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)

ISO 15223-1:2012 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 ISO 15223-1:2012.
ISO 15223-1:2012 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 ISO 15223-1:2012 are not intended to apply to symbols specified in other standards.

Medizinprodukte - Bei Aufschriften von Medizinprodukten zu verwendende Symbole, Kennzeichnung und zu liefernde Informationen - Teil 1: Allgemeine Anforderungen (ISO 15223-1:2012)

Dieser Teil der ISO 15223 legt Anforderungen an Symbole zur Verwendung in Kennzeichnungen von Medizinpro¬dukten fest, die zur Lieferung von Informationen für die sichere und wirkungsvolle Anwendung von Medizin¬produkten angewendet werden. Sie führt auch eine Liste von Symbolen auf, die den Anforderungen dieses Teils der ISO 15223 entsprechen.
Dieser Teil der ISO 15223 gilt für Symbole, die auf ein breites Spektrum von Medizinprodukten anwendbar sind, die weltweit in Verkehr gebracht werden und daher unterschiedliche behördliche Anforderungen erfüllen müssen.
Diese Symbole dürfen auf dem Medizinprodukt selbst, auf seiner Verpackung oder in den zugehörigen Dokumenten verwendet werden. Die Anforderungen dieses Teils der ISO 15223 sind nicht dazu vorgesehen, für Symbole zu gelten, die in anderen Normen festgelegt sind.

Dispositifs médicaux - Symboles à utiliser avec les étiquettes, l'étiquetage et les informations à fournir relatifs aux dispositifs médicaux - Partie 1: Exigences générales (ISO 15223-1:2012)

L'ISO 15223-1:2012 identifie les exigences s'appliquant aux symboles utilisés dans l'étiquetage des dispositifs médicaux, susceptibles de fournir des informations en vue d'une utilisation correcte et sûre des dispositifs médicaux. Elle énumère également les symboles satisfaisant aux exigences de la présente partie de l'ISO 15223.
L'ISO 15223-1:2012 s'applique aux symboles utilisés pour une vaste gamme de dispositifs médicaux commercialisés au niveau mondial et tenus de répondre à diverses exigences réglementaires.
Ces symboles peuvent figurer sur le dispositif médical lui-même ou sur son emballage ou dans la documentation associée. Les exigences de l'ISO 15223-1:2012 n'ont pas pour objectif d'être appliquées aux symboles spécifiés dans d'autres normes.

Medicinski pripomočki - Simboli za označevanje medicinskih pripomočkov, označevanje in podatki, ki jih mora podati dobavitelj - 1. del: Splošne zahteve (ISO 15223-1:2012)

Ta mednarodni standard opredeljuje zahteve glede simbolov za označevanje medicinskih pripomočkov, ki lahko podajajo informacije o varni in učinkoviti uporabi medicinskih pripomočkov. Navaja tudi simbole, ki ustrezajo zahtevam iz tega standarda. Standard ISO 15223-1 velja za simbole, ki se uporabljajo na različnih medicinskih pripomočkih na globalnem tržišču in morajo izpolnjevati različne regulatorne zahteve. Ti simboli se uporabljajo na medicinskih pripomočkih samih ali njihovi embalaži ali v njim priloženi dokumentaciji.

General Information

• Status: Withdrawn
• Publication Date: 30-Jun-2012
• Withdrawal Date: 29-Nov-2016
• ICS: 01.080.20 - Graphical symbols for use on specific equipment
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: CEN/CLC/TC 3 - Quality management and corresponding general aspects for medical devices
• Drafting Committee: CEN/CLC/TC 3 - Quality management and corresponding general aspects for medical devices
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 30-Nov-2016
• 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
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Mandate: M/252 - Standardization Mandate to CEN/CENELEC concerning the development of European standards relating to in vitro diagnostic medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST 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)

Relations

• Replaces: EN 980:2008 - Symbols for use in the labelling of medical devices
• Effective Date: 11-Jul-2012
• Replaced By: EN ISO 15223-1:2016 - Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03)
• Effective Date: 05-Dec-2014

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 15223-1:2012
01-oktober-2012
1DGRPHãþD
SIST EN 980:2008
0HGLFLQVNLSULSRPRþNL6LPEROL]DR]QDþHYDQMHPHGLFLQVNLKSULSRPRþNRY
R]QDþHYDQMHLQSRGDWNLNLMLKPRUDSRGDWLGREDYLWHOMGHO6SORãQH]DKWHYH,62

Medical devices - Symbols to be used with medical device labels, labelling and
information to be supplied - Part 1: General requirements (ISO 15223-1:2012)
Medizinprodukte - Bei Aufschriften von Medizinprodukten zu verwendende Symbole,
Kennzeichnung und zu liefernde Informationen - Teil 1: Allgemeine Anforderungen (ISO
15223-1:2012)
Dispositifs médicaux - Symboles à utiliser avec les étiquettes, l'étiquetage et les
informations à fournir relatifs aux dispositifs médicaux - Partie 1: Exigences générales
(ISO 15223-1:2012)
Ta slovenski standard je istoveten z: EN ISO 15223-1:2012
ICS:
01.080.20 *UDILþQLVLPEROL]DSRVHEQR Graphical symbols for use on
RSUHPR specific equipment
11.040.01 Medicinska oprema na Medical equipment in general
splošno
SIST EN ISO 15223-1:2012 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN ISO 15223-1:2012

---------------------- Page: 2 ----------------------

SIST EN ISO 15223-1:2012


EUROPEAN STANDARD
EN ISO 15223-1

NORME EUROPÉENNE

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.

---------------------- Page: 3 ----------------------

SIST EN ISO 15223-1:2012
EN ISO 15223-1:2012 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices .4
Annex ZB (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 90/385/EEC on active implantable medical devices .5
Annex ZC (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 98/79/EC on in vitro diagnostic medical devices .6

2

---------------------- Page: 4 ----------------------

SIST EN ISO 15223-1:2012
EN ISO 15223-1:2012 (E)
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 th
...