| 无菌医疗器械生产洁净室监测问题的探讨 |
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| 引用本文： | 李竹,马艳斌,梁文,迟戈,李非. 无菌医疗器械生产洁净室监测问题的探讨[J]. 中国医疗器械信息, 2010, 16(8): 49-51 |
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| 作者姓名： | 李竹 马艳斌 梁文 迟戈 李非 |
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| 作者单位： | 辽宁省食品药品监督管理局技术审评中心,沈阳,110003 |
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| 摘 要： | 目的：如何有效地对无菌医疗器械生产洁净室进行监测,使洁净室的洁净度达到规定的要求。方法及结果：借鉴药品生产洁净室的设计和监测,从药品及无菌医疗器械生产洁净室两方面考虑,找出共同因素对无菌医疗器械生产洁净室监测的影响。结论：洁净室的设计、建设、监测与管理,是无菌医疗器械洁净室监测符合要求的重要保证。
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| 关 键 词： | 无菌医疗器械 洁净室 监测 |
Study on Monitorning the Sterile Medical Devices Cleanrooms' Cleanliness |
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| LI Zhu,MA Yan-bin,LIANG Wen,CHI Ge,LI Fei. Study on Monitorning the Sterile Medical Devices Cleanrooms' Cleanliness[J]. China Medical Devices Information, 2010, 16(8): 49-51 |
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| Authors: | LI Zhu MA Yan-bin LIANG Wen CHI Ge LI Fei |
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| Affiliation: | (Liaoning Food and Drug Administration Technical Evaluation Center (Shenyang 110003)) |
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| Abstract: | Objective：To making the cleanrooms＇ cleanliness comply to requments,it＇s essential to monitor the sterile medical devices cleanrooms,Methods and Results：From two aspects,drugs and sterile medical devices,to find out the same influence to monitoring the sterile medical devices cleanrooms.Conclusion：Cleanrooms＇ design,contrustion,monitoring and management is important,to quarantee the sterile medical devices cleanrooms＇ cleanliness comply to requments. |
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| Keywords: | sterile medical devices cleanrooms monitor |
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