Biological evaluation of medical devices -- Part 16: Toxicokinetic study design for degradation products and leachables
2015
Document Number: NL ISO 10993 16 : 2015
Sector: Health Care Technology
TC: NL TC 3001
ICS: 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.