I.S. EN ISO 17511:2021
Current
The latest, up-to-date edition.
In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
Hardcopy , PDF
English
06-21-2021
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions, symbols and abbreviated terms
4 General requirements to be fulfilled by a manufacturer for establishing, validating
and documenting metrological traceability of human sample values determined
with a specified IVD MD
5 Model calibration hierarchies for metrological traceability
6 Labelling information to be provided to end-users by the manufacturer
Bibliography
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