世界中医药
文章摘要
引用本文:徐晓婷1,张海明2.由医疗器械国际标准化特点试论中医医疗器械国际标准化发展[J].世界中医药,2017,(05):.  
由医疗器械国际标准化特点试论中医医疗器械国际标准化发展
Analysis the development on international standardization of TCM medical devices from the characteristics of international standardization of medical devices
投稿时间:2017-03-25  
DOI:10.3969/j.issn.1673-7202.2017.05.056
中文关键词:  医疗器械  中医医疗器械  标准化
English Keywords:Medical device  TCM medical device  Standardization
基金项目:上海市中医药事业发展三年行动计划(编号:ZY3-GJHZ-1-1001)——中医药国际标准化建设
作者单位
徐晓婷1,张海明2 1 上海市中医药研究院中医药国际标准化研究所,上海,201203
2 天津市医疗器械质量监督检验中心,天津,300384 
摘要点击次数: 1041
全文下载次数: 1666
中文摘要:
      从ISO/IEC中与医疗器械相关技术委员会内各成员国参与度、交叉领域发展现状、标准体系完善情况以及国际标准与各国法律法规相适配等方面入手,总结分析和比较当前中医医疗器械国际标准化现状并对其发展提出建议:注重人才培养,鼓励企业积极参与;关注市场需求,考虑与各国法律法规相适配;加强与有关组织之间的沟通与协调,协同发展;完善中医医疗器械标准化体系。
English Summary:
      From the participation of member bodies in different technical committees of ISO/IEC, development on overlapping areas of medical devices, standardization system and adaption between international standards and national regulations, this article is to analyze and conclude the development situation on international standardization of TCM medical devices and put forward the following suggestions: strengthening on talents education and training, encouraging participation from TCM medical devices enterprises, focusing on market demands, taking the adaption between the international standards and national regulations into consideration and strengthening the communication and cooperation between different organizations to improve the standard system of TCM medical devices.
查看全文  查看/发表评论  下载PDF阅读器