IEC 62366-1:2015 医疗器械.第1部分:可用性工程在医疗器械上的应用

标准编号：IEC 62366-1:2015

中文名称：医疗器械.第1部分:可用性工程在医疗器械上的应用

英文名称：Medical devices - Part 1: Application of usability engineering to medical devices

发布日期：2015-02-24

标准范围

IEC 62366-1:2015规定了制造商分析、规定、开发和评估与安全相关的医疗器械可用性的过程。此可用性工程（人为因素工程）过程允许制造商评估和减轻与正确使用和使用错误（即正常使用）相关的风险。它可用于识别但不评估或减轻与异常使用相关的风险。IEC 62366-1第一版与IEC 62366-2第一版一起取消并取代2007年发布的IEC 62366第一版及其修正案1（2014）。第1部分已经更新，包括了可用性工程的当代概念，同时也简化了过程。它加强了与ISO 14971:2007以及适用于医疗器械用户界面安全相关方面的风险管理相关方法的链接。第2部分包含教程信息，以帮助制造商遵守第1部分的规定，并提供可用性工程方法的更详细描述，这些方法可以更广泛地应用于医疗设备，超出医疗设备用户界面的安全相关方面。

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, 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 contains 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.

标准预览图