BS EN ISO 23640:2013 - In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents

BS EN ISO 23640:2013

In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents

Status : Withdrawn, Revised   Published : March 2013 Replaced By : BS EN ISO 23640:2015

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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.




Standard NumberBS EN ISO 23640:2013
TitleIn vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents
StatusWithdrawn, Revised
Publication Date31 March 2013
Withdrawn Date30 June 2015
Normative References(Required to achieve compliance to this standard)ISO 14971
Informative References(Provided for Information)ISO 18113-1:2009, EN 13640, 98/79/EC
Replaced ByBS EN ISO 23640:2015
ReplacesBS EN ISO 23640:2011
International RelationshipsEN ISO 23640:2013,ISO 23640:2013
DescriptorsDiagnostic reagents, Diagnosis (medical), Chemical reagents, Stability testing, Stability, Storage, Life (durability), Verification, Medical equipment
ICS11.100.10
Title in FrenchDispositifs médicaux de diagnostic in vitro. Évaluation de la stabilité des réactifs de diagnostic in vitro
Title in GermanIn-vitro-Diagnostika. Haltbarkeitsprüfung von Reagenzien für in-vitro-diagnostische Untersuchungen
CommitteeCH/212
ISBN978 0 580 82256 8
PublisherBSI
FormatA4
DeliveryNo
Pages16
File Size1.13 MB
Price£130.00


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