ISO/FDIS 33401

FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 33401
ISO/TC 334
Reference materials — Contents of
Secretariat: SABS
certificates, labels and accompanying
Voting begins on:
2023-09-08 documentation
Voting terminates on:
Matériaux de référence — Contenu des certificats, des étiquettes et de
2023-11-03
la documentation d'accompagnement
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
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/FDIS 33401:2023(E)
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. © ISO 2023

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ISO/FDIS 33401:2023(E)
FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 33401
ISO/TC 334
Reference materials — Contents of
Secretariat: SABS
certificates, labels and accompanying
Voting begins on:
documentation
Voting terminates on:
Matériaux de référence — Contenu des certificats, des étiquettes et de
la documentation d'accompagnement
COPYRIGHT PROTECTED DOCUMENT
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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or ISO’s member body in the country of the requester.
RECIPIENTS OF THIS DRAFT ARE INVITED TO
ISO copyright office
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
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THEY ARE AWARE AND TO PROVIDE SUPPOR TING
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DOCUMENTATION.
Phone: +41 22 749 01 11
IN ADDITION TO THEIR EVALUATION AS
Reference number
Email: copyright@iso.org
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/FDIS 33401:2023(E)
Website: www.iso.org
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
Published in Switzerland
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN­
DARDS TO WHICH REFERENCE MAY BE MADE IN
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  © ISO 2023 – All rights reserved
NATIONAL REGULATIONS. © ISO 2023

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ISO/FDIS 33401:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General . 3
5 The contents of a product information sheet or reference material certificate .3
5.1 General . 3
5.2 Information required in the RM document. 4
5.2.1 General . 4
5.2.2 Title of the document . 4
5.2.3 Unique identifier of the RM . 5
5.2.4 Name of the RM . 5
5.2.5 Name and contact details of the RM producer . 5
5.2.6 Intended use . 5
5.2.7 Minimum sample size . 6
5.2.8 Period of validity . 6
5.2.9 Commutability . 6
5.2.10 Storage information . . 6
5.2.11 Instructions for handling and use . 6
5.2.12 Document components . 7
5.2.13 Document version. 7
5.2.14 Measurement procedures for operationally defined measurands . 7
5.2.15 Property of interest . 7
5.3 The information required in an RM certificate . 7
5.3.1 General . 7
5.3.2 Description of the material . 7
5.3.3 Property value and associated uncertainty . 8
5.3.4 Metrological traceability . 8
5.3.5 Name and function of the RM producer’s approving officer . 8
5.4 Other useful information . 8
5.4.1 General . 8
5.4.2 Measurement methods for non-operationally defined measurands . 8
5.4.3 Health and safety information . 9
5.4.4 Subcontractors . 9
5.4.5 Indicative values . 9
5 .4 . 6 L e g a l not ic e . 9
5.4.7 Reference to a certification report . 9
6 Labels . 9
Bibliography .10
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ISO/FDIS 33401:2023(E)
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 non­governmental, 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 www.iso.org/patents. ISO shall not be held responsible for identifying any or all
such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
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 of ISO 33401 cancels and replaces ISO Guide 31:2015, which has been technically
revised.
The main changes are as follows:
— transformation from a Guide to an International Standard;
— addition of requirements for product information sheets and revision of Table 1 accordingly;
— editorial changes for clarification.
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.
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ISO/FDIS 33401:2023(E)
Introduction
Reference materials (RMs) are essential for quality assurance in various fields of measurement. RMs
are used in diverse measurement processes, including calibration, quality control, proficiency testing
and method validation.
Users of RMs obtain the information necessary for their proper use through the documentation
that accompanies RMs. Therefore, standardization is required for the content and format of RM
documentation. In response to growing needs, the ISO Committee on Reference Materials (ISO/REMCO)
published the first, second and third editions of ISO Guide 31 in 1981, 2000 and 2015, respectively. The
first edition of ISO Guide 31 discussed the difference between the information provided on the label,
the certificate and the certification report, and stressed the brief synoptic nature of the certificate.
The second edition focused on the required content of the certificate of a certified reference material
(CRM). The third edition introduced the concepts of a “product information sheet” and a “reference
material certificate” and described the information that should be included in these RM documents.
Having assumed the responsibilities of ISO/REMCO, ISO/TC 334 publishes this first edition of
International Standard, which largely follows the third edition of ISO Guide 31. This document is
intended to be complementary to ISO 17034 and provides support for the implementation of ISO 17034
on the requirements for RM documentation.
In this document, the term “certification” refers to the certification of RMs.
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FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 33401:2023(E)
Reference materials — Contents of certificates, labels and
accompanying documentation
1 Scope
This document is intended to help reference material producers (RMPs) in preparing clear and concise
documentation to accompany a reference material (RM). It lists and explains mandatory, recommended
and other categories of information to be considered in the preparation of product information sheets
and RM certificates. This information can be used by RM users and other stakeholders in confirming
the suitability of an RM or certified reference material (CRM).
This document also contains the minimum requirements for a label attached to the container of an
individual RM unit.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO Guide 30:2015, Reference materials — Selected terms and definitions
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO Guide 30 and the following
apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
reference material
RM
material, sufficiently homogeneous and stable with respect to one or more specified properties, which
has been established to be fit for its intended use in a measurement process
Note 1 to entry: RM is a generic term.
Note 2 to entry: Properties can be quantitative or qualitative, e.g. identity of substances or species.
Note 3 to entry: Uses can include the calibration of a measurement system, assessment of a measurement
procedure, assigning values to other materials and quality control.
Note 4 to entry: ISO/IEC Guide 99:2007 (VIM), 5.13 has an analogous definition but restricts the term
“measurement” to apply to quantitative values. However, ISO/IEC Guide 99:2007, 5.13, NOTE 3 specifically
includes qualitative properties, called “nominal properties”.
[SOURCE: ISO Guide 30:2015, 2.1.1, modified — Note 4 to entry revised.]
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ISO/FDIS 33401:2023(E)
3.2
certified reference material
CRM
reference material (3.1) characterized by a metrologically valid procedure for one or more specified
properties, accompanied by a reference material certificate (3.4) that provides the value of the specified
property, its associated uncertainty and a statement of metrological traceability
Note 1 to entry: The concept of value includes a nominal property or a qualitative attribute such as identity or
sequence. Uncertainties for such attributes may be expressed as probabilities or levels of confidence.
Note 2 to entry: ISO/IEC Guide 99:2007, 5.14 has an analogous definition.
[SOURCE: ISO Guide 30:2015, 2.1.2, modified — Notes 2 and 3 to entry deleted.]
3.3
product information sheet
document containing all the information that is essential for using a reference material (3.1) other than
a certified reference material (3.2)
[SOURCE: ISO Guide 30:2015, 2.3.4]
3.4
reference material certificate
RM certificate
document containing the essential information for the use of a certified reference material (3.2),
confirming that the necessary procedures have been carried out to ensure the validity and metrological
traceability of the stated property values
[SOURCE: ISO Guide 30:2015, 2.3.2, modified — Note 1 to entry deleted.]
3.5
reference material document
RM document
document containing all the information that is essential for using any reference material (3.1)
Note 1 to entry: The reference material document covers both the product information sheet and the reference
material certificate.
3.6
reference material producer
RMP
body (organization or company, public or private) that is fully responsible for project planning and
management; assignment of and decision on property values and relevant uncertainties; authorization
of property values; and issuance of a reference material certificate (3.4) or other statements for the
reference materials (3.1) it produces
[SOURCE: ISO Guide 30:2015, 2.3.5]
3.7
operationally defined measurand
measurand that is defined by reference to a documented and widely accepted measurement procedure
to which only results obtained by the same procedure can be compared
EXAMPLE Crude fibre in foods, impact toughness, enzyme activities and extractable lead in soils.
[SOURCE: ISO 17034:2016, 3.7, modified — Note 1 to entry changed to EXAMPLES.]
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ISO/FDIS 33401:2023(E)
3.8
certification report
document giving detailed information in addition to that contained in a reference material certificate
(3.4), e.g. on the preparation of the material, methods of measurement, factors affecting accuracy,
statistical treatment of results or the way in which metrological traceability was established
[SOURCE: ISO Guide 30:2015, 2.3.3, modified — Term revised and Note 1 to entry deleted.]
4 General
In this document, the term “reference material certificate” is used for a document accompanying a
CRM and the term “product information sheet” is used for a document accompanying any other type
of RM. RM document covers the concepts of both the reference material certificate and the product
information sheet.
The specifications for product information sheets, RM certificates and labels given in the following
clauses include those mentioned in ISO 17034.
...