FDA-recognized standard · Radiology
IEC 62359: Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields
Yes. FDA recognizes IEC 62359 Edition 2.1 2017-09 CONSOLIDATED VERSION as recognition 12-316, entered 2018-06-07.
Recognized editions of IEC 62359
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 12-316 | IEC 62359 Edition 2.1 2017-09 CONSOLIDATED VERSION | 2018-06-07 | Complete | — |
Regulations
FDA lists these classification regulations against IEC 62359: 21 CFR 892.1540, 21 CFR 892.1550, 21 CFR 892.1560, 21 CFR 892.1570.
Product codes that cite IEC 62359
5 FDA product codes cite IEC 62359, including ITX, IYN, IYO, JAF, MUI.
- ITX Transducer, Ultrasonic, Diagnostic
- IYN System, Imaging, Pulsed Doppler, Ultrasonic
- IYO System, Imaging, Pulsed Echo, Ultrasonic
- JAF
- MUI Media, Coupling, Ultrasound
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.