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

[中文适用范围]： 本国际标准规定了一个过程，供制造商分析、规范、设计、验证和确认医用电气设备（以下简称ME设备）的适用性，该适用性与ME设备的基本安全和主要性能相关。该适用性工程过程评估并减轻与正确使用和误用（即正常使用）相关的适用性问题引起的风险。它可以用于识别但与异常使用相关的风险不进行评估或减轻。如果已遵守本辅助标准中详细说明的适用性工程过程，并且符合在适用性验证计划中记录的可接受标准（见IEC 62366:2007的5.9），则与ME设备适用性相关的残余风险（如ISO 14971所定义）应被视为可接受，除非有相反的确凿证据（见IEC 62366:2007的4.1.2）。 本辅助标准的目的是规定除通用标准之外的附加通用要求，并作为特定标准的依据。 本国际标准规定了一个过程，供制造商分析、规范、设计、验证和确认医用电气设备（以下简称ME设备）的适用性，该适用性与ME设备的基本安全和主要性能相关。该适用性工程过程评估并减轻与正确使用和误用（即正常使用）相关的适用性问题引起的风险。它可以用于识别但与异常使用相关的风险不进行评估或减轻。如果已遵守本辅助标准中详细说明的适用性工程过程，并且符合在适用性验证计划中记录的可接受标准（见IEC 62366:2007的5.9），则与ME设备适用性相关的残余风险（如ISO 14971所定义）应被视为可接受，除非有相反的确凿证据（见IEC 62366:2007的4.1.2）。本辅助标准的目的是规定除通用标准之外的附加通用要求，并作为特定标准的依据。 [外文原描述]： 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.