warning

statement that alerts users about a situation that, if not avoided, could result in hazards or other serious adverse consequences from the use of an IVD medical device

Note 1

The designation of a hazard alert as a warning is reserved for the most significant consequences.

Note 2

The distinction between a warning and a precaution (3.53) is a matter of degree, considering the likelihood and seriousness of the hazard (3.20).

Note 3

Use includes use errors (3.71) and reasonably foreseeable misuse. See ISO 14971 and IEC 62366 for discussions of these concepts.

Note 4

Adapted from Reference [50].

Norm

NEN-EN-ISO 18113-1:2011 en

Titel

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

Paragraaf

3.74

warning

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