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Does your device incorporate or consist of nanomaterials?
19a
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?
19b
internal exposure refers to the dose of a nanomaterial that becomes systemically available via a given route of exposure.
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