IEC 60601-2-22:2019 医疗电气设备 - 第2-22部分:手术 化妆品 治疗和诊断激光设备的基本安全和基本性能的特殊要求

标准编号：IEC 60601-2-22:2019

中文名称：医疗电气设备 - 第2-22部分:手术 化妆品 治疗和诊断激光设备的基本安全和基本性能的特殊要求

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

发布日期：2019-11-20

标准范围

IEC 60601-2-22:20 19作为IEC 60601-2-22:20 19 RLV提供，其中包含国际标准及其红线版本，显示了与上一版本相比技术内容的所有变化。IEC 60601-2-22:20 19适用于用于人类或动物的外科、治疗、医疗诊断、美容或兽医应用的激光设备的基本安全和基本性能，被归类为1C类激光产品，其中封闭的激光属于3B类或4类，或3B类或4类。医疗电气设备或医疗电气系统，其结合了激光器作为被传递给患者或动物的能量源，并且其中激光器如上所述，在本文中被称为“激光设备”。用于这些应用的激光产品被分类为1类、1M类、2类、2M类或3R类激光产品，由IEC 60825-1:20 14和一般标准。如果一个条款或子条款特别旨在仅适用于ME设备，或仅适用于ME系统，该条款或子条款的标题和内容将如此说明。如果不是这种情况，该条款或子条款适用于相关的ME设备和ME系统。除通用标准7.2.13生理效应外，本文件中的具体要求未涵盖本文件范围内激光设备预期生理功能中固有的危害。如果激光设备根据IEC 60825-1:20 14属于1C类，并且在家庭中用作激光设备，则IEC 60335-2-113:2016涵盖该设备。本第四版取消并取代了2007年出版的第三版和修正案1:20 12。本版构成技术修订版。与上一版相比，此版本包括以下重大技术变更:a)它考虑了自第三版出版以来已出版的IEC 60601-1:20 05/AMD1:2012和IEC 60825-1:20 14；b)它解决了自第三版出版以来出现的技术和安全问题；c)本第四版的范围与第三版的范围不同。它现在包括IEC 60825-1:20 14中定义的1C类激光设备，当封闭激光器为3B或4类时；d)LED（发光二极管）产品现在被排除在本文件之外，因为医用LED产品可能被IEC 60601-2-57覆盖。

IEC 60601-2-22:2019 is available as IEC 60601-2-22:2019 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the 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.

标准预览图