BS EN ISO 17511:2003 - In vitro diagnostic medical devices. Measurement of quantities in biological samples. Metrological traceability of values assigned to calibrators and control materials – BSI British Standards

BS EN ISO 17511:2003

In vitro diagnostic medical devices. Measurement of quantities in biological samples. Metrological traceability of values assigned to calibrators and control materials

Status : Current, Under review   Published : August 2003

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BS EN ISO 17511:2003 specifies how to assure the metrological traceability of values assigned to calibrators and control materials intended to establish or verify trueness of measurement. 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.

External quality assessment (survey) samples, with proven commutability, whose values have been assigned by means of internationally agreed reference measurement systems or internationally agreed conventional reference measurement systems fall within the scope of this European Standard.

This European Standard is not applicable to:

a) 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)

b) 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

c) correlation between results of two measurement procedures at the same metrological level, purporting to measure the same quantity, because such 'horizontal' correlation does not provide metrological traceability

d) calibration derived from correlation between the results of two measurement procedures at different metrological levels, but with quantities having analytes of different characteristics

e) metrological traceability of routine results to the product calibrator and their relations to any medical discrimination limit

f) properties involving nominal scales, i.e. where no magnitude is involved (e.g. identification of blood cells).




Standard NumberBS EN ISO 17511:2003
TitleIn vitro diagnostic medical devices. Measurement of quantities in biological samples. Metrological traceability of values assigned to calibrators and control materials
StatusCurrent, Under review
Publication Date19 August 2003
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 RelationshipsISO 17511:2003
Draft Superseded By00/565675 DC
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 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, die Kalibriermaterialien und Kontrollmaterialien zugeordnet sind
CommitteeCH/212
ISBN0 580 42473 1
PublisherBSI
FormatA4
DeliveryYes
Pages32
File Size453 KB
Price£182.00


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