标准摘要
[中文适用范围]： 广泛，涉及医疗设备制造商、医疗机构、监管机构等多个相关方。 ***此介绍可能不准确，请注意参考原文。 [外文原描述]： 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. The contents of the corrigendum of July 2014 and the interpretation sheet 1 of March 2021 have been included in this copy.
英文名称Amendment 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance