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.
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- ASTM F756-17 (2017). Standard Practice for Assessment of Hemolytic Properties of Materials. ASTM International. · URL
- ISO 10993-4:2017. Biological Evaluation of Medical Devices. Part 4: Selection of tests for interactions with blood. · URL
- Tomos, M. S., Morrison, S., & Williams, D. F. (2012). Comparison of hemolytic methods for assessing the blood compatibility of biomaterials. Journal of Biomedical Materials Research, 105(7), 1926-1933. · URL
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