具药新生儿脐带敷料的细胞毒性试验  

Experiment on the Cytotoxicity of Medicated Dressing of Newborn Umbilical Cord

作　　者：王昕[1] 施燕平[1] 朱雪涛[1] 

机构地区：[1]国家食品药品监督管理局济南医疗器械产品质量监督检验中心,济南250013

出　　处：《生物医学工程研究》2005年第4期263-265,共3页Journal Of Biomedical Engineering Research

摘　　要：具药新生儿脐带敷料的细胞毒性试验是用细胞培养方法进行毒理学风险评价。此研究是按国际标准ISO10993-5《医疗器械生物学评价第5部分:体外细胞毒性试验》的规定进行的。测试执行方法为ISO10993-5体外细胞毒性试验浸提液法,依据USP24进行评价。在此基础上进一步定量化,更精确地反应产品的细胞毒性。Test for in vitro cytotoxicity of medicated dressing of newborn umbilical cord , is applied technology of cell culture to evaluate the potential toxicity for organize. This study is conducted based on the requirements of the International Organization for standardization 10993： Biological Evaluation of Medical Devices , part 5 ： test for in vitro cytotoxicity. Evaluation of the results is based on the USP24. The study is quantitative and can reveal cytotoxicity accurately.

关 键 词：具药新生儿脐带敷料 细胞毒性 浸提液 

分 类 号：R318[医药卫生—生物医学工程]