Manufacturers are often advised to perform an extractables study after completing a biological evaluation of their medical devices, a procedure that is very well described in ISO10993-18. The standard includes guidance regarding how the extractions need to be performed, how the analytical chemistry should be completed, and how the results should be reported. Unfortunately, it is not always as straightforward as it seems. The universe of devices, materials, production processes, and applications is so diverse that a single, unified approach does not always fit each device. In such cases, it is important to build an alternative testing strategy, in which you move away from the standard testing. This presentation will show you how to work through a successful extractables and leachables program.

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