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DIN EN ISO 15194

In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation (ISO 15194:2009)

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Organization: DIN
Publication Date: 1 October 2009
Status: active
Page Count: 25
ICS Code (In vitro diagnostic test systems): 11.100.10

Document History

DIN EN ISO 15194
February 1, 2024
In vitro diagnostic medical devices - Requirements for certified reference materials and the content of supporting documentation (ISO/DIS 15194:2023); German and English version prEN ISO 15194:2023
A description is not available for this item.
DIN EN ISO 15194
October 1, 2009
In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation (ISO 15194:2009)
A description is not available for this item.

References

This document is referenced by:
DIN EN ISO 15189 - Medizinische Laboratorien - Anforderungen an die Qualitaet und Kompetenz (ISO 15189:2012, korrigierte Fassung 2014-08-15); Deutsche Fassung EN ISO 15189:2012
Published by DIN on November 1, 2014
Diese Internationale Norm legt Anforderungen an die Qualität und Kompetenz in medizinischen Laboratorien fest. Diese Internationale Norm kann für die Anwendung durch medizinische Laboratorien bei der...
This document is referenced by:
DIN EN ISO 17034 - General requirements for the competence of reference material producers (ISO 17034:2016); German and English version EN ISO 17034:2016
Published by DIN on April 1, 2017
This International Standard specifies general requirements for the competence and consistent operation of reference material producers. This International Standard sets out the requirements in...
This document is referenced by:
DIN EN ISO 15189 - Medical laboratories - Requirements for quality and competence (ISO 15189:2022)
Published by DIN on March 1, 2023
A description is not available for this item.
This document is referenced by:
DIN EN ISO 15197 - In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013); German version EN ISO 15197:2015
Published by DIN on December 1, 2015
Die vorliegende Internationale Norm legt Anforderungen an In-vitro-Glukosemesssysteme zur Messung von Glukosekonzentrationen in Kapillarblutproben für spezifische Design-Verifizierungsverfahren und...
This document is referenced by:
DIN EN ISO 15197 - In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)
Published by DIN on December 1, 2015
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 referenced by:
DIN EN ISO/IEC 17025 - General requirements for the competence of testing and calibration laboratories (ISO/IEC 17025:2017); German and English version EN ISO/IEC 17025:2017
Published by DIN on March 1, 2018
This document specifies the general requirements for the competence, impartiality and consistent operation of laboratories. This document is applicable to all organizations performing laboratory...
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