Header Artwork
Header Artwork


The new ISO 10993 – 18 Standard and its Impact on Chemical Characterization of Medical Devices

April 9, 2020

To meet the heightened focus on chemical characterization in ISO 10993-1:2018, a major revision of ISO 10993-18 “Chemical characterization of medical device materials within a risk management process” was undertaken. The revised document published in January 2020. In this presentation, Dr Ted Heise focuses on key parts of the new document, bringing in experience and lessons learned from multi-stakeholder development of the final standard.

The presentation was recorded at our Open House Event in Leuven on 4 March.