Reference number
ISO 15193:2009
© ISO 2025
International Standard
ISO 15193:2009
In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Requirements for content and presentation of reference measurement procedures
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 15193:2009

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Format
CHF 132
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Abstract

ISO 15193:2009 specifies requirements for the content of a reference measurement procedure for in vitro diagnostic medical devices and medical laboratories.

ISO 15193:2009 applies to reference measurement procedures providing values of differential or rational quantities. Annex A provides information on nominal properties and ordinal quantities.

ISO 15193:2009 is valid for any person, body or institution involved in one of the various branches of laboratory medicine whose intention is to write a document to serve as a reference measurement procedure.

General information

  • Status
     : Published
    Publication date
     : 2009-05
    Corrected version (fr)
     : 2009-09
    Stage
    : International Standard to be revised [90.92]
  • Edition
     : 2
    Number of pages
     : 19
  • Technical Committee :
    ISO/TC 212
    ICS :
    11.100.10 
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