SIST EN ISO 15193:2026
(Main)In vitro diagnostic medical devices - Requirements for reference measurement procedures (ISO 15193:2026)
- Abstract
This document specifies requirements for reference measurement procedures (RMP) for measurands used in laboratory medicine.
This document applies to:
RMPs providing values of differential or rational quantities where each quantity value is a numerical value multiplied by a measurement unit. Annex A provides information on ordinal quantities and nominal properties;
any person, body or institution developing RMPs for measurands used in laboratory medicine.
- Status
- Published
- Public Enquiry End Date
- 17-Mar-2024
- Publication Date
- 19-Aug-2026
- Technical Committee
- VAZ - Healthcare
- Current Stage
- 6060 - National Implementation/Publication (Adopted Project)
- Start Date
- 30-Jul-2026
- Due Date
- 04-Oct-2026
- Completion Date
- 20-Aug-2026
SIST EN ISO 15193:2026 is the Slovenian adoption of EN ISO 15193:2026, which republishes ISO 15193:2026 for in vitro diagnostic medical devices. It specifies requirements for reference measurement procedures (RMP) used in laboratory medicine, so that they can support traceability, calibration, trueness assessment, and value assignment.
The standard is aimed at the people and organizations that develop RMPs for measurands in laboratory medicine. In practice, it tells the reader what an RMP has to contain, how it should be validated, and how its results should be reported.
What does SIST EN ISO 15193:2026 specify?
SIST EN ISO 15193:2026 specifies the requirements for reference measurement procedures (RMP) for measurands used in laboratory medicine. Its main focus is on RMPs for differential or rational quantities, where a quantity value is expressed as a numerical value multiplied by a measurement unit.
The scope also points readers to Annex A for ordinal quantities and nominal properties, which are treated as special cases. The document is organized around Clause 4, which sets out the technical requirements, plus two annexes.
| Annex | What it covers |
|---|---|
| Annex A | Reference procedures for ordinal quantities and nominal properties |
| Annex ZA | Relationship between the European Standard and Regulation (EU) 2017/746 |
Clause 4 is arranged to take a procedure from definition and materials through operation, data processing, validation, reporting, and quality assurance. That structure matters because it shows what a complete RMP description must cover.
What are the key requirements of SIST EN ISO 15193:2026?
SIST EN ISO 15193:2026 requires an RMP to be publicly available and described in enough detail to serve as the basis of a documented measurement procedure. In practical terms, a developer should be able to hand the description to another competent laboratory and have the procedure understood and implemented.
RMP content and documentation
Clause 4.2 says the RMP description has to include the mandatory elements listed in Table 1, such as warning and safety precautions, introduction, scope, measurement principle and method, reagents and materials, apparatus and equipment, sampling, preparation, operation, data processing, validation, reporting, quality assurance, and dates of authorization and revision. This is important because it turns the procedure into a structured, reviewable document rather than a loose laboratory method.
Clause 4.4 requires the introduction to identify the measurand, explain its role in health care, describe the measurement principle and method, and place the procedure in a metrological traceability hierarchy. That helps readers understand what quantity is being measured and how the procedure fits into calibration and value assignment.
Clause 4.5 requires the scope to state intended use, applicable sample types, interferences, and the measurement interval. For a buyer or quality manager, this is the quickest check that the procedure matches the intended samples and the measurement range.
Materials, sampling, and setup
Clause 4.8 requires reagents and materials to be defined clearly, including analytical properties, concentration expressions, dilution expressions, storage, shelf life, disposal, and safety information. It also sets a preference for SI-based concentration expressions and gives specific rules for how dilution should be written.
Clause 4.11 requires consideration of pre-analytical factors and the properties of the primary sample, including collection, transport, storage, and handling. That matters because many measurement errors start before the analytical step begins.
Clause 4.12 covers preparation of the measuring system and the analytical portion, including apparatus preparation, calibration, analytical sample types, series design, and analytical portion preparation. It requires calibration to be described in detail, including calibrator choice, preparation, measurement, computation of the calibration function, acceptance criteria, and re-calibration intervals.
Operation, data processing, validation, and reporting
Clause 4.13 requires the sequence of measurement steps to be stated unambiguously, including verification of equipment performance, the measurement steps on the analytical portion or analytical solution, and system indication. Clause 4.14 then requires the calculation model, raw data treatment, calibration function construction, the final calculation equation, the result units, rounding, and measurement uncertainty calculation.
Clause 4.15 is the validation core of the document. It requires evidence that the RMP is fit for its intended use and asks for documented values, with uncertainties where relevant, for calibration function, analytical measurement function, sensitivity, influence quantities, blank measurement, carry-over, recovery, trueness, precision, limit of detection, measurement interval, comparison with reference materials, interlaboratory comparison, and measurement uncertainty. In practice, this is the part that shows whether the procedure performs well enough for reference use.
Clause 4.17 requires the measurement report to identify the MP used, the calibration materials, the result with quantity name, numerical value, unit, and uncertainty, plus relevant observations and any modifications. Clause 4.18 requires internal quality control and external quality assessment where available, so the procedure is not only validated once but also controlled in routine use.
What terms does SIST EN ISO 15193:2026 define?
- measurand - the quantity intended to be measured, such as a named concentration in a specific biological system.
- measurement procedure (MP) - a written specification of how a measurement is performed, including reagents, equipment, calculations, and operating steps.
- reference measurement procedure (RMP) - a measurement procedure accepted as fit for assessing trueness, calibration, or assigning a quantity value to a CRM.
- reference material (RM) - a material that is sufficiently homogeneous and stable for a specified use in measurement or examination.
- certified reference material (CRM) - an RM with documentation from an authoritative body, including a specified property value, uncertainty, and traceability.
- metrological traceability - the property of a measurement result being linked to a reference through a documented unbroken chain of calibrations.
- measurement uncertainty - the non-negative parameter that characterizes the dispersion of values attributed to a measurand.
- analytical selectivity - the property of a measuring system to give values for one or more measurands that are independent of other quantities present.
Who uses SIST EN ISO 15193:2026?
SIST EN ISO 15193:2026 is used by people, bodies, and institutions that develop RMPs for measurands in laboratory medicine. It is also relevant to reference laboratories, calibration laboratories, and manufacturers that need to assign values to calibrators, trueness control materials, or human samples.
Medical laboratories use it when they need procedures that support comparable results across different measuring systems. Quality managers and technical assessors use it to review validation evidence, uncertainty budgets, and the completeness of the procedure description.
What changed in SIST EN ISO 15193:2026 from the previous edition?
SIST EN ISO 15193:2026 replaces SIST EN ISO 15193:2009. The third edition is described as technically revised, with these stated changes:
- requirements, concepts, and definitions were aligned with ISO 17511, ISO 15194, and ISO 15195
- the content was adapted so it applies to all types of measurands
- Clause 4 was revised to present the requirements more transparently
- subclause 4.1 was added to emphasize quality requirements for an RMP
- subclause 4.15 was updated and its validation aspects were summarized
Which standards are used with SIST EN ISO 15193:2026?
The document normatively references these standards:
- ISO/IEC Guide 98-3 - guidance for expressing measurement uncertainty
- ISO/IEC Guide 99 - the metrology vocabulary used for key terms and definitions
- ISO 15194 - requirements for certified reference materials and supporting documentation
- ISO 17511:2020 - requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials, and human samples
The text also points to related standards and guidance used alongside it, including ISO 15195, ISO 14971, ISO 15190, ISO 5725-1, ISO 5725-2, ISO 5725-3, ISO 5725-4, ISO 11095, ISO 17034, ISO 33403, ISO 33405, ISO/IEC Guide 51, ISO/IEC Guide 63, and ISO 78-2. These support topics such as calibration laboratory competence, risk management, safety, precision and trueness studies, linear calibration, reference material production, and standard layout.
What does the SIST EN ISO 15193:2026 document contain?
The document contains a structured technical framework for writing and validating an RMP. Table 1 in Clause 4.2 lists the required content elements, and Clause 4.15 gives the validation topics that have to be addressed for a procedure to be considered fit for purpose.
It also includes detailed treatment of sampling, sample preparation, calibration, analytical series design, data processing, and result reporting. Annex A provides guidance on how RMP-style procedures can be approached for ordinal quantities and nominal properties, including the kinds of statistics that are appropriate for each.
For the European edition, Annex ZA maps the standard to Regulation (EU) 2017/746 and its General Safety and Performance Requirements. That annex is used when the standard is applied in support of EU regulatory conformity.
Relations
- Effective Date
- 01-Sep-2026
- Effective Date
- 12-Aug-2026
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Frequently Asked Questions
SIST EN ISO 15193:2026 is a standard published by the Slovenian Institute for Standardization (SIST). Its full title is "In vitro diagnostic medical devices - Requirements for reference measurement procedures (ISO 15193:2026)". This standard covers: This document specifies requirements for reference measurement procedures (RMP) for measurands used in laboratory medicine. This document applies to: RMPs providing values of differential or rational quantities where each quantity value is a numerical value multiplied by a measurement unit. Annex A provides information on ordinal quantities and nominal properties; any person, body or institution developing RMPs for measurands used in laboratory medicine.
This document specifies requirements for reference measurement procedures (RMP) for measurands used in laboratory medicine. This document applies to: RMPs providing values of differential or rational quantities where each quantity value is a numerical value multiplied by a measurement unit. Annex A provides information on ordinal quantities and nominal properties; any person, body or institution developing RMPs for measurands used in laboratory medicine.
SIST EN ISO 15193:2026 is classified under the following ICS (International Classification for Standards) categories: 11.100.10 - In vitro diagnostic test systems. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN ISO 15193:2026 has the following relationships with other standards: It is inter standard links to SIST EN ISO 15193:2009, SIST-V ISO/IEC Vodilo 99:2012. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN ISO 15193:2026 is associated with the following European legislation: EU Directives/Regulations: 2017/746; Standardization Mandates: M/575, M/575 AMD 2. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
SIST EN ISO 15193:2026 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)
SLOVENSKI STANDARD
01-september-2026
Nadomešča:
SIST EN ISO 15193:2009
Diagnostični medicinski pripomočki in vitro - Zahteve za referenčne merilne
postopke (ISO 15193:2026)
In vitro diagnostic medical devices - Requirements for reference measurement
procedures (ISO 15193:2026)
In-vitro-Diagnostika - Anforderungen an Referenzmessverfahren (ISO 15193:2026)
Dispositifs médicaux de diagnostic in vitro - Exigences relatives aux procédures de
mesure de référence (ISO 15193:2026)
Ta slovenski standard je istoveten z: EN ISO 15193:2026
ICS:
11.100.10 Diagnostični preskusni In vitro diagnostic test
sistemi in vitro systems
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 15193
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2026
EUROPÄISCHE NORM
ICS 11.100.10 Supersedes EN ISO 15193:2009
English Version
In vitro diagnostic medical devices - Requirements for
reference measurement procedures (ISO 15193:2026)
Dispositifs médicaux de diagnostic in vitro - Exigences In-vitro-Diagnostika - Anforderungen an
relatives aux procédures de mesure de référence (ISO Referenzmessverfahren (ISO 15193:2026)
15193:2026)
This European Standard was approved by CEN on 21 June 2026.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2026 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15193:2026 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard the General Safety
and Performance Requirements of Regulation (EU) 2017/746 aimed to be covered . 4
European foreword
This document (EN ISO 15193:2026) has been prepared by Technical Committee ISO/TC 212 "Medical
laboratories and in vitro diagnostic systems" in collaboration with Technical Committee CEN/TC 140
“In vitro diagnostic medical devices” the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by January 2027, and conflicting national standards shall
be withdrawn at the latest by July 2029.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 15193:2009.
This document has been prepared under a standardization request addressed to CEN by the European
Commission. The Standing Committee of the EFTA States subsequently approves these requests for its
Member States.
For the relationship with EU Legislation, see informative Annex ZA, which is an integral part of this
document.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 15193:2026 has been approved by CEN as EN ISO 15193:2026 without any modification.
Annex ZA
(informative)
Relationship between this European Standard the General Safety and
Performance Requirements of Regulation (EU) 2017/746 aimed to be
covered
This European standard has been prepared under M/575 to provide one voluntary means of
conforming to the General Safety and Performance Requirements of Regulation (EU) 2017/746 of 5
April 2017 concerning in vitro diagnostic medical devices [OJ L 117] and to system or process
requirements including those relating to quality management systems, risk management, post-market
surveillance systems, performance studies, clinical evidence or post-market performance follow-up.
Once this standard is cited in the Official Journal of the European Union under that Regulation,
compliance with the normative clauses of this standard given in Tables ZA.1, ZA.3, ZA.4 and application
of the edition of the normatively referenced standards as given in Table ZA.2 confers, within the limits
of the scope of this standard, a presumption of conformity with the corresponding General Safety and
Performance Requirements of that Regulation, and associated EFTA Regulations.
Where a definition in this standard differs from a definition of the same term set out in Regulation (EU)
2017/746, the differences shall be indicated in the Annex ZA. For the purpose of using this standard in
support of the requirements set out in Regulation (EU) 2017/746, the definitions set out in this
Regulation prevail.
Where the European standard is an adoption of an International Standard, the scope of this standard
can differ from the scope of the European Regulation that it supports. As the scope of the applicable
regulatory requirements differ from nation to nation and region to region, the standard can only
support European regulatory requirements to the extent of the scope of the In vitro Diagnostic
Regulation (EU) 2017/746.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Regulation (EU) 2017/746. This means that risks have to be
‘reduced as far as possible’, ‘reduced to a level as low as reasonably practicable’, ‘reduced to the lowest possible
level’, ‘reduced as far as possible and appropriate’, ‘removed or reduced as far as possible’, ‘eliminated or reduced
as far as possible’, ‘prevented’ or ‘minimized’, according to the wording of the corresponding General Safety and
Performance Requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with General Safety
and Performance Requirements 1, 2, 3, 4, 5, 8, 10, 11, 13, 15, 16, 17, 18 and 19 of the Regulation.
NOTE 3 When a General Safety and Performance Requirement does not appear in Table ZA.1, it means that it is
not addressed by this European Standard.
Table ZA.1— Correspondence between this European Standard and Annex I of
Regulation (EU) 2017/746 [OJ L 117] and to system or process requirements including
those relating to quality management systems, risk management, post-market surveillance
systems, clinical investigations, clinical evaluation or post-market clinical follow-up
General Safety and
Clause(s) / sub-
Performance
clause(s)
Remarks / Notes
Requirements of
of this EN
Regulation (EU) 2017/746
9.3 4.1, 4.12.3, 4.15 Covered with respect to
The description of suitable reference
measurement procedures.
The use of calibrators.
The requirements of suitable reference
measurement procedures and their
validation.
NOTE: The expression of uncertainty
in measurements is not covered by
this standard.
Table ZA.2— Normative references from Clause 2 of this document and their corresponding
European publications
Column 1 Column 2 Column 3 Column 4
Reference in International Title Corresponding
Clause 2 Standard Edition European Standard
Edition
ISO/IEC Guide 98- ISO/IEC Guide 98- Guide to the expression None
3:2008 3:2008 of uncertainty in
measurement
(GUM:1995)
ISO/IEC Guide 99:20 ISO/IEC Guide 99:2007 International None
07 vocabulary of metrology
— Basic and general
concepts and associated
terms (VIM)
ISO 15194 ISO 15194:2026 In vitro diagnostic EN ISO 15194:2026
medical devices —
Requirements for
certified reference
materials and the
content of supporting
documentation
ISO 17511:2020 ISO 17511:2020 In vitro diagnostic EN ISO 17511:2021
medical devices —
Requirements for
establishing
metrological traceability
Column 1 Column 2 Column 3 Column 4
Reference in International Title Corresponding
Clause 2 Standard Edition European Standard
Edition
of values assigned to
calibrators, trueness
control materials and
human samples
Table ZA.3— Correspondence between this European standard and the requirements
of Article 100 of Regulation (EU) 2017/746 [OJ L 117]
Requirements of Article 100 Clause(s) / sub-clause(s)
Remarks / Notes
of (EU) 2017/746 of this EN
2. (h) 4.15 Covered with respect to the
determination of the performance
criteria (validation) to define the
suitability of a reference
measurement procedure to the
intended use.
Table ZA.4— Correspondence between this European standard and Annex XIII of Regulation
(EU) 2017/746 [OJ L 117] and to requirements for the performance evaluation, performance
studies and post-market performance follow-up
Clause(s) / sub-clause(s)
Annex XIII of (EU) 2017/746 Remarks / Notes
of this EN
th
1.1. 5 bullet point 4.2 Covered with respect to
information to identify the
applied reference
measurement procedure.
The documents listed in the Column 1 of Table ZA.2, in whole or in part, are normatively referenced in
this document and are indispensable for its application. The achievement of the presumption of
conformity is subject to the application of the edition of Standards as listed in Column 4 or, if no
European Standard Edition exists, the International Standard Edition given in Column 2 of Table ZA.2.
WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European
standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2 — Other Union legislation may be applicable to the product(s) falling within the scope of
this standard.
International
Standard
ISO 15193
Third edition
In vitro diagnostic medical
2026-06
devices — Requirements for
reference measurement procedures
Dispositifs médicaux de diagnostic in vitro — Exigences relatives
aux procédures de mesure de référence
Reference number
ISO 15193:2026(en) © ISO 2026
ISO 15193:2026(en)
© ISO 2026
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
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Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 15193:2026(en)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements for a reference measurement procedure .10
4.1 General .10
4.2 Elements of a reference measurement procedure .11
4.3 Warning and safety precautions .11
4.4 Introduction . 12
4.5 Scope . . 12
4.6 Terms, definitions, symbols, and abbreviated terms . 12
4.6.1 Concepts . 12
4.6.2 Nomenclature . 12
4.6.3 Trivial names . 13
4.7 Measurement principle and measurement method . 13
4.8 Reagents and materials . 13
4.8.1 General . 13
4.8.2 Descriptive items . 13
4.8.3 Expression of concentration .14
4.8.4 Expression of dilution . 15
4.8.5 Reference to patented items . 15
4.9 Apparatus and equipment . 15
4.9.1 Description . 15
4.9.2 Auxiliary equipment . 15
4.10 Consumables . . . 15
4.11 Sampling and sample . 15
4.11.1 General . 15
4.11.2 Samples . 15
4.12 Preparation of measuring system and analytical portion .16
4.12.1 General .16
4.12.2 Preparation of apparatus . .16
4.12.3 Calibration . . .16
4.12.4 Types of analytical sample .17
4.12.5 Design of analytical series .17
4.12.6 Analytical portion .17
4.12.7 Analytical solution .17
4.13 Operation of measuring system .17
4.13.1 Sequence of measurement steps .17
4.13.2 Blank .17
4.13.3 Validation of measurement conditions .18
4.14 Data processing.18
4.14.1 Calculation of measurement results .18
4.14.2 Conversion equations .18
4.15 Validation .19
4.15.1 Concepts, values, and their use . .19
4.15.2 Analytical calibration function .19
4.15.3 Analytical measurement function .19
4.15.4 Analytical sensitivity .19
4.15.5 Analytical influence quantities .19
4.15.6 Blank measurement . 20
4.15.7 Carry-over . 20
4.15.8 Recovery studies . 20
4.15.9 Measurement trueness . 20
iii
ISO 15193:2026(en)
4.15.10 Measurement precision . 20
4.15.11 Limit of detection .21
4.15.12 Measurement interval .21
4.15.13 Validation by using RM .21
4.15.14 Interlaboratory comparison .21
4.15.15 Measurement uncertainty .21
4.16 Special cases . 22
4.17 Reporting of measurement results. 22
4.18 Quality assurance . 22
4.19 Bibliography . 23
4.20 Dates of authorization and revision . 23
Annex A (informative) Reference procedures for ordinal quantities and nominal properties .24
Bibliography .25
iv
ISO 15193:2026(en)
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 documents 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 212, Medical laboratories and in vitro diagnostic
systems, in collaboration with the European Committee for Standardization (CEN) Technical Committee
CEN/TC 140, In vitro diagnostic medical devices, in accordance with the Agreement on technical cooperation
between ISO and CEN (Vienna Agreement).
This third edition cancels and replaces the second edition (ISO 15193:2009), which has been technically
revised.
The main changes are as follows:
— incorporated requirements, concepts and definitions for consistency with ISO 17511, ISO 15194, and
ISO 15195;
— adapted content to make the document applicable to all types of measurands;
— revised Clause 4 to present requirements more transparently;
— added 4.1 added to emphasize quality requirements for a reference measurement procedure (MP);
— updated and summarized aspects of validation in 4.15.
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.
v
ISO 15193:2026(en)
Introduction
Reference measurement systems are needed to enable the results produced by end user measurement
procedures (MPs) to be metrologically traceable to either measurement standards, or measurement
procedures, or both of the highest metrological level. Such systems exist within a metrological traceability
chain/calibration hierarchy as described in ISO 17511. In the context of in vitro diagnostic (IVD) medical
devices, traceability to the highest metrological level reduces the risk of harm to patients by avoiding
inconsistent results from different measuring systems.
Reference measurement procedures play a crucial role in this metrological traceability system, because they
can be used for the following:
a) assessing performance properties of measuring systems – comprising measuring instruments, auxiliary
equipment as well as reagents,
b) assessing whether there is a functional interchangeability of different end user measurement procedures
purporting to measure the same quantity,
c) assigning quantity values to reference materials that are then used for purposes of calibration or
measurement trueness control of measurement procedures, and
d) detecting analytical influence quantities in biological samples measured using end user measurement
procedures.
For medical laboratory measurements, in particular, it is important to both patient care and health screening
that the measurement results reported by different end user measuring systems be equivalent, comparable
over time, reproducible and accurate. Establishing metrological traceability of an end user measuring system
to a reference measurement procedure enables equivalent results to be reported. A reference measurement
procedure should be specified, especially when
— it is required by e.g. standards, technical specifications, or technical regulations,
— quantity values are to be stated by the manufacturer, and
— technical requirements have a direct relationship to the performance of a product or process.
vi
International Standard ISO 15193:2026(en)
In vitro diagnostic medical devices — Requirements for
reference measurement procedures
1 Scope
This document specifies requirements for reference measurement procedures (RMP) for measurands used
in laboratory medicine.
This document applies to:
a) RMPs providing values of differential or rational quantities where each quantity value is a numerical
value multiplied by a measurement unit. Annex A provides information on ordinal quantities and
nominal properties;
b) any person, body or institution developing RMPs for measurands used in laboratory medicine.
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/IEC Guide 98-3, Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in
me a s ur ement (GUM: 1995)
ISO/IEC Guide 99, International vocabulary of metrology — Basic and general concepts and associated terms
(VIM)
ISO 15194, In vitro diagnostic medical devices — Requirements for certified reference materials and the content
of supporting documentation
ISO 17511:2020, In vitro diagnostic medical devices — Requirements for establishing metrological traceability
of values assigned to calibrators, trueness control materials and human samples
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO/IEC Guide 99, ISO 15194, and
ISO 17511 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
analyte
component represented in the name of a measurable quantity (3.31)
EXAMPLE In the type of quantity “mass of protein in 24-hour urine”, “protein” is the analyte. In “amount of
substance of glucose in plasma”, “glucose” is the analyte. In both cases the full phrase describes the measurand (3.18).
[SOURCE: ISO 17511:2020, 3.1]
ISO 15193:2026(en)
3.2
analytical portion
portion of material taken from the analytical sample (3.3) and on which the measurement is actually carried
out, either directly or following dissolution
Note 1 to entry: The analytical portion is taken directly from the primary sample (3.30) or laboratory sample (3.15) if
no preparation of these is required. The analytical portion is sometimes dissolved to give an analytical solution (3.6)
before being exposed to the measuring device.
3.3
analytical sample
sample prepared from the laboratory sample (3.15) and from which analytical portions (3.2) can be taken
Note 1 to entry: The analytical sample can be subjected to various treatments before an analytical portion is taken.
3.4
analytical selectivity
selectivity of a measuring system
selectivity
property of a measuring system (3.27), used with a specified measurement procedure (MP) (3.23), whereby
it provides measured quantity (3.31) values for one or more measurands (3.18) such that the values of each
measurand are independent of other measurands or other quantities in the phenomenon, body, or substance
being investigated
[SOURCE: ISO 17511:2020, 3.2, modified — the example and the Notes to entry were removed.]
3.5
analytical sensitivity
quotient of the change in an indication of a measuring system (3.27) and the corresponding change in the
value of a quantity (3.31) being measured
Note 1 to entry: ISO/IEC Guide 99:2007, 4.12 uses the term “sensitivity of a measuring system”.
3.6
analytical solution
solution prepared prior to measurement by dissolving an analytical portion (3.2) in a liquid material or
dispersing it in a solid material, with or without reaction
3.7
blank
lack of the analyte (3.1) or another component necessary to produce an indication of a measuring system
(3.27) that is specific to the analyte
3.8
calibrator
certified reference material (CRM) (3.10) or reference material (RM) (3.33) with a traceable assigned quantity
(3.31) value used in calibration of a measuring system (3.27) according to a specified measurement procedure
(MP) (3.23)
[SOURCE: ISO 17511:2020, 3.6, modified — in the definition, “measurement standard” was changed to “CRM
or RM with a traceable assigned quantity value”.]
3.9
carry-over
contamination from one analytical portion (3.2) to the next
ISO 15193:2026(en)
3.10
certified reference material
CRM
reference material RM (3.33), accompanied by documentation issued by an authoritative body and providing
one or more specified property values with associated uncertainty and traceability using valid procedures
EXAMPLE Human serum with an assigned quantity (3.31) value and associated measurement uncertainty (3.26)
for concentration (amount of substance per unit volume) of cholesterol inherently present in the serum and used as a
calibrator (3.8) or as a trueness control material (3.11).
Note 1 to entry: “Documentation” is given in the form of a reference material certificate and a certification report.
Note 2 to entry: Requirements for the production and characterization of CRM are given in ISO 17034 and ISO 15194.
1)
ISO 33405 provides technical guidance on the characterization and the assessment of the homogeneity and stability
of a CRM.
Note 3 to entry: In this definition, “uncertainty” covers both ‘measurement uncertainty’ and ‘uncertainty associated
with the value of a nominal property’, such as for identity or sequence. “Traceability” covers both ‘metrological
traceability (3.28) of a quantity value’ and ‘traceability of a nominal property’.
Note 4 to entry: Specified quantity values of CRMs require metrological traceability with associated measurement
uncertainty.
Note 5 to entry: Specific requirements for CRMs and the content of supporting documentation (in the field of in vitro
diagnostic (IVD) medical devices) are given in ISO 15194.
Note 6 to entry: For a specified material, a calibration certificate provided by an accredited calibration laboratory is
not by itself sufficient to confer the status of CRM on these types of materials.
[SOURCE: ISO 17511:2020, 3.9, modified — in Note 1 to entry, “certification report” was added; Note 2 to
entry was changed; the original Note 5 to entry was deleted and Notes 6 and 7 were renumbered as Notes 5
and 6; in Note 6 to entry, “does not confer” was changed to “is not by itself sufficient to confer”.]
3.11
control material
substance, material or artefact intended by its producer to be used to verify the performance of a
measurement procedure (MP) (3.23)
Note 1 to entry: The control material should be a certified reference material(CRM) (3.10), if available.
[SOURCE: ISO 17511:2020 3.11, modified — Note 1 to entry was added.]
3.12
examination
set of operations having the objective of determining the numerical value, text value or characteristics of a
property
Note 1 to entry: An examination may be the total of a number of activities, observations or measurements required to
determine a value or characteristic.
Note 2 to entry: Laboratory examinations that determine a numerical value of a property are called “quantitative
examinations”; those that determine the characteristics of a property are called “qualitative examinations”.
[SOURCE: ISO 15189: 2022, 3.8, modified — Note 3 to entry was removed.]
3.13
influence quantity
quantity (3.31) that, in a direct measurement, does not affect a quantity that is actually measured, but affects
the relation between the indication and the measurement result
[SOURCE: ISO/IEC Guide 99:2007, 2.52, modified — the examples and the Notes were removed.]
1) Updated reference: ISO 33405 replaced ISO Guide 35, which has been withdrawn.
ISO 15193:2026(en)
3.14
intermediate precision standard deviation
standard deviation of independent test results obtained with the same method under stipulated conditions
Note 1 to entry: Stipulations can be measurements made at different times, different operators, different equipment,
calibrations carried out between measurements or any combination of those stipulations (from ISO 5725-3:1994,
2)
Table 1 ).
Note 2 to entry: Synonyms are “inter-run standard deviation”, “inter-series standard deviation”, “between-run
standard deviation” and “between-series standard deviation”.
3.15
laboratory sample
subsample of the primary sample (3.30), as prepared for sending to, or as received by, the laboratory and
intended for measurement
Note 1 to entry: In cases where there is no subsample of the primary sample, the primary sample can also be used as
the laboratory sample.
3.16
limit of detection
measured quantity (3.31) value, obtained by a given measurement procedure (MP) (3.23), for which the
probability of falsely claiming the absence of a component in a material is β, given a probability α of falsely
claiming its presence
Note 1 to entry: International Union of Pure and Applied Chemistry (IUPAC) recommends default values for α and β
equal to 0,05.
Note 2 to entry: The abbreviation LOD is sometimes used, but not in this document.
Note 3 to entry: The term “sensitivity” is discouraged for this concept.
[SOURCE: ISO/IEC Guide 99:2007, 4.18, modified — “limit of detection” is used as preferred term, and the
term “detection limit” was removed; in Note 2 to entry “, but not in this document” was added; in Note 3 to
entry, “detection limit” was changed to “this concept”.]
3.17
matrix
system matrix
components of a material, except the analyte (3.1)
Note 1 to entry: The biological system excluding the analyte is the matrix of the material.
EXAMPLE In the measurand (3.18) “mass concentration of protein in urine”, “urine” is the matrix. In the
measurand “amount of substance of glucose in plasma”, “plasma” is the matrix.
[SOURCE: ISO 17511:2020, 3.24, modified — the Example was added.]
3.18
measurand
quantity (3.31) intended to be measured
Note 1 to entry: Specification of a measurand requires knowledge of the kind of quantity, description of the state of the
phenomenon, body, or substance carrying the quantity, including any relevant component, and the chemical entities
involved.
Note 2 to entry: The measurement, including the measuring system (3.27) and the conditions under which the
measurement is carried out, could change the phenomenon, body, or substance such that the quantity being measured
can differ from the measurand as defined. In this case, adequate correction is necessary.
EXAMPLE The length of a steel rod in equilibrium at ambient Celsius temperature of 23 °C will be different from
the length at the specified temperature of 20 °C, which is the measurand. In this case, a correction is necessary.
2) Withdrawn.
ISO 15193:2026(en)
Note 3 to entry: “Analyte” (3.1), or the name of a substance or compound, are terms sometimes used for “measurand”.
This usage is erroneous because these terms do not refer to quantities.
Note 4 to entry: In laboratory medicine, the description of the measurand includes the name of the quantity (e.g.
amount of substance concentration), the component/analyte (e.g. β-D-glucose), and the biological system in which it is
found (e.g. blood plasma).
[SOURCE: ISO 17511:2020, 3.26, modified — the original Note 2 to entry was removed, and Notes 3, 4, and 5
to entry were renumbered.]
3.19
measurement interval
set of values of quantities (3.31) of the same kind that can be measured by a given measuring instrument or
measuring system (3.27) with specified instrumental uncertainty , under defined conditions
3.20
measurement method
method of measurement
generic description of a logical organization of operations used in a measurement
[SOURCE: ISO 17511:2020, 3.30, modified — Note 1 to entry was removed.]
3.21
measurement precision
precision of measurement
closeness of agreement between indications or measured quantity (3.31) values obtained by replicate
measurements on the same or similar objects under specified conditions
Note 1 to entry: Measurement precisi
...