FDA-recognized standard · General II (ES/EMC)
IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
Yes. FDA recognizes IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION as recognition 19-36, in part, entered 2020-12-21.
Recognized editions of IEC 60601-1-2
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 19-36 | IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION also ANSI AAMI IEC 60601-1-2:2014 [Including AMD 1:2021] | 2020-12-21 | Partial | — |
What FDA does not recognize in IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION
Recognition 19-36 is partial. FDA's statement of the extent, verbatim:
Partial recognition. The following part(s) of the standard is (are) not recognized: 1. Figure 3, "nursing homes" as an example of the HOME HEALTHCARE ENVIRONMENT. 2. Subclause 8.9, Table 8 on Page 39: The citation of Note k) under "Conducted disturbances induced by RF fields" (4th Row).
Product codes that cite IEC 60601-1-2
No product code cites IEC 60601-1-2: 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.