Physiotherapy - Related International Standards
The following non-harmonised international standards are related to Physiotherapy for EU MDR compliance reference.
| Standard | Title | Status | GSPRs | Link |
|---|---|---|---|---|
| IEC 60601-2-10:2012+AMD1:2016+AMD2:2023 | Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators | active | 14, 18 | Link |
| IEC 60601-2-3:2012+AMD1:2016+AMD2:2022 | Medical electrical equipment - Part 2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment | active | 14, 18 | Link |
| IEC 60601-2-5:2009 | Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment | active | 14, 18 | Link |
| ISO 13091-1:2001/Amd 2:2021 | Mechanical vibration - Vibrotactile perception thresholds for the assessment of nerve dysfunction - Part 1: Methods of measurement at the fingertips | active | 14, 18 | Link |
| ISO 22675:2025 | Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2024) | active | 10, 10.1, 10.3, 14 | Link |