This webinar elaborates on the importance of chemical characterisation of medical devices within the biological evaluation and the connected risk management process. The underlying standards such as the ISO 10993-1, ISO 10993-17 and especially ISO 10993-18 are explained.
Additionally, topics on basic principles from extractables and leachables to the AET and the different analytical methods are explained too. By bringing this knowledge together, it creates a better understanding of the whole process of chemical characterisation and the concept of how to assess and prove the chemical safety of a medical device.
Date: 29 April 2021, Thursday
Time: 10:00 AM CEST/ 1:30 PM IST/ 1:00 AM PDT (Session 1)
3:00 PM CEST/ 6:30 PM IST/ 6:00 AM PDT (Session 2)
Duration: 1h 15 mins (including Q&A)
Main changes in New Release of 10993-18
AET (Analytical Evaluation Threshold)
Analytical techniques and qualitative/quantitative analysis
Ms. Elena Ciofi
Head of Healthcare, Food Contact and Food laboratories, TÜV Italia SRL
Ms. Elena Ciofi graduate in chemistry and has been working in pH Laboratories, now part of the TÜV SÜD Group, since 2006, where she headed the Chemical Department for about 10 years before taking on the role of "Head of Lab Food" in 2014.
A specialist in the development and validation of analytical methods for the food world, with a previous experience in a pharmaceutical laboratory, she also had experience in the environmental field, which she managed for about a year. These experiences have enabled her to broaden her vision of the testing world to 360°. From 2020 she is in charge of the management of lab of Healthcare dedicated to testing on medical devices.