What is the FDA recognition number for ISO 10993-23?

2-291: ISO 10993-23 First edition 2021-01 (partial recognition).

FDA-recognized standard · Biocompatibility

ISO 10993-23: Biological evaluation of medical devices - Part 23: Tests for irritation

Yes. FDA recognizes ISO 10993-23 First edition 2021-01 as recognition 2-291, in part, entered 2021-06-07.

Recognized editions of ISO 10993-23

FDA recognitions of ISO 10993-23, newest first (FDA database snapshot of 2026-09-01)
Recognition	Edition	Entered	Extent	Transition ends
2-291	ISO 10993-23 First edition 2021-01	2021-06-07	Partial	—

What FDA does not recognize in ISO 10993-23 First edition 2021-01

Recognition 2-291 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 Clause 6 In vitro irritation tests Annex B Annex C

Product codes that cite ISO 10993-23

No product code cites ISO 10993-23: 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.