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中国医疗器械杂志 2011, Vol. 35 Issue (4) :269-273    DOI: 10.3969/j.issn.1671-7104.2011.04.010
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血管内导管研究进展及美国FDA相关性能要求
张世庆, 鲁景艳, 章金刚
张世庆,国家食品药品监督管理局医疗器械技术审评中心,军事医学科学院野战输血研究所。鲁景艳,军事医学科学院野战输血研究所。章金刚,军事医学科学院野战输血研究所,国家食品药品监督管理局医疗器械技术审评中心
Summary about the Progress and Specificationsof FDA Regarding Intravascular Catheters
 ZHANG  Shi-Qing, LU  Jing-Yan, ZHANG  Jin-Gang
ZHANG  Shi-Qing,Center of Medical Device Evaluation of SFD,Institute of Transfusion Medicine, Academy of Military Medical Sciences.  LU  Jing-Yan,Institute of Transfusion Medicine, Academy of Military Medical Sciences.  ZHANG  Jin-Gang,Center of Medical Device Evaluation of SFD,Institute of Transfusion Medicine, Academy of Military Medical Sciences.

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摘要 文就血管内导管研究进展及美国FDA对血管内导管性能的技术要求进行了综述,以期能为相关研发生产人士提供借鉴。
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张世庆
鲁景艳
章金刚
关键词血管内导管   技术要求   美国FDA     
Abstract:  Intravascular catheters are very important in clinical therapy and public healthy. As the primary constitute of product performance, intravascular catheters’ specifications are mostly responsible for its safety and effectiveness. This article summarizes the progress and specifications of FDA regarding intravascular catheters, and hope this would be helpful to related persons.
Keywordsfont-size: 12pt   mso-hansi-font-family: 宋体   mso-ansi-language: EN-US   mso-fareast-language: ZH-CN   mso-bidi-language: AR-SA   Intravascular catheters')" href="#">mso-fareast-font-family: 宋体" lang="EN-US">Intravascular catheters   specifications   FDA     
Received 2011-04-27;
Corresponding Authors: 章金刚     Email: zhangjg@nic.bmi.ac.cn
引用本文:   
张世庆, 鲁景艳, 章金刚.血管内导管研究进展及美国FDA相关性能要求[J]  中国医疗器械杂志, 2011,V35(4): 269-273
ZHANG Shi-Qing, LU Jing-Yan, ZHANG Jin-Gang.Summary about the Progress and Specificationsof FDA Regarding Intravascular Catheters[J]  Chinese Journal of Medical Instrumentation, 2011,V35(4): 269-273
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