SIST EN 980:2003
(Main)Graphical symbols for use in the labelling of medical devices
Graphical symbols for use in the labelling of medical devices
This European Standard specifies graphical symbols for use in the information supplied by the manufacturer with medical devices.
NOTE This standard does not specify the circumstances under which particular symbols are used. Guidance on this is given in EN 1041.
Graphische Symbole zur Kennzeichnung von Medizinprodukten
Diese Europäische Norm legt die graphischen Symbole fest, die von den Herstellern für Informationen zu Medizinprodukten bereitgestellt werden.
ANMERKUNG Diese Norm legt nicht die Umstände fest, unter denen die besonderen Symbole angewendet werden. Anleitungen dazu werden in prEN 1041 gegeben.
Symboles graphiques utilisés pour l'étiquetage des dispositifs médicaux
La présente Norme européenne spécifie les symboles graphiques destinés a etre utilisés avec les informations fournies par le fabricant avec les dispositifs médicaux (y compris les dispositifs médicaux de diagnostic in vitro).
NOTE La présente norme ne spécifie pas les cas dans lesquels des symboles particuliers sont utilisés. Des indications sont données dans l'EN 1041.
Grafični simboli za označevanje medicinskih pripomočkov
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 980:2003
01-september-2003
1DGRPHãþD
SIST EN 980:2000
SIST EN 980:2000/A1:2000
SIST EN 980:2000/A2:2002
*UDILþQLVLPEROL]DR]QDþHYDQMHPHGLFLQVNLKSULSRPRþNRY
Graphical symbols for use in the labelling of medical devices
Graphische Symbole zur Kennzeichnung von Medizinprodukten
Symboles graphiques utilisés pour l'étiquetage des dispositifs médicaux
Ta slovenski standard je istoveten z: EN 980:2003
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 980:2003 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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EUROPEAN STANDARD
EN 980
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2003
ICS 01.080.20; 11.040.01; 11.120.01 Supersedes EN 980:1996
English version
Graphical symbols for use in the labelling of medical devices
Symboles graphiques utilisés pour l'étiquetage des Graphische Symbole zur Kennzeichnung von
dispositifs médicaux Medizinprodukten
This European Standard was approved by CEN on 9 January 2003.
CEN 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 Management Centre or to any CEN 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 member into its own language and notified to the Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2003 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 980:2003 E
worldwide for CEN national Members.
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EN 980:2003 (E)
Contents
Foreword.4
Introduction .5
1 Scope .6
2 Normative references .6
3 General requirements.6
4 Symbols already in use .6
4.1 General.6
4.2 Symbol for "DO NOT REUSE" .7
4.3 Symbol for "USE BY" .7
4.4 Symbol for "BATCH CODE".8
4.5 Symbol for "SERIAL NUMBER".8
4.6 Symbol for "DATE OF MANUFACTURE".9
4.7 Symbol for "STERILE".9
4.8 Symbols for "STERILE", including the "METHOD OF STERILIZATION" .10
4.8.1 Symbol for method of sterilization using ethylene oxide.10
4.8.2 Symbol for method of sterilization using irradiation .11
4.8.3 Symbol for method of sterilization using steam or dry heat.11
4.9 Symbol for "CATALOGUE NUMBER" .12
4.10 Symbol for "CAUTION, CONSULT ACCOMPANYING DOCUMENTS " .12
4.11 Symbol for sterile medical devices processed using aseptic technique .13
5 New symbols .13
5.1 General.13
5.2 Symbol for "MANUFACTURER" .13
5.3 Symbol for "AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY" .14
5.4 Symbol for "CONTAINS SUFFICIENT FOR TESTS".14
5.5 Symbol for "FOR IVD PERFORMANCE EVALUATION ONLY " .15
5.6 Symbol for "IN VITRO DIAGNOSTIC MEDICAL DEVICE" .15
5.7 Symbols for temperature limits.15
5.7.1 Symbol for "UPPER LIMIT OF TEMPERATURE" .16
5.7.2 Symbol for "LOWER LIMIT OF TEMPERATURE" .16
5.7.3 Symbol for "TEMPERATURE LIMITATION".17
5.8 Symbol for "CONSULT INSTRUCTIONS FOR USE" .17
5.9 Symbol for "BIOLOGICAL RISKS" .18
Annex A (informative) Examples of uses of symbols given in this standard .19
A.1 Examples of use of symbol for "USE BY".19
A.2 Example of use of symbol for "BATCH CODE" .19
A.3 Examples of use of symbol for "SERIAL NUMBER" .19
A.4 Examples of use of symbol for "DATE OF MANUFACTURE" .19
A.5 Examples of use of symbol for "CATALOGUE NUMBER" .20
A.6 Examples of use of symbol for "MANUFACTURER".20
A.7 Examples of use of symbol for " AUTHORISED REPRESENTATIVE IN THE EUROPEAN
COMMUNITY" .20
A.8 Examples of use of symbol for "CONTAINS SUFFICIENT FOR TESTS" .20
A.9 Example of use of symbol for "UPPER LIMIT OF TEMPERATURE".20
A.10 Example of use of symbol for "LOWER LIMIT OF TEMPERATURE".21
A.11 Example of use of symbol for "TEMPERATURE LIMITATION".21
Annex ZA (informative) Clauses of this European Standard addressing essential requirements or other
provisions of the Council Directive 93/42/EEC concerning medical devices.22
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 .23
2
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EN 980:2003 (E)
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 .24
Bibliography .25
3
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EN 980:2003 (E)
Foreword
This document (EN 980:2003) has been prepared by Technical Committee CEN/TC 257 “Symbols and information
provided with medical devices and nomenclature for regulatory data exchange”, the secretariat of which is held by
SFS.
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 October 2003, and conflicting national standards shall be withdrawn at the latest
by October 2003.
This document supersedes EN 980:1996 (as amended).
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 annexes ZA, ZB and C 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, Czech Republic, Denmark, Finland,
France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain,
Sweden, Switzerland and the United Kingdom.
Annex A is informative.
This document includes a Bibliography.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal,
Slovakia, Spain, Sweden, Switzerland and the United Kingdom.
4
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EN 980:2003 (E)
Introduction
This European Standard has been prepared to reduce the need for multiple translation of words into national
languages, 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 EEC Directives on
medical devices including active implantable and in vitro diagnostic medical devices.
The meaning of some of these symbols is self-evident. Some are already in widespread use and familiar to health care
professionals. The meaning of others will become clear with use or when viewed in the context of the device itself. If
appropriate the meaning of symbols should be explained in accompanying literature when provided. Symbols used with
medical devices for use by other than health care professionals can require additional explanations.
This revision incorporates a different approach to the previously published version. The symbols in clause 4 of the
existing standard have now been in general use by manufacturers for some time and users have some degree of
familiarity with these. Additional symbols are now being introduced, most of these will be new to manufacturers and
users. As a precaution, clause 5 of this revision to the standard requires that the meaning of these new symbols be
explained in the accompanying literature. This is without prejudice to the harmonisation of the remaining
requirements of this standard. It is anticipated that in time, the requirement to explain the meaning of symbols in
clause 5 will be dropped. 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. An additional informative bibliography is given.
5
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EN 980:2003 (E)
1 Scope
This European Standard specifies graphical symbols for use in the information supplied by the manufacturer with
medical devices (including in vitro diagnostic medical devices).
NOTE This standard does not specify the circumstances under which particular symbols are used. Guidance on this is
given in EN 1041.
2 Normative references
This European Standard incorporates by dated or undated reference, provisions from other publications. These
normative references are cited at the appropriate places in the text, and the publications are listed hereafter. For dated
references, subsequent amendments to or revisions of any of these publications apply to this European Standard only
when incorporated in it by amendment or revision. For undated references the latest edition of the publication referred
to applies (including amendments).
EN 375:2001, Information supplied by the manufacturer with in vitro diagnostic reagents for professional use.
EN 376:2002, 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 28601:1992, Data elements and interchange formats - Information interchange - Representation of dates and
times (ISO 8601:1988 and its technical corrigendum 1:1991).
3 General requirements
Graphical symbols used to convey the information given in 4.2 to 4.11 and 5.2 to 5.9 are given in this standard.
NOTE 1 Other symbols can be used to convey other information. Where graphical symbols are not taken from a Harmonized
Standard, their meaning should be described in the documentation supplied with the device. Many other standards specify
symbols for particular purposes and/or for particular kinds of device. The Bibliography lists some of these standards.
Enclosures shown in 4.2, 4.4, 4.7, 4.8.1, 4.8.2, 4.8.3, 4.10, 4.11, 5.3, 5.4, 5.6 and 5.8 shall be included as part of these
symbols.
NOTE 2 The use of similar enclosures around other symbols is not precluded (e.g. 4.5 and 4.9).
All symbols and accompanying information 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 3 Colours and minimum dimensions are not specified in this standard.
4 Symbols already in use
4.1 General
This clause presents symbols that are well-understood and already in use and are recognised to be suitable
without need for further explanation.
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EN 980:2003 (E)
4.2 Symbol for "DO NOT REUSE"
NOTE 1 This symbol is as given in ISO 7000/1051 and as symbol No. 3.2 in ISO 15223.
NOTE 2 Synonyms for "do not reuse" are "single use", "use only once".
NOTE 3 See Council Directive 93/42/EEC concerning medical devices, Annex I, 13.3 (f).
4.3 Symbol for "USE BY"
This symbol shall be accompanied by the dat
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