Historical
ANSI/AAMI/ISO 10993-16-1997 (R2003)
Biological Evaluation of Medical Devices - Part 16: Toxicokinetic Study Design for Degradation Products and Leachables from Medcial Devices
Gives principles on how toxicokinetic studies relevant to medical devices should be designed and performed.
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Association for the Advancement of Medical Instrumentation [aami]