无源医疗器械标准制修订现状和发展方向

Current Situations of Passive Medical Device Standards Setting and Revised and the Development Direction

目的为我国无源医疗器械标准制修订工作提供参考。方法对我国医疗器械国家和行业标准制修订的现状进行了分析与研究。结果无源医疗器械标准制订修订工作取得一定成绩,但仍存在较大提高空间。结论应进一步加强医疗器械标准制修订工作的基础研究,加大无源医疗器械标准制修订工作力度。

Objective To provide reference for passive medical device standards setting and revised. Methods Current situations of passive medical device national standards and industrial standards setting and revised were analyzed and studied. Results The work of passive medical device standards has great achievements, but there is a big space for improving. Conclusion It should be enhanced the elemental study of passive medical device standards setting and revised and also it should be strengthened the work of passive medical device standards setting and revised.