Register for our webinar on Chemical Characterization of Medical Device Materials According to ISO 10993-18:2020.

Starts

March 25, 2021
16:00

Ends

March 25, 2021
17:00

Location

Online

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

Target Audience

Professionals in the medical device industry.

Speaker

Dujuan Lu – Global E&L Manager at SGS

For more information, please contact:

Aurelia Resines
Global Marketing Manager
t: +41 22 739 9111