EN ISO 18113-5:2024

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2022)

This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for self-testing.
This document is also applicable to apparatus and equipment intended to be used with IVD instruments for self-testing.
This document can also be applicable to accessories.
This document does not apply to:
a) instructions for instrument servicing or repair;
b) IVD reagents, including calibrators and control materials for use in control of the reagent;
c) IVD instruments for professional use.

In‑vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller (Kennzeichnung) - Teil 5: Geräte für in‑vitro-diagnostische Untersuchungen zur Eigenanwendung (ISO 18113‑5:2022)

Dieses Dokument legt Anforderungen an die durch den Hersteller von in vitro-diagnostischen (IVD )Geräten für Untersuchungen zur Eigenanwendung bereitgestellten Informationen fest.
Dieses Dokument ist anwendbar auch für Geräte und Ausrüstungen, die für den Gebrauch zusammen mit IVD Geräten für Untersuchungen zur Eigenanwendung vorgesehen sind.
Dieses Dokument kann auch auf Zubehör angewendet werden.
Dieses Dokument ist nicht anwendbar für:
a)   Anweisungen für die Geräteinstandhaltung oder  reparatur;
b)   IVD Reagenzien, einschließlich Kalibriermaterialien und Kontrollmaterialien zur Kontrolle des Reagenzes;
c)   IVD Geräte für den Gebrauch durch Fachpersonal.

Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant (étiquetage) - Partie 5: Instruments de diagnostic in vitro destinés aux autodiagnostics (ISO 18113-5:2022)

Le présent document spécifie les exigences relatives aux informations fournies par le fabricant d’instruments de diagnostic in vitro (DIV) destinés aux autodiagnostics.
Le présent document est également applicable aux appareillages et équipements destinés à être utilisés avec les instruments de DIV destinés aux autodiagnostics.
Le présent document peut aussi s’appliquer aux accessoires.
Le présent document ne s’applique pas à ce qui suit:
a) instructions d’entretien ou de réparation des instruments;
b) réactifs de DIV, y compris les étalons et les matériaux de contrôle à utiliser dans le contrôle du réactif;
c) instruments de DIV à usage professionnel.

In vitro diagnostični preskusni sistemi - Informacije proizvajalca (označevanje) - 5. del: Diagnostični instrumenti in vitro za samopreskušanje (ISO 18113-5:2022)

Ta dokument določa zahteve za informacije, ki jih mora zagotoviti proizvajalec diagnostičnih instrumentov in vitro (IVD), namenjenih za samopreskušanje.
Ta dokument se uporablja tudi za naprave in opremo, namenjene uporabi z diagnostičnimi instrumenti in vitro za samopreskušanje.
Uporabiti ga je mogoče tudi za dodatno opremo.
Ta dokument se ne uporablja za:
a) navodila za servisiranje ali popravilo instrumentov;
b) diagnostične reagente in vitro, vključno s kalibratorji in kontrolnim materialom za uporabo pri nadzoru reagentov;
c) diagnostične instrumente in vitro za strokovno uporabo.

General Information

• Status: Published
• Publication Date: 11-Jun-2024
• ICS: 11.100.10 - In vitro diagnostic test systems
• Technical Committee: CEN/TC 140 - In vitro diagnostic systems
• Drafting Committee: CEN/TC 140 - In vitro diagnostic systems
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 12-Jun-2024
• Completion Date: 12-Jun-2024
• Directive: 2017/746 - Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Mandate: M/575 AMD 2 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medicial devices in support of Regulation (EU) 2017746
• Ref Project: SIST EN ISO 18113-5:2024 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2022)

Relations

• Replaces: EN ISO 18113-5:2011 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)
• Effective Date: 19-Jan-2023

Overview

EN ISO 18113-5:2024 (ISO 18113-5:2022) defines the information that manufacturers must supply (labelling and instructions for use) for in vitro diagnostic (IVD) instruments intended for self‑testing. Adopted by CEN as a European Standard, it applies to IVD instruments for lay use, associated apparatus/equipment and accessories - but excludes servicing/repair instructions, IVD reagents (including calibrators and controls) and IVD instruments intended for professional use. EN ISO 18113-5 is part of the EN ISO 18113 series and should be read together with Part 1 (terms, definitions and general requirements).

Key topics and requirements

This standard sets out technical labelling and information requirements focused on safe and correct self‑testing:

• Essential requirements for information supplied by the manufacturer (scope and applicability).
• Labels and marking: mandatory marking elements and placement rules for self‑test instruments.
• Identification elements: device name, serial number, batch/lot code, and UDI (unique device identifier) where applicable.
• Software and module identification: versioning and software/module labelling for instrument components.
• Instructions for use (IFU) - required content: intended use, target users, limitations of use, storage and handling, set‑up before use, installation/connectivity, interpretation/readout of results, residual risks and safety information, maintenance and disposal.
• Information to support intended performance: verification of performance, warnings related to invalid results, and result interpretation guidance.
• Regulatory alignment: informative linkage to Regulation (EU) 2017/746 (IVDR) and cross‑references to related standards for risk management, symbols, usability, electrical and EMC safety.

Normative references cited include ISO 18113‑1, ISO 14971 (risk management), ISO 15223‑1 (symbols), IEC 61010 series and IEC 61326‑2‑6 (safety/EMC), and IEC 62366‑1 (usability).

Applications and who uses this standard

EN ISO 18113-5 is essential for:

• IVD manufacturers designing or marketing self‑testing instruments (labelling, IFU, UDI implementation).
• Regulatory affairs and quality teams preparing technical documentation, CE/UKCA marking files and IVDR conformity evidence.
• Product managers and designers ensuring usability, software version control and clear end‑user instructions.
• Notified bodies, conformity assessors and distributors verifying compliance with labelling and information requirements.
• Accessories and peripheral equipment suppliers used with self‑test IVD instruments.

Using EN ISO 18113-5 helps manufacturers reduce user errors, improve patient safety, and streamline regulatory submissions for self‑testing IVD devices.

Related standards

• ISO 18113-1 (labelling - terms & general requirements)
• ISO 14971 (risk management)
• ISO 15223-1 (symbols for medical device labelling)
• IEC 61010 series, IEC 61326-2-6 (electrical safety, EMC for laboratory/IVD equipment)
• IEC 62366-1 (usability engineering)

Keywords: EN ISO 18113-5:2024, ISO 18113-5, IVD self-testing labelling, in vitro diagnostic instruments for self-testing, instructions for use, UDI, IVDR compliance.

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2024
In vitro diagnostični preskusni sistemi - Informacije proizvajalca (označevanje) - 5.
del: Diagnostični instrumenti in vitro za samopreskušanje (ISO 18113-5:2022)
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling)
- Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2022)
In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller - Teil 5:
Geräte für in-vitro-diagnostische Untersuchungen zur Eigenanwendung (ISO 18113-
5:2022)
Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant
(étiquetage) - Partie 5: Instruments de diagnostic in vitro destinés aux autodiagnostics
(ISO 18113-5:2022)
Ta slovenski standard je istoveten z: EN ISO 18113-5:2024
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 18113-5
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2024
EUROPÄISCHE NORM
ICS 11.100.10 Supersedes EN ISO 18113-5:2011
English Version
In vitro diagnostic medical devices - Information supplied
by the manufacturer (labelling) - Part 5: In vitro diagnostic
instruments for self-testing (ISO 18113-5:2022)
Dispositifs médicaux de diagnostic in vitro - In-vitro-Diagnostika - Bereitstellung von
Informations fournies par le fabricant (étiquetage) - Informationen durch den Hersteller - Teil 5: Geräte für
Partie 5: Instruments de diagnostic in vitro destinés in-vitro-diagnostische Untersuchungen zur
aux autodiagnostics (ISO 18113-5:2022) Eigenanwendung (ISO 18113-5:2022)
This European Standard was approved by CEN on 2 October 2022.

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
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 18113-5:2024 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 18113-5:2024) 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 December 2024, and conflicting national standards
shall be withdrawn at the latest by June 2027.
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 18113-5:2011.
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 18113-5:2022 has been approved by CEN as EN ISO 18113-5:2024 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 Table ZA.1 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.
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.
This document needs to be considered together with the other parts of EN ISO 18113-series to fully
apply the concepts of this labelling standard series. EN ISO 18113-1 provides definitions and overall
concepts which may be further applied or directed to specific device format and labelling location.
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).
Where the standard includes notes that require alignment to local or regional regulations, all clauses
need to be read in the context of 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)
Requirements of Remarks / Notes
Regulation (EU)
of this EN
2017/746
Covered with respect to the information provided
7 7.4
regarding storage and handling
19.1 Covered with respect to labelling requirements
7.11, 7.13
Covered with respect to verification of the
19.3
7.14, 7.18 intended performance and warnings related to

invalid results
20.1 c) 5.2.4 Covered
20.2 a) 5.2.1 Covered
Covered with respect to the indication of in-vitro
20.2 e) 5.2.3
diagnostic medical device
Covered with respect to serial number and batch
20.2 f) 5.2.2
code
20.2 g) 5.2.4 Covered
20.4.1 b) 7.2. Covered
20.4.1 c) 7.3 Covered
20.4.1 e) 7.3 Covered
20.4.1 f) 7.7 Covered
Covered with respect to instruction for
st
20.4.1. j) 1 bullet 7.6.1
installation and connectivity information
20.4.1. k) 7.4 Covered
Covered with respect to information on residual
20.4.1 n) i) 7.5
risks and safety
20.4.1 n) ii) Covered with respect to information on residual
7.5
risks and safety
20.4.1 n) iii) Covered with respect to information on residual
7.5
risks and safety
20.4.1 r) 7.6.3, 7.10 Covered with respect to the set-up before use
Covered with respect to installation and
20.4.1 s) 7.6, 7.14, 7.17
maintenance
20.4.1 t) 7.12 Covered
20.4.1 ab) 7.9 Covered with respect to limitation of use
General Safety and
Clause(s) / sub-
Performance
clause(s)
Requirements of Remarks / Notes
Regulation (EU)
of this EN
2017/746
st
20.4.1 ac) 1 sentence 7.16 Covered
Covered with respect to the information on the
20.4.1 ad) 7.1
Authorized Representative
20.4.2 a) 7.10, 7.11, 7.14 Covered
Covered with respect to the content of the
20.4.2 b) 7.6
instructions for use
Covered with respect to the information for
20.4.2 c) 7.3, 7.13
correct interpretation of the results
Covered with respect to the read out of test
20.4.2 d) 7.13
results
Table ZA.2 — Applicable Standards to confer presumption of conformity as described in this
Annex ZA
Column 1 Column 2 International Column 3 Column 4
Reference in Standard Edition
Title Corresponding European
Clause 2
Standard Edition
ISO 14971 ISO 14971:2019 Medical devices — EN ISO 14971:2019
Application of risk
EN ISO
management to medical
14971:2019/A11:2021
devices
ISO 15223-1 ISO 15223-1:2021 Medical devices — Symbols EN ISO 15223-1:2021
to be used with information
to be supplied by the
manufacturer — Part 1:
General requirements
ISO 18113-1 ISO 18113-1:2022 In vitro diagnostic medical EN ISO 18113-1:2024
devices — Information
supplied by the
manufacturer (labelling) —
Part 1: Terms, definitions,
and general requirements
IEC 61010-1 IEC 61010-1:2010 Safety requirements for EN 61010-1:2010
electrical equipment for
IEC 61010-1:2010/A1:2016 EN 61010-1:2010/A1:2019
measurement, control and
IEC 61010-1:2010/A1:2016 EN 61010-1:2010/A1:2019/
laboratory use — Part 1:
/COR1:2019 AC:2019
General requirements
IEC 61010-2- IEC 61010-2-101:2018 Safety requirements for EN IEC 61010-2-101:2022
101 electrical equipment for
EN IEC 61010-2-
measurement, control and
101:2022/A11:2022
laboratory use — Part 2-101:
Particular requirements for
in vitro diagnostic (IVD)
medical equipment
IEC 61326-2- IEC 61326-2-6:2020 Electrical equipment for EN 61326-2-6:2021
6 measurement, control and
laboratory use — EMC
requirements — Part 2-6:
Particular requirements —
In vitro diagnostic (IVD)
medical equipment
IEC 62366-1 IEC 62366-1:2015 Medical devices — EN 62366-1:2015
Application of usability
IEC 62366-1:2015/Cor EN 62366-1:2015/AC:2015
engineering to medical
1:2016
EN 62366-1:2015/A1:2020
devices
IEC 62366-1:2015/A1:2020
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 ISO
STANDARD 18113-5
Second edition
2022-10
In vitro diagnostic medical devices —
Information supplied by the
manufacturer (labelling) —
Part 5:
In vitro diagnostic instruments for
self-testing
Dispositifs médicaux de diagnostic in vitro — Informations fournies
par le fabricant (étiquetage) —
Partie 5: Instruments de diagnostic in vitro destinés aux
autodiagnostics
Reference number
ISO 18113-5:2022(E)
ISO 18113-5:2022(E)
© ISO 2022
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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ISO 18113-5:2022(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Essential requirements . 2
5 Labels and marking . 2
5.1 General . 2
5.2 Identification of the IVD instrument . 2
5.2.1 IVD instrument name . 2
5.2.2 Serial number . 2
5.2.3 In vitro diagnostic use . 2
5.2.4 Unique device identifier (UDI) . 3
6 Elements of the instructions for use . 3
7 Content of the instructions for use .4
7.1 Manufacturer . 4
7.2 Identification of the IVD instrument . 4
7.2.1 IVD instrument name . 4
7.2.2 Module and software identification . 5
7.3 Intended use/Intended purpose . 5
7.4 Storage and handling . 5
7.5 Warnings and precautions and/or measures to be taken and limitations of use
regarding the instrument . 5
7.6 Instrument installation . 6
7.6.1 General . 6
7.6.2 Action upon delivery . 6
7.6.3 Bringing into operation . 6
7.7 Principles of measurement . 6
7.8 Performance of the IVD instrument . 6
7.9 Limitations of use. 6
7.10 Preparation prior to operation . 6
7.11 Operating procedure . 7
7.12 Control procedure . 7
7.13 Reading of examination results . 7
7.14 Special functions . 7
7.15 Shut-down procedure . 7
7.16 Disposal information . 8
7.17 Maintenance . 8
7.18 Troubleshooting . 8
7.19 Follow-up action . 8
7.20 Document control . 8
Bibliography . 9
iii
ISO 18113-5:2022(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 re
...