Does your device incorporate or consist of nanomaterials?

A nanomatieral is 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 nm - 100 nm.

What is the potential for internal exposure?

internal exposure refers to the dose of a nanomaterial that becomes systemically available via a given route of exposure.