International Standard
ISO 21151:2020
In vitro diagnostic medical devices — Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples
Reference number
ISO 21151:2020
Edition 1
2020-05
International Standard
Read sample
ISO 21151:2020
69985
Published (Edition 1, 2020)

ISO 21151:2020

ISO 21151:2020
69985
Language
Format
CHF 129
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Abstract

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.

General information

  •  : Published
     : 2020-05
    : International Standard published [60.60]
  •  : 1
     : 20
  • ISO/TC 212
    11.100.10 
  • RSS updates

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

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