Fig 4 - Importance of Standardizing Analytical Characterization Methodology for Improved Reliability of the Nanomedicine Literature

Characterization requirements for medical devices containing nanostructures and nanomaterials as recommended by ISO/TR 10993-22. The extent of characterization is dependent on the type and state of nano-based medical devices. The nanomaterial exposure risk via direct contact or unintended nanoparticle leakage from the device needs to be considered in the device characterization to properly assess safety and efficacy of nanotechnology-based medical devices. The degradation or dissolution and stability of nanostructures in relevant biological media need to be monitored and characterized over the shelf life and active lifetime of medical devices. Finally, the structures need to be fully characterized both in vitro and in in vivo proxies to ensure the design and physicochemical properties do not compromise the safety and efficacy of the medical devices. The scrutiny of the evaluation will increase if the nanostructures are designed to release from the device or pose the risk of undesired release in biological fluids. In addition to the above-mentioned evaluations, further tests (e.g., biodistribution, toxicity, and release kinetics of nanomaterials) are required to ensure the nanomedical device is safe for use in the clinic. The ISO/TR 10993-22 standards provide a framework and guidelines for characterization of nanomaterials. More specific physicochemical characteristic testing of nanomaterials is detailed in ISO/TR 13014. The figure is drawn based on the information provided in ISO/TR 10993-22 [41]