Usability and standards of medical devices.
- Author:
Liu XIN
1
Author Information
1. Center for Certification & Evaluation, Shanghai Food and Drug Administration, Shanghai, 200021. liuxin@smda.gov.cn
- Publication Type:Journal Article
- MeSH:
Equipment Design;
standards;
Risk Assessment
- From:
Chinese Journal of Medical Instrumentation
2010;34(1):47-49
- CountryChina
- Language:Chinese
-
Abstract:
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.
