SIST 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 - Zu verwendende Symbole mit durch den Hersteller bereitgestellten 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
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 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.
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SIST EN ISO 15223-1:2021
EN ISO 15223-1:2021 (E)
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.
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SIST EN ISO 15223-1:2021
EN ISO 15223-1:2021 (E)
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.
5
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SIST EN ISO 15223-1:2021
EN ISO 15223-1:2021 (E)
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
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SIST EN ISO 15223-1:2021
EN ISO 15223-1:2021 (E)
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
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EN ISO 15223-1:2021 (E)
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
5
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.
23.2 (d) 5.1.2 Covered: used as part of the label
information to identify the authorised
representative and registered place of
business (address).
23.2 (e) 5.4.6 Covered: used as part of the label
information to identify that the medical
5.4.7
device contains or incorporates a
5.4.8
medicinal substance, including a human
5.4.9
blood or plasma derivative; or tissues or
cells, or their derivatives, of human origin;
or tissues or cells of animal origin, or their
derivatives.
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EN ISO 15223-1:2021 (E)
23.2 (f) 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 have endocrine-
disrupting properties.
23.2 (g) 5.1.5 Covered: used on the label to replace the
words ‘LOT NUMBER’ and ‘SERIAL
5.1.7
NUMBER’
23.2 (h) 5.7.10 Partially covered: symbol used on the
label to indicate the UDI carrier
23.2 (i) 5.1.4 Covered: used on the label to indicate the
time limit for use or implant of the medical
device, accompanied by the date (to
include at least year and month).
23.2 (j) 5.1.3 Covered: used on the label to indicate the
date of manufacture for the medical
5.1.11
device, accompanied by the date (to
include at least year and month).
23.2 (k) 5.3.1 Covered: used on the label to indicate
information that the medical device is:
5.3.2
fragile.
5.3.3
needs protection from sunlight and other
5.3.4
light sources, or heat and radioactive
5.3.5
sources, or moisture.
5.3.6
5.3.7
Covered: used on the label to indicate that
5.3.8
for safe use and effectiveness the medical
5.3.9 device has:
an upper limit of temperature
accompanied by the temperature
value.
a lower limit of temperature accompanied
by the temperature value.
upper and lower limits of temperature
accompanied by the upper and lower
temperature values.
upper and lower limits of humidity
accompanied by the upper and lower
humidity values.
upper and lower limits of pressure
accompanied by the upper and lower
pressure values.
23.2 (l) 5.2.1 Covered: used on the label to specify an
indication of the medical device’s sterile
5.2.2
state and the method of sterilization.
5.2.3
5.2.4
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EN ISO 15223-1:2021 (E)
5.2.5 If symbol 5.2.1 is used, the GSPR is only
partially covered as this symbol does not
5.2.10
indicate the method of sterilization.
23.2 (m) 5.2.6 Partially covered: used to draw user’s
attention on the label to the more detailed
5.2.7
warnings or precautions found in the
5.2.8
instructions for use or accompanying
5.3.1
information.
5.3.2
5.3.3
5.3.4
5.3.5
5.3.6
5.3.7
5.3.8
5.3.9
5.4.1
5.4.2
5.4.3
5.4.4
5.4.5
5.4.10
23.2 (n) 5.4.2 Covered: used to specify on the label that
the medical device is intended for single
use.
23.2 (q) 5.7.7 Covered: used to specify on the label that
the device is a medical device.
Not covered: for labelling of devices
intended for clinical investigation only.
23.2 (s) 5.1.5 Covered: used on the label to replace the
words ‘LOT NUMBER’ and ‘SERIAL
5.1.7
NUMBER’
23.3 (a) 5.2.11 Covered: used to specify on the packaging
that it is sterile packaging (sterile barrier
5.2.12
system).
5.2.13
5.2.14
23.3 (b) 5.2.1 Covered: used on the packaging to identify
the medical device is sterile.
5.2.2
5.2.3
5.2.4
5.2.5
5.2.10
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EN ISO 15223-1:2021 (E)
23.3 (c) 5.2.2 Covered: used on the packaging to specify
the method of sterilization.
5.2.3
5.2.4
5.2.5
5.2.10
23.3 (d) 5.1.1 Covered: used on the packaging to identify
the manufacturer and registered place of
business (address).
23.3 (h) 5.1.3 Covered: used on the packaging to indicate
the date of manufacture for the medical
5.1.11
device, accompanied by the date (to
include at least year and month).
23.3 (i) 5.1.4 Covered: used on the packaging to indicate
the time limit for use or implant of the
medical device, accompanied by the date
(to include at least year and month).
23.3 (j) 5.2.8 Covered: used to draw user’s attention on
the packaging to the more detailed
5.4.3
warnings or precautions found in the
instructions for use or accompanying
information if the packaging is damaged or
opened.
23.4 (a) 5.1.1 Covered: used in the instructions for use
to identify that the medical device
5.2.1
contains or incorporates:
5.2.2
a medicinal substance, including a human
5.2.3
blood or plasma derivative (23.2 (e)).
5.2.4
tissues or cells, or their derivatives, of
5.2.5
human origin (23.2 (e)).
5.2.10
tissues or cells of animal origin, or their
5.3.1 derivatives (23.2 (e)).
5.3.2
5.3.3 Covered: used to indicate in the
instructions for use that the medical
5.3.4
device is:
5.3.5
fragile (23.2 (k)).
5.3.6
needs protection from sunlight and other
5.3.7
light sources, or heat and radioactive
5.3.8
sources, or moisture (23.2 (k)).
5.3.9
intended for single use (23.2 (n)).
5.4.2
5.4.3
Covered: used on the label to specify an
5.4.4 indication of the medical device’s non-
sterile or sterile state and the method of
5.4.6
sterilization.
5.4.7
5.4.8
If symbol 5.2.1 is used, the GSPR is only
5.4.9
partially covered as this symbol does not
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EN ISO 15223-1:2021 (E)
5.4.10 indicate the method of sterilization (23.2
(l)).
Covered: used in the instructions for use
to indicate that for safe use and
effectiveness the medical device has:
an upper limit of temperature
accompanied by the temperature
value (23.2 (k)).
a lower limit of temperature accompanied
by the temperature value (23.2 (k)).
upper and lower limits of temperature
accompanied by the upper and lower
temperature values (23.2 (k)).
upper and lower limits of humidity
accompanied by the upper and lower
humidity values (23.2 (k)).
upper and lower limits of pressure
accompanied by the upper and lower
pressure values (23.2 (k)).
Partially covered: used in the instructions
for use to identify the manufacturer and
registered place of business (address)
(23.2 (c)).
Partially covered: used to draw user’s
attention to the safety information placed
in the instructions for use of the presence
of substances that are hazardous,
carcinogenic, mutagenic, toxic to
reproduction and/or have endocrine-
disrupting properties (23.2 (f)).
Not covered: the trade name or registered
trademark (23.2 (a)), (23.2 (c)).
23.4 (l) 5.2.8 Partially covered: used to draw user’s
attention to the more detailed warnings or
5.4.3
precautions found in the instructions for
use if the packaging is damaged or opened.
Not covered: instructions in the event of
damage or unintentional opening.
23.4 (p) 5.4.2 Partially covered: used in the instructions
for use to specify that the medical device is
intended for single use.
Not covered: information and technical
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factors that could pose a risk if re-used.
23.4 (aa) 5.1.1 Partially covered: used on information
provided to the patient to draw attention
5.1.5
to the more detailed information
5.1.7
regarding the implanted medical device.
5.1.10
5.7.3
Not covered: specific information
5.7.4
regarding the implanted medical device.
5.7.5
5.7.6
5.7.7
5.7.10
WARNING 1: Presumption of conformity stays valid only as long as a reference to this European
standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2: Other Union legislation may be applicable to the product(s) falling within the scope of this
standard.
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EN ISO 15223-1:2021 (E)
Annex ZB
(informative)
Relationship between this European standard and the General Safety and
Performance Requirements of Regulation (EU) 2017/746 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 requirements of Regulation (EU) 2017/746 of 5 April 2017
concerning in vitro diagnostic 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 ZB.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) 2017/746. This means that risks have to be
‘reduced as far as possible’, ‘reduced to a level as low as reasonably practicable’, ‘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’, ‘prevented’ 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, 10, 11, 13, 15, 16, 17, 18 and 19 of the Regulation.
NOTE 3 This Annex ZB 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 ZB.1, it means that it is
not addressed by this European Standard.
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Table ZB.1 – Correspondence between this European standard and Annex I of Regulation (EU)
2017/746 [OJ L 117]
Clause(s) / sub-
General Safety and Performance
clause(s)
Requirements of Regulation (EU) Remarks / Notes
2017/746
of this EN
4 (c) 5.2.6 Partially covered: used on the label to draw
user’s attention to the safety information
5.2.7
placed in the instructions for use or
5.2.8
accompanying information and of any
5.3.1
residual risks and need for training for
users.
5.3.2
5.3.3
5.3.4 Not covered: does not provide information
for safety nor training.
5.3.5
5.3.6
5.3.7
5.3.8
5.3.9
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
11.2 5.2.1 Partially covered: used as part of the label
to identify sterile or non-sterile in vitro
5.2.2
diagnostic medical devices.
5.2.3
5.2.4
Not covered: Design, manufacture, and
5.2.5
packaging.
5.2.7
5.2.10
11.6 5.2.1 Covered: used as part of the label to
distinguish between identical sterile and
5.2.7
non-sterile in vitro diagnostic medical
devices.
19.1 5 Partially covered: used to convey specific
label information in a format that is easy
for the intended user to understand.
15
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SIST EN ISO 15223-1:2021
EN ISO 15223-1:2021 (E)
Not covered: the design and manufacture
for appropriate performance, taking user’s
skills into account; the understanding and
application of the instructions for use.
20.1 (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.
20.1 (b) 5 Partially covered: used to provide label
information directly on an in vitro
diagnostic 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 in vitro
diagnostic medical device but that can be
placed on the device or the packaging.
20.1 (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.
20.1 (g) 5.4.4 Partially covered: may be used to draw
user’s attention on the label to the safety
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.
20.1 (h) 4.2 Covered: symbols used to convey
information in combination with risk
5
management. Symbols addressed in 5.1
may be used on labels without a
description of the symbol required in the
instructions for use or accompanying
information to convey information.
Not covered: use of other symbols will
16
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SIST EN ISO 15223-1:2021
EN ISO 15223-1:2021 (E)
require a description of the symbol in the
instructions for use or accompanying
information.
20.2 (b) 5.1.6 Partially covered: used as part of the label
information to identify the in vitro
5.1.7
diagnostic medical device and the
5.7.10
packaging contents.
Not covered: the intended purpose of the in
vitro diagnostic medical device.
20.2 (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.
20.2 (d) 5.1.2 Covered: used as part of the label
information to identify the authorised
representative and registered place of
business (address).
20.2 (e) 5.5.1 Covered: used as part of the label
information to identify that the device is an
5.5.6
in vitro diagnostic medical device, or that
the in vitro diagnostic medical device is
intended for performance studies.
20.2 (f) 5.1.5 Covered: used on the label to replace the
words ‘LOT NUMBER’ and ‘SERIAL
5.1.7
NUMBER’.
20.2 (g) 5.7.10 Partially covered: used on the label to
indicate the UDI carrier.
20.2 (h) 5.1.4 Covered: used on the label to indicate the
time limit for use, accompanied by the date
(to include at least year and month, and if
relevant, day).
20.2 (i) 5.1.3 Covered: used on the label to indicate the
date of manufacture for the in vitro
diagnostic device, accompanied by t
...
SLOVENSKI STANDARD
oSIST prEN ISO 15223-1:2020
01-april-2020
Medicinski pripomočki - Simboli za označevanje medicinskih pripomočkov,
označevanje in podatki, ki jih mora podati dobavitelj - 1. del: Splošne zahteve
(ISO/DIS 15223-1:2020)
Medical devices - Symbols to be used with medical device labels, labelling and
information to be supplied - Part 1: General requirements (ISO/DIS 15223-1:2020)
Medizinprodukte - Bei Aufschriften von Medizinprodukten zu verwendende Symbole,
Kennzeichnung und zu liefernde Informationen - Teil 1: Allgemeine Anforderungen
(ISO/DIS 15223-1:2020)
Dispositifs médicaux - Symboles à utiliser avec les étiquettes, l'étiquetage et les
informations à fournir relatifs aux dispositifs médicaux - Partie 1: Exigences générales
(ISO/DIS 15223-1:2020)
Ta slovenski standard je istoveten z: prEN ISO 15223-1
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
oSIST prEN ISO 15223-1:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 15223-1:2020
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oSIST prEN ISO 15223-1:2020
DRAFT INTERNATIONAL STANDARD
ISO/DIS 15223-1
ISO/TC 210 Secretariat: ANSI
Voting begins on: Voting terminates on:
2020-02-20 2020-05-14
Medical devices — Symbols to be used with medical device
labels, labelling and information to be supplied —
Part 1:
General requirements
Dispositifs médicaux — Symboles à utiliser avec les étiquettes, l'étiquetage et les informations à fournir
relatifs aux dispositifs médicaux —
Partie 1: Exigences générales
ICS: 01.080.20; 11.040.01
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 15223-1:2020(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2020
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oSIST prEN ISO 15223-1:2020
ISO/DIS 15223-1:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
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oSIST prEN ISO 15223-1:2020
ISO/DIS 15223-1:2020(E)
Contents Page
Foreword . 4
Introduction . 5
1 Scope. 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 7
5 Symbols . 8
Annex A (informative) Examples . 35
Annex B (informative) Use of general prohibition symbol and negation symbol . 41
Annex C (informative) Terminology - Alphabetized index of defined terms . 42
Bibliography . 43
iii
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oSIST prEN ISO 15223-1:2020
ISO/DIS 15223-1:2020(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national
standards bodies (ISO member bodies). The work of preparing International Standards is normally
carried out through ISO technical committees. Each member body interested in a subject for which a
technical committee has been established has the right to be represented on that committee.
International organizations, governmental and non-governmental, in liaison with ISO, also take part in
the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all
matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO's adherence to the World Trade Organization (WTO)
principles in the Technical Barriers to Trade (TBT) see the following URL:
www.iso.org/iso/foreword.html.
The committee responsible for this document is ISO/TC 210, Quality management and corresponding
general aspects for medical devices.
This fourth edition cancels and replaces the third edition (ISO 15223-1:2016), which has been
technically revised with the following principal revisions:
− Addition of 20 new symbols that were validated per ISO 15223-2
− Addition of 5 symbols from ISO 7000, ISO 7001 and IEC 60417
− Deletion of the defined term ‘labelling’
− Inclusion of defined terms from ISO 20417, ISO 13485 and ISO 14971.
− Expansion of the informative annex containing examples
− Moved information about European Regulations to informative notes
A list of all parts in the ISO 15223 series can be found on the ISO website.
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oSIST prEN ISO 15223-1:2020
ISO/DIS 15223-1:2020(E)
Introduction
Medical device manufacturers and others in the supply chain must provide specific information that is
essential for the safe and proper use of the medical device. This information can be on the medical
device itself, as part of the packaging, or in other accompanying information. For simplicity and
translation reasons, this information can be provided as symbols that have a specific meaning. This
document does not specify the information that needs to be provided, but does specify internationally
recognized symbols for the provision of this specific information.
The symbols included in this document have been published in ISO 7000, ISO 7010, IEC 60417 or have
been subjected to a formal symbol validation process.
This document is intended to be used by manufacturers of medical devices and others who desire to use
these symbols to portray information without translation of text into multiple languages In this
document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of
the conditions is true.
The verbal forms used in this document conform to usage described in ISO/IEC Directives, 129 Part 2.
For the purposes of this document, the auxiliary verb:
− “shall” means that conformance with a requirement or a test is mandatory for conformance with
this document;
− “should” means that conformance with a requirement or a test is recommended but is not
mandatory for conformance with this document;
− “may” is used to describe permission (e.g. a permissible way to achieve conformance with a
requirement or test);
− "can" is used to describe a possibility or capability; and
− "must" is used to express an external constraint.
Symbols added during the revision of this document were placed at the end of the pertinent section so
as to preserve the numbering of existing symbols which facilitates easy referencing in other documents.
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oSIST prEN ISO 15223-1:2020
ISO/DIS 15223-1:2020(E)
Medical Devices — Symbols to be used with medical device labels,
labelling and information to be supplied — Part 1: General
requirements
1 Scope
This document 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.
This document 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 are marked on the medical device itself, placed on its packaging or placed in the
associated accompanying information. The requirements of this document are not intended to apply to
symbols specified in other standards.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 7000 (database), Graphical symbols for use on equipment — Registered symbols
ISO 7001:2019, Graphical symbols — Public information symbols
ISO 8601-1:2019, Date and time — Representations for information interchange — Part 1: Basic rules
ISO 8601-2:2019, Date and time — Representations for information interchange — Part 2: Extensions
ISO 14971:2019, Medical devices -- Application of risk management to medical devices
ISO 13485:2016, Medical devices – Quality management systems – Requirements for regulatory purposes
ISO 15223-2:2010, Medical devices — Symbols to be used with medical device labels, labelling, and
information to be supplied — Part 2: Symbol development, selection and validation
1
ISO 20417:---- , Medical Devices - Information to be supplied by the manufacturer
IEC 60417 (database), Graphical symbols for use on equipment
IEC 80416-1:2008, Basic principles for graphical symbols for use on equipment — Part 1: Creation of
graphical symbols for registration
3 Terms and definitions
For the purposes of this document the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http://www.electropedia.org/
— ISO Online browsing platform: available at http://www.iso.org/obp
1
Under preparation. Currently in FDIS stage.
1
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oSIST prEN ISO 15223-1:2020
ISO/DIS 15223-1:2020(E)
— Numbers in square brackets refer to the Bibliography
3.1
accompanying information
information accompanying or marked on a medical device or accessory for the user or those accountable
for the installation, use, processing, maintenance, decommissioning and disposal of the medical device
or accessory, particularly regarding safe use
Note 1 to entry: The accompanying information shall be regarded as part of the medical device or accessory.
Note 2 to entry: The accompanying information can consist of the label, marking, instructions for use, technical description,
installation manual, quick reference guide, etc.
Note 3 to entry: Accompanying information is not necessarily a written or printed document but could involve auditory, visual,
or tactile materials and multiple media types (e.g. CD/DVD-ROM, USB stick, website).
Note 4 to entry: See Figure 1
[SOURCE: ISO 20417:---- [15], definition 3.2]
Information supplied by the manufacturer
ACCOMPANYING
INFORMATION
Auditory
Electronic
Multi-media
Printed
Tactile
Figure 1 – Relationship of terms used to describe information supplied by the manufacturer
3.2
batch code
batch number
lot code
lot number
production control containing a combination of letters or numbers associated with a single batch or lot
[SOURCE: ISO 20417:---- [15], definition 3.15]
3.3
catalogue number
commercial product code
commercial product name
value given by the manufacturer to identify a specific medical device or accessory as it relates to its
form/fit, function and process (i.e., manufacturing processes requiring differentiation for the end user)
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oSIST prEN ISO 15223-1:2020
ISO/DIS 15223-1:2020(E)
Note 1 to entry: A catalogue number shall consist of letters or numbers.
Note 2 to entry: For the purposes of this standard, commercial product code should not be confused with the US FDA, ‘product
code’ or procode classification.
Note 3 to entry: See ISO 20417:2020 Figure 2.
[SOURCE: ISO 20417:---- [15], definition 3.3 - modified to make note 3 an external reference]
3.4
characteristic information
information that represents the property or properties of a symbol
3.5
description
normative text which defines the purpose, application and use of the symbol
[SOURCE: IEC 80416-1:2008 [10], definition 3.2]
3.6
distributor
natural or legal person, different from the manufacturer or importer, in the supply chain who, on their
own behalf, furthers the availability of a medical device or accessory to the user
Note 1 to entry: More than one distributor may be involved in the supply chain.
Note 2 to entry: For the purposes of this document, persons in the supply chain involved in activities such as storage and
transport on behalf of the manufacturer, importer or distributor, are not distributors.
[SOURCE: ISO 20417:---- [15], definition 3.5]
3.7
importer
natural or legal person who imports a medical device or accessory into a locale, which was
manufactured in another locale, for the purposes of marketing
[SOURCE: ISO 20417:---- [15], definition 3.8]
3.8
information supplied by the manufacturer
all information related to the identification and use of a medical device or accessory, in whatever form
provided, intended to ensure the safe and effective use of the medical device or accessory
Note 1 to entry: For the purposes of this document, e-documentation is included in information supplied by the manufacturer.
Note 2 to entry: For the purposes of this document, shipping documents and promotional material are excluded from
information supplied by the manufacturer. However, some authorities having jurisdiction can consider such supplemental
information as information supplied by the manufacturer.
Note 3 to entry: The primary purpose of information supplied by the manufacturer is to identify the medical device and its
manufacturer, and provide essential information about its safety, performance, and appropriate use to the user or other
relevant persons.
[SOURCE: ISO 20417:---- [15], definition 3.10]
3.9
instructions for use
IFU
3
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oSIST prEN ISO 15223-1:2020
ISO/DIS 15223-1:2020(E)
package insert
portion of the accompanying information that is essential for the safe and effective use of a medical
device or accessory directed to the user of the medical device
Note 1 to entry: For the purposes of this document, a user can be either a lay user or professional user with relevant
specialized training.
Note 2 to entry: For the purposes of this document, instructions for the professional processing between uses of a medical
device or accessory can be included in the instructions for use.
Note 3 to entry: The instructions for use, or portions thereof, can be located on the display of a medical device.
Note 4 to entry: Medical devices or accessories that can be used safely and effectively without instructions for use are exempted
from having instructions for use by some authorities with jurisdiction.
Note 5 to entry: See Figure 1.
[SOURCE: ISO 20417:---- [15], definition 3.11]
3.10
label
written, printed or graphic information marked on the item itself, or on the packaging of each item, or
on the packaging of multiple items
Note 1 to entry: For the purposes of this document, the term labelled is used to designate the corresponding act.
Note 2 to entry: Label includes the marking on the medical device or accessory.
Note 3 to entry: See Figure 1.
[SOURCE: ISO 20417:---- [15], definition 3.12]
3.11
manufacturer
natural or legal person with responsibility for design and/or manufacture of a medical device with the
intention of making the medical device available for use, under his name; whether or not such a medical
device is designed and/or manufactured by that person himself or on his behalf by another person(s)
Note 1 to entry: The natural or legal person has ultimate legal responsibility for ensuring compliance with all applicable
regulatory requirements for the medical devices in the countries or jurisdictions where it is intended to be made available or
sold, unless this responsibility is specifically imposed on another person by the Regulatory Authority (RA) within that
jurisdiction.
Note 2 to entry: The manufacturer’s responsibilities are described in other GHTF guidance documents. These responsibilities
include meeting both pre-market requirements and post-market requirements, such as adverse event reporting and
notification of corrective actions.
Note 3 to entry: “Design and/or manufacture”, may include specification development, production, fabrication, assembly,
processing, packaging, repackaging, labelling, relabelling, sterilization, installation, or remanufacturing of a medical device; or
putting a collection of devices, and possibly other products, together for a medical purpose.
Note 4 to entry: Any person who assembles or adapts a medical device that has already been supplied by another person for an
individual patient, in accordance with the instructions for use, is not the manufacturer, provided the assembly or adaptation
does not change the intended use of the medical device.
Note 5 to entry: Any person who changes the intended use of, or modifies, a medical device without acting on behalf of the
original manufacturer and who makes it available for use under his own name, should be considered the manufacturer of the
modified medical device.
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ISO/DIS 15223-1:2020(E)
Note 6 to entry: An authorized representative, distributor or importer who only adds its own address and contact details to the
medical device or the packaging, without covering or changing the existing labelling, is not considered a manufacturer.
Note 7 to entry: To the extent that an accessory is subject to the regulatory requirements of a medical device, the person
responsible for the design and/or manufacture of that accessory is considered to be a manufacturer.
[SOURCE: ISO 14971:2019 [3], definition 3.9]
3.12
marking
information, in text or graphical format, durably affixed, printed, etched (or equivalent) to a medical
device or accessory
Note 1 to entry: For the purposes of this document, the term marked is used to designate the corresponding act.
Note 2 to entry: For the purposes of this document, marking is different from ‘direct marking’ as described in unique device
identification (UDI). A UDI ‘direct marking’ is a type of marking.
Note 4 to entry: See Figure 1.
[SOURCE: ISO 20147:---- [15], definition 3.16]
3.13
medical device
material or other similar or related article, intended by the manufacturer to be used, alone or in
combination, for human beings, for one or more of the specific medical purpose(s) of:
— diagnosis, prevention, monitoring, treatment or alleviation of disease;
— diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
— investigation, replacement, modification, or support of the anatomy or of a physiological process;
— supporting or sustaining life;
— control of conception;
— disinfection of medical devices;
— providing information by means of in vitro examination of specimens derived from the human body;
and does not achieve its primary intended action by pharmacological, immunological or metabolic
means, in or on the human body, but which may be assisted in its intended function by such means
Note 1 to entry: Products which may be considered to be medical devices in some jurisdictions but not in others include:
— disinfection substances;
— aids for persons with disabilities;
— devices incorporating animal and/or human tissues;
— devices for in vitro fertilization or assisted reproduction technologies.
[SOURCE: ISO 13485:2016 [16], definition 3.11]
3.14
post-market surveillance
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systematic process to collect and analyse experience gained from medical devices that have been placed
on the market
[SOURCE: ISO 13485:2016 [16], definition 3.14]
3.15
risk
combination of the probability of occurrence of harm and the severity of that harm
[SOURCE: ISO 14971:2019 [3], definition 3.18]
3.16
risk assessment
overall process comprising a risk analysis and a risk evaluation
[SOURCE: ISO 14971:2019 [3], definition 3.20]
3.17
serial number
production control containing a combination of letters or numbers, selected by the manufacturer,
intended for quality control and identification purposes to uniquely distinguish an individual medical
device from other medical devices with the same catalogue number or model number
[SOURCE: ISO 20147:---- [15], definition 3.22]
3.18
single patient multiple use
intended by the manufacturer to be reused on an individual patient for
multiple uses
Note 1 to entry: A single patient multiple use medical device or accessory may require processing
between uses.
Note 2 to entry: For an implantable medical device, the duration of a single use is from implanting to
explanting the medical device.
[SOURCE: ISO 20147:----[15], definition 3.25]
3.19
single use
do not re-use
use only once
intended by the manufacturer to be used on an individual patient or
specimen during a single procedure and then disposed of
Note 1 to entry: A single use medical device or accessory is not intended by its manufacturer to be used
again. This includes undergoing processing
[SOURCE: ISO 20147:---- [15], definition 3.26]
3.20
sterile
free from viable microorganisms
[SOURCE: ISO 20147:2020 [15], definition 3.28]
3.21
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ISO/DIS 15223-1:2020(E)
symbol
graphical representation appearing on the label (3.10) and/or associated documentation of a medical
device that communicates characteristic information (3.4) without the need for the supplier or receiver
of the information to have knowledge of the language of a particular nation or people
Note 1 to entry: The symbol can be an abstract pictorial or a graphical representation, or one that uses familiar objects,
including alphanumeric characters (with sufficient justification).
3.22
title
unique name by which a graphical symbol is identified and referenced
[SOURCE: IEC 80416 -1:2008 [10], definition 3.9 – modified –replaced ‘spoken of’ with ‘referenced’.]
4 General requirements
4.1 Proposal of symbols for adoption
a) Symbols proposed for adoption in this document (with the exception of symbols already
registered under ISO 7000, ISO 7001 or IEC 60417) shall be validated in accordance with
ISO 15223-2.
b) Any symbol proposed for adoption in this document shall be applicable to a range of medical
devices and have global or regional applicability.
4.2 Requirements for usage
a) When a need identifies use of symbols as an appropriate method for conveying information
essential for the proper use of a medical device, the symbols given in Table 1 may be marked on
the medical device, appear on its packaging or in associated documentation.
NOTE ISO and IEC jointly maintain an online database of graphical symbols for use on equipment, which contains
the complete set of graphical symbols included in ISO 7000, ISO 7001 and IEC 60417 available at
https://www.iso.org/obp/ui/#search. This online collection shows each graphical symbol and identifies it by a
reference number and a title. The graphical symbols are available in different formats (e.g. AI, DWG, EPS) and some
additional data as applicable is provided. Various search and navigation facilities allow for easy retrieval of graphical
symbols.
b) The manufacturer should determine the appropriate size for the symbol to be legible for its
intended function.
NOTE This document does not specify colours or minimum size for the symbols in Table 1, nor does it specify the
relative size of symbols and that of indicated information.
c) It is important that symbols be used properly. Guidance on the application of graphical symbols
may be found in IEC 80416-3:2011. Before symbols are used, the manufacturer shall carry out a
risk assessment that indicates that the use of the symbol does not introduce an unacceptable risk.
d) All dates and times presented in association with symbols shall use the conventions set out in
ISO 8601-1:2019 and ISO 8601-2:2019.
4.3 Other symbols
Other standards specify additional symbols that are applicable to particular kinds or groups of medical
devices or to particular situations. The bibliography provides examples of sources for additional
symbols.
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5 Symbols
a) When appropriate, information essential for proper use shall be indicated on the medical device,
its packaging, or in the accompanying information by using the corresponding symbols given in
Table 1.
b) A manufacturer may use any appropriate symbol.
NOTE 1 Table 1 has been organized into symbol categories for ease of use. The category into which a symbol is
grouped does not have any significance as far as usage is concerned. The order of appearance of symbols and the
categories in which they are placed are not prioritized. Examples of the use of symbols can be found in Annex A.
NOTE 2 The number and date found in the last column of Table 1 is the reference number and registration date
that is listed in one of the following standards: ISO 7000, ISO 7001 or IEC 60417.
8
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oSIST prEN ISO 15223-1:2020
1 Table 1 — Symbols to convey information essential for proper use
2
Reference Title of symbol Description of Requirements Informative notes Restrictions of Additional Symbol
number of symbol use requirements number /
symbol and registration
a
symbol graphic date
5.1. Manufacture
5.1.1. Manufacturer Indicates the This symbol shall NOTE 1 This symbol is The use of this ISO 7000-3082
medical device be accompanied used to indicate symbol with a date
2011-10-02
manufacturer by the name and information that is of manufacture
address of the required in Europe and precludes the use
manufacturer can be required by other of symbol 5.1.3
adjacent to the authorities having with a date of
symbol. jurisdiction. manufacture
NOTE 2 For use in
Europe the full definition
of “manufacturer” is
given in EU Regulations
2017/745 and
2017/746. Other
jurisdictions can have
unique definitions
...
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