| 如何对识别出的医疗器械危险(源) 进行风险评定 |
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| 引用本文： | 吴平,刘成虎,辛仁东.如何对识别出的医疗器械危险(源) 进行风险评定[J].中国医疗器械信息,2011,17(8):25-28. |
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| 作者姓名： | 吴平 刘成虎 辛仁东 |
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| 作者单位： | 山东省医疗器械产品质量检验中心,济南,250101 |
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| 摘 要： | 本文通过举例描述了如何对医疗器械识别出的危险(源)进行风险评定,目的是帮助大家更好地理解YY/T 0316-2008.同时,本文还指出了YY/T 0316-2008与我国相关标准中应统一的几个关键术语.
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| 关 键 词： | 医疗器械 危害/危险(源) 伤害/损害 风险评定 |
How to Take Risk Assessment for the Identified Hazards of Medical Devices |
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| WU Ping,LIU Cheng-hu,XIN Ren-dong.How to Take Risk Assessment for the Identified Hazards of Medical Devices[J].China Medical Devices Information,2011,17(8):25-28. |
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| Authors: | WU Ping LIU Cheng-hu XIN Ren-dong |
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| Institution: | WU Ping LIU Cheng-hu XIN Ren-dong Shandong Quality Inspection Center for Medical Devices(Ji'nan 250101) |
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| Abstract: | To help us better understand the standard of YY/T 0316-2008,we illustrated with examples on how to take risk assessment for the identified hazards of medical devices.At the same time,we also pointed out some critical terms in YY/T 0316-2008 which should be unified with other related standards in China. |
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| Keywords: | medical device hazard harm risk assessment |
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