标准摘要
[中文适用范围]: 将现有的第一个虚线项目替换为: – “通用标准”单独指定 IEC 60601-1(IEC 60601-1-1:2005+A1:2012); 将现有的第二个虚线项目替换为: – “本并列标准”指定单独 IEC 60601-1-10(IEC 60601-1-10:2007+A1:2013)
英文名称Amendment 1 - Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers