ISO 33406:2024
(Main)Approaches for the production of reference materials with qualitative properties
Approaches for the production of reference materials with qualitative properties
This document notes the requirements of ISO 17034 and provides guidance on the implementation of ISO 17034 in the production of RMs having one or more assigned qualitative property values, for expressing uncertainties for qualitative property values, and for establishing traceability. NOTE The concepts of traceability and uncertainty address characteristics similar to those addressed by the concepts of traceability and measurement uncertainty as used in the metrology of quantitative properties. This document therefore does not describe aspects related to the production of RMs with quantitative property values. NOTE Annex A provides examples of types of RMs within the scope of this document.
Approches pour la production de matériaux de référence avec des propriétés qualitatives
Le présent document mentionne les exigences de l’ISO 17034 et fournit des recommandations concernant la mise en œuvre de l’ISO 17034 dans la production de MR possédant une ou plusieurs valeurs attribuées de propriétés qualitatives, pour l’expression des incertitudes relatives aux valeurs de propriétés qualitatives ou pour l’établissement de la traçabilité. NOTE Les concepts de traçabilité et d’incertitude couvrent des caractéristiques similaires à celles couvertes par les concepts de traçabilité et d’incertitude de mesurage tels qu’ils sont utilisés pour la métrologie des propriétés quantitatives. Par conséquent, le présent document ne décrit pas les aspects liés à la production de MR avec des valeurs de propriétés quantitatives. NOTE L’Annexe A fournit des exemples de types de MR au sein du domaine d’application du présent document.
General Information
Buy Standard
Standards Content (Sample)
International
Standard
ISO 33406
First edition
Approaches for the production of
2024-05
reference materials with qualitative
properties
Approches pour la production de matériaux de référence avec des
propriétés qualitatives
Reference number
ISO 33406:2024(en) © ISO 2024
---------------------- Page: 1 ----------------------
ISO 33406:2024(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.
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
© ISO 2024 – All rights reserved
ii
---------------------- Page: 2 ----------------------
ISO 33406:2024(en)
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
5.1.2 Materials characterized based on provenance .2
5.1.3 Materials characterized for identity based on measurements .2
5.1.4 Characterization by a combination of methods .3
5.2 Application of metrological traceability to qualitative determinations .4
5.2.1 General .4
5.2.2 Metrological traceability .5
5.2.3 Reference data and reference materials for qualitative determinations.5
5.2.4 Qualitative value assigned based on provenance .5
5.3 Measurement uncertainty and confidence in qualitative values .6
5.3.1 General considerations .6
5.3.2 Measurement uncertainty .6
5.3.3 Confidence in qualitative values .
...
Norme
internationale
ISO 33406
Première édition
Approches pour la production de
2024-05
matériaux de référence avec des
propriétés qualitatives
Approaches for the production of reference materials with
qualitative properties
Numéro de référence
ISO 33406:2024(fr) © ISO 2024
---------------------- Page: 1 ----------------------
ISO 33406:2024(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
Case postale 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Genève
Tél.: +41 22 749 01 11
E-mail: copyright@iso.org
Web: www.iso.org
Publié en Suisse
© ISO 2024 – Tous droits réservés
ii
---------------------- Page: 2 ----------------------
ISO 33406:2024(fr)
Sommaire Page
Avant-propos .iv
Introduction .v
1 Domaine d’application . 1
2 Références normatives . 1
3 Termes et définitions . 1
4 Propriétés qualitatives . 1
5 Satisfaction des exigences techniques et des exigences de production . 2
5.1 Caractérisation .2
5.1.1 Considérations générales .2
5.1.2 Matériaux caractérisés sur la base de la provenance .2
5.1.3 Matériaux dont l’identité est caractérisée sur la base de mesurages .3
5.1.4 Caractérisation par une combinaison de méthodes .4
5.2 Application de la traçabilité métrologique aux déterminations qualitatives .5
5.2.1 Généralités .5
5.2.2 Traçabilité métrologique .5
5.2.3 Données de référence et matériaux de référence pour les déterminations
qualitatives .5
5.2.4 Valeur qualitative attribuée sur la base de la provenance .6
5.3 Incertitude de mesurage et confiance dans les valeurs qualitatives .6
5.3.1 Considérations générales .6
5.3.2 Incertitude de mesurage .7
5.3.3 Confiance dans les valeur
...
FINAL DRAFT
International
Standard
ISO/FDIS 33406
ISO/TC 334
Approaches for the production of
Secretariat: SABS
reference materials with qualitative
Voting begins on:
properties
2024-01-31
Approches pour la production de matériaux de référence avec des
Voting terminates on:
propriétés qualitatives
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 33406:2024(en) © ISO 2024
---------------------- Page: 1 ----------------------
FINAL DRAFT
ISO/FDIS 33406:2024(en)
International
Standard
ISO/FDIS 33406
ISO/TC 334
Approaches for the production of
Secretariat: SABS
reference materials with qualitative
Voting begins on:
properties
Approches pour la production de matériaux de référence avec des
Voting terminates on:
propriétés qualitatives
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 33406:2024(en) © ISO 2024
© ISO 2024 – All rights reserved
ii
---------------------- Page: 2 ----------------------
ISO/FDIS 33406:2024(en)
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
5.1.2 Materials characterized based on provenance .2
5.1.3 Materials characterized for identity based on measurements .2
5.1.4 Characterization by a combination of methods .3
5.2 Application of metrologi
...
ISO/FDIS 33406:2023(E)
ISO/TC 334
Date: 2023-11-13
Secretariat: SABS
Approaches for the production of reference materials with
qualitative properties
Approches pour la production de matériaux de référence avec des propriétés qualitatives
FDIS stage
---------------------- Page: 1 ----------------------
ISO/FDIS 33406:2023(E2024(en)
© 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
ii © ISO 2023 – All rights reserved
© ISO 2024 – All rights reserved
ii
---------------------- Page: 2 ----------------------
ISO/FDIS 33406:2023(E2024(en)
Contents
1
Foreword viii
Introduction ix
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
5.1.2 Materials characterized based on provenance 2
5.1.3 Materials characterized for identity based on measurements 3
5.1.4 Characterization by a combination of methods 4
5.2 Application of metrological traceability to qualitative determinations 5
5.2.1 General 5
5.2.2 Metrological traceability 5
5.2.3 Reference data and reference materials for qualitative determinations 5
5.2.4 Qualitative value assigned based on provenance 6
5.3 Measurement uncertainty and confidence in qualitative values 6
5.3.1 General considerations 6
5.3.2 Measurement uncertainty 7
5.3.3 Confidence in qualitative values 8
5.4 General considerations for the selection of statistical approaches 9
5.5 Assessment of homogeneity 10
5.5.1 General considerations 10
5.5.2 Experimental designs for homogeneity assessment for qualitative values 10
5.5.3 Statistical approaches for homogeneity assessment for qualitative properties 11
5.6 Assessment of stability 13
5.6.1 General considerations for stability assessment 13
5.6.2 Designs for experimental stability studies for qualitative properties 14
5.7 Commutability assessment 17
5.7.1 General considerations 17
5.7.2 Commutability assessment for qualitative properties 18
5.7.3 Commutability statement 18
Annex A (informative) Guidance for DNA and protein reference materials 19
© ISO 2023 – All rights reserved iii
© ISO 2024 – All rights reserved
iii
---------------------- Page: 3 ----------------------
ISO/FDIS 33406:2023(E2024(en)
A.1 DNA reference materials 19
A.1.1 Value assignment of qualitative DNA reference materials 19
A.1.2 Controlled origin and purity 19
A.1.3 Application to other nucleic acid material 19
A.2 Protein reference materials 20
A.2.1 Value assignment of qualitative protein reference materials 20
A.2.2 Determination of amino acid sequence 20
A.2.3 Identification of a single protein or proteins in complex materials 20
Annex B (informative) Expressing confidence in qualitative values 22
B.1 General considerations for expressing confidence in qualitative values 22
B.2 Performance measures for qualitative property tests 22
B.3 Quantitative indicators of agreement or similarity for nominal values 25
B.3.1 Introduction to indicators of agreement 25
B.3.2 The Gower Index 25
B.3.3 Nucleic acid or protein sequence match scores 26
B.4 Selected expressions of confidence in nominal values 26
B.4.1 Likelihood ratio 26
B.4.2 Posterior probability 27
B.4.3 Entropy 28
Annex C (informative) Statistical procedures 30
C.1 Chi-squared test for a two-way contingency table 30
C.1.1 Purpose 30
C.1.2 Data requirement 30
C.1.3 Procedure 30
C.2 Confidence limit for proportion of non-compliant RM units 32
C.2.1 Purpose 32
C.2.2 Data requirement 32
C.2.3 Procedure 32
C.2.4 Lower confidence limit for proportion of compliant RM units 33
Annex D (informative) Examples of homogeneity and stability studies of reference materials with qualitative
properties 34
D.1 Homogeneity study for a meat species control material 34
D.1.1 Overview 34
D.1.2 Study design and results 34
Table D.1 — Results of a homogeneity test for a candidate qualitative positive control material 34
D.1.3 Chi-squared test for significant inhomogeneity 34
D.1.4 Confidence limit for proportion of defective RM units 35
iv © ISO 2023 – All rights reserved
© ISO 2024 – All rights reserved
iv
---------------------- Page: 4 ----------------------
ISO/FDIS 33406:2023(E2024(en)
D.2 Accelerated short term (transportation) stability study 36
D.2.1 Overview 36
D.2.2 Study design and re
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.