Norm

NEN-EN-ISO 18153:2003 en

In-vitro-diagnostische medische systemen - Meting van grootheden in monsters van biologische oorsprong - Metrologische traceerbaarheid van waarden voor katalytische concentratie van enzymen toegewezen aan kalibratiemiddelen en controlematerialen

48,19

Over deze norm

Status Definitief
Aantal pagina's 16
Commissie In vitro diagnostica
Gepubliceerd op 01-09-2003
Taal Engels
This European Standard specifies how to assure the metrological traceability of values assigned to calibrators and control materials intended to establish or verify trueness of measurement of the catalytic concentration of enzymes. The calibrators and control materials are those provided by the manufacturers as part of, or to be used together with, in vitro diagnostic medical devices. The following subjects are outside the scope of this standard: a) requirements for the design or selection of a reference measurement procedure; b) quantities involving mass of enzyme or immunoreactivity of enzymes; c) control materials that do not have an assigned value and are used only for assessing the precision of a measurement procedure, either its repeatability or reproducibility (precision control materials); d) control materials intended for intralaboratory quality control purposes and supplied with intervals of suggested acceptable values, each interval obtained by interlaboratory consensus with respect to one specified measurement procedure, and with limiting values that are not metrologically traceable; e) metrological traceability of routine results to the product calibrator and their relations to any medical discrimination limit; f) properties involving nominal and ordinal scales.

Details

ICS-code 07.100.10
11.100.10
Nederlandse titel In-vitro-diagnostische medische systemen - Meting van grootheden in monsters van biologische oorsprong - Metrologische traceerbaarheid van waarden voor katalytische concentratie van enzymen toegewezen aan kalibratiemiddelen en controlematerialen
Engelse titel In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability for catalytic concentration of enzymes assigned to calibrators and control materials
Vervangt
Normatieve verwijzingen
  • 98/79/EG, In vitro diagnostica

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