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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
    Edition: 2020
    $411.69
    / user per year

Description of BS ISO 21151:2020 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.



Standard NumberBS ISO 21151:2020
TitleIn vitro diagnostic medical devices. Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples
StatusDefinitive
Publication Date2020-05-27
Identical National Standard OfISO 21151
DescriptorsTest methods, Harmonization, Biological tests, Measurement, Medical equipment
ICS11.100.10 In vitro diagnostic test systems
CommitteeCH/212
ISBN978 0 539 01126 5
PublisherBSI
Pages28

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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