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BS ISO 21151:2020

BS ISO 21151:2020

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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

Language(s)

English

Published date

27-05-2020

Publisher

British Standards Institution

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.

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 ISO17511:2020.

Committee
CH/212
DocumentType
Standard
ISBN
9780539011265
Pages
28
PublisherName
British Standards Institution
Status
Current

Standards Relationship
ISO 21151:2020 Identical

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Hardcopy - English
PDF - English
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