医疗器械标准化技术委员会国内外对比研究

Comparative Study on Standardization Technical Committees on Medical Devices at Home and Abroad

本文通过研究ISO、IEC和国内的医疗器械标准化技术委员会建设情况,梳理国内与ISO、IEC医疗器械标准化技术委员会的对应关系,并从技术领域方向上进行对比分析,发现我国医疗器械标准化技术委员会的设置与国际上的差距已逐步减小,在部分领域甚至领先于国际。结合我国医疗器械标准体系现状,提出了进一步完善我国医疗器械标准化工作的建议。

By studying the construction of standardization technical committees on medical devices in ISO,IEC and China,this paper sorts out the corresponding relationship of Chinese standardization technical committees on medical devices and those in ISO and IEC,and conducts a comparative analysis from the technological perspective,which finds that the gap in setting standardization technical committees for medical devices between China and international organizations has been gradually reduced,with China even leading international partners in some fields.According to the current situation of standards system for medical devices in our country,the paper puts forward suggestions to further improve China’s standardization of medical devices.