EN ISO 15223-1:2021
(Main)Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
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
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 or by endorsement, at the latest by March 2022, and conflicting national standards shall
be withdrawn at the latest by March 2022.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN-CENELEC shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 15223-1:2016.
This document has been prepared under a Standardization Request given to CEN and CENELEC by the
European Commission and the European Free Trade Association, and supports essential requirements
of EU Directive(s) / Regulation(s).
For the relationship with EU Directive(s) / Regulation(s), see informative Annex ZA and ZB, which is an
integral part of this document.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN and CENELEC
websites.
This document is an adoption of an International Standard. The definitions in applicable regulatory
requirements differ from nation to nation and region to region. As a result, the definitions in this
document can differ in wording from those in European Regulations. For use in support of European
requirements, definitions in the European regulations for medical devices take precedence.
The following referenced documents are indispensable for the application of this document. For
undated references, the latest edition of the referenced document (including any amendments) applies.
For dated references, only the edition cited applies. However, for any use of this standard “within the
meaning of Annex ZA and Annex ZB”, the user should always check that any referenced document has
not been superseded and that its relevant contents can still be considered the generally acknowledged
state-of-art.
When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a
normative reference to the corresponding EN standard, if available, and otherwise to the dated version
of the ISO or IEC standard, as listed below.
NOTE The way in which these references documents are cited in normative requirements determines the
extent (in whole or in part) to which they apply.
Table — Correlations between normative references and dated EN and ISO standards
Normative references as listed in
Equivalent dated standard
Clause 2 of the ISO standard
EN ISO or IEC
a
ISO 8601-1 -- ISO 8601-1:2019
a
ISO 8601-2 -- ISO 8601-2:2019
ISO 15223-2 -- ISO 15223-2:2010
ISO 3166-1 EN ISO 3166-1:2020 ISO 3166-1: 2020
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: 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 the
United Kingdom.
Endorsement notice
The text of ISO 15223-1:2021 has been approved by CEN-CENELEC as EN ISO 15223-1:2021 without
any modification.
Annex ZA
(informative)
Relationship between this European standard and the General Safety and
Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered
This European standard has been prepared under a Commission’s standardisation request to provide
one voluntary means of conforming to the General Safety and Performance Requirements of Regulation
(EU) 2017/745 of 5 April 2017 concerning medical devices [OJ L 117].
Once this standard is cited in the Official Journal of the European Union under that Regulation,
compliance with the normative clauses of this standard given in Table ZA.1 confers, within the limits of
the scope of this standard, a presumption of conformity with the corresponding General Safety and
Performance Requirements of that Regulation, and associated EFTA regulations.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Regulation (EU) 2017/745. This means that risks have to be
‘reduced as far as possible’, ‘reduced to the lowest possible level’, ‘reduced as far as possible and appropriate’,
‘removed or reduced as far as possible’, ‘eliminated or reduced as far as possible’, ’removed or minimized as far as
possible’, or ‘minimized’, according to the wording of the corresponding General Safety and Performance
Requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with General Safety
and Performance Requirements 1, 2, 3, 4, 5, 8, 9, 10, 11, 14, 16, 17, 18, 19, 20, 21 and 22 of the Regulation.
NOTE 3 This Annex ZA is based on normative references according to the table of references in the European
Foreword, replacing the references in the core text.
NOTE 4 When a General Safety and Performance Requirement does not appear in Table ZA.1, it means that it is
not addressed by this European Standard.
Table ZA.1 – Correspondence between this European standard and Annex I of Regulation (EU)
2017/745 [OJ L 117]
General Safety and
Clause(s) / sub-clause(s)
Performance Requirements of Remarks / Notes
of this EN
Regulation (EU) 2017/745
4 (c) 5.2.6 Partially covered: used to draw user’s
attention on the label to the safety
5.2.7
information such as
5.2.8
warnings/precautions/contraindications
5.3.1
only for the aspects dealt with by these
5.3.2 symbols placed in the instructions for use
or accompanying information and of any
5.3.3
residual risks and need for training for
5.3.4
users.
5.3.5
5.3.6
Not covered: does not provide further
5.3.7
information for safety about
warning/precautions/contraindications
5.3.8
other than the ones dealt with by these
5.3.9
symbols, nor training.
5.4.1
5.4.2
5.4.3
5.4.4
5.4.5
5.4.6
5.4.7
5.4.8
5.4.9
5.4.10
5.4.11
5.4.12
10.4.5 5.4.3 Partially covered: used to draw user’s
attention on the label to the safety
5.4.10
information placed in the instructions for
use or accompanying information of the
presence of substances that are
carcinogenic, mutagenic, toxic to
reproduction and/or having endocrine-
disrupting properties.
11.3 5.2.1 Partially covered: used as part of the label
to identify sterile or non-sterile medical
5.2.2
devices.
5.2.3
5.2.4
Not covered: Design, manufacture, and
5.2.5
packaging.
5.2.7
5.2.10
11.8 5.2.1 Covered: used as part of the label to
distinguish between identical sterile and
5.2.3
non-sterile medical devices.
5.2.4
5.2.5
5.2.7
5.2.10
14.1 5.4.3 Partially covered: used to draw user’s
attention on the labelling to the safety
5.4.4
information in the instructions for use.
22.1 5 Partially covered: used to convey specific
label information in a format that is easy
for the intended user to understand.
Not covered: the design and manufacture
for appropriate performance, taking user’s
skills into account; the understanding and
application of the instructions for use.
23.1 (first sentence) 5.1.1 Partially covered: used to identify the
medical device and its manufacturer.
5.1.3
5.1.5
5.1.6
5.1.7
5.1.10
5.1.11
23.1 (a) 5 Partially covered: used to convey label
information in a format that is easy to
understand.
Not covered: the medium, format, content,
legibility and location of the label,
instructions for use, and accompanying
information; the technical knowledge,
experience, and training of the intended
user; understanding of the intended use,
drawings, or diagrams.
23.1 (b) 5 Partially covered: used to provide label
information directly on a medical device in
a symbol format that would be otherwise
impracticable by use of text.
Not covered: the information that is
required on the label and/or medical
device, but that can be placed on the
medical device or the packaging.
23.1 (c) 5 Partially covered: used to provide label
information in a human readable format
that would be otherwise impracticable by
use of text.
Not covered: machine-readable
information.
23.1 (g) 5.4.3 Partially covered: may be used to draw
user’s attention on the label to the safety
5.4.4
information concerning limitation, contra-
indications, precautions, or warnings.
Not covered: the residual risks required to
be communicated by way of limitations,
contra-indications, precautions, or
warnings.
23.1 (h) 4.2 Covered: symbols used to convey
information in combination with risk
management. Symbols addressed in 5 are
used on labels without a description of the
symbol required in the instructions for use
or accompanying information to convey
information.
Not covered: the use of other symbols will
require a description of the symbol in the
instructions for use or accompanying
information.
23.2 (b) 5.1.6 Partially covered: used as part of the label
information to identify the medical device
5.1.10
and the packaging contents.
5.7.10
Not covered: the intended purpose of the
medical device.
23.2 (c) 5.1.1 Partially covered: used as part of the label
information to identify the manufacturer
and registered place of business (address).
Not covered: the trade name or registered
trademark.
...
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