[Usability and standards of medical devices].
This article discusses about the definition of usability of medical devices and introduces the related international standards. It describes the significance of usability and the relationship with the risk analysis. Some advices are given to improve the usability and reduce the risk of medical devices by explaining the standards.
Xin
Liu
L
Center for Certification & Evaluation, Shanghai Food and Drug Administration, Shanghai, 200021. liuxin@smda.gov.cn
D004867:Equipment Design / Q000592:standards*; D018570:Risk Assessment