FDA-recognized standard · Sterility
ISO 11737-2: Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition validation and maintenance of a sterilization process
Yes. FDA recognizes ISO 11737-2 Third edition 2019-12 as recognition 14-540, entered 2020-07-06.
Recognized editions of ISO 11737-2
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 14-540 | ISO 11737-2 Third edition 2019-12 also ANSI AAMI ISO 11737-2:2019 | 2020-07-06 | Complete | — |
Product codes that cite ISO 11737-2
No product code cites ISO 11737-2: 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.