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Historical
ANSI/AAMI/ISO 10993-16:1997 (R2009)
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables from medical devices
Provides principles on how toxicokinetic studies relevant to medical devices should be designed and performed. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.
CONTENT PROVIDER
Association for the Advancement of Medical Instrumentation [aami]
Association for the Advancement of Medical Instrumentation [aami]