Overview

Chemical characterization, as per ISO 10993-18 guidance, has become an important component of biocompatibility testing for medical devices. 

The beginning of 2020 saw a major update to ISO 10993-18, titled “Chemical characterization of medical device materials within a risk management process”, with a subsequent amendment published in 2022. 

This presentation will focus on the recent regulatory expectations regarding the chemical characterization of medical devices. 

Objective

 In our discussion, the audience will gain insight into the key steps required by ISO 10993, as well as learn the latest trends and regulatory expectations for the chemical characterization of medical devices.

 

Agenda

• Understanding the key steps of ISO 10993 and EU MDR
• Strategies of exhaustive extractions for long-term or permanent contact devices.
• Discuss the ISO 10993-18 amendment published in 2022
• Method qualification/validation of screening methods 
• Q&A

Target Audience: The webinar is aimed at professionals in the medical device industry, or anyone interested in the chemical characterization of medical devices.

Language: English

Can't make a live session? Register now and receive a complimentary recording after the live event. For further information, please contact: healthscience@sgs.com

_1735213317274