Chemical Characterization of Medical Device Materials According to ISO 10993-18:2020

Overview

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.

Objective

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.

Agenda

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
Q&A