FDA-recognized standard · General I (QS/RM)
IEC 62366-1: Medical devices - Part 1: Application of usability engineering to medical devices
Yes. FDA recognizes IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION as recognition 5-129, entered 2020-07-06.
Recognized editions of IEC 62366-1
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 5-129 | IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION also ANSI AAMI IEC 62366-1:2015+AMD1:2020 (Consolidated Text) | 2020-07-06 | Complete | — |
Product codes that cite IEC 62366-1
No product code cites IEC 62366-1: 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.