FDA-recognized standard · Biocompatibility
ISO 10993-1: Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process
Yes. FDA recognizes ISO 10993-1 Sixth edition 2025-11 as recognition 2-313, in part, entered 2026-05-25. FDA also lists ISO 10993-1 Fifth edition 2018-08 (recognition 2-258, transition period ending 2029-07-01).
Recognized editions of ISO 10993-1
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 2-313 | ISO 10993-1 Sixth edition 2025-11 | 2026-05-25 | Partial | — |
| 2-258 | ISO 10993-1 Fifth edition 2018-08 also ANSI AAMI ISO 10993-1: 2018 | 2019-01-14 | Partial | 2029-07-01 |
What FDA does not recognize in ISO 10993-1 Sixth edition 2025-11
Recognition 2-313 is partial. FDA's statement of the extent, verbatim:
Partial recognition. The following part(s) of the standard is (are) not recognized: Phrase "consumer products" in clause 6.5.11.3 Clause 6.9 Biological risk estimation
What FDA does not recognize in ISO 10993-1 Fifth edition 2018-08
Recognition 2-258 is partial. FDA's statement of the extent, verbatim:
Partial recognition. The following part(s) of the standard is (are) not recognized: Table A.1 in Annex A.
Product codes that cite ISO 10993-1
No product code cites ISO 10993-1: 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.