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Standard [WITHDRAWN]

DIN EN ISO 23640:2012-03

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

German title
In-vitro-Diagnostika - Haltbarkeitsprüfung von Reagenzien für in-vitro-diagnostische Untersuchungen (ISO 23640:2011); Deutsche Fassung EN ISO 23640:2011
Publication date
2012-03
Original language
German
Pages
15

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Publication date
2012-03
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 the 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; - the establishment of stability after the first opening of the primary container and - the monitoring of stability of IVD reagents already placed on the market.

Content
ICS
11.100.10
Replacement amendments

This document replaces DIN EN 13640:2002-06 .

This document has been replaced by: DIN EN ISO 23640:2013-09 , DIN EN ISO 23640:2015-12 .

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