| 有源植入式医疗器械标准研究 |
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| 引用本文： | 陈甜甜,付丽,于晓慧,田佳,张克.有源植入式医疗器械标准研究[J].医疗卫生装备,2021(3):74-76,101. |
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| 作者姓名： | 陈甜甜 付丽 于晓慧 田佳 张克 |
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| 作者单位： | 山东省医疗器械产品质量检验中心 |
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| 基金项目： | 国家重点研发计划项目(2017YFC0111004)。 |
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| 摘 要： | 介绍了国内、国际有源植入物分技术委员会及有源植入式医疗器械标准的现状。结合日常检测和具体实例,对现行标准中标记要求、包装要求和混合医疗相关要求等进行了总结和论述,有助于正确理解标准要求,并为该类医疗器械的研发、检验和评审等提供了思路和参考,保障了医患的用械安全。
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| 关 键 词： | 有源植入式医疗器械 ISO 14708 GB 16174 YY 0989 混合医疗 |
Research on active implantable medical device standards |
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| CHEN Tian-tian,FU Li,YU Xiao-hui,TIAN Jia,ZHANG Ke.Research on active implantable medical device standards[J].Chinese Medical Equipment Journal,2021(3):74-76,101. |
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| Authors: | CHEN Tian-tian FU Li YU Xiao-hui TIAN Jia ZHANG Ke |
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| Institution: | (Shandong Quality Inspection Center for Medical Devices,Jinan 250101,China) |
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| Abstract: | The current statuses of sub-technical committees and standards for active implantable medical device in foreign countries and China were introduced.Combining daily testing and specific examples,the marking requirements,packaging requirements and mixed medical-related requirements in the current standards were summarized and discussed,which helped to understand the standard requirements correctly,provided references for the research and development,inspection and evaluation of active implantable medical device and ensured its safety for doctors and patients. |
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| Keywords: | active implantable medical device ISO 14708 GB 16174 YY 0989 miscellaneous medical treatment |
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