ISO/FDIS 33403
(Main)Reference materials — Requirements and recommendations for use
Reference materials — Requirements and recommendations for use
ISO Guide 33:2015 describes good practice in using reference materials (RMs), and certified reference materials (CRMs) in particular, in measurement processes. These uses include the assessment of precision and trueness of measurement methods, quality control, assigning values to materials, calibration, and the establishment of conventional scales. This Guide also relates key characteristics of various types of RMs to the different applications. For CRMs, the metrological traceability of the property values to international scales or other measurement standards has been established. For RMs not being CRMs, this kind of traceability of property values has often not been established. Nevertheless, these RMs can still be used for assessing parts of measurement procedures, including evaluating various levels of precision Mainstream applications of RM include precision control, bias assessment, calibration, preparation of calibration RMs and maintaining conventional scales. NOTE Not all types of RMs can be used for all indicated purposes. The preparation of RMs for calibration is also part of the scope of ISO Guides 34 and 35. The treatment in this Guide is limited to the fundamentals of small-scale preparation of RMs and the value assignment, as used by laboratories to calibrate their equipment. Larger scale production of such RMs, with the possible aim of distribution is beyond the scope of this Guide. This type of activity is covered in ISO Guides 34 and 35. The development of working standards, as used in, e.g. natural gas analysis, clinical chemistry, and the pharmaceutical industry is not covered in this Guide. This type of activity is covered in ISO Guides 34 and 35.
Matériaux de référence — Exigences et recommandations pour l'utilisation
L'ISO Guide 33:2015 décrit les bonnes pratiques d'utilisation des matériaux de référence (MR), et notamment des matériaux de référence certifiés (MRC), dans les processus de mesurage. Ces utilisations incluent l'évaluation de la fidélité et de la justesse des méthodes de mesurage, le contrôle de la qualité, l'attribution de valeurs de propriété à des matériaux, l'étalonnage et l'établissement d'échelles conventionnelles. Le présent Guide fournit également les caractéristiques essentielles des divers types de MR en fonction des différentes applications. Dans le cas des MRC, la traçabilité métrologique des valeurs de propriétés à des échelles internationales ou à d'autres étalons a été établie. Ce type de traçabilité des valeurs de propriétés n'a souvent pas été établi pour les MR qui ne sont pas des MRC. Néanmoins, ces MR peuvent encore être utilisés pour évaluer des parties de procédures de mesure, y compris divers niveaux de fidélité. Les principales applications des MR comprennent le contrôle de la fidélité (Article 8), l'évaluation du biais (Article 9), l'étalonnage (Article 10), la préparation de MR pour étalonnage (Article 11) et le maintien d'échelles conventionnelles (Article 12). NOTE Les différents types de MR ne peuvent pas tous être utilisés pour tous les usages indiqués. La préparation des MR pour étalonnage relève également du domaine d'application des Guides ISO 34[1] et 35[2]. Dans le présent Guide, le traitement se limite aux principes fondamentaux de préparation des MR à petite échelle et d'attributions de valeurs de propriété, tels qu'ils sont appliqués par les laboratoires pour étalonner leurs équipements. La production de tels MR à plus grande échelle, en vue d'une distribution éventuelle, ne relève pas du domaine d'application du présent Guide. Ce type d'activité est traité dans les Guides ISO 34[1] et 35[2]. La mise au point d'étalons de travail, tels que ceux utilisés, par exemple, dans l'analyse du gaz naturel, la chimie clinique et l'industrie pharmaceutique, n'est pas traitée dans le présent Guide. Ce type d'activité est traité dans les Guides ISO 34[1] et 35[2].
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ISO/FDIS 33403
ISO/TC 334
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ISO/FDIS 33403:2024(en) © ISO 2024
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ISO/FDIS 33403:2024(en)
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ISO/FDIS 33403
ISO/TC 334
Reference materials —
Secretariat: SABS
Requirements and
Voting begins on:
recommendations for use
Matériaux de référence — Exigences et recommandations pour
Voting terminates on:
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All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
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Published in Switzerland Reference number
ISO/FDIS 33403:2024(en) © ISO 2024
© ISO 2024 – All rights reserved
ii
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ISO/FDIS 33403:2024(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Symbols . 2
5 Conventions . 2
6 RMs and their role in measurement . 3
6.1 Common applications of RMs .3
6.2 Property values . .5
6.2.1 General .5
6.2.2 Specification of
...
ISO/FDIS 33403:2023(E)
ISO/TC 334
Secretariat: SABS
Date: 2023-10-132024-01-19
Guidance for the use of referenceReference materials —
Requirements and recommendations for use
Guide pour l’utilisation des matériauxMatériaux de référence — Exigences et recommandations pour
l'utilisation
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FDIS stage
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ISO/FDIS 33403:2023(E)
© ISO 20232024
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this
publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical,
including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can
be requested from either ISO at the address below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: + 41 22 749 01 11
EmailE-mail: copyright@iso.org
Website: www.iso.orgwww.iso.org
Published in Switzerland
© ISO 2023 – All rights reserved iii
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ISO/FDIS 33403:2023(E)
Contents
Foreword . vii
Introduction . ix
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Symbols . 1
5 Conventions . 2
6 RMs and their role in measurement . 2
6.1 Common applications of RMs . 2
6.2 Property values . 6
6.2.1 General . 6
6.2.2 Specification of the property . 7
6.3 Uncertainty statement . 7
6.4 Traceability statement . 8
7 Handling of RMs and CRMs . 9
8 Assessment of precision . 10
8.1 General . 10
8.2 Number of replicate measurements . 10
8.3 Requirements with respect to the RM . 11
8.4 Measurement . 11
8.5 Data treatment .
...
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