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CEN - EN 13640

Stability Testing of in Vitro Diagnostic Reagents

inactive, Most Current
Organization: CEN
Publication Date: 1 March 2002
Status: inactive
Page Count: 14
ICS Code (Laboratory medicine): 11.100

Document History

EN 13640
March 1, 2002
Stability Testing of in Vitro Diagnostic Reagents
A description is not available for this item.

References

This document is referenced by:
CLSI EP25 - Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline
Published by CLSI on September 1, 2009
This guidance document provides information on the establishment and verification of shelf-life and in-use stability claims for quantitative and qualitative in vitro diagnostic (IVD) reagents. It...
This document is referenced by:
BS EN ISO 18113-1 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) -Part 1: Terms, definitions and general requirements
Published by BSI on October 31, 2011
A description is not available for this item.
This document is referenced by:
AENOR UNE-EN ISO 23640 E - In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
Published by AENOR on September 23, 2015
A description is not available for this item.
This document is referenced by:
ISO 15197 - In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
Published by ISO on May 15, 2013
This International Standard specifies requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples, for specific design verification procedures...
This document is superseded by:
EN ISO 23640 - In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
Published by CEN on June 1, 2015
This International Standard is applicable to the stability evaluation of in vitro diagnostic medical devices, including reagents, calibrators, control materials, diluents, buffers and reagent kits,...
This document is superseded by:
EN ISO 23640 - In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
Published by CEN on June 1, 2015
This International Standard is applicable to the stability evaluation of in vitro diagnostic medical devices, including reagents, calibrators, control materials, diluents, buffers and reagent kits,...
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