Agglomerate

For the purposes of the definition of nanomaterial in point (18), a collection of weakly bound particles or aggregates where the resulting external surface area is similar to the sum of the surface areas of the individual components.

Reference: MDR Article 2(20)

Aggregate

For the purposes of the definition of nanomaterial in point (18), a particle comprising of strongly bound or fused particles.

Reference: MDR Article 2(21)

Derivative

A ‘non-cellular substance’ extracted from human or animal tissue or cells through a manufacturing process. The final substance used for manufacturing of the device in this case does not contain any cells or tissues.

Reference: MDR Article 2(17)

Nanomaterial

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.

Reference: MDR Article 2(18)

Non-viable

Having no potential for metabolism or multiplication.

Reference: MDR Article 2(16)

Particle

For the purposes of the definition of nanomaterial in point (18), a minute piece of matter with defined physical boundaries.

Reference: MDR Article 2(19)