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.
Association for the Advancement of Medical Instrumentation [aami]