FREE LIVE WEBINAR: Biocompatibility testing of breathing gas pathway devices (ISO 18562 and ISO 10993) – Regulatory and technical backgrounds and proposed changes to the ISO 18562 series
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About the webinar
Manufacturers of breathing gas pathway devices, such as ventilators and breathing systems, must evaluate their products in such a way that they can demonstrate the safety of these products during the clinical use. One of the safety aspects is the biological safety. Typically, such evaluation is performed using the ISO 18562 series of standards. However, at least for parts having direct patient contact or indirect via condensates, additional evaluations per ISO 10993-1 have to be considered. To ensure all requirements are met, a close cooperation between various experts – including engineers, analytical chemists, and toxicologists – is necessary.
Topics:
During this webinar, our experts will provide insight into:
- Expectations of regulatory authorities regarding the biological evaluation plan (BEP).
- Details of the test approaches, focusing on the ISO 18562 series of standards.
- How to evaluate the data coming from the various tests?
- Additional requirements of US FDA.
- Proposed changes for ISO 18562 series of standards.
At the end of the webinar session there is going to be a Q&A Session with the two speakers, where you would get a chance to clarify some specific questions.
Who should attend?
The event is aimed at anyone involved in the development or production of breathing gas pathway devices.
When?
03.05.2023
16:00 - 17:00 (CET)
Speakers:
This webinar is presented by
Carry Hermans, Manager Molecular Analysis, Eurofins Materials Science Eindhoven, part of Eurofins Materials Science & Engineering Europe
Carry Hermans has been working in the field of inorganic and organic material analysis with various analytical techniques since 2005 and is employed as Manager Molecular Analysis at Eurofins Materials Science in Eindhoven, the Netherlands, since October 2020.
Carry Hermans’ expertise includes chemical characterization for a broad range of application areas like lighting, healthcare and semiconductors. After many years of building experience with various analytical techniques in the laboratory, she is now leading the molecular analysis group within Eurofins Materials Science in Eindhoven.
Jan Peeters, Senior Consulting Specialist, Eurofins BioPharma Services Consulting Munich GmbH
Jan Peeters has been working in the field of testing and evaluating the safety of medical devices since 1995 and is employed as Senior Consulting Specialist at Eurofins BioPharma Services Consulting Munich GmbH in Planegg, Germany, since October 2017.
Jan Peeters' expertise includes the chemical characterization of medical devices and related toxicological issues, biocompatibility, packaging validation and stability testing, including transport simulations, validation of reprocessing methods and testing of ophthalmic products. He actively participates in many national and international standardization groups in the fields of biocompatibility
