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shelf-life

period of time until the expiry date during which an IVD reagent in its original packaging maintains its stability under the storage conditions specified by the manufacturer

Note 1
Stability (3.68)

and expiry date (3.17) are related concepts.

Note 2

Adapted from EN 375:2001, definition 3.16.

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
3.66
Terug

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