| 在用医疗器械的检验技术要求 |
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| 引用本文： | 李澍,王权,张艳丽,任海萍. 在用医疗器械的检验技术要求[J]. 医疗设备信息, 2014, 0(10): 58-61 |
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| 作者姓名： | 李澍 王权 张艳丽 任海萍 |
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| 作者单位： | 中国食品药品检定研究院医疗器械检定所,北京100050 |
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| 基金项目： | 国家科技支撑计划课题（2012BA122804）. |
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| 摘 要： | 本文首先介绍了国外医疗器械质量控制现状，然后从安全性、基本性能、生命周期、标准化的器械检测车等四个方面对我国医疗器械检验现状及问题进行分析，并提出相应的意见，以期提高在用医疗器械管理和质量控制水平。
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| 关 键 词： | 在用医疗设备 质量控制 医疗器械生命周期 |
Requirements on the Inspection Technique of In-Use Medical Devices |
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| LI Shu,WANG Quan,ZHANG Yan-li,REN Hai-ping. Requirements on the Inspection Technique of In-Use Medical Devices[J]. Information of Medical Equipment, 2014, 0(10): 58-61 |
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| Authors: | LI Shu WANG Quan ZHANG Yan-li REN Hai-ping |
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| Affiliation: | (Institute of Medical Devices Testing,National Institutes for Food and Drug Control,Beijing 100050,China) |
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| Abstract: | This paper ifrstly introduced the overseas quality control status of medical devices, and then analyzed the current situation and problems of medical devices inspection in China from the perspectives of safety, basic performance, lifecycle and standardized instruments checkout vehicles. Finally, corresponding suggestions were put forward in order to improve the management and quality control levels of in-use medical devices. |
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| Keywords: | in-use medical device quality control life cycle of medical devices |
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