The 6th edition of ISO 10993-1 is published! It brings significant updates for biological evaluation processes in medical device development. While it’s not a mandate for new testing, manufacturers will need to assess existing processes and evaluations against the revised framework.
Key Changes You Need to Know
Stronger integration of biological evaluation with risk management
ISO 10993-1 has long been part of risk management but the changes made to this 6th edition emphasize this point throughout. The updated standard brings with it an expectation that the biological evaluation process and the risk management process are interrelated and interoperable. Some elements are new to biological evaluation (e.g. reasonably foreseeable misuse) but should not be new since they are established elements of an ISO 14971 risk management process.
Updated terms, definitions, and categorization criteria.
Categorization terms and the method for calculating contact duration have been significantly updated. While this will impact every manufacturer’s biological evaluation process, it is most likely to have more impact on those categorization of devices with transient contact and intermittent contact but frequent or cumulative use.
Expanded consideration of biological effects and reasonably foreseeable misuse.
Biological endpoints are no more, they are now biological effects. To emphasize to readers that this is not a checklist process, the old Annex A table has been split up into four new tables with additional considerations for each device category. Reasonably foreseeable misuse should be considered when re-evaluating based on updated device category.
What Does This Mean for You?
- Assess the differences between your current biological evaluation process and the requirements and contents of ISO 10993-1:2025. The significance of those differences will influence how quickly you need to update your process and assess your existing biological evaluations.
- For medical devices on the market, their biological evaluation does need to be assessed to determine whether the device needs to be categorized differently, whether additional biological effects need to be considered and thus whether there is a need for additional data. None of this can happen instantaneously, so the important aspect is for this to be driven by your gap assessments and be proportionate to the risk.
- The same applies for medical devices currently under development. Citing the 2018 edition of the standard will be of no use at the point of conformity assessment if you don’t understand the impact of the updates on your process and your product.
- Regulatory acceptance of this 6th edition will vary by region. Continue to monitor the applicable regulatory authorities and their response to this 6th edition to help you assess the impact on your products and process, and to help you prioritize specific devices and biological testing as necessary.
How RQM+ Can Help:
- Training on ISO 10993-1 changes.
- Gap assessments for your processes.
- Remediation and updates for biological evaluations and risk management files.
- Biocompatibility testing, chemical characterization, and toxicological risk assessments.
Don’t wait for compliance challenges—start planning now to stay ahead of regulatory expectations.
Contact us today to learn how RQM+ can support your transition to ISO 10993-1:2025.
