DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE
Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
Abstract
NOTE 1 The scope of this 4th edition differs from the scope of the 3rd edition. It now includes CLASS 1C laser equipment, as defined in IEC 60825-1:2014, when the ENCLOSED LASER is laser CLASS 3B or 4. LED (light emitting diode) products are now excluded from this standard as medical LED products may be covered by IEC 60601-2-57. This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of laser equipment for surgical, therapeutic, medical diagnostic, cosmetic or veterinary applications, intended for use on humans or animals, classified as LASER PRODUCT of CLASS 1C where the ENCLOSED LASER is CLASS 3B or 4, or CLASS 3B, or CLASS 4, hereafter referred to as LASER EQUIPMENT. NOTE 2 Laser products for these applications classified as a CLASS 1, 1M, 2, 2M or4LASER PRODUCT, are covered by IEC 60825-1:2014 and IEC 60601-1:2012. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13, Physiological effects, of the General Standard. NOTE 3 See also 4.2, Risk management process, of the General Standard. NOTE 4 If the laser equipment is classified as laser CLASS 1C according to IEC 60825-1:2014 and is used as a laser appliance in a household or in beauty salons and similar premises, it is covered by IEC 60335-2-113:2016
Begin
2025-07-23
Planned document number
DIN EN IEC 60601-2-22/AA
Project number
02233308
