[Analysis on Evaluation Method of Mechanically-Induced Hemolysis of Medical Devices]

Mechanically-induced hemolysis is an important index for evaluating the blood compatibility of medical devices. It mainly evaluates the risk of mechanical hemolysis under simulated clinical use conditions of medical devices. The existing hemolysis test standards mainly evaluate the risk of material-induced hemolysis and cannot evaluate the risk of mechanically-induced hemolysis. Although some institutions have conducted research on mechanically-induced hemolysis caused by medical devices, systematic evaluation standards have not yet been established. This study mainly summarizes the evaluation process, selection of evaluation models, and steps for assessing mechanically-induced hemolysis, providing a reference for relevant evaluations and standard establishment.