ISO 15193:2009 Preview

In vitro diagnostic medical devices -- Measurement of quantities in samples of biological origin -- Requirements for content and presentation of reference measurement procedures

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
  • Edition : 2
    Number of pages : 19
  • :
    ISO/TC 212
    Clinical laboratory testing and in vitro diagnostic test systems
  • 11.100.10
    In vitro diagnostic test systems

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