In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
Covers how metrological traceability is established for values assigned to calibrators, trueness control materials and human samples.
The text of this standard is sold by ISO and is not reproduced here. This page gives the code, edition, scope and what each market says about it.
Whether the market recognizes, harmonizes or adopts this standard, and which edition it accepts
| Market | Status | Edition accepted | National code | Details |
|---|---|---|---|---|
| European Union | Harmonized | EN ISO 17511:2021 (ISO 17511:2020) | - | Recognition number IVDR entry 9. Effective January 7, 2022. Devices that conform to the standard are presumed to conform with the requirements of the Regulation that the standard covers. |
Open the market page and its pathway pages for the full requirement, protocol and report content
Related standards: CLSI EP06, CLSI EP07, CLSI EP09c, CLSI EP12, CLSI EP19, CLSI EP21, CLSI EP25, CLSI EP35, ISO 20916, NPAAC in-house IVD standard, CLSI EP05, CLSI EP14. See all standards.
Not legal or regulatory advice. Check the current official rules before you act. Parts of the approvals data are official open data reused under open licences. Data sources.