AS/NZS ISO 33406:2024
Approaches for the production of reference materials with qualitative properties
Standard identically adopts ISO 33406:2024, which supplements AS ISO 17034 and provides guidance on the implementation of AS 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.
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AS/NZS ISO 33406:2024 Approaches for the production of reference materials with qualitative properties
Preface
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Qualitative properties
5 Meeting technical and production requirements
5.1 Characterization
5.1.1 General considerations
5.1.2 Materials characterized based on provenance
5.1.3 Materials characterized for identity based on measurements
5.1.4 Characterization by a combination of methods
5.2 Application of metrological traceability to qualitative determinations
5.2.1 General
5.2.2 Metrological traceability
5.2.3 Reference data and reference materials for qualitative determinations
5.2.4 Qualitative value assigned based on provenance
5.3 Measurement uncertainty and confidence in qualitative values
5.3.1 General considerations
5.3.2 Measurement uncertainty
5.3.3 Confidence in qualitative values
5.4 General considerations for the selection of statistical approaches
5.5 Assessment of homogeneity
5.5.1 General considerations
5.5.2 Experimental designs for homogeneity assessment for qualitative values
5.5.3 Statistical approaches for homogeneity assessment for qualitative properties
5.6 Assessment of stability
5.6.1 General considerations for stability assessment
5.6.2 Designs for experimental stability studies for qualitative properties
5.7 Commutability assessment
5.7.1 General considerations
5.7.2 Commutability assessment for qualitative properties
5.7.3 Commutability statement
Annex A (informative) Guidance for DNA and protein reference materials
Annex B (informative) Expressing confidence in qualitative values
Annex C (informative) Statistical procedures
Annex D (informative) Examples of homogeneity and stability studies of reference materials with qualitative properties
Bibliography
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AS/NZS ISO 33406:2024 Approaches for the production of reference materials with qualitative properties
Preface
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Qualitative properties
5 Meeting technical and production requirements
5.1 Characterization
5.1.1 General considerations
5.1.2 Materials characterized based on provenance
5.1.3 Materials characterized for identity based on measurements
5.1.4 Characterization by a combination of methods
5.2 Application of metrological traceability to qualitative determinations
5.2.1 General
5.2.2 Metrological traceability
5.2.3 Reference data and reference materials for qualitative determinations
5.2.4 Qualitative value assigned based on provenance
5.3 Measurement uncertainty and confidence in qualitative values
5.3.1 General considerations
5.3.2 Measurement uncertainty
5.3.3 Confidence in qualitative values
5.4 General considerations for the selection of statistical approaches
5.5 Assessment of homogeneity
5.5.1 General considerations
5.5.2 Experimental designs for homogeneity assessment for qualitative values
5.5.3 Statistical approaches for homogeneity assessment for qualitative properties
5.6 Assessment of stability
5.6.1 General considerations for stability assessment
5.6.2 Designs for experimental stability studies for qualitative properties
5.7 Commutability assessment
5.7.1 General considerations
5.7.2 Commutability assessment for qualitative properties
5.7.3 Commutability statement
Annex A (informative) Guidance for DNA and protein reference materials
Annex B (informative) Expressing confidence in qualitative values
Annex C (informative) Statistical procedures
Annex D (informative) Examples of homogeneity and stability studies of reference materials with qualitative properties
Bibliography
AS/NZS ISO 33406:2024
Online Library subscription information
Online library subscriptions provide a cost-effective solution for organisations of any size to access the latest standards, offering 24/7 access to a personalised catalogue. The service ensures subscribers have have the most up-to-date version of selected standards, incluing automatic updates for any amendments or versions. Pricing is dependent on the chosen standards and the number of concurrent users, with discounts applied from the standards PDF price. For customised subscriptions or further inquiries, contact the Online Library team.