Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
|Publication Date:||15 February 2010|
|ICS Code (Biological evaluation of medical devices):||11.100.20|
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.