医疗器械溶血性能三种评价方法的比较

Comparison of Three Evaluation Assays of Hemolytic Properties of Medical Devices

与血液接触的医疗器械和材料在临床前的安全性评价中经常要进行直接和/或间接溶血试验。目前使用频率较高的溶血试验方法主要有三种:NIH法、ASTM法和MHLW法。虽然三种方法在国际上常规评价医疗器械/材料溶血性能方面得到广泛认可,但是缺乏对三种方法进行比较研究的数据。目前ISO/TC 194工作组正在组织溶血Round robin(国际比对)试验,但是具体的试验草案还在完善当中。文章从原理、血源、方法和结果判定等方面对此三种方法进行了全面介绍,为Round robin试验提供理论方面的帮助。

The preclinical safety evaluation of medical devices and materials that will contact with blood often call for a direct and/or indirect hemolysis test. This test is frequently performed using the NIH, ASTM and MHLW methods. The three hemolysis assays are well- recognized tests used internationally for routine evaluation of the hemolytic capacity of medical devices/materials. However, the data of the comparative studies that contrast the three methods are generally nonexistent. The hemolysis round robin study was designed by ISO/TCI94 group, but the detailed draft protocol would be complete. This article introduced the principle, blood collection, method and result of the three methods in detail and provided theoretical help for the round robin study.