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)

This document specifies symbols used to express information supplied for a medical device. This document is applicable to symbols used in a broad spectrum of medical devices, that are available globally and need to meet different regulatory requirements.
These symbols can be used on the medical device itself, on its packaging or in the accompanying information. The requirements of this document are not intended to apply to symbols specified in other standards.

Medizinprodukte - Symbole zur Verwendung im Rahmen der vom Hersteller bereitzustellenden Informationen - Teil 1: Allgemeine Anforderungen (ISO 15223-1:2021)

Dieses Dokument legt Symbole fest, die zur Angabe von für ein Medizinprodukt bereitgestellten Informationen zu verwenden sind. Dieses Dokument ist anzuwenden für Symbole, die auf ein breites Spektrum von Medizinprodukten anwendbar sind, die weltweit verfügbar sind und unterschiedliche behördliche Anforderungen erfüllen müssen.
Diese Symbole können auf dem Medizinprodukt selbst, auf seiner Verpackung oder in den Begleitinformationen verwendet werden. Die Anforderungen dieses Dokuments sind nicht dazu vorgesehen, für Symbole zu gelten, die in anderen Normen festgelegt sind.

Dispositifs médicaux - Symboles à utiliser avec les informations à fournir par le fabricant - Partie 1: Exigences générales (ISO 15223-1:2021)

Le présent document spécifie les symboles utilisés pour exprimer les informations fournies pour un dispositif médical. Le présent document s’applique aux symboles utilisés pour une vaste gamme de dispositifs médicaux disponibles au niveau mondial et devant répondre à diverses exigences réglementaires.
Ces symboles peuvent figurer sur le dispositif médical lui-même, sur son emballage ou dans les informations d’accompagnement. 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 podatkov, ki jih mora podati dobavitelj - 1. del: Splošne zahteve (ISO 15223-1:2021)

General Information

• Status: Published
• Publication Date: 28-Sep-2021
• Withdrawal Date: 30-Mar-2022
• 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: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 29-Sep-2021
• Completion Date: 29-Sep-2021
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Directive: 2017/746 - Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
• Mandate: M/565 - Medical devices and in vitro diagnostic medical devices in support of Regulation (EU) 2017/745 of the European Parliament and of the Council and Regulation (EU) 2017/746
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Mandate: M/MDR - Medical devices and in vitro diagnostic medical devices in support of Regulation (EU) 2017/745 of the European Parliament and of the Council and Regulation (EU) 2017/746
• Ref Project: SIST 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)

Relations

• Replaces: 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: 06-Oct-2021

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 15223-1:2021
01-december-2021
Nadomešča:
SIST EN ISO 15223-1:2017
Medicinski pripomočki - Simboli za označevanje podatkov, ki jih mora podati
dobavitelj - 1. del: Splošne zahteve (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)
Medizinprodukte - Zu verwendende Symbole mit durch den Hersteller bereitgestellten
Informationen - Teil 1: Allgemeine Anforderungen (ISO 15223-1:2021)
Dispositifs médicaux - Symboles à utiliser avec les informations à fournir par le fabricant
- Partie 1: Exigences générales (ISO 15223-1:2021)
Ta slovenski standard je istoveten z: EN ISO 15223-1:2021
ICS:
01.080.20 Grafični simboli za posebno Graphical symbols for use on
opremo specific equipment
11.040.01 Medicinska oprema na Medical equipment in general
splošno
SIST EN ISO 15223-1:2021 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 15223-1:2021

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SIST EN ISO 15223-1:2021


EUROPEAN STANDARD EN ISO 15223-1

NORME EUROPÉENNE

EUROPÄISCHE NORM
September 2021
ICS 01.080.20; 11.040.01
Supersedes EN ISO 15223-1:2016
English version

Medical devices - Symbols to be used with information to
be supplied by the manufacturer - Part 1: General
requirements (ISO 15223-1:2021)
Dispositifs médicaux - Symboles à utiliser avec les Medizinprodukte - Zu verwendende Symbole mit
informations à fournir par le fabricant - Partie 1: durch den Hersteller bereitgestellten Informationen -
Exigences générales (ISO 15223-1:2021) Teil 1: Allgemeine Anforderungen (ISO 15223-1:2021)
This European Standard was approved by CEN on 4 June 2021.

This European Standard was corrected and reissued by the CEN-CENELEC Management Centre on 13 October 2021.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia,
Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.


















CEN-CENELEC Management Centre:
Rue de la Science 23, B-1040 Brussels
© 2021 CEN/CENELEC All rights of exploitation in any form and by any means Ref. No. EN ISO 15223-1:2021 E
reserved worldwide for CEN national Members and for
CENELEC Members.

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SIST EN ISO 15223-1:2021
EN ISO 15223-1:2021 (E)

Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered. 5
Annex ZB (informative)  Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/746 aimed to be
covered. 14

2

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SIST EN ISO 15223-1:2021
EN ISO 15223-1:2021 (E)

European foreword
This document (EN ISO 15223-1:2021) has been prepared by Technical Committee ISO/TC 210 "Quality
management and corresponding general aspects for medical devices" in collaboration with Technical
Committee CEN-CENELEC/ JTC 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 o
...