FDA-recognized standard · General I (QS/RM)
IEC 60601-1-8: Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
Yes. FDA recognizes IEC 60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION as recognition 5-131, entered 2020-12-21.
Recognized editions of IEC 60601-1-8
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 5-131 | IEC 60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION also ANSI AAMI IEC 60601-1-8:2006 and A1:2012 [Including AMD 2:2021] | 2020-12-21 | Complete | — |
Product codes that cite IEC 60601-1-8
No product code cites IEC 60601-1-8: 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.