Increased awareness of the importance of the physical and chemical properties of medical devices and materials in devices has led to updated requirements in the EU medical device regulation (MDR) and the international ISO 10993-standards for biocompatibility. The requirements recommend the use of physical/chemical characterisation, chemical analyses and toxicological risk assessment in the evaluation of safety.
A newly updated version of the ISO 10993-18 on chemical characterisation has been approved by the ISO-committees and is expected to be published soon. Some of the requirements in the new standard is already requested by authorities – challenging industry to provide additional chemical analyses and toxicological data.
In a series of three webinars on the safety requirements for medical devices, this second webinar is about safety assessment by means of chemical characterization.
In this webinar you will get an overview of the requirements and recommendations in ISO 10993-18, including:
• Chemical characterization
- Which data to collect
- Selection of tests and analyses to support biological evaluation
- Requirements for studies of extractable and leachable substances for medical devices
- How to determine the Analytical Evaluation Threshold
- Toxicological input and perspectives for the chemical characterization studies
In addition, you will learn how to use chemical characterisation data as input for the evaluation of biocompatibility and safety of a device by methods of toxicological risk assessment.
Professionals in RA, QA or R&D who are responsible for medical device safety in companies that manufacture, import or sell medical devices and drug-device combination products on the EU market.
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