标准摘要
[中文适用范围]： 本标准适用于医疗设备（ME 设备）和医疗电气系统（ME 系统）的基本安全和基本性能。如果某条条款或子条款专门适用于 ME 设备或 ME 系统，则该条款或子标题和内容会明确指出。如果并非如此，则该条款或子条款适用于相关的 ME 设备和 ME 系统。本标准范围内 ME 设备或 ME 系统固有的、与预期生理功能相关的危害，除 7.2.13 和 8.4.1 外，未被本标准的特定要求所涵盖。本标准也可适用于用于治疗、补偿或缓解疾病、损伤或残疾的设备。体外诊断设备若不符合 ME 设备的定义，则属于 IEC 61010 系列的范围。本标准不适用于受 ISO 14708-1 覆盖的有源植入式医疗器械的植入部分。IEC 60601 系列不适用于：不符合 ME 设备定义的体外诊断设备（属于 IEC 61010 系列）；受 ISO 14708 系列覆盖的有源植入式医疗器械的植入部分；以及受 ISO 7396-1 覆盖的医疗气体管道系统。 [外文原描述]： IEC 60601-1:2005+A1:2012 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. This consolidated version consists of the third edition (2005) and its amendment 1 (2012). Therefore, there is no need to order the amendment in addition to this publication. This document includes the contents of the corrigenda 1 (2006), 2 (2007) and 3 (2022), the contents of the corrigendum to Amendment 1 (2014), as well as the interpretation sheets 1 (2008), 2 (2009), 3 (2013) and interpretation sheet to amendment 1 (2021). IEC TR 62348:2012 provides a tool to assist users of IEC 60601-1:2005 to assess the impact of the most significant changes in Amendment 1:2012, and to trace requirements between the third edition and the amended second edition.
英文名称Medical electrical equipment - Part 1: General requirements for basic safety and essential performance