The primary goal of medical device chemical characterization is to generate meaningful data for an unambiguous toxicological risk assessment (TRA). To meet this objective, the medical device chemical characterization study must encompass a broad scope, maintain sensitivity to avoid overlooking potentially toxic compounds, and achieve positive identifications at the required analytical evaluation threshold (AET).
This presentation will delve into the comprehensive process of chemical characterization as outlined by ISO 10993-18. It will cover various aspects, ranging from the selection of extraction solvents and conditions to the detection, identification, and quantification of the extractables present. Additionally, the presentation will shed light on strategies to address potential issues that toxicologists might encounter during the assessment of chemical characterization.