expiration date

upper limit of the time interval during which the performance characteristics of a material stored under specified conditions can be assured

Note 1

Expiry dates are assigned to IVD reagents, calibrators, control materials and other components by the manufacturer, based on experimentally determined stability properties (see 3.68).

Note 2

Guidelines for determining the stability of IVD medical devices are found in EN 13640.

Note 3

Adapted from EN 375:2001, definition 3.6.

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

3.17

expiration date

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