EN 980:2008

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 Medizinprodukten
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 375, EN 376, EN 591, EN 592 und EN 1041.

Symboles utilisés pour l'étiquetage des dispostifs médicaux

La présente Norme européenne spécifie les symboles graphiques destinés à être utilisés parmi les
informations fournies par le fabricant avec les dispositifs médicaux. Les exigences de la présente Norme
européenne ne sont pas destinées à s’appliquer aux symboles spécifiés dans d’autres normes. Cependant, il
convient de mettre tous les moyens en oeuvre pour empêcher la création de symboles différents ayant la
même signification. La présente norme ne spécifie pas les exigences sur les informations à fournir avec les
dispositifs médicaux, traitées dans les normes EN 375, EN 376, EN 591, EN 592 et EN 1041.

Simboli za označevanje medicinskih pripomočkov

General Information

• Status: Withdrawn
• Publication Date: 20-May-2008
• Withdrawal Date: 30-Jun-2012
• ICS: 01.080.20 - Graphical symbols for use on specific equipment
• ICS: 11.120.01 - Pharmaceutics in general
• Technical Committee: CEN/CLC/TC 3 - Quality management and corresponding general aspects for medical devices
• Drafting Committee: CEN/TC 257/WG 2 - Information provided with medical devices by the manufacturer
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 01-Jul-2012
• Completion Date: 01-Jul-2012
• Directive: 90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Directive: 98/79/EC - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
• Ref Project: SIST EN 980:2008 - Symbols for use in the labelling of medical devices

Relations

• Replaces: EN 980:2003 - Graphical symbols for use in the labelling of medical devices
• Effective Date: 22-Dec-2008
• Replaced By: EN ISO 15223-1:2012 - Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2012)
• Effective Date: 11-Jul-2012

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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SIST EN 980:2008
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".
...