FDA-recognized standard · Sterility
ISO 11135: Sterilization of health-care products - Ethylene oxide - Requirements for the development validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)]
Yes. FDA recognizes ISO 11135 Second edition 2014-07-15 as recognition 14-529, entered 2019-07-15.
Recognized editions of ISO 11135
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 14-529 | ISO 11135 Second edition 2014-07-15 also ANSI AAMI ISO 11135:2014/A1:2018 | 2019-07-15 | Complete | — |
Product codes that cite ISO 11135
No product code cites ISO 11135: 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.