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ANSI/AAMI/ISO TIR10993-20:2006
Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices
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.
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Association for the Advancement of Medical Instrumentation [aami]
