FDA-recognized standard · Radiology
IEC 60601-2-37: Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
Yes. FDA recognizes IEC 60601-2-37 Edition 3.0 2024-07 as recognition 12-380, entered 2025-05-26. FDA also lists IEC 60601-2-37 Edition 2.1 2015 (recognition 12-293, transition period ending 2028-07-02).
Recognized editions of IEC 60601-2-37
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 12-380 | IEC 60601-2-37 Edition 3.0 2024-07 | 2025-05-26 | Complete | — |
| 12-293 | IEC 60601-2-37 Edition 2.1 2015 | 2016-06-27 | Complete | 2028-07-02 |
Regulations
FDA lists these classification regulations against IEC 60601-2-37: 21 CFR 892.1550, 21 CFR 892.1560, 21 CFR 892.1570.
Product codes that cite IEC 60601-2-37
6 FDA product codes cite IEC 60601-2-37, including ITX, IYN, IYO, MUI, NQQ.
- ITX Transducer, Ultrasonic, Diagnostic
- IYN System, Imaging, Pulsed Doppler, Ultrasonic
- IYO System, Imaging, Pulsed Echo, Ultrasonic
- MUI Media, Coupling, Ultrasound
- NQQ System, Imaging, Optical Coherence Tomography (Oct)
- OIJ
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.