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USP Class VI ends Dec 1: which resins also have ISO 10993 data?
By The MedResin team · Published 2026-10-23 · Data: 417 public grades, checked 2026-10-20
Summary: On December 1, 2026 the revised USP general chapter <88> becomes official, and the Class I to VI classification of plastics goes with it. We counted how many medical-grade resins in MedResin state USP Class VI in their supplier literature and how many of those also carry an ISO 10993 statement. 262 of 417 grades (63%) state USP Class VI. 182 of those 262 (69%) also state ISO 10993. The other 80 (31%) do not have a counted ISO 10993 statement in the cited source.
What changes on December 1
USP's notice states that revised chapter <88> Biological Reactivity Tests, In Vivo "will be official on December 1, 2026" (USP-NF notice of intent to revise). The current chapter defines three in vivo tests and a table that assigns plastics to Classes I to VI. The revised chapter keeps only the Systemic Injection Test and drops the classification (see also the ISPE summary). Its scope is packaging for drugs and for combination products regulated by FDA's drug center (CDER). For medical devices it refers readers to FDA's device guidance. The in vitro chapter <87> is revised on the same date with the same scope (revised <87>).
Three points are easy to miss:
- Old Class VI data is not voided. Tests already run still describe what was tested. What ends is a current USP definition to cite for new "Class VI" claims.
- ISO 10993 is not USP's replacement. For devices, FDA's biocompatibility guidance has been built on ISO 10993-1 for years (FDA ISO 10993-1 guidance). Class VI was supporting evidence, not the device framework.
- Resin data supports a device evaluation; it does not replace one. That holds for both USP and ISO statements at resin level.
The practical question for a material choice is therefore: if a supplier's main biocompatibility claim is USP Class VI, what else does it publish?
The numbers
| Measure | Grades | Share |
|---|---|---|
| Public grades in MedResin | 417 | 29 manufacturers |
| Supplier states USP Class VI | 262 | 63% of all grades |
| …and also states ISO 10993 | 182 | 69% of USP VI grades |
| …without a counted ISO 10993 statement | 80 | 31% of USP VI grades |
| of which cite cytotoxicity testing only (ISO 10993-5 or unspecified) | 53 | |
| of which report a failed ISO 10993 endpoint (VESTAMID Care ME26) | 1 | |
| of which have no ISO 10993 or cytotoxicity mention in the cited source | 26 | 10% of USP VI grades |
| Supplier states ISO 10993 but not USP Class VI | 40 | |
| Manufacturers stating USP Class VI on at least one grade | 24 of 29 |
"Counted" follows MedResin's written rule: ISO 10993 is marked only when the manufacturer's own source states ISO 10993 evaluation beyond cytotoxicity alone. Cytotoxicity is one endpoint, so a cytotoxicity-only statement is noted on the grade page but not counted. The full rule is in the USP Class VI vs ISO 10993 guide.
By polymer group
USP Class VI grades in each polymer group, split by what the cited source says about ISO 10993. Labels show grades with both statements out of USP VI grades.
| Polymer group | Grades | USP VI stated | …also ISO 10993 | Share with both |
|---|---|---|---|---|
| Polycarbonate and PC blends | 42 | 32 | 32 | 100% |
| PEEK | 29 | 28 | 27 | 96% |
| Polypropylene | 52 | 27 | 8 | 30% |
| Styrenics (ABS, ASA, MABS, MBS, SAN, SBC, SMMA, S-TPE) | 31 | 27 | 27 | 100% |
| Silicone and LSR | 24 | 21 | 21 | 100% |
| Polyamide (PA12, transparent PA) | 19 | 19 | 19 | 100% |
| Acetal (POM) | 24 | 17 | 0 | 0% |
| PEBA | 15 | 15 | 14 | 93% |
| Polyethylene (HDPE, LDPE, UHMW-PE, plastomer) | 23 | 14 | 1 | 7% |
| Polyesters (PBT, copolyester) | 18 | 13 | 8 | 62% |
| TPU (chemistry not stated) | 9 | 9 | 9 | 100% |
| Aromatic TPU | 36 | 8 | 0 | 0% |
| COC and COP | 9 | 6 | 6 | 100% |
| PVC | 6 | 6 | 6 | 100% |
| LCP | 5 | 5 | 0 | 0% |
| TPE tubing compounds | 21 | 5 | 0 | 0% |
| Acrylic | 3 | 3 | 0 | 0% |
| Sulfones (PSU, PESU, PPSU) | 10 | 3 | 2 | 67% |
| PPS | 2 | 2 | 0 | 0% |
| PEI | 10 | 1 | 1 | 100% |
| PVDF | 1 | 1 | 1 | 100% |
| Aliphatic TPU | 28 | 0 | 0 | – |
| All groups | 417 | 262 | 182 | 69% |
Group names link to the full grade list for that group. Groups with fewer than 10 grades are shown for completeness; their shares describe only the grades in MedResin, not the market.
Where the data is strongest
In 7 groups with at least five USP Class VI grades, every one of them also states ISO 10993: Polycarbonate and PC blends (32 of 32), Styrenics (ABS, ASA, MABS, MBS, SAN, SBC, SMMA, S-TPE) (27 of 27), Silicone and LSR (21 of 21), Polyamide (PA12, transparent PA) (19 of 19), TPU (chemistry not stated) (9 of 9), COC and COP (6 of 6) and PVC (6 of 6). PEEK (27 of 28) and PEBA (14 of 15) are one grade short. In these groups the supplier literature usually presents USP Class VI and ISO 10993 together.
Where the data is thinnest
6 groups with at least five USP Class VI grades have ISO 10993 on fewer than half of them: Polypropylene (8 of 27), Acetal (POM) (0 of 17), Polyethylene (HDPE, LDPE, UHMW-PE, plastomer) (1 of 14), Aromatic TPU (0 of 8), LCP (0 of 5) and TPE tubing compounds (0 of 5). The reasons differ:
- Cytotoxicity only. All 17 USP VI acetal grades, the LCP and PPS grades, the TPE tubing compounds and 14 polypropylene grades cite cytotoxicity testing next to USP Class VI, and no other ISO 10993 part.
- No ISO mention at all. The 8 USP VI aromatic TPU grades and 8 of the polyethylene grades state USP Class VI with no ISO 10993 or cytotoxicity mention in the cited source. Polypropylene and polyethylene together account for 13 of the 26 no-mention grades.
A blank means "not stated in the cited source", not "not tested". Several of these suppliers may hold ISO 10993 data that they share on request. That is the point of the next section.
What to ask your supplier
- Which ISO 10993 parts have been tested, on what test article? Ask for the report summaries, not just a statement. Note whether tests were run on resin, molded plaques or extracts, and the extraction conditions.
- Is the data for this exact grade and color? Family-level statements and natural-color data may not cover a pigmented or modified variant.
- What will you provide after December 1, 2026? Will new certificates still reference USP <88>, the revised <87>, ISO 10993, or a mix? Will existing Class VI letters be reissued or withdrawn?
- How old are the tests, and what triggers a retest? Ask about the change-notification policy for formulation, additive or site changes.
- Is there an FDA master file, and will you authorize a reference to it?
- Is the grade under a healthcare policy that allows your intended use and contact duration? Some suppliers restrict implant or long-term use regardless of test data.
Whatever the answers, the device evaluation follows ISO 10993-1 on the finished, processed and sterilized device.
Browse the grades
Grades stating both, and the 80 without a counted ISO statement · All 262 USP Class VI grades · All ISO 10993 grades · Grades by polymer group · Compare grades side by side · Download the data
Method
Counts come from the 417 public grade records in MedResin (the same data as the CSV download), computed when this page was built, so they update with the data. Each grade records what its manufacturer's public literature states; each grade page cites the source. Distributor literature and gated portals are not used for these fields. Polymer groups are the site's own groups.
Sources for the USP <88> change: USP-NF notice (targeted official date 01-Dec-2026) · revised <88> (USP DOI) · current <88> (USP DOI) · revised <87> (USP DOI) · FDA ISO 10993-1 guidance · ISPE.
Grade data last checked 2026-10-20. Blank cells mean not stated by the source. Each grade page cites its source. About the data · Suggest a correction
More guides: Which medical plastics survive gamma sterilization? · Autoclave-safe resins compared · USP Class VI vs ISO 10993 · EtO-compatible materials for catheters and tubing · Choosing a TPU for medical tubing · All guides
Overview of every polymer group: Medical-grade plastics: grades by polymer and sterilization