ISO 10993-18 - Introduction to Extractables and Leachables testing for medical devices

This presentation starts with a brief introduction on Extractables and Leachables testing for medical devices, as described in ISO 10993-18. Starting from the test item, by applying extraction solvents, ratios and conditions, extracts containing the compounds that might migrate from the medical device into the patient are obtained. These extracts are subsequently analyzed by chromatographic screening techniques resulting in chromatograms. Luckily, the concept of the analytical evaluation threshold has been developed so that not all compounds present need to be identified and quantified.
Ans De Roeck PhD, Senior E&L Expert Nelson Labs Europe