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Normas DIN – AENOR
DIN EN ISO 17511:2019-05

DIN EN ISO 17511:2019-05

In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO/DIS 17511:2019); German and English version prEN ISO 17511:2019 / Note: Date of issue 2019-04-05*Intended as replacement for DIN EN ISO 17511 (2003-11).

Dispositifs médicaux de diagnostic in vitro - Mesurage des grandeurs dans des échantillons d'origine biologique - Traçabilité métrologique des valeurs attribuées aux agents d'étalonnage et aux matériaux de contrôle (ISO/DIS 17511:2019); Version allemande et anglaise prEN ISO 17511:2019 / Attention: Date de parution 2019-04-05*Prévu pour remplacer DIN EN ISO 17511 (2003-11).

In-vitro-Diagnostika - Messung von Größen in Proben biologischen Ursprungs - Metrologische Rückführbarkeit von Werten, die Kalibratoren und Kontrollmaterialien zugeordnet sind (ISO/DIS 17511:2019); Deutsche und Englische Fassung prEN ISO 17511:2019 / Achtung: Erscheinungsdatum 2019-04-05*Vorgesehen als Ersatz für DIN EN ISO 17511 (2003-11).

Fecha:
2019-05 /Active
Equivalencias internacionales:

ISO/DIS 17511 (2019-03)

prEN ISO 17511 (2019-03)

Resumen:
This European Standard specifies how to assure the metrological traceability of values assigned to calibrators and control materials intended to establish or verify trueness of measurement, and provided by the manufacturers as part of, or to be used together with, in vitro diagnostic medical devices. Control materials that do not have an assigned value and are used only for assessing the precision of a measurement procedure, either its repeatability or reproducibility, are outside the scope of this European Standard.
Keywords:
Biochemicals, Biological materials, Calibration materials, Calibrator, CE marking, Characterisations, Characteristics, Check material, Chemical analysis and testing, Classification, Classification systems, Definitions, Descriptions, Diagnosis, Diagnosis (medical), Diagnostic equipment, Enzymes, Evaluations, Human, Human medicine, In vitro, In-vitro diagnostic, Laboratories, Laboratory medicine, Lists, Measured value, Measurement, Measuring systems, Measuring techniques, Medical devices, Medical sciences, Metrology, Recirculation, Samples, Size, Specification (approval), Systemology, Traceability, Verification, Wear-quantity
138,41
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