Standard Svensk standard · SS-EN ISO 23640:2013

Laboratoriemedicin - Stabilitetsutvärdering av in vitro-diagnostisk reagens (ISO 23640:2011)

Status: Upphävd

· Ersätts av: SS-EN ISO 23640:2015
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Standard Svensk standard · SS-EN ISO 23640:2013

Laboratoriemedicin - Stabilitetsutvärdering av in vitro-diagnostisk reagens (ISO 23640:2011)
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Omfattning
ISO 23640:2011 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. ISO 23640:2011 can also be applied to specimen collection devices that contain substances used to preserve samples or to initiate reactions for further processing of the sample in the collection device.
ISO 23640:2011 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 monitoring of stability of IVD reagents already placed on the market;
the verification of stability specifications after modifications of the IVD reagent that might affect stability.

Ämnesområden

(11.100.10)


Köp denna standard

Standard Svensk standard · SS-EN ISO 23640:2013

Laboratoriemedicin - Stabilitetsutvärdering av in vitro-diagnostisk reagens (ISO 23640:2011)
Prenumerera på standarden - Läs mer Dölj
Pris: 735 SEK
standard ikon pdf

PDF

Pris: 735 SEK
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Produktinformation

Språk: Engelska

Framtagen av: Medicinsk diagnostik, SIS/TK 331

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

Artikelnummer: STD-98317

Utgåva: 2

Fastställd: 2013-06-05

Antal sidor: 24

Ersätter: SS-EN ISO 23640:2011

Ersätts av: SS-EN ISO 23640:2015