生物医学工程研究Issue(4)：264-267,4.
医疗器械溶血性能评价方法－ASTM直接接触法和间接接触法的比较
Comparison between Direct and Indirect Methods of ASTM-One Evaluation Assay of Hemolytic Properties of Medical Devices
乔春霞 1侯丽 2赵增琳1
作者信息
- 1. 山东恒信检测技术开发中心，济南250101
- 2. 国家食品药品监督管理局济南医疗器械质量监督检验中心，山东省医疗器械生物学评价重点实验室，山东济南 250101
- 折叠
摘要
Abstract
In this study,the direct and indirect methods of ASTM were used to assay the hemolytic properties of 6 kinds of differ-ent materials.The results showed that the hemolytic grade using the two methods were basically consistent on the Polyethylene,Nitrile glove and Rubber#2.The hemolytic grade using the two methods were inconsistent on the Latex glove,Rubber#1 and Buna rubber. The hemolytic index of the two methods of the Latex glove and Rubber#1 were significant different.We analyze the causes of the incon-sistent and offer some suggestions about the measurement of hemolytic properties of medical devices or materials and supply data support for the publication and execution of the new standards.关键词
医疗器械/溶血性能/美国材料与试验协会方法/直接接触法/间接接触法Key words
Medical devices/Hemolytic properties/ASTM method/Direct methed/Indirect method分类
医药卫生引用本文复制引用
乔春霞,侯丽,赵增琳..医疗器械溶血性能评价方法－ASTM直接接触法和间接接触法的比较[J].生物医学工程研究,2014,(4):264-267,4.
