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以GB/T16886.4-2003标准为基础,采用部分凝血激活酶时间(PTT)试验和全血凝固时间(CT)试验对5种以金属与高分子为主要材质的心血管系统外部接入器械的凝血性能进行了研究。结果提示PTT试验能够较好地反映材料对凝血系统的激活,可以应用于医疗器械凝血性能评价。在GB/T16886.4-2003标准中PTT试验被作为外部接入器械凝血性能评价的推荐方法之一。CT试验受凝血过程的各个相关因素影响较多,试验还受到动物个体差异的影响,在操作上不容易标准化。与PTT试验相比,按照GB/T14233.2-2005标准附录中试管法(Lee-White法)进行的CT试验数据变异度更大。因为其较多的影响因素,怎样确定合适的阴性对照来进行CT试验的器械材料凝血评价也需进行进一步的研究。
On the basis of GB / T16886.4-2003 standard, five kinds of external access devices of cardiovascular system, which mainly made of metal and polymer, were tested by partial thromboplastin time (PTT) test and whole blood coagulation time (CT) The coagulation properties were studied. The results suggest that PTT test can better reflect the material activation of the coagulation system, can be applied to the evaluation of coagulation properties of medical devices. In the GB / T16886.4-2003 standard PTT test as the external access device coagulation performance evaluation of one of the recommended methods. CT test by the coagulation process affected by more relevant factors, the test is also subject to animal differences in the impact of the operation is not easy to standardize. Compared with the PTT test, the CT test data according to the GB-T14233.2-2005 standard appendix test tube method (Lee-White method) data variation is greater. Because of its more influential factors, how to determine the appropriate negative control CT materials to carry out coagulation evaluation of materials also need further study.