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ISO 21151:2020

Current
Current

The latest, up-to-date edition.

In vitro diagnostic medical devices Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples
Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English, French

Published date

05-25-2020

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.

DocumentType
Standard
Pages
20
PublisherName
International Organization for Standardization
Status
Current

Standards Relationship
NF ISO 21151:2020 Identical
NEN-ISO 21151:2020 en Identical
BS ISO 21151:2020 Identical
UNI ISO 21151:2021 Identical

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