Biocompatibility Under the New ISO 10993-1: Practical Strategies and Case Studies

Course objective and outcome

By attending this course, you will gain comprehensive insights into the major changes introduced in the new ISO 10993-1:2025 and understand how these updates impact the biological evaluation of medical devices. You will learn how to implement a risk-based approach, define acceptance criteria, and prepare robust Biological Evaluation Plans and Reports that meet global regulatory expectations.

Content

The course covers the following key topics:

• Overview of Key Changes in ISO 10993-1:2025
  • New definitions and acronyms
  • Integration of Risk Management Framework with ISO 14971
• Biological Evaluation Plan and Report
  • Essential content and structure
• Material Selections and Design Considerations in product development
• Exposure duration and categorization of medical devices
  • Exposure duration and its implications
  • Practical implications for device classification
  • Understand the new categories
• Reasonably foreseeable misuse
  • How to address in risk assessment
• Risk Estimation and Acceptance criteria
  • Setting scientifically sound thresholds
• Biological equivalence
  • Strategies for justification and documentation
• Bioaccumulation and Long-term Risks
  • Mechanisms, testing approaches, and regulatory expectations
• Life cycle management
  •  Continuous evaluation and post-market surveillance
• Testing strategies and challenges
  • Updated testing strategies due to new categorization
  • New testing requirements
  • In vitro vs. in vivo considerations
• Global regulatory expectations for implementations
• Interactive Case Studies
  • Re-categorization exercises
  • Risk-based evaluation scenarios

The training format consists of presentations with interactive discussions and group discussions linked to case studies.

Who should attend

The course is relevant for:

• Experienced biocompatibility specialists and biosafety specialists
• Toxicologist working with medical devices
• Regulatory affairs managers