国内外有源植入式心室辅助装置标准化现状研究  

Study on the current situation of the standardization of active implantable VAD at home and abroad

作　　者：徐东紫 陈娟[1] 欧阳昭连[1] XU Dong-zi;CHEN Juan;OUYANG Zhao-lian(Institute of Medical Information,Chinese Academy of Medical Sciences,Beijing 100020,China;不详)

机构地区：[1]中国医学科学院医学信息研究所,北京100020

出　　处：《中国医学装备》2022年第1期17-20,共4页China Medical Equipment

基　　金：国家自然科学基金(L1924064)“面向2035的我国再生医学创新与产业发展战略研究”;中国医学科学院医学与健康科技创新工程(2021-I2M-1-056)“医学知识管理与智能化知识服务关键技术研究”。

摘　　要：目的:梳理国内外有源植入式心室辅助装置(VAD)标准制定情况,分析我国有源植入式VAD标准化进程。方法:针对有源植入式VAD标准进行文献调研和网络调研,对国际标准化组织(ISO)、美国、欧盟和我国的标准化现状进行总结分析。结果:国际标准ISO14708-5是针对有源植入式VAD的国际通用标准,已被美国采标,我国和欧盟也在采标过程中。在国际标准ISO14708-5中提供了指导性要求,但相关技术测试指标未做具体要求,各国在采标的过程中会根据各国法规和技术条件进行转标。结论:我国在进行此类高风险有源植入式医疗器械的标准制定时,应根据具体的国情、法规和技术条件,在技术测试方面提出具有可操作性的相关标准。Objective:To organize the status of formulating the standards of active implantable ventricular assist device(VAD)at home and abroad,and analyze the process of the standardization in China.Methods:This study conducted literature survey and network survey according to the standards of active implantable type of VAD,and summarized and analyzed the current situation of the standardization in International Organization for Standardization(ISO),United States of America(USA),European Union(EU)and China.Results:At present,ISO 14708-5 is a general international standard for active implantable VAD,which has been adopted by the United States,and China and the EU are also in the process of adopting the standard.ISO 14708-5 only provides guiding requirements,and it does not require specific contents for the indicators of relevant technical test.Each country would transform standard according to the laws,regulations and technical condition of them in the process of adopting standards.Conclusion:In the formulation of standards for such active implantable medical devices with high-risk in China,relevant standards with operability should be put forward in terms of technical testing according to the specific national conditions,laws and regulations,and technical conditions of China.

关 键 词：有源植入式 心室辅助装置(VAD) 标准化 国际标准化组织(ISO)14708-5 采标 

分 类 号：R318.1[医药卫生—生物医学工程]