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

ISO 18153:2003

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

This international 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.

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Publication Details

Date of Publication: August 15, 2003

Order Code PDF: ISO18153E

Order Code Print: print not available

Edition: First

Pages: 10

ISO 18153:2003 Additional Details

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.

Technical Committee: ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems