Standards [Withdrawn]

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

Title (German)

In-vitro-Diagnostika - Haltbarkeitsprüfung von Reagenzien für in-vitro-diagnostische Untersuchungen (ISO 23640:2011); Deutsche Fassung EN ISO 23640:2013

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.

Document: references other documents

Document: referenced in other documents

Responsible national committee

NA 176-08-08 AA - Quality management in medical laboratories  

Responsible european committee

CEN/TC 140 - In vitro diagnostic medical devices  

Responsible international committee

ISO/TC 212 - Medical laboratories and in vitro diagnostic systems  

Edition 2013-09
Original language German
Translation English
Price from 70.50 €
Table of contents

Contact

Dipl.-Ing. (FH)

Björn Hermes

Am DIN-Platz, Burggrafenstr. 6
10787 Berlin

Tel.: +49 30 2601-2404
Fax: +49 30 2601-42404

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