It has now been more than 3 years ago since the adoption and implementation of the new ISO 10993-18 standard in Chemical Characterization for Medical Devices. With this implementation the science of E/L-testing on medical devices, which is mainly based on Non-Targeted Analysis (NTA), has improved substantially. However, there is a clear consensus from both the Industry as well as from the Regulators that more guidance and harmonization is needed and necessary.
Aspects in Quantification and Identification will need to be better defined if the outcome of E/L-studies should be comparable between different labs. While the outcome of a structure elucidation (identification) exercise for detected compounds is binary – it is either true or false – for quantitation based upon the existing quantification practices lead to a broad range of reported concentrations for compounds? An idea on how to harmonize on the quantitative aspect of an E/L study is to introduce the concept of “protective concentrations” versus accurate concentrations. The presentation will also explore what consequence this would have on the currently existing and accepted AET calculations.
Presenter: Piet Christiaens PhD, Scientific Director Nelson Labs Europe
This presentation, by Piet Christiaens, was recorded at the Open House seminar, in Leuven, in April 2023 and is part of a series of videos.