Preparation of Positive Control with Different Oscillation Rate in the Ap-pl-ication of Medical Devices Biological Evaluation
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 Shandong 250101, China
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.
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.
SUN Xiao-xia, HUANG Jing-chun, WANG Luan-luan, WANG Xin, HOU Li. Preparation of Positive Control with Different Oscillation Rate in the Ap-pl-ication of Medical Devices Biological Evaluation. China Medical Devices, 2017, 32(2): 5-8.
