高风险有源植入式医疗器械标准

High-risk Active Implantable Medical Devices Standards

目的我国当前产业发展呼唤完善的高风险有源植入式医疗器械标准,探讨标准制定的问题和思路。方法分析我国有源植入医疗器械标准现状,对有源植入医疗器械国际标准举例,分析高风险有源植入医疗器械这一蓬勃发展的领域,国际标准制定的问题,思路和趋势。结果依据中国医疗器械产业实际自主研发制定标准的能力,是我国有源植入医疗器械标准当前发展的瓶颈。我国自主研发,具有自主核心技术的有源植入式医疗器械,对应的自主标准研究,正是推动中国标准国际化的契机。结论完善以技术为依托的我国自主创新有源植入式医疗器械标准。结合我国自主研发,在现有国际标准问题基础上深入研究,进一步完善和发展国际标准,进行引领国际标准的高水平技术标准研究。

Objective 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.Methods 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. Results 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.Conclusion 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.