ISO 33405:2024
(Main)Reference materials — Approaches for characterization and assessment of homogeneity and stability
Reference materials — Approaches for characterization and assessment of homogeneity and stability
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.
Matériaux de référence — Approches pour la caractérisation et l’évaluation de l’homogénéité et la stabilité
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.
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International
Standard
ISO 33405
First edition
Reference materials — Approaches
2024-05
for characterization and assessment
of homogeneity and stability
Matériaux de référence — Approches pour la caractérisation et
l’évaluation de l’homogénéité et la stabilité
Reference number
ISO 33405:2024(en) © ISO 2024
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ISO 33405:2024(en)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2024
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.
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Published in Switzerland
© ISO 2024 – All rights reserved
ii
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ISO 33405:2024(en)
Contents Page
Foreword .vi
Introduction .vii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Symbols . 2
5 Conventions . 3
6 Overview of reference material production . 3
6.1 General .3
6.2 Summary of project design . . .3
6.3 Acquisition of starting material .5
6.4 Feasibility studies .6
6.5 Reference material processing .6
6.6 Homogeneity assessment .6
6.7 Stability assessment .6
6.8 Choice of measurement procedures .7
6.9 Metrological traceability .7
6.10 Characterization and uncertainty evaluation .
...
Norme
internationale
ISO 33405
Première édition
Matériaux de référence —
2024-05
Approches pour la caractérisation
et l’évaluation de l’homogénéité et
la stabilité
Reference materials — Approaches for characterization and
assessment of homogeneity and stability
Numéro de référence
ISO 33405:2024(fr) © ISO 2024
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ISO 33405:2024(fr)
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2024
Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette
publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,
y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut
être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
ISO copyright office
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Publié en Suisse
© ISO 2024 – Tous droits réservés
ii
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ISO 33405:2024(fr)
Sommaire Page
Avant-propos .vi
Introduction .vii
1 Domaine d’application . 1
2 Références normatives . 1
3 Termes et définitions . 2
4 Symboles . 2
5 Conventions . 3
6 Vue d’ensemble de la production des matériaux de référence . 3
6.1 Généralités .3
6.2 Résumé du plan de projet.4
6.3 Acquisition du matériau de départ .5
6.4 Études de faisabilité .6
6.5 Procédé de fabrication du matériau de référence .6
6.6 Évaluation de l’homogénéité .6
6.7 Évaluation de la stabilité .6
6.8 Choix des procédures de mesure .7
6.9 Traçabilité métrologique .7
6.10 Caractérisation et évaluation de l’incertitude .7
6.11 Évaluation de la commutab
...
FINAL DRAFT
International
Standard
ISO/FDIS 33405
ISO/TC 334
Reference materials — Approaches
Secretariat: SABS
for characterization and assessment
Voting begins on:
of homogeneity and stability
2024-01-31
Voting terminates on:
2024-03-27
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INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
ISO/FDIS 33405:2024(en) © ISO 2024
---------------------- Page: 1 ----------------------
FINAL DRAFT
ISO/FDIS 33405:2024(en)
International
Standard
ISO/FDIS 33405
ISO/TC 334
Reference materials — Approaches
Secretariat: SABS
for characterization and
Voting begins on:
assessment of homogeneity and
stability
Voting terminates on:
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
COPYRIGHT PROTECTED DOCUMENT
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
© ISO 2024
IN ADDITION TO THEIR EVALUATION AS
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.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ISO/FDIS 33405:2024(en) © ISO 2024
© ISO 2024 – All rights reserved
ii
---------------------- Page: 2 ----------------------
ISO/FDIS 33405:2024(en)
Contents Page
Foreword .vi
Introduction .vii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Symbols . 2
5 Conventions . 3
6 Overview of reference material (RM) production . 3
6.1 General .3
6.2 Summary of project design . . .3
6.3 Acquisition of starting material .5
6.4 Feasibility studies .
...
ISO/FDIS 33405:2023(E)
ISO/TC 334
Secretariat: SABS
Date: 2023-10-17
Reference materials — Approaches for characterization and
assessment of homogeneity and stability
FDIS stage
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ISO/FDIS 33405:2024(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 2024 – All rights reserved
ii
---------------------- Page: 2 ----------------------
ISO/FDIS 33405:2024(E)
Contents
Foreword . xiii
Introduction . xiv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Symbols . 2
5 Conventions . 3
6 Overview of reference material (RM) production . 3
6.1 General . 3
6.2 Summary of project design . 3
6.3 Acquisition of starting material . 6
6.4 Feasibility studies . 7
6.5 Reference material processing . 7
6.6 Homogeneity assessment . 7
6.7 Stability assessment . 8
6.8 Choice of measurement procedures . 8
6.9 Metrological traceability . 8
6.10 Characterization and uncertainty evaluation . 8
6.11 Commutability assessment . 8
6.12 Transport issues . 9
6.13 Value assignment . 9
6.14 Stability monitoring .
...
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