label

printed, written or graphic information placed on a medical device or its container

Note 1

A label permanently affixed to an IVD instrument is considered marking (3.37).

Note 2

Adapted from EN 375:2001, definition 3.12.

Norm

Titel

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

Paragraaf

3.33