Historical
ANSI/AAMI/ISO 10993-16-1997 (R2014)
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
Gives 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]