Major changes are here—are you ready?
Join NAMSA’s expert-led webinar to explore the most impactful updates in the newly revised ISO 10993-1 standard. Whether you’re in regulatory, R&D, or quality, this session will help you understand what’s changed, why it matters, and how to prepare.
This webinar will cover several key updates in the revised ISO 10993-1 standard. We’ll discuss how risk management principles from ISO 14971 are now deeply embedded in ISO 10993-1 and what this means for biological evaluations. The session will explain why reasonably foreseeable misuse, including all aspects of human behavior—intentional or not—must now be considered in assessments. There is a new emphasis on contact duration, focusing on daily and intermittent exposure, bioaccumulation, and more nuanced definitions of prolonged use. Table A.1 has been reorganized into four targeted tables based on tissue contact type, and device categories have been updated, with “implant” no longer a standalone category. We’ll also address the removal of material mediated pyrogenicity from the tables, while highlighting its continued importance, and discuss the shift away from tabulated physical and chemical data, which remain essential for identifying biological hazards. The biological equivalence pathway is now more detailed, though it lacks the practical examples found in ISO 10993-18. Additionally, systemic toxicity is now treated as a single effect, with the depth of evaluation determined by device use, and genotoxicity testing for prolonged exposure is newly required for all but skin contact.
Key Learning Objectives:
- Understand the implications of the new standard
- Identify gaps in your current BEPs and BERs
- Prepare for regulatory expectations with confidence
- Be the first to understand what’s changing—and how to stay compliant
Speakers
Principal Strategy Consultant, Biocompatibility at NAMSA
Don Pohl holds a Bachelor’s degree from Ohio State University. Don has over 20 years of experience in the preclinical evaluation of medical devices for biological safety. During his career, he has held a variety of positions ranging from laboratory supervision/management, GLP Study Director, Technical Specialist for Laboratory Information Management System, Technical Specialist and project manager for Biological safety and biological risk assessment consultation. He has specific expertise in the evaluation process outlined in ISO 10993-1 as well as the expectations of the USFDA and other countries in their interpretation of the biological safety evaluation of medical devices.
Toxicologist at NAMSA
Michelle Kelly joined NAMSA in August 2021 as a Toxicologist working in the Biological Safety and Validation Team. Prior to NAMSA, she was the Biological Safety Manager at UK Competent Authority, MHRA. Her responsibilities included serving as Principal Lead for clinical trial applications for biological safety, providing expert biological safety advice and directing the Regulatory and Safety and Surveillance Teams on compliance, vigilance and Notified Body matters. Michelle also d continues to work with key stakeholders toward the development of international standards to help innovation to the UK market. She is currently the Chair of CH/194, a committee responsible for the UK input to ISO/TC 194 and CEN/TC 206 for standards relating to biological evaluation of medical devices. Michelle has a BSc in Biomedical and Advanced Materials from University of Limerick in Ireland, an MSc in Applied Toxicology from University of Surrey and she is a European Registered Toxicologist.
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This is a free educational webinar.
