ISO18153
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 establishes requirements for ensuring metrological traceability of values assigned to calibrators and control materials used in measuring the catalytic concentration of enzymes. It helps verify measurement trueness in in vitro diagnostic medical devices, ensuring accuracy and consistency in enzyme testing.
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{{FormatPrice(nonMemberPrice)}} List PriceISO 18153: 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 traceability of assigned values 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.
Organization: ISO
Date of Publication: 08/15/2003
Edition: First Edition
Pages: 10
ISO 18153: 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 traceability of assigned values 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.
Organization: ISO
Date of Publication: 08/15/2003
Edition: First Edition
Pages: 10