IEC 60601-2-31:2008 医疗电气设备 - 第2-31部分:具有内部电源的外部心脏起搏器的基本安全性和基本性能的特殊要求

标准编号：IEC 60601-2-31:2008

中文名称：医疗电气设备 - 第2-31部分:具有内部电源的外部心脏起搏器的基本安全性和基本性能的特殊要求

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

发布日期：2008-03-26

标准范围

IEC 60601-2-31:2008适用于由内部电源供电的外部起搏器的基本安全和基本性能。本特定标准中规定的最低安全要求被认为是为带内部电源的体外心脏起搏器的操作提供了实际的安全程度。本特殊标准修订和补充了IEC 60601-1（2005年第三版）:医用电气设备第1部分:基本安全和基本性能的一般要求。第二版取消并取代1994年出版的第一版及其修正案1（1998）。IEC 60601-2-31的第二版与IEC 60601-1:2005一致，并包含第一版的最低技术修订。

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.

标准预览图