International ISO 4 Standard IS033406 Approaches for the production of First edition reference materials with qualitative 2024-05 properties Approches pour la production de materiaux de reference avec des propriétés qualitatives Reference number ISO33406:2024(en) @ ISO 2024 IS02024 All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may 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 40i : Ch. de Blandonnet 8 CH-1214 Vernier, Geneva Phone: +41 22 749 01 11 Email: [email protected] Website: www.iso.org Publishedin Switzerland @IS0 2024 - All rights reserved ii Contents Page Foreword. .iv Introduction V 1 Scope. .1 2 Normative references ..1 3 Terms and definitions .1 4 Qualitative properties .1 5 Meeting technical and production requirements .2 5.1 Characterization .2 5.1.1 General considerations. .2 Materials characterized based on provenance .2 5.1.2 5.1.3 Materials characterized for identity based on measurements. .2 5.1.4 Characterizationbyacombinationofmethods .3 5.2 Application of metrological traceability to qualitative determinations .4 5.2.1 General 5.2.2 Metrological traceability. .5 5.2.3 Reference data and reference materials for qualitative determinations. .5 5.2.4 Oualitativevalueassignedbasedonprovenance .5 5.3 Measurement uncertainty and confidence in qualitative values 6 5.3.1 Generalconsiderations .6 5.3.2 Measurement uncertainty .6 5.3.3 Confidence in qualitative values .7 5.4 General considerations for the selection of statistical approaches .8 5.5 Assessment of homogeneity .9 5.5.1 Generalconsiderations ..9 5.5.2 Experimental designs for homogeneity assessment for qualitative values .9 5.5.3 Statistical approaches for homogeneity assessment for qualitative properties 10 5.6 Assessmentofstability 12 5.6.1 General considerations for stability assessment 12 5.6.2 Designs for experimental stability studies for qualitative properties .13 5.7 Commutability assessment. 15 5.7.1 General considerations .15 5.7.2 Commutability assessment for qualitative properties .16 5.7.3 Commutability statement. .16 Annex A (informative) Guidance for DNA and protein reference materials .18 Annex B (informative) Expressing confidence in qualitative values .21 Annex C (informative) Statistical procedures .28 Annex D (informative) Examples of homogeneity and stability studies of reference materials ..32 with qualitative properties. Bibliography .37 @ IS0 2024 - All rights reserved iii Foreword Iso (the International Organization for Standardization) is a worldwide federation of national standards bodies (IsO member bodies). The work of preparing International Standards is normally carried out through IsO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with IsO, also take part in the work. IsO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization The procedures used to develop this document and those intended for its further maintenance are described in the Iso/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types of IsO document should be noted. This document was drafted in accordance with the editorial rules of the ISo/IEC Directives, Part 2 (see www.iso.org/directives). Iso draws attention to the possibility that the implementation of this document may involve the use of (a) patent(s). Iso takes no position concerning the evidence, validity or applicability of any claimed patent rights in respect thereof. As of the date of publication of this document, Iso had not received notice of (a) p