ISO/FDIS 33405

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

ISO/Guide 35:2017 explains concepts and provides approaches to the following aspects of the production of reference materials: - 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 a reference material; - the evaluation of uncertainty for certified values; - the establishment of the metrological traceability of certified property values. The guidance given supports the implementation of ISO 17034. Other approaches may 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 9.10) is provided together with brief guidance on sampling such materials for homogeneity tests (Clause 7). However, statistical methods for the assessment of the homogeneity and stability of reference materials for qualitative properties are not covered. This document is also not applicable to multivariate quantities, such as spectral data.

Matériaux de référence — Approches pour la caractérisation et l’évaluation de l’homogénéité et la stabilité

ISO/Guide 35:2017 explique des concepts et offre des approches concernant les aspects suivants de la production de matériaux de référence: - 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 matériau de référence; - l'évaluation de l'incertitude pour des valeurs certifiées; - l'établissement de la traçabilité métrologique des valeurs de propriétés certifiées. Les lignes directrices données viennent appuyer la mise en ?uvre de l'ISO 17034. D'autres approches peuvent également être utilisées tant que les exigences de l'ISO 17034 sont satisfaites. ISO/Guide 35:2017 donne des lignes directrices succinctes concernant la nécessité d'évaluer la commutabilité (6.11), mais ne procure aucun détail technique à ce sujet. Une courte introduction sur la caractérisation des propriétés qualitatives (9.6 à 9.10) est fournie avec des lignes directrices succinctes concernant l'échantillonnage de tels matériaux pour les essais d'homogénéité (Article 7). Néanmoins, le présent document ne traite pas des méthodes statistiques pour l'évaluation de l'homogénéité et de la stabilité des matériaux de référence 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.

General Information

• Status: Not Published
• ICS: 71.040.30 - Chemical reagents
• Technical Committee: ISO/TC 334 - Reference materials
• Drafting Committee: ISO/TC 334 - Reference materials
• Current Stage: 5020 - FDIS ballot initiated: 2 months. Proof sent to secretariat
• Start Date: 31-Jan-2024
• Completion Date: 31-Jan-2024

Relations

• Revises: ISO Guide 35:2017 - Reference materials — Guidance for characterization and assessment of homogeneity and stability
• Effective Date: 06-Jun-2022

Standards Content (Sample)

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
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
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: [phone]
Email: [e-mail]
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

---------------------- Page: 1 ----------------------
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: [e-mail]
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 .
...