Biocompatibility testing of breathing gas pathway devices – Regulatory and technical backgrounds and proposed changes to the ISO 18562 series

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.

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.