FDA-recognized standard · Sterility
ISO 11607-2: Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming sealing and assembly processes [Including Amendment 1 (2023)].
Yes. FDA recognizes ISO 11607-2 Second edition 2019-02 [Including AMD1:2023] as recognition 14-595, entered 2023-12-18. FDA also lists ISO 11607-2 Second edition 2019-02 (recognition 14-531, transition period ending 2026-12-20).
Recognized editions of ISO 11607-2
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 14-595 | ISO 11607-2 Second edition 2019-02 [Including AMD1:2023] | 2023-12-18 | Complete | — |
| 14-531 | ISO 11607-2 Second edition 2019-02 also ANSI AAMI ISO 11607-2:2019 | 2019-07-15 | Complete | 2026-12-20 |
Product codes that cite ISO 11607-2
No product code cites ISO 11607-2: 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.