SIST EN ISO 15223-1:2017/oprA1:2019

Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016)

20200402JO- link to MDD,IVD, AIMD and M/023,M/252,M/295 removed. These links are included in the previous published version  EN ISO 15223-1:2016 - JT003045

Medizinprodukte - Bei Aufschriften von Medizinprodukten zu verwendende Symbole, Kennzeichnung und zu liefernde Informationen - Teil 1: Allgemeine Anforderungen (ISO 15223-1:2016)

Dispositifs médicaux - Symboles à utiliser avec les étiquettes, l'étiquetage et les informations à fournir relatifs aux dispositifs médicaux - Partie 1: Exigences générales (ISO 15223-1:2016)

Medicinski pripomočki - Simboli za označevanje medicinskih pripomočkov, označevanje in podatki, ki jih mora podati dobavitelj - 1. del: Splošne zahteve (ISO 15223-1:2016)

General Information

• Status: Not Published
• Public Enquiry End Date: 19-Dec-2019
• ICS: 01.080.20 - Graphical symbols for use on specific equipment
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: VAZ - Healthcare
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 07-Nov-2019
• Due Date: 26-Mar-2020
• Completion Date: 20-Dec-2019
• 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
• Directive: 90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Directive: 98/79/EC - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Mandate: M/252 - Standardization Mandate to CEN/CENELEC concerning the development of European standards relating to in vitro diagnostic medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN ISO 15223-1:2016/FprA11 - Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, including corrected version 2017-03)

Relations

• Amends: SIST EN ISO 15223-1:2017 - Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016)
• Effective Date: 01-Dec-2019

Overview

SIST EN ISO 15223-1:2017/oprA1:2019 is a European standard developed by CEN that specifies the symbols to be used with medical device labels, labelling, and supplier information. This standard aligns with the general requirements of ISO 15223-1:2016 and its corrected version 2017-03. It ensures consistent usage of graphical symbols to convey essential information about medical devices, improving communication, safety, and compliance with regulatory frameworks.

This standard supports manufacturers, regulatory bodies, and healthcare providers by providing a unified approach to medical device labelling, ensuring that symbols are clearly understood across different languages and regions. The standard plays a crucial role in harmonizing medical device information under the EU Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746.

Key Topics

• Graphical Symbols: Defines the set of internationally recognized symbols for use on medical device labels and packaging.
• General Requirements: Covers the criteria for symbol design, clarity, and usage without extensive text descriptions.
• Labelling and Information: Specifies the obligations of suppliers in providing symbols alongside relevant device information.
• Compliance Alignment: Supports conformity with EU regulations MDR 2017/745 and IVDR 2017/746.
• Sterility and Handling: Includes symbols for sterilization methods, single-use indication, fragility, temperature limits, and storage conditions.
• Risk Communication: Symbols are used to highlight safety information such as warnings, precautions, risks, and limitations related to device usage.
• Manufacturer Identification: Uses symbols for lot number, serial number, manufacturing and expiry dates, authorized representatives, and place of business.
• User Clarity: Emphasizes creating easily understandable labels to minimize misunderstandings, increase safety, and improve device traceability.

Applications

• Medical Device Manufacturing: Enables manufacturers to apply standardized symbols on device labels and packaging, ensuring global regulatory compliance and ease of use.
• Regulatory Submissions: Facilitates meeting labelling requirements for CE marking under European medical device and in vitro diagnostic regulations.
• Healthcare Communication: Enhances user comprehension of device handling, sterilization status, usage limitations, and precautions without language barriers.
• Quality Management Systems: Supports quality control in labelling consistent with ISO/TC 210 standards related to medical devices.
• Inventory and Supply Chain: Enables better identification and traceability of devices through standardized lot and serial number symbols.
• International Trade: Streamlines medical device import/export by using universally recognized symbols accepted across various jurisdictions.

Related Standards

• ISO 15223-1:2016: The foundational international standard on medical device symbols incorporated fully by EN ISO 15223-1.
• Regulation (EU) 2017/745 (MDR): Defines requirements for medical devices within the European Union that this standard supports.
• Regulation (EU) 2017/746 (IVDR): European regulation for in vitro diagnostic devices, with which the symbols standard aids compliance.
• ISO/TC 210 Series: Technical standards under ISO focusing on quality management and corresponding aspects of medical devices.
• Other Labeling Standards: Standards governing device identification, traceability, and user instructions complementing symbol usage.

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By adopting SIST EN ISO 15223-1:2017/oprA1:2019, organizations in the medical device sector ensure consistent, clear, and compliant labeling practices, critical for patient safety, regulatory acceptance, and effective global communication in healthcare environments.

Standards Content (Sample)

SLOVENSKI STANDARD
01-december-2019
Medicinski pripomočki - Simboli za označevanje medicinskih pripomočkov,
označevanje in podatki, ki jih mora podati dobavitelj - 1. del: Splošne zahteve (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)
Medizinprodukte - Bei Aufschriften von Medizinprodukten zu verwendende Symbole,
Kennzeichnung und zu liefernde Informationen - Teil 1: Allgemeine Anforderungen (ISO
15223-1:2016)
Dispositifs médicaux - Symboles à utiliser avec les étiquettes, l'étiquetage et les
informations à fournir relatifs aux dispositifs médicaux - Partie 1: Exigences générales
(ISO 15223-1:2016)
Ta slovenski standard je istoveten z: EN ISO 15223-1:2016/prA1
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
DRAFT
EN ISO 15223-1:2016
NORME EUROPÉENNE
EUROPÄISCHE NORM
prA1
October 2019
ICS 01.080.20; 11.040.01
English version
Medical devices - Symbols to be used with medical device
labels, labelling and information to be supplied - Part 1:
General requirements (ISO 15223-1:2016)
Dispositifs médicaux - Symboles à utiliser avec les Medizinprodukte - Bei Aufschriften von
étiquettes, l'étiquetage et les informations à fournir Medizinprodukten zu verwendende Symbole,
relatifs aux dispositifs médicaux - Partie 1: Exigences Kennzeichnung und zu liefernde Informationen - Teil
générales (ISO 15223-1:2016) 1: Allgemeine Anforderungen (ISO 15223-1:2016)
This draft amendment is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee
CEN/CLC/JTC 3.
This draft amendment A1, if approved, will modify the European Standard EN ISO 15223-1:2016. If this draft becomes an
amendment, 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.

This draft amendment was established by CEN and CENELEC 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.

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.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.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.

EN ISO 15223-1:2016/prA1:2019 (E)
Contents Page
European foreword . 3
Annex ZD (informative) Relationship between this European standard and the
requirements of Regulation (EU) 2017/745 aimed to be covered . 4
Annex ZE (informative) Relationship between this European standard and the
requirements of Regulation (EU) 2017/746 aimed to be covered . 9
EN ISO 15223-1:2016/prA1:2019 (E)
European foreword
The text of ISO 15223-1:2016 has been prepared by Technical Committee ISO/TC 210 “Quality
management and corresponding general aspects for medical devices” of the International Organization
for Standardization (ISO) and has been taken over as EN ISO 15223-1:2016/prA1:2019 by Technical
Committee CEN/CLC/TC 3 “Quality management and corresponding general aspects for medical
devices” the secretariat of which is held by NEN.
This document is currently submitted to the CEN Enquiry.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZD and ZE, which are an integral part of
this document.
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”, 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
Endorsement notice
The text of ISO 15223-1:2016 has been approved by CEN as EN ISO 15223-1:/prA1:2019 without any
modification.
EN ISO 15223-1:2016/prA1:2019 (E)

Annex ZD
(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 M/xxx 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 ZD.1 – Correspondence between this European standard and Annex I of Regulation
(EU) 2017/745 [OJ L 117]
General Safety and
Performance Requirements Clause(s) / sub-clause(s)
Remarks / Notes
of Regulation (EU) of this EN
2017/745
4 (c) 5.4.4 Partially covered: used to draw user’s
attention on the labelling to the
safety information placed in the
instructions for use and of any
residual risks and need for training
for users.
Not covered: does not provide
further information for safety nor
training.
5.4.4 Partially covered: used on labelling to
10.4.5
alert users to the presence of
substances that are carcinogenic,
mutagenic, toxic to reproduction
EN ISO 15223-1:2016/prA1:2019 (E)
and/or having endocrine-disrupting
properties.
5.2.1 Partially covered: used as part of the
11.3
5.2.2 labelling to identify sterile or non-
5.2.3 sterile products.
5.2.4 Not covered: Design, manufacture
5.2.5 and packaging.
5.2.7
11.8 5.2.1 Partially covered: used as part of the
5.2.7 labelling to identify sterile or non-
sterile products.
Not covered: the additional labelling
required to distinguish between
identical or similar sterile and non-
sterile product.
22.1 5 Partially covered: used to convey
specific labelling 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 5.1.1 Partially covered: used as part of the
labelling information to identify the
manufacturer and registered place of
business (address).
Not covered: the information needed
to identify the device and its
manufacturer, safety and
performance information.
23.1 (a) 5 Partially covered: used to convey
labelling information in a format that
is easy to understand.
Not covered: the medium, format,
content, legibility and location of the
label and instructions for use; 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
labelling information directly on a
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 device;
which information can be placed on
the device or the packaging.
23.1 (c) 5 Partially covered: used to provide
labelling information in a human
readable format that would be
otherwise impracticable by use of
text.
Not covered: machine-readable
information.
23.1 (g) 5.4.4 Partially covered: may be used to
draw user’s attention on the labelling
to the safety information concerning
limitation, contra-indications,
precautions or warnings.
EN ISO 15223-1:2016/prA1:2019 (E)
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
5 information in combination with risk

management. Symbols addressed in
5.1 are used on labelling without a
description of the symbol in the
instructions for use to convey
information.
Not covered: the use of other
symbols will require a description of
the symbol in the instructions for
use.
5.1.6
23.2, (b) Partially covered: used as part of the
5.1.7
labelling information to identify the
device and the packaging contents.
Not covered: the intended purpose of
the device.
23.2 (c) 5.1.1 Partially covered: used as part of the
labelling information to identify the
manufacturer and registered place of
business (address).
Not covered: the trade name or
registered trademark.
5.1.2 Covered: used as part of the labelling
23.2 (d)
information to identify the
authorised representative and
registered place of business
(address).
23.2, (f) 5.4.4 Partially covered: used on labelling to
alert users to the presence of
substances that are carcinogenic,
mutagenic, toxic to reproduction
and/or having endocrine-disrupting
properties.
23.2 (g) 5.1.5 Covered: symbol used to replace the
words ‘LOT NUMBER’.
23.2 (g) 5.1.7 Covered: this symbol used to replace
the words ‘SERIAL NUMBER’.
23.2 (i) 5.1.4 Covered: this symbol used to indicate
the time limit information for use or
implant of the device, accompanied
by the date (at least year and month).
23.2 (j) 5.1.3 Covered: this symbol used to indicate
the date of manufacture information
for the device, accompanied by the
date (that will be clearly identifiable).
5.3.1 Covered: this symbol used to indicate
23.2 (k)
that the device is fragile.
5.3.2 Covered: this symbol used to indicate
23.2 (k)
that the device needs protection from
sunlight and other light sources.
5.3.3 Covered: this symbol used to indicate
23.2 (k)
that the device needs protection from
heat and radioactive sources.
5.3.4 Covered: this symbol used to indicate
23.2 (k)
that the device needs protection from
moisture.
5.3.5 Covered: this symbol used to indicate
23.2 (k)
the lower limit of temperature that
the device may be safely exposed to,
accompanied by the temperature
EN ISO 15223-1:2016/prA1:2019 (E)
value.
5.3.6 Partially covered: this symbol used to
23.2 (k)
indicate the upper limit of
temperature that the device may be
safely exposed to, accompanied by
the temperature value.
5.3.7 Partially covered: this symbol used to
23.2 (k)
indicate the upper and lower limits of
temperature that the device may be
safely exposed to, accompanied by
the upper and lower temperature
values.
5.3.8 Partially covered: this symbol used to
23.2 (k)
indicate the upper and lower limits of
humidity that the device may be
safely exposed to. It will be
accompanied by the upper and lower
humidity values.
5.3.9 Partially covered: this symbol used to
23.2 (k)
indicate the upper and lower limits of
pressure that the device may be
safely exposed to, accompanied by
the upper and lower pressure values.
23.2 (l) 5.2.1 Partially covered: used to indicate
that a device is sterile.
Not covered: the method of
sterilization is not specified (see
symbols 5.2.2, 5.2.3, 5.2.4, 5.2.5).
23.2 (l) 5.2.2 Covered: used on the labelling to
5.2.3 specify an indication of the device’s
5.2.4 sterile state and the method of
sterilization.
23.2 (l) 5.2.5 Partially covered: used to indicate
that a device is heat-sterilized.
Not covered: the method of
sterilization (dry heat, moist heat).
23.2 (m) 5.4.3 Partially covered: used to draw user’s
attention on the labelling to the more
detailed warnings or precautions
found in the instructions for use.
Not covered: warnings or
precautions.
23.2 (n) 5.4.2 Covered: used to specify on the
labelling that the device is intended
for single use.
23.2 (s) 5.1.5 Covered: this symbol used to replace
the words ‘LOT NUMBER’.
23.2 (s) 5.1.7 Covered: this symbol used to replace
the words ‘SERIAL NUMBER’.
23.3 (b) 5.2.1 Covered; used as part of the labelling
5.2.2 to identify the device is sterile.
5.2.3
5.2.4
5.2.5
23.3 (c) 5.2.2 Covered: used to specify on the
5.2.3 labelling the method of sterilization.
5.2.4
23.3 (c) 5.2.5 Partially covered: used to indicate
that a device is heat-sterilized.
Not covered: the method of
sterilization (dry heat, moist heat).
23.3 (d) 5.1.1 Co
...