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Norm
ÖNORM EN ISO 23640
Issue date: 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, b...
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Withdrawn
: 2013 05 15
Publisher:
Austrian Standards International
Format:
Digital | 14 Pages
Language:
German
| English
| Download GER/ENG
Currently valid:
Optionally co-design standards:
ICS
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.
ÖNORM EN ISO 23640
2015 12 15
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 2...
Norm
ÖNORM EN ISO 23640
2013 05 15
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 2...
Norm
ÖNORM EN ISO 23640
2012 03 15
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 2...
Norm
↖
Norm
ISO 14971:2007
Issue date :
2007 02 28
Medical devices — Application of risk management to medical devices (Corrected version 2007-09)
Norm
ISO 14971:2019
Issue date :
2019 12 10
Medical devices — Application of risk management to medical devices
Norm
ÖNORM EN ISO 23640
Issue date :
2013 05 15
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)