The final draft revision of part 18 of the ISO 10993 series, now titled “Chemical Characterization of Medical Device Materials within a Risk Management Process,” is available for purchase from several websites. This new title signals significant changes from the previous version, reflecting a more integrated approach to chemical characterization within the broader context of risk management for medical devices.
This webinar will highlight the main changes introduced in the revised ISO 10993-18, emphasizing the incorporation of an Analytical Evaluation Threshold (AET). The AET is a crucial concept that aids in the accurate identification and quantification of compounds, which is essential for subsequent toxicological assessments. Understanding how to determine and apply the AET is vital for ensuring the safety and compliance of medical devices.
One of the critical aspects covered in the webinar is when to perform an Extractables study, how to design it, and how it differs from a Leachables study. Extractables studies are essential for identifying potential leachable compounds under exaggerated conditions, while Leachables studies focus on compounds that actually migrate into the product under normal conditions. Distinguishing between these two types of studies and knowing when to implement each is crucial for effective risk management.
By the end of the webinar, participants will have a comprehensive understanding of several key points. They will learn when and how to set up Extractables and Leachables studies as part of an overall risk management strategy. The webinar will also clarify the differences between screening and targeted analytical techniques, which are fundamental for accurate chemical characterization.
Participants will gain insights into why and how to calculate an Analytical Evaluation Threshold, a critical step for determining the relevance of detected compounds. Additionally, the importance of reliable compound identification and quantification will be emphasized, highlighting the need for precise analytical methods and thorough documentation.
This webinar aims to equip attendees with the knowledge necessary to navigate the changes in the revised ISO 10993-18. By understanding these new requirements and methodologies, participants will be better prepared to ensure the safety and regulatory compliance of their medical devices through effective chemical characterization and risk management practices.