EN ISO 18113-4:2024
(Main)In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2022)
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2022)
This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents, calibrators, and controls intended for self-testing.
This document can also be applicable to accessories.
This document is applicable to the labels for outer and immediate containers and to the instructions for use.
This document does not apply to:
a) IVD instruments or equipment;
b) IVD reagents for professional use.
In‑vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller (Kennzeichnung) - Teil 4: Reagenzien für in‑vitro-diagnostische Untersuchungen zur Eigenanwendung (ISO 18113‑4:2022)
Dieses Dokument legt Anforderungen an die durch den Hersteller von in vitro-diagnostischen (IVD )Reagenzien, Kalibriermaterialien und Kontrollmaterialien für Untersuchungen zur Eigenanwendung bereitgestellten Informationen fest.
Dieses Dokument kann auch auf Zubehör angewendet werden.
Dieses Dokument ist anwendbar für Etiketten für die äußeren und Primärbehälter sowie für die Gebrauchsanleitung.
Dieses Dokument ist nicht anwendbar für:
a) IVD Geräte oder Ausrüstungen;
b) IVD Reagenzien für den Gebrauch durch Fachpersonal.
Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant (étiquetage) - Partie 4: Réactifs de diagnostic in vitro destinés aux autodiagnostics (ISO 18113-4:2022)
Le présent document spécifie les exigences relatives aux informations fournies par le fabricant de réactifs de diagnostic in vitro (DIV), d’étalons et de matériaux de contrôle destinés aux autodiagnostics.
Le présent document peut aussi s’appliquer aux accessoires.
Le présent document est applicable aux étiquettes apposées sur l’emballage externe et le contenant primaire, ainsi qu’aux notices d’utilisation.
Le présent document ne s’applique pas à ce qui suit:
a) les instruments ou les équipements de DIV;
b) les réactifs de DIV à usage professionnel.
In vitro diagnostični preskusni sistemi - Informacije proizvajalca (označevanje) - 4. del: Diagnostični reagenti in vitro za samopreskušanje (ISO 18113-4:2022)
Ta dokument določa zahteve za informacije, ki jih mora zagotoviti proizvajalec diagnostičnih reagentov in vitro (IVD), kalibratorjev in kontrolnega materiala, namenjenih za samopreskušanje.
Uporabiti ga je mogoče tudi za dodatno opremo.
Ta dokument se uporablja za oznake za stične in zunanje vsebnike ter navodila za uporabo.
Ta dokument se ne uporablja za:
a) diagnostične instrumente ali opremo in vitro;
b) diagnostične reagente in vitro za strokovno uporabo.
General Information
Relations
Overview
EN ISO 18113-4:2024 - In vitro diagnostic medical devices: Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2022) specifies labelling and instructions-for-use (IFU) requirements for IVD reagents, calibrators and controls intended for self-testing. Adopted by CEN in 2024, this standard applies to outer and immediate container labels and to IFUs for self-test reagents and related accessories. It does not cover IVD instruments/equipment or reagents intended for professional use.
Key topics and technical requirements
The standard defines the essential labelling content and presentation rules to support safe, effective self-testing. Major technical topics include:
- Manufacturer identification: clear manufacturer name and contact details on the outer container and/or IFU.
- Identification of the IVD reagent: unambiguous device name and description to differentiate kit components.
- Batch code / lot number: traceability requirements for recall and quality control.
- Unique Device Identifier (UDI): UDI placement and format guidance relevant to self-test reagents.
- Contents and kit component identification: listing of reagents, accessories and single-use items.
- Intended use / intended purpose: user-focused statement of what the self-test detects and limitations.
- In vitro diagnostic use statement: clear indication that the device is an IVD for self-testing.
- Storage and handling conditions: temperature, humidity, and special handling instructions.
- Expiry date and stability: labelling of expiry and any conditions affecting shelf life.
- Warnings and precautions: critical safety information and user alerts that must be prominent in IFU and labels.
- Presentation of IFU: layout, readability and component identification to support lay users.
The standard also addresses how to present information on both outer and immediate containers (single-container vs multi-component kits) and cross-references risk management and symbol standards.
Practical applications and users
EN ISO 18113-4:2024 is intended for:
- IVD manufacturers preparing labels and IFUs for consumer self-test kits (e.g., rapid antigen tests, home pregnancy tests, self-sampling reagents).
- Regulatory affairs and quality teams ensuring compliance with EU IVDR (Regulation (EU) 2017/746) and national regulations.
- Technical writers and labelling designers creating user-centred IFUs and packaging.
- Notified bodies and conformity assessors evaluating labelling compliance during audits.
- Distributors and importers verifying labelling meets market requirements.
Applying this standard improves user safety, traceability, and regulatory conformity for consumer-facing IVD products.
Related standards
- ISO 18113-1 (terms, definitions and general requirements)
- ISO 14971 (risk management for medical devices)
- ISO 15223-1 (symbols for medical device labelling)
- EU Regulation (EU) 2017/746 (IVDR) - Annex ZA maps presumption of conformity where applicable
Keywords: EN ISO 18113-4:2024, in vitro diagnostic, IVD reagents, self-testing, labelling, instructions for use, UDI, IVDR compliance.
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2024
In vitro diagnostični preskusni sistemi - Informacije proizvajalca (označevanje) - 4.
del: Diagnostični reagenti in vitro za samopreskušanje (ISO 18113-4:2022)
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling)
- Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2022)
In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller - Teil 4:
Reagenzien für in-vitro-diagnostische Untersuchungen zur Eigenanwendung (ISO 18113
-4:2022)
Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant
(étiquetage) - Partie 4: Réactifs de diagnostic in vitro destinés aux autodiagnostics (ISO
18113-4:2022)
Ta slovenski standard je istoveten z: EN ISO 18113-4:2024
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 18113-4
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2024
EUROPÄISCHE NORM
ICS 11.100.10 Supersedes EN ISO 18113-4:2011
English Version
In vitro diagnostic medical devices - Information supplied
by the manufacturer (labelling) - Part 4: In vitro diagnostic
reagents for self-testing (ISO 18113-4:2022)
Dispositifs médicaux de diagnostic in vitro - In-vitro-Diagnostika - Bereitstellung von
Informations fournies par le fabricant (étiquetage) - Informationen durch den Hersteller - Teil 4:
Partie 4: Réactifs de diagnostic in vitro destinés aux Reagenzien für in-vitro-diagnostische Untersuchungen
autodiagnostics (ISO 18113-4:2022) zur Eigenanwendung (ISO 18113-4:2022)
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 18113-4:2024 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 18113-4:2024) 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 18113-4:2011.
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 18113-4:2022 has been approved by CEN as EN ISO 18113-4:2024 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-clause(s)
Performance Requirements
Remarks / Notes
of Regulation (EU)
of this EN
2017/746
Covered with respect to the
19.1 4.3, 7.3
labelling requirements only
20.1 a) 4.3, 7.3 Covered with respect to IFU
Covered with respect to small
20.1. b) 6.1.2 labels and the impracticability to
include information there
Covered with respect to the HRI
20.1 c) 5.2.3
format of UDI
Covered with respect to warnings
20.1 g) 7.9
and precautions
Covered with respect to storage
20.1 h) 5.6
and handling conditions symbols
20.2 a) 5.2.1, 6.3.1 Covered
Covered with respect to additional
20.2 b) 5.2.1, 6.3.1
details to identify the device
20.2 c) 5.1, 6.2 Covered
Covered with respect to the
20.2 e) 5.5, 6.5 indication of in vitro diagnostic
medical device
20.2 g) 5.2.3, 6.3.3 Covered
20.2 j) 5.3, 6.1.2, 6.4 Covered
20.2 k) 5.6 Covered
Covered with respect to warnings
or precautions to be taken that
20.2 m) 5.8, 6.8
need to be brought to the
immediate attention of the user
20.2 t) 4.2, 5.2.2 Covered
20.4.1 a) 7.2 Covered
20.4.1 b) 7.2 Covered
20.4.1. f) 7.4 Covered
20.4.1 j) first bullet 7.7 Covered
st
20.4.1 n) i) 7.9 1 bullet Covered
nd
20.4. 1 n) ii) 7.9 2 bullet Covered
General Safety and
Clause(s) / sub-clause(s)
Performance Requirements
Remarks / Notes
of Regulation (EU)
of this EN
2017/746
20.4.1 n) v) 7.9 Covered
20.4.1. o) 7.9 Covered
20.4.1. q) 7.10 Covered
20.4.1 r) 7.7 Covered
20.4.1 t) 7.12 Covered
20.4.1 u) 7.5 Covered
20.4.1 w) 7.15, 7.17 Covered
20.4.1. aa) 7.16 Covered
Covered with respect to
20.4.1 ac) i) 7.9 information on disposal of
hazardous material.
Covered with respect to
20.4.1 ac) ii) 7.9. information on disposal of
hazardous material.
Covered with respect to
20.4.1 ac) iii) 7.9 information on disposal of
hazardous material.
20.4.1. ad) 7.1 Covered
Covered with respect to document
20.4.1. ae) 7.19
and change control
20.4.2 a) 7.4, 7.7, 7.11, 7.13, 7.14 Covered
20.4.2 b) 7.4 Covered
20.4.2 c) 7.3 Covered
20.4.2 e) 7.14, 7.17 Covered
20.4.2 f) 7.14 Covered with respect to
information regarding the
consultation of a healthcare
provider before taking a medical
decision
20.4.2 g) 7.14 Covered
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
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 18113-4
Second edition
2022-10
In vitro diagnostic medical devices —
Information supplied by the
manufacturer (labelling) —
Part 4:
In vitro diagnostic reagents for self-
testing
Dispositifs médicaux de diagnostic in vitro — Informations fournies
par le fabricant (étiquetage) —
Partie 4: Réactifs de diagnostic in vitro destinés aux autodiagnostics
Reference number
ISO 18113-4:2022(E)
ISO 18113-4:2022(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: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 18113-4:2022(E)
Contents Page
Foreword .v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General . 1
4.1 Essential requirements . 1
4.2 Identification of kit components . 2
4.3 Presentation of the instructions for use . 2
5 Content of the outer container .2
5.1 Manufacturer . 2
5.2 Identification of the IVD reagent . 2
5.2.1 IVD reagent name . 2
5.2.2 Batch code / lot number . 2
5.2.3 Unique device identifier (UDI) . 3
5.3 Contents . 3
5.4 Intended use/Intended purpose . 3
5.5 In vitro diagnostic use . 3
5.6 Storage and handling conditions . 4
5.7 Expiry date . 4
5.8 Warnings and precautions . 4
6 Content of the immediate container label . 4
6.1 General provisions . 4
6.1.1 Single container . 4
6.1.2 Small label . 5
6.2 Manufacturer . 5
6.3 Identification of the IVD reagent . 5
6.3.1 IVD reagent or component name . 5
6.3.2 Batch code/lot number . 5
6.3.3 Unique device identifier (UDI) . 5
6.4 Contents . 5
6.5 In vitro diagnostic use . 5
6.6 Storage and handling conditions . 5
6.7 Expiry date . 5
6.8 Warnings and precautions . 6
7 Content of the instructions for use .6
7.1 Manufacturer . 6
7.2 Identification of the IVD reagent . 6
7.3 Intended purpose/Intended use . 6
7.4 Principles of the method . 6
7.5 Traceability of values assigned to calibrators and trueness-control materials . 7
7.6 Components . 7
7.7 Additional required equipment and / or materials . 7
7.8 Storage and shelf life after first opening . 8
7.9 Warnings and precautions . 8
7.10 Primary sample collection, handling and storage . 8
7.11 Procedure to obtain a result . 8
7.12 Control procedure . 9
7.13 Reading of test results . 9
7.14 Interpretation of results . 9
7.15 Performance characteristics . 9
7.15.1 General . 9
iii
ISO 18113-4:2022(E)
7.15.2 Measuring interval . 9
7.16 Biological reference intervals . 9
7.17 Limitations of the procedure . 10
7.18 Literature references . 10
7.19 Document control . 10
Bibliography .11
iv
ISO 18113-4:2022(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 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).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
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, Clinical laboratory testing and in
vitro diagnostic test 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 second edition cancels and replaces the first edition (ISO 18113-4:2009), which has been
technically revised.
The main changes are as follows:
— Updated text to reflect changes in regulations and provide examples for clarity;
— Added information pertaining to unique device identifier-device identifier (UDI);
— Updated the Bibliography.
A list of all parts in the ISO 18113 series can be found on the ISO website.
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 18113-4:2022(E)
Introduction
Manufacturers of in vitro diagnostic (IVD) reagents for self-testing,
...
Frequently Asked Questions
EN ISO 18113-4:2024 is a standard published by the European Committee for Standardization (CEN). Its full title is "In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2022)". This standard covers: This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents, calibrators, and controls intended for self-testing. This document can also be applicable to accessories. This document is applicable to the labels for outer and immediate containers and to the instructions for use. This document does not apply to: a) IVD instruments or equipment; b) IVD reagents for professional use.
This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents, calibrators, and controls intended for self-testing. This document can also be applicable to accessories. This document is applicable to the labels for outer and immediate containers and to the instructions for use. This document does not apply to: a) IVD instruments or equipment; b) IVD reagents for professional use.
EN ISO 18113-4:2024 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.
EN ISO 18113-4:2024 has the following relationships with other standards: It is inter standard links to EN ISO 18113-4:2011. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 18113-4:2024 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.
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Die Norm EN ISO 18113-4:2024 stellt eine wesentliche Grundlage für die Kennzeichnung von In-vitro-Diagnostika (IVD) dar, insbesondere für Reagenzien, Kalibratoren und Kontrollen, die für Selbsttests bestimmt sind. Die Anforderungen, die in diesem Dokument festgelegt sind, gewährleisten, dass die vom Hersteller bereitgestellten Informationen klar, präzise und benutzerfreundlich sind, um die Sicherheit und Effektivität der Selbsttests zu maximieren. Ein hervorstechendes Merkmal dieser Norm ist der Fokus auf die Bereitstellung von Informationen, die für den Endbenutzer kritisch sind. Der Geltungsbereich umfasst alle wesentlichen Aspekte der Kennzeichnung, einschließlich der Etiketten für äußere und unmittelbare Behälter sowie der Gebrauchsanweisungen. Dies hilft, Missverständnisse zu minimieren und ermöglicht es den Anwendern, die Produkte sicher und effektiv zu verwenden. Die Norm regelt zudem den Umgang mit Zubehör, was die Relevanz und Anwendbarkeit in der modernen Diagnostik weiter erhöht. Durch ihre spezifischen Anforderungen trägt EN ISO 18113-4:2024 dazu bei, die Qualität und Transparenz von Selbsttestlösungen zu erhöhen, was besonders in einem Markt von Bedeutung ist, der von einem stetig wachsenden Angebot an Heimdiagnosetests geprägt ist. Ein entscheidender Vorteil dieser Norm liegt in ihrer klaren Abgrenzung hinsichtlich der Nicht-Anwendbarkeit auf IVD-Instrumente oder -Geräte sowie auf IVD-Reagenzien für den professionellen Gebrauch. Diese Fokussierung auf Produkte für den Endverbraucher trägt dazu bei, die regulatorischen Rahmenbedingungen klarer zu gestalten und die Anforderungen an die Herstellersicherheit und Benutzerfreundlichkeit zu schärfen. Insgesamt ist die Norm EN ISO 18113-4:2024 ein wertvolles Dokument, das sowohl die Hersteller als auch die Nutzer von In-vitro-Diagnostika unterstützt, und spielt somit eine entscheidende Rolle in der Gewährleistung von Qualität und Sicherheit in der Selbstdiagnosetechnologie.
EN ISO 18113-4:2024は、自己検査用の体外診断（IVD）試薬、キャリブレーター、およびコントロールの製造者が提供する情報に関する要求事項を明確に定義しています。この文書の適用範囲には、自己検査を目的としたIVD試薬とその付属品、外装および即時容器ラベル、使用説明書が含まれます。 この標準の強みは、ユーザーが試薬を適切に使用するために必要な全ての情報が含まれていることです。具体的には、ラベルや使用説明書において明確で理解しやすい情報が提供され、消費者が自己検査を安全かつ効果的に行えるように設計されています。また、IVD試薬の種類や特性に応じたカスタマイズ可能な要求事項が盛り込まれており、多様な製品に対して適用される柔軟性を持っています。 さらに、EN ISO 18113-4:2024は、自己検査用の試薬に関する国際的な基準として、その重要性が増しています。特に、自己管理型医療が進展する現代において、患者が自分で健康状態を把握するためのツールとしてのIVD試薬の役割は非常に大きいです。この標準が提供する明確な情報は、患者の安全性を向上させ、誤診や誤使用のリスクを軽減します。 ただし、今標準はIVD機器や専門的使用向けの試薬には適用されないため、その点については留意が必要です。全体として、EN ISO 18113-4:2024は、自己検査用体外診断試薬に対するラベリングと情報提供に関する非常に重要な基準であり、多くの製造者がこのガイドラインに沿って製品を提供することが期待されます。
The EN ISO 18113-4:2024 standard provides a comprehensive framework for the labeling and information requirements for in vitro diagnostic (IVD) reagents intended for self-testing. This standard is pivotal in ensuring that manufacturers furnish clear, concise, and accurate information about their products, which enhances user understanding and safety. The scope of the standard specifically targets the information supplied by the manufacturer regarding IVD reagents, calibrators, and controls for self-testing applications. Additionally, it is noteworthy that the document extends its applicability to accessories related to these IVD products. By addressing both outer and immediate container labels as well as instructions for use, the standard ensures that users receive coherent guidance across all aspects of the product. One of the significant strengths of EN ISO 18113-4:2024 is its focus on self-testing, which is increasingly relevant in today's healthcare landscape. As the demand for home diagnostic solutions grows, this standard becomes crucial for maintaining quality and reliability in the consumer health market. It strategically excludes IVD instruments and reagents intended for professional use, allowing for a tailored approach that prioritizes the unique needs of self-testing environments. Furthermore, this standard promotes safety and effectiveness by mandating that all necessary information is presented in an understandable manner, which is essential for users who may not have professional training. The provision of clear labeling and informative instructions not only enhances user confidence but also mitigates the risk of misuse. In summary, the EN ISO 18113-4:2024 standard stands as an essential benchmark for manufacturers of in vitro diagnostic reagents for self-testing. Its thorough guidelines for labeling and information provision reinforce the importance of user comprehension and safety, making it a critical document in the realm of health diagnostics.
La norme EN ISO 18113-4:2024, intitulée "Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant (étiquetage) - Partie 4 : Réactifs de diagnostic in vitro pour auto-test", établit les exigences essentielles concernant l'information fournie par le fabricant pour les réactifs de diagnostic in vitro (IVD), ainsi que pour les étalons et les contrôles destinés à l'auto-test. Cette norme s'applique également aux accessoires associés. Le champ d'application de la norme est particulièrement pertinent dans le contexte actuel, où l'auto-diagnostic devient de plus en plus courant. En fournissant des directives claires sur les étiquettes et les instructions d'utilisation, EN ISO 18113-4:2024 assure que les utilisateurs finaux reçoivent des informations précises et accessibles, ce qui est vital pour garantir la sécurité et l'efficacité de l'auto-évaluation de la santé. Les points forts de cette norme résident dans son approche systématique pour réguler l'étiquetage des réactifs de test à usage personnel, ce qui contribue à réduire les risques d'erreurs d'interprétation. En spécifiant les exigences pour l'étiquetage des conteneurs extérieurs et immédiats, ainsi que pour les instructions d'utilisation, cette norme favorise une meilleure conformité et une compréhension accrue chez les utilisateurs. De plus, la norme ne s'applique pas aux instruments ou équipements IVD, ni aux réactifs IVD destinés à un usage professionnel, ce qui permet de clarifier son champ d'application et de spécifier clairement à quel type de produits elle s'adresse. Cela renforce sa pertinence en ciblant spécifiquement les produits destinés aux auto-tests, qui nécessitent une attention particulière en matière d'information utilisateur. En résumé, EN ISO 18113-4:2024 se révèle être une norme cruciale pour le secteur des dispositifs médicaux de diagnostic in vitro, en garantissant que les informations fournies par le fabricant soient à la fois claires et conformes aux meilleures pratiques, tout en soutenant l'autonomie des utilisateurs dans le cadre de leur santé personnelle.
EN ISO 18113-4:2024 문서는 자가 진단용으로 설정된 체외 진단(IVD) 시약, 교정제 및 제어의 제조업체가 제공하는 정보에 대한 요구 사항을 명확히 규명하고 있습니다. 이 표준은 자가 검사 용도로 사용되는 IVD 시약의 라벨링 및 사용 설명서에 대한 기초적인 지침을 제공하며, 외부 및 즉각적인 용기의 라벨에도 적용됩니다. 이 표준의 강점 중 하나는 명확하고 일관된 정보 제공을 통해 사용자가 제품을 제대로 이해하고 활용할 수 있도록 돕는 것입니다. 이를 통해 소비자는 자가 진단의 정확성과 안전성을 보장받을 수 있습니다. 자가 검사가 반드시 필요한 현대 사회에서, EN ISO 18113-4:2024는 정보의 표준화를 통해 신뢰성을 높이고 있습니다. 또한, 이 문서는 IVD 기기나 전문 용도의 IVD 시약에는 적용되지 않으며, 특정 범위 내에서의 명확한 가이드라인을 유지하고 있다는 점에서도 큰 장점을 갖습니다. 이는 사용자들이 보다 쉽게 이해하고 잘못된 정보를 피할 수 있도록 돕습니다. 결론적으로, EN ISO 18113-4:2024는 자가 진단용 체외 진단 시약에 관한 정보의 표준화된 요구 사항을 제공하며, 사용자에게 필요한 신뢰성과 정보를 제공하는 데 큰 기여를 하고 있습니다. 이 표준을 통해 제조업체는 사용자에게 중요하고 정확한 정보를 제공함으로써, 자가 진단 기기의 효율성과 효과성을 높일 수 있습니다.
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