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In vitro hemocompatibility testing of biomaterials according to the ISO 10993-4

机译：根据ISO 10993-4进行生物材料的体外血液相容性测试

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The development of synthetic materials, textured polymers and metals and their increasing use in medicine make research of biomaterials' hemocompatibility very relevant. Problems arise from the polymorphism and diversity of the different materials, the static and dynamic test models and the patients' individual biologic factors. First, methods, models, tests as well as preanalytical factors have to be standardized according to the current knowledge in medicine laid down in the ISO 10993 part 4. The routine controls used in clinical chemistry and hematology have to be performed. Information about normal ranges (mean value, standard deviation, 95% confidence interval) should be provided. Tests have to be performed within a minimal delay of usually 2 h since some properties of blood change rapidly following collection. Various conditions (depending on the wall shear rate) were simulated within the centrifugation system and a Chandler system. Qualities and aspects of hemocompatibility such as platelet activation, oxidative burst, hemolysis, fibrinolysis, fibrin formation, generation of thrombin, contact activation, and complement activation were analysed and the results were entered non-dimensionally into a non-dimensional score system, where 0 points stand for the best and 65 points for the worst evaluation. We found a good correlation between the total score and contact activation, thrombin generation and leukocyte activation in a low shear stress system and a good correlation between the total score and thrombin generation, hemolysis and platelet activation in the high shear stress system. Further on the effect of additives and sterilization procedures can be measured. The concepts presented underline the relevance/importance of an efficient diagnostic approach to hemocompatibility that takes account of clinical and socio-economic concerns.
机译：合成材料，织构聚合物和金属的发展以及它们在医学中的越来越多的使用，使生物材料的血液相容性研究变得非常重要。问题来自于不同材料的多态性和多样性，静态和动态测试模型以及患者的个体生物学因素。首先，必须根据ISO 10993第4部分中规定的最新医学知识对方法，模型，测试以及分析前因素进行标准化。必须执行临床化学和血液学中的常规控制。应提供有关正常范围的信息（平均值，标准偏差，95％置信区间）。由于血液的某些特性在采集后会迅速变化，因此测试必须在通常2小时的最小延迟内进行。在离心系统和钱德勒系统中模拟了各种条件（取决于壁面剪切速率）。分析血液相容性的质量和方面，例如血小板活化，氧化爆发，溶血，纤维蛋白溶解，血纤蛋白形成，凝血酶的产生，接触活化和补体活化，并将结果无因次输入无因次评分系统，其中0最高分代表最高分，最差代表65分。我们发现在低切应力系统中总得分与接触活化，凝血酶生成和白细胞活化之间有良好的相关性，在高切应力系统中总得分与凝血酶生成，溶血和血小板活化之间具有良好的相关性。进一步可以测量添加剂的作用和灭菌程序。提出的概念强调了考虑到临床和社会经济问题的血液相容性有效诊断方法的相关性/重要性。

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