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NBN ISO 21151:2021
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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Summary
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.
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.
Technical characteristics
| Publisher | Bureau de Normalisation Belge (NBN) |
| Publication Date | 05/13/2021 |
| Page Count | 30 |
| EAN | --- |
| ISBN | --- |
| Weight (in grams) | --- |
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