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ISO 21151:2020 PDF

ISO 21151:2020 PDF

Name:
ISO 21151:2020 PDF

Published Date:
06/01/2020

Status:
Active

Description:

In vitro diagnostic medical devices - Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples

Publisher:
International Organization for Standardization

Document status:
Active
Format:
Electronic (PDF)
Delivery time:
10 minutes
Delivery time (for Russian version):
200 business days
SKU:
Choose Document Language:
$49.8
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ISO 21151:2020 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.


Edition : 1st
File Size : 1 file , 2.2 MB
Note : This product is unavailable in Ukraine, Russia, Belarus
Number of Pages : 28
Published : 06/01/2020
Same As : ISO 21151:2020

History

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