年修改版和IEC 60601-1第3版的附加条款之间的映射

[中文适用范围]： 该技术报告提供了一个工具，可帮助 IEC 60601-1 的用户追踪第三版之间的要求及其在构成第三版基础的文档中的来源；主要是修订后的第二版。本报告旨在供以下人员使用： – 必须将基于 IEC 60601-1 第二版和第三版的标准进行调整的人员； – 医疗电气设备或医疗电气系统制造商； – 医疗保健监管机构、测试机构和其他负责实施医疗电气设备和医疗电气系统标准的组织。 [外文原描述]： This technical report 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; - manufacturers of medical electrical equipment or medical electrical systems; - health care regulatory authorities, test houses and other organizations responsible for implementing standards for medical electrical equipment and medical electrical systems.