kSIST FprEN ISO 18113-2:2022
(Main)In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO/FDIS 18113-2:2022)
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO/FDIS 18113-2:2022)
This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents, calibrators and controls intended for professional use.
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 self-testing.
In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller - Teil 2: In-vitro-diagnostische Reagenzien für den Gebrauch durch Fachpersonal (ISO/FDIS 18113-2:2022)
Dieses Dokument legt Anforderungen an die durch den Hersteller von IVD-Reagenzien, -Kalibriermaterialien und -Kontrollmaterialien für den Gebrauch durch Fachpersonal 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 zur Eigenanwendung.
Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant (étiquetage) - Partie 2: Réactifs de diagnostic in vitro à usage professionnel (ISO/FDIS 18113-2:2022)
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 à usage professionnel.
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 destinés à des autodiagnostics.
In vitro diagnostični preskusni sistemi - Informacije proizvajalca (označevanje) - 2. del: Diagnostični reagenti in vitro za poklicno uporabo (ISO/FDIS 18113-2:2022)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN ISO 18113-2:2021
01-oktober-2021
In vitro diagnostični preskusni sistemi - Informacije proizvajalca (označevanje) - 2.
del: Diagnostični reagenti in vitro za poklicno uporabo (ISO/DIS 18113-2:2021)
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling)
- Part 2: In vitro diagnostic reagents for professional use (ISO/DIS 18113-2:2021)
In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller - Teil 2: In-
vitro-diagnostische Reagenzien für den Gebrauch durch Fachpersonal (ISO/DIS 18113-
2:2021)
Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant
(étiquetage) - Partie 2: Réactifs de diagnostic in vitro à usage professionnel (ISO/DIS
18113-2:2021)
Ta slovenski standard je istoveten z: prEN ISO 18113-2
ICS:
11.100.10 Diagnostični preskusni In vitro diagnostic test
sistemi in vitro systems
oSIST prEN ISO 18113-2:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 18113-2:2021
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oSIST prEN ISO 18113-2:2021
DRAFT INTERNATIONAL STANDARD
ISO/DIS 18113-2
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 2:
In vitro diagnostic reagents for professional use
Partie 2: Réactifs de diagnostic in vitro à usage professionnel
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 18113-2:2021(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 18113-2:2021
ISO/DIS 18113-2:2021(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
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Email: copyright@iso.org
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Published in Switzerland
ii © ISO 2021 – All rights reserved
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oSIST prEN ISO 18113-2:2021
ISO/DIS 18113-2:2021(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General . 2
4.1 Essential requirements . 2
4.2 Identification of kit components . 2
5 Content of the outer container label . 2
5.1 Manufacturer . 2
5.2 Identification of the in vitro diagnostic (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) . 2
5.3 Contents . 3
5.4 Intended use/Intended purpose . 3
5.5 in vitro diagnostic use . 3
5.6 Storage, transport, and handling conditions . 3
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. 4
6.2 Manufacturer . 4
6.3 Identification of the IVD reagent . 4
6.3.1 IVD reagent or component name. 4
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 . 5
7 Content of the instructions for use . 6
7.1 Manufacturer . 6
7.2 Identification of the IVD reagent . 6
7.3 Intended use/Intended Purpose . 6
7.4 Principles of the examination method. 7
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 Reagent preparation. 8
7.9 Storage and shelf life after first opening . 8
7.10 Warnings and precautions and/or measures to be taken and limitations of use
regarding the device . 8
7.11 Primary sample collection, handling, and storage . 8
7.12 Examination procedure . 9
7.13 Control procedure . 9
7.14 Calculation of examination results . 9
7.15 Interpretation of results . 9
7.16 Performance characteristics. 9
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7.16.1 Analytical performance characteristics . 9
7.16.2 Clinical performance characteristics .10
7.16.3 Measuring interval .10
7.17 Biological reference intervals .10
7.18 Limitations of the examination procedure .10
7.19 Literature references .10
7.20 Document control .10
Bibliography .11
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oSIST prEN ISO 18113-2:2021
ISO/DIS 18113-2:2021(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.
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:
— Added Information pertaining to UDI (Unique Device Identifier/Identification)
— Updated with examples to reference European Union and other regulations
— Added additional detail for clarification
— 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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oSIST prEN ISO 18113-2:2021
ISO/DIS 18113-2:2021(E)
Introduction
Manufacturers of in vitro diagnostic (IVD) reagents for professional use, supply users with information
to enable their safe use and the 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 harmonization of labelling requirements for IVD reagents for professional use.
This document is concerned solely with information supplied with IVD reagents, calibrators and control
materials intended for professional use. 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 [6] partners,
as well as other countries that have 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 18113-3.
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oSIST prEN ISO 18113-2:2021
DRAFT INTERNATIONAL STANDARD ISO/DIS 18113-2:2021(E)
In vitro diagnostic medical devices — Information supplied
by the manufacturer (labelling) —
Part 2:
In vitro diagnostic reagents for professional use
1 Scope
This document specifies requirements for information supplied by the manufacturer of IVD reagents,
calibrators and controls intended for professional use.
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 self-testing.
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 8601-1, Date and time — Representations for information interchange — Part 1: Basic rules
ISO 8601-2, Date and time — Representations for information interchange — Part 2: Extensions
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/
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ISO/DIS 18113-2:2021(E)
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.
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 UDI is not required on the immediate label of kit components unless the component is a device in its
own right.
5 Content of the outer container label
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, 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 in vitro diagnostic (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.
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).
NOTE 1 The content, format, and size of the UDI is defined by the accredited UDI issuing agency selected.
NOTE 2 When AIDC carriers other than the UDI Carrier are part of the product labelling, the UDI Carrier shall
be readily identifiable.
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ISO/DIS 18113-2:2021(E)
NOTE 3 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 4 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 15415:2011 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 or an appropriate symbol, 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 given in the instructions for use.
NOTE In some countries, authorities having jurisdiction may set local requirements for the content of the
intended use statement. For example, in the European Union, an indication is given that the device is intended for
near-patient testing.
5.5 in vitro diagnostic use
The IVD use of the reagent shall be indicated.
EXAMPLES “For in vitro diagnostic use” or the graphical symbol for “in vitro diagnostic medical device”.
5.6 Storage, transport, and handling conditions
The storage conditions necessary to maintain the stability of the reagents, calibrators and control
materials in the unopened state shall be indicated. Use of non-specific temperature or humidity
indications that are open to interpretation shall be avoided.
EXAMPLE 1 2 °C to 8 °C or 2…8 °C or graphical symbol; −18 °C or below or ≤ −18 °C or graphical symbol.
Other conditions that affect stability shall be indicated.
EXAMPLE 2 Light, humidity.
Any other conditions that affect the handling, transport or storage of the reagents, calibrators, and
control materials shall be specified.
EXAMPLE 3 Fragile.
EXAMPLE 4 Keep vials protected from light.
Other protective measures which users should take to mitigate conditions that can affect stability shall
be stated.
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ISO/DIS 18113-2:2021(E)
5.7 Expiry date
An expiry date based upon the stated storage instructions shall be indicated.
Expiry dates shall be expressed as the year, the month, and, where relevant, the day. The requirements
of ISO 8601 apply.
EXAMPLES “YYYY-MM-DD” or “YYYY-MM”.
If only the year and month are given, the expiry date shall be the last day of the month indicated.
The label of the outer container shall indicate the expiry date of the component having the earliest
expiry date, or an earlier date, where appropriate.
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 word, product identifiers, hazard statements and precautionary
statements should be included. However, where there is insufficient space, the hazard pictogram shall
be given on the outer container label and the other information shall be given in the instructions for
use.
EXAMPLES Chemical, radioactive, and biological hazards.
In the case of chemical hazards, if the IVD reagent is not accompanied by instructions for use containing
the appropriate risk and safety statements, these statements shall be given on the label of the outer
container.
Statements or warning symbols for specific hazards may be required by local, national or regional
regulations.
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.
6.1.2 Small label
If the available space on the immediate container label is too small to include all the information listed
below, the information about contents (6.4), IVD 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.
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6.3.2 Batch code/lot number
A batch code and where appropriate, a lot number, shall be given.
6.3.3 Unique device identifier/identification (UDI)
If an UDI is required by the regulatory authority, the UDI shall be included as specified in 5.2.3.
NOTE The UDI on the immediate container label may not be the same as the UDI on the outer container.
Refer to applicable regulations and issuing agencies for requirements.
6.4 Contents
If not indicated by another means, the contents shall be specified.
EXAMPLES Mass, volume, volume after reconstitution and/or the number of examinations.
6.5 in vitro diagnostic use
The
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