Wang Weiming, Li Luming, Hao Hongwei, Liu Fangjun, Wen Xiongwei, Hu Chunhua, Ma Bozhi
Zhongguo Yi Liao Qi Xie Za Zhi. 2016 Nov;40(6):428-33.
Comprehensive standards of active implantable medical devices with high risks are required by China's current industrial development, and standard problems and ideas are discussed in this paper.
Analysis of the status of China's active implantable medical device standards and international standards. For the booming field for active implantable medical devices with high risks, international standard’s problems, ideas and trends are analyzed.
Bottleneck of the development of China's active implantable medical device standards is the lack of Chinese medical devices industry actual independent research and development capability. China's independent standard research on the basis of independent core technology of active implantable medical devices is the opportunity to promote the internationalization of China standard.
Improving the standards of active implantable medical devices based on independent core technology, combined with problems of existing international standards, to further improve and develop international standards and lead high level international technical standards.
我国当前产业发展需要高风险有源植入式医疗器械的综合标准，本文对标准问题及思路进行探讨。
分析我国有源植入式医疗器械标准现状及国际标准情况。针对蓬勃发展的高风险有源植入式医疗器械领域，分析国际标准存在的问题、思路及趋势。
我国有源植入式医疗器械标准发展的瓶颈在于缺乏我国医疗器械产业实际自主研发能力。基于有源植入式医疗器械自主核心技术开展我国自主标准研究是推动我国标准国际化的契机。
基于自主核心技术提高有源植入式医疗器械标准，结合现有国际标准存在的问题，进一步完善和发展国际标准，引领高水平国际技术标准。
