EN ISO 15223-1:2016

Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03)

ISO 15223-1:2016 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 document.
ISO 15223-1:2016 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 document are not intended to apply to symbols specified in other standards.

Medizinprodukte - Bei Aufschriften von Medizinprodukten zu verwendende Symbole, Kennzeichnung und zu liefernde Informationen - Teil 1: Allgemeine Anforderungen (ISO 15223-1:2016, korrigierte Fassung 2017-03)

Dieser Teil der ISO 15223 legt Anforderungen an Symbole zur Verwendung in Kennzeichnungen von Medizinprodukten fest, die zur Lieferung von Informationen für die sichere und wirkungsvolle Anwendung von Medizinprodukten angewendet werden. Sie führt auch eine Liste von Symbolen auf, die den Anforderungen dieses Teils der ISO 15223 entsprechen.
Dieser Teil der ISO 15223 gilt für Symbole, die auf ein breites Spektrum von Medizinprodukten anwendbar sind, die weltweit in Verkehr gebracht werden und daher unterschiedliche behördliche Anforderungen erfüllen müssen.
Diese Symbole dürfen auf dem Medizinprodukt selbst, auf seiner Verpackung oder in den zugehörigen Dokumenten verwendet werden. Die Anforderungen dieses Teils der ISO 15223 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 15223-1:2016, Version corrigée 2017-03)

ISO 15223-1:2016 identifie les exigences s'appliquant aux symboles utilisés dans l'étiquetage des dispositifs médicaux et fournissant des informations en vue d'une utilisation correcte et sûre de ces dispositifs. Il répertorie également les symboles satisfaisant à ses exigences.
ISO 15223-1:2016 s'applique aux symboles utilisés pour une vaste gamme de dispositifs médicaux commercialisés au niveau mondial et devant à ce titre répondre à diverses exigences réglementaires.
Ces symboles peuvent figurer sur le dispositif médical lui-même, sur son emballage ou dans la documentation associée. Les exigences du présent document 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 15223-1:2016)

Ta dokument opredeljuje zahteve glede simbolov za označevanje medicinskih pripomočkov, ki podajajo informacije o varni in učinkoviti uporabi medicinskih pripomočkov. Navaja tudi simbole, ki ustrezajo zahtevam iz tega dokumenta.
Ta dokument se uporablja za simbole, ki se uporabljajo pri različnih medicinskih pripomočkih na globalnem tržišču in morajo zato izpolnjevati različne predpisane zahteve.
Ti simboli se uporabljajo na samih medicinskih pripomočkih, na njihovi embalaži ali v priloženi dokumentaciji. Zahteve tega dokumenta se ne uporabljajo za simbole, ki so določeni v drugih standardih.

General Information

• Status: Withdrawn
• Publication Date: 29-Nov-2016
• Withdrawal Date: 13-Apr-2025
• ICS: 01.080.20 - Graphical symbols for use on specific equipment
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: CEN/CLC/TC 3 - Quality management and corresponding general aspects for medical devices
• Drafting Committee: CEN/CLC/TC 3 - Quality management and corresponding general aspects for medical devices
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 29-Sep-2021
• Completion Date: 14-Apr-2025
• 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: 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)

Relations

• Replaces: 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)
• Effective Date: 05-Dec-2014
• Replaced By: EN ISO 15223-1:2021 - Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)
• Effective Date: 06-Oct-2021
• Amended By: EN ISO 15223-1:2016/FprA11 - Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, including corrected version 2017-03)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
01-februar-2017
1DGRPHãþD
SIST EN ISO 15223-1:2012
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 15223-1:2016)
Medizinprodukte - Bei Aufschriften von Medizinprodukten zu verwendende Symbole,
Kennzeichnung und zu liefernde Informationen - Teil 1: Allgemeine Anforderungen (ISO
15223-1:2016)
Dispositifs médicaux - Symboles à utiliser avec les étiquettes, l'étiquetage et les
informations à fournir relatifs aux dispositifs médicaux - Partie 1: Exigences générales
(ISO 15223-1:2016)
Ta slovenski standard je istoveten z: EN ISO 15223-1:2016
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 15223-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2016
ICS 01.080.20; 11.040.01
Supersedes EN ISO 15223-1:2012
English version
Medical devices - Symbols to be used with medical device
labels, labelling and information to be supplied - Part 1:
General requirements (ISO 15223-1:2016)
Dispositifs médicaux - Symboles à utiliser avec les Medizinprodukte - Bei Aufschriften von
étiquettes, l'étiquetage et les informations à fournir Medizinprodukten zu verwendende Symbole,
relatifs aux dispositifs médicaux - Partie 1: Exigences Kennzeichnung und zu liefernde Informationen - Teil
générales (ISO 15223-1:2016) 1: Allgemeine Anforderungen (ISO 15223-1:2016)
This European Standard was approved by CEN on 22 October 2016.

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
© 2016 CEN/CENELEC All rights of exploitation in any form and by any means Ref. No. EN ISO 15223-1:2016 E
reserved worldwide for CEN national Members and for
CENELEC Members.
Contents Page
European foreword . 3
Annex ZA (informative)  Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC [OJ L 169] on Medical Devices . 5
Annex ZB (informative)  Relationship between this European standard and the essential
requirements of Directive 90/385/EEC [OJ L 189] aimed to be covered . 8
Annex ZC (informative)  Relationship between this European standard and the essential
requirements of Directive 98/79/EC [OJ L 331] aimed to be covered . 10
European foreword
This document (EN ISO 15223-1:2016) 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 May 2017, and conflicting national standards shall be
withdrawn at the latest by May 2017.
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 ISO 15223-1:2012.
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 Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, Annex ZB and Annex ZC, which are
integral parts of this document.
The following referenced documents are indispensable for the application of this document. For
undated references, the latest edition of the referenced document (including any amendments) applies.
For dated references, only the edition cited applies. However, for any use of this standard “within the
meaning of Annex ZA/Annex ZB/Annex ZC”, the user should always check that any referenced
document has not been superseded and that its relevant contents can still be considered the generally
acknowledged state-of-art.
When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a
normative reference to the corresponding EN standard, if available, and otherwise to the dated version
of the ISO or IEC standard, as listed below.
NOTE The way in which these referenced documents are cited in normative requirements determines the
extent (in whole or in part) to which they apply.
Table 1 — Correlations between normative references and dated EN and ISO standards
Normative references Equivalent dated standard
as listed in Clause 2 of the ISO
EN ISO
standard
a
ISO 7000 — ISO 7000:2014
ISO 8601 — ISO 8601:2004
ISO 14971 EN ISO 14971:2012 ISO 14971:2007
ISO 15223-2 — ISO 15223-2:2010
a
Available only in database format from ISO or IEC.
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,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 15223-1:2016 has been approved by CEN as EN ISO 15223-1:2016 without any
modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC [OJ L 169] on Medical Devices
This European Standard has been prepared under a Commission's standardization request 'M/023
concerning the development of European standards related to medical devices’ to provide one
voluntary means of conforming to essential requirements of Council Directive 93/42/EEC of 14 June
1993 concerning medical devices [OJ L 169].
Once this standard is cited in the Official Journal of the European Union under that Directive,
compliance with the normative 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.
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 Directive 93/42/EEC as amended by 2007/47/EC. This
means that risks have to be reduced “as far as possible”, “to a minimum”, “to the lowest possible level”,
“minimized” or “removed”, according to the wording of the corresponding essential requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with Essential
Requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.
NOTE 3 This Annex ZA is based on normative references according to the table of references in the European
foreword, replacing the references in the core text.
NOTE 4 When an Essential 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 Directive
93/42/EEC [OJ L 169]
Essential Requirements (ERs) Clause(s)/subclause(s) of this Qualifying remarks/Notes
of Directive 93/42/EEC European Standard
8.7 5.2.7 Provided that the symbol is
provided according to the
general requirements indicated
in the ER 13.1 of Directive
93/42/EEC and only for non-
sterile products.
13.2 4.2, 4.3 Only the first sentence of this
ERs is covered, provided that the
symbol is provided on the label
and according to the general
requirements indicated in the ER
13.1 of Directive 93/42/EEC.
13.3 (a) 5.1.1, 5.1.2 Provided that the symbol is
provided on the label and
according to the general
requirements indicated in the ER
13.1 of Directive 93/42/EEC.
13.3 (c) 5.2.1, 5.2.2, 5.2.3, 5.2.4, 5.2.5, Provided that the symbol is
5.2.9 provided on the label and
according to the general
requirements indicated in the ER
13.1 of Directive 93/42/EEC.
13.3 (d) 5.1.5, 5.1.7 Provided that the symbol is
provided on the label and
according to the general
requirements indicated in the ER
13.1 of Directive 93/42/EEC. If a
Serial number is not provided
the symbol for 'LOT' must
precede the batch code.
13.3 (e) 5.1.4 Provided that the symbol is
provided on the label and
according to the general
requirements indicated in the ER
13.1 of Directive 93/42/EEC, the
“use-by” date must be expressed
as, at least, the year and the
month.
13.3 (f) 5.4.2 Only the first sentence of this ER
is covered, provided that the
symbol is provided on the label
and according to the general
requirements indicated in the ER
13.1 of Directive 93/42/EEC.
13.3 (i) 5.3.1, 5.3.2, 5.3.3, 5.3.4, 5.3.5, Provided that the symbol is
5.3.6, 5.3.7, 5.3.8, 5.3.9 provided on the label and
according to the general
requirements indicated in the ER
13.1 of Directive 93/42/EEC, the
ER is only covered with respect
to the conditions indicated by
the symbols. For other
conditions, other symbols or
other means of indication may
be needed.
13.3 (k) 5.2.6, 5.2.7, 5.2.8, 5.4.1, 5.4.4, Provided that the symbol is
5.4.5 provided on the label and
according to the general
requirements indicated in the ER
13.1 of Directive 93/42/EEC, the
ER is only covered with respect
to the warnings indicated by the
symbols. For other warnings,
other symbols or other means of
indication may be needed.
13.3 (l) 5.1.3 Provided that the symbol is
provided on the label and
according to the general
requirements indicated in the ER
13.1 of Directive 93/42/EEC.
Active medical devices must be
labelled with at least the year of
manufacture unless a “use-by”
date (5.1.4) is given. The date of
manufacture may be included in
the batch or serial number
(5.1.5, 5.1.7).
13.3 (m) 5.2.2, 5.2.3, 5.2.4, 5.2.5 Provided that the symbol is
provided on the label and
according to the general
requirements indicated in the ER
13.1 of Directive 93/42/EEC, the
ER is only covered with respect
to the conditions indicated by
the symbols.
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 requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.
Annex ZB
(informative)
Relationship between this European standard and the essential
requirements of Directive 90/385/EEC [OJ L 189] aimed to be covered
This European standard has been prepared under a Commission’s standardisation request 'M/023
concerning the development of European standards related to medical devices’ to provide one
voluntary means of conforming to essential requirements of Council Directive of 20 June 1990 on the
approximation of the laws of the Member States relating to active implantable medical devices [OJ L
189].
Once this standard is cited in the Official Journal of the European Union under that Directive,
compliance with the normative 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.
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 Directive 90/385/EEC as amended by 2007/47/EC. This
means that risks have to be reduced “as far as possible”, “to a minimum”, “to the lowest possible level”,
“minimized” or “removed”, according to the wording of the corresponding essential requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with Essential
Requirements 1, 4, 5, 8, 9 and 10 of the Directive.
NOTE 3 This Annex ZB is based on normative references according to the table of references in the European
foreword, replacing the references in the core text.
NOTE 4 When an Essential Requirement does not appear in Table ZB.1, it means that it is not addressed by this
European Standard.
Table ZB.1 — Correspondence between this European Standard and Directive 90/385/EEC on
active implantable medical devices
Essential Requirements (ERs) Clause(s)/subclause(s) of this Qualifying remarks/Notes
of Directive 90/385/EEC European Standard
11 5.1.5, 5.1.6, 5.1.7 ER is covered only for indication
of batch code or serial number.
Components are not covered”.
14.1, 1st indent 5.2.2, 5.2.3, 5.2.4, 5.2.5 Provided that the symbol is
provided on the sterile pack,
This ER is only covered with
respect to the conditions
indicated by the symbols. For
other warnings, other symbols
or other means of indication
may be needed.
14.1, 2nd indent 5.2.1, 5.2.2, 5.2.3, 5.2.4. 5.2.5 Provided that the symbol is
provided on the sterile pack.
14.1, 3rd indent 5.1.1 Provided that the symbol is
provided on the sterile pack.
14.1, 7th indent 5.2.1, 5.2.2, 5.2.3, 5.2.4, 5.2.5 Provided that the symbol is
provided on the sterile pack.
14.1, 8th indent 5.1.3 Provided that the symbol is
provided on the sterile pack.
Active implantable medical
devices must be labelled with at
least the month and year of
manufacture.
14.1, 9th indent 5.1.4 Provided that the symbol is
provided on the sterile pack.
14.2, 1st indent 5.1.1, 5.1.2 Provided that the symbol is
provided on the sales packaging.
The 'Trade name' of the
manufacturer must not be used
with this symbol.
14.2, 7th indent 5.2.1 Provided that the symbol is
provided on the sales packaging.
14.2, 8th indent 5.1.3 Provided that the symbol is
provided on the sales packaging.
14.2, 9th indent 5.1.4 Provided that the symbol is
provided on the sales packaging.
14.2, 10th indent 5.3.1, 5.3.2, 5.3.3, 5.3.4, 5.3.5, Provided that the symbol is
5.3.6, 5.3.7, 5.3.8, 5.3.9 provided on the sales packaging,
The ER is only covered in
respect of the conditions
indicated by the symbols. For
other conditions, other symbols
or other means of indication
may be needed.
15, 8th indent 5.2.8 Provided that the symbol is
provided in the instructions for
use, only the warning “do not
use the product, if the product
sterile barrier system or its
packaging is compromised” is
addressed.
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 requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.
Annex ZC
(informative)
Relationship between this European standard and the essential
requirements of Directive 98/79/EC [OJ L 331] aimed to be covered
This European standard has been prepared under a Commission’s standardisation request 'M/252,
concerning the development of European standards relating to in vitro diagnostic medical devices' to
provide one voluntary means of conforming to essential requirements of Directive 98/79/EC of the
European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices [OJ L
331].
Once this standard is cited in the Official Journal of the European Union under that Directive,
compliance with the normative 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.
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 Directive 98/79/EC. This means that risks have to be
reduced “as far as possible”, “to a minimum”, “to the lowest possible level”, “minimized” or “removed”, according
to the wording of the corresponding essential requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with Essential
Requirements Part A: 1, 2 and 5; Part B: 1.2, 2, 3, 5, 6 and 7 of the Directive.
NOTE 3 This Annex ZC is based on normative references according to the table of references in the European
foreword, replacing the references in the core text.
NOTE 4 When an Essential Requirement does not appear in Table ZC.1, it means that it is not addressed by this
European Standard.
Table ZC.1 — Correspondence between this European Standard and Directive 98/79/EC on in
vitro diagnostic medical devices
Essential Requirements (ERs) Clause(s)/subclause(s) of this Qualifying remarks/Notes
of Directive 98/79/EC European Standard
B.8.2 4.2, Clause 5 Only the first two sentences of
this ER are covered with regard
to the use of symbols.
B.8.4 (a) 5.1.1, 5.1.2 In Directive 98/79/EC the
requirements of Annex I, ER
B.8.4(a) refer to the IVD device
label, which must show the
name and address of the
manufacturer and, where
necessary, also of the EC
authorised representative.
When the IVD device is a kit (i.e.
a set of several components
packaged together), the kit itself
shall be labelled as above with
the name and address of
manufacturer and, where
necessary, also of the EC
authorised representative.
B.8.4 (b) 5.1.3, 5.1.6, 5.5.2, 5.5.3, 5.5.4, The ER is only covered with
5.5.5 respect to the conditions
indicated by the symbols.
B.8.4 (c) 5.2.1, 5.2.2, 5.2.3, 5.2.4, 5.2.5,
5.2.9
B.8.4 (d) 5.1.5, 5.1.7 If a Serial number is not
provided the symbol for 'LOT'
must precede the batch code.
B.8.4 (e) 5.1.4 The date must be expressed as
the year, the month and where
relevant the day, in that order.
B.8.4 (g) 5.5.1
B.8.4 (h) 5.3.1, 5.3.2, 5.3.3, 5.3.4, 5.3.5, The ER is only covered with
5.3.6, 5.3.7, 5.3.8, 5.3.9 respect to the conditions
indicated by the symbols.
B.8.4 (j) 5.2.6 , 5.2.8, 5.4.1, 5.4.2, 5.4.4, The ER is only covered with
5.4.5 respect to the conditions
indicated by the symbols.
B.8.6 5.1.5, 5.1.7
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 requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.

INTERNATIONAL ISO
STANDARD 15223-1
Third edition
2016-11-01
Corrected version
2016-12-15
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 15223-1:2016(E)
©
ISO 2016
ISO 15223-1:2016(E)
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, 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.
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ii © ISO 2016 – All rights reserved

ISO 15223-1:2016(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
Annex A (informative) Examples .20
Annex B (informative) Use of general prohibition symbol and negation symbol.24
Bibliography .25
ISO 15223-1:2016(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 on 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 the following URL: www.iso.org/iso/foreword.html.
The committee responsible for this document is ISO/TC 210, Quality management and corresponding
general aspects for medical devices.
This third edition cancels and replaces the second edition (ISO 15223-1:2012), which has been
technically revised with the following principal revisions:
— Clause 2, updated the title of ISO 7000 and added the “date of release” for each of the registered
symbols to Table 1;
— symbol 5.1.1, modified the requirement related to the placement of the manufacturer’s name and
address on IVD labels;
— symbol 5.1.2, modified the requirement related to the placement of name and address of the
authorized representative in the European Union on IVD labels;
— symbol 5.4.3, added the information used to indicate an instruction to consult an electronic
instructions for use (eIFU);
— symbol 5.4.5, added the reference to ISO 7000, symbol 2725, “Contains or presence of”;
— symbol 5.5.5, modified the description of the symbol and the requirement regarding use with IVD;
— A.15, added the examples of the placement of the eIFU indicator.
A list of all parts in the ISO 15223 series can be found on the ISO website.
NOTE Future symbols intended to appear in this document are to be validated in accordance with
ISO 15223-2.
This corrected version of ISO 15223-1:2016 incorporates the following correction:
— in A.9, the graphical symbol of NOTE 2 has been corrected.
iv © ISO 2016 – All rights reserved

ISO 15223-1:2016(E)
Introduction
This document 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 document proposes solutions to these problems through the use of internationally recognized
symbols with precisely defined descriptions.
While compiling symbols to be included in this document, 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 document 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.
INTERNATIONAL STANDARD ISO 15223-1:2016(E)
Medical devices — Symbols to be used with medical device
labels, labelling and information to be supplied —
Part 1:
General requirements
1 Scope
This document 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 document.
This document 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 document are not intended to apply to symbols specified in
other standards.
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.
1)
ISO 7000 , Graphical symbols for use on equipment — Registered symbols
ISO 8601, Data elements and interchange formats — Information interchange — Representation of dates
and times
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.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http://www.electropedia.org/
— ISO Online browsing platform: available at http://www.iso.org/obp
3.1
characteristic information
information that represents the property or properties of a symbol
1) The collection of ISO 7000 graphical symbols and additional information concerning their use are available at
https://www.iso.org/obp/ui/#search. Each symbol in the database has a “registration date”. These dates are given
in the ISO Registration Number column in Table 1.
ISO 15223-1:2016(E)
3.2
description
normative text which defines the purpose, application and use of the symbol
[SOURCE: IEC 80416-1:2008, 3.2]
3.3
label
written, printed or graphic information provided upon the medical device itself
[SOURCE: 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 to entry: This information relates to the identification, technical description (3.2) and use of the medical
device, but excludes shipping documents.
Note 2 to entry: 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 (3.3) and/or associated documentation of a medical
device that communicates characteristic information (3.1) without the need for the supplier or receiver
of the information to have knowledge of the language of a particular nation or people
Note 1 to entry: 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
[SOURCE: IEC 80416-1:2008, 3.9]
4 General requirements
4.1 Proposal of symbols for adoption
Symbols proposed for adoption in this document shall be validated in accordance with ISO 15223-2.
Any symbol proposed for adoption in this document 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.
2 © ISO 2016 – All rights reserved

ISO 15223-1:2016(E)
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 available at https://www.
iso.org/obp/ui/#search. This online collection shows each graphical symbol and identifies it by a reference
number and a title (in English and French). The graphical symbols are available in different formats (e.g. AI, DWG,
EPS) and some additional data as applicable is provided. Various search and navigation facilities allow for easy
retrieval of graphical symbols.
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 document 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 document 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.
ISO 15223-1:2016(E)
4 © ISO 2016 – All rights reserved
Table 1 — Symbols to convey information essential for proper use
Reference
Description of Informative Restrictions of Additional ISO 7000
number of Title of symbol Requirements
a
symbol notes use requirements Reg. no.
symbol
5.1  Manufacture
Manufacturer Indicates the medical This symbol shall be NOTE 1  This symbol is used to 3082
5.1.1
device manufacturer, as accompanied by the name indicate information that is
b 2011-10-02
defined in and address of the required in Europe.
EU Directives 90/385/ manufacturer (i.e. the
NOTE 2  The full definition of
EEC, 93/42/EEC and person placing the medical
“manufacturer” is given in EU
98/79/EC. device on the market),
Directives 90/385/EEC, 93/42/EEC
adjacent to the symbol.
and 98/79/EC.
NOTE 3  Guidance on the
requirements for EU Directives
90/385/EEC and 93/42/EEC is
given in EN 1041.
NOTE 4  Guidance on the
requirements for EU Directive
98/79/EC is given in ISO 18113-1,
ISO 18113-2, ISO 18113-3,
ISO 18113-4 and ISO 18113-5.
NOTE 5  The date of manufacture,
as well as the name and address of
the manufacturer, can be combined
in one symbol.
NOTE 6  The relative size of the
symbol and the size of the name and
address are not specified.
ISO 15223-1:2016(E)
Table 1 (continued)
Reference
Description of Informative Restrictions of Additional ISO 7000
number of Title of symbol Requirements
a
symbol notes use requirements Reg. no.
symbol
5.1.2 Authorized Indicates the authorized This symbol shall be NOTE 1  This symbol is used to N/A
representative in the representative in the accompanied by the name indicate information that is
European European Community. and address of the required in the European Commu-
Community authorized representative nity.
in the European
NOTE 2  Guidance on the
Community, adjacent to the
requirements for EU Directives
symbol.
90/385/EEC and 93/42/EEC is
given in EN 1041.
NOTE 3  Guidance on the
requirements for EU Directive
98/79/EC is given in ISO 18113-1,
ISO 18113-2, ISO 18113-3,
ISO 18113-4 and ISO 18113-5.
NOTE 4  The relative size of the
symbol and the size of the name and
address are not specified.
ISO 15223-1:2016(E)
6 © ISO 2016 – All rights reserved
Table 1 (continued)
Reference
Description of Informative Restrictions of Additional ISO 7000
number of Title of symbol Requirements
a
symbol notes use requirements Reg. no.
symbol
b
5.1.3 Date of Indicates the date when This symbol shall be NOTE  The relative size of the In Europe: 2497
manufacture the medical device was accompanied by a date symbol and the size of the date are
—  the date could be a 2004-01-15
manufactured. to indicate the date of not specified.
year, year and month, or
manufacture. This shall be
year, month and day, as
expressed as in ISO 8601
required in the relevant
as four digits for the year
EU Directive;
and, where appropriate,
two digits for the month
—  this symbol may
and two digits for the day.
be used to identify
the month and year of
The date shall be located
manufacture for active
adjacent to the symbol.
implantable medical
devices, or the year of
manufacture for active
medical devices where
no use-by date is given,
as required by the ap-
propriate EU Directive.
ISO 15223-1:2016(E)
Table 1 (continued)
Reference
Description of Informative Restrictions of Additional ISO 7000
number of Title of symbol Requirements
a
symbol notes use requirements Reg. no.
symbol
b
5.1.4 Use-by date Indicates the date after This symbol shall be NOTE 1  For example, June 2002 is In Europe: 2607
which the medical accompanied by a date to expressed as 2002-06.
—  the date could be a 2004-01-15
device is not to be used. indicate that the medical
NOTE 2  The relative size of the year, year and month, or
device should not be used
symbol and the size of the date are year, month and day, as
after the end of the year,
not specified. required by the
month or day shown.
relevant
NOTE 3  Synonym for “use-by date”
The date shall be EU Directive;
is “use by”.
expressed as in ISO 8601
—  this symbol can be
as four digits for the year
NOTE 4  For some medical devices
used to identify the time
and, where appropriate,
(e.g. IVDs), this date is only valid
limit for implanting
two digits for the month
when the medical device is
an active implantable
and two digits for the day.
unopened.
medical device
The date shall be located safely as required
adjacent to the symbol. by EU Directive 90/385/
EEC.
5.1.5 Batch code Indicates the This symbol shall be NOTE 1  The relative size of the 2492
manufacturer’s batch accompanied by the symbol and the size of the batch
2004-01-15
code so that the batch or manufacturer’s batch code. code are not specified.
lot can be identified. The batch code shall be
NOTE 2  Synonyms for “batch
adjacent to the symbol.
code” are “lot number” and “batch
number”.
ISO 15223-1:2016(E)
8 © ISO 2016 – All rights reserved
Table 1 (continued)
Reference
Description of Informative Restrictions of A
...