30.60 May 14, 2025
ISO
ISO/TC 194
International Standard
ISO 10993-16:2017 provides principles on designing and performing toxicokinetic evaluation relevant to medical devices. Annex A describes the considerations for inclusion of toxicokinetic evaluation in the biological evaluation of medical devices.
PUBLISHED
ISO 10993-16:2017
PROJECT
ISO/CD 10993-16
30.60
Close of voting/ comment period
May 14, 2025
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
10.99 New project approved