SIST EN ISO 15223-1:2021/A1:2026

SLOVENSKI STANDARD
01-januar-2026
Medicinski pripomočki - Simboli za označevanje podatkov, ki jih mora zagotoviti
dobavitelj - 1. del: Splošne zahteve - Dopolnilo 1: Dodajanje opredeljenega izraza
za pooblaščenega zastopnika in sprememba simbola EC REP, ne da bi bil ta vezan
na točno določeno državo ali regijo (ISO 15223 1:2021/Amd 1:2025)
Medical devices - Symbols to be used with information to be supplied by the
manufacturer - Part 1: General requirements - Amendment 1: Addition of defined term for
authorized representative and modified EC REP symbol to not be country or region
specific (ISO 15223 1:2021/Amd 1:2025)
Medizinprodukte - Symbole zur Verwendung im Rahmen der vom Hersteller
bereitzustellenden Informationen - Teil 1: Allgemeine Anforderungen - Änderung 1 (ISO
15223 1:2021/Amd 1:2025)
Dispositifs médicaux - Symboles à utiliser avec les informations à fournir par le fabricant
- Partie 1: Exigences générales - Amendement 1: Ajout du terme défini représentant
autorisé (mandataire) et modification du symbole EC REP pour ne pas être spécifique
d’un pays ou d’une région (ISO 15223 1:2021/Amd 1:2025)
Ta slovenski standard je istoveten z: EN ISO 15223-1:2021/A1:2025
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 15223-1:2021/A1

NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2025
ICS 11.040.01; 01.080.20
English version
Medical devices - Symbols to be used with information to
be supplied by the manufacturer - Part 1: General
requirements - Amendment 1: Addition of defined term for
authorized representative and modified EC REP symbol to
not be country or region specific (ISO 15223 1:2021/Amd
1:2025)
Dispositifs médicaux - Symboles à utiliser avec les Medizinprodukte - Symbole zur Verwendung im
informations à fournir par le fabricant - Partie 1: Rahmen der vom Hersteller bereitzustellenden
Exigences générales - Amendement 1: Ajout du terme Informationen - Teil 1: Allgemeine Anforderungen -
défini représentant autorisé (mandataire) et Änderung 1 (ISO 15223 1:2021/Amd 1:2025)
modification du symbole EC REP pour ne pas être
spécifique d'un pays ou d'une région (ISO 15223
1:2021/Amd 1:2025)
This amendment A1 modifies the European Standard EN ISO 15223-1:2021; it was approved by CEN on 16 September 2024.

CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for
inclusion of this amendment into the relevant 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 amendment 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, Türkiye and United Kingdom.

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. 4
Annex ZB (informative)  Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/746 aimed to be
covered. 18

European foreword
This document (EN ISO 15223-1:2021/A1:2025) has been prepared by Technical Committee ISO/TC
210 "Quality management and corresponding general aspects for products with a health purpose
including 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 Amendment to the European Standard EN ISO 15223-1:2021 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by May 2026, and
conflicting national standards shall be withdrawn at the latest by May 2026.
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 has been prepared under a standardization request addressed to CEN and CENELEC by
the European Commission. The Standing Committee of the EFTA States subsequently approves these
requests for its Member States.
For the relationship with EU Legislation, see informative Annex ZA and ZB, which are an integral parts
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.
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, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 15223-1:2021/Amd 1:2025 has been approved by CEN-CENELEC as EN ISO 15223-
1:2021/A1:2025 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 M/575 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] and to system or process requirements including
those relating to quality management systems, risk management, post-market surveillance systems,
clinical investigations, clinical evaluation or post-market clinical follow-up.
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.
Where a definition in this standard differs from a definition of the same term set out in Regulation (EU)
2017/745, the differences shall be indicated in this Annex Z. For the purpose of using this standard in
support of the requirements set out in Regulation (EU) 2017/745, the definitions set out in this
Regulation prevail.
Where the European standard is an adoption of an International Standard, the scope of this standard
can differ from the scope of the European Regulation that it supports. As the scope of the applicable
regulatory requirements differ from nation to nation and region to region, the standard can only
support European regulatory requirements to the extent of the scope of the European regulation for
medical devices (EU) 2017/745).
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 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] and to system or process requirements including those relating to quality
management systems, risk management, post-market surveillance systems, clinical
investigations, clinical evaluation or post-market clinical follow-up
General Safety and
Clause(s) / sub-
Performance
clause(s)
Requirements of Remarks / Notes
Regulation (EU)
of this EN
2017/745
4 (c) 5.2.6 Partially covered: used to draw user’s attention
on the label to the safety information such as
5.2.7
warnings/precautions/contraindications only for
5.2.8
the aspects dealt with by these symbols placed in
5.3.1
the instructions for use or accompanying
5.3.2
information and of any residual risks and need
for training for users.
5.3.3
5.3.4
Not covered: does not provide further
5.3.5
information for safety about
5.3.6
warning/precautions/contraindications other
5.3.7
than the ones dealt with by these symbols, nor
5.3.8
training.
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
10.4.5 5.4.3 Partially covered: used to draw user’s attention
on the label to the safety information placed in
5.4.10
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 devices.
5.2.2
5.2.3
Not covered: Design, manufacture, and
5.2.4
packaging.
5.2.5
5.2.7
5.2.10
11.8 5.2.1 Covered: used as part of the label to distinguish
between identical sterile and non-sterile medical
5.2.3
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 information in the
5.4.4
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 information
5.4.4
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 and
5.1.10
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
regi
...