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。

    关键词: 具药新生儿脐带敷料;细胞毒性;浸提液

    Experiment on the Cytotoxicity of Medicated Dressing of Newborn Umbilical Cord

    WANG Xin，SHI Yan-Ping，ZHU Xue-Tao

    (State Drug and Food Administration Jinan Quality Supervision and Inspection Center for Medical Devices，Jinan250013，Shandong China)

    Abstract: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 standardization10993:Biological Evaluation of Medical Devices ......