Chemical characterisation: how to perform an E&L study for drug-like medical devices?

ISO 10993-18 was released in 2020 and specifies how to identify and quantify the constituents of a medical device, allowing the identification of biological hazards and the estimation and control of biological risks from material constituents. When it comes to extract medical devices this Standard provides useful guidelines on the solvent, methods and conditions to be used. But how to approach substance-based and drug-like medical devices?

This webinar will show the critical aspects of determining the appropriate strategy for chemical characterisation of substance-based and drug-like medical devices. Practical example will be presented providing insights into the techniques recommended for conducting Extractables and Leachables testing in this specific context.