SIST EN ISO 15223-1:2012

Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2012)

This International Standard identifies requirements for symbols used in medical device labelling that may convey information on the safe and effective use of medical devices. It also lists symbols that satisfy the requirements of this standard. ISO 15223-1 is applicable to symbols used in a broad spectrum of medical devices that are marketed globally and need to meet different regulatory requirements. These symbols may be used on the medical device itself or its package or in the associated documentation.

Medizinprodukte - Bei Aufschriften von Medizinprodukten zu verwendende Symbole, Kennzeichnung und zu liefernde Informationen - Teil 1: Allgemeine Anforderungen (ISO 15223-1:2012)

Diese Internationale Norm legt Anforderungen an Symbole zur Verwendung in Aufschriften von Medizinpro-dukten fest, die zur Lieferung von Informationen für die sichere und wirkungsvolle Anwendung von Medizin-produkten angewendet werden dürfen. Sie führt auch eine Liste von Symbolen auf, die den Anforderungen dieser Norm entsprechen.
ISO 15223 1 gilt für Symbole, die auf ein breites Spektrum von Medizinprodukten anwendbar sind, die weltweit in Verkehr gebracht werden und unterschiedliche behördliche Anforderungen erfüllen müssen. Diese Symbole dürfen auf dem Medizinprodukt selbst oder seiner Verpackung oder in den zugehörigen Dokumenten verwendet werden. Die Anforderungen der ISO 15223 1 sind nicht dazu vorgesehen, für Symbole zu gelten, die in anderen Normen festgelegt sind.

Dispositifs médicaux - Symboles à utiliser avec les étiquettes, l'étiquetage et les informations à fournir relatifs aux dispositifs médicaux - Partie 1: Exigences générales (ISO 15223-1:2012)

L'ISO 15223-1:2012 identifie les exigences s'appliquant aux symboles utilisés dans l'étiquetage des dispositifs médicaux, susceptibles de fournir des informations en vue d'une utilisation correcte et sûre des dispositifs médicaux. Elle énumère également les symboles satisfaisant aux exigences de la présente partie de l'ISO 15223.
L'ISO 15223-1:2012 s'applique aux symboles utilisés pour une vaste gamme de dispositifs médicaux commercialisés au niveau mondial et tenus de répondre à diverses exigences réglementaires.
Ces symboles peuvent figurer sur le dispositif médical lui-même ou sur son emballage ou dans la documentation associée. Les exigences de l'ISO 15223-1:2012 n'ont pas pour objectif d'être appliquées aux symboles spécifiés dans d'autres normes.

Medicinski pripomočki - Simboli za označevanje medicinskih pripomočkov, označevanje in podatki, ki jih mora podati dobavitelj - 1. del: Splošne zahteve (ISO 15223-1:2012)

Ta mednarodni standard opredeljuje zahteve glede simbolov za označevanje medicinskih pripomočkov, ki lahko podajajo informacije o varni in učinkoviti uporabi medicinskih pripomočkov. Navaja tudi simbole, ki ustrezajo zahtevam iz tega standarda. Standard ISO 15223-1 velja za simbole, ki se uporabljajo na različnih medicinskih pripomočkih na globalnem tržišču in morajo izpolnjevati različne regulatorne zahteve. Ti simboli se uporabljajo na medicinskih pripomočkih samih ali njihovi embalaži ali v njim priloženi dokumentaciji.

General Information

• Status: Withdrawn
• Public Enquiry End Date: 14-Oct-2009
• Publication Date: 25-Sep-2012
• Withdrawal Date: 09-Jan-2017
• ICS: 01.080.20 - Graphical symbols for use on specific equipment
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 10-Jan-2017
• Due Date: 02-Feb-2017
• Completion Date: 10-Jan-2017
• Directive: 90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Directive: 98/79/EC - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Mandate: M/252 - Standardization Mandate to CEN/CENELEC concerning the development of European standards relating to in vitro diagnostic medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN ISO 15223-1:2012 - Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2012)

Relations

• Replaced By: SIST EN ISO 15223-1:2017 - Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016)
• Effective Date: 01-Feb-2017
• Replaced By: SIST EN ISO 15223-1:2017 - Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016)
• Effective Date: 08-Jun-2022
• Replaces: SIST EN 980:2008 - Symbols for use in the labelling of medical devices
• Effective Date: 01-Oct-2012

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 15223-1:2012
01-oktober-2012
1DGRPHãþD
SIST EN 980:2008
0HGLFLQVNLSULSRPRþNL6LPEROL]DR]QDþHYDQMHPHGLFLQVNLKSULSRPRþNRY
R]QDþHYDQMHLQSRGDWNLNLMLKPRUDSRGDWLGREDYLWHOMGHO6SORãQH]DKWHYH,62

Medical devices - Symbols to be used with medical device labels, labelling and
information to be supplied - Part 1: General requirements (ISO 15223-1:2012)
Medizinprodukte - Bei Aufschriften von Medizinprodukten zu verwendende Symbole,
Kennzeichnung und zu liefernde Informationen - Teil 1: Allgemeine Anforderungen (ISO
15223-1:2012)
Dispositifs médicaux - Symboles à utiliser avec les étiquettes, l'étiquetage et les
informations à fournir relatifs aux dispositifs médicaux - Partie 1: Exigences générales
(ISO 15223-1:2012)
Ta slovenski standard je istoveten z: EN ISO 15223-1:2012
ICS:
01.080.20 *UDILþQLVLPEROL]DSRVHEQR Graphical symbols for use on
RSUHPR specific equipment
11.040.01 Medicinska oprema na Medical equipment in general
splošno
SIST EN ISO 15223-1:2012 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 15223-1:2012

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SIST EN ISO 15223-1:2012


EUROPEAN STANDARD
EN ISO 15223-1

NORME EUROPÉENNE

EUROPÄISCHE NORM
July 2012
ICS 01.080.20; 11.040.01 Supersedes EN 980:2008
English version
Medical devices - Symbols to be used with medical device
labels, labelling and information to be supplied - Part 1: General
requirements (ISO 15223-1:2012)
Dispositifs médicaux - Symboles à utiliser avec les Medizinprodukte - Bei Aufschriften von Medizinprodukten
étiquettes, l'étiquetage et les informations à fournir relatifs zu verwendende Symbole, Kennzeichnung und zu liefernde
aux dispositifs médicaux - Partie 1: Exigences générales Informationen - Teil 1: Allgemeine Anforderungen (ISO
(ISO 15223-1:2012) 15223-1:2012)
This European Standard was approved by CEN on 24 May 2012.

CEN and CENELEC 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 and CENELEC
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 and CENELEC member into its own language and notified to the CEN-CENELEC Management Centre
has the same status as the official versions.

CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia,
Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.






CEN-CENELEC Management Centre:
Avenue Marnix 17, B-1000 Brussels
© 2012 CEN/CENELEC All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15223-1:2012 E
worldwide for CEN national Members and for CENELEC
Members.

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SIST EN ISO 15223-1:2012
EN ISO 15223-1:2012 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices .4
Annex ZB (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 90/385/EEC on active implantable medical devices .5
Annex ZC (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 98/79/EC on in vitro diagnostic medical devices .6

2

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SIST EN ISO 15223-1:2012
EN ISO 15223-1:2012 (E)
Foreword
This document (EN ISO 15223-1:2012) has been prepared by Technical Committee ISO/TC 210 "Quality
management and corresponding general aspects for medical devices" in collaboration with Technical
Committee CEN/CLC/TC 3 “Quality management and corresponding general aspects for medical devices” the
secretariat of which is held by NEN.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by January 2013, and conflicting national standards shall be withdrawn at
the latest by January 2013.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 980:2008.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directives.
For relationship with EU Directives, see informative Annex ZA, ZB and ZC, which are integral parts of this
document.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 15223-1:2012 has been approved by CEN as a EN ISO 15223-1:2012 without any
modification.

3

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SIST EN ISO 15223-1:2012
EN ISO 15223-1:2012 (E)
Annex ZA
(informative)

Relationship between this European Standard and the Essential Requirements of EU
Directive 93/42/EEC on medical devices
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC on medical devices.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 — Correspondence between this European Standard and
Directive 93/42/EEC on medical devices
Clauses/subclauses of this Essential Requirements (ERs) of
Qualifying remarks/notes
European Standard Directive 93/42/EEC
5.2.7 8.7
4 13.2 Only the first two sentences of this ER
are covered.
5.1.1, 5.1.2 13.3 (a)
5.1.6 13.3 (b)
5.2.1, 5.2.2, 5.2.3, 5.2.4, 5.2.5, 5.2.9 13.3 (c)
5.1.5, 5.1.7 13.3 (d)
5.1.4 13.3 (e)
5.4.2 13.3 (f) Only the first sentence of this ER is
covered.
5.3.1, 5.3.2, 5.3.3, 5.3.4,5.3.5, 5.3.6, 13.3 (i)
5.3.7, 5.3.8, 5.3.9
5.4.3 13.3 (j)
5.2.6, 5.2.7, 5.2.8, 5.4.1, 5.4.4, 5.4.5 13.3 (k) This ER is covered only in respect of the
particular warnings or precautions that
these symbols indicate. For other
warnings, other symbols or other means
of indication may be needed.
5.1.3 13.3 (l)
5.2.2, 5.2.3, 5.2.4, 5.2.5 13.3 (m)

WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.
4

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SIST EN ISO 15223-1:2012
EN ISO 15223-1:2012 (E)
Annex ZB
(informative)

Relationship between this European Standard and the Essential Requirements of EU
Directive 90/385/EEC on active implantable medical devices
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 90/385/EEC on active implantable medical devices.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in Table ZB.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZB.1 — Correspondence between this European Standard and
Directive 90/385/EEC on active implantable medical devices
Clauses/subclauses of this Essential Requirements (ERs) of
Qualifying remarks/notes
European Standard Directive 90/385/EEC
5.1.5, 5.1.6, 5.1.7 11
4 14 Only with regard to the use of symbols.
5.2.2, 5.2.3, 5.2.4, 5.2.5 14.1, 1st indent
5.1.6 14.1, 2nd indent
5.1.1 14.1, 3rd indent
5.1.5, 5.1.6, 5.1.7, 5.4.3, 5.4.4 14.1, 4th indent Only identifying the model and batch or
serial number, and directing users to the
instructions for use for further
information and precautions.
5.2.1 14.1, 7th indent
5.1.3 14.1, 8th indent
5.1.4 14.1, 9th indent
5.1.1, 5.1.2 14.2, 1st indent
5.1.5, 5.1.6, 5.1.7, 5.4.3, 5.4.4 14.2, 2nd indent Only identifying the model and batch or
serial number, and directing users to the
instructions for use for further
information and precautions.
5.2.6, 5.2.7 14.2, 4th indent
5.2.1 14.2, 7th indent
5.1.3 14.2, 8th indent
5.1.4 14.2, 9th indent
5.3.1, 5.3.2, 5.3.3, 5.3.4, 5.3.5, 5.3.6, 14.2, 10th indent Only the conditions for transporting and
5.3.7, 5.3.8, 5.3.9 storing the device are addressed.
5.2.8 15, 8th indent Only the warning “do not use the
product, if the product sterile barrier
system or its packaging is
compromised” is addressed.

WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.
5

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SIST EN ISO 15223-1:2012
EN ISO 15223-1:2012 (E)
Annex ZC
(informative)

Relationship between this European Standard and the Essential Requirements of EU
Directive 98/79/EC on in vitro diagnostic medical devices
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 98/79/EC on in vitro diagnostic medical devices.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in Table ZC.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZC.1 — Correspondence between this European Standard and
Directive 98/79/EC on in vitro diagnostic medical devices
Clauses/subclauses of this Essential Requirements (ERs) of
Qualifying remarks/notes
European Standard Directive 98/79/EC
5.4.3 B.8.1 Only the second part of the fourth
paragraph is covered: “If individual full
labelling of each unit is not practicable,
the information must be set out on the
packaging and/or in the instructions for
use supplied with one or more devices”.
4 B.8.2 Only the first two sentences of this ER
are covered.
5.1.1, 5.1.2 B.8.4 (a)
5.1.3, 5.1.6, 5.5.2, 5.5.3, 5.5.4, 5.5.5 B.8.4 (b)
5.2.1, 5.2.2, 5.2.3, 5.2.4, 5.2.5, 5.2.7, B.8.4 (c)
5.2.9
5.1.5, 5.1.7 B.8.4 (d)
5.1.4 B.8.4 (e)
5.5.6 B.8.4 (f)
5.5.1 B.8.4 (g)
5.3.1, 5.3.2, 5.3.3, 5.3.4, 5.3.5, 5.3.6, B.8.4 (h)
5.3.7, 5.3.8, 5.3.9
5.4.3 B.8.4 (i)
5.2.6 , 5.2.8, 5.4.1, 5.4.2, 5.4.4, 5.4.5 B.8.4 (j)
5.1.5, 5.1.7 B.8.6

WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.


6

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SIST EN ISO 15223-1:2012

INTERNATIONAL ISO
STANDARD 15223-1
Second edition
2012-07-01


Medical devices — Symbols to be used
with medical device labels, labelling and
information to be supplied —
Part 1:
General requirements
Dispositifs médicaux — Symboles à utiliser avec les étiquettes,
l'étiquetage et les informations à fournir relatifs aux dispositifs
médicaux —
Partie 1: Exigences générales




Reference number
ISO 15223-1:2012(E)
©
ISO 2012

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SIST EN ISO 15223-1:2012
ISO 15223-1:2012(E)

COPYRIGHT PROTECTED DOCUMENT


©  ISO 2012
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56  CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail [e-mail]
Web www.iso.org
Published in Switzerland

ii © ISO 2012 – All rights reserved

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SIST EN ISO 15223-1:2012
ISO 15223-1:2012(E)
Contents Page
Foreword . iv
Introduction . v
1  Scope . 1
2  Normative references . 1
3  Terms and definitions . 1
4  General requirements . 2
4.1  Proposal of symbols for adoption . 2
4.2  Requirements for usage . 2
4.3  Other symbols . 3
5  Symbols . 3
5.1  Manufacture . 4
5.2  Sterility. 6
5.3  Storage . 9
5.4  Safe use . 11
5.5  IVD-specific . 12
5.6  Transfusion/infusion . 14
5.7  Other . 16
Annex A (informative) Examples . 17
Annex B (informative) Use of general prohibition symbol and negation symbol . 21
Bibliography . 22

© ISO 2012 – All rights reserved iii

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SIST EN ISO 15223-1:2012
ISO 15223-1:2012(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 15223-1 was prepared by Technical Committee ISO/TC 210, Quality management and corresponding
general aspects for medical devices.
This second edition cancels and replaces the first edition (ISO 15223-1:2007) and EN 980:2008, which have
been technically revised. It also incorporates the amendment ISO 15223-1:2007/Amd.1:2008.
ISO 15223 consists of the following parts, under the general title Medical devices — Symbols to be used with
medical device labels, labelling and information to be supplied:
 Part 1: General requirements
 Part 2: Symbol development, selection and validation
NOTE Future symbols intended to appear in this part of ISO 15223 are to be validated in accordance with
ISO 15223-2.
iv © ISO 2012 – All rights reserved

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SIST EN ISO 15223-1:2012
ISO 15223-1:2012(E)
Introduction
This part of ISO 15223 addresses the presentation of certain items of information that are considered by
regulatory authorities to be essential for the safe and proper use of medical devices. As such, the items are
required to appear with the medical device in most regulatory domains. The information can be required to
appear on the medical device itself, as part of the label, or provided with the medical device.
Many countries require that their own language be used to display textual information with medical devices. At
the same time, manufacturers seek to take costs out of labelling by reducing or rationalizing variants. This can
cause problems in relation to translation, design and logistics when multiple languages are included on a
single label or piece of documentation. For example, users of medical devices labelled in a number of different
languages can experience confusion and delay in locating the appropriate language.
This part of ISO 15223 proposes solutions to these problems through the use of internationally recognized
symbols with precisely defined descriptions.
While compiling symbols to be included in this part of ISO 15223, ISO/TC 210 recognized the need for
systematic methodology for the selection, development and validation of symbols proposed for adoption. This
is the subject of ISO 15223-2.
This part of ISO 15223 is primarily intended to be used by manufacturers of medical devices who market
identical products in countries where there are different language requirements for medical device labelling. It
can also be of assistance to:
 distributors of medical devices or other representatives of manufacturers;
 healthcare providers responsible for training as well as those being trained;
 those responsible for post-market vigilance;
 healthcare regulatory authorities, testing organizations, certification bodies and other organizations which
are responsible for implementing regulations affecting medical devices and which have responsibility for
post-market surveillance; and
 consumers or end users of medical devices who draw their supplies from a number of sources and can
have varied language capabilities.
This part of ISO 15223 constitutes a technical revision of both ISO 15223-1:2007 and EN 980:2008,
combining the symbols and requirements of both standards for the first time. There has been a steady
convergence of the symbol requirements in ISO 15223-1 and EN 980 over recent years, with many of the
previous differences between the standards resolved. This part of ISO 15223 represents a significant advance
in the safe and effective use of symbols to transcend language, giving manufacturers, regulators and others a
single set of global symbols for use with medical devices.

© ISO 2012 – All rights reserved v

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SIST EN ISO 15223-1:2012

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SIST EN ISO 15223-1:2012
INTERNATIONAL STANDARD ISO 15223-1:2012(E)

Medical devices — Symbols to be used with medical device
labels, labelling and information to be supplied —
Part 1:
General requirements
1 Scope
This part of ISO 15223 identifies requirements for symbols used in medical device labelling that convey
information on the safe and effective use of medical devices. It also lists symbols that satisfy the requirements
of this part of ISO 15223.
This part of ISO 15223 is applicable to symbols used in a broad spectrum of medical devices, which are
marketed globally and therefore need to meet different regulatory requirements.
These symbols may be used on the medical device itself, on its packaging or in the associated documentation.
The requirements of this part of ISO 15223 are not intended to apply to symbols specified in other standards.
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 7000, Graphical symbols for use on equipment — Index and synopsis
ISO 8601, Data elements and interchange formats — Information interchange — Representation of dates and
times
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 15223-2, Medical devices — Symbols to be used with medical device labels, labelling and information to
be supplied — Part 2: Symbol development, selection and validation
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 14971 and the following apply.
3.1
characteristic information
information that represents the property or properties of a symbol
3.2
description
normative text which defines the purpose, application and use of the symbol
NOTE Adapted from IEC 80416-1:2008, definition 3.2.
© ISO 2012 – All rights reserved 1

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SIST EN ISO 15223-1:2012
ISO 15223-1:2012(E)
3.3
label
written, printed or graphic information provided upon the medical device itself
NOTE Adapted from GHTF/SG1/N43:2005.
3.4
labelling
information supplied by the manufacturer that is provided for, associated with, or affixed to, a medical device
or any of its containers or wrappers
NOTE 1 This information relates to the identification, technical description and use of the medical device, but excludes
shipping documents.
NOTE 2 Some regional and national regulations refer to “labelling” as “information supplied by the manufacturer”.
3.5
symbol used in medical device labelling
graphical representation appearing on the label and/or associated documentation of a medical device that
communicates characteristic information without the need for the supplier or receiver of the information to
have knowledge of the language of a particular nation or people
NOTE The symbol can be an abstract pictorial or a graphical representation, or one that uses familiar objects,
including alphanumeric characters.
3.6
title
unique name by which a graphical symbol is identified and spoken of
NOTE Adapted from IEC 80416-1:2008, definition 3.9.
4 General requirements
4.1 Proposal of symbols for adoption
Symbols proposed for adoption in this part of ISO 15223 shall be validated in accordance with ISO 15223-2.
Any symbol proposed for adoption in this part of ISO 15223 shall be applicable to a range of medical devices
and have global or regional applicability.
4.2 Requirements for usage
When risk management shows it to be appropriate for symbols to be used to convey information essential for
proper use on the medical device, its packaging or in associated documentation, the symbols given in Table 1
may be used.
Symbols that are registered in ISO 7000 shall comply with the graphical representation in ISO 7000,
especially with respect to relative dimensions, including relative line thickness, orientation and the absence or
presence of filled or shaded areas.
NOTE 1 ISO and IEC jointly maintain an online database of graphical symbols for use on equipment, which contains
the complete set of graphical symbols included in ISO 7000 and IEC 60417. In that database, each graphical symbol is
identified by a reference number and contains a title (in English and French), a graphical representation in GIF and
vectorized PDF format, and some additional data as applicable. Various search and navigation facilities allow for easy
retrieval of graphical symbols. Information on how to subscribe in order to access this database is available through the
ISO Store, the IEC Web Store or by contacting your local national standards body.
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SIST EN ISO 15223-1:2012
ISO 15223-1:2012(E)
As part of risk management, the manufacturer should determine the appropriate size for the symbol to be
legible for its intended function.
NOTE 2 This part of ISO 15223 does not specify colours or minimum size for the symbols in Table 1, nor does it
specify the relative size of symbols and that of indicated information.
It is important that symbols be used properly. Guidance on appropriate use of the general prohibition symbol
and the negation symbol is given in Annex B.
Before symbols are used, the manufacturer shall carry out a risk assessment that indicates that the use of the
symbol does not introduce an unacceptable risk.
NOTE 3 Additional information regarding risk assessment can be found in ISO 14971.
Symbols may be used without accompanying text. Where regulations require accompanying text, the title of
the symbol given in this part of ISO 15223 should be considered sufficient. All dates and times presented in
association with symbols shall use the conventions set out in ISO 8601.
4.3 Other symbols
Other standards specify additional symbols that are applicable to particular kinds or groups of medical devices
or to particular situations. Examples of sources for such symbols are identified in the Bibliography. This listing
is not exhaustive.
5 Symbols
When appropriate, information essential for proper use shall be indicated on the medical device, its packaging,
or in the associated documentation by using the corresponding symbols given in Table 1.
A manufacturer may use any appropriate symbol regardless of category.
NOTE Table 1 has been organized into symbol categories for ease of use. The category into which a symbol is
grouped does not have any significance as far as usage is concerned. The order of appearance of symbols and the
categories in which they are placed are not prioritized. Examples of the use of symbols can be found in Annex A.
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SIST EN ISO 15223-1:2012
ISO 15223-1:2012(E)
Table 1 — Symbols to convey information essential for proper use
Description of
Reference number ISO 7000
Title of symbol Requirements Informative notes Restrictions of use Additional requirements
a
of symbol Reg. no.
symbol
5.1 Manufacture
NOTE 1 This symbol is
5.1.1 Manufacturer Indicates the This symbol shall be  3082
used to indicate information
medical device accompanied by the name
b
that is required in Europe .
manufacturer, as and address of th
...