The blood collection and transfusion equipment with leukocyte filtration is used in the filtration of whole blood or red blood cell suspension. In vitro evaluation of hemocompatibility was conducted to ensure its safety when the product is used in clinic. Three major components of the product, the flexible pipeline, plastic blood bag and filtration membrane, were chosen for the samples, and the same parts from same type import products for the reference material. According to the GB/T 16886.4-2003 and the GB/T 14233.2 - 2005, three parameters of hemolysis, PTT and the blood platelet aggregation assay were tested. The experimental results showed that the hemolysis rates of the samples were below 5 per cent. There were no significant differences in the partial thromboplastin time and the platelet maximum aggregation rate between the samples and the reference materials (P ＞ 0. 05 ). These results indicated that the blood collection and transfusion equipment with leukocyte filtration emerged little harmful effects on the blood ingredients and functions, and it was of good hemocompatibility.%去白细胞采输血器是用于过滤全血或红细胞悬液中白细胞的医疗器械类产品,为保证其临床应用的安全性,本文对去白细胞采输血器(型号:NGL/RF-XZ-200)进行血液相容性体外评价.选择去白细胞采输血器的3个主要部件:软管、塑料血袋和去白细胞滤器滤膜为试验样品,以进口同类产品作为参照,按照GB/T 16886.4-2003和GB/T 14233.2-2005标准的要求和方法,进行溶血、PTT以及体外自发性血小板聚集3个体外血液相容性指标测试.结果 显示试验样品溶血率小于5%,样品凝血时间和血小板最大聚集率与参照样品无显著性差异(P>0.05).该结果表明去白细胞采输血器对血液成分和功能无明显不良影响,具有良好的血液相容性.
展开▼
