中国医疗设备2017，Vol.32Issue(2)：5-8,4.DOI:10.3969/j.issn.1674-1633.2017.02.002
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 Application of Medical Devices Biological Evaluation
摘要
Abstract
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Key words
SPU-ZDEC/cytotoxicity/oscillation rate/constant shaking incubator/microplate reader分类
医药卫生引用本文复制引用
孙晓霞,黄经春,王鸾鸾,王昕,侯丽..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[J].中国医疗设备,2017,32(2):5-8,4.基金项目
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 （ZR2014CQ041）
2016YFC1103205). （）
