in vitro Hemolysis

Hemolysis is the rupture of erythrocytes (red blood cells), accompanied by release of hemoglobin into the blood plasma. Erythrocytes are quite prone to environmental stress like changes in osmotic pressure, shear stress and mechanical trauma¹. Hemolytic properties of medical devices need to be evaluated to circumvent patient harm through reduced oxygen transport, toxicity and altered kidney function.

The hemolytic properties of medical devices are tested e.g. through the spectrometric determination of free plasma hemoglobin, released from ruptured or damaged erythrocytes.²

The hemolysis tests are performed in accordance with the ISO guidelines 10993-1³, 10993-4⁴ and 10993-12⁵ or ASTM F756 – 17⁶ and F 619 – 20⁷ at Eurofins BioPharma Product Testing Munich GmbH.

ISO vs ASTM testing

References

Weber M, Steinle H, Golombek S, Hann L, Schlensak C, Wendel HP, Avci-Adali M. Blood-Contacting Biomaterials: In Vitro Evaluation of the Hemocompatibility. Front Bioeng Biotechnol. 2018 Jul 16;6:99. doi: 10.3389/fbioe.2018.00099. PMID: 30062094; PMCID: PMC6054932.
Blakney GB, Dinwoodie AJ. A spectrophotometric scanning technique for the rapid determination of plasma hemoglobin. Clin Biochem. 1975 Apr;8(2):96-102. doi: 10.1016/s0009-9120(75)91005-x. PMID: 236098.
ISO 10993-1: “Evaluation and testing within a risk management process”
ISO 10993-4: “Selection of tests for interactions with blood”
ISO 10993-12: “Sample preparation and reference materials”
ASTM F 756 – 17: “Standard Practice for Assessment of Hemolytic Properties of Materials”
ASTM F 619 – 20: “Standard Practice for Extraction of Materials used in Medical Devices”