标准摘要
[中文适用范围]： 本国际标准规定了分析、设计、验证和验证可用性的过程的要求，因为它涉及医疗电气设备（以下简称 ME 设备）的基本安全和基本性能。该并列标准涉及正常使用和使用错误，但不包括异常使用。 [外文原描述]： Specifies requirements for a process to analyse, design, verify and validate the usability, as it relates to basic safety and essential performance of medical electrical equipment. This collateral standard addresses normal use and use errors but excludes abnormal use. The object of this collateral standard is to specify general requirements that are in addition to those of the general standard IEC 60601-1 and to serve as the basis for particular standards.
英文名称Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability