IEC 60601-1-6:2010 医疗电气设备 - 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

标准编号：IEC 60601-1-6:2010

中文名称：医疗电气设备 - 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

英文名称：Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

发布日期：2010-01-27

标准范围

IEC 60601-1-6:2010规定了制造商分析、规定、设计、验证和验证可用性的过程，因为它与医疗电气设备的基本安全和基本性能有关。此可用性工程过程评估并减轻与正确使用和使用错误（即正常使用）相关的可用性问题所造成的风险。它可用于识别但不评估或减轻与异常使用相关的风险。如果符合本附带标准中详述的可用性工程过程，并且符合可用性验证计划中记录的验收标准（见IEC 62366第5.9节:2007），则ISO 14971中定义的与医用电气设备可用性相关的剩余风险被认为是可接受的，除非有相反的客观证据（见IEC 62366:2007的4.1.2）。本附带标准的目的是规定除通用标准外的一般要求，并作为特定标准的基础。本文件取消并取代了IEC 60601-1-6第二版，该版本已经过技术修订。它被修改为符合IEC 62366中的可用性工程过程。允许设备制造商和测试机构生产产品，并根据第三版进行修订测试，SC 62A建议，本文件的内容不得在新设计设备出版之日起3年内强制执行，已投产设备出版之日起5年内强制执行。

IEC 60601-1-6:2010 specifies a process for a manufacturer to analyse, 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.

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