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Laser Surgery - Related International Standards

The following non-harmonised international standards are related to Laser Surgery for EU MDR compliance reference.

StandardTitleStatusGSPRsLink
IEC 60601-2-22:2019+AMD1:2026Medical electrical equipment - Part 2-22: Particular requirements for the basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipmentactive14, 16Link
IEC 60825-1:2014Safety of laser products - Part 1: Equipment classification and requirementsactive14, 18Link
ISO 11810:2015Lasers 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 ignitionactive14, 18Link

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