High-risk Active Implantable Medical Devices Standards
10.3969/j.issn.1671-7104.2016.06.010
- VernacularTitle:高风险有源植入式医疗器械标准
- Author:
Weiming WANG
1
;
Luming LI
;
Hongwei HAO
;
Fangjun LIU
;
Xiongwei WEN
;
Chunhua HU
;
Bozhi MA
Author Information
1. 清华大学航天航空学院
- Keywords:
active implantable medical device;
neurostimulator;
international standard status and trends;
standard research
- From:
Chinese Journal of Medical Instrumentation
2016;40(6):428-433
- CountryChina
- Language:Chinese
-
Abstract:
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.
