FDA-recognized standard · General II (ES/EMC)
IEC 60601-1-11: Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
Yes. FDA recognizes IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION as recognition 19-38, in part, entered 2020-12-21.
Recognized editions of IEC 60601-1-11
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 19-38 | IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION | 2020-12-21 | Partial | — |
What FDA does not recognize in IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION
Recognition 19-38 is partial. FDA's statement of the extent, verbatim:
Partial recognition. The following part(s) of the standard is (are) not recognized: "Note 2 to entry" in Sub-clause 3.1 (Home Healthcare Environment).
Product codes that cite IEC 60601-1-11
No product code cites IEC 60601-1-11: 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.