FDA-recognized standard · Biocompatibility
ISO 10993-5: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
Yes. FDA recognizes ISO 10993-5 Third edition 2009-06-01 as recognition 2-245, entered 2016-12-23.
Recognized editions of ISO 10993-5
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 2-245 | ISO 10993-5 Third edition 2009-06-01 also ANSI AAMI ISO 10993-5:2009/(R)2014 | 2016-12-23 | Complete | — |
Product codes that cite ISO 10993-5
No product code cites ISO 10993-5: 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.