Laboratoriemedicin

Kommittébeteckning: SIS/TK 340/AG 02 (Biologisk säkerhet)
Källa: CEN
Svarsdatum: den 10 feb 2026
Se merSe mindre
 

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.