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体外循环管路的生物学评价
引用本文:杨立峰,柯军,李伟松,林美琼.体外循环管路的生物学评价[J].中国医疗器械信息,2009,15(11):69-70,74.
作者姓名:杨立峰  柯军  李伟松  林美琼
作者单位:广东省医疗器械质量监督检验所,广州,510080
摘    要:体外循环管路主要用于心肺手术和血液透析,属于三类医疗器械。本文通过细胞毒性试验、热原试验、致敏试验、皮内反应试验、急性全身毒性试验和溶血试验对某体外循环管路产品进行了生物学评价。结果显示其具有良好的生物相容性。

关 键 词:体外循环管路  生物相容性  细胞毒性

Biological Evaluation of Extracorporeal Blood Circuit
YANG Li-feng,KE Jun,LI Wei-song,Lin Mei-qiong.Biological Evaluation of Extracorporeal Blood Circuit[J].China Medical Devices Information,2009,15(11):69-70,74.
Authors:YANG Li-feng  KE Jun  LI Wei-song  Lin Mei-qiong
Institution:(Guangdong Medical Devices Quality Serveillanee and Test Institute (Guangzhou 510080)
Abstract:Extracorporeal blood circuit mainly use for cardiopulmonary bypass surgery and hemodialysis, which is class-III medical device. In this paper, extracorporeal blood circuit was evaluated, including tests of cytotoxicity, pyrogen, delayed-type hypersensitivity , intracutaneous reactivity, systemic toxicity and hemolysis. The results show that it has good biocompatibility.
Keywords:extracorporeal blood circuit  biocompatibility  cytotoxicity
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