Therapeutic Ultrasound - Related International Standards
The following non-harmonised international standards are related to Therapeutic Ultrasound for EU MDR compliance reference.
| Standard | Title | Status | GSPRs | Link |
|---|---|---|---|---|
| IEC 60601-2-62:2013 | Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment | active | 14, 14.1 | Link |
| IEC 61161:2013 | Ultrasonics - Power measurement - Radiation force balances and performance requirements | active | 14, 18 | Link |
| IEC 61689:2022 | Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz | active | 14, 18 | Link |