Comparison between Direct and Indirect Methods of ASTM-One Evaluation Assay of Hemolytic Properties of Medical Devices
QIAO Chunxia
HOU Li
ZHAO Zenglin
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.
Keywords：Medical devicesHemolytic propertiesASTM methodDirect methedIndirect method
Publication Date：2014-01-01
Online Publishing Date：2026-09-11(First online date of this platform, not the publication date of the document)
Pages：4( 264-267 )