BS DD ISO/TS 10993-20-2006 医疗设备的生物学评定.医疗设备的免疫毒理学试验的原理和方法

标准号：BS DD ISO/TS 10993-20-2006
中文标准名称：医疗设备的生物学评定.医疗设备的免疫毒理学试验的原理和方法
英文标准名称：Biological evaluation of medical devices - Principles and methods for immunotoxicology testing of medical devices
标准类型：C30
发布日期：2006/9/29 12:00:00
实施日期：2006/9/29 12:00:00
中国标准分类号：C30
国际标准分类号：11.100.20
适用范围：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. NOTE See also Bibliographic Reference [11].