In response to the heightened focus on chemical characterization outlined in ISO 10993-1:2018, a significant revision of ISO 10993-18, titled “Chemical Characterization of Medical Device Materials within a Risk Management Process,” was undertaken. The revised document was published in January 2020, reflecting extensive updates to meet contemporary regulatory and safety requirements.
This presentation by Dr. Ted Heise will delve into the key parts of the revised ISO 10993-18 document. Dr. Heise will share valuable insights and lessons learned from the multi-stakeholder development process that led to the final standard. This experience-based perspective will help attendees understand the practical implications of the changes and how to implement them effectively in their own chemical characterization processes.
The presentation will highlight the essential updates and new requirements introduced in the revised ISO 10993-18. Attendees will learn about the enhanced emphasis on thorough chemical characterization within a risk management framework, ensuring that medical device materials are accurately assessed for safety and compliance.
By exploring the collaborative efforts involved in the revision process, Dr. Heise will provide a comprehensive overview of the challenges and considerations that shaped the final document. This context will be invaluable for manufacturers and regulatory professionals aiming to align their practices with the latest standards.
Participants will gain a deep understanding of how to apply the revised ISO 10993-18 in their chemical characterization efforts. This includes detailed guidance on conducting risk assessments, identifying potential chemical hazards, and implementing robust testing protocols to ensure the safety of medical device materials.
Through this presentation, attendees will be better equipped to meet the stringent requirements of ISO 10993-18, enhancing their ability to manage chemical risks effectively and maintain compliance with global regulatory standards.