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reference measurement procedure

measurement procedure accepted as providing measurement results fit for their intended use in assessing measurement trueness of measured quantity values obtained from other measurement procedures for quantities of the same kind, in calibration or in characterizing reference materials

Note 1

Requirements for reference measurement procedures for IVD medical devices are described in ISO 15193[11].

Note 2

Examples of the use of reference measurement procedures to assign values to IVD calibrators are given in ISO 17511[16] and ISO 18153[18].

Note 3

A measurement procedure used to obtain a measurement result without relation to a measurement standard for a quantity of the same kind is called a primary reference measurement procedure. See ISO/IEC Guide 99:2007, 2.8[28]).

Bron

ISO/IEC Guide 99:2007, definition 2.7

Norm
NEN-EN-ISO 18113-1:2011 en
Titel
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements
Paragraaf
3.59
Terug

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