FDA-recognized standard · General Plastic Surgery/General Hospital
IEC 80601-2-77: Medical electrical equipment - Part 2-77: Particular requirements for the BASIC SAFETY and essential performance of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT
Yes. FDA recognizes IEC 80601-2-77 Edition 1.1 2023-11 CONSOLIDATED VERSION as recognition 6-510, entered 2025-05-26. FDA also lists IEC 80601-2-77 Edition 1.0 2019-07 (recognition 6-438, transition period ending 2028-07-02).
Recognized editions of IEC 80601-2-77
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 6-510 | IEC 80601-2-77 Edition 1.1 2023-11 CONSOLIDATED VERSION | 2025-05-26 | Complete | — |
| 6-438 | IEC 80601-2-77 Edition 1.0 2019-07 also ANSI AAMI IEC 80601-2-77:2020 | 2019-12-23 | Complete | 2028-07-02 |
Regulations
FDA lists these classification regulations against IEC 80601-2-77: 21 CFR 876.1500, 21 CFR 878.4961, 21 CFR 878.4962, 21 CFR 878.4963, 21 CFR 878.4964, 21 CFR 878.4965.
Product codes that cite IEC 80601-2-77
6 FDA product codes cite IEC 80601-2-77, including NAY, QNM, SAB, SAQ, SCV.
- NAY System, Surgical, Computer Controlled Instrument
- QNM
- SAB
- SAQ
- SCV
- SDD
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.