CAJ | 학술논문

　　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。
　　여혈액접촉적의료기계화재료재림상전적안전성평개중경상요진행직접화/혹간접용혈시험。목전사용빈솔교고적용혈시험방법주요유삼충：NIH법、ASTM법화MHLW법。수연삼충방법재국제상상규평개의료기계/재료용혈성능방면득도엄범인가，단시결핍대삼충방법진행비교연구적수거。목전ISO/TC 194공작조정재조직용혈Round robin（국제비대）시험，단시구체적시험초안환재완선당중。문장종원리、혈원、방법화결과판정등방면대차삼충방법진행료전면개소，위Round robin시험제공이론방면적방조。
The preclinical safety evaluation of medical devices and materials that wil contact with blood often cal 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 wel -recognized tests used international y for routine evaluation of the hemolytic capacity of medical devices/materials. However, the data of the comparative studies that contrast the three methods are general y nonexistent. The hemolysis round robin study was designed by ISO/TC194 group, but the detailed draft protocol would be complete. This article introduced the principle, blood col ection, method and result of the three methods in detail and provided theoretical help for the round robin study.