Analysis of Usability Engineering to Medical Devices
LI Qing-yu1, Shi Yan-ping1,
LIU Mei-li2, YANG Jing 2
1. Shandong Quality Inspection Center
for Medical Devices, Jinan Shandong
250101, China; 2. Shandong Heng Xin
Inspection Technique Exploiture Center,
Jinan Shandong 250101, China
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.
李庆雨1，施燕平1，刘美丽2，杨婧2. 医疗器械的可用性工程浅析[J]. 中国医疗设备, 2017, 32(2): 1-4.
LI Qing-yu1, Shi Yan-ping1,
LIU Mei-li2, YANG Jing 2. Analysis of Usability Engineering to Medical Devices. China Medical Devices, 2017, 32(2): 1-4.
