Biological evaluation of medical devices - Principles and methods for immunotoxicology testing of medical devices
Biological evaluation of medical devices - Principles and methods for immunotoxicology testing of medical devices
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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].
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