中国医疗设备2017，Vol.32Issue(2)：1-4,4.DOI:10.3969/j.issn.1674-1633.2017.02.001
医疗器械的可用性工程浅析
Analysis of Usability Engineering to Medical Devices
摘要
Abstract
This article introduced the usability of active medical devices,meaning of usability engineering as well as the working process of usability engineering;and also introduced the relationship between usability engineering and risk management in combination with the requirements of risk management.For the risk management process,issues related to usability,such as safety-related features,should be considered in risk analysis;results of usability validation should better be taken into account in the assessment of residual risks;it is better to include usability in the post-production information assessment during risk management process.The goal of usability engineering process is to provide for the safety of patient,operator,and other personnel in terms of usability of user interface.For this reason,usability engineering should be conducted early and carried out throughout the entire development cycle of the medical device,finally forming the usability engineering documents,which can be part of risk management document.关键词
医疗器械/可用性/可用性工程/风险管理/人机交互Key words
medical devices/usability/usability engineering/risk management/man-machine interaction分类
矿业与冶金引用本文复制引用
李庆雨,施燕平,刘美丽,杨婧..医疗器械的可用性工程浅析[J].中国医疗设备,2017,32(2):1-4,4.基金项目
国家重点研发计划试点专项(2016YFC0106001). （2016YFC0106001）
