| 同种骨应用中的风险与管理 |
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| 引用本文： | 许伟.同种骨应用中的风险与管理[J].中国医疗器械信息,2009,15(12):6-9. |
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| 作者姓名： | 许伟 |
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| 作者单位： | 国家食品药品监督管理局医疗器械审评中心,北京,100044 |
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| 摘 要： | 同种骨作为植入人体的医疗器械己广泛应用于临床，但它们存在疾病传播和免疫排斥的风险，应该加强管理，以保证其应用的安全性与有效性。本文分析了同种骨在应用过程中可能存在的安全风险，并阐述了同种骨应用中的风险控制与管理措施。
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| 关 键 词： | 同种骨 风险 管理 |
Risks and Regulation in the Transplantation of Human Bone Allograft |
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| XU Wei.Risks and Regulation in the Transplantation of Human Bone Allograft[J].China Medical Devices Information,2009,15(12):6-9. |
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| Authors: | XU Wei |
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| Institution: | XU Wei( Center for Medical Devices Evaluation, SFDA Beijing 100044) |
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| Abstract: | Bone allograft has been extensively used in clinical. The regulation should be emphasized on the safety and effectiveness since the potential risks of virus transmission and immunological rejection. This paper analyzed the potential risks associated with the application of bone allograft. The present situation on the regulation of these products also summarized and gives some new suggestions and comments on the risk control. |
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| Keywords: | bone allograft risks regulation |
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