ISO 10993-16:2010 Preview
Biological evaluation of medical devices -- Part 16: Toxicokinetic study design for degradation products and leachables
This standard was last reviewed and confirmed* in 2013.
*Therefore this version remains current
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.