| 全国医疗器械检测机构比对实验工作的思考 |
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| 引用本文： | 母瑞红,陈鸿波,徐红,王越,白东亭. 全国医疗器械检测机构比对实验工作的思考[J]. 中国药事, 2010, 24(8): 767-768,779 |
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| 作者姓名： | 母瑞红 陈鸿波 徐红 王越 白东亭 |
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| 作者单位： | 中国药品生物制品检定所,北京,100050 |
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| 摘 要： | 目的通过比对实验促进医疗器械检测能力和水平的整体提高。方法通过对2008年全国医疗器械检测机构比对实验工作的总结分析,找出医疗器械检验机构质量管理体系中存在的问题。结果发现个别检测机构在质量体系管理中存在漏洞,影响了检验质量。结论对医疗器械检验机构的监督管理提出了建设性意见。
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| 关 键 词： | 医疗器械 比对实验 质量管理 |
Thinking on Interlaboratory Comparisons of Medical Device Testing Institutions |
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| Mu Ruihong,Chen Hongbo,Xu Hong,Wang Yue,Bai Dongting. Thinking on Interlaboratory Comparisons of Medical Device Testing Institutions[J]. Chinese Pharmaceutical Affairs, 2010, 24(8): 767-768,779 |
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| Authors: | Mu Ruihong Chen Hongbo Xu Hong Wang Yue Bai Dongting |
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| Affiliation: | (National Institute for the Control of Pharmaceutical ＆ Biological Products,Beijing 100050) |
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| Abstract: | Objective To improve the capability and level of testing medical devices.Methods Based on the summary of the interlaboratory comparisons of medical device testing institutions in 2008,the analysis was carried out on problems of the quality management in the institutions.Results The lacks of the quality management were found in the several institutions.Conclusion The suggestions were put forward for the supervision and administration to medical device testing institutions. |
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| Keywords: | medical device interlaboratory comparison quality management |
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