STANDARDS AS/NZS ISO 33405:2024 NEWZEALAND STANDARDS TE MANA TAUTIKANGA OAOTEAROA ISO 33405:2024 Australian/New Zealand StandardTM Reference materials Approaches for characterization and assessment of homogeneity and stability AS/NZS ISO 33405:2024 This Joint Australian/New Zealand StandardTM was prepared by Joint Technical Committee Development and Accreditation Committee on 19 July 2024 and by the New Zealand StandardsApprovalBoardon07August2024. This Standard was published on 30 August 2024. The following are represented on Committee CH-040: Australian Radiation Protection and Nuclear Safety Agency CSIRO Global Proficiency International Accreditation New Zealand Metrology Society of Australasia National Association of Testing Authorities Australia National Measurement Institute NewZealandLeather&ShoeResearchAssociation Responsible Care New Zealand University of New South Wales This Standard was issued in draft form for comment as DR AS/NZS ISO 33405:2024. Keeping Standards up-to-date Ensure you have the latest versions of our publications and keep up-to-date about Amendments, Rulings, Withdrawals, and new projects by visiting: www.standards.org.au www.standards.govt.nz ISBN 978 1 76139 782 0 AS/NZS ISO 33405:2024 ISO 33405:2024 Australian/New Zealand StandardTM Reference materials - Approaches for characterization and assessment of homogeneity and stability Originated as SAA/SANZ HB 19.35:1991. Revised and redesignated as SA HB 19.35:2018. Jointly revised and redesignated as AS/NZS ISO 33405:2024. COPYRIGHT @ IS0 2024 - All rights reserved @ Standards Australia Limited/the Crown in right of New Zealand, administered by the New Zealand Standards Executive 2024 All rights are reserved. No part of this work may be reproduced or copied in any form or by any means, electronic or mechanical, including photocopying, without the written permission of the publisher, unless otherwise permitted under the Copyright Act 1968 (Cth) or the Copyright Act 1994 (New Zealand). ii AS/NZSIS033405:2024 Preface This Standard was prepared by the Joint Standards Australia/Standards New Zealand Committee CH- 040, Reference Materials, to supersede SA HB 19.35:2018, Reference materials, Part 35: Guidance for characterization and assessment of homogeneity and stability. The objective of this document is to explain concepts and provide approaches to the following aspects of the production of reference materials (RMs): (a) Assessment of homogeneity. (b) Assessment of stability and the management of the risks associated with possible stability issues related to the properties of interest. (g) Characterization and value assignment of properties of an RM. (d) Evaluation of uncertainty for certified values. (e) Establishment of the metrological traceability of certified values. The guidance given supports the implementation of AS ISO 17034. Other approaches can also be used as long as the requirements of AS IS0 17034 are fulfilled. This document is identical with, and has been reproduced from, IS0 33405:2024, Reference materials - Approaches for characterization and assessment of homogeneity and stability. As this document has been reproduced from an international document, a full point substitutes for a comma when referring to a decimal marker. Australian or Australian/New Zealand Standards that are identical adoptions of international normative references may be used interchangeably. Refer to the online catalogue for information on specific Standards. The terms “normative" and "informative" are used in Standards to define the application of the appendices or annexes to which they apply. A “normative" appendix or annex is an integral part of a Standard, whereas an "informative" appendix or annex is only for information and guidance. StandardsAustraliaLimited/StandardsNewZealand2024 ii AS/NZS IS0 33405:2024 Contents Preface .ii Foreword. ..vi Introduction. ... i 1 Scope. 2 Normative references. 3 Terms and definitions ..1 Symbols .2 4 5 Conventions 6 Over