Biological evaluation of medical devices - Toxicokinetic study design for degradation products and leachables included-in-kit but visual methods can be

but visual methods can be subjective

products or beverages for human or animal consumption

BS EN 62369-1:2009 Evaluation of human exposure to electromagnetic fields from short range devices (SRDs) in various applications over the frequency range 0 GHz to 300 GHz

whether you are preparing new systems

Biological evaluation of medical devices - Toxicokinetic study design for degradation products and leachables included-in-kit but visual methods can be1 Scope This document provides principles on designing and performing toxicokinetic studies relevant to medical devices. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.