hazardous situation

circumstance in which people, property or the environment are exposed to one or more hazards

Note 1

Incorrect IVD examination results can contribute to a hazardous situation for a patient. See ISO 14971:2007, Annex H.

Bron

ISO/IEC Guide 51:1999, definition 3.6

Norm

Titel

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

Paragraaf

3.21