NF EN ISO 23640 : 2015
Current
The latest, up-to-date edition.
IN VITRO DIAGNOSTIC MEDICAL DEVICES - EVALUATION OF STABILITY OF IN VITRO DIAGNOSTIC REAGENTS
12-01-2013
Describes the stability evaluation of in vitro diagnostic medical devices, including reagents, calibrators, control materials, diluents, buffers and reagent kits, hereinafter called IVD reagents. It is 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.
| DevelopmentNote |
Indice de classement: S92-032. (01/2012) PR NF EN ISO 23640 November 2013. (11/2013) 2014 version is still active. (01/2016) Supersedes NF EN 13640. (03/2016)
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| DocumentType |
Standard
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| PublisherName |
Association Francaise de Normalisation
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| Status |
Current
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| Standards | Relationship |
| EN ISO 23640:2015 | Identical |
| ISO 23640:2011 | Identical |
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