摘要
本文阐述了实施医疗器械可用性工程的必要性和意义,介绍了可用性工程与风险管理的关系,可用性标准的制修订进展和可用性工程过程,以期为相关从业人员提供有益参考。
This paper introduces the necessity and significance of implementing the usability engineering of medical devices, the relationship between usability engineering and risk management,the development and revision of usability standards and the process of usability engineering, in order to provide useful references for practitioners of usability engineering technology.
作者
张鑫
孙腾
Zhang Xin;Sun Teng(lInstrumentation Technology and Economy Institute,Beijing 100055)
出处
《中国仪器仪表》
2022年第7期31-33,共3页
China Instrumentation
基金
2021年产业技术基础公共服务平台项目“医学影像装备首台(套)重大技术装备试验验证平台建设”。
关键词
医疗器械
可用性工程
风险管理
Medical equipment
Usability engineering
Risk management
