a b c d e f g h i j k l m n o p q r s t u v w x y z

control procedure

set of operations at the point of use, described specifically, intended to monitor the performance characteristics of an IVD medical device and fulfil requirements for quality

Note 1

Control procedures can be intended to monitor all or part of the IVD examination process, from the collection of the sample to reporting the result of the examination.

Note 2

Adapted from ISO 15198:2004, definition 3.5.

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
3.14
Terug

Gerelateerde termen

Geen termen gevonden