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NORM

ZURÜCKGEZOGEN

ÖNORM EN ISO 23640

Erscheinungsdatum: 2012 03 15

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

This International Standard is applicable to the stability testing of in vitro diagnostic medical devices, including reagents, calibrators, control materials, diluents, buffers and reagent kits., hereinafter called IVD reagents. It can also be applied to specimen collection devices that contain substances used to preserve specimens or to initiate reactions for further processing of the specimen in the collection device. It specifies general requirements for stability testing and gives specific requirements for real-time testing and accelerated testing when generating data.

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Allgemeine Information zur ÖNORM EN ISO 23640

Format

Digital | 14 Seiten

Sprache

German | English | Download GER/ENG

Herausgeber

Austrian Standards International

Komitee 179 Medical technology

Historie

Eine Übersicht über die Entwicklung der ÖNORM EN ISO 23640 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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Normative Verweise

Hier finden Sie einen Auszug der normativen Verweise. Die vollständige Liste entnehmen Sie bitte dem Dokument selbst.

Dokumentnummer	Titel	Ausgabedatum	Art	Link
Dokumentnummer ISO 14971:2019	Titel Medical devices — Application of risk management to medical devices	Ausgabedatum 2019 12 10	Art Norm	Zur Produktseite

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