| 医用分子筛制氧设备的标准及应用现状 |
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| 引用本文： | 蓝翁驰,许伟.医用分子筛制氧设备的标准及应用现状[J].中国医疗器械信息,2012,18(5):30-32. |
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| 作者姓名： | 蓝翁驰 许伟 |
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| 作者单位： | 国家食品药品监督管理局医疗器械技术审评中心,北京,100044 |
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| 摘 要： | 本文介绍了国内外医用分子筛制氧设备的标准、应用和管理现状.美国、欧盟和我国均建立了医用分子筛制氧设备的标准并实施了有效的管理.我国已有92 家企业获得123 个注册证书.医用分子筛制氧设备具有便捷、经济、安全以及有效的特点,作为医疗机构中心供氧系统集中供氧的氧源设备已广泛应用于临床.
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| 关 键 词： | 医用分子筛制氧设备 医疗器械标准 临床用氧 医用设备管理 |
Standards, Management and Development of Medical Molecular Sieve Oxygen Generator |
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| LAN Weng-chi
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XU Wei.Standards, Management and Development of Medical Molecular Sieve Oxygen Generator[J].China Medical Devices Information,2012,18(5):30-32. |
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| Authors: | LAN Weng-chi XU Wei |
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| Institution: | Center for Medical Device Evaluation,SFDA(Beijing 100044) |
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| Abstract: | The paper reviewed on the standard,inspection and development of medical molecular sieve oxygen generators.Standards of medical molecular sieve oxygen generators have been established in United State of America,European Union and China as well as other countries.Inspection and management on the application of those oxygen generators are sufficiently conducted by the government authorities worldwide.In China,there are 123 registration licenses for 92 companies as medical molecular sieve oxygen generators.The devises have been widely applied in the clinical practice for the convenient,safety,low cost and effective. |
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| Keywords: | medical molecular sieve oxygen generator standard of medical devises oxygen for clinical use inspection of medical devise |
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