FDA-recognized standard · Software/Informatics
IEC 81001-5-1: Health software and health IT systems safety effectiveness and security - Part 5-1: Security - Activities in the product life cycle
Yes. FDA recognizes IEC 81001-5-1 Edition 1.0 2021-12 as recognition 13-122, entered 2022-12-19.
Recognized editions of IEC 81001-5-1
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 13-122 | IEC 81001-5-1 Edition 1.0 2021-12 | 2022-12-19 | Complete | — |
Product codes that cite IEC 81001-5-1
No product code cites IEC 81001-5-1: 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.