DD ISO/TS 10993-20:2006

1   Scope 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].