不同振荡速率制备阳性对照在医疗器械生物学评价中的应用  

Preparation of Positive Control with Different Oscillation Rate in the Ap pl ication of Medical Devices Biological Evaluation

作　　者：孙晓霞[1] 黄经春[1] 王鸾鸾[1] 王昕[1] 侯丽[1] 王瑾晔 SUN Xiao-xia;HUANG Jing-chun;WANG Luan-luan;WANG Xin;HOU Li(Key Lab of Biological Evaluation of Medical Devices of Shandong Province,Jinan Quality Supervision and Inspection Center for Medical Devices, State Food and Drug Administration, Jinan dong 250101, China)

机构地区：[1]国家食品药品监督管理局济南医疗器械质量监督检验中心山东省医疗器械生物学评价重点实验室,山东济南250101 [2]不详

出　　处：《中国医疗设备》2017年第2期5-8,共4页China Medical Devices

基　　金：山东省自然科学基金青年基金项目(ZR2014CQ041);国家重点研发计划课题(2016YFC1103202;2016YFC1103205)

摘　　要：医疗器械生物学评价中试验样品制备的标准化是保证其试验结果具有可靠性和可比性的关键。为了进一步明确样品制备过程中振荡速率对浸提液溶出物的影响,本研究以国际标准ISO10993-12:2007中推荐的阳性标准物质(SPU-ZDEC)为试验样品,检测了不同振荡速度下浸提液的细胞毒性。结果表明,医疗器械生物学实验中不同的样品振荡速率对检测结果具有显著影响,本研究对于今后标准制定中规定样品制备的标准化问题提供可靠的实验依据,有着重要的参考意义。Standardization of test sample preparation is key to ensuring a reliable and comparable test results in biological evaluation of medical devices. In order to further clarify the effect of oscillation rate during soluble material extraction, we tested the positive standard material of SPU-ZDEC recommended by ISO10993-12: 2007 and detected the cytotoxicity of extract with different oscillation rate. Results showed that different sample oscillation rates have significant impacts on test results in biological tests of medical devices. This study provided a reliable experimental basis for the standardization of sample preparation, which is of great reference meaning.

关 键 词：二乙基二硫代氨基甲酸锌 细胞毒性 振荡速率 恒温培养振荡器 酶标仪 

分 类 号：R197.39[医药卫生—卫生事业管理]