Abstract Preview
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
-
Status : PublishedPublication date : 2020-05
-
Edition : 1Number of pages : 20
-
- ICS :
-
In vitro diagnostic test systems
Buy this standard
Format | Language | |
---|---|---|
PDF + ePub | ||
Paper |
- CHF118
Got a question?
Check out our FAQs
Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)
Keep up to date with ISO
Sign up to our newsletter for the latest news, views and product information.