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Navigating upcoming changes in Chemical Characterization according to revised ISO 10993-18

Published Date: September 5, 2019

The revision of part 18 of the ISO 10993 series is now available as final draft and can be purchased from several websites. The new title “chemical characterization of medical device materials within a risk management process” suggests some important changes compared to the previous version.

In this webinar the main changes are highlighted including the use of an Analytical Evaluation Threshold (AET) and the importance of accurate identification and quantification of compounds for a subsequent toxicological assessment. In addition, we’ll explain when an Extractables study should be performed, how to design this study and how it differs from a Leachables study.

By the end of this webinar you should know:

  1. When and how to set-up an Extractables and/or Leachables study as part of an overall risk management
  2. The difference between a screening and targeting analytical technique
  3. Why and how to calculate an Analytical Evaluation Threshold
  4. The importance of reliable compound identification and quantification

Sophie Michel

PhD, Study Director Nelson Labs Europe

Sophie Michel got her PhD in biomedical engineering from the University in Maastricht in 2014. Thanks to her broad experience in chemistry and biocompatibility, she joined the team of Study Directors at Nelson Labs Europe in 2015, where she currently focuses on the biological evaluation of Medical Devices through classical biocompatibility tests and chemical characterization. In 2019, Sophie Michel became a member of the ISO 10993 committee.


Annelies Vertommen

Chemical Characterization of Medical Devices and Compendial Testing Expert

Annelies Vertommen started her career at Nelson Labs as a Study Director for extractables and leachables projects for the pharmaceutical industry. In recent years, her focus changed to chemical characterization studies for the medical device industry. She closely follows all changes in this field by actively participating in the ISO10993-18 committee and following the discussions in the ISO 10993-17 committee.

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