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ISO 33405:2024

Reference materials — Approaches for characterization and assessment of homogeneity and stability

Edition date: 2024-05-03
In Force
Available languages: French, English
Summary:

This document explains concepts and provides approaches to the following aspects of the production of reference materials (RMs):

—     the assessment of homogeneity;

—     the assessment of stability and the management of the risks associated with possible stability issues related to the properties of interest;

—     the characterization and value assignment of properties of an RM;

—     the evaluation of uncertainty for certified values;

—     the establishment of the metrological traceability of certified values.

The guidance given supports the implementation of ISO 17034. Other approaches can also be used as long as the requirements of ISO 17034 are fulfilled.

Brief guidance on the need for commutability assessment (6.11) is given in this document, but no technical details are provided. A brief introduction for the characterization of qualitative properties (9.6 to 9.8) is provided, together with brief guidance on sampling such materials for homogeneity tests (7.4.1.2). However, statistical methods for the assessment of the homogeneity and stability of RMs for qualitative properties are not covered. This document is also not applicable to multivariate quantities, such as spectral data.

NOTE            ISO 33406 gives more information on the production of RMs with one or more qualitative property values.



Le présent document explique des concepts et offre des approches concernant les aspects suivants de la production de matériaux de référence (MR):

—     l’évaluation de l’homogénéité;

—     l’évaluation de la stabilité et la gestion des risques associés aux problèmes potentiels de stabilité liés aux propriétés d’intérêt;

—     la caractérisation et l’attribution de valeurs pour les propriétés d’un MR;

—     l’évaluation de l’incertitude pour des valeurs certifiées;

—     l’établissement de la traçabilité métrologique des valeurs de propriétés certifiées.

Les recommandations données viennent en appui de la mise en œuvre de l’ISO 17034. D’autres approches peuvent également être utilisées tant que les exigences de l’ISO 17034 sont respectées.

Le présent document formule des recommandations succinctes concernant la nécessité d’évaluer la commutabilité (6.11), mais ne procure aucun détail technique à ce sujet. Une courte introduction consacrée à la caractérisation des propriétés qualitatives (9.6 à 9.8) est fournie avec des recommandations succinctes relatives à l’échantillonnage de ces matériaux pour les essais d’homogénéité (7.4.1.2). Néanmoins, le présent document ne traite pas des méthodes statistiques pour l’évaluation de l’homogénéité et de la stabilité des MR en ce qui concerne les propriétés qualitatives. Le présent document ne s’applique pas non plus aux grandeurs à plusieurs variables, telles que les données spectrales.

NOTE            L’ISO 33406 fournit de plus amples informations sur la production de MR associés à une ou plusieurs valeurs de propriété qualitative.
ICS: 71.040.30-Chemical reagents
CTN: ISO/TC 334 - 8300629

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