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)

ISO 15223-1:2016 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 document.
ISO 15223-1:2016 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 document 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 15223-1:2016, korrigierte Fassung 2017-03)

Dieser Teil der ISO 15223 legt Anforderungen an Symbole zur Verwendung in Kennzeichnungen von Medizinprodukten fest, die zur Lieferung von Informationen für die sichere und wirkungsvolle Anwendung von Medizinprodukten 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 15223-1:2016, Version corrigée 2017-03)

ISO 15223-1:2016 identifie les exigences s'appliquant aux symboles utilisés dans l'étiquetage des dispositifs médicaux et fournissant des informations en vue d'une utilisation correcte et sûre de ces dispositifs. Il répertorie également les symboles satisfaisant à ses exigences.
ISO 15223-1:2016 s'applique aux symboles utilisés pour une vaste gamme de dispositifs médicaux commercialisés au niveau mondial et devant à ce titre répondre à diverses exigences réglementaires.
Ces symboles peuvent figurer sur le dispositif médical lui-même, sur son emballage ou dans la documentation associée. Les exigences du présent document 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 15223-1:2016)

Ta dokument opredeljuje zahteve glede simbolov za označevanje medicinskih pripomočkov, ki podajajo informacije o varni in učinkoviti uporabi medicinskih pripomočkov. Navaja tudi simbole, ki ustrezajo zahtevam iz tega dokumenta.
Ta dokument se uporablja za simbole, ki se uporabljajo pri različnih medicinskih pripomočkih na globalnem tržišču in morajo zato izpolnjevati različne predpisane zahteve.
Ti simboli se uporabljajo na samih medicinskih pripomočkih, na njihovi embalaži ali v priloženi dokumentaciji. Zahteve tega dokumenta se ne uporabljajo za simbole, ki so določeni v drugih standardih.

General Information

• Status: Withdrawn
• Publication Date: 29-Nov-2016
• Withdrawal Date: 28-Sep-2021
• 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: 29-Sep-2021
• 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 15223-1:2017 - Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016)

Relations

• Replaces: 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: 05-Dec-2014
• Replaced By: EN ISO 15223-1:2021 - Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)
• Effective Date: 06-Oct-2021
• Amended By: EN ISO 15223-1:2016/FprA11 - Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, including corrected version 2017-03)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 15223-1:2017
01-februar-2017
1DGRPHãþD
SIST EN ISO 15223-1:2012
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 15223-1:2016)
Medizinprodukte - Bei Aufschriften von Medizinprodukten zu verwendende Symbole,
Kennzeichnung und zu liefernde Informationen - Teil 1: Allgemeine Anforderungen (ISO
15223-1:2016)
Dispositifs médicaux - Symboles à utiliser avec les étiquettes, l'étiquetage et les
informations à fournir relatifs aux dispositifs médicaux - Partie 1: Exigences générales
(ISO 15223-1:2016)
Ta slovenski standard je istoveten z: EN ISO 15223-1:2016
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 15223-1:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 15223-1:2017

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SIST EN ISO 15223-1:2017


EUROPEAN STANDARD
EN ISO 15223-1

NORME EUROPÉENNE

EUROPÄISCHE NORM
November 2016
ICS 01.080.20; 11.040.01
Supersedes EN ISO 15223-1:2012
English version

Medical devices - Symbols to be used with medical device
labels, labelling and information to be supplied - Part 1:
General requirements (ISO 15223-1:2016)
Dispositifs médicaux - Symboles à utiliser avec les Medizinprodukte - Bei Aufschriften von
étiquettes, l'étiquetage et les informations à fournir Medizinprodukten zu verwendende Symbole,
relatifs aux dispositifs médicaux - Partie 1: Exigences Kennzeichnung und zu liefernde Informationen - Teil
générales (ISO 15223-1:2016) 1: Allgemeine Anforderungen (ISO 15223-1:2016)
This European Standard was approved by CEN on 22 October 2016.

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
© 2016 CEN/CENELEC All rights of exploitation in any form and by any means Ref. No. EN ISO 15223-1:2016 E
reserved worldwide for CEN national Members and for
CENELEC Members.

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SIST EN ISO 15223-1:2017
EN ISO 15223-1:2016 (E)
Contents Page
European foreword . 3
Annex ZA (informative)  Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC [OJ L 169] on Medical Devices . 5
Annex ZB (informative)  Relationship between this European standard and the essential
requirements of Directive 90/385/EEC [OJ L 189] aimed to be covered . 8
Annex ZC (informative)  Relationship between this European standard and the essential
requirements of Directive 98/79/EC [OJ L 331] aimed to be covered . 10
2

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SIST EN ISO 15223-1:2017
EN ISO 15223-1:2016 (E)
European foreword
This document (EN ISO 15223-1:2016) 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 th
...