Hemolysis Assay

The hemolysis assay is a standard method for evaluating the blood compatibility of biomaterials by quantifying the extent to which a material or substance damages red blood cells (RBCs) and causes hemoglobin release. Codified in standards including ASTM F756 and ISO 10993-4, the hemolysis assay is essential for regulatory approval of blood-contacting devices such as stents, catheters, artificial heart valves, and hemodialysis membranes. The assay provides a simple, quantitative measure of hemolytic potential that correlates with clinical safety.