标准修改件1中最显著变化的影响评定和IEC 60601-1-2005标准条款与前一个版本的映射

[中文适用范围]： 本技术报告提供了一个工具，旨在帮助IEC 60601-1:2005的用户评估2012年修订1中最重要的变更所带来的影响。 本技术报告还提供了一个工具，帮助IEC 60601-1的用户追踪第三版与其来源文件（主要是修订后的第二版）之间的要求。 本报告适用于： - 那些必须将基于IEC 60601-1第二版的标准与修订后的第三版对齐的人员； - 医疗电气设备或医疗电气系统的制造商； - 医疗电气设备和医疗电气系统的标准实施负责机构，如医疗监管机构、测试机构和其他组织。 [外文原描述]： IEC/TR 62348:2012(E) which is a technical report, provides a tool to assist users of IEC 60601-1:2005 to assess the impact of the most significant changes in Amendment 1:2012. This technical report also provides a tool to assist users of IEC 60601-1 to trace requirements between the third edition and their source in the documents that form the basis of the third edition; principally the second edition as amended. This report is intended to be used by: - those who must align standards based on the second edition of IEC 60601-1 with the third edition as amended; - manufacturers of medical electrical equipment or medical electrical systems; and - health care regulatory authorities, test houses and other organizations responsible for implementing standards for medical electrical equipment and medical electrical systems. This second edition cancels and replaces the first edition published in 2006. The second edition retains the mapping that traces the requirements of IEC 60601-1:2005 and its Amendment A1:2012 (Edition 3.1) from their source in the documents that relate to IEC 60601-1:1998 and its amendments (Edition 2.2). The second edition adds an assessment of the impact of the most significant changes in Amendment 1:2012.