SIST EN 980:2008
Symbols for use in the labelling of medical devices
Symbols for use in the labelling of medical devices
This European Standard specifies symbols for use in the information supplied by the manufacturer with medical devices. The requirements of this European Standard are not intended to apply to symbols specified in other standards. However, every effort should be made to prevent the specifying of different symbols with the same meaning. This standard does not specify the requirements for information to be supplied with medical devices, which are addressed by EN 375, EN 376, EN 591, EN 592 and EN 1041.
Symbole zur Kennzeichnung von Medizinprodukten
Diese Europäische Norm legt die Symbole fest, die von den Herstellern für Informationen zu Medizinproduk¬ten bereitgestellt werden. Es ist nicht beabsichtigt, dass die Anforderungen dieser Europäischen Norm auf in anderen Normen festgelegte Symbole angewendet werden. Allerdings sollte jede mögliche Anstrengung unternommen werden, um zu verhindern, dass verschiedene Symbole für die gleiche Bedeutung festgelegt werden. Diese Norm legt keine Anforderungen an die Informationen, die mit einem Medizinprodukt geliefert werden, fest; diese Anforderungen finden sich in EN 1041.
Symboles utilisés pour l'étiquetage des dispositifs médicaux
La présente Norme européenne spécifie les symboles graphiques destinés a etre utilisés parmi les informations fournies par le fabricant avec les dispositifs médicaux. Les exigences de la présente Norme européenne ne sont pas destinées a s’appliquer aux symboles spécifiés dans d’autres normes. Cependant, il convient de mettre tous les moyens en ouvre pour empecher la création de symboles différents ayant la meme signification. La présente norme ne spécifie pas les exigences sur les informations a fournir avec les dispositifs médicaux, traitées dans la norme EN 1041.
Simboli za označevanje medicinskih pripomočkov
General Information
Relations
Related Packages
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 980:2008
01-september-2008
1DGRPHãþD
SIST EN 980:2003
6LPEROL]DR]QDþHYDQMHPHGLFLQVNLKSULSRPRþNRY
Symbols for use in the labelling of medical devices
Symbole zur Kennzeichnung von Medizinprodukten
Symboles utilisés pour l'étiquetage des dispositifs médicaux
Ta slovenski standard je istoveten z: EN 980:2008
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
11.120.01 Farmacija na splošno Pharmaceutics in general
SIST EN 980:2008 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 980:2008
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SIST EN 980:2008
EUROPEAN STANDARD
EN 980
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2008
ICS 01.080.20; 11.120.01 Supersedes EN 980:2003
English version
Symbols for use in the labelling of medical devices
Symboles utilisés pour l'étiquetage des dispostifs médicaux Symbole zur Kennzeichnung von Medizinprodukten
This European Standard was approved by CEN on 18 April 2008.
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 Management Centre or to any CEN or 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/or CENELEC member into its own language and notified to the CEN Management Centre has the
same status as the official versions.
CEN and CENELEC members are the national standards bodies and national electrotechnical committees, respectively, of Austria,
Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and
United Kingdom.
CEN Management Centre: CENELEC Central Secretariat:
rue de Stassart, 36 B-1050 Brussels rue de Stassart, 35 B-1050 Brussels
© 2008 CEN/CENELEC All rights of exploitation in any form and by any means reserved Ref. No. EN 980:2008 E
worldwide for CEN national Members and for CENELEC
Members.
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EN 980:2008 (E)
Contents
Foreword.4
Introduction .5
1 Scope .6
2 Normative references .6
3 Terms and definitions .6
4 General requirements.7
4.1 Proposal of symbols for adoption .7
4.2 Requirements for usage.7
5 Symbols already in use.8
5.1 General.8
5.2 Symbol for "DO NOT REUSE" .8
5.3 Symbol for "USE BY" .9
5.4 Symbol for "BATCH CODE".9
5.5 Symbol for "SERIAL NUMBER".10
5.6 Symbol for "DATE OF MANUFACTURE".10
5.7 Symbol for "STERILE" .11
5.8 Symbols for "STERILE", including the method of sterilization .11
5.9 Symbol for “STERILE USING ASEPTIC PROCESSING TECHNIQUES” .12
5.10 Symbol for "CATALOGUE NUMBER".13
5.11 Symbol for "CAUTION" .13
5.12 Symbol for "MANUFACTURER".14
5.13 Symbol for "AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY" .14
5.14 Symbol for " SUFFICIENT FOR ".15
5.15 Symbol for "FOR IVD PERFORMANCE EVALUATION ONLY" .15
5.16 Symbol for "IN VITRO DIAGNOSTIC MEDICAL DEVICE" .16
5.17 Symbols for "TEMPERATURE LIMITS” including indication of limits of temperature.16
5.18 Symbol for "CONSULT INSTRUCTIONS FOR USE".18
5.19 Symbol for "BIOLOGICAL RISKS".18
5.20 Symbol for “KEEP AWAY FROM SUNLIGHT” .18
5.21 Symbol for “KEEP DRY” .19
5.22 Symbol for “DO NOT RESTERILIZE”.19
5.23 Symbol for “NON-STERILE” .20
5.24 Symbol for “CONTROL”.20
5.25 Symbol for “NEGATIVE CONTROL” .21
5.26 Symbol for “POSITIVE CONTROL”.21
6 New symbols.21
6.1 General.21
6.2 Symbol for “CONTAINS OR PRESENCE OF NATURAL RUBBER LATEX” .22
6.3 Symbol for “DO NOT USE IF PACKAGE IS DAMAGED”.22
6.4 Symbol for “STERILE FLUID PATH”.22
Annex A (informative) Examples of uses of symbols given in this standard .24
A.1 Examples of use of symbol for "USE BY".24
A.2 Example of use of symbol for "BATCH CODE" .24
A.3 Examples of use of symbol for "SERIAL NUMBER".24
A.4 Examples of use of symbol for "DATE OF MANUFACTURE" .24
A.5 Examples of use of symbol for "CATALOGUE NUMBER" .25
A.6 Example of use of symbol for "MANUFACTURER" .25
A.7 Example of use of symbol for “MANUFACTURER” combined with “DATE OF MANUFACTURE” .25
A.8 Example of use of symbol for " AUTHORISED REPRESENTATIVE IN THE EUROPEAN
COMMUNITY" .25
A.9 Examples of use of symbol for " SUFFICIENT FOR" .26
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A.10 Example of use of symbol for "UPPER LIMIT OF TEMPERATURE" .26
A.11 Example of use of symbol for "LOWER LIMIT OF TEMPERATURE" .26
A.12 Example of use of symbol for "TEMPERATURE LIMITATION".26
A.13 Examples of use of symbol for “STERILE FLUID PATH” .27
Annex B (informative) Use of the general prohibition symbol and the negation symbol.28
B.1 The general prohibition symbol .28
B.2 The negation symbol.28
Annex ZA (informative) Clauses of this European Standard addressing essential requirements or
other provisions of the Council Directive 93/42/EEC concerning medical devices .29
Annex ZB (informative) Clauses of this European Standard addressing essential requirements or
other provisions of the Council Directive 90/385/EEC relating to active implantable medical
devices.31
Annex ZC (informative) Clauses of this European Standard addressing essential requirements or
other provisions of the European Parliament and the Council Directive 98/79/EC on in vitro
diagnostic medical devices .32
Bibliography.34
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Foreword
This document (EN 980:2008) has been prepared by Technical Committee CEN/CLC/TC 3 "Quality management
and corresponding general aspects for medical devices" (former CEN/TC 257 “Symbols and information provided
with medical devices and nomenclature for regulatory data exchange”), 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 November 2008, and conflicting national standards shall be withdrawn at the latest
by May 2010.
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 980:2003.
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 EC Directive(s).
For relationship with EC Directive(s), see informative Annex ZA, ZB, and ZC, which are an integral part 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, Cyprus, Czech Republic,
Denmark, Estonia, Finland, 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.
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Introduction
This European Standard has been prepared to give expression to the legislative preference within the European Union
for the use of symbols in medical device labelling, thereby reducing the need for multiple translations of words into
national languages. It is also intended to simplify labelling wherever possible and to prevent separate development of
different symbols to convey the same information. It has been prepared to align the presentation of information required
by all European Directives on medical devices.
The meaning of some of these symbols is self-evident. Some are already in widespread use and familiar to healthcare
professionals. The meaning of others will become clear with use or when viewed in the context of the device itself.
Symbols used with medical devices for use by other than healthcare professionals can require additional explanations.
In this respect, attention is drawn to the fact that risk management, e.g. the use of EN ISO 14971, is an integral
element in medical device design and manufacturing. The use of appropriate symbols can, therefore, be an important
element in risk reduction, which is a key part of risk management and is also specifically referred to in the relevant
medical device directives. Symbols should only be used without explanation when risk assessment by the
manufacturer indicates that it is appropriate.
The symbols in Clause 5 of this European Standard have been in general use for some time and users have some
degree of familiarity with them. Additional symbols are now being introduced in Clause 6 which may be new or
unfamiliar to users. As a precaution, Clause 6 requires that the meaning of these new symbols be explained in the
information supplied by the manufacturer. This is without prejudice to the harmonization of this European Standard and
the symbols therein.
It is not always possible to develop symbols for all information presented with the device. Not all symbols are
appropriate for all types of medical devices. The validity of information conveyed by a symbol can be adversely affected
by subsequent events e.g. damage to a package can affect the sterility of a device.
Annex A provides examples of how some of the symbols can be used. These are illustrative only and do not represent
the only ways in which the requirements of this standard can be met.
Annex B provides information about the use of the general prohibition symbol.
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1 Scope
This European Standard specifies symbols for use in the information supplied by the manufacturer with medical
devices. The requirements of this European Standard are not intended to apply to symbols specified in other
standards. However, every effort should be made to prevent the specifying of different symbols with the same
meaning. This standard does not specify the requirements for information to be supplied with medical devices,
which are addressed by EN 375, EN 376, EN 591, EN 592 and EN 1041.
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.
EN 375, Information supplied by the manufacturer with in vitro diagnostic reagents for professional use
EN 376, Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing
EN 556-1:2001, Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" –
Part 1: Requirements for terminally sterilized medical devices
EN 591, Instructions for use for in vitro diagnostic instruments for professional use
EN 592, Instructions for use for in vitro diagnostic instruments for self-testing
EN 1041, Information supplied by the manufacturer with medical devices
EN ISO 15225, Nomenclature – Specification for a nomenclature system for medical devices for the purpose of
regulatory data exchange (ISO 15225: 2000)
ISO 8601, Data elements and interchange formats – Information interchange – Representation of dates and times
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
symbol used in medical device labelling
object presented on the label and/or on the device itself and/or associated documentation of a medical device,
which may utilise symbolic or iconic presentation, that communicates characteristic information (see 3.4) without
relying on knowledge of the language of a particular nation or people by the giver or receiver of the information
3.2
symbolic presentation
abstract pictorial or graphic representation
3.3
iconic presentation
pictorial or graphic representation using familiar objects including alphanumeric characters
3.4
characteristic information
mental representation of a property or properties of an object or set of objects
[EN 12264:2005]
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4 General requirements
4.1 Proposal of symbols for adoption
4.1.1 Proposals for symbols for adoption into this European Standard shall be submitted by a body contributing to
CEN/CLC/TC 3, that is, one in association, liaison or participating in the work of that committee.
4.1.2 Symbols should only be proposed when they represent requirements already defined in a published
standard. E.g., the requirements represented by 5.8 are defined in EN 556-1.
4.1.3 Symbols being proposed shall be presented following the dimensional criteria and design principles set out
in ISO/IEC 80416. Where the presentation is symbolic (see 3.2), alphanumeric characters shall not be part of the
symbol. Alphanumeric characters may be used when appropriate and relevant in an iconic symbol (see 3.3).
4.1.4 Any symbol proposed for adoption into this European Standard shall be applicable to a range of devices, at
least comprising one category of the Global Medical Device Nomenclature (see EN ISO 15225).
4.1.5 When a symbol is presented for adoption, the following details are required:
a brief, unique title sufficient only to identify the symbol;
conditions of use for the symbol and identity of proposed audience;
information on any existing or proposed related symbols;
information on any validation or evaluation of the symbol in use;
a graphic file (bitmap, JPEG, TIF or similar) with a print-out of the file.
4.2 Requirements for usage
4.2.1 Symbols contained in Clause 5 may be used without explanation in the information supplied by the
manufacturer.
4.2.2 The meaning of symbols contained in Clause 6 shall be explained in the information supplied by the
manufacturer.
4.2.3 Symbols shown in 5.2 to 5.26 and 6.2 to 6.4 are used to convey the information described in the headings
and notes of those sub-clauses.
NOTE 1 Other symbols can be used to convey different information. Many other standards specify symbols for particular
purposes and/or for particular kinds of device. The Bibliography lists some of these standards.
NOTE 2 ISO and IEC jointly maintain an on-line database of graphical symbols for use on equipment that contains the
complete set of graphical symbols included in ISO 7000, IEC 60417-1 and IEC 60417-2. 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 access this database is available through the ISO Store, the IEC Web Store or by
contacting your local national standards body.
4.2.4 Symbols presented in this standard shall be reproduced as illustrated with the exception of 5.5 and 5.10,
which may be reproduced with or without the enclosure.
NOTE Future editions of this standard may remove this exception for 5.5 and 5.10 and an enclosure may be required as
defined in ISO 7000:2004 and ISO 15223-1:2007.
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4.2.5 All symbols and information intended for visual recognition shall be legible when viewed under an
illumination of 215 lx using normal vision, corrected if necessary, at a distance which takes into account the
specifics and size of the individual medical device.
NOTE Colours and minimum dimensions are not specified in this standard.
4.2.6 Guidance on the appropriate use of the general prohibition symbol is given in Annex B.
5 Symbols already in use
5.1 General
This Clause contains symbols that are already in use, and are deemed to be suitable without need for further
explanation.
NOTE Symbols used with medical devices for use by other than healthcare professionals can require additional
explanations.
Annexes ZA, ZB and ZC can be used to determine the symbols that address essential requirements of Council
Directives 93/42/EEC, 90/385/EEC and 98/79/EC respectively.
5.2 Symbol for "DO NOT REUSE"
NOTE 1 Synonyms for "Do not reuse" are "single use”, "Use only once".
NOTE 2 This symbol corresponds to that given in ISO 7000-1051 and to symbol number 5.2 in ISO 15223-1:2007
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5.3 Symbol for "USE BY"
This symbol shall be accompanied by a date to indicate that the device should not be used after the end of the year,
month or day shown. The date shall be expressed as given in ISO 8601, as four digits for the year and, where
appropriate, two digits for the month and two digits for the day. The date could be a year, year and month, or year,
month, and day, as required by the relevant Directive. The date shall be located adjacent to the symbol (see A.1).
NOTE 1 For example, June 2007 becomes 2007-06.
NOTE 2 The relative sizes of the symbol and the date are not specified.
NOTE 3 This symbol can be used to identify the time limit for implanting an active implantable device safely as required by
Directive 90/385/EEC.
NOTE 4 This symbol corresponds to that given in ISO 7000-2607 and to symbol No. 5.12 in ISO 15223-1:2007.
5.4 Symbol for "BATCH CODE"
This symbol shall be accompanied by the manufacturer's batch code. The batch code shall be adjacent to the symbol
(see A.2).
NOTE 1 The relative size of the symbol and the size of the batch code are not specified.
NOTE 2 Synonyms for "batch code" are "lot number", "batch number".
NOTE 3 This symbol corresponds to that given in ISO 7000-2492 and to symbol number 5.14 in ISO 15223-1:2007.
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5.5 Symbol for "SERIAL NUMBER"
This symbol shall be accompanied by the manufacturer's serial number. The serial number shall be after or below the
symbol, adjacent to it (see A.3).
NOTE 1 The relative size of the symbol and the size of the serial number are not specified.
NOTE 2 This symbol corresponds to that given in ISO 7000-2498 and to symbol number 5.16 in ISO 15223-1:2007.
5.6 Symbol for "DATE OF MANUFACTURE"
This symbol shall be accompanied by a date to indicate the date of manufacture, expressed as given in ISO 8601, as
four digits for the year, and where appropriate, two digits for the month and two digits for the day. The date could be a
year, year and month, or year, month, and day, as required by the relevant Directive. The date shall be located
adjacent to the symbol (see A.4).
NOTE 1 The relative sizes of the symbol and the date are not specified.
NOTE 2 This symbol can be filled or unfilled. If filled, the date of manufacture as well as the name and address of the
manufacturer can be combined in one symbol (see A.7).
NOTE 3 This symbol can be used to identify the month and year of manufacture for active implantable medical devices or
the year of manufacture for active medical devices where no use by date is given, as required by the appropriate Directive.
NOTE 4 This symbol corresponds to that given in ISO 7000-2497 and to symbol number 5.13 in ISO 15223-1:2007.
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5.7 Symbol for "STERILE"
This symbol shall only be used for terminally-sterilized medical devices. Sub-clause 4.1 (including its associated
Note) of EN 556-1:2001 applies.
NOTE This symbol corresponds to that given in ISO 7000-2499 and to symbol number 5.20 in ISO 15223-1:2007.
5.8 Symbols for "STERILE", including the method of sterilization
5.8.1 General
These symbols shall only be used for terminally-sterilized medical devices. Sub clause 4.1 (including its associated
Note) of EN 556-1:2001 applies.
NOTE If any of the symbols given in 5.8.2 to 5.8.4 are used, it is not necessary in addition to use the symbol for sterile as
shown in 5.7.
5.8.2 Symbol for “STERILIZED USING ETHYLENE OXIDE”
NOTE This symbol corresponds to that given in ISO 7000-2501 and to symbol number 5.22 in ISO 15223-1:2007.
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5.8.3 Symbol for “STERILIZED USING IRRADIATION”
NOTE This symbol corresponds to that given in ISO 7000-2502 and to symbol number 5.23 in ISO 15223-1:2007.
5.8.4 Symbol for “STERILIZED USING STEAM OR DRY HEAT”
NOTE This symbol corresponds to that given in ISO 7000-2503 and to symbol number 5.24 in ISO 15223-1:2007.
5.9 Symbol for "STERILE USING ASEPTIC PROCESSING TECHNIQUES"
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NOTE 1 Aseptic techniques can include filtration.
NOTE 2 This symbol corresponds to that given in ISO 7000-2500 and to symbol number 5.21 in ISO 15223-1:2007.
5.10 Symbol for "CATALOGUE NUMBER"
The manufacturer's catalogue number shall be after or below the symbol adjacent to it (See A.5).
NOTE 1 The relative size of the symbol and the size of the catalogue number are not specified.
NOTE 2 Synonyms for "catalogue number" are "reference number", "re-order number".
NOTE 3 This symbol corresponds to that given in ISO 7000-2493 and to symbol number 5.15 in ISO 15223-1:2007.
5.11 Symbol for "CAUTION"
NOTE 1 This symbol is essentially a safety symbol and should be used to highlight the fact that there are specific warnings
or precautions associated with the device, which are not otherwise found on the label. The symbol “Caution” is still sometimes
used to have the meaning of “Attention, see instructions for use” (see 5.18).
NOTE 2 The symbol A or B in ISO 7000-0434 can be used. The symbol No 5.4 in ISO 15223-1:2007 (“Caution, consult
accompanying documents”) corresponds to this symbol. It appears with similar meaning in other documents (e.g. EN 60601-1
and EN 61010-1). The shape of the bar or triangle is not specified.
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5.12 Symbol for "MANUFACTURER"
This symbol shall be accompanied by the name and the address of the manufacturer (the person placing the
device on the market), adjacent to the symbol (see A.6). The address is not required with the symbol on an in vitro
diagnostic device immediate container as specified in EN 375, EN 376, EN 591 and EN 592, except when the
immediate container is also the outer container. Guidance on the requirements for Council Directive 90/385/EEC
and Council Directive 93/42/EEC is given in EN 1041.
NOTE 1 The relative size of the symbol and the size of the name and address are not specified.
NOTE 2 The full definition of ‘manufacturer’ is given in Council Directives 90/385/EEC, 93/42/EEC and 98/79/EC.
NOTE 3 The date of manufacture as well as the name and address of the manufacturer can be combined in one symbol (see
A.7).
5.13 Symbo
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