EN ISO 15223 1 2012 en

EUROPEAN STANDARD EN ISO 15223-1
NORME EUROPÉENNE
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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.
EN ISO 15223-1:2012
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×ÍÑ ïëîîíóïæîðïî
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, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 15223-1:2012 has been approved by CEN as a EN ISO 15223-1:2012 without any
modification.
3
EN ISO 15223-1:2012
ÛÊÍóÛÒ (E)
Annex ZA
(informative)
Relationship between this European Standard and the Essential Requirements of EU

Directive 93/42/EEC on medical devices
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC on medical devices.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 Correspondence between this European Standard and

Directive 93/42/EEC on medical devices
Clauses/subclauses of this Essential Requirements (ERs) of

Qualifying remarks/notes
European Standard Directive 93/42/EEC
5.2.7 8.7
4 13.2 Only the first two sentences of this ER
are covered.
5.1.1, 5.1.2 13.3 (a)
5.1.6 13.3 (b)
5.2.1, 5.2.2, 5.2.3, 5.2.4, 5.2.5, 5.2.9 13.3 (c)
5.1.5, 5.1.7 13.3 (d)
5.1.4 13.3 (e)
5.4.2 13.3 (f) Only the first sentence of this ER is
covered.
5.3.1, 5.3.2, 5.3.3, 5.3.4,5.3.5, 5.3.6, 13.3 (i)
5.3.7, 5.3.8, 5.3.9
5.4.3 13.3 (j)
5.2.6, 5.2.7, 5.2.8, 5.4.1, 5.4.4, 5.4.5 13.3 (k) This ER is covered only in respect of the
particular warnings or precautions that
these symbols indicate. For other
warnings, other symbols or other means
of indication may be needed.
5.1.3 13.3 (l)
5.2.2, 5.2.3, 5.2.4, 5.2.5 13.3 (m)
WARNING Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.
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EN ISO 15223-1:2012
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Annex ZB
(informative)

Directive 90/385/EEC on active implantable medical devices
New Approach Directive 90/385/EEC on active implantable medical devices.
standard given in Table ZB.1 confers, within the limits of the scope of this standard, a presumption of
Table ZB.1 Correspondence between this European Standard and

Directive 90/385/EEC on active implantable medical devices
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.
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EN ISO 15223-1:2012
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Annex ZC
(informative)

Directive 98/79/EC on in vitro diagnostic medical devices
New Approach Directive 98/79/EC on in vitro diagnostic medical devices.
standard given in Table ZC.1 confers, within the limits of the scope of this standard, a presumption of
Table ZC.1 Correspondence between this European Standard and

Directive 98/79/EC on in vitro diagnostic medical devices

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

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

INTERNATIONAL STANDARD ISO ×ÍÑ
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Medical devices Symbols to be used with medical device
labels, labelling and information to be supplied
Part 1:
General requirements
1 Scope
This part of ISO 15223 identifies requirements for symbols used in medical device labelling that convey
information on the safe and effective use of medical devices. It also lists symbols that satisfy the requirements
of this part of ISO 15223.
This part of ISO 15223 is applicable to symbols used in a broad spectrum of medical devices, which are
marketed globally and therefore need to meet different regulatory requirements.
These symbols may be used on the medical device itself, on its packaging or in the associated documentation.
The requirements of this part of ISO 15223 are not intended to apply to symbols specified in other standards.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 7000, Graphical symbols for use on equipment Index and synopsis
ISO 8601, Data elements and interchange formats Information interchange Representation of dates and
times
ISO 14971, Medical devices Application of risk management to medical devices
ISO 15223-2, Medical devices Symbols to be used with medical device labels, labelling and information to
be supplied Part 2: Symbol development, selection and validation
3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 14971 and the following apply.
3.1
characteristic information
information that represents the property or properties of a symbol
3.2
description
normative text which defines the purpose, application and use of the symbol
NOTE Adapted from IEC 80416-1:2008, definition 3.2.
© ISO 2012 All rights reserved 1

ISO 15223-1:2012(E)
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3.3
label
written, printed or graphic information provided upon the medical device itself
NOTE Adapted from GHTF/SG1/N43:2005.
3.4
labelling
information supplied by the manufacturer that is provided for, associated with, or affixed to, a medical device
or any of its containers or wrappers
NOTE 1 This information relates to the identification, technical description and use of the medical device, but excludes
shipping documents.
NOTE 2 Some regional and national regulations refer to labelling as information supplied by the manufacturer.
3.5
symbol used in medical device labelling
graphical representation appearing on the label and/or associated documentation of a medical device that
communicates characteristic information without the need for the supplier or receiver of the information to
have knowledge of the language of a particular nation or people
NOTE The symbol can be an abstract pictorial or a graphical representation, or one that uses familiar objects,
including alphanumeric characters.
3.6
title
unique name by which a graphical symbol is identified and spoken of
NOTE Adapted from IEC 80416-1:2008, definition 3.9.
4 General requirements
4.1 Proposal of symbols for adoption
Symbols proposed for adoption in this part of ISO 15223 shall be validated in accordance with ISO 15223-2.
Any symbol proposed for adoption in this part of ISO 15223 shall be applicable to a range of medical devices
and have global or regional applicability.
4.2 Requirements for usage
When risk management shows it to be appropriate for symbols to be used to convey information essential for
proper use on the medical device, its packaging or in associated documentation, the symbols given in Table 1
may be used.
Symbols that are registered in ISO 7000 shall comply with the graphical representation in ISO 7000,
especially with respect to relative dimensions, including relative line thickness, orientation and the absence or
presence of filled or shaded areas.
NOTE 1 ISO and IEC jointly maintain an online database of graphical symbols for use on equipment, which contains
the complete set of graphical symbols included in ISO 7000 and IEC 60417. In that database, each graphical symbol is
identified by a reference number and contains a title (in English and French), a graphical representation in GIF and
vectorized PDF format, and some additional data as applicable. Various search and navigation facilities allow for easy
retrieval of graphical symbols. Information on how to subscribe in order to access this database is available through the
ISO Store, the IEC Web Store or by contacting your local national standards body.
2 © ISO 2012 All rights reserved

ISO ×ÍÑ
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As part of risk management, the manufacturer should determine the appropriate size for the symbol to be
legible for its intended function.
NOTE 2 This part of ISO 15223 does not specify colours or minimum size for the symbols in Table 1, nor does it
specify the relative size of symbols and that of indicated information.
It is important that symbols be used properly. Guidance on appropriate use of the general prohibition symbol
and the negation symbol is given in Annex B.
Before symbols are used, the manufacturer shall carry out a risk assessment that indicates that the use of the
symbol does not introduce an unacceptable risk.
NOTE 3 Additional information regarding risk assessment can be found in ISO 14971.
Symbols may be used without accompanying text. Where regulations require accompanying text, the title of
the symbol given in this part of ISO 15223 should be considered sufficient. All dates and times presented in
association with symbols shall use the conventions set out in ISO 8601.
4.3 Other symbols
Other standards specify additional symbols that are applicable to particular kinds or groups of medical devices
or to particular situations. Examples of sources for such symbols are identified in the Bibliography. This listing
is not exhaustive.
5 Symbols
When appropriate, information essential for proper use shall be indicated on the medical device, its packaging,
or in the associated documentation by using the corresponding symbols given in Table 1.
A manufacturer may use any appropriate symbol regardless of category.
NOTE Table 1 has been organized into symbol categories for ease of use. The category into which a symbol is
grouped does not have any significance as far as usage is concerned. The order of appearance of symbols and the
categories in which they are placed are not prioritized. Examples of the use of symbols can be found in Annex A.

ISO 15223-1:2012(E)
Table 1 Symbols to convey information essential for proper use
Reference number Description of ISO 7000

Title of symbol Requirements Informative notes Restrictions of use Additional requirements
of symbol symbola Reg. no.
5.1 Manufacture
5.1.1 Manufacturer Indicates the This symbol shall be NOTE 1 This symbol is 3082
medical device accompanied by the name used to indicate information
manufacturer, as and address of the that is required in Europeb.
defined in EU manufacturer (i.e. the
NOTE 2 The full definition
Directives person placing the medical of manufacturer is given in
90/385/EEC, device on the market), EU Directives 90/385/EEC,
93/42/EEC and adjacent to the symbol. 93/42/EEC and 98/79/EC.
98/79/EC.
According to EU Directive NOTE 3 Guidance on the
98/79/EC, the address is requirements for EU Directives
not required with the 90/385/EEC and 93/42/EEC is
symbol on an IVD medical given in EN 1041.
device's immediate
container, as specified in NOTE 4 The date of
manufacture, as well as the
ISO 18113-2,
name and address of the
ISO 18113-3, ISO 18113-4
manufacturer, can be
and ISO 18113-5, except
combined in one symbol.
when the immediate
container is also the outer NOTE 5 The relative size
container. of the symbol and the size of
the name and address are not
specified.
5.1.2 Authorized Indicates the This symbol shall be NOTE 1 This symbol is
representative Authorized accompanied by the name used to indicate information
in the European representative in the and address of the that is required in the
Community European authorized representative European Community.
Community. in the European NOTE 2 Guidance on the
Community, adjacent to requirements for EU Directives
the symbol. 90/385/EEC and 93/42/EEC is
given in EN 1041.
The address is not
required with the symbol NOTE 3 The relative size
on an in vitro diagnostic of the symbol and the size of
medical device's the name and address are not
immediate container, as specified.
specified in ISO 18113-2,
ISO 18113-3, ISO 18113-4
and ISO 18113-5, except
when the immediate
container is also the outer
container.
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ISO 15223-1:2012(E)
Table 1 (continued)

5.1.3 Date of Indicates the date This symbol shall be NOTE 1 The relative size In Europeb: 2497
manufacture when the medical accompanied by a date to of the symbol and the size of
device was indicate the date of the date are not specified. the date could be a
manufactured. manufacture. This shall be year, year and month,
NOTE 2 This symbol can or year, month and
expressed as in ISO 8601 be filled or unfilled. If filled, the
as four digits for the year day, as required in the
date of manufacture as well as relevant EU Directive;
and, where appropriate, the name and address of the
two digits for the month manufacture can be combined this symbol may be
and two digits for the day. in one symbol. used to identify the
The date shall be located month and year of
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 appropriate EU
Directive.
5.1.4 Use-by date Indicates the date This symbol shall be NOTE 1 For example, In Europeb: 2607
after which the accompanied by a date to June 2002 is expressed as
medical device is indicate that the medical 2002-06. the date could be a
not to be used. device should not be used year, year and month,
NOTE 2 The relative size or year, month and
after the end of the year, of the symbol and the size of
month or day shown. day, as required by the
the date are not specified. relevant EU Directive;
The date shall be NOTE 3 Synonym for
expressed as in ISO 8601 this symbol can be
use-by date is use by.
as four digits for the year used to identify the
and, where appropriate, NOTE 4 For some time limit for implanting
medical devices (e.g. IVDs), an active implantable
two digits for the month
this date is only valid when the medical device safely
and two digits for the day.
medical device is unopened. as required by EU
The date shall be located Directive 90/385/EEC.
adjacent to the symbol.
5.1.5 Batch code Indicates the This symbol shall be NOTE 1 The relative size 2492
manufacturer's accompanied by the of the symbol and the size of
batch code so that manufacturer's batch code. the batch code are not
the batch or lot can The batch code shall be specified.
be identified. adjacent to the symbol. NOTE 2 Synonyms for
batch code are lot number
and batch number.
© ISO
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ISO 15223-1:2012(E)
Table 1 (continued)

5.1.6 Catalogue Indicates the The manufacturer's NOTE 1 The relative size In Europeb, the 2493
number manufacturer's catalogue number shall be of the symbol and the size of manufacturer's catalogue
catalogue number adjacent to the symbol. the catalogue number are not number shall be placed after
so that the medical specified. or below the symbol and
device can be NOTE 2 Synonyms for adjacent to it. This symbol
identified. catalogue number are may currently be shown
reference number and without the enclosure;
reorder number. however, it is intended that
this option be withdrawn in a
future edition of this part of
ISO 15223.
5.1.7 Serial number Indicates the This symbol shall be NOTE The relative size In Europeb, the 2498
manufacturer's accompanied by the of the symbol and the size of manufacturer's serial
serial number so manufacturer's serial the serial number are not number shall be placed after
that a specific number. The serial number specified. or below the symbol and
medical device can shall be adjacent to the adjacent to it. This symbol
be identified. symbol. may currently be shown
without the enclosure;
however, it is intended that
this option be withdrawn in a
future edition of this part of
ISO 15223.
5.2 Sterility
5.2.1 Sterile Indicates a medical NOTE Use of this In Europeb, this symbol is 2499
device that has symbol precludes the use of restricted to use on
been subjected to a symbols 5.2.2 to 5.2.5. terminally sterilized medical
sterilization process. devices (4.1 of
EN 556-1:2001 applies,
including its associated
note).
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ISO 15223-1:2012(E)
Table 1 (continued)

5.2.2 Sterilized using Indicates a medical NOTE 1 Aseptic 2500

aseptic device that has techniques can include
processing been manufactured filtration.
techniques using accepted
NOTE 2 Use of this
aseptic techniques. symbol precludes the use of
symbol 5.2.1.
5.2.3 Sterilized using Indicates a medical NOTE Use of this In Europeb, this symbol is 2501
ethylene oxide device that has symbol precludes the use of restricted to use on
been sterilized using symbol 5.2.1. terminally sterilized medical
ethylene oxide. devices (4.1 of
note).
5.2.4 Sterilized using Indicates a medical NOTE 1 This symbol can In Europeb, this symbol is 2502
irradiation device that has be used to indicate that the restricted to use on
been sterilized using product has been subjected to terminally sterilized medical
irradiation. irradiation processes. devices (4.1 of
NOTE 2 Use of this EN 556-1:2001 applies,
symbol precludes the use of including its associated
symbol 5.2.1. note).
5.2.5 Sterilized using Indicates a medical NOTE Use of this In Europeb, this symbol is 2503
steam or dry device that has symbol precludes the use of restricted to use on
heat been sterilized using symbol 5.2.1. terminally sterilized medical
steam or dry heat. devices (4.1 of
note).
© ISO
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7 Ý»²¬®» º±® Í¬¿²¼¿®¼·-¿¬·±²
ISO 15223-1:2012(E)
Table 1 (continued)

5.2.6 Do not Indicates a medical 2608

resterilize device that is not to
be resterilized.
5.2.7 Non-sterile Indicates a medical This symbol should only be 2609

device that has not used to distinguish between
been subjected to a identical or similar medical
sterilization process. devices sold in both sterile
and non-sterile conditions.
5.2.8 Do not use if Indicates a medical NOTE This symbol may In Europeb, this symbol shall 2606
package is device that should also mean "Do not use if the be explained in the
damaged not be used if the product sterile barrier system information supplied by the
package has been or its packaging is manufacturer.
damaged or compromised.
opened.
5.2.9 Sterile fluid Indicates the The method of sterilization In Europeb, this symbol shall 3084
path presence of a sterile shall be indicated in the be explained in the
fluid path within the empty box, as appropriate. information supplied by the
medical device in manufacturer.
cases when other The part of the medical
parts of the medical device that is sterile shall
device, including the be identified in the
exterior, might not information supplied by the
be supplied sterile. manufacturer.
Í·²¹´»ó«-»® ´·½»²½»ò Î·¹¸¬ © ISO 2012

¾»´±²¹- ¬± ¬¸»reserved
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ISO 15223-1:2012(E)
Table 1 (continued)

5.3 Storage
5.3.1 Fragile, handle Indicates a medical 0621
with care device that can be
broken or damaged
if not handled
carefully.
5.3.2 Keep away Indicates a medical NOTE This symbol can 0624
from sunlight device that needs also mean Keep away from
protection from light heat, as referenced in
sources. ISO 7000:1989.
b
5.3.3 Protect from Indicates a medical NOTE This symbol can In Europe , this symbol shall 0615
heat and device that needs also mean Keep away from be explained in the
radioactive protection from heat sunlight and radioactive information supplied by the
sources and radioactive sources. manufacturer.
sources.
5.3.4 Keep dry Indicates a medical NOTE This symbol can 0626
device that needs to also mean Keep away from
be protected from rain as referenced in
moisture. ISO 7000.
© ISO
Í·²¹´»ó«-»® ´·½»²½»ò Î·¹¸¬ 2012
»´»½¬®±²·½ ¼±½«³»²¬æ Ì»½²±ó³»¼ ×²¹»²·»®±- ÍÔô ¬¸» ®·¹¸¬ ¬± ®»°®±¼«½» ¿²¼ ¼·-¬®·¾«¬» ¾»´±²¹- ¬± ¬¸» Û-¬±²·¿²
9 Ý»²¬®» º±® Í¬¿²¼¿®¼·-¿¬·±²
ISO 15223-1:2012(E)
Table 1 (continued)

5.3.5 Lower limit of Indicates the lower The lower limit of 0534
temperature limit of temperature temperature shall be
to which the medical indicated adjacent to the
device can be safely lower horizontal line.
exposed.
5.3.6 Upper limit of Indicates the upper The upper limit of 0533
temperature limit of temperature temperature shall be
to which the medical indicated adjacent to the
device can be safely upper horizontal line.
exposed.
5.3.7 Temperature Indicates the The upper and lower limits 0632
limit temperature limits to of temperature shall be
which the medical indicated adjacent to the
device can be safely upper and lower horizontal
exposed. lines.
b
5.3.8 Humidity Indicates the range The humidity limitation In Europe , this symbol shall 2620
limitation of humidity to which shall be indicated adjacent be explained in the
the medical device to the upper and lower information supplied by the
can be safely horizontal lines. manufacturer.
exposed.
Í·²¹´»ó«-»® ´·½»²½»ò Î·¹¸¬ © ISO 2012

10±º Ë-» ±º ¬¸·- »´»½¬®±²·½ ¼±½«³»²¬æ Ì»½²±ó³»¼ ×²¹»²·»®±- ÍÔô ¬¸» ®·¹¸¬ ¬± ®»°®±¼«½» ¿²¼ ¼·-¬®·¾«¬» All rights
¾»´±²¹- ¬± ¬¸»reserved
Û-¬±²·¿² Ý»²¬®» º±® Í¬¿²¼¿®¼·-¿¬·±²
ISO 15223-1:2012(E)
Table 1 (continued)

5.3.9 Atmospheric Indicates the range The atmospheric pressure In Europe b, this symbol shall 2621
pressure of atmospheric limitations shall be be explained in the
limitation pressure to which indicated adjacent to the information supplied by the
the medical device upper and lower horizontal manufacturer.
can be safely lines.
exposed.
5.4 Safe use

5.4.1 Biological risks Indicates that there NOTE This symbol is 0659
are potential not to be confused with the
biological risks Biohazard sign intended to
associated with the be used in the workplace.
medical device. See ISO 7010.
5.4.2 Do not re-use Indicates a medical NOTE Synonyms for 1051

device that is Do not re-use are single
intended for one use and use only once.
use, or for use on a
single patient during
a single procedure.
5.4.3 Consult Indicates the need NOTE 1 Synonym for 1641

instructions for for the user to Consult instructions for use is
use consult the Consult operating
instructions for use. instructions.
NOTE 2 Consider the

difference between the
description of this symbol and
that of symbol 5.4.4.
© ISO
Í·²¹´»ó«-»® ´·½»²½»ò Î·¹¸¬ 2012
»´»½¬®±²·½ ¼±½«³»²¬æ Ì»½²±ó³»¼ ×²¹»²·»®±- ÍÔô ¬¸» ®·¹¸¬ ¬± ®»°®±¼«½» ¿²¼ ¼·-¬®·¾«¬» ¾»´±²¹- ¬± ¬¸» Û-¬±²·¿²
11 Ý»²¬®» º±® Í¬¿²¼¿®¼·-¿¬·±²
ISO 15223-1:2012(E)
Table 1 (continued)

5.4.4 Caution Indicates the need The symbol variant NOTE 1 Consider the This symbol is not to be 0434A
for the user to ISO 7000-0434B difference between the confused with the Caution
consult the (Caution) may be used. description of this symbol and sign intended to be used in
instructions for use that of symbol 5.4.3. the workplace.
for important NOTE 2 This symbol is
cautionary essentially a cautionary
information such as symbol and should be used to
warnings and highlight the fact that there are
precautions that specific warnings or
cannot, for a variety precautions associated with
of reasons, be the medical device, which are
presented on the not otherwise found on the
medical device label.
itself.
5.4.5 Contains or Indicates the NOTE This symbol is This symbol should not be In Europeb, this symbol shall N/A
presence of presence of natural intended to warn those people used for medical devices be explained in the
natural rubber rubber or dry natural who may have allergic containing synthetic information supplied by the
latex rubber latex as a reactions to certain proteins in rubber. manufacturer.
material of latex.
construction within
the medical device
or the packaging of
a medical device.
5.5 IVD-specific
5.5.1 In vitro Indicates a medical This symbol should only be In Europeb, this symbol is
diagnostic device that is used to identify in vitro only used to identify in vitro
medical device intended to be used diagnostic medical devices diagnostic medical devices
as an in vitro and not to specify that the as defined in EU
diagnostic medical medical device is for in vitro Directive 98/79/EC.
device. use.
Í·²¹´»ó«-»® ´·½»²½»ò Î·¹¸¬ © ISO 2012

¾»´±²¹- ¬± ¬¸»reserved
Û-¬±²·¿² Ý»²¬®» º±® Í¬¿²¼¿®¼·-¿¬·±²
ISO 15223-1:2012(E)
Table 1 (continued)

5.5.2 Control Indicates a control NOTE For negative 2494

material that is controls, use symbol 5.5.3 and
intended to verify for positive controls, use
the performance symbol 5.5.4.
characteristics of
another medical
device.
5.5.3 Negative Indicates a control 2495

control material that is
intended to verify
the results in the
expected negative
range.
5.5.4 Positive control Indicates a control 2496

material that is
intended to verify
the results in the
expected positive
range.
5.5.5 Contains Indicates the total The number of tests that NOTE The relative size 0518
sufficient for number of IVD tests can be performed with the of the symbol and the number
n tests that can be kit reagents shall appear of tests performed can vary.
performed with the adjacent to the symbol.
IVD kit reagents.
© ISO
Í·²¹´»ó«-»® ´·½»²½»ò Î·¹¸¬ 2012
»´»½¬®±²·½ ¼±½«³»²¬æ Ì»½²±ó³»¼ ×²¹»²·»®±- ÍÔô ¬¸» ®·¹¸¬ ¬± ®»°®±¼«½» ¿²¼ ¼·-¬®·¾«¬» ¾»´±²¹- ¬± ¬¸» Û-¬±²·¿²
13 Ý»²¬®» º±® Í¬¿²¼¿®¼·-¿¬·±²
ISO 15223-1:2012(E)
Table 1 (continued)

5.5.6 For IVD Indicates an IVD NOTE 1 A synonym is This symbol shall not appear Application
performance device that is IVD for investigational use jointly on the label or in the of
evaluation only intended to be used only. labelling of an IVD device ISO 7000-
only for evaluating bearing the symbol 3083
NOTE 2 A medical device
its performance that is for IVD performance
characteristics evaluation only is not intended
before it is placed to be used for an in vitro
on the market for diagnostic examination for which means that the
medical diagnostic medical purposes (i.e. to yield medical device is an in vitro
use. diagnostic results). diagnostic medical device
intended by the
manufacturer to be used for
an in vitro diagnostic
examination.
5.6 Transfusion/infusion
b
5.6.1 Sampling site Indicates a medical NOTE This is not to be In Europe , this symbol shall 2715
device or blood associated with a site on a be explained in the
processing patient where samples are information supplied by the
application that taken. manufacturer.
includes a system
dedicated to the
collection of
samples of a given
substance stored in
the medical device
or blood container.
b
5.6.2 Fluid path Indicates the In Europe , this symbol shall 2722
presence of a fluid be explained in the
path. information supplied by the
manufacturer.
Í·²¹´»ó«-»® ´·½»²½»ò Î·¹¸¬ © ISO 2012

¾»´±²¹- ¬± ¬¸»reserved
Û-¬±²·¿² Ý»²¬®» º±® Í¬¿²¼¿®¼·-¿¬·±²
ISO 15223-1:2012(E)
Table 1 (continued)

5.6.3 Non-pyrogenic Indicates a medical In Europe b, this symbol shall 2724

device that is be explained in the
non-pyrogenic. information supplied by the
manufacturer.
5.6.4 Drops per Indicates the NOTE The number of In Europe b, this symbol shall 2726
millilitre number of drops per drops per millilitre is specified; be explained in the
millilitre. 20 is shown as an example information supplied by the
and should be replaced by the manufacturer.
appropriate number of drops
per millilitre.
b
5.6.5 Liquid filter with Indicates an infusion NOTE The nominal In Europe , this symbol shall 2727
pore size or transfusion pore size of the filter is be explained in the
system of the specified; 15 is shown as an information supplied by the
medical device that example and should be manufacturer.
contains a filter of a replaced by the appropriate
particular nominal pore size.
pore size.
b
5.6.6 One-way valve Indicates a medical NOTE It is important for In Europe , this symbol shall 2728
device with a valve the user to know that the flow be explained in the
that allows flow in is only possible in one information supplied by the
only one direction. direction and cannot be manufacturer.
reversed.
© ISO
Í·²¹´»ó«-»® ´·½»²½»ò Î·¹¸¬ 2012
»´»½¬®±²·½ ¼±½«³»²¬æ Ì»½²±ó³»¼ ×²¹»²·»®±- ÍÔô ¬¸» ®·¹¸¬ ¬± ®»°®±¼«½» ¿²¼ ¼·-¬®·¾«¬» ¾»´±²¹- ¬± ¬¸» Û-¬±²·¿²
15 Ý»²¬®» º±® Í¬¿²¼¿®¼·-¿¬·±²
ISO 15223-1:2012(E)
Table 1 (continued)

5.7 Other
b
5.7.1 Patient number Indicates a unique In Europe , this symbol shall 2610
number associated be explained in the
with an individual information supplied by the
patient. manufacturer.
a This column is a new addition, not previously existing in either ISO 15223-1 or EN 980.
b At the moment, only countries applying the principles laid down in the EU Directives have this requirement or restriction.
Í·²¹´»ó«-»® ´·½»²½»ò Î·¹¸¬ © ISO 2012

¾»´±²¹- ¬± ¬¸»reserved
Û-¬±²·¿² Ý»²¬®» º±® Í¬¿²¼¿®¼·-¿¬·±²
ISO ×ÍÑ
ÛÊÍóÛÒ 15223-1:2012(E)
Annex A
(informative)
Examples
A.1 Example of use of symbol 5.1.1, Manufacturer
Name Address
A.2 Example of use of symbol 5.1.1, Manufacturer, combined with 5.1.3, Date of
manufacture
Name Address 2005-06
A.3 Example of use of symbol 5.1.2, Authorized representative in the European

Community
Name Address
A.4 Examples of use of symbol 5.1.3, Date of manufacture
2004
2004-06

ISO 15223-1:2012(E)
A.5 Examples of use of symbol 5.1.4, Use-by date
2005-09
2005-09-15
A.6 Example of use of symbol 5.1.5, Batch code
ABC123
A.7 Example of use of symbol 5.1.6, Catalogue number
ABC123
A.8 Example of use of symbol 5.1.7, Serial number
ABC123
A.9 Examples of use of symbols for Sterile fluid path
NOTE 1 Medical device contains a sterile fluid path that has been sterilized using ethylene oxide.

ISO ×ÍÑ
ÛÊÍóÛÒ 15223-1:2012(E)
NOTE 2 Medical device contains a sterile fluid path that has been sterilized using irradiation.
NOTE 3 Medical device contains a sterile fluid path that has been sterilized using steam or dry heat.
A.10 Examples of use of symbols for temperature limits
Upper limit of Lower limit of

Temperature limit
temperature temperature
A.11 Examples of use of symbol 5.3.8, Humidity limitation
A.12 Example of use of symbol 5.3.9, Atmospheric pressure limitation

ISO 15223-1:2012(E)
A.13 Examples of use of symbol 5.5.5, Contains sufficient for n tests
A.14 Example of use of symbol 5.7.1, Patient number
ABC123

ISO ×ÍÑ
ÛÊÍóÛÒ 15223-1:2012(E)
Annex B
(informative)
Use of general prohibition symbol and negation symbol
B.1 General prohibition symbol

The general prohibition symbol (as used in ISO 3864-1) is intended to indicate a prohibited action. For medical
device labelling, the prohibition circle with a diagonal bar should be used to mean do not, e.g. symbol 5.4.2
Do not re-use. It is sometimes used out of context in medical device labelling, e.g. to mean does not
contain. It is important that usage be consistent with the intended meaning so that hazards do not arise from
misunderstanding.
B.2 Negation symbol
Manufacturers wishing to communicate the meaning does not or is not where a symbol expressing this
meaning does not exist, should follow the method set out in Clause 7 of IEC 80416-3:2002 (a large X placed
over the symbol). Although it is not generally recommended that this symbology be used with any of the
symbols given in this part of ISO 152231, the use of the negation symbol is permitted.

ISO 15223-1:2012(E)
Bibliography
[1] ISO 3864-1, Graphical symbols Safety colours and safety signs Part 1: Design principles for
safety signs and safety markings
[2] ISO 7000:1989, Graphical symbols for use on equipment Index and synopsis 1)
[3] ISO 7010, Graphical symbols Safety colours and safety signs Registered safety signs
[4] ISO/TR 7239, Development and principles for application of public information symbols 2)
[5] ISO 15225, Medical devices Quality management Medical device nomenclature data structure
[6] ISO 18113-2, In vitro diagnostic medical devices Information supplied by the manufacturer
(labelling) Part 2: In vitro diagnostic reagents for professional use 3)
(labelling) Part 3: In vitro diagnostic instruments for professional use 4)
(labelling) Part 4: In vitro diagnostic reagents for self-testing 5)
(labelling) Part 5: In vitro diagnostic instruments for self-testing 6)
[10] ISO 80416-2, Basic principles for graphical symbols for use on equipment Part 2: Form and use of
arrows
[11] ISO/IEC 13251, Collection of graphical symbols for office equipment
[12] IEC 60417 ISO 7000-DB, Graphical symbols for use on equipment
[13] IEC/TR 60878, Graphical symbols for electrical equipment in medical practice
[14] IEC 62366, Medical devices Application of usability engineering to medical devices
[15] IEC 80416-1:2008, Basic principles for graphical symbols for use on equipment Part 1: Creation of
graphical symbols for registration
[16] IEC 80416-3:2002, Basic principles for graphical symbols for use on equipment Part 3: Guidelines
for the application of graphical symbols
[17] EN 556-1:2001, Sterilization of medical devices Requirements for medical devices to be designated
STERILE Part 1: Requirements for terminally sterilized medical devices
1) Withdrawn. The graphical symbol collections of ISO 7000, ISO 7001 and ISO 7010 are also available online in the
ISO webstore. For more information, go to http://www.iso.org/iso/publications_and_e-products/databases.htm.
2) Withdrawn.
3) Cancels and replaces EN 375:2001.

ISO ×ÍÑ
ÛÊÍóÛÒ 15223-1:2012(E)
[18] EN 980:2008, Symbols for use in the labelling of medical devices
[19] EN 1041, Information supplied by the manufacturer of medical devices
[20] GHTF/SG1/N43:2005, Labelling for Medical Devices Available

at: http://www.ghtf.org/documents/sg1/sg1final-n43.pdf

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EUROPEAN STANDARD EN ISO 15223-1

ICS 01.080.20; 11.040.01 Supersedes EN 980:2008

Medical devices - Symbols to be used with medical device

This European Standard was approved by CEN on 24 May 2012.

CEN-CENELEC Management Centre:

This document supersedes EN 980:2008.

Relationship between this European Standard and the Essential Requirements of EU

Table ZA.1  Correspondence between this European Standard and

Clauses/subclauses of this Essential Requirements (ERs) of

Relationship between this European Standard and the Essential Requirements of EU

Table ZB.1  Correspondence between this European Standard and

Relationship between this European Standard and the Essential Requirements of EU

Table ZC.1  Correspondence between this European Standard and

Clauses/subclauses of this Essential Requirements (ERs) of

5.4.3 B.8.1 Only the second part of the fourth

© ISO 2012  All rights reserved iii

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;

© ISO 2012  All rights reserved v

ISO 14971, Medical devices  Application of risk management to medical devices

3 Terms and definitions

NOTE Adapted from IEC 80416-1:2008, definition 3.2.

© ISO 2012  All rights reserved 1

NOTE Adapted from GHTF/SG1/N43:2005.

NOTE Adapted from IEC 80416-1:2008, definition 3.9.

4.1 Proposal of symbols for adoption

4.2 Requirements for usage

2 © ISO 2012  All rights reserved

4.3 Other symbols

A manufacturer may use any appropriate symbol regardless of category.

© ISO 2012  All rights reserved 3

Table 1  Symbols to convey information essential for proper use

Reference number Description of ISO 7000

Í·²¹´»ó«-»® ´·½»²½»ò Î·¹¸¬ © ISO 2012

Reference number Description of ISO 7000

Reference number Description of ISO 7000

Í·²¹´»ó«-»® ´·½»²½»ò Î·¹¸¬ © ISO 2012

Reference number Description of ISO 7000

5.2.2 Sterilized using Indicates a medical NOTE 1 Aseptic 2500

Reference number Description of ISO 7000

5.2.6 Do not Indicates a medical 2608

5.2.7 Non-sterile Indicates a medical This symbol should only be 2609

Í·²¹´»ó«-»® ´·½»²½»ò Î·¹¸¬ © ISO 2012

Reference number Description of ISO 7000

Reference number Description of ISO 7000

Í·²¹´»ó«-»® ´·½»²½»ò Î·¹¸¬ © ISO 2012

Reference number Description of ISO 7000

5.4 Safe use

5.4.2 Do not re-use Indicates a medical NOTE Synonyms for 1051

5.4.3 Consult Indicates the need NOTE 1 Synonym for 1641

NOTE 2 Consider the

Reference number Description of ISO 7000

Í·²¹´»ó«-»® ´·½»²½»ò Î·¹¸¬ © ISO 2012

Reference number Description of ISO 7000

5.5.2 Control Indicates a control NOTE For negative 2494

5.5.3 Negative Indicates a control 2495

5.5.4 Positive control Indicates a control 2496

Reference number Description of ISO 7000

Table ZA.1 Correspondence between this European Standard and

Table ZB.1 Correspondence between this European Standard and

Table ZC.1 Correspondence between this European Standard and

© ISO 2012 All rights reserved iii

© ISO 2012 All rights reserved v

ISO 14971, Medical devices Application of risk management to medical devices

© ISO 2012 All rights reserved 1

2 © ISO 2012 All rights reserved

© ISO 2012 All rights reserved 3

Table 1 Symbols to convey information essential for proper use

A.1 Example of use of symbol 5.1.1, Manufacturer

A.3 Example of use of symbol 5.1.2, Authorized representative in the European

A.4 Examples of use of symbol 5.1.3, Date of manufacture

© ISO 2012 All rights reserved 17

A.6 Example of use of symbol 5.1.5, Batch code

A.7 Example of use of symbol 5.1.6, Catalogue number

A.8 Example of use of symbol 5.1.7, Serial number

A.9 Examples of use of symbols for Sterile fluid path

18 © ISO 2012 All rights reserved

A.11 Examples of use of symbol 5.3.8, Humidity limitation

A.12 Example of use of symbol 5.3.9, Atmospheric pressure limitation

© ISO 2012 All rights reserved 19

A.14 Example of use of symbol 5.7.1, Patient number

20 © ISO 2012 All rights reserved

© ISO 2012 All rights reserved 21

22 © ISO 2012 All rights reserved

© ISO 2012 All rights reserved 23