| IEC 62359 Edition 2.1 2017-09 CONSOLIDATED VERSION Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields |
| Recognition Number | Radiology |
| Recognition Date | 2018-06-07 |
| Recognition List | 049 |
| Recognition Number | 12-316 |
| Extent | Complete standard |
| Standards Orgs | IEC International Electrotechnical Commission http://www.iec.ch/ |
| STG | Radiology |
| FDA Tech | Keith Wear FDA/OMPT/CDRH/OSEL/DAM/ 301-796-2538 keith.wear@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
This International standard is applicable to medical diagnostic ultrasound fields.
This standard establishes
- parameters related to thermal and non-thermal exposure aspects of diagnostic ultrasonic fields;
- methods for the determination of an exposure parameter relating to temperature rise in theoretical tissue-equivalent models, resulting from absorption of ultrasound;
- methods for the determination of an exposure parameter appropriate to certain nonthermal effects.
| Regulation Number | Device Name | Device Class | Product Code |
| §892.1570 | Media, Coupling, Ultrasound | Class 2 | MUI |
| §892.1570 | Transducer, Ultrasonic, Diagnostic | Class 2 | ITX |
| §892.1560 | System, Imaging, Pulsed Echo, Ultrasonic | Class 2 | IYO |
| §892.1550 | System, Imaging, Pulsed Doppler, Ultrasonic | Class 2 | IYN |
| §892.1540 | Monitor, Ultrasonic, Nonfetal | Class 2 | JAF |
| Guidance for Industry and FDA Staff: Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, Issued September 2008. |