医用电气设备第2-22部分:外科、美容、治疗和诊断激光设备的基本安全和基本性能的特殊要求

[中文适用范围]： 本部分 IEC 60601 适用于用于外科、治疗、医学诊断、美容或兽医应用的激光设备的基本安全和基本性能，这些设备用于人类或动物，根据 IEC 60825-1 的 3.22 和 3.23 条定义为 3B 类或 4 类激光产品，以下简称激光设备或 1C 类激光产品（其中封闭激光为 3B 类或 4 类）或 3B 类或 4 类激光产品。在本国际标准中，每当使用“激光”一词时，均包括发光二极管（LED）。 [外文原描述]： IEC 60601-2-22:2019 RLV contains both the official IEC International Standard and its Redline version. The Redline version is available in English only and provides you with a quick and easy way to compare all the changes between the official IEC Standard and its previous edition. IEC 60601-2-22:2019 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. 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. 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. This fourth edition cancels and replaces the third edition published in 2007 and Amendment 1:2012. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) it takes account of IEC 60601-1:2005/AMD1:2012 and IEC 60825-1:2014, which have been published since publication of the third edition; b) it addresses technical and safety issues which have arisen since publication of the third edition; c) the scope of this fourth edition differs from the scope of the third edition. It now includes Class 1C laser equipment, as defined in IEC 60825-1:2014, when the Enclosed Laser is Class 3B or 4; d) LED (light emitting diode) products are now excluded from this document as medical LED products may be covered by IEC 60601-2-57.