precaution

statement that alerts users to special care or activities necessary for safe and effective use of an IVD medical device or to avoid damage to the IVD medical device that could occur as a result of use, including misuse

Note 1

The distinction between warnings and precautions is a matter of degree, considering the likelihood and seriousness of the hazard. See the definition of warning (3.74).

Note 2

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

3.53

precaution

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