GB/T 15000.9-2026Directives for the work of reference materials - Part 9: Approaches for the production of reference materials with qualitative properties (English PDF)

Foreword

This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1: Structure and Drafting Rules of Standardization Documents".

Drafting.

This document is Part 9 of GB/T 15000, "Guidelines for the Work of Standard Samples". GB/T 15000 has already published the following parts.

---Part 1: General provisions for standard samples in technical standards;

---Part 2: Common Terms and Definitions;

---Part 3: Standard Sample Assignment and Homogeneity and Stability Assessment;

---Part 4: Contents of Certificates, Labels, and Accompanying Documents;

---Part 5: Internal Development of Quality Control Samples;

---Part 6: General Rules for Packaging Standard Samples;

---Part 7: General Requirements for Standard Sample Producer Capabilities;

---Part 8: Use of Standard Samples;

---Part 9: Development of Qualitative Characteristic Standard Samples this document is equivalent to ISO 33406:2024 "Development of standard specimens for qualitative characteristics".

The following minimal editorial changes have been made to this document.

---To align with existing standards, the standard title has been changed to "Standard Sample Working Guidelines Part 9: Development of Qualitative Characteristic Standard Samples".

system";

---The two distribution scenarios in example B.4.3.1 have been modified to be consistent with the calculation formula in example B.4.3.2.

Please note that some content in this document may involve patents. The issuing organization of this document assumes no responsibility for identifying patents.

This document was proposed and is under the jurisdiction of the National Technical Committee on Standard Samples (SAC/TC118).

Introduction

In.2015, the International Organization for Standardization/Standards and Samples Committee (ISO/REMCO, the predecessor of ISO/TC334) published ISO/TR ISO/T R79 summarizes the latest progress in the development of qualitative characteristic standard samples. ISO/T R79 does not define the term "qualitative characteristics" or limit its use.

Therefore, at that time, "qualitative characteristics" was used as a superordinate term for nominal characteristics and ordinal characteristics, while "classification characteristics" was a synonym for "qualitative characteristics".

ISO/T R79 provides examples of standard samples (RMs), which have standard values for qualitative characteristics, or are considered to be characterized by...

Standard samples characterized by their properties and used internally in the laboratory. The examples listed are based on ISO 33405[18] and ISO/T R33402[17].

The principles outlined in ISO/T R79 are not subject to a consensus-building process.

For standard samples, naming characteristics are a special type of qualitative characteristic (the other type is ordinal characteristics). Polychlorinated biphenyls (PCBs) the identity of (PCB) and the taxonomic status of maple (Acer genus) are both nomenclature characteristics; the former has more than.200 possible values, and the latter has more than 160 possible values.

Values. These characteristic values are the names of specific chemical substances or biological species (e.g., PCB105, silver maple). The naming characteristic values are unique among each other.

A meaningful comparison is one in which they are the same or different.

Ordinal characteristic values may be ordered from minimum to maximum or from lowest to highest (i.e., hierarchical), but even if these values are represented numerically, their differences...

Values or ratios are also meaningless in practice.

In many fields, such as chemistry and biology, there are no explicit rules for describing qualitative characteristics. Qualitative characteristics can be described in different ways.

Characteristics, this depends on the characteristic itself, and even on the form in which a particular characteristic is expressed. For example, "color" might be considered a qualitative characteristic.

In this context, "red" is a value of that characteristic. Alternatively, some might suggest that "color" is a general characteristic while "red" is an individual case. Furthermore, pure color can...

The wavelengths of light are sufficient to describe this, with red light ranging from 625 nm to 740 nm. Therefore, the qualitative characteristic of "color" may be...

Assign a quantitative (or semi-quantitative) value, such as a wavelength of 700 nm.

Qualitative characteristic values can also be assigned based on their intended use. For example, "ethanol" can be considered the name of a specific compound.

An alcohol is an example of a class of compounds that possess the general characteristic of "alcohol," which can be considered as a general characteristic of "chemical substances." example.

In the technical system of standard samples, GB/T 15000 "Guidelines for Standard Sample Work" is the fundamental and general guideline for standard sample work in my country.

GB/T 15000 aims to establish universally applicable standards for the preparation, determination, packaging, storage, distribution, and application of standard samples by their manufacturers.

The requirements are proposed to consist of 9 parts.

---Part 1: General Provisions for Describing Standard Samples in Technical Standards. The purpose is to specify the requirements for describing standard samples in the development of technical standards.

General requirements for samples, the relationship between standard samples and technical standards, and technical criteria for selecting standard samples.

---Part 2: Common Terms and Definitions. The purpose is to define the terms and definitions related to standard samples, particularly those used with reference to standard samples.

The terminology used in product manuals, certificates, and relevant research and development reports.

---Part 3: Standard Sample Assignment and Homogeneity and Stability Assessment. The aim is to provide more specific guidance on technical issues.

It guides and provides a basic model for evaluating the homogeneity and stability of standard samples and for determining their values.

---Part 4: Contents of Certificates, Labels, and Accompanying Documents. The purpose is to establish the applicable procedures for preparing standard sample certificates, labels, and accompanying documents.

The relevant requirements to be followed when including file content.

---Part 5: Internal Development of Quality Control Samples. The purpose is to standardize and guide the development and use of quality control samples.

---Part 6: General Rules for Standard Sample Packaging. The purpose is to establish basic principles applicable to the packaging, storage, and transportation of standard samples.

rule.

---Part 7: General Requirements for the Competence of Standard Sample Producers. The purpose is to specify the organizational, management, and operational requirements to ensure...

Standard sample producers are able to produce standard samples that meet the requirements.

---Part 8: Use of Standard Samples. This section aims to provide users of standard samples with proper application guidance.

---Part 9: Development of Qualitative Characteristic Standard Samples. The purpose is to study the assignment of values, homogeneity, and stability of qualitative characteristic standard samples.

Technical aspects such as the evaluation of interchangeability provide more specific guidance for the development and production of qualitative characteristic standard samples.

Given the increasing number of standard samples for qualitative characteristics and the progress made in determining or identifying qualitative characteristics, in 2018, ISO/REMCO decided to begin drafting internationally unified guidelines for the development of such standard samples.

This raises some issues related to terminology. ISO Guide 30 defines a Certified Reference Sample (CRM) as requiring a standard sample.

Product certificates provide specific characteristic values, associated uncertainties, and statements regarding metrological traceability. However, metrological traceability differs from that of certificates with qualitative characteristic values.

The relevance of standard samples may not be clear. The notes in ISO Guide 30 regarding the definitions of standard samples and certified standard samples clarify that...

The concept includes qualitative characteristic values, such as identity or sequence, and the uncertainty of qualitative characteristic values can be expressed as probability or confidence level [19]. But Yes, qualitative characteristics do not have numerical values, and the current ISO/IEC Guide 98-3 (GUM) does not provide a method for determining the uncertainty of such characteristic values.

According to ISO/IEC Guide 99 (VIM), metrological traceability is defined as an attribute of measurement results that is verified through a documented, uninterrupted calibration chain.

It is associated with a reference value. Therefore, this does not apply to qualitative characteristic values either.

To provide guidance for the development and production of such standard samples, this document.

---Explain how to express the degree of certainty regarding qualitative characteristic values;

---Documented, uninterrupted description (when determining qualitative characteristic values by comparison with qualitative characteristic reference values or reference information) of qualitative characteristics.

Correlation of sexual characteristics comparison chains;

---This indicates that the determination of many qualitative characteristics depends on data given by quantitative measurements, while measurement uncertainty and metrological traceability are related to...

These measurements are related.

ISO 17034 describes the general requirements, structural requirements, resource requirements, and management requirements for the production of standard samples. These requirements apply to...

Development/production of qualitative characteristic standard samples. The qualitative characteristic standard samples provided in this document concern their value assignment, homogeneity, stability, and interchangeability.

The guidelines on assessment and other aspects are a valuable supplement to ISO 17034 and other relevant documents.

Standard Sample Working Guide Part 9: Development of Qualitative Characteristic Standard Samples

1 Scope

1.1 This document contains the requirements of ISO 17034 and provides guidelines for the development of standard samples with one or more specific qualitative characteristic values.

Provide guidance on implementing ISO 17034 and offer guidelines for expressing qualitative characteristic value uncertainties and establishing traceability.

Note. The concepts of traceability and uncertainty related to qualitative characteristics are similar to the concepts of metrological traceability and measurement uncertainty used for quantitative characteristics.

1.2 This document applies to the development of qualitative characteristic standard samples and does not include content related to the production of quantitative characteristic standard samples.

Note. Appendix A provides examples of various types of standard samples within the scope of this document.

2 Normative references

The contents of the following documents, through normative references within the text, constitute essential provisions of this document. Dated citations are not included.

For references to documents, only the version corresponding to that date applies to this document; for undated references, the latest version (including all amendments) applies.

This document.

Note. GB/T 15000.7-2021 Guidelines for the Work of Standard Samples Part 7: General Requirements for the Competence of Standard Sample Producers (ISO 17034:2016) IDT) Contents of ISO 33401 standard sample certificate, label and accompanying documents (Reference materials - Contents of Note. GB/T 15000.4-2026 Guidelines for Standard Sample Work - Part 4: Contents of Certificates, Labels and Accompanying Documents (ISO 33401:2024, IDT) Note. GB/T 15000.2-2019 Standard Sample Working Guidelines Part 2: Common Terms and Definitions (ISO Guide 30.2015, IDT) ISO/IEC Guide 99 International Metrology Vocabulary. Basic and General Concepts and Related Terms (VIM)

3 Terms and Definitions

The terms and definitions defined in ISO 17034, ISO Guide 30, ISO 33401 and ISO/IEC Guide 99 apply to this document.

The URLs for the terminology databases maintained by ISO and IEC for standardization are as follows.

4 Qualitative characteristics

Qualitative characteristics, also known as classification characteristics, include nomenclature characteristics and ordinal characteristics. Nomenclature characteristic values classify a group of materials possessing that characteristic into...

Different categories are defined so that all materials within the same category have the same property values, and the only way to compare property values is by their relative properties.