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

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.

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

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)

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
Public Enquiry End Date
29-Oct-2015
Publication Date
10-Jan-2017
Withdrawal Date
07-Nov-2021
Technical Committee
Current Stage
9900 - Withdrawal (Adopted Project)
Start Date
13-Oct-2021
Due Date
05-Nov-2021
Completion Date
08-Nov-2021

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SLOVENSKI STANDARD
SIST EN ISO 15223-1:2017
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
SIST EN ISO 15223-1:2017 en

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

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SIST EN ISO 15223-1:2017
---------------------- Page: 2 ----------------------
SIST EN ISO 15223-1:2017
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.
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SIST EN ISO 15223-1:2017
EN ISO 15223-1:2016 (E)
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

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SIST EN ISO 15223-1:2017
EN ISO 15223-1:2016 (E)
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
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
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,

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SIST EN ISO 15223-1:2017
EN ISO 15223-1:2016 (E)

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.
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SIST EN ISO 15223-1:2017
EN ISO 15223-1:2016 (E)
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.
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SIST EN ISO 15223-1:2017
EN ISO 15223-1:2016 (E)
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.
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SIST EN ISO 15223-1:2017
EN ISO 15223-1:2016 (E)
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.
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SIST EN ISO 15223-1:2017
EN ISO 15223-1:2016 (E)
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.
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SIST EN ISO 15223-1:2017
EN ISO 15223-1:2016 (E)
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.
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SIST EN ISO 15223-1:2017
EN ISO 15223-1:2016 (E)
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.
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SIST EN ISO 15223-1:2017
EN ISO 15223-1:2016 (E)
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.
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SIST EN ISO 15223-1:2017
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SIST EN ISO 15223-1:2017
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
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SIST EN ISO 15223-1:2017
ISO 15223-1:2016(E)
COPYRIGHT PROTECTED DOCUMENT
© 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.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
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Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved
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SIST EN ISO 15223-1:2017
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 2016 – All rights reserved iii
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SIST EN ISO 15223-1:2017
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
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SIST EN ISO 15223-1:2017
ISO 15223-1:2016(E)
Introduction

This document addresses the presentation of certain items of information that are considered by

regulatory authorities to be e
...

Questions, Comments and Discussion

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