摘要
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.
作者
钱文文
石林
夏忠诚
黄芝香
郑建
QIAN Wen-wen;SHI Lin;XIA Zhong-cheng;HUANG Zhi-xiang;ZHENG Jian(Zhejiang Institute of Medical Device Testing)
出处
《中国标准化》
2024年第9期69-75,共7页
China Standardization
基金
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。
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
medical device
standardization technical committee
technical counterpart
standards system