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EN ISO 15194:2026

In vitro diagnostic medical devices - Requirements for certified reference materials and the content of supporting documentation (ISO 15194:2026)

Edition date: 2026-07-22
In Force
Available languages: English, French
Summary: Dieses Dokument legt Anforderungen an zertifizierte Referenzmaterialien höherer metrologischer Ordnung sowie den Inhalt der Begleitdokumentation und der Kalibrierhierarchien fest, wie in ISO 17511:2020, 5.2.1, 5.3.1, 5.4.1, 5.5.1, 5.6.1, 5.7.1. Es ist auf ZRM anwendbar, deren bestimmungsgemäße Anwendung entweder ein primäres Referenzmaterial (PRM), ein Sekundärkalibrator oder ein international vereinbarter Kalibrator in Kalibrierhierarchien für in der Labormedizin verwendete Messgrößen ist, oder die Anwendung als Richtigkeitskontrollmaterial. Außerdem werden darin Anforderungen an die Bestimmung des zertifizierten Werts eines ZRM festgelegt, einschließlich Beurteilung und Berichterstellung der zugeordneten Unsicherheit. Dieses Dokument ist in erster Linie auf ZRM mit zugeordneten Eigenschaftswerten anwendbar, wobei die Eigenschaft eine Größenordnung aufweist, die sich als quantitative Skalenzahl oder ein Verhältnis zu einer Referenz ausdrücken lässt, oder sich auf eine Zählskala bezieht, die ebenfalls in ISO 17511:2020, Abschnitt 1, beschrieben ist. Umfasst ein ZRM mehrere Messgrößen, wird diese Norm auf alle zertifizierten Größenwerte des ZRM angewandt. Zwar ist die Anwendung dieser Norm auf Hersteller von ZRM vorgesehen, sie ist aber auch von Nutzen für RM, die nicht die vollständigen metrologischen Anforderungen eines ZRM erfüllen. So ist diese Internationale Norm beispielsweise nicht anwendbar auf ein von IVD-Herstellern produziertes RM, das als funktionierender Kalibrator oder Endanwenderkalibrator in einer Kalibrierhierarchie vorgesehen ist, die auf ein ZRM rückführbar ist, obwohl einige Inhalte für die Beurteilung seiner Leistung von Nutzen sein können.

This document specifies requirements for certified reference materials (CRMs) of higher metrological order and the content of the supporting documentation and the calibration hierarchies as described in ISO 17511:2020, 5.2.1, 5.3.1, 5.4.1, 5.5.1, 5.6.1, 5.7.1. It is applicable to CRMs intended for use as either primary reference materials (PRMs), secondary calibrators or international conventional calibrators within calibration hierarchies appropriate for measurands used in laboratory medicine, or for applications as trueness controls. It also specifies requirements for determining the certified value of a CRM, including evaluation, and reporting of the assigned uncertainty. This document is applicable primarily to CRMs with assigned property values where the property has a magnitude that can be expressed as a quantitative scalar number or ratio to a reference or refers to a counting scale as also described in ISO 17511:2020, Clause 1. When a CRM includes multiple measurands, this document is applied to each of the certified quantity values present in the CRM. Although intended to be applicable to producers of CRMs, this document is also useful for reference materials (RMs) that are not in conformity with the full metrological requirements of CRMs. For example, this document does not apply to an RM created by an in vitro diagnostic medical device (IVD MD) manufacturer for use as working calibrator or end-user calibrator within a calibration hierarchy traceable to a CRM, although some content can be useful in assessing its performance.

Le présent document spécifie les exigences relatives aux matériaux de référence certifiés (MRC) de niveau métrologique supérieur, ainsi que le contenu de la documentation associée et les hiérarchies d’étalonnage telles que décrites dans l’ISO 17511:2020, 5.2.1, 5.3.1, 5.4.1, 5.5.1, 5.6.1, 5.7.1. Il est applicable aux MRC destinés à être utilisés comme matériaux de référence primaires (MRP), étalons secondaires ou étalons internationaux conventionnels au sein des hiérarchies d’étalonnage appropriées pour les mesurandes utilisés en biologie médicale, ou pour les applications en tant que contrôles de justesse. Il spécifie également les exigences pour la détermination de la valeur certifiée d’un MRC, incluant l’évaluation et la déclaration de l’incertitude attribuée. Le présent document est essentiellement applicable aux MRC avec des valeurs de propriété attribuées lorsque l’amplitude de la propriété peut être exprimée sous la forme d’un nombre scalaire quantitatif ou d’un rapport à une référence ou se réfère à une échelle de dénombrement comme également décrit dans l’ISO 17511:2020, Article 1. Lorsqu’un MRC inclut plusieurs mesurandes, le présent document est appliqué à chacune des valeurs de grandeur certifiées présentes dans le MRC. Bien qu’il soit destiné à être applicable aux producteurs de MRC, le présent document est également utile pour les matériaux de référence (MR) qui ne sont pas conformes à toutes les exigences métrologiques des MRC. Par exemple, le présent document ne s’applique pas à un MR créé par un fabricant de dispositifs médicaux de diagnostic in vitro (DM DIV) et destiné à être utilisé comme étalon de travail ou étalon d’utilisateur final au sein d’une hiérarchie d’étalonnage traçable à un MRC, bien qu’une partie du contenu puisse être utile pour évaluer ses performances.
ICS: 11.100.10-In vitro diagnostic test systems
CTN: CEN/TC 140 - 6122

Otras Relaciones

Acuerdo de Viena ISO 15194:2026

Reemplazo Normas

Reemplaza a EN ISO 15194:2009

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