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

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ISO/DIS 15223-1:2020(E)
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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

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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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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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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

ISO 20417:----1, 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.
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— 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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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
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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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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
<medical device, accessory> 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
<medical device, accessory> 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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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.

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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
symbol graphic date a
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.
NOTE 3 The date of
manufacture, as well as
the name and address of
the manufacturer, can be
combined in one symbol.
 Reference Title of symbol Description of Requirements Informative notes Restrictions of Additional Symbol
number of symbol use requirements number /
symbol and registration
symbol graphic date a
5.1.2. Authorized Indicates the This symbol shall NOTE 1 This symbol is N/A
representative authorized be accompanied, used to indicate
in the representative in adjacent to the information that is
European the European symbol, by the required in the European
EC REP Community / Community / name and address Community / European
European European Union. of the authorized Union.
Union representative. NOTE 2 Additional
For other guidance can be found in
locations that EN 1041, ISO 18113-1,
require ISO 18113-2, ISO
identification of 18113-3, ISO 18113-4
the authorized and ISO 18113-5.
representative, a NOTE 3 If multiple
manufacturer may symbols (i.e., Authorized
replace the letters Representative,
EC with the two or Importer, Distributor,
three letter Translation, or
country code for Repackaging) identify
that location. the same responsible
entity, the name and
address need not be
duplicated and all
applicable symbols may
be grouped together next
to the single address.
 Reference Title of symbol Description of Requirements Informative notes Restrictions of Additional Symbol
number of symbol use requirements number /
symbol and registration
symbol graphic date a
5.1.3. Date of Indicates the This symbol shall The use of this ISO 7000-2497
manufacture date when the be accompanied symbol precludes 2004-01-15
medical device by a date to the use of symbol
was indicate the date 5.1.11 with a date
manufactured. of manufacture. of manufacture
This shall be
expressed in
accordance with
ISO 8601-1.
The date shall be
located adjacent to
the symbol.
5.1.4. Use-by date Indicates the This symbol shall NOTE Synonym for ISO 7000-2607
date after which be accompanied “use-by date” is “use by”. 2004-01-15
the medical by a date to
device is not to indicate that the
be used. medical device
should not be used
after the end of the
year, month or day
shown.
The date shall be
expressed in
accordance with
ISO 8601-1.
The date shall be
located adjacent to
the symbol.
 Reference Title of symbol Description of Requirements Informative notes Restrictions of Additional Symbol
number of symbol use requirements number /
symbol and registration
symbol graphic date a
5.1.5. Batch code Indicates the This symbol shall NOTE Synonyms for ISO 7000-2492
manufacturer’s be accompanied “batch code” are “lot 2004-01-15
batch code so by the number” and “batch
that the batch or manufacturer’s number”.
lot can be batch code. The
identified. batch code shall be
adjacent to the
symbol.

5.1.6. Catalogue Indicates the The NOTE Synonyms for The ISO 7000-2493
number manufacturer’s manufacturer’s “catalogue number” are manufacturer’s 2004-01-15
catalogue catalogue number “reference number” and catalogue number
number so that shall be adjacent “reorder number”. shall be placed
the medical to the symbol. after or below the
device can be symbol and
identified. adjacent to it.

5.1.7. Serial number Indicates the This symbol shall The ISO 7000-2498
manufacturer’s be accompanied manufacturer's 2004-01-15
serial number so by the serial number
that a specific manufacturer’s shall be placed
medical device serial number. The after or below the
can be identified. serial number shall symbol and
be adjacent to the adjacent to it.
symbol.
 Reference Title of symbol Description of Requirements Informative notes Restrictions of Additional Symbol
number of symbol use requirements number /
symbol and registration
symbol graphic date a
5.1.8. Importer Indicates the This symbol shall NOTE If multiple ISO 7000-3725
entity importing be accompanied symbols (i.e., Authorized 2019-11-01
the medical by the name and Representative,
device into the address of the Importer, Distributor,
locale importing entity, Translation, or
adjacent to the Repackaging) identify
symbol the same responsible
entity, the name and
address need not be
duplicated.

5.1.9. Distributor Indicates the This symbol shall NOTE If multiple ISO 7000-3724
entity be accompanied symbols (i.e., Authorized 2019-11-01
distributing the by the name and Representative,
medical device address of the Importer, Distributor,
into the locale distributing entity Translation, or
adjacent to the Repackaging) identify
symbol the same responsible
entity, the name and
address need not be
duplicated.
5.1.10. Model number To identify the This symbol shall ISO 7000-6050
model number be accompanied 2012-07-14
or type number by the model
of a product number of the
product, adjacent
to the symbol.
 Reference Title of symbol Description of Requirements Informative notes Restrictions of Additional Symbol
number of symbol use requirements number /
symbol and registration
symbol graphic date a
5.1.11. Country of To identify the In the application NOTE Not all The use of this ISO 7000-6049
manufacture country of of this symbol, the authorities with symbol with a date 2012-07-14
manufacture of "CC" shall be jurisdiction recognize of manufacture
products replaced by either the two letter or three precludes the use
the two letter letter country codes of symbol 5.1.3
country code or found in ISO 3166-1.
the three letter
country code
defined in ISO
3166-1.
The date of
manufacture may
be added adjacent
to this symbol.
5.2. Sterility
5.2.1. Sterile Indicates a Use of this symbol ISO 7000-2499
medical device precludes the use 2004-01-15
that has been of symbols 5.2.2 to
subjected to a 5.2.5 or 5.2.10.
sterilization
process.

5.2.2. Sterilized using Indicates a NOTE Aseptic Use of this symbol ISO 7000-2500
aseptic medical device techniques can include precludes the use 2004-01-15
processing that has been filtration. of symbol 5.2.1.
techniques manufactured
using accepted
aseptic
techniques.
 Reference Title of symbol Description of Requirements Informative notes Restrictions of Additional Symbol
number of symbol use requirements number /
symbol and registration
symbol graphic date a
5.2.3. Sterilized using Indicates a Use of this symbol ISO 7000-2501
ethylene oxide medical device precludes the use 2004-01-15
that has been of symbol 5.2.1.
sterilized using
ethylene oxide.

5.2.4. Sterilized using Indicates a Use of this symbol ISO 7000-2502

irradiation medical device precludes the use 2004-01-15
that has been of symbol 5.2.1.
sterilized using
irradiation.

5.2.5. Sterilized using Indicates a Use of this symbol ISO 7000-2503

steam or dry medical device precludes the use 2004-01-15
heat that has been of symbol 5.2.1.
sterilized using
steam or dry
heat.
 Reference Title of symbol Description of Requirements Informative notes Restrictions of Additional Symbol
number of symbol use requirements number /
symbol and registration
symbol graphic date a
5.2.6. Do not Indicates a This symbol is ISO 7000-2608
resterilize medical device only to be used 2004-01-15
that is not to be when there is an
resterilized. accompanying
Sterile symbol
(5.2.1 to 5.2.5 or
5.2.10).
This symbol is not
to be used on
reusable medical
devices that are
intended to be
sterilized between
uses.
5.2.7. Non-sterile Indicates a This symbol ISO 7000-2609
medical device should only be 2004-01-15
that has not been used to
subjected to a distinguish
sterilization between identical
process. or similar medical
devices sold in
both sterile and
non-sterile
conditions.
 Reference Title of symbol Description of Requirements Informative notes Restrictions of Additional Symbol
number of symbol use requirements number /
symbol and registration
symbol graphic date a
5.2.8. Do not use if Indicates a NOTE 1 This symbol ISO 7000-2606
package is medical device may also mean “Do not 2004-01-15
damaged and that should not use if the product sterile
consult be used if the barrier system or its
instructions for package has packaging is
use been damaged or compromised:.
opened and that NOTE 2 For products
the user should which do not have
consult the instructions for use, the
instructions for recommendation to
use for additional consult them does not
information. apply.
5.2.9. Sterile fluid Indicates the The method of ISO 7000-3084
path presence of a sterilization shall 2011-10-05
sterile fluid path be indicated in the
within the empty box, as
medical device in appropriate.
cases when other The part of the
parts of the medical device that
medical device, is sterile shall be
including the identified in the
exterior, might information
not be supplied supplied by the
sterile. manufacturer.
5.2.10. Sterilized using Indicates a NOTE 1 This symbol can Use of this symbol N/A
vaporized medical device be used to indicate that precludes the use
hydrogen that has been the product has been of symbol 5.2.1.
peroxide sterilized using subjected to vapour
vaporized phase hydrogen
hydrogen peroxide processes.
peroxide NOTE 2 The use of this
symbol in Europe is
explained in EN 556-1,
clause 4.1 and the
associated note.
 Reference Title of symbol Description of Requirements Informative notes Restrictions of Additional Symbol
number of symbol use requirements number /
symbol and registration
symbol graphic date a
5.2.11. Single sterile Indicates a single This symbol shall NOTE 1 A solid line ISO 7000-3707
barrier system sterile barrier be placed adjacent identifies a sterile barrier 2019-10-18
system to or in system.
combination with NOTE 2 Additional
symbol 5.2.1, 5.2.2, information on sterile
5.2.3, 5.2.4, 5.2.5, barrier systems can be
5.2.9 or 5.2.10 found in ISO 11607-1
and ISO 11607-2.
5.2.12. Double sterile Indicates two This symbol shall NOTE 1 A solid line ISO 7000-3704
barrier system sterile barrier be placed adjacent indicates a sterile barrier
2019-10-18
systems to or in system.
combination with NOTE 2 Additional
symbol 5.2.1, 5.2.2, information on sterile
5.2.3, 5.2.4, 5.2.5, barrier systems can be
5.2.9 or 5.2.10 found in ISO 11607-1
and ISO 11607-2.
5.2.13. Single sterile Indicates a single This symbol shall NOTE 1 The protective ISO 7000-3708
barrier system sterile barrier be placed adjacent packaging located inside 2019-10-18
with protective system with to or in the sterile barrier system
packaging protective combination with is designed to prevent
inside packaging inside symbol 5.2.1, 5.2.2, damage to the contents
5.2.3, 5.2.4, 5.2.5, or to help with aseptic
5.2.9 or 5.2.10 presentation. It does not
provide a microbial
barrier to maintain
sterility.
NOTE 2 Additional
information on sterile
barrier systems can be
found in ISO 11607-1
and ISO 11607-2.
 Reference Title of symbol Description of Requirements Informative notes Restrictions of Additional Symbol
number of symbol use requirements number /
symbol and registration
symbol graphic date a
5.2.14. Single sterile Indicates a single This symbol shall NOTE 1 The protective ISO 7000-3709
barrier system sterile barrier be placed adjacent packaging located 2019-10-18
with protective system with to or in outside the sterile
packaging protective combination with barrier system is
outside packaging symbol 5.2.1, 5.2.2, designed to prevent
outside 5.2.3, 5.2.4, 5.2.5, damage to the sterile
5.2.9 or 5.2.10 barrier system and the
contents. The protection
can be against physical
hazards, particulate
contamination or other
environmental hazards,
but it does not include a
microbial barrier.
NOTE 2 Additional
information on sterile
barrier systems can be
found in ISO 11607-1
and ISO 11607-2.
5.3. Storage
5.3.1. Fragile, handle Indicates a ISO 7000-0621
with care medical device 2014-06-04
that can be
broken or
damaged if not
handled
carefully.
 Reference Title of symbol Description of Requirements Informative notes Restrictions of Additional Symbol
number of symbol use requirements number /
symbol and registration
symbol graphic date a
5.3.2. Keep away Indicates a ISO 7000-0624
from sunlight medical device 2014-06-04
that needs
protection from
light sources.

5.3.3. Protect from Indicates a NOTE This symbol can ISO 7000-0615
heat and medical device also mean protect from 2004-01-15
radioactive that needs sunlight and radioactive
sources protection from sources.
heat and
radioactive
sources.

5.3.4. Keep dry Indicates a NOTE This symbol can ISO 7000-0626
medical device also mean “Keep away 2014-06-04
that needs to be from rain” as referenced
protected from in ISO 7000.
moisture.

5.3.5. Lower limit of Indicates the The lower limit of ISO 7000-0534
temperature lower limit of temperature shall 2004-01-15
temperature to be indicated
which the adjacent to the
medical device lower horizontal
can be safely line.
exposed.
 Reference Title of symbol Description of Requirements Informative notes Restrictions of Additional Symbol
number of symbol use requirements number /
symbol and registration
symbol graphic date a
5.3.6. Upper limit of Indicates the The upper limit of ISO 7000-0533
temperature upper limit of temperature shall 2004-01-15
temperature to be indicated
which the adjacent to the
medical device upper horizontal
can be safely line.
exposed.

5.3.7. Temperature Indicates the The upper and ISO 7000-0632

limit temperature lower limits of 2014-06-04
limits to which temperature shall
the medical be indicated
device can be adjacent to the
safely exposed. upper and lower
horizontal lines.

5.3.8. Humidity Indicates the The humidity ISO 7000-2620

limitation range of limitation shall be 2004-01-15
humidity to indicated adjacent
which the to the upper and
medical device lower horizontal
can be safely lines.
exposed.

5.3.9. Atmospheric Indicates the The atmospheric ISO 7000-2621

pressure range of pressure 2004-01-15
limitation atmospheric limitations shall be
pressure to indicated adjacent
which the to the upper and
medical device lower horizontal
can be safely lines.
exposed.

5.4. Safe use

 Reference Title of symbol Description of Requirements Informative notes Restrictions of Additional Symbol
number of symbol use requirements number /
symbol and registration
symbol graphic date a
5.4.1. Biological risks Indicates that NOTE This ISO 7000-0659
there are symbol is not to be 2004-01-15
potential confused with the
biological risks “Biological hazard”
associated with sign ISO 7010-
the medical W009..
device.

5.4.2. Do not re-use Indicates a NOTE Synonyms for “Do ISO 7000-1051
medical device not re-use” are “single 2004-01-15
that is intended use” and “use only once”.
for one single use
only.

5.4.3. Consult Indicates the NOTE 1 Synonym for See A.15 for ISO 7000-1641
instructions for need for the user “Consult instructions for examples and 2004-01-15
use or consult to consult the use” is “Consult for use in
electronic instructions for operating instructions”. directing users
instructions for use. NOTE 2 See also ISO to consult the
use 20417:2020 and the electronic
safety sign ISO 7010- instructions for
M002 use.
 Reference Title of symbol Description of Requirements Informative notes Restrictions of Additional Symbol
number of symbol use requirements number /
symbol and registration
symbol graphic date a
5.4.4. Caution To indicate that The symbol variant ISO 7000-
caution is ISO 7000-0434B 0434A
necessary when (“Caution”) may be 2004-01-15
operating the used.
device or control
close to where
the symbol is
placed, or to
indicate that the
current situation
needs operator
awareness or
operator action
in order to avoid
undesirable
consequences.
5.4.5. Contains or Indicates the NOTE This symbol is This symbol Application of
presence of presence of dry intended to warn those should not be ISO 7000,
natural rubber natural rubber people who can have used for medical symbol 2725
latex or natural allergic reactions to devices containing 2005-09-08
rubber latex as a certain latex proteins. “synthetic
material of rubber”.
construction
within the
medical device or
the packaging of
a medical device.
5.4.6. Contains Indicates a The embedded ISO 7000-3701
human blood medical device cross may be 2010-10-18
or plasma that contains or deleted or
derivatives incorporates replaced with
human blood or another element
plasma appropriate with
derivatives. cultural
requirements
 Reference Title of symbol Description of Requirements Informative notes Restrictions of Additional Symbol
number of symbol use requirements number /
symbol and registration
symbol graphic date a
5.4.7. Contains a Indicates a The embedded ISO 7000-3702
medicinal medical device cross may be 2019-10-18
substance that contains or deleted or
incorporates a replaced with
medicinal another element
substance appropriate with
cultural
requirements
5.4.8. Contains Indicates a ISO 7000-3699
biological medical device 2019-10-18
material of that contains
animal origin biological tissue,
cells, or their
derivatives, of
animal origin

5.4.9. Contains Indicates a ISO 7000-3700

biological medical device 2019-10-18
material of that contains
human origin biological tissue,
cells, or their
derivatives, of
human origin
 Reference Title of symbol Description of Requirements Informative notes Restrictions of Additional Symbol
number of symbol use requirements number /
symbol and registration
symbol graphic date a
5.4.10. Contains Indicates a ISO 7000-3723
hazardous medical device 2019-11-01
substances that contains
substances that
can be
carcinogenic,
mutagenic,
reprotoxic
(CMR), or
substances with
endocrine
disrupting
properties
5.4.11. Contains nano Indicates a ISO 7000-3703
materials medical device 2019-10-18
that contains
nano materials

5.4.12. Single patient Indicates a ISO 7000-3706

multiple use medical device 2019-10-18
that may be used
multiple times
(multiple
procedures) on a
single patient
 Reference Title of symbol Description of Requirements Informative notes Restrictions of Additional Symbol
number of symbol use requirements number /
symbol and registration
symbol graphic date a
5.5. IVD-specific
5.5.1. In vitro Indicates a This symbol N/A
diagnostic medical device should only be
medical device that is intended used to identify in
to be used as an vitro diagnostic
in vitro medical devices or
diagnostic their accessories
medical device. and not to specify
that the medical
device is for “in
vitro use”.
5.5.2. Control Indicates a NOTE For negative N/A
control material controls, use symbol 5.5.3
that is intended and for positive controls
to verify the use symbol 5.5.4
performance of
another medical
device.

5.5.3. Negative Indicates a ISO 7000-2495

control control material 2004-01-15
that is intended
to verify the
results in the
expected
negative range.
 Reference Title of symbol Description of Requirements Informative notes Restrictions of Additional Symbol
number of symbol use requirements number /
symbol and registration
symbol graphic date a
5.5.4. Positive control Indicates a ISO 7000-2496
control material 2004-01-15
that is intended
to verify the
results in the
expected
positive range.

5.5.5. Contains Indicates the The number of ISO 7000-

sufficient for total number of tests that can be 0518
<n> tests IVD tests that performed with 2004-01-15
can be the IVD medical
performed with device shall appear
the IVD medical adjacent to the
device. symbol.

5.5.6. For IVD Indicates an IVD NOTE 1 A synonym is This symbol shall ISO 7000-3083
performance medical device “IVD for investigational not appear jointly 2011-10-03
evaluation only that is intended use only”. with symbol 5.5.1
to be used only NOTE 2 A medical which means that
for evaluating its device that is for IVD the medical device
performance performance evaluation is an in vitro
characteristics only is not intended to diagnostic medical
before it is be used for an in vitro device intended by
placed on the diagnostic examination the manufacturer
market for for medical purposes (i.e. to be used for an
medical to yield diagnostic in vitro diagnostic
diagnostic use. results). examination.
 Reference Title of symbol Description of Requirements Informative notes Restrictions of Additional Symbol
number of symbol use requirements number /
symbol and registration
symbol graphic date a
5.6. Transfusion/infusion
5.6.1. Sampling site Indicates a NOTE This is not to be ISO 7000-2715
medical device or associated with a site on 2005-09-08
blood processing a patient where samples
application that are taken.
includes a
system
dedicated to the
collection of
samples of a
given substance
stored in the
medical device or
blood container.
5.6.2. Fluid path Indicates the ISO 7000-2722
presence of a 2005-09-08
fluid path.

5.6.3. Non-pyrogenic Indicates a ISO 7000-2724

medical device 2005-09-08
that is non-
pyrogenic.
 Reference Title of symbol Description of Requirements Informative notes Restrictions of Additional Symbol
number of symbol use requirements number /
symbol and registration
symbol graphic date a
5.6.4. Drops per Indicates the NOTE The number of ISO 7000-2726
millilitre number of drops drops per millilitre is 2005-09-08
per millilitre. specified; 20 is shown as
an example and will be
replaced by the
appropriate number of
drops per millilitre.

5.6.5. Liquid filter Indicates an NOTE The nominal pore ISO 7000-2727
with pore size infusion or size of the filter is 2005-09-08
transfusion specified; 15 is shown as
system of the an example and will be
medical device replaced by the
that contains a appropriate pore size.
filter of a
particular
nominal pore
size.

5.6.6. One-way valve Indicates a NOTE It is important for ISO 7000-2728

medical device the user to know that the 2005-09-08
with a valve that flow is only possible in
allows flow in one direction and cannot
only one be reversed.
direction.
 Reference Title of symbol Description of Requirements Informative notes Restrictions of Additional Symbol
number of symbol use requirements number /
symbol and registration
symbol graphic date a
5.7. Others
5.7.1. Patient number Indicates a NOTE 1 The hash mark ISO 7000-2610
unique number (#) is part of the symbol. 2004-01-15
associated with The patient number
an individual appears adjacent to the
patient. symbol.
NOTE 2 Usage is to
indicate a data entry
field (e.g. medical device
input screen or implant
card) or in information
provided to the patient.
5.7.2. Patient name Indicates the NOTE Usage is to ISO 7000-3726
name of the indicate a data entry 2019-11-01
patient field (e.g. medical device
input screen or implant
card) or in information
provided to the patient.

5.7.3. Patient Indicates the NOTE Usage is to ISO 7000-5664

identification identification indicate a data entry 2002-10-07
data of the field (e.g. medical device
patient input screen or implant
card) or in information
provided to the patient
 Reference Title of symbol Description of Requirements Informative notes Restrictions of Additional Symbol
number of symbol use requirements number /
symbol and registration
symbol graphic date a
5.7.4. Patient Indicates a This symbol shall NOTE Usage is to ISO 7000-3705
information website where a be accompanied indicate location of 2019-10-18
website patient can by the web information available to
obtain additional address adjacent the patient
information on to the symbol
the medical
product

5.7.5. Health care To indicate the This symbol shall NOTE 1 The embedded ISO 7001
centre or address of the be accompanied, cross can be deleted or PI PF 044
doctor health care adjacent to the replaced with another
2013-05-31
centre or doctor symbol, by the element appropriate
where medical address of the with cultural
information health care centre requirements.
about the patient or doctor NOTE 2 Usage is to
may be found indicate a data entry
field (e.g. medical device
input screen or implant
card) or in information
provided to the patient
5.7.6. Date To identify the This symbol shall NOTE Usage is to ISO 7000-5662
date that be accompanied, indicate a data entry 2002-10-07
information was adjacent to the field (e.g. medical device
entered or a symbol, by the date input screen or implant
medical appropriate for card) or in information
procedure took the use of the provided to the patient
place symbol
 Reference Title of symbol Description of Requirements Informative notes Restrictions of Additional Symbol
number of symbol use requirements number /
symbol and registration
symbol graphic date a
5.7.7. Medical device Indicates the N/A
item is a medical
device

5.7.8. Translation To identify that This symbol shall NOTE If multiple This symbol shall ISO 7000-3728
the original be accompanied symbols (i.e., Authorized only be used 2019-11-01
medical device by the name and Representative, when the
information has address of the Importer, Distributor, translation
undergone a entity that is Translation, or activity was
translation responsible for the Repackaging) identify undertaken by
which translation the same responsible someone other
supplements or activity, adjacent entity, the name and than the
replaces the to the symbol. address need not be manufacturer.
original duplicated.
information
 Reference Title of symbol Description of Requirements Informative notes Restrictions of Additional Symbol
number of symbol use requirements number /
symbol and registration
symbol graphic date a
5.7.9. Repackaging To identify that a This symbol shall NOTE 1 Depending on This symbol shall ISO 7000-3727
modification to be accompanied the authority having only be used 2019-11-01
the original by the name and jurisdiction, additional when the
medical device address of the information (i.e. date of repackaging
packaging entity that is repackaging) can be activity was
configuration responsible for the needed. undertaken by
has occurred repackaging someone other
activity, adjacent NOTE 2 If multiple than the
to the symbol symbols (i.e., Authorized manufacturer.
Representative,
Importer, Distributor,
Translation, or
Repackaging) identify
the same responsible
entity, the name and
address need not be
duplicated.

5.7.10. Unique Device Indicates a The use of this NOTE Used to identify N/A
Identifier carrier that symbol is optional, which information is
contains Unique but may be used associated with Unique
Device Identifier when multiple Device Identifier
information data carriers are
present on the
label. If used, this
symbol shall be
placed adjacent to
the Unique Device
Identifier carrier.
a
Each symbol in the ISO/IEC symbols database (available at https://www.iso.org/obp/ui) has a “registration date”. This date is shown below the
Symbol number.
 3 Annex A
4 (informative)
5
6 Examples
7

8 NOTE These examples show the requested information (e.g. Name, Address, Date, etc.) either to the right side of the
9 symbol or below it. If the association between the symbol and the requested information is unambiguous, a manufacturer may
10 choose to put the requested information to the left or above the symbol.

11 A.1 Examples of use of symbol 5.1.1, “Manufacturer”

Name
Address

Name
Address

12 A.2 Examples of use of symbol 5.1.1, “Manufacturer”, combined with

13 5.1.3, “Date of manufacture”

Name
Address
2019-12-01

Name
Address
2019-06

14 A.3 Example of use of symbol 5.1.2, “Authorized representative in the

15 European Community / European Union”
Examples for an
authorized
Name
representative in EC REP EC REP
the European Address
Community
Name
Address
16

Example for an Example for an

authorized Name authorized
ECU REP representative JP REP
representative Address
in Ecuador in Japan

Name
Address
17
18 A.4 Examples of use of symbol 5.1.3, “Date of manufacture”

2016-12-01

2016-06

19 A.5 Examples of use of symbol 5.1.4, “Use-by date”

2016-12-01

2016-06

20 A.6 Examples of use of symbol 5.1.5, “Batch code”

ABC123

ABC123

21 A.7 Examples of use of symbol 5.1.6, “Catalogue number”

ABC123

ABC123

22 A.8 Examples of use of symbol 5.1.7, “Serial number”

ABC123

ABC123

23 A.9 Examples of use of symbol 5.1.8, “Importer”

Name
Address

Name
Address
24

25 A.10 Examples of use of symbol 5.1.9, “Distributor”

Name
Address

Name
Address

26 A.11 Examples of use of symbol 5.1.11, “Country of manufacture”

27 NOTE CC is the two or three letter country code as defined in ISO 3166-1.

2019-06

2019-12-01

28

29 A.12 Examples of use of symbol 5.2.9 for “Sterile fluid path”

30
31 NOTE 1 Medical device contains a sterile fluid path that has been sterilized using ethylene oxide.

32
33 NOTE 2 Medical device contains a sterile fluid path that has been sterilized using irradiation.

34
35 NOTE 3 Medical device contains a sterile fluid path that has been sterilized using steam or dry heat.
36 A.13 Examples of use of symbols 5.3.5, 5.3.6 and 5.3.7 for temperature
37 limits

Upper limit of Lower limit of Temperature

temperature temperature limit

38 A.14 Examples of use of symbol 5.3.8, “Humidity limitation”

39 A.15 Example of use of symbol 5.3.9, “Atmospheric pressure limitation”

40

41 A.16 Example of use of symbol 5.4.3, “Consult instructions for use or

42 consult electronic instructions for use” for an electronic instruction for use
43 (eIFU)

eIFU
Indicator

eIFU Indicator
44

45 NOTE The eIFU indicator can be a manufacturer’s website URL or some other appropriate indication that the instructions
46 for use are available in an electronic format.

47 A.17 Examples of use of symbol 5.5.5, “Contains sufficient for <n> tests”
48 A.18 Example of use of symbol 5.7.1, “Patient number”

ABC123

ABC123

49

50 A.19 Examples of use of symbol 5.7.8, “Translation”

Name
Address

Name
Address

51 A.20 Examples of use of symbol 5.7.9, “Repackaging”

Name
Address

Name
Address

52 A.21 Examples of use of symbol 5.7.10, “Unique Device Identifier”

53

A.22 Explanation on how to deal with multiple symbols used together

The symbols EC REP, Importer, Distributor, Repackaging and Translation each have a note indicating
that when multiple symbols all apply to the same responsible entity, the name and address need not
be duplicated. The following shows some of the possible ways that may be accomplished.

The intent is for the name and address to be unambiguously associated with the symbols. Additional
graphical elements may be used for the association. Several additional graphical elements ae shown
below.

When two symbols apply, the symbols may appear grouped vertically or horizontally with the name
and address adjacent to the symbols [i.e. either above, below, to the left, or to the right].

Symbol Symbol Symbol

1 1 2

Symbol
2
Name
Address
Name
Symbol
Name 2 Address
Address

When three symbols apply, the symbols may appear grouped vertically or horizontally with the name
and address adjacent to the symbols [i.e. either above, below, to the left, or to the right].

Symbol Symbol Symbol Symbol

1 2 3 1

Name
Name Symbol Name
Symbol Address
Address 2
2 Address

Symbol
3
Symbol
3

When four or five symbols apply, the symbols may appear grouped in any convenient way that is
unambiguous, with the name and address adjacent to the symbols. [i.e. ether above, below, to the left,
to the right, or with the grouping].

Symbol Symbol
Symbol Symbol Symbol 1 2
1 3 4 Symbol Symbol Symbol Symbol
Name 1 2 3 4
Name Address
Symbol Symbol
2 Address 5 Symbol Symbol
Name, Address
3 4
54 Annex B
55 (informative)
56
57 Use of general prohibition symbol and negation symbol

58 B.1 General prohibition symbol

59 The general prohibition symbol (as used in ISO 3864-1) is intended to indicate a prohibited action. For
60 medical device labelling, the prohibition circle with a diagonal bar should be used to mean “do not”, e.g.
61 symbol 5.4.2 “Do not re-use”. It is sometimes used out of context in medical device labels, e.g. to mean
62 “does not contain”. It is important that usage be consistent with the intended meaning so that hazards
63 do not arise from misunderstanding.
64 B.2 Negation symbol
65 Manufacturers wishing to communicate the meaning “does not” or “is not” where a symbol expressing
66 this meaning does not exist, should follow the method set out in IEC 80416-3:2002, Clause 7 (a large “X”
67 placed over the symbol). Although it is not generally recommended that this symbology be used with
68 any of the symbols given in this document, the use of the negation symbol is permitted.
69 Annex C
70 (informative)
71
72 Terminology - Alphabetized index of defined terms

Term Source

accompanying information 3.1

batch code 3.2

catalogue number 3.3

characteristic information 3.4

description 3.5

distributer 3.6

importer 3.7

information supplied by the manufacturer 3.8

Instructions for use 3.9

label 3.10

manufacturer 3.11

marking 3.12

medical device 3.13

post-market surveillance 3.14

risk 3.15

risk assessment 3.16

Serial number 3.17

single patient multiple use 3.18

single use 3.19

sterile 3.20

symbol 3.21

title 3.22
73
 74 Bibliography

75 [1] ISO 3864-1:2011, Graphical symbols — Safety colours and safety signs — Part 1: Design principles
76 for safety signs and safety markings

77 [2] ISO 7010:2019, Graphical symbols — Safety colours and safety signs — Registered safety signs

78 [3] ISO 14971:2019, Medical devices — Application of risk management to medical devices

79 [4] ISO 18113-1:2009, In vitro diagnostic medical devices — Information supplied by the
80 manufacturer (labelling) — Part 1: Terms, definitions and general requirements

81 [5] ISO 18113-2:2009, In vitro diagnostic medical devices — Information supplied by the
82 manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use

83 [6] ISO 18113-3:2009, In vitro diagnostic medical devices — Information supplied by the
84 manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use

85 [7] ISO 18113-4:2009, In vitro diagnostic medical devices — Information supplied by the
86 manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing

87 [8] ISO 18113-5:2009, In vitro diagnostic medical devices — Information supplied by the
88 manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing

89 [9] IEC 60417 (database), Graphical symbols for use on equipment

90 [10] IEC 80416-1:2008, Basic principles for graphical symbols for use on equipment — Part 1: Creation
91 of graphical symbols for registration

92 [11] IEC 80416-3:2011, Basic principles for graphical symbols for use on equipment — Part 3:
93 Guidelines for the application of graphical symbols

94 [12] EN 556-1:2001, Sterilization of medical devices — Requirements for medical devices to be

95 designated “STERILE” — Part 1: Requirements for terminally sterilized medical devices

96 [13] EN 1041:2008+A1:2013, Information supplied by the manufacturer of medical devices

97 [14] IEC 60878:2015, Graphical Symbols for Electrical Equipment in Medical Practice

98 [15]1 ISO 20417:----, Medical devices - Information to be supplied by the manufacturer

99 [16] ISO 13485:2016, Medical devices — Quality management systems — Requirements for regulatory
100 purposes

101 [17] ISO 8601-1:2019, Date and time — Representations for information interchange — Part 1: Basic
102 rules

103 [18] ISO 8601-2:2019, Date and time — Representations for information interchange — Part 2:
104 Extensions

105 [19] ISO 7000 (database), Graphical symbols for use on equipment— Registered symbols

106 [20] ISO 7001:2019, Graphical symbols — Public information symbols

107 1 Under preparation. Currently in FDIS stage.