Skip to Menu Skip to Search Contact Us Global Websites & Languages Skip to Content
US Flag

You are accessing SGS’s website from the USA.

Visit the US website instead

Stay on the global website and remember my choice

About

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