DIN EN ISO 23640:2012-03

In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011); German version EN ISO 23640:2011

Dispositifs médicaux de diagnostic in vitro - Évaluation de la stabilité des réactifs de diagnostic in vitro (ISO 23640:2011); Version allemande EN ISO 23640:2011

In-vitro-Diagnostika - Haltbarkeitsprüfung von Reagenzien für in-vitro-diagnostische Untersuchungen (ISO 23640:2011); Deutsche Fassung EN ISO 23640:2011

Información:

Fecha Anulación:

2013-09 /Withdrawn

ICS:

11.100.10 - In vitro diagnostic test systems

Equivalencias internacionales:

EN ISO 23640 (2011-12)

ISO 23640 (2011-12)

Relación con otras normas DIN:

Reemplaza a: DIN EN 13640:2002-06

Reemplaza a: DIN EN ISO 23640:2009-12

Reemplazada por: DIN EN ISO 23640:2013-09

Resumen:

This European Standard is applicable to the stability testing of in vitro diagnostic reagents including reagent products, calibrators, control materials and kits.

Keywords:

Biochemicals, Buffer solutions, Calibration, Calibrator, Check material, Chemical analysis and testing, Control charts, Definitions, Diagnosis, Diagnosis (medical), Diluents, Durability, In vitro, In-vitro diagnostic, Life (durability), Medical devices, Medical products, Medical sciences, Reagent solutions, Reagents, Real-time, Specification (approval), Stability, Storage, Testing, Transport conditions

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