医疗器械免疫毒理学试验原则与方法——介绍ISO/TS 10993-20:2005

医疗器械和材料的某些成分和降解产物可能会使人体免疫系统产生免疫应答(免疫毒性),因此医疗器械和材料对人体免疫系统的影响已引起越来越多的关注。ISO/TC194目前正在制定ISO/TS10993-20《医疗器械生物学评价第20部分:医疗器械免疫毒理学试验原则与方法》,标准给出了医疗器械对免疫系统不良作用方面的评价与试验指南。本文将系统介绍ISO/TS10993-20:2005,并给出免疫毒理学实验设计等相关信息。

Principles and Methods for Immunotoxicology Testing of Medical Devices——Explanation for ISO/TS 10993-20:2005

There has been increasing attention on the potential for medical devices and materials to cause changes in humans immune system, as some components and degradation products of medical devices and materials may induce immune response (immunotoxicity). ISO/TS 10993-20 has been developed by ISO/TC 194. This document provides evaluation and testing guidance to address adverse effects of medical devices on the immune system. ISO/TS 10993-20:2005 was introduced in this paper, as well as introduced the relevant information on the design for immunotoxicology testing.