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Standard [WITHDRAWN]

DIN EN ISO 23640:2013-09

In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011); German version EN ISO 23640:2013

German title
In-vitro-Diagnostika - Haltbarkeitsprüfung von Reagenzien für in-vitro-diagnostische Untersuchungen (ISO 23640:2011); Deutsche Fassung EN ISO 23640:2013
Publication date
2013-09
Original language
German
Pages
15

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Publication date
2013-09
Original language
German
Pages
15

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Overview

This standard is applicable to the stability evaluation of in vitro diagnostic medical devices, including reagents, calibrators, control materials, diluents, buffers and reagent kits, hereinafter called IVD reagents. It specifies general requirements for stability evaluation and gives specific requirements for real time and accelerated stability evaluation when generating data in: - the establishment of IVD reagent shelf life, including transport conditions suitable to ensure that product specifications are maintained; - the establishment of stability of the IVD reagent in use after the first opening of the primary container. The new edition of the standard has been initiated by the required revision of Annex ZA.

Content
ICS
11.100.10
Replacement amendments

This document replaces DIN EN ISO 23640:2012-03 .

This document has been replaced by: DIN EN ISO 23640:2015-12 .

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