As identified in ISO 10993-4, elevated levels of free plasma hemoglobin may cause stress and toxicity for organ systems. Hemolysis, induced through physical damage of erythrocytes or through toxic extractables from a device, is evaluated using the procedure outlined in ASTM F756.
iuvo performs both static and mechanical hemolysis assessments as part of a GLP Biocompatibility package or as a screening tool during product development.