NEN-ISO 21151:2020 en
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In vitro diagnostic medical devices - Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples
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English
01-06-2020
NEN-ISO 21151 specifies requirements for a protocol implemented by an international body to achieve equivalent results among two or more IVD MDs for the same measurand for cases where there are noreference measurement procedures and no fit-for-purpose certified reference materials or international conventional calibrators.
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