IEC TR 62366-2:2016 医疗器械.第2部分:医疗器械可用性工程应用指南

标准编号：IEC TR 62366-2:2016

中文名称：医疗器械.第2部分:医疗器械可用性工程应用指南

英文名称：Medical devices - Part 2: Guidance on the application of usability engineering to medical devices

发布日期：2016-04-27

标准范围

IEC TR 62366-2:20 16（E）是一份技术报告，包含背景信息并提供指导，解决经验表明对实施IEC 62366-1:20 15中定义的可用性工程（人为因素工程）流程和支持安全性以外的目标的人员有帮助的特定领域。本技术报告不打算用于监管目的。它不包含任何要求，仅提供指导和教程信息。本出版物应与IEC 62366-1:20 15一起阅读。

IEC TR 62366-2:2016(E), 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.

This publication is to be read in conjunction with IEC 62366-1:2015.

标准预览图