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Medical Device Chemical Characterization: What the toxicologist needs to know from the chemist

Published Date: October 23, 2023

Join this webinar, by our Study Director Medical Devices (E&L), Koen Van der Plas, MSc, to gain insight in medical device chemical characterization.

The primary goal of medical device chemical characterization is to generate meaningful data for an unambiguous toxicological risk assessment (TRA). To meet this objective, the medical device chemical characterization study must encompass a broad scope, maintain sensitivity to avoid overlooking potentially toxic compounds, and achieve positive identifications at the required analytical evaluation threshold (AET).

This presentation will delve into the comprehensive process of chemical characterization as outlined by ISO 10993-18. It will cover various aspects, ranging from the selection of extraction solvents and conditions to the detection, identification, and quantification of the extractables present. Additionally, the presentation will shed light on strategies to address potential issues that toxicologists might encounter during the assessment of chemical characterization.


Koen Van Der Plas

Senior E&L Expert

Koen Van der Plas graduated in 2004 as Industrial Engineer Chemistry (option Industrial Chemistry) at the University of Ghent (Belgium). Before joining Nelson Labs, he worked for 2 years in different analytical/environmental labs specialized in routine water and soil analyses gaining great practical experience with various analytical techniques such as GC/MS, LC/MS and ICP. He started his career at Nelson Labs (formerly Toxikon) in 2006 in the GC/MS department of the analytical lab. After a period of 7 years, where he witnessed the beginning of extractables and leachables (E&L) testing, he moved to the study director (SD) department where he worked for 5 years in different SD groups specialized and responsible for E&L testing of various pharmaceutical applications for the industry. The last 5 years, he is part of the study director group at Nelson Labs focusing on E&L testing of medical devices (chemical characterization).

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