IEC 60601-1-6:20 0+A1:2013+A2:2020规定了制造商分析、指定、设计、验证和确认可用性的流程，因为它涉及医疗电气设备的基本安全性和基本性能。该可用性工程过程评估并减轻由与正确使用和使用错误（即正常使用）相关的可用性问题引起的风险。它可用于识别但不评估或减轻与异常使用相关的风险。如果遵守了本辅助标准中详述的可用性工程过程，并且满足了可用性确认计划中记录的验收标准（参见IEC 62366:2007的5.9），则假定ISO 14971中定义的与医用电气设备可用性相关的剩余风险是可接受的，除非有相反的客观证据（参见4。IEC 62366:2007的1.2)。本辅助标准的目的是规定除一般标准之外的一般要求，并作为特定标准的基础。本文件取消并取代已进行技术修订的IEC 60601-1-6第二版。对其进行了修订，以符合IEC 62366中的可用性工程流程。为了使设备制造商和测试组织能够根据第三版制造产品并装备自己进行修订后的测试，SC 62A建议，对于新设计的设备，不得在发布之日起3年内采用本文件的内容，对于已在生产的设备，不得在发布之日起5年内强制实施。该合并版本由第三版（2010年）、修正案1（2013年）和修正案2（2020年）组成。因此，除了本出版物之外，没有必要下令进行修订。

IEC 60601-1-6:2010+A1:2013+A2:2020 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), its amendment 1 (2013) and its amendment 2 (2020). Therefore, no need to order amendments in addition to this publication.