医疗器械.第1部分:医疗器械可用性工程的应用

[中文适用范围]： 本部分的 IEC 62366 规定了制造商分析和评估医疗器械与安全性相关的可用性（Usability）的流程。该可用性工程（人因工程）流程允许制造商评估和减轻与正确使用（Correct Use）和使用错误（Use Error），即正常使用（Normal Use）相关的风险。它可以用于识别但与不正常（Abnormal）使用相关的风险无关。如果符合本国际标准中详述的可用性工程流程，则与安全性相关的医疗器械可用性被推定为可接受，除非有客观证据表明相反。 [外文原描述]： IEC 62366-1:2015 specifies a process for a manufacturer to analyse, specify, develop and evaluate the usability of a medical device as it relates to safety. This usability engineering (human factors engineering) process permits the manufacturer to assess and mitigate risks 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. This first edition of IEC 62366-1, together with the first edition of IEC 62366-2 (not published yet), cancels and replaces the first edition of IEC 62366 published in 2007 and its Amendment 1:2014. Part 1 has been updated to include contemporary concepts of usability engineering, while also streamlining the process. It strengthens links to ISO 14971:2007 and the related methods of risk management as applied to safety related aspects of medical device user interfaces. Part 2, once published, will contain tutorial information to assist manufactures in complying with Part 1, as well as offering more detailed descriptions of usability engineering methods that can be applied more generally to medical devices that go beyond safety-related aspects of medical device user interfaces. The contents of the corrigendum of July 2016 have been included in this copy.