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NF 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

Language(s)

English - French

Published date

12-01-2020

1 Domaine d'application
2 Références normatives
3 Termes et définitions
4 Termes abrégés et symboles
5 Exigences relatives aux protocoles d'harmonisation
6 Informations relatives à la traçabilité métrologique à fournir dans les instructions d'utilisation
Annexe A Exemple pratique d'un protocole d'harmonisation
Bibliographie

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.

Committee
ISO/TC 212
DocumentType
Standard
Pages
26
PublisherName
Association Francaise de Normalisation
Status
Current

Standards Relationship
ISO 21151:2020 Identical

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