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EVS-EN ISO 18153:2003

In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability for catalytic concentration of enzymes assigned to calibrators and control materials

General information

Valid from 06.10.2003
Base Documents
ISO 18153:2003; EN ISO 18153:2003
Directives or regulations
None

Standard history

Status
Date
Type
Name
06.10.2003
Main
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

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