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)

ISO 15223-1:2012 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 ISO 15223-1:2012.
ISO 15223-1:2012 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 ISO 15223-1:2012 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 15223-1:2012)

Dieser Teil der ISO 15223 legt Anforderungen an Symbole zur Verwendung in Kennzeichnungen von Medizinpro¬dukten fest, die zur Lieferung von Informationen für die sichere und wirkungsvolle Anwendung von Medizin¬produkten 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 15223-1:2012)

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
• Publication Date: 30-Jun-2012
• Withdrawal Date: 29-Nov-2016
• 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
• Completion Date: 30-Nov-2016
• 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 15223-1:2012 - 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

• Replaces: EN 980:2008 - Symbols for use in the labelling of medical devices
• Effective Date: 11-Jul-2012
• Replaced By: 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)
• Effective Date: 05-Dec-2014

Standards Content (Sample)

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

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.
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

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.
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.
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.
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.

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
ISO 15223-1:2012(E)
©  ISO 2012
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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 .
...