stability

ability of an IVD medical device to maintain its performance characteristics within the limits specified by the manufacturer

Note 1

Stability applies to —

IVD reagents, calibrators and controls, when stored, transported and used in the conditions specified by the manufacturer,

—

reconstituted lyophilised materials, working solutions and materials removed from sealed containers, when prepared, used and stored according to the manufacturer’s instructions for use,

—

measuring instruments or measuring systems after calibration.

Note 2

Stability of an IVD reagent or measuring system is normally quantified with respect to time —

in terms of the duration of a time interval over which a metrological property changes by a stated amount or

—

in terms of the change of a property over a stated time interval.

Note 3

Adapted from “stability of a measuring instrument” in ISO/IEC Guide 99:2007^[28], 4.19.

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

3.68

stability

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