residual risk

risk remaining after risk control measures have been taken

Note 1

Residual risks are disclosed to users in the instructions for use. See ISO 14971:2007, Annex H.

Bron

ISO/IEC Guide 51:1999, definition 3.9

Norm

Titel

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements

Paragraaf

3.60