Biological evaluation of medical devices - Part 22 : guidance on nanomaterials

This document describes the aspects to be taken into account for the biological evaluation of medical devices which contain or are composed of nanomaterials. These guidelines can also be applied for the assessment of nano-elements generated as degradation or wear products, or as a result of mechanical processing (e.g. in situ grinding or polishing of medical devices) of devices. products or their components, made without nanomaterials.