医疗电气设备.第2-22部分:外科、整容、治疗和诊断用激光设备基本安全和基本性能的特殊要求

[中文适用范围]： 本国际标准适用于外科、治疗、医学诊断、美容或兽医用激光设备的基本安全和基本性能，这些设备旨在用于人类或动物，被归类为 IEC 60825-1 中 3.22 和 3.23 定义的 3B 类或 4 类激光产品，以下简称激光设备。在本国际标准中，只要使用“激光”一词，即包括发光二极管 (LED)。注 1 请参阅 IEC 60825-1 中的定义 3.49。注 2 用于这些用途的激光产品被归类为 1 类、1M 类、2 类、2M 类或 3R 类激光产品，受 IEC 60825-1 和 IEC 60601-1 的约束。如果某一条款或子条款明确规定仅适用于 ME 设备或仅适用于 ME 系统，则该条款或子条款的标题和内容将予以说明。如果不是这样，则该条款或子条款同时适用于 ME 设备和 ME 系统（视情况而定）。本标准范围内的 ME 设备或 ME 系统预期生理功能中固有的危险不受本标准特定要求的约束，通用标准 7.2.13 和 8.4.1 除外。注：另请参见通用标准 4.2。本标准还可适用于用于补偿或缓解疾病、伤害或残疾的手术、美容、治疗和诊断激光设备。 [外文原描述]： Applies to the safety and essential performance of laser equipment for either surgical, therapeutic, medical diagnostic, cosmetic, or veterinary applications, intended for its use on humans or animals, classified as a class 3B or class 4 laser product as defined by 3.22 and 3.23 in IEC 60825-1, hereafter referred to as laser equipment. Throughout this International Standard, light emitting diodes (LED) are included whenever the word "laser" is used. This standard can also be applied to surgical, cosmetic, therapeutic and diagnostic laser equipment used for compensation or alleviation of disease, injury or disability. This third edition cancels and replaces the second edition of IEC 60601-2-22, published in 1995. This edition constitutes a technical revision. This third edition takes account of the recently published new editions of the General Standard IEC 60601-1 and publication IEC 60825-1. Additionally, it addresses technical and safety issues which have arisen in the time following the previous second edition.