摘要
单采血细胞分离器是用于人体血液成分的采集和分离的医疗器械产品,对产品进行血液相容性检测,以保障产品临床使用的安全性和有效性。选择单采血细胞分离器3个主要部件:软管、泵管和收集袋为试验样品,以进口同类型产品为阴性参照品,按照GB/T16886.4-2003和GB/T14233.2-2005标准的要求和方法进行溶血试验、PTT试验和体外自发性血小板聚集等3个体外试验。试验结果显示试验样品的溶血率小于5%,凝血时间和血小板最大聚集率和阴性参照品无显著性差异(P>0.05)。表明单采血细胞分离器对血液红细胞、凝血系统和血小板功能无明显不良影响,产品具有良好的血液相容性。
The single blood cell separator is the medical devices used in collecting and separating human blood components.To ensure the products clinical use safety and effectiveness,the hemocompatibility tests were conducted.Three major components： the flexible pipeline,pump line and collecting bag were chosen for the samples,and the same type imports products for the negative reference material.According to the GB/T 16886.4-2003 and the GB/T14233.2-2005,the hemolysis test,the partial thrombo plastin time test and the blood platelet aggregation assay were conducted.The results showed that the hemolysis ratios of the samples were below than 5 percent.There were no significant differences in the partial thrombo plastin time and the platelet maximum aggregation rate between the samples and the negative reference materials（P0.05）.The results indicated that there were little harmful effects of the single blood cell separator on the red blood cells,the coagulation system and the platelet function.The product had good hemocompatibility.
出处
《中国医疗设备》
2011年第5期119-121,共3页
China Medical Devices
