Standard Swedish standard · SS-ISO 21151:2020

In vitro diagnostic medical devices - Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples (ISO 21151:2020, IDT)

Status: Valid

Buy this standard

Standard Swedish standard · SS-ISO 21151:2020

In vitro diagnostic medical devices - Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples (ISO 21151:2020, IDT)
Subscribe on standards - Read more Dölj
Price: 1 013 SEK
standard ikon pdf

PDF

Price: 1 013 SEK
standard ikon

Paper

Price: 1 620,80 SEK
standard ikon pdf + standard ikon

PDF + paper

Show more Show less
Preview this standard
Scope
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.

Subjects

In vitro diagnostic test systems (11.100.10)


Buy this standard

Standard Swedish standard · SS-ISO 21151:2020

In vitro diagnostic medical devices - Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples (ISO 21151:2020, IDT)
Subscribe on standards - Read more Dölj
Price: 1 013 SEK
standard ikon pdf

PDF

Price: 1 013 SEK
standard ikon

Paper

Price: 1 620,80 SEK
standard ikon pdf + standard ikon

PDF + paper

Show more Show less

Product information

Language: English

Written by: Svenska institutet för standarder

International title:

Article no: STD-80023688

Edition: 1

Approved: 8/18/2020

No of pages: 28