| 具有抗菌消毒作用的无源医疗器械分类界定工作思考 |
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| 引用本文： | 母瑞红,汤京龙,马立翠,温莉茵.具有抗菌消毒作用的无源医疗器械分类界定工作思考[J].中国药事,2019,33(8):871-874. |
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| 作者姓名： | 母瑞红 汤京龙 马立翠 温莉茵 |
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| 作者单位： | 中国食品药品检定研究院 国家药品监督管理局医疗器械标准管理中心, 北京 102629,中国食品药品检定研究院 国家药品监督管理局医疗器械标准管理中心, 北京 102629,中国食品药品检定研究院 国家药品监督管理局医疗器械标准管理中心, 北京 102629,中国食品药品检定研究院 国家药品监督管理局医疗器械标准管理中心, 北京 102629 |
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| 摘 要： | 目的：分析总结我国具有抗菌消毒作用的医疗产品的分类原则及管理现状，发现我国该类产品分类界定中存在的问题，提出完善措施，为科学监管决策提供技术支撑。方法：对国内外消毒剂、含抗菌消毒成分的医疗器械及药械组合产品的分类原则和管理情况进行对比研究分析。结果与结论：参考美国、欧盟分类原则，提出了完善具有抗菌消毒作用的无源医疗器械分类界定原则和管理建议。
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| 关 键 词： | 医疗器械 分类 抗菌 消毒 |
| 收稿时间： | 2019/3/6 0:00:00 |
On Classification of Non-active Medical Devices with Antibacterial or Disinfection Effects |
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| Mu Ruihong,Tang Jinglong,Ma Licui and Wen Liyin.On Classification of Non-active Medical Devices with Antibacterial or Disinfection Effects[J].Chinese Pharmaceutical Affairs,2019,33(8):871-874. |
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| Authors: | Mu Ruihong Tang Jinglong Ma Licui and Wen Liyin |
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| Institution: | National Institutes for Food and Drug Control, Center for Medical Device Standardization Administration, NMPA, Beijing 102629, China,National Institutes for Food and Drug Control, Center for Medical Device Standardization Administration, NMPA, Beijing 102629, China,National Institutes for Food and Drug Control, Center for Medical Device Standardization Administration, NMPA, Beijing 102629, China and National Institutes for Food and Drug Control, Center for Medical Device Standardization Administration, NMPA, Beijing 102629, China |
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| Abstract: | Objective:To analyze and summarize the classification principles and management status of the nonactive medical products with antibacterial or disinfection effects, to find out the problems in the classification of this kind of products in China, to put forward improvement measures in order to provide technical supports for decision-making of scientific regulation. Methods:The classification principles and management status of disinfectant, the non-active medical devices with antibacterial or disinfection effects and combination products of drug-medical devices at home and abroad were compared and analyzed. Results and Conclusion:According to the classification principles of USA and Europe, classification principles and management suggestions for the nonactive medical products with antibacterial or disinfection effects were put forward. |
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| Keywords: | medical device classification antibacterial disinfection |
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