The primary goal of medical device chemical characterization is to provide meaningful data for an unambiguous toxicological risk assessment (TRA). To meet that requirement the medical device chemical characterization study must be broad in scope, sensitive to avoid missing potentially toxic compounds, and provide positive identifications at the required analytical evaluation threshold (AET). In this presentation chemical characterization according to ISO 10993-18 will be explained in detail from the selection of extraction solvents and conditions to the detection, identification, and quantification of the extractables present. The presentation will also highlight how certain issues the toxicologist might encounter during a chemical characterization’s assessment can be addressed.
