FDA-recognized standard · Biocompatibility
ISO 10993-11: Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
Yes. FDA recognizes ISO 10993-11 Third edition 2017-09 as recognition 2-255, entered 2018-09-17.
Recognized editions of ISO 10993-11
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 2-255 | ISO 10993-11 Third edition 2017-09 also ANSI AAMI ISO 10993-11: 2017 | 2018-09-17 | Complete | — |
Product codes that cite ISO 10993-11
No product code cites ISO 10993-11: 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.