FDA-recognized standard · Sterility
ISO 17665-1: Sterilization of health care products - Moist heat - Part 1: Requirements for the development validation and routine control of a sterilization process for medical devices
Yes. FDA recognizes ISO 17665-1 First edition 2006-08-15 as recognition 14-333, entered 2016-04-04. Its transition period ends 2027-07-04.
Recognized editions of ISO 17665-1
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 14-333 | ISO 17665-1 First edition 2006-08-15 also ANSI AAMI ISO 17665-1:2006/(R)2013 | 2016-04-04 | Complete | 2027-07-04 |
Product codes that cite ISO 17665-1
No product code cites ISO 17665-1: 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.