ISO/TS 10993-20:2006 医疗器械的生物学评价 第20部分：医疗器械免疫毒物学测试的原理与方法

标准编号：ISO/TS 10993-20:2006

中文名称：医疗器械的生物学评价 第20部分：医疗器械免疫毒物学测试的原理与方法

英文名称：Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices

发布日期：2006-08

标准范围

This part of ISO 10993 presents an overview of immunotoxicology with particular reference to the potentialimmunotoxicity of medical devices. It gives guidance on methods for testing for immunotoxicity of varioustypes of medical devices.This part of ISO 10993 is based on several publications written by various groups of immunotoxicologists overthe last few decades in which the development of immunotoxicology as a separate entity within toxicologytook place.The current state of knowledge with regard to immunotoxicity is described in Annex A. A summary of clinicalexperience to date with immunotoxicology associated with medical devices is given in Annex B.NOTE See also Bibliographic Reference [11].

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