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

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

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Referenced standards

DIN 1333ISO 15194ISO 17511ISO 18153ISO 3696ISO 4791-1ISO 5725-1ISO 5725-2ISO 5725-3ISO 5725-4ISO 5725-5ISO 5725-6ISO 6353-2ISO 6353-3ISO 78-2ISO Guide 32ISO Guide 33ISO Guide 34ISO/IEC Guide 15ISO/IEC Guide 98-3:2008ISO/IEC Guide 99:2007
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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.

Edition2009
Published Date2009
Published ByInternational Standardization Organisation
Page Count19