标准摘要
[中文适用范围]： 替代：本国际标准适用于由内部电源供电的外部起搏器（以下简称ME设备）的基本安全和基本性能。本标准适用于 201.3 中定义的患者电缆。 109. 如果某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，则该条款或子条款适用于相关的 ME 设备和 ME 系统。除通用标准 7.2.13 和 8.4.1 外，本标准范围内 ME 设备预期生理功能固有的危险不属于本标准具体要求的范围。注：另见通用标准4.2。本标准不适用于 ISO 14708-1 涵盖的有源植入式医疗器械的植入部件 本标准不适用于可直接或间接连接至电源的外部起搏器。本标准不适用于经胸和食管起搏ME设备和抗心动过速ME设备。 [外文原描述]： IEC 60601-2-31:2008 applies to the basic safety and essential performance of external pacemakers powered by an internal electrical power source. The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of external cardiac pacemakers with an internal power source. This particular standard amends and supplements IEC 60601-1 (third edition, 2005): Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. This second edition cancels and replaces the first edition published in 1994 and its Amendment 1 (1998). This second edition of IEC 60601-2-31 is aligned with IEC 60601-1:2005, and contains minimal technical revisions from the first edition.
英文名称Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source