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目的血脂分离器是用于分离和清除血脂的医疗器械产品,进行产品与血液相互作用试验,以评价产品的血液相容性。方法 选择血脂分离器4种主要材料PVC软管、PVC收集袋、PC块和遮光PC块为试验样品,以进口已上市同类材料为阴性参照品,按照GB/T 16886.4-2003、GB/T 14233.2-2005和ASTM F 2382-04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个与血液相互作用的体外试验。结果试验样品的溶血率小于5%,血小板最大聚集率小于10%。PC块和遮光PC块的部分凝血激活酶时间较空白血浆缩短(P<0.01),试验样品4种材料的凝血时间和阴性参照品相比均无显著性差异。结论 血脂分离器对血液红细胞和血小板功能无明显不良影响,产品对血液凝血性能的影响与进口同类材料等同,产品具有较好的血液相容性,以保障临床应用的生物安全性。
Purpose The lipid separator is a medical device product used to separate and clear blood lipids and conduct product-blood interaction tests to evaluate the product’s blood compatibility. Methods Four main materials of blood lipid separator, PVC hose, PVC bag, PC block and light-shielding PC block, were selected as test samples to import the same kind of reference material which has been listed as negative reference substance. According to GB / T 16886.4-2003 and GB / T 14233.2 -2005 and ASTM F 2382-04 standard requirements and methods of hemolysis test, PTT test and in vitro spontaneous platelet aggregation and other three in vitro interactions with the blood test. Results The hemolysis rate of the test sample was less than 5% and the maximum platelet aggregation rate was less than 10%. The clotting time of PC and occluding PC blocks was shorter than that of blank plasma (P <0.01). There was no significant difference in clotting time between the four materials in the test sample and the negative control. Conclusion The blood lipid separator has no obvious adverse effect on the blood erythrocyte and platelet function. The product has the same effect on blood coagulation as the imported similar materials, and the product has good blood compatibility to ensure the biosafety in clinical application.