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In vitro diagnostic medical devices. Requirements for reference measurement procedures

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1 Scope

This document specifies requirements for reference measurement procedures (RMP) for measurands used in laboratory medicine.

This document applies to:

  1. RMPs providing values of differential or rational quantities where each quantity value is a numerical value multiplied by a measurement unit. Annex A provides information on ordinal quantities and nominal properties;

  2. any person, body or institution developing RMPs for measurands used in laboratory medicine.