NF EN ISO 17511
In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials
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. ISO 17511:2003 is not applicable to 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 (precision control materials); control materials intended for intralaboratory quality control purposes and supplied with intervals of suggested acceptable values, each interval obtained by interlaboratory consensus with respect to one specified measurement procedure, and with limiting values that are not metrologically traceable; correlation between results of two measurement procedures at the same metrological level, purporting to measure the same quantity, because such "horizontal" correlation does not provide metrological traceability; calibration derived from correlation between the results of two measurement procedures at different metrological levels, but with quantities having analytes of different characteristics; metrological traceability of routine results to the product calibrator and their relations to any medical discrimination limit; and properties involving nominal scales, i.e. where no magnitude is involved (e.g. identification of blood cells).
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.
ISO 17511:2003 is not applicable to 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 (precision control materials); control materials intended for intralaboratory quality control purposes and supplied with intervals of suggested acceptable values, each interval obtained by interlaboratory consensus with respect to one specified measurement procedure, and with limiting values that are not metrologically traceable; correlation between results of two measurement procedures at the same metrological level, purporting to measure the same quantity, because such "horizontal" correlation does not provide metrological traceability; calibration derived from correlation between the results of two measurement procedures at different metrological levels, but with quantities having analytes of different characteristics; metrological traceability of routine results to the product calibrator and their relations to any medical discrimination limit; and properties involving nominal scales, i.e. where no magnitude is involved (e.g. identification of blood cells).
- Avant-propos3
- Introduction4
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1Domaine d'application 5
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2Références normatives 6
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3Termes et définitions 7
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4Chaîne de traçabilité et hiérarchie d'étalonnage 12
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4.1Principes 12
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4.2Structure et nomenclature 13
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4.3Facteurs à prendre en compte pour l'établissement de la traçabilité 17
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4.4Fonctions des matériaux de référence 18
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5Protocoles de transfert d'étalonnage 18
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5.1Disponibilité et structure des protocoles de transfert 18
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5.2Cas où l'on dispose d'un mode opératoire de mesure de référence primaire et de matériau(x) de référence primaires) avec traçabilité au Système international d'unités 19
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5.3Cas où l'on dispose d'un mode opératoire de mesure de référence conventionnel international (non primaire) et de matériaux) d'étalonnage conventionnel(s) international (internationaux) sans traçabilité au Système international d'unités 20
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5.4Cas où l'on dispose d'un mode opératoire de mesure de référence conventionnel international (non primaire) mais sans matériau d'étalonnage conventionnel international ni traçabilité au Système international d'unités 21
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5.5Cas où l'on dispose d'un matériau d'étalonnage conventionnel international (qui n'est pas primaire) sans mode opératoire de mesure de référence conventionnel international ni traçabilité au Système international d'unités 22
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5.6Cas où l'on dispose d'un mode opératoire de mesure choisi par le fabricant sans mode opératoire de mesure de référence conventionnel reconnu au niveau international ni matériau d'étalonnage conventionnel international et sans traçabilité au Système international des unités 23
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5.7Matériaux de contrôle de la justesse 24
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6Détermination et expression de l'incertitude de mesure 24
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7Validation d'un étalonnage traçable métrologiquement 25
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8Informations relatives à la traçabilité à faire figurer dans le mode d'emploi d'un dispositif de diagnostic médical in vitro 26
- Annexe ZA (informative) Articles de la présente Norme européenne concernant les exigences essentielles ou d'autres dispositions des Directives UE27
- Bibliographie28
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