ISO 10993-16:1997, Biological evaluation of medical devices -- Part 16: Toxicokinetic study design for degradation products and leachables

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. This title may contain less than 24 pages of technical content.