Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (First revision) (ISO 10993-16:2010, IDT)
This Malaysian Standard 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.
Published
• (none) / (none) / MS ISO 10993-16:2005
PDF
29/05/2019
21
NSC 18 - Medical Devices and Facilities for Healthcare
