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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
Description
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 materialsBS EN ISO 18153: 2003 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: a)
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Besides its conventional meaning
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