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instructions for use

information supplied by the manufacturer to enable the safe and proper use of an IVD medical device

Note 1

Includes the directions supplied by the manufacturer for the use, maintenance, troubleshooting and disposal of an IVD medical device, as well as warnings and precautions.

Note 2

Adapted from EN 376:2002, definition 3.9 and EN 591:2001, definition 3.3.

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
3.30
Terug

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