Medical devices. Biological evaluation of medical devices. Part 22. Guidance on nanomaterials

This standard applies to medical devices (hereinafter referred to as MD) containing or consisting of nanomaterials and establishes requirements for the assessment of their biological effects (hereinafter referred to as biological assessment). This standard can be used to assess the biological effects of nanoobjects released as a result of degradation, wear, or mechanical processing of MD (e.g., abrasion, polishing of MD in situ) or their components manufactured without the use of nanomaterials.