FDA-recognized standard · Sterility
ISO 11137-1: Sterilization of health care products - Radiation - Part 1: Requirements for the development validation and routine control of a sterilization process for medical devices
Yes. FDA recognizes ISO 11137-1 Second edition 2025-04 as recognition 14-611, entered 2025-05-26. FDA also lists ISO 11137-1 First edition 2006-04-15 (recognition 14-528, transition period ending 2027-07-04).
Recognized editions of ISO 11137-1
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 14-611 | ISO 11137-1 Second edition 2025-04 | 2025-05-26 | Complete | — |
| 14-528 | ISO 11137-1 First edition 2006-04-15 also ANSI AAMI ISO 11137-1:2006/(R)2015 | 2019-07-15 | Complete | 2027-07-04 |
Product codes that cite ISO 11137-1
No product code cites ISO 11137-1: 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.