医疗器械专用标准体系研究

Research on Special Standard System of Medical Device

在医疗器械标准体系框架内,通过对医疗器械专用标准概念、特点及标准制定情况的研究,分析现有各技术领域内专用标准体系的现状,发现存在的问题,提出专用标准体系建设思路及具体工作建议。

In the standard system framework of medical device, by research on the special standard concept, features and standard formulation, analysis of the present situation of the special standard system in the existing technical fields, the problems were found out, to provide opinions and suggestions for special standard system construction.