DS/EN IEC 60601-2-22:2020

Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment

201.1 Scope, object and related standards*Clause 1 of the general standard1 applies, except as follows:*201.1.1 Scope*Replacement:*This part of IEC 60601 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 of CLASS 3B or 4, or CLASS 3B, or CLASS 4.*MEDICAL ELECTRICAL EQUIPMENT or MEDICAL ELECTRICAL SYSTEMS which incorporate lasers as*sources of energy being transferred to the PATIENT or animal and where the lasers are*specified as above, are referred to as laser equipment” in this document.*NOTE 1 – LASER PRODUCTS for these applications classified as a Class 1, Class 1M, CLASS 2, Class 2M or*CLASS 3R LASER PRODUCT, are covered by IEC 60825-1:2014 and by the general standard.*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 laser equipment within the scope of*this document are not covered by specific requirements in this document except in 7.2.13,*Physiological effects, of the general standard.*NOTE 2 – See also 4.2, RISK MANAGEMENT process, of the general standard.*NOTE 3 – If the laser equipment is CLASS 1C according to IEC 60825-1:2014 and is used as a laser appliance in a*household, it is covered by IEC 60335-2-113:2016.*201.1.2 Object*Replacement:*The object of this document is to establish particular BASIC SAFETY and ESSENTIAL*PERFORMANCE requirements for the safety of surgical, cosmetic, therapeutic and diagnostic*laser equipment.*201.1.3 Collateral standards*Addition:*This document refers to those applicable collateral standards that are listed in Clause 2 of the*general standard and Clause 201.2 of this document.*201.1.4 Particular standards*Addition:*For brevity, IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 are referred to in this*document*The numbering of sections, clauses and subclauses of this document corresponds to that of*the general standard or applicable collateral standard. The changes to the text of the general*standard are specified by the use of the following words:*Replacement means that the clause or subclause of the general standard or applicable*collateral standard is replaced completely by the text of this document.*Addition means that the text of this document is additional to the requirements of the*general standard or applicable collateral standard.*Amendment means that the clause or subclause of the general standard or applicable*collateral standard is amended as indicated by the text of this document.*Subclauses or figures which are additional to those of the general standard are numbered*starting from 201.101, additional annexes are lettered AA, BB, etc., and additional items aa),*bb), etc.*Subclauses or figures which are additional to those of a collateral standard are numbered*starting from 20x, where x” is the number of the collateral standard, e.g. 202 for*IEC 60601-1-2, 203 for IEC 60601-1-3, etc.*The term this document is used to make reference to the general standard, any applicable*collateral standards and this document taken together.*Where there is no corresponding section, clause or subclause in this document, the section,*clause or subclause of the general standard or applicable collateral standard, although*possibly not relevant, applies without modification; where it is intended that any part of the*general standard or applicable collateral standard, although possibly relevant, is not to be*applied, a statement to that effect is given in this document.*Concerning laser radiation safety of laser equipment, IEC 60825-1:2014 applies, except for*the relevant requirements that are specified, changed or amended in this document.