標準號：BS DD ISO/TS 10993-20-2006
中文標準名稱：醫療設備的生物學評定.醫療設備的免疫毒理學試驗的原理和方法
英文標準名稱：Biological evaluation of medical devices - Principles and methods for immunotoxicology testing of medical devices
標準類型：C30
發布日期：2006/9/29 12:00:00
實施日期：2006/9/29 12:00:00
中國標準分類號：C30
國際標準分類號：11.100.20
適用范圍：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].