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  • BSI
    BS EN ISO 15194:2009 In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Requirements for certified reference materials and the content of supporting documentation
    Edition: 2016
    $435.35
    / user per year

Description of BS EN ISO 15194:2009 2016

This International Standard specifies requirements for certified reference materials and the content of their supporting documentation, in order for them to be considered of higher metrological order in accordance with ISO 17511. It is applicable to certified reference materials classifiable as primary measurement standards, secondary measurement standards and international conventional calibrators that function either as calibrators or trueness control materials. This International Standard also provides requirements on how to collect data for value determination and how to present the assigned value and its measurement uncertainty.

This International Standard applies to certified reference materials with assigned values of differential or rational quantities. Annex A provides information on nominal properties and ordinal quantities.

This International Standard does not apply to reference materials that are parts of an in vitro diagnostic measuring system, although it is possible that many elements are helpful.



Standard NumberBS EN ISO 15194:2009
TitleIn vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Requirements for certified reference materials and the content of supporting documentation
StatusUnder Review
Publication Date2016-01-31
ReplacesBS EN 12287:1999
Identical National Standard OfISO 15194:2009, EN ISO 15194:2009
CorrectsBS EN ISO 15194:2009
DescriptorsClassification systems, Medical specimens, Certificates of conformity, Identification methods, Marking, Experimental design, Calibration, Biological analysis and testing, Terminology, Chemical properties, Test specimens, Instructions for use, Safety measures, Diagnosis (medical), Control samples, Microbiological analysis, Reports
ICS11.100.10 In vitro diagnostic test systems
CommitteeCH/212
ISBN978 0 580 92900 7
PublisherBSI
Pages26

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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