use error

act or omission of an act that has a different medical device response to that intended by the manufacturer or expected by the operator

Note 1

Use error includes slips, lapses and mistakes.

Note 2

IEC 62366:2007, Annexe B and D.1.3

, give a discussion and examples of use errors.

Bron

IEC 62366:2007, definition 2.12

Norm

Titel

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

Paragraaf

3.71