Analysis on Evaluation Method of Mechanically-Induced Hemolysis of Medical Devices
10.12455/j.issn.1671-7104.240168
- VernacularTitle:医疗器械机械力介导溶血评价方法探析
- Author:
Jianxiu ZHU
1
;
Zhichen ZHAI
Author Information
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
- Keywords:
medical device;
mechanically-induced hemolysis;
blood compatibility
- From:
Chinese Journal of Medical Instrumentation
2024;48(6):689-693
- CountryChina
- Language:Chinese
-
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.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.
