医疗器械机械力介导溶血评价方法探析

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

      • 摘要: 机械力介导溶血是医疗器械血液相容性重要评价指标,主要评估其在医疗器械模拟临床使用条件下的机械性溶血风险。现有溶血检测标准主要用于评估材料介导的溶血风险,而无法对机械性溶血风险进行评估。虽然有机构开展了医疗器械机械力介导溶血的相关研究,然而尚未建立起系统的评价标准。该研究主要对医疗器械机械力介导溶血评价流程、评价模型选择及具体评价步骤进行论述,为开展相关评价及标准制定提供参考依据。

         

        Abstract: 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. Systematic evaluation standards have not yet been established. Although some institutions have conducted research on mechanically-induced hemolysis caused by medical devices, 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.

         

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