+AMD1:2013+AMD2:2020 CSV 医用电气设备.第1-6部分:基本安全和基本性能的一般要求.附带标准:可用性

[中文适用范围]： 本国际标准规定了一个制造商的流程，用于分析、规范、设计、验证和确认与医疗电气设备的基本安全和基本性能相关的可用性，随后简称医疗设备。该可用性工程过程评估并减轻与正确使用和误用（即正常使用）相关的可用性问题的风险。它可以用来识别但与异常使用相关的风险无关的评估或减轻。如果符合本旁侧标准中详细说明的可用性工程过程，并且可用性验证计划中记录的验收标准已满足，则与医疗设备可用性相关的残余风险（如ISO 14971所定义）被认为是可接受的，除非有客观证据表明相反的情况。如果符合本旁侧标准中详细说明的可用性工程过程，则医疗设备中与基本安全和基本性能相关的可用性被认为是可接受的，除非有客观证据表明相反的情况。 [外文原描述]： 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.