FDA-recognized standard · General Plastic Surgery/General Hospital
IEC 60601-2-2: Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
Yes. FDA recognizes IEC 60601-2-2 Edition 6.1 2023-02 CONSOLIDATED VERSION Corrected Version 2025-11 as recognition 6-521, entered 2026-05-25. FDA also lists IEC 60601-2-2 Edition 6.0 2017-03 (recognition 6-389, transition period ending 2029-07-01).
Recognized editions of IEC 60601-2-2
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 6-521 | IEC 60601-2-2 Edition 6.1 2023-02 CONSOLIDATED VERSION Corrected Version 2025-11 | 2026-05-25 | Complete | — |
| 6-389 | IEC 60601-2-2 Edition 6.0 2017-03 also ANSI AAMI IEC 60601-2-2:2017 | 2021-06-07 | Partial | 2029-07-01 |
What FDA does not recognize in IEC 60601-2-2 Edition 6.0 2017-03
Recognition 6-389 is partial. FDA's statement of the extent, verbatim:
Partial recognition. The following part(s) of the standard is (are) not recognized: Subclause 202.7 ELECTROMAGNETIC EMISSIONS requirements for ME EQUIPMENT and ME SYSTEMS Subclause 202.8 Electromagnetic IMMUNITY requirements for ME EQUIPMENT and ME SYSTEMS
Regulations
FDA lists these classification regulations against IEC 60601-2-2: 21 CFR 876.1500, 21 CFR 876.4300, 21 CFR 876.4480, 21 CFR 878.4400, 21 CFR 884.4120, 21 CFR 884.4150, 21 CFR 884.4160.
Product codes that cite IEC 60601-2-2
30 FDA product codes cite IEC 60601-2-2, including FAJ, FAM, FAR, FAS, FBN.
- FAJ Cystoscope And Accessories, Flexible/Rigid
- FAM
- FAR
- FAS
- FBN Choledochoscope And Accessories, Flexible/Rigid
- FBO
- FDA
- FDF Colonoscope And Accessories, Flexible/Rigid
- FDI Snare, Flexible
- FDS Gastroscope And Accessories, Flexible/Rigid
- FDT Duodenoscope And Accessories, Flexible/Rigid
- FEH
- FER
- FFK
- FGB Ureteroscope And Accessories, Flexible/Rigid
- FGC
- FJL
- GCM
- GCQ
- GEI Electrosurgical, Cutting & Coagulation & Accessories
- HGI
- HIN
- JOS
- KGE Forceps, Biopsy, Electric
- KNF
- NEY System, Ablation, Microwave And Accessories
- NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
- OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
- ODF
- ODR
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.