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  • BSI
    BS EN ISO 23640:2015 - TC Tracked Changes. In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents
    Edition: 2020
    $439.53
    / user per year

Description of BS EN ISO 23640:2015 - TC 2020

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 23640:2015 - TC
TitleTracked Changes. In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents
StatusUnder Review
Publication Date2020-02-24
DescriptorsMedical equipment, Diagnostic reagents, Stability testing, Verification, Life (durability), Storage, Stability, Chemical reagents, Diagnosis (medical)
ICS11.100.10 In vitro diagnostic test systems
CommitteeCH/212
ISBN978-0-539-08506-8
PublisherBSI
Pages0

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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