NF EN 12286/A1
In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Presentation of reference measurement procedures
Le présent amendement à l'EN 12286 vise à conférer à cette norme européenne le statut de norme harmonisée.
Le présent amendement à l'EN 12286 vise à conférer à cette norme européenne le statut de norme harmonisée.
<p>ISO 15193:2009 specifies requirements for the content of a reference measurement procedure for <i>in vitro</i> diagnostic medical devices and medical laboratories.</p> <p>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.</p> <p>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.</p>
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