標(biāo)準(zhǔn)號(hào)：IEC 60601-2-22-2007
中文標(biāo)準(zhǔn)名稱：醫(yī)療電氣設(shè)備.第2-22部分:外科、整容、治療和診斷用激光設(shè)備基本安全和基本性能的特殊要求
英文標(biāo)準(zhǔn)名稱：Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
標(biāo)準(zhǔn)類型：C41
發(fā)布日期：1999/12/31 12:00:00
實(shí)施日期：1999/12/31 12:00:00
中國(guó)標(biāo)準(zhǔn)分類號(hào)：C41
國(guó)際標(biāo)準(zhǔn)分類號(hào)：11.040.55;11.040.60
適用范圍：This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of laserequipment for either surgical, therapeutic, medical diagnostic, cosmetic, or veterinaryapplications, intended for its use on humans or animals, classified as a CLASS 3B or CLASS 4LASER PRODUCT as defined by 3.22 and 3.23 in IEC 60825-1, hereafter referred to as LASEREQUIPMENT.Throughout this International Standard, light emitting diodes (LED) are included whenever theword “l(fā)aser” is used.NOTE 1 Refer to Definition 3.49 in IEC 60825-1.NOTE 2 Laser products for these applications classified as a CLASS 1, 1M, 2, 2M or CLASS 3R LASER PRODUCT, arecovered by IEC 60825-1 and IEC 60601-1.If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or toME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not thecase, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMSwithin the scope of this standard are not covered by specific requirements in this standardexcept in 7.2.13 and 8.4.1 of the General Standard.NOTE See also 4.2 of the General Standard.This standard can also be applied to surgical, cosmetic, therapeutic and diagnostic laserequipment used for compensation or alleviation of disease, injury or disability.