Laser Surgery - Related International Standards
The following non-harmonised international standards are related to Laser Surgery for EU MDR compliance reference.
| Standard | Title | Status | GSPRs | Link |
|---|---|---|---|---|
| IEC 60601-2-22:2019+AMD1:2026 | Medical electrical equipment - Part 2-22: Particular requirements for the basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment | active | 14, 16 | Link |
| IEC 60825-1:2014 | Safety of laser products - Part 1: Equipment classification and requirements | active | 14, 18 | Link |
| ISO 11810:2015 | Lasers and laser-related equipment - Test method and classification for the laser resistance of surgical drapes and/or patient protective covers - Primary ignition, penetration, flame spread and secondary ignition | active | 14, 18 | Link |

