ISO/TR 10993-22:2017

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.

NOTE Examples of unintentional nanostructures on the surface of a medical device are extrusion draw lines and machining/tool marks.

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. As a technical report (TR), this document represents the current technical knowledge related to nanomaterials. No detailed testing protocols are outlined or provided. This document can serve as a basis for future documents containing detailed protocols with a focus on nanomaterial testing.