| 含银医疗器械质量检验中的几点建议 |
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| 引用本文： | 母瑞红,杨晓芳,冯晓明,奚廷斐,白东亭. 含银医疗器械质量检验中的几点建议[J]. 中国医疗器械信息, 2008, 14(10): 29-31 |
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| 作者姓名： | 母瑞红 杨晓芳 冯晓明 奚廷斐 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： | 含银医疗器械因没有相应的国家标准和行业标准可依，企业注册质量标准技术要求不统一，给市场监管带来不便。本文对目前含银医疗器械质量检验过程中出现的问题进行了分析，并对质量技术要求及银含量检测方法提出了相应的建议。
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| 关 键 词： | 含银医疗器械 纳米银 原子吸收光谱法 细胞毒性 |
Several Quality Inspection Suggestions of Medical Devices Which Containing Silver |
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| MU Rui-hong,YANG Xiao-fang,FENG Xiao-ming,XI Ting-fei,Bai Dong-ting. Several Quality Inspection Suggestions of Medical Devices Which Containing Silver[J]. China Medical Devices Information, 2008, 14(10): 29-31 |
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| Authors: | MU Rui-hong YANG Xiao-fang FENG Xiao-ming XI Ting-fei Bai Dong-ting |
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| Affiliation: | (National Institute for the Control of Pharmaceutical ＆ Biological Products (Beijing 100050)) |
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| Abstract: | As there are no homologous national standard and profession standard on the medicaldevices containing silver,the enterprise quality standards have different requests,This will bring inconvenience for the Supervision and Administration of the kind of the products.The analysis was carried out on the problems which appear in quality inspection of the medical devices containing silver,and several suggestions were put forward for technical standards and testing method of silver content in this paper |
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| Keywords: | Medical Devices Containing Silver Nanoparticulate Siliver Atomic Absorption Spectrometry Cytotoxicity |
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