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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

Standard Details

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
Standard Type: Main
Document No: ISO 15193:2009
Document Year: 2009
Pages: 19
Edition: 2
  • Section Volume:
  • ISO/TC 212. Clinical laboratory testing and in vitro diagnostic test systems
  • ICS:
  • 11.100.10 In vitro diagnostic test systems

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ISO 15193:2009
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