Reference number
ISO 15194:2009
© ISO 2024
International Standard
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 2
2009-05
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Published (Edition 2, 2009)
This publication was last reviewed and confirmed in 2015. Therefore this version remains current.

ISO 15194:2009

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Format
CHF 96
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Abstract

ISO 15194:2009 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. ISO 15194:2009 also provides requirements on how to collect data for value determination and how to present the assigned value and its measurement uncertainty.

ISO 15194:2009 applies to certified reference materials with assigned values of differential or rational quantities. Annex A provides information on nominal properties and ordinal quantities.

ISO 15194:2009 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.

General information

  • Status
     : Published
    Publication date
     : 2009-05
    Stage
    : International Standard to be revised [90.92]
  • Edition
     : 2
    Number of pages
     : 16
  • Technical Committee :
    ISO/TC 212
    ICS :
    11.100.10 
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