评价医疗器械体外细胞毒性的常用方法概述-现代医学

评价医疗器械体外细胞毒性的常用方法概述

单位：哈尔滨医科大学附属第二医院骨关节科, 黑龙江哈尔滨 150086

分类号：R197.39

出版年·卷·期（页码）：2020·48·第一期（146-150）

摘要：

医疗器械和材料应用于临床之前需要进行生物相容性评价。国内外均将细胞毒性试验列在生物相容性评价的首位。细胞毒性试验分为三大类：浸提液试验、直接接触试验和间接接触试验。文章将对三种细胞毒性试验的核心要素和主要步骤加以介绍，并对三种细胞毒性试验的敏感性特点及相互关系加以概述。

Biocompatibility assessment of medical devices and materials is required before clinical application. Cytotoxicity test has been listed as the first step in biocompatibility evaluation both at home and abroad. Cytotoxicity tests can be divided into three categories:extraction test, direct contact test and indirect contact test. This article will introduce the core elements and main steps of the three cytotoxicity tests, and summary the sensitivity and correlation of the three cytotoxicity tests.

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