FDA-recognized standard · Physical Medicine
IEC 80601-2-78: Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation assessment compensation or alleviation
Yes. FDA recognizes IEC 80601-2-78 Edition 1.0 2019-07 as recognition 16-232, entered 2021-12-20.
Recognized editions of IEC 80601-2-78
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 16-232 | IEC 80601-2-78 Edition 1.0 2019-07 | 2021-12-20 | Complete | — |
Regulations
FDA lists these classification regulations against IEC 80601-2-78: 21 CFR 890.1925, 21 CFR 890.3475, 21 CFR 890.3480.
Product codes that cite IEC 80601-2-78
13 FDA product codes cite IEC 80601-2-78, including IKK, ILE, ILG, ILH, IOY.
- IKK
- ILE
- ILG
- ILH
- IOY
- IQI
- ITM
- ITQ
- ITS
- ITW
- KNP
- OHI
- PHL Powered Exoskeleton
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.