FDA-recognized standard · General I (QS/RM)
IEC 60601-1-6: Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
Yes. FDA recognizes IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION as recognition 5-132, entered 2020-12-21.
Recognized editions of IEC 60601-1-6
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 5-132 | IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION | 2020-12-21 | Complete | — |
Product codes that cite IEC 60601-1-6
No product code cites IEC 60601-1-6: 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.