中国标准化Issue(9)：69-75,7.DOI:10.3969/j.issn.1002-5944.2024.09.006
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
摘要
Abstract
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.关键词
医疗器械/标准化技术委员会/技术对口单位/标准体系Key words
medical device/standardization technical committee/technical counterpart/standards system引用本文复制引用
钱文文,石林,夏忠诚,黄芝香,郑建..医疗器械标准化技术委员会国内外对比研究[J].中国标准化,2024,(9):69-75,7.基金项目
本文受浙江省药品监督管理局浙江药品监管科技计划项目"高质量发展医疗器械标准化工作体系的对策研究"(项目编号:2023046)资助. （项目编号:2023046）
