This International Standard specifies requirements for the content of a reference measurement procedure for in vitro diagnostic medical devices and medical laboratories. This International Standard applies to reference measurement procedures providing values of differential or rational quantities. Annex A provides information on nominal properties and ordinal quantities. This International Standard 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. Full descriptions of measurement methods are usually published in scientific literature, in which methods are described in sufficient detail that they can be used as the basis of a documented measurement procedure.
Diese ÖNORM EN ISO legt Anforderungen an Inhalt und Format eines Referenzmessverfahrens fest. Diese Internationale Norm gilt für Referenzmessverfahren, die Werte für Differenz- oder Teilmengen liefern. Diese Internationale Norm gilt für alle Personen, Körperschaften oder Institutionen, die in einen der verschiedenen labormedizinischen Bereiche eingebunden sind und beabsichtigen, ein Dokument zu schreiben, das als Referenzmessverfahren dienen soll.