| Firebird冠脉涂膜支架系统生物学安全性评价研究 |
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| 引用本文： | 姜华,樊铂,刘欣,褚婕,任力敏,关景芳,程琳,唐智荣,徐益民,李湘媛,袁霞辉. Firebird冠脉涂膜支架系统生物学安全性评价研究[J]. 中国医疗器械杂志, 2004, 28(3): 185-189 |
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| 作者姓名： | 姜华 樊铂 刘欣 褚婕 任力敏 关景芳 程琳 唐智荣 徐益民 李湘媛 袁霞辉 |
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| 作者单位： | 1. 天津市医用生物材料监测研究中心,天津,300070
2. 微创医疗器械(上海)有限公司,上海,201203 |
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| 摘 要： | 依据国家标准GB/T16175-1996,选择10项试验对Firebird冠脉涂膜支架系统进行生物学安全性评价[1],结果表明该支架系统的血液相容性良好,无全身毒性和细胞毒性,无热源性、致敏性、刺激性,也无遗传毒性,组织相容性尚可,是一种生物相容性优良的Firebird冠脉涂膜支架系统.
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| 关 键 词： | 医疗器械 Firebird冠脉涂膜支架系统 生物学评价 |
| 文章编号： | 1671-7104(2004)03-0185-05 |
| 修稿时间： | 2003-11-11 |
Biological Safety Evaluation of the Firebird Coronary Drug Coated Stent System |
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| JIANG Hua,FAN Bo,LIU Xin,CHU Jie,REN Li-Min,GUAN Jing-fang,CENG Lin,TANG Zhi-rong,Xu Yi-min,Li Xiang-yuan,YUAN Xia-hui Tianjin Center of Inspection and Research of Medical Biomaterials Micropor Medical. Biological Safety Evaluation of the Firebird Coronary Drug Coated Stent System[J]. Chinese journal of medical instrumentation, 2004, 28(3): 185-189 |
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| Authors: | JIANG Hua FAN Bo LIU Xin CHU Jie REN Li-Min GUAN Jing-fang CENG Lin TANG Zhi-rong Xu Yi-min Li Xiang-yuan YUAN Xia-hui Tianjin Center of Inspection Research of Medical Biomaterials Micropor Medical |
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| Abstract: | We conducted 10 experiments to evaluate the biological safety of the Firebird drug-coated stent systems according tothe national standard(GB/T16175-1996). The experiment results demonstrate that the Firebird drug coated stentsystems have a good hemo-compatibility. no cytotoxicity, systemic toxicity (acute toxicity), sensitization, intracutaneousreactivity,pyrogen,genotoxicity. Therefore, we conclude that the biocompatibility and the safety of the Firebird drugcoated stent systems are good. |
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| Keywords: | medical device Firebird drug coated stent system biological evaluation |
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