标准摘要
[中文适用范围]： 本国际标准适用于医疗电气设备和医疗电气系统（以下简称ME设备和ME系统）的基本安全和基本性能。如果某个条款或子条款专门旨在仅适用于 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如此说明。如果情况并非如此，则该条款或子条款同时适用于 ME设备和 ME 系统，如相关。除 7.2.13 和 8.4.1 之外，本标准中的具体要求不涵盖本标准范围内 ME 设备或 ME 系统的预期生理功能所固有的危险。本标准也适用于用于补偿或减轻疾病、伤害或残疾的设备。 IEC 61010 系列 2) 涵盖了不属于 ME 设备定义范围的体外诊断设备。本标准不适用于 ISO 14708-1 3) 涵盖的有源植入式医疗设备的植入部件。 [外文原描述]： IEC 60601-1:2005 contains requirements concerning basic safety and essential performance that are generally applicable to medical electrical equipment. For certain types of medical electrical equipment, these requirements are either supplemented or modified by the special requirements of a collateral or particular standard. Where particular standards exist, this standard should not be used alone. The contents of the corrigenda of December 2006, December 2007 and December 2022, the interpretation sheets of April 2008, January 2009 and May 2013 have been included in this copy.
英文名称Medical electrical equipment - Part 1: General requirements for basic safety and essential performance