BS EN ISO 10993-16:2010

Biological evaluation of medical devices. Toxicokinetic study design for degradation products and leachables | Status: Superseded, Withdrawn

1 Scope This part of ISO 10993 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.