Our characterization matrix provides general guidance on which tests should be conducted given the end use of a device or material and its expected level and duration of exposure to human tissue and fluids. Results characterize the material, confirming its identity and enabling assessment of reproducibility in manufacturing and processing. This is especially useful for evaluating polymers and other product components for purity, uniformity, composition, sterilant residuals and general extractables.
Guidelines and Standards References
Our materials characterization testing follows these guidelines and standards:
- U.S. FDA Blue Book Memorandum GP#95-1
- ISO Standard 10993-1, “Biological Evaluation of Medical Devices”
- ISO Standard 10993-18, “Chemical Characterization of Materials”
- FDA Guidance Document, “Container Closure Systems for Packaging Human Drugs and Biologics”
E Extractable: An extract of the device is prepared and characterized, resulting in a fingerprint that can be interpreted as being bioavailable
M Material: (Ceramics, Metals, and Polymeric Materials) In addition to extractables, materials are characterized and evaluated for their physical and mechanical properties, surface morphology, thermal properties, etc.
P Polymeric Material: The individual unaltered device component is used for characterization. Test procedures indicated with P are appropriate for polymeric materials only.