FDA-recognized standard · Sterility
ISO 11737-1: Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on product [Including Amendment 1 (2021)]
Yes. FDA recognizes ISO 11737-1 Third edition 2018-01 [Including AMD1:2021] as recognition 14-577, entered 2022-05-30.
Recognized editions of ISO 11737-1
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 14-577 | ISO 11737-1 Third edition 2018-01 [Including AMD1:2021] | 2022-05-30 | Complete | — |
Product codes that cite ISO 11737-1
No product code cites ISO 11737-1: 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.