| 对在用医疗器械实施风险管理的思考 |
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| 引用本文： | 蒋海洪,梁学林,奚健.对在用医疗器械实施风险管理的思考[J].中国医疗器械杂志,2012,36(2):128-132. |
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| 作者姓名： | 蒋海洪 梁学林 奚健 |
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| 作者单位： | 1. 上海医疗器械高等专科学校,上海,200093
2. 上海食品药品监督管理局杨浦分局,上海,200093 |
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| 基金项目： | 上海市教育委员会科研创新项目资助 |
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| 摘 要： | 风险管理贯穿于医疗器械监管的全过程,对在用医疗器械也十分必要。文在分析在用医疗器械风险管理的现状基础上,对医疗器械使用环节风险管理的主体、参与者及切入点等重要内容进行了思考。
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| 关 键 词： | 在用医疗器械 风险管理 全过程监管 全寿命管理 |
Study on the risk management for medical devices in use |
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| Jiang Haihong
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Liang Xuelin
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Xi Jian.Study on the risk management for medical devices in use[J].Chinese Journal of Medical Instrumentation,2012,36(2):128-132. |
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| Authors: | Jiang Haihong Liang Xuelin Xi Jian |
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| Institution: | Shanghai medical Instrumentation College, Shanghai 200093. jianghh168@hotmail.com |
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| Abstract: | Risk management penetrate the entire process of medical device regulation, and it is also very necessary for medical devices in use. Based on the analyzing of the status of risk management for medical devices, this paper discusses the principal, participants and entry point of risk management for medical devices. |
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| Keywords: | the used medical devices risk management overall-process supervision life-cycle management |
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