IEC 60601-1-6:20 0+A1:2013规定了制造商分析、指定、设计、验证和确认可用性的流程，因为它 涉及医疗的基本安全和基本性能 电气设备。此可用性工程过程评估 并减轻由与 纠正使用和使用错误，即正常使用。它可以用于 识别但不评估或减轻与 异常使用。如果本文中详述的可用性工程过程 符合抵押品标准，验收合格 符合可用性确认计划中记录的标准 （参见IEC 62366:2007的5.9），则剩余风险，定义见 ISO 14971，与me设备的可用性相关，假定为 可予接受，除非有相反的客观证据 （参见IEC 62366:2007的4.1.2）。本抵押品的标的 标准是规定除 一般标准的那些，并作为基础 特定标准。本文件取消并取代第二份文件 经过技术修订的IEC 60601-1-6版本。是的 修订以与IEC中的可用性工程流程保持一致 62366.允许设备制造商和测试 组织制造产品并装备自己 根据第三版进行修订测试，它 SC 62A建议本文件的内容不 于三年内采纳强制实施 新设计设备的发布日期且不早于此 自公布之日起超过5年的设备 生产。 本合并版本由第三版（2010年）组成 及其修正案1（2013年）。因此，无须在 本出版物的补充。

IEC 60601-1-6:2010+A1:2013 specifies a process for a manufacturer toanalyse, specify, design, verify and validate usability, as it relates to basic safety and essential performance of medical electrical equipment. This usability engineering process assesses and mitigates risks caused by usability problems associated with correct use and use errors, i.e., normal use. It can be used to identify but does not assess or mitigate risks associated with abnormal use. If the usability engineering process detailed in this collateral standard has been complied with and the acceptance criteria documented in the usability validation plan have been met (see 5.9 of IEC 62366:2007), then the residual risks, as defined in ISO 14971, associated with usability of me equipment are presumed to be acceptable, unless there is objective evidence to the contrary (see 4.1.2 of IEC 62366:2007). The object of this collateral standard is to specify general requirements that are in addition to those of the general standard and to serve as the basis for particular standards. This document cancels and replaces the second edition of IEC 60601-1-6 which has been technically revised. It was revised to align with the usability engineering process in IEC 62366. To allow for equipment manufacturers and testing organizations to make products and to equip themselves for conducting revised tests in accordance with this third edition, it is recommended by SC 62A that the content of this document not be adopted for mandatory implementation earlier than 3 years from the date of publication for equipment newly designed and not earlier than 5 years from the date of publication for equipment already in production. This consolidated version consists of the third edition (2010) and its amendment 1 (2013). Therefore, no need to order amendment in addition to this publication.