Chemical Characterization According to Iso10993 18 - Dries Cardoen

Manufacturers are often advised to perform an extractables study after
completing a biological evaluation of their medical devices. This doesn’t
need to be a concern as the procedure 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.