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 – BSI British Standards

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

Status : Confirmed, Current   Published : August 2003

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BS EN ISO 18153:2003 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.




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, Current
Publication Date19 August 2003
Confirm Date28 June 2019
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)No other standards are informatively referenced
International RelationshipsEN ISO 18153:2003,ISO 18153:2003
DescriptorsMeasurement, Control samples, Clinical investigation instruments, Medical instruments
ICS11.100.10
Title in FrenchDispositifs medicaux de diagnostic in vitro. Mesurage des grandeurs dans des echantillons d'origine biologique. Tracabilite metrologique des valeurs de concentration catalytique des enzymes attribuees aux agents d'etalonnage et aux materiaux de controle
Title in GermanIn-vitro-Diagnostika. Messung von Groessen in Proben biologischen Ursprungs. Metrologische Rueckfuehrbarkeit von Werten der katalytischen Konzentration von Enzymen, die Kalibratoren und Kontrollmaterialien zugeordnet sind
CommitteeCH/212
ISBN0 580 42141 4
PublisherBSI
FormatA4
DeliveryYes
Pages20
File Size175 KB
Price£130.00


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