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DIN EN ISO 17511

In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003)

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Organization: DIN
Publication Date: 1 November 2003
Status: active
Page Count: 31
ICS Code (In vitro diagnostic test systems): 11.100.10

Document History

DIN EN ISO 17511
November 1, 2021
In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020)
A description is not available for this item.
DIN EN ISO 17511
May 1, 2019
In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO/DIS 17511:2019); German and English version prEN ISO 17511:2019
A description is not available for this item.
DIN EN ISO 17511
November 1, 2003
In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003)
A description is not available for this item.

References

This document is referenced by:
DIN 58964 - Quality assurance of POCT results - Assessment criteria for comparison measurement and implementation
Published by DIN on September 1, 2015
This standard is aimed at manufacturers and users. In the following, procedures for the assessment of comparison measurements are described that consider the specific situation of simultaneous...
This document is referenced by:
DIN EN ISO 16140-1 - Microbiology of the food chain - Method validation - Part 1: Vocabulary (ISO 16140-1:2016)
Published by DIN on November 1, 2016
This part of ISO 16140 defines general terms and definitions relating to method validation of microbiology in the food chain. This part of ISO 16140 is applicable to the validation of methods for the...
This document is referenced by:
DIN EN ISO 14971 - Medical devices - Application of risk management to medical devices (ISO 14971:2019)
Published by DIN on July 1, 2020
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 18113-1 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)
Published by DIN on January 1, 2013
This part of ISO 18113 defines concepts, establishes general principles and specifies essential requirements for information supplied by the manufacturer of IVD medical devices. This part of ISO...
This document is referenced by:
DIN EN ISO 18113-1 - In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller - Teil 1: Begriffe und allgemeine Anforderungen (ISO 18113-1:2009); Deutsche Fassung EN ISO 18113-1:2011
Published by DIN on January 1, 2013
Dieser Teil von ISO 18113 definiert Konzepte, stellt allgemeine Prinzipien auf und legt wesentliche Anforderungen an die durch den Hersteller von In-vitro-Diagnostika bereitzustellenden Informationen...
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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