Phototherapy - Related International Standards
The following non-harmonised international standards are related to Phototherapy for EU MDR compliance reference.
| Standard | Title | Status | GSPRs | Link |
|---|---|---|---|---|
| IEC 60601-2-57:2023 | Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use | active | 14, 16 | Link |
| IEC 60601-2-75:2017+AMD1:2023 | Medical electrical equipment - Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment | active | 14, 16 | Link |
| IEC 60601-2-83:2019 | Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment | active | 14, 16 | Link |