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现行 AAMI/IEC TIR62366-2:2016
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Medical Devices Part 2: Guidance on the Application of Usability Engineering to Medical Devices 医疗器械第2部分:可用性工程在医疗器械中的应用指南
发布日期: 2016-07-24
IEC 62366的这一部分是一份技术报告,包含背景信息,并提供指导,以解决经验表明可能有助于实施IEC 62366-1:2015中定义的可用性工程(人为因素工程)过程以及安全以外的支持目标的特定领域。本技术报告不用于监管目的。它不包含任何要求,只提供指导和教程信息。
This Part of IEC 62366, which is a Technical Report, contains background information and provides guidance that addresses specific areas that experience suggests can be helpful for those implementing a USABILITY ENGINEERING (HUMAN FACTORS ENGINEERING) PROCESS both as defined in IEC 62366-1:2015 and as supporting goals other than SAFETY. This technical report is not intended to be used for regulatory purposes. It contains no requirements and only provides guidance and tutorial information.
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