| 医用临床检验实验室及体外诊断系统标准体系研究 |
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| 引用本文： | 贺学英,廖晓曼,刘毅,杜海鸥,胡冬梅. 医用临床检验实验室及体外诊断系统标准体系研究[J]. 医疗装备, 2009, 22(7): 12-16 |
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| 作者姓名： | 贺学英 廖晓曼 刘毅 杜海鸥 胡冬梅 |
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| 作者单位： | 北京市医疗器械检验所,北京,100011 |
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| 摘 要： | 目的：体外诊断系统给疾病正确诊断和治疗提供重要的信息，与生命健康息息相关，因此对体外诊断系统产品质量的监管必不可少，标准是监管的重要依据，完善的标准体系建设对科学管理体外诊断系统具有重要的意义。本文介绍了体外诊断系统标准现状，分析了体系化管理的必要性，提出了体系建设的建议。
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| 关 键 词： | 体外诊断 标准体系 |
Research on the Standardization System of Medical Clinical Test Lab and in Vitro Diagnostic System |
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| HE Xue-ying,LIAO Xiao-man,LIU Yi,DU Hai-ou,HU Dong-mei. Research on the Standardization System of Medical Clinical Test Lab and in Vitro Diagnostic System[J]. Medical Equipment, 2009, 22(7): 12-16 |
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| Authors: | HE Xue-ying LIAO Xiao-man LIU Yi DU Hai-ou HU Dong-mei |
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| Affiliation: | HE Xue - ying, LIAO Xiao - man, LIU Yi, DU Hai - ou, HU Dong- mei (Beijing Institute of Medical Test . Beijing 100011. China) |
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| Abstract: | Objective： in vitro diagnostic system can offer the significant information for the diagnoses and treatment of diseases.It is closely related to our life health. It is essential to supervise the product quality of in vitro diagnostic system which on the basis of standard. Perfecting the construction of standardization system is relevant to the scientific management of in vitro diagnostic system. In this paper, the status quo of in vitro diagnostic system standardization is introduced. As well as the necessity of systematism management is analyzed. There are also some suggestions about the construction of this system. |
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| Keywords: | in vitro diagnosis standardization system |
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