Last verified: 2026-10-23 against the cited manufacturer source · Changelog
THERMOLAST M MC/HE series (TMxHET) is a S-TPE grade from KRAIBURG TPE. The cited source lists it as compatible with gamma, EtO and steam/autoclave sterilization. Source
Data comes from public supplier literature (cited on each grade page). A blank cell means not stated in the source, not "no". Always confirm with the supplier's current documentation before use.
Reference only: Compiled from public manufacturer literature for reference only; it may be incomplete or outdated. Before using any grade in a device, verify the current manufacturer data sheet and complete your own testing and regulatory review.
Series record: Series record: the source states values for the THERMOLAST M MC/HE series as a whole, not one compound. Values apply to the family or series as stated by the source; confirm the exact grade with the manufacturer.
USP VI
✔ stated yes
ISO 10993
✔ stated yes
Gamma
✔ stated yes
EtO
✔ stated yes
Autoclave
✔ stated yes
VHP
not stated
FDA master file
DMF
Gamma dose (as stated)
2 x 35 kGy (as stated)
Autoclave / steam (as stated)
134 °C (as stated; cycle count not stated)
Key properties (as stated on the data sheet)
Property
Value
Test standard
Conditions
Source
Tensile strength
18.0–19.0 MPa
DIN 53504/ISO 37
series-level range across compounds TM9HET and TM0HET, 40–52 Shore D; S2 test piece, 200 mm/min
Typical values copied from the manufacturer's data sheet, not specification limits. Units and test methods are as the sheet states them; properties the sheet does not give are left out.
Data note: Series record from the KRAIBURG TPE medical brochure: ISO 10993-4, -5, -10, -11 and USP <88> Class VI; US DMF listed. Sterilizable as stated: autoclave 134 °C, beta/gamma radiation 2 x 35 kGy, EtO. Confirmed against the KRAIBURG TPE series data sheet (checked 2026-10-23): Data sheet lists ISO 10993-4, -5, -10, -11, USP <88> Class VI and US FDA CFR 21 (raw material conformity); US DMF listed. Sterilizable as stated (autoclave 134 °C, beta/gamma 2 x 35 kGy, EtO). KRAIBURG notes that approvals are shown for the series collectively and not every one applies to each compound.