ISO 10993的这一部分概述了免疫毒理学，特别是医疗器械的潜在免疫毒性。它为各类医疗器械的免疫毒性测试方法提供了指导。ISO 10993的这一部分基于过去几十年中免疫毒理学作为毒理学中一个独立实体的发展，由不同免疫毒理学组撰写的若干出版物。有关免疫毒性的知识现状见附件A。与医疗器械相关的免疫毒理学的临床经验总结见附件B。

This part of ISO 10993 presents an overview of immunotoxicology with particular reference to the potential immunotoxicity of medical devices. It gives guidance on methods for testing for immunotoxicity of various types of medical devices.This part of ISO 10993 is based on several publications written by various groups of immunotoxicologists over the last few decades in which the development of immunotoxicology as a separate entity within toxicology took place.The current state of knowledge with regard to immunotoxicity is described in Annex A. A summary of clinical experience to date with immunotoxicology associated with medical devices is given in Annex B.