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ÖNORM EN 13640

Erscheinungsdatum: 2002 06 01

Stability testing of in vitro diagnostic reagents

This European Standard is applicable to the stability testing of in vitro diagnostic reagents including reagent products, calibrators, control materials and kits, hereinafter called IVD reagents. It specifies general requirements for stability testing and gives specific requirements for real-time testing and accelerated testing when generating stability data in the determination of IVD reagent shelf-life including transport stability; determination of stability of the IVD reagent in use after the first opening of the primary container (e. g. on-board stability); monitoring of stability of IVD reagents already placed on the market; verification of stability after IVD reagent modifications that may affect stability. This standard does not apply to instruments, apparatus, equipment, systems, or specimen receptacles.

Allgemeine Information zur ÖNORM EN 13640

Format

Digital | 11 Seiten

Sprache

German | English | Download GER/ENG

Herausgeber

Austrian Standards International

Komitee 179 Medical technology

Historie

Eine Übersicht über die Entwicklung der ÖNORM EN 13640 von 2002 bis heute.

ÖNORM EN ISO 23640

2015 12 15 Norm ÖNORM EN ISO 23640, Ausgabe: 2015 12 15

In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 2...
ÖNORM EN ISO 23640

2013 05 15 Norm ÖNORM EN ISO 23640, Ausgabe: 2013 05 15

In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 2...
ÖNORM EN ISO 23640

2012 03 15 Norm ÖNORM EN ISO 23640, Ausgabe: 2012 03 15

In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 2...
ÖNORM EN 13640

2002 06 01 Norm ÖNORM EN 13640, Ausgabe: 2002 06 01

Stability testing of in vitro diagnostic reagents

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ÖNORM EN 13640 - Stability testing of in vitro diagnostic reagents

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