Chemical characterization is the initial step in the biological evaluation of any medical device with direct or indirect patient contact. If a chemical characterization assessment on a medical device is conducted and evaluated appropriately, it can potentially minimize the need for additional biological testing. The recent revision to ISO 10993-1 highlights the importance of chemical characterization and the ongoing revisions to ISO 10993-18 provide more detail on how to appropriately carry out this assessment.
This presentation will provide a framework on how to appropriately chemically characterize a device including: An overall step by step guide through the characterization procedure, details on how to perform an appropriate extractables or leachables study, as well as examples of actual application of the standards in case studies.
