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BSI BS ISO 21151:2020

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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BSI BS ISO 21151:2020

In vitro diagnostic medical devices. Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples

PUBLISH DATE 2020
PAGES 28
BSI BS ISO 21151:2020

This document 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 no reference measurement procedures and no fit-for-purpose certified reference materials or international conventional calibrators. In this case, the harmonisation protocol defines the highest level of metrological traceability for the stated measurand.

This document can be applied in cases when certified reference materials or international conventional calibrators exist but are not fit-for-purpose because, for example, they are not commutable with human samples.

NOTE

This document addresses one case of traceability of assigned and measured values described in 5.6 in ISO 17511:2020.

SDO BSI: British Standards Institution
Document Number ISO 21151
Publication Date May 27, 2020
Language en - English
Page Count 28
Revision Level
Supercedes
Committee CH/212
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