FDA-recognized standard · Sterility
ISO 11137-2: Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose [Including Amendment 1 (2022)]
Yes. FDA recognizes ISO 11137-2 Third edition 2013-06 [Including AMD1:2022] as recognition 14-580, entered 2022-12-19.
Recognized editions of ISO 11137-2
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 14-580 | ISO 11137-2 Third edition 2013-06 [Including AMD1:2022] | 2022-12-19 | Complete | — |
Product codes that cite ISO 11137-2
No product code cites ISO 11137-2: 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.