| 医疗器械质量管理规范的建立 |
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| 引用本文： | 汤黎明,吴敏,刘铁兵,戚仕涛.医疗器械质量管理规范的建立[J].解放军医院管理杂志,2009,16(7):622-623. |
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| 作者姓名： | 汤黎明 吴敏 刘铁兵 戚仕涛 |
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| 作者单位： | 南京军区南京总医院,南京,210002 |
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| 摘 要： | 医疗器械质量管理技术规范研究是当前医院医学工程部门重点发展的技术之一，是医院长期稳定发展的重要保证。本文从质量保证、质量控制、医疗器械计量管理和医疗器械不良事件报告制度4个方面，对医疗器械质量管理规范的建立进行了探讨。
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| 关 键 词： | 医疗器械 质量管理 质量控制 质量保证 |
Rules of Quality Management for Medical Apparatus & Equipment in Hospitals |
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| TANG Li-ming,WU Min,LIU Tie-bing,QI Shi-tao.Rules of Quality Management for Medical Apparatus & Equipment in Hospitals[J].Hospital Administration Journal of Chinese People's Liberation Army,2009,16(7):622-623. |
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| Authors: | TANG Li-ming WU Min LIU Tie-bing QI Shi-tao |
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| Affiliation: | ( Nanjing General Hospital, Nanjing Military Area Command, Nanjing 210002) |
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| Abstract: | The quality management technique for medical device, as an important technique of medical engineering department in hospital, is a guarantee of the hospital＇s development, with which the quality level of hospital will be fully improved. From four aspects the measures were discussed to set up scientific rules of quality management for medical apparatus and equipment as quality guarantee, quality control, computation management and report system for badness incident for medical apparatus. |
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| Keywords: | medical apparatus quality management quality control quality guarantee |
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