prEN ISO 10993-16 rev

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables prEN ISO 10993-16 rev

Scope

ISO 10993-16:2017 provides principles on designing and performing toxicokinetic studies relevant to medical devices. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.