Nanomaterial

Devices that incorporate or consist of nanomaterial are classified under EU MDR Rule 19, where the class depends on the potential for internal exposure. The test counts particles in the number size distribution, not mass, so a small mass fraction of nanoparticles can still meet the definition.

‘nanomaterial’ means a natural, incidental or manufactured material containing particles in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1-100 nm; Fullerenes, graphene flakes and single-wall carbon nanotubes with one or more external dimensions below 1 nm shall also be deemed to be nanomaterials;

EU MDR, Article 2(18)