In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values assigned to calibrators and control materials

ISO 17511:2003

In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values assigned to calibrators and control materials

This international standard specifies how to assure the metrological traceability of values assigned to calibrators and control materials intended to establish or verify trueness of measurement. The calibrators and control materials are those provided by the manufacturers as part of, or to be used together with, in vitro diagnostic medical devices.

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Publication Details

Date of Publication: August 15, 2003

Order Code PDF: ISO17511E

Order Code Print: print not available

Edition: First

Pages: 23

ISO 17511:2003 Additional Details

External quality assessment (survey) samples, with proven commutability, whose values have been assigned by means of internationally agreed reference measurement systems or internationally agreed conventional reference measurement systems fall within the scope of ISO 17511:2003.

Technical Committee: ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems