When the updated ISO 10993-18 becomes a challenge: Are your Medical Device materials and components appropriately characterized?

11 March, 2020

With recent updates to ISO 10993-18 in January 2020 and increasing regulatory demands, it is critical that manufacturers appreciate the requirements for chemical characterization, and how materials and components of Medical Devices should comply with this newly implemented standard.

The updated ISO 10993-18:2020 standard, promotes greater integration and harmonization across the ISO 10993 series and introduces additional updates:

  • Chemical characterization is described as a tiered approach, starting with detailed description of material composition. In consequence, more detailed information from raw material suppliers is necessary (e.g. certificates of analysis, technical data sheets, formulation disclosure, etc.) in order to identify biological hazard arising from constituents.
  • The chemical characterization process is defined in a more detailed manner. This may result in the need for additional analytical testing and/or modification to test methods and conditions.
  • The more stringent requirement for analytical method validation warrants a closer collaboration between manufacturers and analytical laboratories to ensure that the experimental design and approach are suitable/applicable for their intended purpose.
  • Derivation of Analytical Evaluation Threshold (AET) is now essential for organic extractables/leachables. This requires toxicological expertise to establish limit values. Calculated AET values may impact limits of quantification (LOQ) and result in adaptation of test conditions (e.g. concentration of extracts, method adaptations).

Overall, the update of ISO 10993-18 results in a more complex material and chemical characterization. knoell’s experts can provide support and guidance to manufacturers by e.g. communication with raw material suppliers, providing recommendations for testing strategies and helping to determine relevant analytical parameters and conditions specific to the needs of each material and/or Medical Device.  In addition, our experts carry extensive experience with biological evaluations and toxicological risk assessments for chemical constituents and extractable/leachable compounds in order to satisfy international standards and regulatory requirements.

For more information and details on material and chemical characterization please contact us!

Dr. med. Isabelle Lang-Zwosta Global Regulatory Affairs and Business Development Medical Devices
+1 615 374 1242 send mail