ISO 33400:2026
(Main)Reference materials — Vocabulary
- Abstract
This document defines terms related with the production and use of reference materials including certified reference materials.
- Status
- Published
- Publication Date
- 21-Jun-2026
- Technical Committee
- ISO/TC 334 - Reference materials
- Drafting Committee
- ISO/TC 334/WG 10 - RM Terms and definitions
- Current Stage
- 6060 - International Standard published
- Start Date
- 22-Jun-2026
- Due Date
- 08-Jan-2027
- Completion Date
- 22-Jun-2026
ISO 33400:2026 is an International Standard published by the International Organization for Standardization (ISO) that defines the vocabulary for reference materials (RMs), including certified reference materials (CRMs). It gives the terms used for producing, characterizing, certifying, documenting, and using RMs, so producers, laboratories, and buyers can work with the same language.
What does ISO 33400:2026 specify?
ISO 33400:2026 specifies the terms and definitions related to the production and use of reference materials, including certified reference materials. It is a vocabulary standard, so its job is to fix meaning and usage rather than to prescribe test methods or product requirements.
The document is organized into:
- Clause 1 - Scope
- Clause 2 - Normative references
- Clause 3 - Terms and definitions, grouped into:
- 3.1 General terms
- 3.2 Terms related to reference material production
- 3.3 Terms related to reference material characterization
- 3.4 Terms related to use of reference materials
- Bibliography
- Index
Clause 3 is the core of the document. In practice, this layout helps a reader find the right term quickly, whether they are writing a certificate, reviewing a producer’s documentation, or checking whether a material fits a measurement task.
What are the key requirements of ISO 33400:2026?
ISO 33400:2026 does not set performance limits, but it gives the definitions that control how reference materials are described and used. The most important points are the distinctions between RM, CRM, values, documents, production roles, and stability concepts.
Core material and value terms
- Clause 3.1.1 defines a reference material as sufficiently homogeneous and stable for one or more specified properties, and fit for its intended use. In practice, the material must be suitable for the purpose claimed by the producer.
- Clause 3.1.2 defines a CRM as an RM with at least one certified value. That matters because a CRM carries formally established property values, not just general information.
- Clauses 3.1.3 and 3.1.4 distinguish certified value from indicative value. A certified value is assigned by a metrologically valid procedure with uncertainty and traceability, while an indicative value is only suitable for specific purposes identified in the document.
Documentation and responsibility
- Clauses 3.1.5 to 3.1.9 define the RM document, RM certificate, product information sheet, production report, and certification report. These terms matter because the document type tells the user what information is essential and how much detail is available.
- Clause 3.2.1 defines RM production as the full set of activities needed to develop an RM and make it available to the user. The note makes clear that this can include planning, handling, storage, processing, homogeneity and stability assessment, characterization, value assignment, and issue of the document.
- Clauses 3.2.2 and 3.2.3 define the RM producer and subcontractor. The practical point is that the producer remains fully responsible even when selected tasks are subcontracted.
- Clause 3.2.4 defines a candidate RM, and 3.2.5 defines matrix RM. These terms help users understand whether a material is still under development and whether it is representative of real samples.
Characterization, stability, and use
- Clauses 3.3.1 to 3.3.3 define characterization, value assignment, and certification. Together they describe how values are established and authorized before they are issued.
- Clauses 3.3.8 to 3.3.17 cover homogeneity and stability, including between-unit homogeneity, within-unit homogeneity, transport stability, long-term stability, and the different stability study approaches. In practice, these terms guide the studies used to show that assigned values remain suitable over time and during transport.
- Clauses 3.4.1 to 3.4.4 define intended use, period of validity, minimum sample size, and commutability. These are the checks a user needs to confirm that the RM fits the measurement procedure and sample intake they plan to use.
What terms does ISO 33400:2026 define?
- Reference material (RM) - A material that is homogeneous and stable enough for specified properties and intended use.
- Certified reference material (CRM) - An RM with at least one certified value.
- Certified value - A property value established by a metrologically valid procedure, with uncertainty and metrological traceability stated.
- Indicative value - A value that does not meet all certified value requirements but is still suitable for specific identified purposes.
- Reference material producer (RMP) - The body fully responsible for RM production.
- Reference material document - The essential document that provides the information needed to use an RM.
- Commutability - The extent to which an RM behaves like representative samples when different measurement procedures are compared.
Who uses ISO 33400:2026?
ISO 33400:2026 is used by reference material producers, laboratory staff, calibration and measurement specialists, quality managers, and buyers who need to interpret RM documentation correctly. It is also used in measurement procedure evaluation, internal and external quality control, accreditation work, and standardization activities. The introduction notes its relevance in biology and material sciences as well as in broader laboratory practice.
What changed in ISO 33400:2026 from the previous edition?
ISO 33400:2026 is the first edition and it cancels and replaces ISO Guide 30:2015. The stated changes are:
- the order of presentation of the terms and definitions has been revised and regrouped;
- the definitions of certified reference material and certified value have been revised;
- the definition of indicative value has been revised to better match typical characteristics and intended uses.
Which standards are used with ISO 33400:2026?
ISO 33400:2026 points to related documents in notes and the bibliography:
- ISO 17034 - requirements for the competence of reference material producers, and background for RM document content.
- ISO 33401 - contents of certificates, labels, and accompanying documentation.
- ISO 33403 - requirements and recommendations for the use of reference materials.
- ISO 33405 - approaches for characterization and assessment of homogeneity and stability.
- ISO 33406:2024 - production of reference materials with qualitative properties.
- ISO/IEC 17000:2020 - the distinction between declaration and certification in conformity assessment.
- ISO/IEC Guide 99:2007 - an analogous definition for reference material.
- ISO 17511:2020 - metrological traceability for values assigned to calibrators, trueness control materials, and human samples.
What does the ISO 33400:2026 document contain?
ISO 33400:2026 contains a structured vocabulary with terms, definitions, notes to entry, examples, and source notes. Clause 3 groups the terms into general terms, production, characterization, and use, so readers can move from basic concepts to the way values are assigned and applied. The bibliography connects the vocabulary to related ISO documents on producer competence, document content, use, homogeneity, stability, qualitative properties, and traceability. The index supports practical lookup of the terms and abbreviations used throughout the standard.
Relations
- Effective Date
- 11-Jan-2025
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Frequently Asked Questions
ISO 33400:2026 is a standard published by the International Organization for Standardization (ISO). Its full title is "Reference materials — Vocabulary". This standard covers: This document defines terms related with the production and use of reference materials including certified reference materials.
This document defines terms related with the production and use of reference materials including certified reference materials.
ISO 33400:2026 is classified under the following ICS (International Classification for Standards) categories: 01.040.71 - Chemical technology (Vocabularies); 71.040.30 - Chemical reagents. The ICS classification helps identify the subject area and facilitates finding related standards.
ISO 33400:2026 has the following relationships with other standards: It is inter standard links to ISO Guide 30:2015. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
ISO 33400:2026 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
International
Standard
ISO 33400
First edition
Reference materials — Vocabulary
2026-06
Matériaux de référence — Vocabulaire
Reference number
© ISO 2026
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Published in Switzerland
ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
3.1 General terms .1
3.2 Terms related to reference material production .3
3.3 Terms related to reference material characterization .4
3.4 Terms related to use of reference materials .7
Bibliography . 9
Index . 10
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)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
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constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 334, Reference materials.
This first edition cancels and replaces the third edition (ISO Guide 30:2015), which has been technically
revised.
The main changes are as follows:
— order of presentation of the terms and definitions has been revised and regrouped;
— definitions of certified reference material and certified value have been revised;
— definition of indicative value has been revised to be more consistent with the typical characteristics and
intended uses of such values.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
iv
Introduction
Reference materials (RMs) are widely used for the calibration of measuring systems, for the evaluation of
measurement procedures, and for the internal or external quality control of measurements and laboratories.
They can also enable the expression of functional properties in arbitrary units, for instance in certain
cases relevant for biology or material sciences. RMs play an important role in national and international
standardization activities and in the accreditation of laboratories.
This document defines terms used in connection with the production and use of RMs and certified reference
materials (CRMs). It aims to ensure use of consistent terminology by organizations worldwide that work
with RMs and CRMs.
v
International Standard ISO 33400:2026(en)
Reference materials — Vocabulary
1 Scope
This document defines terms related with the production and use of reference materials including certified
reference materials.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— IEC Electropedia: available at http:// www .electropedia .org/
— ISO Online browsing platform: available at http:// www .iso .org/ obp
3.1 General terms
3.1.1
reference material
RM, noun
material, sufficiently homogeneous and stable with respect to one or more specified properties, which has
been established to be fit for its intended use (3.4.1)
Note 1 to entry: The specified properties can be quantitative or qualitative (nominal property (3.3.5) or ordinal
property (3.3.6)).
[1]
Note 2 to entry: ISO/IEC Guide 99:2007 has an analogous definition (5.13).
3.1.2
certified reference material
CRM, noun
reference material (3.1.1) that has at least one certified value (3.1.3)
Note 1 to entry: A certified reference material can also have one or more indicative values (3.1.4).
3.1.3
certified value
certified property value, noun
value, determined by a metrologically valid procedure and accompanied by an uncertainty statement and a
statement of metrological traceability, assigned to a property of a reference material (3.1.1) and identified as
such in the reference material document (3.1.5)
Note 1 to entry: Certified values can be suitable for, for example, calibration of a measurement system, validation of
measurement procedures, assessing precision and/or accuracy of a method, and assessing stability of the composition
of materials to which they are assigned. Additional information on uses of certified values can be found in ISO 33403
[2]
.
Note 2 to entry: In the case of a quantitative property, the uncertainty statement is a reported measurement
[3]
uncertainty. ISO 33405 gives further details of measurement uncertainty and metrological traceability for
quantitative certified values.
Note 3 to entry: In the case of a qualitative (nominal or ordinal) property, the uncertainty statement can be a statement
of confidence, and the statement of metrological traceability refers to the metrological traceability of measured values
used in assigning the qualitative value, together with information on qualitative reference materials or data used in
[4]
assigning the value. ISO 33406:2024 gives further information on statements of confidence and traceability for
qualitative reference materials.
Note 4 to entry: The uncertainty statement for a certified value generally includes contributions from reference
material characterization (3.3.1) and assessment of reference material homogeneity (3.3.8) and reference material
stability (3.3.11).
Note 5 to entry: Examples of metrologically valid procedures for reference material characterization (3.3.1) are
[3]
described in ISO 33405 .
3.1.4
indicative value, noun
information value, noun
value, assigned to a property of a reference material (3.1.1), that does not fulfil all the requirements of a
certified value (3.1.3), but is warranted as suitable for specific purposes as identified in the reference material
document (3.1.5)
Note 1 to entry: Indicative values can be suitable for, for example, comparison of laboratory results with an average
or consensus from other laboratories, use in method harmonization, assessing precision of a method, and assessing
stability of the composition of materials to which they are assigned. Because indicative values do not fulfil all the
requirements of a certified value, they are not usually suitable for use in calibration.
Note 2 to entry: Terms other than those listed can be used to refer to indicative values (e.g., assessed value, informative
value, reference value, and non-certified value).
3.1.5
reference material document
RM document, noun
document containing all the information that is essential for using a reference material (3.1.1)
[5]
Note 1 to entry: The required and recommended content of a reference material document is described in ISO 17034
[6]
and ISO 33401 . For the purposes of this definition, the required content is regarded as information that is essential
for using a reference material (3.1.1).
Note 2 to entry: Reference material producers (3.2.2) can use different terms to describe a reference material document,
including certificate, reference material certificate (3.1.6), certificate of analysis, or product information sheet (3.1.7).
3.1.6
reference material certificate
RM certificate, noun
reference material document (3.1.5) for a certified reference material (3.1.2), stating the certified value (3.1.3)
and confirming that the necessary procedures have been carried out to ensure its validity and metrological
traceability
3.1.7
product information sheet
reference material document (3.1.5) for a reference material (3.1.1) that is not a certified reference material
(3.1.2)
3.1.8
reference material production report
production report, noun
document giving detailed descriptions of all the steps taken in reference material production (3.2.1) of a
reference material (3.1.1) that is not a certified reference material (3.1.2)
Note 1 to entry: Information in a reference material production report can include descriptions of the preparation of
the reference material (3.1.1), methods of measurement, factors affecting accuracy, and statistical treatment of results.
3.1.9
reference material certification report
certification report, noun
document giving detailed descriptions of all the steps taken in reference material production (3.2.1) of a
certified reference material (3.1.2)
Note 1 to entry: Information in a reference material certification report can include descriptions of the preparation
of the certified reference material (3.1.2), methods of measurement, factors affecting accuracy, statistical treatment of
results, and the way in which metrological traceability has been established.
Note 2 to entry: The reference material producer (3.2.2) can include descriptions pertaining to indicative values (3.1.4)
in the reference material certification report.
3.2 Terms related to reference material production
3.2.1
reference material production
RM production, noun
production, noun
activities and tasks that are necessary in the development of a reference material (3.1.1) leading to, and
including, the reference material (3.1.1) becoming available to the user
Note 1 to entry: Necessary activities can include, for example, project planning, material handling and storage,
material processing, assessment of reference material homogeneity (3.3.8), assessment of reference material stability
(3.3.11), reference material characterization (3.3.1), where applicable, assignment of property values and statements of
their uncertainties and metrological traceability, and authorization and issue of a reference material document (3.1.5).
[5]
Note 2 to entry: Requirements for reference material production are described in ISO 17034 .
3.2.2
reference material producer
RM producer, noun
RMP, noun
body that is fully responsible for the reference material production (3.2.1)
Note 1 to entry: The body can be any organization or company, public or private.
3.2.3
subcontractor
body that undertakes selected aspects of reference material production (3.2.1) under its own management
system on behalf of the reference material producer (3.2.2)
Note 1 to entry: Aspects of reference material production that may be subcontracted by the reference material producer
[5]
(3.2.2) are specified in ISO 17034 .
Note 2 to entry: Subcontractors can be paid or unpaid.
Note 3 to entry: Advisors, who can be asked for recommendat
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