FDA-recognized standard · Neurology
IEC 60601-2-40: Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment
Yes. FDA recognizes IEC 60601-2-40 Third edition 2024-12 as recognition 17-20, entered 2025-05-26.
Recognized editions of IEC 60601-2-40
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 17-20 | IEC 60601-2-40 Third edition 2024-12 | 2025-05-26 | Complete | — |
Regulations
FDA lists these classification regulations against IEC 60601-2-40: 21 CFR 882.1320, 21 CFR 890.1375, 21 CFR 890.1385, 21 CFR 890.1850, 21 CFR 890.3450.
Product codes that cite IEC 60601-2-40
7 FDA product codes cite IEC 60601-2-40, including GXY, IKN, IKT, ISB, KZM.
- GXY Electrode, Cutaneous
- IKN
- IKT
- ISB
- KZM
- OAL
- PAE
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.