prEN ISO 18113-4

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO/DIS 18113-4:2021)

Decision BT C87/2011 (extension of DOW): DOW = DAV + 36 months

In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller - Teil 4: Reagenzien für in-vitro-diagnostische Untersuchungen zur Eigenanwendung (ISO/DIS 18113-4:2021)

Dieses Dokument legt Anforderungen an die durch den Hersteller von IVD-Reagenzien, -Kalibriermaterialien und -Kontrollmaterialien für Untersuchungen zur Eigenanwendung bereitgestellten Informationen fest.
Dieses Dokument kann auch auf Zubehör angewendet werden.
Dieses Dokument gilt für Etiketten für die äußeren und Primärbehälter sowie für die Gebrauchsanleitung.
Dieses Dokument gilt nicht 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 pour auto-tests (ISO/DIS 18113-4:2021)

In vitro diagnostični preskusni sistemi - Informacije proizvajalca (označevanje) - 4. del: Diagnostični reagenti in vitro za samopreskušanje (ISO/DIS 18113-4:2021)

General Information

• Status: Not Published
• ICS: 11.100.10 - In vitro diagnostic test systems
• Technical Committee: CEN/TC 140 - In vitro diagnostic systems
• Current Stage: 4599 - Dispatch of FV draft to CMC - Finalization for Vote
• Due Date: 14-Apr-2022
• Completion Date: 14-Apr-2022
• 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
• Ref Project: oSIST prEN ISO 18113-4:2021 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO/DIS 18113-4:2021)

RELATIONS

• Revised: EN ISO 18113-4:2011 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)
• Effective Date: 27-Nov-2019

Standards Content (sample)

SLOVENSKI STANDARD
oSIST prEN ISO 18113-4:2021
01-oktober-2021

In vitro diagnostični preskusni sistemi - Informacije proizvajalca (označevanje) - 4.

del: Diagnostični reagenti in vitro za samopreskušanje (ISO/DIS 18113-4:2021)

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling)

- Part 4: In vitro diagnostic reagents for self-testing (ISO/DIS 18113-4:2021)

In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller - Teil 4:

Reagenzien für in-vitro-diagnostische Untersuchungen zur Eigenanwendung (ISO/DIS
18113-4:2021)

Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant

(étiquetage) - Partie 4: Réactifs de diagnostic in vitro pour auto-tests (ISO/DIS 18113-

4:2021)
Ta slovenski standard je istoveten z: prEN ISO 18113-4
ICS:
11.100.10 Diagnostični preskusni In vitro diagnostic test
sistemi in vitro systems
oSIST prEN ISO 18113-4:2021 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 18113-4:2021
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oSIST prEN ISO 18113-4:2021
DRAFT INTERNATIONAL STANDARD
ISO/DIS 18113-4
ISO/TC 212 Secretariat: ANSI
Voting begins on: Voting terminates on:
2021-08-02 2021-10-25
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 pour auto-tests
ICS: 11.100.10
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 18113-4:2021(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. ISO 2021
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oSIST prEN ISO 18113-4:2021
ISO/DIS 18113-4:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021

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 2021 – All rights reserved
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oSIST prEN ISO 18113-4:2021
ISO/DIS 18113-4:2021(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/identification (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/identification (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

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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

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oSIST prEN ISO 18113-4:2021
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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.

This second edition cancels and replaces the first edition (ISO 18113:2009), which has been technically

revised.
The main changes compared to the previous edition are as follows:

— Updated text to reflect changes in regulations and provide examples for clarity

— Added information pertaining to UDI (Unique Device Identification)
— Updated the bibliography

In this document, the following verbal forms are used: — “shall” indicates a requirement; — “should”

indicates a recommendation; — “may” indicates a permission; — “can” indicates a possibility or a

capability. Information marked as “NOTE” is for guidance in understanding or clarifying the associated

requirement.
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.
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Introduction

Manufacturers of in vitro diagnostic (IVD) reagents for self-testing supply users with information

to enable the safe use and expected performance of their devices. The type and level of detail varies

according to the intended uses and country-specific regulations.

The International Medical Devices Regulatory Forum (IMDRF) encourages convergence of the evolution

of regulatory systems for medical devices at the global level. Eliminating differences among regulatory

jurisdictions could allow patients earlier access to new technologies and treatments. This document

provides a basis for the harmonization of labelling requirements for IVD reagents for self-testing.

This document is concerned solely with information supplied with IVD reagents, calibrators, and

control materials intended for self-testing. It is intended to be used in conjunction with ISO 18113-1,

which contains the general requirements for information supplied by the manufacturer and definitions

of general labelling concepts.

This document is intended to support the essential labelling requirements of all the IMDRF [9] partners,

as well as other countries that have enacted or plan to enact labelling regulations for IVD medical

devices.

For IVD reagents, calibrators and/or control materials that are intended to be used as a system with

an instrument provided by the same manufacturer, this document is also intended to be used together

with ISO 18113-1 and ISO 18113-5.
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oSIST prEN ISO 18113-4:2021
DRAFT INTERNATIONAL STANDARD ISO/DIS 18113-4:2021(E)
In vitro diagnostic medical devices — Information supplied
by the manufacturer (labelling) —
Part 4:
In vitro diagnostic reagents for self-testing
1 Scope

This document specifies requirements for information supplied by the manufacturer of IVD reagents,

calibrators, and controls intended for self-testing.
This document can also be applied to accessories.

This document applies 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.
2 Normative references

The following referenced documents are indispensable for the application 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 14971, Medical devices — Application of risk management to medical devices

ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to

be supplied — Part 1: General requirements

ISO 18113-1, In vitro diagnostic medical devices —Information supplied by the manufacturer (labelling) —

Part 1: Terms, definitions and general requirements
3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 18113-1 apply.

ISO and IEC maintain terminological 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/
4 General
4.1 Essential requirements

The requirements of ISO 18113-1 apply. For the use of symbols, the requirements of ISO 15223-1 apply.

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ISO standards for specific IVD medical devices may also contain requirements for information supplied

by the manufacturer.
EXAMPLES ISO 15197; ISO 17593.
4.2 Identification of kit components

In the case of a kit, each component shall be identified by name, letter, number, symbol, colour, or

graphics in the same manner on all labels and in the instructions for use.

NOTE A unique device identifier/identification (UDI) is not required on the immediate label of kit

components unless the component is a device in its own right.
4.3 Presentation of the instructions for use

4.3.1 The instructions for use shall be written or provided in a language that is easily understood and

applied by a lay person, and where appropriate, supplemented with drawings and diagrams and/or

video.
Some devices may require separate information for the healthcare professional.

4.3.2 The information supplied shall be sufficient to enable a lay person to use the IVD reagent safely

and properly, to confirm that the device is operating or has operated as intended, to understand the IVD

examination results and follow up actions and/or recommendations.

NOTE Recommendations for developing user instruction manuals for IVD medical devices used in home

health care are found in Reference [10].
5 Content of the outer container
5.1 Manufacturer

The name and address of the manufacturer shall be given. The address indicates a single point at which

the manufacturer can be contacted, for example, street, number, city, postal code and country. If a full

address is not practical, an abbreviated version may be sufficient provided the full address is included

in the instructions for use.

If an Authorized Representative is acting on behalf of the manufacturer in the country/jurisdiction,

the label shall also contain the address of the Authorized Representative if required by the regulatory

authority having jurisdiction.
5.2 Identification of the IVD reagent
5.2.1 IVD reagent name

The name or trade name of the IVD reagent shall be given. This brand or trade name should allow its

differentiation from other products of the same or similar type.

When the name does not uniquely identify the IVD reagent, an additional means of identification shall

also be given.
EXAMPLES Catalogue number, commodity number.
5.2.2 Batch code / lot number
A batch code/lot number shall be given.
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If a kit contains different components bearing different batch codes, the batch code indicated on

the outer container shall enable the individual batch code of each component to be traced from the

manufacturer's production record.
5.2.3 Unique device identifier/identification (UDI)

If an IVD reagent is subject to unique identification rules by the regulatory authority, the outer label

shall include the UDI including the UDI carrier (Automatic Identification Data Carrier ‘AIDC’ format),

and Human Readable Interpretation (HRI). When AIDC carriers other than the UDI Carrier are part of

the product labelling, the UDI Carrier shall be readily identifiable.

NOTE 1 The content, format, and size of the UDI is defined by the accredited UDI issuing agency selected.

NOTE 2 HRI text is not the same as the text that is already placed on the label and is a legible interpretation of

the data characters encoded in the UDI Carrier.

The UDI shall include both the UDI device identifier (UDI-DI) and the UDI production identifier (UDI-PI)

unless specifically exempted by regulations.

For the IVD reagent, the UDI-PI shall include at least the batch code and the expiry date.

NOTE 3 If there also is a manufacturing date on the label for reasons other than batch control purposes, it

does NOT need to be included in the UDI-PI unless required by specific regulation.

If there are significant constraints limiting the use of both AIDC and HRI on the label, the AIDC format

shall be generally preferred except for environments where HRI is more appropriate to the user.

The UDI Carrier should be readable during normal use, storage conditions, and throughout intended life

of the IVD reagent. Refer to ISO/IEC 15415 for quality control criteria.
Local, national or regional regulations may apply.
5.3 Contents

The net quantity of contents expressed in terms of mass, volume, volume after reconstitution, numerical

or a combination of these or other terms that accurately reflect the contents shall be indicated.

5.4 Intended use/Intended purpose

If the intended use is not indicated by the name of the IVD reagent, then an abbreviated intended use

that contains enough detail for the user to identify the device and its use shall be given. A full intended

use statement shall be included in the instructions for use in terminology suitable for a lay person.

EXAMPLES Pregnancy test, HIV-1 Antibody test

The fact that the IVD reagent is intended for self-testing shall be clearly indicated.

NOTE In some countries, authorities having jurisdiction can set local requirements for the content of the

intended use statement.
5.5 in vitro diagnostic use

The IVD use of the reagent shall be indicated in terminology suitable for a lay person.

EXAMPLE Only for use outside the body.
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5.6 Storage and handling conditions

The storage conditions and, if necessary, the handling conditions required to maintain the stability and

performance of the reagents, calibrators, and control materials in the unopened state shall be indicated

in terminology suitable for a lay person.

EXAMPLE 1 2 °C to 8 °C or 2…8 °C or graphical symbol; −18 °C or below or graphical symbol.

Other conditions that affect stability shall be indicated.
EXAMPLE 2 Light, humidity (e.g. store in a cool, dry environment).

Any other conditions that affect the handling or storage of the reagents, calibrators and control

materials shall be specified.
EXAMPLE 3 Fragile, do not shake.
5.7 Expiry date
An expiry date based upon the stated storage instructions shall be indicated.

Expiry dates shall be expressed in a format generally familiar to the lay person.

EXAMPLE Formats 2007–05–01, 2007-May–01, May 01, 2007.

If only the year and month are given, the expiry date shall be the last day of the month indicated.

The label on the outer container shall indicate the expiry date of the component having the earliest

expiry date or an earlier date.
Local, national or regional regulations may apply.
5.8 Warnings and precautions

If an IVD reagent is considered hazardous, the outer container label shall include the appropriate hazard

pictogram(s).The appropriate signal words, product identifiers, hazard statements and precautionary

statement should be included. However, where there is insufficient space, the hazard pictograms shall

be given on the outer container label and the other information shall be given in the instructions for

use.
EXAMPLES Chemical and biological hazards.

Statements or warning pictograms or symbols for specific hazards may be required by local, national

or regional regulations.

If pictograms or symbols are used, text explaining the meaning of the pictogram or symbol shall be

provided in the instructions for use if the label space does not allow the text to be included.

6 Content of the immediate container label
6.1 General provisions
6.1.1 Single container

If the immediate container is the outer container, the requirements specified in Clause 5 apply.

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6.1.2 Small label

If the available space on the immediate container label is too small to include all of the information

listed below, the information about contents (6.4), in vitro diagnostic use (6.5) and storage and handling

conditions (6.6) may be abbreviated or eliminated.
Local, national or regional regulations may apply.
6.2 Manufacturer

The manufacturer shall be identified. The name of the manufacturer or an unequivocal trade name or

logo is sufficient.
6.3 Identification of the IVD reagent
6.3.1 IVD reagent or component name

The name shall ensure proper identification to the user of the IVD reagent or component.

6.3.2 Batch code/lot number
A batch code/lot number shall be given.
6.3.3 Unique device identifier/identification (UDI)
If required by the regulatory auth
...