- high-resolution terminology - matching measurements at high-resolution
ISO 17511:2003 In vitro diagnostic medical devices
Description
ISO 17511:2003 In vitro diagnostic medical devices -- Measurement of quantities in biological samples -- Metrological traceability of values assigned to calibrators and control materials: For measurements of quantities in laboratory medicine, it is essential that the quantity is adequately defined and that the results reported to the physicians or other health care personel and patients are adequately accurate (true and precise) to allow correct medical interpretation and comparability over time and space.
ISO 17511:2003 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.
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.
Abbreviation: ISO 17511:2003
MitoPedia concepts: "MitoFit Quality Control System" is not in the list (MiP concept, Respiratory state, Respiratory control ratio, SUIT concept, SUIT protocol, SUIT A, SUIT B, SUIT C, SUIT state, Recommended, ...) of allowed values for the "MitoPedia concept" property.
MitoFit Quality Control System"MitoFit Quality Control System" is not in the list (Enzyme, Medium, Inhibitor, Substrate and metabolite, Uncoupler, Sample preparation, Permeabilization agent, EAGLE, MitoGlobal Organizations, MitoGlobal Centres, ...) of allowed values for the "MitoPedia topic" property.
- In this European Standard the concept "accuracy of measurement" (see 3.1) is related to both "trueness of measurement" (see 3.33) and "precision of measurement" (see 3.23) whereas the Directive 98/79/EC on in vitro diagnostic medical devices uses the term "accuracy" instead of "trueness".
- To allow 'correct medical interpretation' involves more than the metrological (analytical) aspects of the traceability chain. As the measurement results are eventually used by the physician for the benefit of the patients, the physician should gather information on a number of other aspects, such as knowledge about the pre- and post-analytical phase, the diagnostic sensitivity and specificity, and relevant reference interval(s). The present European Standard deals only with the analytical aspects of measurements in Laboratory Medicine (see also 1 e)).
- The measurement of quantities in biological samples requires reference measurement systems including:
- — the definition of the analyte in the biological sample with regard to the intended clinical use of the measurement results;
- — a reference measurement procedure for the selected quantity in human samples;
- — suitable reference materials for the selected quantity, e.g. primary calibrators and secondary matrix-based calibrators that are commutable.
