FDA-recognized standard · General II (ES/EMC)
IEC 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Note: This standard is recognized with relevant US national differences applied see references #1 and #2 in the Relevant FDA Guidance and/or Supportive Publication section below.
Yes. FDA recognizes IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION as recognition 19-49, entered 2023-04-03.
Recognized editions of IEC 60601-1
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 19-49 | IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION | 2023-04-03 | Complete | — |
Product codes that cite IEC 60601-1
No product code cites IEC 60601-1: 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.