ISO 10993 webinar series: Chemical characterisation of medical devices (Part 1 of 7)



Learn about the chemical characterisation of medical devices for the assessment of the chemical safety

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: 1:30 PM IST / 10:00 AM CEST 
Duration: 1h 15 mins (including Q&A)


  • Main changes in New Release of 10993-18  

  • AET (Analytical Evaluation Threshold)

  • Extraction conditions

  • Analytical techniques and qualitative/quantitative analysis

  • Test report


Elena CiofiMs. 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.



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