ISO 10993: not stated
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: DMF 031607
- Source: https://www.borealisgroup.com/storage/Industries/Healthcare-literature/SummaryDataSheet_Healthcare_062025.pdf
- Note: US DMF number per Borealis Bormed summary data sheet; pharmacopeia/ISO 10993 status per grade medical statement.

## Bormed RF830MO (Borealis, PP)
- Page: https://medresin.com/grades/borealis-bormed-rf830mo
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: DMF 031609
- Source: https://www.borealisgroup.com/storage/Industries/Healthcare-literature/SummaryDataSheet_Healthcare_062025.pdf
- Additional source: https://www.borealisgroup.com/storage/Industries/Healthcare-literature/Brochure_BormedSolutionsHealthcare_032025.pdf
- Note: Radiation package; Borealis states it was specially developed for gamma irradiation. US DMF number per Borealis Bormed summary data sheet; pharmacopeia/ISO 10993 status per grade medical statement.

## Bormed RG835MO (Borealis, PP)
- Page: https://medresin.com/grades/borealis-bormed-rg835mo
- USP VI: not stated
- ISO 10993: not stated
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: DMF 031608
- Source: https://www.borealisgroup.com/storage/Industries/Healthcare-literature/SummaryDataSheet_Healthcare_062025.pdf
- Note: US DMF number per Borealis Bormed summary data sheet; pharmacopeia/ISO 10993 status per grade medical statement.

## Bormed RJ880MO (Borealis, PP)
- Page: https://medresin.com/grades/borealis-bormed-rj880mo
- USP VI: not stated
- ISO 10993: not stated
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: DMF 027840
- Source: https://www.borealisgroup.com/storage/Industries/Healthcare-literature/SummaryDataSheet_Healthcare_062025.pdf
- Note: US DMF number per Borealis Bormed summary data sheet; pharmacopeia/ISO 10993 status per grade medical statement.

## Bormed BJ868MO (Borealis, PP)
- Page: https://medresin.com/grades/borealis-bormed-bj868mo
- USP VI: not stated
- ISO 10993: not stated
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: DMF 033438
- Source: https://www.borealisgroup.com/storage/Industries/Healthcare-literature/SummaryDataSheet_Healthcare_062025.pdf
- Note: US DMF number per Borealis Bormed summary data sheet; pharmacopeia/ISO 10993 status per grade medical statement.

## Bormed SC820CF (Borealis, PP)
- Page: https://medresin.com/grades/borealis-bormed-sc820cf
- USP VI: not stated
- ISO 10993: not stated
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: DMF 020243
- Source: https://www.borealisgroup.com/storage/Industries/Healthcare-literature/SummaryDataSheet_Healthcare_062025.pdf
- Note: US DMF number per Borealis Bormed summary data sheet; pharmacopeia/ISO 10993 status per grade medical statement.

## Bormed SC876CF (Borealis, PP)
- Page: https://medresin.com/grades/borealis-bormed-sc876cf
- USP VI: not stated
- ISO 10993: not stated
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: DMF 027916
- Source: https://www.borealisgroup.com/storage/Industries/Healthcare-literature/SummaryDataSheet_Healthcare_062025.pdf
- Note: US DMF number per Borealis Bormed summary data sheet; pharmacopeia/ISO 10993 status per grade medical statement.

## Bormed TD109CF (Borealis, PP)
- Page: https://medresin.com/grades/borealis-bormed-td109cf
- USP VI: not stated
- ISO 10993: not stated
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: DMF 024931
- Source: https://www.borealisgroup.com/storage/Industries/Healthcare-literature/SummaryDataSheet_Healthcare_062025.pdf
- Note: US DMF number per Borealis Bormed summary data sheet; pharmacopeia/ISO 10993 status per grade medical statement.

## Bormed HE2581-PH (Borealis, HDPE)
- Page: https://medresin.com/grades/borealis-bormed-he2581-ph
- USP VI: not stated
- ISO 10993: not stated
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: DMF 027656
- Source: https://www.borealisgroup.com/storage/Industries/Healthcare-literature/SummaryDataSheet_Healthcare_062025.pdf
- Note: US DMF number per Borealis Bormed summary data sheet; pharmacopeia/ISO 10993 status per grade medical statement.

## Bormed HE7541-PH (Borealis, HDPE)
- Page: https://medresin.com/grades/borealis-bormed-he7541-ph
- USP VI: not stated
- ISO 10993: not stated
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: DMF 027654
- Source: https://www.borealisgroup.com/storage/Industries/Healthcare-literature/SummaryDataSheet_Healthcare_062025.pdf
- Note: US DMF number per Borealis Bormed summary data sheet; pharmacopeia/ISO 10993 status per grade medical statement.

## Bormed HE9621-PH (Borealis, HDPE)
- Page: https://medresin.com/grades/borealis-bormed-he9621-ph
- USP VI: not stated
- ISO 10993: not stated
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: DMF 029149
- Source: https://www.borealisgroup.com/storage/Industries/Healthcare-literature/SummaryDataSheet_Healthcare_062025.pdf
- Note: US DMF number per Borealis Bormed summary data sheet; pharmacopeia/ISO 10993 status per grade medical statement.

## Bormed LE6607-PH (Borealis, LDPE)
- Page: https://medresin.com/grades/borealis-bormed-le6607-ph
- USP VI: not stated
- ISO 10993: not stated
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: DMF 008124/027108
- Source: https://www.borealisgroup.com/storage/Industries/Healthcare-literature/SummaryDataSheet_Healthcare_062025.pdf
- Note: US DMF number per Borealis Bormed summary data sheet; pharmacopeia/ISO 10993 status per grade medical statement.

## Bormed LE6609-PH (Borealis, LDPE)
- Page: https://medresin.com/grades/borealis-bormed-le6609-ph
- USP VI: not stated
- ISO 10993: not stated
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: DMF 017927/028752
- Source: https://www.borealisgroup.com/storage/Industries/Healthcare-literature/SummaryDataSheet_Healthcare_062025.pdf
- Note: US DMF number per Borealis Bormed summary data sheet; pharmacopeia/ISO 10993 status per grade medical statement.

## Bormed LE6600-PH (Borealis, LDPE)
- Page: https://medresin.com/grades/borealis-bormed-le6600-ph
- USP VI: not stated
- ISO 10993: not stated
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: DMF 027587
- Source: https://www.borealisgroup.com/storage/Industries/Healthcare-literature/SummaryDataSheet_Healthcare_062025.pdf
- Note: US DMF number per Borealis Bormed summary data sheet; pharmacopeia/ISO 10993 status per grade medical statement.

## Bormed PL8830-PH (Borealis, Plastomer)
- Page: https://medresin.com/grades/borealis-bormed-pl8830-ph
- USP VI: not stated
- ISO 10993: not stated
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: DMF 033070
- Source: https://www.borealisgroup.com/storage/Industries/Healthcare-literature/SummaryDataSheet_Healthcare_062025.pdf
- Note: US DMF number per Borealis Bormed summary data sheet; pharmacopeia/ISO 10993 status per grade medical statement.

## NuSil MED-4950 (NuSil (Avantor), Silicone)
- Page: https://medresin.com/grades/nusil-avantor-nusil-med-4950
- USP VI: not stated
- ISO 10993: not stated
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: MAF
- Source: https://nusil.avantorsciences.com/nusil/en/product/MED-4950/liquid-silicone-rubber
- Data sheet: https://digitalassets.avantorsciences.com/adaptivemedia/rendition?clid=SAPDAM&id=021948162de963f56096e10c117d3356b7260d61&prid=original&vid=a46ef6128bbd50a43bcc15853e8f8c404bcadce7
- Note: Restricted: not for implantation >29 days. Data sheet lists only cytotoxicity testing (USP <87> / ISO 10993-5, pass), so the ISO 10993 column is left blank under MedResin's rule; FDA Master File filed.

## NuSil MED-6015 (NuSil (Avantor), Silicone)
- Page: https://medresin.com/grades/nusil-avantor-nusil-med-6015
- USP VI: not stated
- ISO 10993: not stated
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: MAF
- Source: https://digitalassets.avantorsciences.com/adaptivemedia/rendition?clid=SAPDAM&id=b7ea5de6768acc836fcadd86c904c0e75d243cf3&prid=original&vid=63281615773810b401b5f22bf5253c36d3a5127f
- Data sheet: https://digitalassets.avantorsciences.com/adaptivemedia/rendition?clid=SAPDAM&id=b7ea5de6768acc836fcadd86c904c0e75d243cf3&prid=original&vid=63281615773810b401b5f22bf5253c36d3a5127f
- Note: Restricted: not for implantation >29 days. Data sheet lists only cytotoxicity testing (USP <87> / ISO 10993-5, pass), so the ISO 10993 column is left blank under MedResin's rule; FDA Master File filed.

## ULTEM HU2310 (SABIC, PEI (30% GF))
- Page: https://medresin.com/grades/sabic-ultem-hu2310
- USP VI: not stated
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: yes
- FDA master file: not stated
- Source: https://materialfinder.sabic-specialties.com/material/ultem-resin-hu2310
- Data sheet: https://materialfinder.sabic-specialties.com/material/ultem-resin-hu2310
- Note: SABIC: "biocompatible (ISO 10993 or USP Class VI)" - feature list names ISO 10993, so USP column left blank. Healthcare management of change applies. SABIC: may offer steam, hydrogen peroxide, gamma, EtO, UV-C and e-beam resistance for repeated sterilization cycles.

## ULTEM HU1110 (SABIC, PEI)
- Page: https://medresin.com/grades/sabic-ultem-hu1110
- USP VI: not stated
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://materialfinder.sabic-specialties.com/material/ultem-resin-hu1110
- Data sheet: https://materialfinder.sabic-specialties.com/material/ultem-resin-hu1110
- Note: SABIC: "biocompatible (ISO 10993 or USP Class VI)" - feature list names ISO 10993, so USP column left blank. Healthcare management of change applies. SABIC: steam, gamma, EtO and e-beam sterilizable.

## VESTAKEEP i2 G (Evonik, PEEK)
- Page: https://medresin.com/grades/evonik-vestakeep-i2-g
- USP VI: yes
- ISO 10993: yes
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: MAF
- Source: https://www.evonik.com/en/products/hp/pr_52037927.html
- Data sheet: https://www.evonik.com/en/products/hp/pr_52037927.html
- Additional source: https://products.evonik.com/assets/52/23/Online_brochure_medical_biomaterials_EU_V3_5c_251106_SD_EN_Asset_3745223.pdf
- Note: Evonik grade page: biocompatibility tested following ISO 10993-1 recommendations for permanent tissue/bone contact and USP Class VI (implant grade). Evonik biomaterials brochure (V3, 2025-11): Evonik holds FDA master access files (MAF) for VESTAKEEP Implant grade resins and stock shapes. Sterilization: brochure cites stability studies (steam, gamma, x-ray, e-beam) without per-grade ratings, so sterilization columns left blank.

## VESTAKEEP i2 UFP10 (Evonik, PEEK)
- Page: https://medresin.com/grades/evonik-vestakeep-i2-ufp10
- USP VI: yes
- ISO 10993: yes
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: MAF
- Source: https://www.evonik.com/en/products/hp/pr_52046294.html
- Data sheet: https://www.evonik.com/en/products/hp/pr_52046294.html
- Additional source: https://products.evonik.com/assets/52/23/Online_brochure_medical_biomaterials_EU_V3_5c_251106_SD_EN_Asset_3745223.pdf
- Note: Evonik grade page: biocompatibility tested following ISO 10993-1 recommendations for permanent tissue/bone contact and USP Class VI (implant grade). Evonik biomaterials brochure (V3, 2025-11): Evonik holds FDA master access files (MAF) for VESTAKEEP Implant grade resins and stock shapes. Sterilization: brochure cites stability studies (steam, gamma, x-ray, e-beam) without per-grade ratings, so sterilization columns left blank.

## VESTAKEEP i4 G (Evonik, PEEK)
- Page: https://medresin.com/grades/evonik-vestakeep-i4-g
- USP VI: yes
- ISO 10993: yes
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: MAF
- Source: https://www.evonik.com/en/products/hp/pr_52037926.html
- Data sheet: https://www.evonik.com/en/products/hp/pr_52037926.html
- Additional source: https://products.evonik.com/assets/52/23/Online_brochure_medical_biomaterials_EU_V3_5c_251106_SD_EN_Asset_3745223.pdf
- Note: Evonik grade page: biocompatibility tested following ISO 10993-1 recommendations for permanent tissue/bone contact and USP Class VI (implant grade). Evonik biomaterials brochure (V3, 2025-11): Evonik holds FDA master access files (MAF) for VESTAKEEP Implant grade resins and stock shapes. Sterilization: brochure cites stability studies (steam, gamma, x-ray, e-beam) without per-grade ratings, so sterilization columns left blank.

## VESTAKEEP i4 R (Evonik, PEEK)
- Page: https://medresin.com/grades/evonik-vestakeep-i4-r
- USP VI: yes
- ISO 10993: yes
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: MAF
- Source: https://www.evonik.com/en/products/hp/pr_52037896.html
- Data sheet: https://www.evonik.com/en/products/hp/pr_52037896.html
- Additional source: https://products.evonik.com/assets/52/23/Online_brochure_medical_biomaterials_EU_V3_5c_251106_SD_EN_Asset_3745223.pdf
- Note: Evonik grade page: biocompatibility tested following ISO 10993-1 recommendations for permanent tissue/bone contact and USP Class VI (implant grade). Evonik biomaterials brochure (V3, 2025-11): Evonik holds FDA master access files (MAF) for VESTAKEEP Implant grade resins and stock shapes. Sterilization: brochure cites stability studies (steam, gamma, x-ray, e-beam) without per-grade ratings, so sterilization columns left blank.

## VESTAKEEP i4 PL (Evonik, PEEK)
- Page: https://medresin.com/grades/evonik-vestakeep-i4-pl
- USP VI: yes
- ISO 10993: yes
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: MAF
- Source: https://www.evonik.com/en/products/hp/pr_52038596.html
- Data sheet: https://www.evonik.com/en/products/hp/pr_52038596.html
- Additional source: https://products.evonik.com/assets/52/23/Online_brochure_medical_biomaterials_EU_V3_5c_251106_SD_EN_Asset_3745223.pdf
- Note: Evonik grade page: biocompatibility tested following ISO 10993-1 recommendations for permanent tissue/bone contact and USP Class VI (implant grade). Evonik biomaterials brochure (V3, 2025-11): Evonik holds FDA master access files (MAF) for VESTAKEEP Implant grade resins and stock shapes. Sterilization: brochure cites stability studies (steam, gamma, x-ray, e-beam) without per-grade ratings, so sterilization columns left blank.

## VESTAKEEP i5 G (Evonik, PEEK)
- Page: https://medresin.com/grades/evonik-vestakeep-i5-g
- USP VI: yes
- ISO 10993: yes
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: MAF
- Source: https://www.evonik.com/en/products/hp/pr_52037971.html
- Data sheet: https://www.evonik.com/en/products/hp/pr_52037971.html
- Additional source: https://products.evonik.com/assets/52/23/Online_brochure_medical_biomaterials_EU_V3_5c_251106_SD_EN_Asset_3745223.pdf
- Note: Evonik grade page: biocompatibility tested following ISO 10993-1 recommendations for permanent tissue/bone contact and USP Class VI (implant grade). Evonik biomaterials brochure (V3, 2025-11): Evonik holds FDA master access files (MAF) for VESTAKEEP Implant grade resins and stock shapes. Sterilization: brochure cites stability studies (steam, gamma, x-ray, e-beam) without per-grade ratings, so sterilization columns left blank.

## VESTAKEEP i5 R (Evonik, PEEK)
- Page: https://medresin.com/grades/evonik-vestakeep-i5-r
- USP VI: yes
- ISO 10993: yes
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: MAF
- Source: https://www.evonik.com/en/products/hp/pr_52037970.html
- Data sheet: https://www.evonik.com/en/products/hp/pr_52037970.html
- Additional source: https://products.evonik.com/assets/52/23/Online_brochure_medical_biomaterials_EU_V3_5c_251106_SD_EN_Asset_3745223.pdf
- Note: Evonik grade page: biocompatibility tested following ISO 10993-1 recommendations for permanent tissue/bone contact and USP Class VI (implant grade). Evonik biomaterials brochure (V3, 2025-11): Evonik holds FDA master access files (MAF) for VESTAKEEP Implant grade resins and stock shapes. Sterilization: brochure cites stability studies (steam, gamma, x-ray, e-beam) without per-grade ratings, so sterilization columns left blank.

## VESTAKEEP iC4506 G (Evonik, PEEK (6% BaSO4))
- Page: https://medresin.com/grades/evonik-vestakeep-ic4506-g
- USP VI: yes
- ISO 10993: yes
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: MAF
- Source: https://www.evonik.com/en/products/hp/pr_52038043.html
- Data sheet: https://www.evonik.com/en/products/hp/pr_52038043.html
- Additional source: https://products.evonik.com/assets/52/23/Online_brochure_medical_biomaterials_EU_V3_5c_251106_SD_EN_Asset_3745223.pdf
- Note: Evonik grade page: biocompatibility tested following ISO 10993-1 recommendations for permanent tissue/bone contact and USP Class VI (implant grade). Evonik biomaterials brochure (V3, 2025-11): Evonik holds FDA master access files (MAF) for VESTAKEEP Implant grade resins and stock shapes. Sterilization: brochure cites stability studies (steam, gamma, x-ray, e-beam) without per-grade ratings, so sterilization columns left blank.

## VESTAKEEP iC4506 R (Evonik, PEEK (6% BaSO4))
- Page: https://medresin.com/grades/evonik-vestakeep-ic4506-r
- USP VI: yes
- ISO 10993: yes
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: MAF
- Source: https://www.evonik.com/en/products/hp/pr_52038066.html
- Data sheet: https://www.evonik.com/en/products/hp/pr_52038066.html
- Additional source: https://products.evonik.com/assets/52/23/Online_brochure_medical_biomaterials_EU_V3_5c_251106_SD_EN_Asset_3745223.pdf
- Note: Evonik grade page: biocompatibility tested following ISO 10993-1 recommendations for permanent tissue/bone contact and USP Class VI (implant grade). Evonik biomaterials brochure (V3, 2025-11): Evonik holds FDA master access files (MAF) for VESTAKEEP Implant grade resins and stock shapes. Sterilization: brochure cites stability studies (steam, gamma, x-ray, e-beam) without per-grade ratings, so sterilization columns left blank.

## VESTAKEEP iC4520 G (Evonik, PEEK (20% BaSO4))
- Page: https://medresin.com/grades/evonik-vestakeep-ic4520-g
- USP VI: yes
- ISO 10993: yes
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: MAF
- Source: https://www.evonik.com/en/products/hp/pr_52038909.html
- Data sheet: https://www.evonik.com/en/products/hp/pr_52038909.html
- Additional source: https://products.evonik.com/assets/52/23/Online_brochure_medical_biomaterials_EU_V3_5c_251106_SD_EN_Asset_3745223.pdf
- Note: Evonik grade page: biocompatibility tested following ISO 10993-1 recommendations for permanent tissue/bone contact and USP Class VI (implant grade). Evonik biomaterials brochure (V3, 2025-11): Evonik holds FDA master access files (MAF) for VESTAKEEP Implant grade resins and stock shapes. Sterilization: brochure cites stability studies (steam, gamma, x-ray, e-beam) without per-grade ratings, so sterilization columns left blank.

## VESTAKEEP D4 G (Evonik, PEEK)
- Page: https://medresin.com/grades/evonik-vestakeep-d4-g
- USP VI: yes
- ISO 10993: yes
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://www.evonik.com/en/products/hp/pr_52038769.html
- Data sheet: https://www.evonik.com/en/products/hp/pr_52038769.html
- Additional source: https://www.evonik.com/en/markets/market_1345345/vestakeep-peek-for-medical-devices/quality-and-approvals.html
- Note: Evonik grade page: biocompatibility tested following ISO 10993-1 recommendations for permanent mucous membrane contact (dental grade). USP Class VI from Evonik quality-and-approvals table (Dental-Grade column, family-level). Sterilization not stated per grade.

## VESTAKEEP D4 R (Evonik, PEEK)
- Page: https://medresin.com/grades/evonik-vestakeep-d4-r
- USP VI: yes
- ISO 10993: yes
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://www.evonik.com/en/products/hp/pr_52038772.html
- Data sheet: https://www.evonik.com/en/products/hp/pr_52038772.html
- Additional source: https://www.evonik.com/en/markets/market_1345345/vestakeep-peek-for-medical-devices/quality-and-approvals.html
- Note: Evonik grade page: biocompatibility tested following ISO 10993-1 recommendations for permanent mucous membrane contact (dental grade). USP Class VI from Evonik quality-and-approvals table (Dental-Grade column, family-level). Sterilization not stated per grade.

## VESTAKEEP DC4420 G (Evonik, PEEK)
- Page: https://medresin.com/grades/evonik-vestakeep-dc4420-g
- USP VI: yes
- ISO 10993: yes
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://www.evonik.com/en/products/hp/pr_52038770.html
- Data sheet: https://www.evonik.com/en/products/hp/pr_52038770.html
- Additional source: https://www.evonik.com/en/markets/market_1345345/vestakeep-peek-for-medical-devices/quality-and-approvals.html
- Note: Evonik grade page: biocompatibility tested following ISO 10993-1 recommendations for permanent mucous membrane contact (dental grade). USP Class VI from Evonik quality-and-approvals table (Dental-Grade column, family-level). Sterilization not stated per grade.

## VESTAKEEP DC4420 R (Evonik, PEEK)
- Page: https://medresin.com/grades/evonik-vestakeep-dc4420-r
- USP VI: yes
- ISO 10993: yes
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://www.evonik.com/en/products/hp/pr_52037893.html
- Data sheet: https://www.evonik.com/en/products/hp/pr_52037893.html
- Additional source: https://www.evonik.com/en/markets/market_1345345/vestakeep-peek-for-medical-devices/quality-and-approvals.html
- Note: Evonik grade page: biocompatibility tested following ISO 10993-1 recommendations for permanent mucous membrane contact (dental grade). USP Class VI from Evonik quality-and-approvals table (Dental-Grade column, family-level). Sterilization not stated per grade.

## VESTAKEEP DC4450 G (Evonik, PEEK)
- Page: https://medresin.com/grades/evonik-vestakeep-dc4450-g
- USP VI: yes
- ISO 10993: yes
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://www.evonik.com/en/products/hp/pr_52038771.html
- Data sheet: https://www.evonik.com/en/products/hp/pr_52038771.html
- Additional source: https://www.evonik.com/en/markets/market_1345345/vestakeep-peek-for-medical-devices/quality-and-approvals.html
- Note: Evonik grade page: biocompatibility tested following ISO 10993-1 recommendations for permanent mucous membrane contact (dental grade). USP Class VI from Evonik quality-and-approvals table (Dental-Grade column, family-level). Sterilization not stated per grade.

## VESTAKEEP DC4450 R (Evonik, PEEK)
- Page: https://medresin.com/grades/evonik-vestakeep-dc4450-r
- USP VI: yes
- ISO 10993: yes
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://www.evonik.com/en/products/hp/pr_52038773.html
- Data sheet: https://www.evonik.com/en/products/hp/pr_52038773.html
- Additional source: https://www.evonik.com/en/markets/market_1345345/vestakeep-peek-for-medical-devices/quality-and-approvals.html
- Note: Evonik grade page: biocompatibility tested following ISO 10993-1 recommendations for permanent mucous membrane contact (dental grade). USP Class VI from Evonik quality-and-approvals table (Dental-Grade column, family-level). Sterilization not stated per grade.

## VESTAKEEP DC4470 G (Evonik, PEEK)
- Page: https://medresin.com/grades/evonik-vestakeep-dc4470-g
- USP VI: yes
- ISO 10993: yes
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://www.evonik.com/en/products/hp/pr_52038937.html
- Data sheet: https://www.evonik.com/en/products/hp/pr_52038937.html
- Additional source: https://www.evonik.com/en/markets/market_1345345/vestakeep-peek-for-medical-devices/quality-and-approvals.html
- Note: Evonik grade page: biocompatibility tested following ISO 10993-1 recommendations for permanent mucous membrane contact (dental grade). USP Class VI from Evonik quality-and-approvals table (Dental-Grade column, family-level). Sterilization not stated per grade.

## VESTAKEEP DC4470 R (Evonik, PEEK)
- Page: https://medresin.com/grades/evonik-vestakeep-dc4470-r
- USP VI: yes
- ISO 10993: yes
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://www.evonik.com/en/products/hp/pr_52038952.html
- Data sheet: https://www.evonik.com/en/products/hp/pr_52038952.html
- Additional source: https://www.evonik.com/en/markets/market_1345345/vestakeep-peek-for-medical-devices/quality-and-approvals.html
- Note: Evonik grade page: biocompatibility tested following ISO 10993-1 recommendations for permanent mucous membrane contact (dental grade). USP Class VI from Evonik quality-and-approvals table (Dental-Grade column, family-level). Sterilization not stated per grade.

## VESTAKEEP Care M40 R (Evonik, PEEK)
- Page: https://medresin.com/grades/evonik-vestakeep-care-m40-r
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://products.evonik.com/assets/34/33/Evonik_Medical_Care_brochure_1124_EN_243433.pdf
- Gamma dose (as stated): up to 50 kGy (all Evonik Care grades)
- Autoclave/steam (as stated): > 500 autoclave cycles
- Data sheet: https://www.evonik.com/en/products/hp/pr_52038776.html
- Note: Rod stock; shares the M40 G / M40PL / M40 R column in the Evonik Medical Care brochure. Evonik grade page: tested following ISO 10993-1 (up to 30 days body contact); fulfills USP <88> Class VI.

## SILPURAN 6000/05 A/B (Wacker, LSR)
- Page: https://medresin.com/grades/wacker-silpuran-6000-05-a-b
- USP VI: yes
- ISO 10993: yes
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://www.wacker.com/h/en-us/silicone-rubber/liquid-silicone-rubber-lsr/silpuran-600005-ab/p/000011066

## SILPURAN 6000/20 A/B (Wacker, LSR)
- Page: https://medresin.com/grades/wacker-silpuran-6000-20-a-b
- USP VI: yes
- ISO 10993: yes
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: MF (type not stated)
- Source: https://www.wacker.com/h/en-us/silicone-rubber/liquid-silicone-rubber-lsr/silpuran-600020-ab/p/000011068

## SILPURAN 6000/40 A/B (Wacker, LSR)
- Page: https://medresin.com/grades/wacker-silpuran-6000-40-a-b
- USP VI: yes
- ISO 10993: yes
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: MF (type not stated)
- Source: https://www.wacker.com/h/en-us/silicone-rubber/liquid-silicone-rubber-lsr/silpuran-600040-ab/p/000011070

## SILPURAN 6000/70 A/B (Wacker, LSR)
- Page: https://medresin.com/grades/wacker-silpuran-6000-70-a-b
- USP VI: yes
- ISO 10993: yes
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: MF (type not stated)
- Source: https://www.wacker.com/h/en-us/silicone-rubber/liquid-silicone-rubber-lsr/silpuran-600070-ab/p/000011073

## SILPURAN 6600/40 A/B (Wacker, LSR)
- Page: https://medresin.com/grades/wacker-silpuran-6600-40-a-b
- USP VI: yes
- ISO 10993: yes
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://www.wacker.com/h/en-us/silicone-rubber/liquid-silicone-rubber-lsr/silpuran-660040-ab/p/000011077

## SILPURAN 6600/50 A/B (Wacker, LSR)
- Page: https://medresin.com/grades/wacker-silpuran-6600-50-a-b
- USP VI: yes
- ISO 10993: yes
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: MF (type not stated)
- Source: https://www.wacker.com/h/en-us/silicone-rubber/liquid-silicone-rubber-lsr/silpuran-660050-ab/p/000011078

## SILPURAN 6600/60 A/B (Wacker, LSR)
- Page: https://medresin.com/grades/wacker-silpuran-6600-60-a-b
- USP VI: yes
- ISO 10993: yes
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: MF (type not stated)
- Source: https://www.wacker.com/h/en-us/silicone-rubber/liquid-silicone-rubber-lsr/silpuran-660060-ab/p/000011079

## SILPURAN 2420 A/B (Wacker, Silicone)
- Page: https://medresin.com/grades/wacker-silpuran-2420-a-b
- USP VI: yes
- ISO 10993: yes
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://www.wacker.com/h/en-us/c/silpuran-2420-ab/p/000011060
- Note: RTV-2 addition-curing silicone. Wacker: biocompatible, certificates of compatibility with USP Class VI and ISO 10993 available on request.

## Silopren LSR 4030 (Momentive, LSR)
- Page: https://medresin.com/grades/momentive-silopren-lsr-4030
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://www.momentive.com/content/dam/momentive/en-us/products/tds/silopren/silopren-lsr-4030.pdf
- Note: Momentive TDS: biocompatible USP Class VI and ISO 10993 (parts 6, 10, 11); sterilizable with EtO, steam and gamma. Regulatory section: tests were run on "a representative sample of an analogous product" (USP Class VI, max. 29 days tissue contact) (checked 2026-10-20).

## Silopren LSR 4040 (Momentive, LSR)
- Page: https://medresin.com/grades/momentive-silopren-lsr-4040
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://www.momentive.com/content/dam/momentive/en-us/products/tds/silopren/silopren-lsr-4040.pdf
- Note: Momentive TDS: biocompatible USP Class VI and ISO 10993 (parts 5, 6, 10, 11); sterilizable with EtO, steam and gamma. Regulatory section: tests were run on "a representative sample of an analogous product" (USP Class VI, max. 29 days tissue contact) (checked 2026-10-20).

## Silopren LSR 4050 (Momentive, LSR)
- Page: https://medresin.com/grades/momentive-silopren-lsr-4050
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://www.momentive.com/content/dam/momentive/en-us/products/tds/silopren/silopren-lsr-4050.pdf
- Note: Momentive TDS: biocompatible USP Class VI and ISO 10993 (parts 5, 6, 10, 11); sterilizable with EtO, steam and gamma. Regulatory section: tests were run on "a representative sample of an analogous product" (USP Class VI, max. 29 days tissue contact) (checked 2026-10-20).

## Silopren LSR 4070 (Momentive, LSR)
- Page: https://medresin.com/grades/momentive-silopren-lsr-4070
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://www.momentive.com/content/dam/momentive/en-us/products/tds/silopren/silopren-lsr-4070.pdf
- Note: Momentive TDS: biocompatible USP Class VI and ISO 10993 (parts 5, 6, 10, 11); sterilizable with EtO, steam and gamma. Regulatory section: tests were run on "a representative sample of an analogous product" (USP Class VI, max. 29 days tissue contact) (checked 2026-10-20).

## Silopren LSR 4640 (Momentive, LSR)
- Page: https://medresin.com/grades/momentive-silopren-lsr-4640
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://www.momentive.com/content/dam/momentive/en-us/products/tds/silopren/silopren-lsr-4640.pdf
- Note: Momentive TDS: biocompatible USP Class VI and ISO 10993 (parts 5, 6, 10, 11); sterilizable with EtO, steam and gamma. Regulatory section: tests were run on "a representative sample of an analogous product" (USP Class VI, max. 29 days tissue contact) (checked 2026-10-20).

## Silopren LSR 4670 (Momentive, LSR)
- Page: https://medresin.com/grades/momentive-silopren-lsr-4670
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://www.momentive.com/content/dam/momentive/en-us/products/tds/silopren/silopren-lsr-4670.pdf
- Note: Momentive TDS: biocompatible USP Class VI and ISO 10993 (parts 3, 4, 5, 6, 10, 11); sterilizable with EtO, steam and gamma. Regulatory section: tests were run on "a representative sample of an analogous product" (USP Class VI, max. 29 days tissue contact) (checked 2026-10-20).

## Rilsan BMNO MED (Arkema, PA11)
- Page: https://medresin.com/grades/arkema-rilsan-bmno-med
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://hpp.arkema.com/en/markets-and-applications/healthcare/healthcare-material-solutions/
- Data sheet: https://mypolymer.materialdatacenter.com/pds/en/si/rilsanbmnomed
- Note: Arkema healthcare page: all products tested for ISO 10993-4 and -5 and USP Class VI (compliance letters on request); range is gamma, steam and ETO sterilizable. Listed in the Arkema MED grade list.

## Rilsan BESNO MED (Arkema, PA11)
- Page: https://medresin.com/grades/arkema-rilsan-besno-med
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://hpp.arkema.com/en/markets-and-applications/healthcare/healthcare-material-solutions/
- Data sheet: https://mypolymer.materialdatacenter.com/pds/en/si/rilsanbesnomed
- Note: Arkema healthcare page: all products tested for ISO 10993-4 and -5 and USP Class VI (compliance letters on request); range is gamma, steam and ETO sterilizable. Listed in the Arkema MED grade list.

## Rilsan BESVO A MED (Arkema, PA11)
- Page: https://medresin.com/grades/arkema-rilsan-besvo-a-med
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://hpp.arkema.com/en/markets-and-applications/healthcare/healthcare-material-solutions/
- Data sheet: https://mypolymer.materialdatacenter.com/pds/en/si/rilsanbesvoamed
- Note: Arkema healthcare page: all products tested for ISO 10993-4 and -5 and USP Class VI (compliance letters on request); range is gamma, steam and ETO sterilizable. Listed in the Arkema MED grade list.

## Rilsan 8020 (Arkema, PA (translucent copolyamide))
- Page: https://medresin.com/grades/arkema-rilsan-8020
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://hpp.arkema.com/en/markets-and-applications/healthcare/healthcare-material-solutions/
- Data sheet: https://mypolymer.materialdatacenter.com/pds/en/si/rilsan8020
- Note: Arkema healthcare page: all products tested for ISO 10993-4 and -5 and USP Class VI (compliance letters on request); range is gamma, steam and ETO sterilizable. Listed in the Arkema MED grade list.

## Rilsan Clear G850 Rnew MED (Arkema, PA11 (transparent))
- Page: https://medresin.com/grades/arkema-rilsan-clear-g850-rnew-med
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://hpp.arkema.com/en/markets-and-applications/healthcare/healthcare-material-solutions/
- Data sheet: https://mypolymer.materialdatacenter.com/pds/en/si/rilsanclearg850rnewmed
- Note: Arkema healthcare page: all products tested for ISO 10993-4 and -5 and USP Class VI (compliance letters on request); range is gamma, steam and ETO sterilizable. Listed in the Arkema MED grade list.

## Rilsan Clear G170 MED (Arkema, PA12 (transparent))
- Page: https://medresin.com/grades/arkema-rilsan-clear-g170-med
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://hpp.arkema.com/en/markets-and-applications/healthcare/healthcare-material-solutions/
- Data sheet: https://mypolymer.materialdatacenter.com/pds/en/si/rilsanclearg170med
- Note: Arkema healthcare page: all products tested for ISO 10993-4 and -5 and USP Class VI (compliance letters on request); range is gamma, steam and ETO sterilizable. Listed in the Arkema MED grade list.

## Rilsamid AMNO MED (Arkema, PA12)
- Page: https://medresin.com/grades/arkema-rilsamid-amno-med
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://hpp.arkema.com/en/markets-and-applications/healthcare/healthcare-material-solutions/
- Data sheet: https://mypolymer.materialdatacenter.com/pds/en/si/rilsamidamnomed
- Note: Arkema healthcare page: all products tested for ISO 10993-4 and -5 and USP Class VI (compliance letters on request); range is gamma, steam and ETO sterilizable. Listed in the Arkema MED grade list.

## Rilsamid AESNO MED (Arkema, PA12)
- Page: https://medresin.com/grades/arkema-rilsamid-aesno-med
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://hpp.arkema.com/en/markets-and-applications/healthcare/healthcare-material-solutions/
- Data sheet: https://mypolymer.materialdatacenter.com/pds/en/si/rilsamidaesnomed
- Note: Arkema healthcare page: all products tested for ISO 10993-4 and -5 and USP Class VI (compliance letters on request); range is gamma, steam and ETO sterilizable. Listed in the Arkema MED grade list.

## Tritan MX730 (Eastman, Copolyester)
- Page: https://medresin.com/grades/eastman-tritan-mx730
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://productcatalog.eastman.com/tds/ProdDatasheet.aspx?product=71070516
- Data sheet: https://productcatalog.eastman.com/tds/ProdDatasheet.aspx?product=71070516
- Note: Eastman: tested for FDA/ISO 10993 and USP Class VI biological evaluation after gamma and EtO sterilization.

## Tritan MX810 (Eastman, Copolyester)
- Page: https://medresin.com/grades/eastman-tritan-mx810
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://productcatalog.eastman.com/tds/ProdDatasheet.aspx?product=71072159
- Data sheet: https://productcatalog.eastman.com/tds/ProdDatasheet.aspx?product=71072159
- Note: Eastman: tested for FDA/ISO 10993 and USP Class VI biological evaluation after gamma and EtO sterilization.

## Tritan MXF121 (Eastman, Copolyester)
- Page: https://medresin.com/grades/eastman-tritan-mxf121
- USP VI: not stated
- ISO 10993: yes
- Gamma: not stated
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://productcatalog.eastman.com/tds/ProdDatasheet.aspx?product=71097008
- Data sheet: https://productcatalog.eastman.com/tds/ProdDatasheet.aspx?product=71097008
- Note: Eastman TDS: passed FDA/ISO 10993 testing for cytotoxicity, skin sensitization and intracutaneous reactivity. USP Class VI and sterilization not stated. Opaque; contains vegetable-based mold release.

## Eastar MN210 (Eastman, Copolyester)
- Page: https://medresin.com/grades/eastman-eastar-mn210
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://productcatalog.eastman.com/tds/ProdDatasheet.aspx?product=71015997
- Data sheet: https://productcatalog.eastman.com/tds/ProdDatasheet.aspx?product=71015997
- Note: Eastman TDS: "meets ISO 10993 and/or USP Class VI biocompatibility requirement" (which one is not specified, so both left blank). TDS key attribute: suitable for gamma and e-beam irradiation and ethylene oxide sterilization.

## APEX 32033RN-NT1 (Teknor Apex, PVC)
- Page: https://medresin.com/grades/teknor-apex-apex-32033rn-nt1
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://www.teknorapex.com/en-us/teknor-apexs-extensive-product-portfolio-of-vinyl-thermoplastic-elastomers-nylon-and-colorants/vinyl/flexible-pvc-compounds/apex-flexible-pvc/apex-flexible-pvc-medical
- Note: Teknor Apex medical PVC page (family-level): "Biocompatibility backed by USP Class VI & ISO 10993 testing", including ISO 10993-5 cytotoxicity test data; holds color after gamma and e-beam. Series (Shore A 50-90).

## APEX 33022RV-NT (Teknor Apex, PVC)
- Page: https://medresin.com/grades/teknor-apex-apex-33022rv-nt
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://www.teknorapex.com/en-us/teknor-apexs-extensive-product-portfolio-of-vinyl-thermoplastic-elastomers-nylon-and-colorants/vinyl/flexible-pvc-compounds/apex-flexible-pvc/apex-flexible-pvc-medical
- Note: Teknor Apex medical PVC page (family-level): "Biocompatibility backed by USP Class VI & ISO 10993 testing", including ISO 10993-5 cytotoxicity test data; holds color after gamma and e-beam. Series (Shore A 50-90).

## APEX 33033RV-NT1 (Teknor Apex, PVC)
- Page: https://medresin.com/grades/teknor-apex-apex-33033rv-nt1
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://www.teknorapex.com/en-us/teknor-apexs-extensive-product-portfolio-of-vinyl-thermoplastic-elastomers-nylon-and-colorants/vinyl/flexible-pvc-compounds/apex-flexible-pvc/apex-flexible-pvc-medical
- Note: Teknor Apex medical PVC page (family-level): "Biocompatibility backed by USP Class VI & ISO 10993 testing", including ISO 10993-5 cytotoxicity test data; holds color after gamma and e-beam. Series (Shore A 50-90).

## APEX 33042RN-NT (Teknor Apex, PVC)
- Page: https://medresin.com/grades/teknor-apex-apex-33042rn-nt
- USP VI: yes
- ISO 10993: yes
- Gamma: yes
- EtO: not stated
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://www.teknorapex.com/en-us/teknor-apexs-extensive-product-portfolio-of-vinyl-thermoplastic-elastomers-nylon-and-colorants/vinyl/flexible-pvc-compounds/apex-flexible-pvc/apex-flexible-pvc-medical
- Note: Teknor Apex medical PVC page (family-level): "Biocompatibility backed by USP Class VI & ISO 10993 testing", including ISO 10993-5 cytotoxicity test data; holds color after gamma and e-beam. Series (Shore A 50-90).

## Medalist MD-91255 (Teknor Apex, TPE (biopharma tubing))
- Page: https://medresin.com/grades/teknor-apex-medalist-md-91255
- USP VI: yes
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: yes
- VHP: not stated
- FDA master file: not stated
- Source: https://www.teknorapex.com/content/dam/teknorapex/en-us/pdf/technical-literature/Medalist_SellSheet_FINAL.pdf
- Note: Teknor Apex: MD-90000 series meets USP Class VI and ISO 10993-5 (cytotoxicity; ISO column left blank); sterilizable by EO, gamma, e-beam, X-ray and autoclaving.

## Tecoflex SG-93A-G (Lubrizol, TPU (aliphatic polyether))
- Page: https://medresin.com/grades/lubrizol-tecoflex-sg-93a-g
- USP VI: not stated
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: no
- VHP: yes
- FDA master file: not stated
- Source: https://www.lubrizol.com/solutions/products/tecoflex
- Gamma dose (as stated): 25 and 50 kGy recommended (single cycle tested)
- Data sheet: https://media.lubrizol.com/-/media/Project/Lubrizol-Corporation/Lubrizol/Master-Site/Health/Documents/TDS/Tecoflex-Solution-Grade.pdf
- Additional source: https://media.lubrizol.com/-/media/project/lubrizol-corporation/lubrizol/master-site/health/documents/literature/proper-sterilization-methods-for-medical-grade-thermoplastic-polyurethane-tpu-sterilization.pdf
- Note: Sterilization per Lubrizol family-level guidance (single cycle tested); dry heat and autoclave not recommended.

## OPTIX CA-927 G (Plaskolite, Acrylic)
- Page: https://medresin.com/grades/plaskolite-optix-ca-927-g
- USP VI: yes
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://plaskolite.com/docs/default-source/bro/bro072_oap_medical.pdf
- Note: Plaskolite OPTIX medical guide: OPTIX Medical Grade Polymers are USP Class VI; resistant to gamma or (dry) ethylene oxide sterilization; wet EtO not recommended.

## OPTIX CA-927 GHF (Plaskolite, Acrylic)
- Page: https://medresin.com/grades/plaskolite-optix-ca-927-ghf
- USP VI: yes
- ISO 10993: not stated
- Gamma: yes
- EtO: yes
- Autoclave: not stated
- VHP: not stated
- FDA master file: not stated
- Source: https://plaskolite.com/docs/default-source/bro/bro072_oap_medical.pdf
- Note: Plaskolite OPTIX medical guide: OPTIX Medical Grade Polymers are USP Class VI; resistant to gamma or (dry) ethylene oxide sterilization; wet EtO not recommended.