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About

This two day conference will provide the latest updates and technical information around E&L testing

Starts

Jun 29, 2021, 07:30

Ends

Jul 01, 2021, 16:30

Location

Arlington, United States

Join SGS at the Extractable and Leachables USA conference held June 29-July 1 in Arlington, VA and online. This year's topic is Adapting and Thriving in the Face of Change: Navigating the Challenges of an Evolving Landscape and Preparing for the Future of E&L

ATTEND OUR TECHNICAL SEMINAR ON JULY 1 AT 2:00 PM EDT

Analytical Considerations in E/L Studies of Medical Devices per ISO 10993-18, presented by Dr. Dujuan Lu

Chemical characterization (Extractable and Leachable Studies) per ISO 10993 has become an important component of biocompatibility testing for medical devices. A major revision of ISO 10993-18 “Chemical characterization of medical device materials within a risk management process” was recently published in the beginning of 2020. This presentation will focus on the analytical considerations of medical device extractable and leachable (E&L) studies per the new ISO 10993-18 chapter. Topics to be covered will include: 1. Understand the analytical testing requirements per the new ISO 10993-18. 2. How to design an extractable study of medical devices in terms of solvent selection, extraction conditions, setting the suitable analytical evaluation threshold (AET), etc. 3. Analytical case studies per common regulatory deficiency points on medical device E&L studies, including requirements on reference standards during semi-quantitation, spiked recovery, LC-MS ionization modes, analytical uncertainty factor, compound identification status, etc.