FDA-recognized standard · Sterility
ISO 17665: Sterilization of health care products - Moist heat - Requirements for the development validation and routine control of a sterilization process for medical devices
Yes. FDA recognizes ISO 17665 First edition 2024-03 as recognition 14-601, entered 2024-05-29.
Recognized editions of ISO 17665
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 14-601 | ISO 17665 First edition 2024-03 | 2024-05-29 | Complete | — |
Regulations
FDA lists these classification regulations against ISO 17665: 21 CFR 880.2800, 21 CFR 880.6850, 21 CFR 880.6880.
Product codes that cite ISO 17665
6 FDA product codes cite ISO 17665, including FLE, FRC, FRG, JOJ, KCT.
- FLE Sterilizer, Steam
- FRC Indicator, Biological Sterilization Process
- FRG Wrap, Sterilization
- JOJ Indicator, Physical/Chemical Sterilization Process
- KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- QKM
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.