The goal of ISO 10993-18 is to assess medical device biocompatibility by understanding the chemistry of its materials of construction. A significant focus of ISO 10993-18 is extractable testing, whereby potential impurities from the medical device material are discovered, quantitated, and assessed for safety. Leachable studies are conducted in physiologically-simulating solvents to measure realistic patient exposures that may bring greater relevance to the safety assessment.
iuvo BioScience personnel have over 15 years of experience in the chemical characterization of materials using advanced analytical techniques such as LC-MS, GC-MS, and other spectroscopic methods to discover, identify, and quantify extractables and leachables. Our Analytical team can assist you with study design and strategy, execution of the experiments, and provide expert interpretation of the data. From there, we can coordinate with the Toxicology department at iuvo BioScience to provide safety assessments of observed extractables and/or leachables as well as other in vivo and in vitro toxicological experiments.