FDA-recognized standard · Biocompatibility
ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for skin sensitization
Yes. FDA recognizes ISO 10993-10 Fourth edition 2021-11 as recognition 2-296, in part, entered 2022-12-19.
Recognized editions of ISO 10993-10
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 2-296 | ISO 10993-10 Fourth edition 2021-11 | 2022-12-19 | Partial | — |
What FDA does not recognize in ISO 10993-10 Fourth edition 2021-11
Recognition 2-296 is partial. FDA's statement of the extent, verbatim:
Partial recognition. The following part(s) of the standard is (are) not recognized: Clause 4 General principles - Step-wise approach Annex C
Product codes that cite ISO 10993-10
No product code cites ISO 10993-10: it is a horizontal standard, applied across device types rather than tied to particular codes.
Source: FDA Recognized Consensus Standards database, snapshot of 2026-09-01. Search every recognition in the Consensus Standards Lookup, or browse all standards with a page.