Applying ISO 10993-18 on Extractables & Leachables Characterization—Supporting the Medical Device Regulatory Pathway

October 30, 2020
Waters

***Live: Friday, November 20, 2020 at 11am EST| 8am PST| 4pm GMT| 5pm CET***Chemical characterization of medical device materials within a risk management process, addressed in ISO 10993 Part 18, was significantly revised in 2020. Part of this critical standard is to ascertain the extractables and leachables from a medical device to enable the estimation and control of biological risks. Join us for this webcast to learn about an LC–MS workflow to help address this challenge.***On demand available after final airing until NOV. 20, 2021***

Register Free: https://www.chromatographyonline.com/lcgc_w/pathway

Event Overview:A key standard that is utilized by many medical devices regulations is ISO 10993, “Biological evaluation of medical devices,” highlighted by the US FDA, the EU MDR, Chinese NMPA and Japanese PMDA, amongst others. This webinar will focus on a section that was updated in 2020, “Part 18: Chemical characterization of medical device materials within a risk management process.” Part of this critical section of the ISO guideline addresses methods to ascertain the extractables and leachables (E&L) from a medical device to enable the estimation and control of biological risks. Guidance on this aspect of the analysis has increased dramatically from previous revisions. In this webinar, we will discuss the revision and workflows to assist you in addressing this type of analysis in liquid chromatography–mass spectrometry (LC–MS) analysis, addressing both semi and non-volatile organic compounds.

Key Learning Objectives:

  • Insight into regulatory revisions applying to E&L testing of medical devices
  • Overview of the practical application in an E&L workflow
  • Learn about an LC–MS workflow a to simplify adoption of this guideline

Speakers: Rachel Sanig, Applications Scientist, Scientific Operations, Materials Science, Waters Corporation, UK

Ben MacCreath PhD, Senior Strategic Program Development Manager, Materials Science, Waters Corporation, UK

Time and Date: Friday, November 20, 2020 at 11am EST| 8am PST| 4pm GMT| 5pm CET

On Demand Until Nov. 20 2021

Register Free: https://www.chromatographyonline.com/lcgc_w/pathway

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