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BS EN ISO 18153:2003

Current
Current

The latest, up-to-date edition.

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
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

08-19-2003

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Metrological traceability chain and calibration hierarchy
   4.1 Principles
   4.2 Structure
5 Validation of metrologically traceable calibration
   5.1 Principles
   5.2 Analytical specificity of measurement procedures
   5.3 Commutability of calibrators
   5.4 Commutability of control materials
Annex A (informative) List of IFCC primary reference measurement
         procedures
Annex B (informative) List of certified reference materials (CRM)
Annex ZA (informative) Clauses of this European Standard addressing
         essential requirements or other provisions of EU Directives
Bibliography

Defines 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.

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: requirements for the design or selection of a reference measurement procedure; quantities involving mass of enzyme or immunoreactivity of enzymes; 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); 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; metrological traceability of routine results to the product calibrator and their relations to any medical discrimination limit; properties involving nominal and ordinal scales.

Committee
CH/212
DocumentType
Standard
Pages
20
PublisherName
British Standards Institution
Status
Current

EN 12286:1998/A1:2000 IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - PRESENTATION OF REFERENCE MEASUREMENT PROCEDURES
EN 12287 : 1999 IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - DESCRIPTION OF REFERENCE MATERIALS

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