Developing standards and test protocols for testing the hemocompatibility of biomaterials

Abstract

In this chapter, we have emphasized that the standards given by regulatory institutions, such as the ASTM or the ISO norm committee, describe only minimum requirements for studying the thrombogenicity and hemocompatibility of biomaterials. As a consequence, it is still under debate as to which supplementary assays need to be performed to enhance our understanding of the processes at the blood-material interface and to improve the hemocompatibility of new materials for blood-contacting implants. Test for the evaluation of thrombogenicity and hemocompatibility should at least be selected according to the categories formulated in the ISO norm: platelet adhesion and activation, coagulation, thrombosis, hematology, and immunology. In an ideal testing scenario, the selection of all above mentioned parameters should enable a comprehensive interstudy and interlaboratory comparison for different tested materials. Formulation of appropriate standards that allow reproducible testing and harmonized categorization of biomaterials should be consequently approached as a common consensus not just of the regulatory but also of the scientific community as it is already realized in the clinical chemistry and hematology.