FDA-recognized standard · Biocompatibility
ISO 10993-4: Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood [Including Amendment 1 (2025)]
Yes. FDA recognizes ISO 10993-4 Third edition 2017-04 [Including AMD1:2025] as recognition 2-311, entered 2025-12-22. FDA also lists ISO 10993-4 Third edition 2017-04 (recognition 2-248, transition period ending 2028-12-17).
Recognized editions of ISO 10993-4
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 2-311 | ISO 10993-4 Third edition 2017-04 [Including AMD1:2025] | 2025-12-22 | Complete | — |
| 2-248 | ISO 10993-4 Third edition 2017-04 also ANSI AAMI ISO 10993-4: 2017 | 2017-08-21 | Complete | 2028-12-17 |
Product codes that cite ISO 10993-4
No product code cites ISO 10993-4: 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.