FDA-recognized standard · Dental/ENT
IEC 80601-2-60: Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
Yes. FDA recognizes IEC 80601-2-60 Edition 2.0 2019-06 as recognition 4-262, entered 2019-12-23.
Recognized editions of IEC 80601-2-60
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 4-262 | IEC 80601-2-60 Edition 2.0 2019-06 | 2019-12-23 | Complete | — |
Regulations
FDA lists these classification regulations against IEC 80601-2-60: 21 CFR 872.4120, 21 CFR 872.4200, 21 CFR 872.4850, 21 CFR 872.6070, 21 CFR 872.6640.
Product codes that cite IEC 80601-2-60
11 FDA product codes cite IEC 80601-2-60, including EBW, EBZ, EFA, EFB, EGS.
- EBW Controller, Foot, Handpiece And Cord
- EBZ Activator, Ultraviolet, For Polymerization
- EFA
- EFB Handpiece, Air-Powered, Dental
- EGS Handpiece, Contra- And Right-Angle Attachment, Dental
- EIA Unit, Operative Dental
- EKX Handpiece, Direct Drive, Ac-Powered
- EKY
- ELC Scaler, Ultrasonic
- KMW
- NYL
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.