Chemical characterization is an important component of biocompatibility testing for medical devices. Therefore, before conducting medical device extractable and leachable (E&L) studies, it’s crucial that you keep in mind all necessary analytical considerations.
But are you up-to-speed with the latest recommendations set out in ISO 10993-18? If not, or if you’re looking for more guidance on how to remain ISO-compliant moving forward, then you’ve come to the right place.
This presentation will focus on the analytical considerations of medical device extractable and leachable (E&L) studies as per the new ISO 10993-18 chapter. It will also explore common regulatory deficiency points on medical device E&L studies.
- Extraction strategy and solvent selection
- Analytical evaluation threshold (AET) calculation and analytical uncertainty factor considerations
- Testing methodologies and method qualification
- E&L compound identification strategies during GC-MS and LC-MS analysis
Professionals in the medical device industry.
Dujuan Lu – Global E&L Manager at SGS
For more information, please contact:
Global Marketing Manager
t: +41 22 739 9111