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AAMI/ISO TIR10993-20:2006 (R2021)

Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices

This standard covers current state of knowledge in the area of immunotoxicology, including information on methods of assessment and their predictive value; to identify what the problems are and how they have been dealt with in the past; and offers advice on how the problems should be addressed in future standards.

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Association for the Advancement of Medical Instrumentation [aami]

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