Historical
ISO 10993-16:2010
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
ISO 10993-16:2010 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
International Organization for Standardization [iso]