At this year’s MD&M West trade show, Nicholas Christiano, Global Segment Leader for Biological Safety at Nelson Laboratories, presented on updates to the new revision of ISO 10993-1, the cornerstone standard guiding biocompatibility assessments for medical devices.
The current updates coming out of the ISO meetings in October 2024 introduce a more dynamic, risk-based framework. These changes carry implications for device manufacturers and regulatory professionals running biocompatibility studies. The following are some critical points from the updates:
- Stronger emphasis on a risk-based approach while moving away from prescriptive testing protocols
- New emphasis on chemical characterization, where the new ISO 10993-1 improves the ability to predict device safety and mitigate potential toxicological risks
- The incorporation of endpoint-specific risk assessments, such as changes on devices requiring genotoxicity evaluations.
- New requirements to determine biocompatibility throughout a product’s lifecycle, including the end of useful life.
The presentation offered insights into the practical implications of these changes, including how to adapt biocompatibility testing strategies, documentation practices, and regulatory submissions. It also discussed the broader impact of these updates on global harmonization of biocompatibility standards and their alignment with other regulatory frameworks, helping professionals ensure compliance while enhancing product safety and innovation.
Even if you missed the presentation, you can access the slides below. Also, stay tuned for a similar version of this presentation in a live webinar format planned for April.
Download the Presentation Slides:
