Medical Devices: nanomaterial characterization in accordance with the ISO 10993-22 standard

ISO/TR 10993-22:2017 includes considerations on the:

– characterization of nanomaterials;

– sample preparation for testing of nanomaterials;

– release of nano-objects from medical devices;

– toxicokinetics of nano-objects;

– biological evaluation of nanomaterials;

– presentation of results;

– risk assessment of nanomaterials in the context of medical device evaluation;

– biological evaluation report;

– nanostructures on the surface of a medical device, intentionally generated during the engineering, manufacturing or processing of a medical device.

The following are excluded from this document:

– natural and biological nanomaterials, as long as they have not been engineered, manufactured or processed for use in a medical device;

– intrinsic nanostructures in a bulk material;

– nanostructures on the surface of a medical device, generated as an unintentional by-product during the engineering, manufacturing or processing of a medical device.

ISO/TR 10993-22:2017 is intended to provide a general framework and highlights important aspects which need to be considered when assessing the safety of medical devices composed of, containing and/or generating nano-objects. Additionally, the document identifies several common pitfalls and obstacles which have been identified when testing nanomaterials compared to bulk materials or small molecule chemical species.