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

作　　者：朱建秀 翟志臣 ZHU Jianxiu;ZHAI Zhichen(Testing Center,Guangdong Institute of Advanced Biomaterials and Medical Devices,Guangzhou,510535;National Engineering Research Center for Tissue Restoration and Reconstruction,South China University of Technology,Guangzhou,510006;School of Materials Science and Engineering,South China University of Technology,Guangzhou,510640)

机构地区：[1]新型生物材料与高端医疗器械广东研究院检验中心,广州市510535 [2]华南理工大学国家人体组织功能重建工程技术研究中心,广州市510006 [3]华南理工大学材料科学与工程学院,广州市510640

出　　处：《中国医疗器械杂志》2024年第6期689-693,共5页Chinese Journal of Medical Instrumentation

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。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.

关 键 词：医疗器械 机械力介导溶血 血液相容性 

分 类 号：F203[经济管理—国民经济] R318[医药卫生—生物医学工程]