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:
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!