体外替代方法在医疗器械生物相容性评价中的应用  

Application of In Vitro Alternative Method in Biocompatibility Evaluation of Medical Devices

作　　者：韩颖 田林奇 周静 刘康博 柳小军 孟星 HAN Ying;TIAN Linqi;ZHOU Jing;LIU Kangbo;LIU Xiaojun;MENG Xing(NMPA Key Laboratory for Quality Evaluation of Medical Protective and Implant Devices,Henan Institute for Drug and Medical Device Inspection,Zhengzhou Henan 450000,China)

机构地区：[1]河南省药品医疗器械检验院,国家药监局医用生物防护及植入器械质量评价重点实验室,河南郑州450000

出　　处：《中国医疗设备》2024年第11期178-182,共5页China Medical Devices

基　　金：河南省市场监督管理局科技计划项目(2022sj98)。

摘　　要：随着医疗器械产业的迅速发展和不断创新,医疗器械临床使用的安全问题日益突出。良好的生物相容性是医疗器械临床安全有效应用的先决条件,而动物试验目前是评价医疗器械生物相容性的重要手段之一。但在替代、减少和优化动物使用的3R原则的推动下,开展体外替代试验研究是全球发展的趋势。然而与化学品和化妆品相比,医疗器械领域的生物相容性评价体外替代方法研究进展缓慢。本文从监管层面分析开展体外替代试验的重要性,介绍已用于和可用于医疗器械生物相容性评价的体外替代方法,为后续开展医疗器械体外替代试验提供参考。With the rapid development and continuous innovation of the medical device industry,the safety problem of medical devices in clinical use has become increasingly noticeable.Good biocompatibility is a prerequisite for the safe and effective clinical application of medical devices,while animal testing is one of the important means to evaluate the biocompatibility of medical devices.However,driven by the 3R principles of replacing,reducing and optimizing animal use,it is a global trend to carry out in vitro alternative methods.However,compared with chemicals and cosmetics,research on in vitro alternatives for biocompatibility evaluation in the field of medical devices has progressed slowly.This paper analyzed the importance of conducting in vitro alternatives from a regulatory perspective,introduced in vitro substitution methods that had been and could be used for biocompatibility evaluation of medical devices,and provided a reference for subsequent in vitro alternatives of medical devices.

关 键 词：动物试验替代方法 医疗器械 生物相容性评价 单核细胞活化试验 毒理学关注阈值 器官芯片 重组人体表皮 

分 类 号：R197.39[医药卫生—卫生事业管理]