I.S. EN 62366:2009被替代
Medical Devices - Application of Usability Engineering to Medical Devices
出版：National Standards Authority of Ireland
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基本信息
标准编号： I.S. EN 62366:2009
发布时间：2009/2/24 0:00:00
标准类别：Standard
出版单位：National Standards Authority of Ireland
标准页数：104
标准简介
Describes a PROCESS for a MANUFACTURER to analyse, specify, design, VERIFY and VALIDATE USABILITY, as it relates to SAFETY of a MEDICAL DEVICE. 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.
等同采用的国际标准
EN 62366 : 2008 AMD 1 2015 - Identical
