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  • BSI
    BS EN ISO 18153:2003 In vitro diagnostic medical devices. Measurement of quantities in biological samples. Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials
    Edition: 2003
    $316.70
    / user per year

Description of BS EN ISO 18153:2003 2003

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:

  1. requirements for the design or selection of a reference measurement procedure;

  2. quantities involving mass of enzyme or immunoreactivity of enzymes;

  3. 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);

  4. 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;

  5. metrological traceability of routine results to the product calibrator and their relations to any medical discrimination limit;

  6. properties involving nominal and ordinal scales.



Standard NumberBS EN ISO 18153:2003
TitleIn vitro diagnostic medical devices. Measurement of quantities in biological samples. Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials
StatusConfirmed
Publication Date2003-08-19
Identical National Standard OfEN ISO 18153:2003, ISO 18153:2003
DescriptorsMeasurement, Control samples, Clinical investigation instruments, Medical instruments
ICS11.100.10 In vitro diagnostic test systems
CommitteeCH/212
ISBN0 580 42141 4
PublisherBSI
Pages20

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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