FprEN ISO 15223-1
(Main)Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO/FDIS 15223-1:2021)
Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO/FDIS 15223-1:2021)
2021-07-14 - Lack of compliance - publication on hold.
Medizinprodukte - Zu verwendende Symbole mit durch den Hersteller bereitgestellten Informationen - Teil 1: Allgemeine Anforderungen (ISO/FDIS 15223-1:2021)
Dieses Dokument legt Symbole fest, die zur Angabe von für ein Medizinprodukt bereitgestellten Informationen zu verwenden sind. Dieses Dokument gilt für Symbole, die auf ein breites Spektrum von Medizinprodukten anwendbar sind, die weltweit verfügbar sind und unterschiedliche behördliche Anforderungen erfüllen müssen.
Diese Symbole können auf dem Medizinprodukt selbst, auf seiner Verpackung oder in den Begleitinformationen verwendet werden. Die Anforderungen dieses Dokuments sind nicht dazu vorgesehen, für Symbole zu gelten, die in anderen Normen festgelegt sind.
Dispositifs médicaux - Symboles à utiliser avec les étiquettes, l'étiquetage et les informations à fournir relatifs aux dispositifs médicaux - Partie 1: Exigences générales (ISO/FDIS 15223-1:2021)
Medicinski pripomočki - Simboli za označevanje medicinskih pripomočkov, označevanje in podatki, ki jih mora podati dobavitelj - 1. del: Splošne zahteve (ISO/DIS 15223-1:2020)
General Information
RELATIONS
Standards Content (sample)
SLOVENSKI STANDARD
oSIST prEN ISO 15223-1:2020
01-april-2020
Medicinski pripomočki - Simboli za označevanje medicinskih pripomočkov,
označevanje in podatki, ki jih mora podati dobavitelj - 1. del: Splošne zahteve
(ISO/DIS 15223-1:2020)
Medical devices - Symbols to be used with medical device labels, labelling and
information to be supplied - Part 1: General requirements (ISO/DIS 15223-1:2020)
Medizinprodukte - Bei Aufschriften von Medizinprodukten zu verwendende Symbole,
Kennzeichnung und zu liefernde Informationen - Teil 1: Allgemeine Anforderungen
(ISO/DIS 15223-1:2020)
Dispositifs médicaux - Symboles à utiliser avec les étiquettes, l'étiquetage et les
informations à fournir relatifs aux dispositifs médicaux - Partie 1: Exigences générales
(ISO/DIS 15223-1:2020)Ta slovenski standard je istoveten z: prEN ISO 15223-1
ICS:
01.080.20 Grafični simboli za posebno Graphical symbols for use on
opremo specific equipment
11.040.01 Medicinska oprema na Medical equipment in general
splošno
oSIST prEN ISO 15223-1:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 15223-1:2020
DRAFT INTERNATIONAL STANDARD
ISO/DIS 15223-1
ISO/TC 210 Secretariat: ANSI
Voting begins on: Voting terminates on:
2020-02-20 2020-05-14
Medical devices — Symbols to be used with medical device
labels, labelling and information to be supplied —
Part 1:
General requirements
Dispositifs médicaux — Symboles à utiliser avec les étiquettes, l'étiquetage et les informations à fournir
relatifs aux dispositifs médicaux —Partie 1: Exigences générales
ICS: 01.080.20; 11.040.01
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 15223-1:2020(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. ISO 2020
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oSIST prEN ISO 15223-1:2020
ISO/DIS 15223-1:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.ISO copyright office
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Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
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oSIST prEN ISO 15223-1:2020
ISO/DIS 15223-1:2020(E)
Contents Page
Foreword .......................................................................................................................................................................... 4
Introduction .................................................................................................................................................................... 5
1 Scope.................................................................................................................................................................... 1
2 Normative references .................................................................................................................................... 1
3 Terms and definitions ................................................................................................................................... 1
4 General requirements ................................................................................................................................... 7
5 Symbols ............................................................................................................................................................... 8
Annex A (informative) Examples ........................................................................................................................... 35
Annex B (informative) Use of general prohibition symbol and negation symbol ................................ 41
Annex C (informative) Terminology - Alphabetized index of defined terms ........................................ 42
Bibliography ................................................................................................................................................................. 43
iii© ISO 2020 - All rights reserved
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oSIST prEN ISO 15223-1:2020
ISO/DIS 15223-1:2020(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national
standards bodies (ISO member bodies). The work of preparing International Standards is normally
carried out through ISO technical committees. Each member body interested in a subject for which a
technical committee has been established has the right to be represented on that committee.
International organizations, governmental and non-governmental, in liaison with ISO, also take part in
the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all
matters of electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO's adherence to the World Trade Organization (WTO)
principles in the Technical Barriers to Trade (TBT) see the following URL:www.iso.org/iso/foreword.html.
The committee responsible for this document is ISO/TC 210, Quality management and corresponding
general aspects for medical devices.This fourth edition cancels and replaces the third edition (ISO 15223-1:2016), which has been
technically revised with the following principal revisions:− Addition of 20 new symbols that were validated per ISO 15223-2
− Addition of 5 symbols from ISO 7000, ISO 7001 and IEC 60417
− Deletion of the defined term ‘labelling’
− Inclusion of defined terms from ISO 20417, ISO 13485 and ISO 14971.
− Expansion of the informative annex containing examples
− Moved information about European Regulations to informative notes
A list of all parts in the ISO 15223 series can be found on the ISO website.
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oSIST prEN ISO 15223-1:2020
ISO/DIS 15223-1:2020(E)
Introduction
Medical device manufacturers and others in the supply chain must provide specific information that is
essential for the safe and proper use of the medical device. This information can be on the medical
device itself, as part of the packaging, or in other accompanying information. For simplicity and
translation reasons, this information can be provided as symbols that have a specific meaning. This
document does not specify the information that needs to be provided, but does specify internationally
recognized symbols for the provision of this specific information.The symbols included in this document have been published in ISO 7000, ISO 7010, IEC 60417 or have
been subjected to a formal symbol validation process.This document is intended to be used by manufacturers of medical devices and others who desire to use
these symbols to portray information without translation of text into multiple languages In this
document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of
the conditions is true.The verbal forms used in this document conform to usage described in ISO/IEC Directives, 129 Part 2.
For the purposes of this document, the auxiliary verb:− “shall” means that conformance with a requirement or a test is mandatory for conformance with
this document;− “should” means that conformance with a requirement or a test is recommended but is not
mandatory for conformance with this document;− “may” is used to describe permission (e.g. a permissible way to achieve conformance with a
requirement or test);− "can" is used to describe a possibility or capability; and
− "must" is used to express an external constraint.
Symbols added during the revision of this document were placed at the end of the pertinent section so
as to preserve the numbering of existing symbols which facilitates easy referencing in other documents.
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oSIST prEN ISO 15223-1:2020
ISO/DIS 15223-1:2020(E)
Medical Devices — Symbols to be used with medical device labels,
labelling and information to be supplied — Part 1: General
requirements
1 Scope
This document identifies requirements for symbols used in medical device labelling that convey
information on the safe and effective use of medical devices. It also lists symbols that satisfy the
requirements of this document.This document is applicable to symbols used in a broad spectrum of medical devices, which are marketed
globally and therefore need to meet different regulatory requirements.These symbols are marked on the medical device itself, placed on its packaging or placed in the
associated accompanying information. The requirements of this document are not intended to apply to
symbols specified in other standards.2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 7000 (database), Graphical symbols for use on equipment — Registered symbolsISO 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:---- , Medical Devices - Information to be supplied by the manufacturer
IEC 60417 (database), Graphical symbols for use on equipmentIEC 80416-1:2008, Basic principles for graphical symbols for use on equipment — Part 1: Creation of
graphical symbols for registration3 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
Under preparation. Currently in FDIS stage.
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oSIST prEN ISO 15223-1:2020
ISO/DIS 15223-1:2020(E)
— Numbers in square brackets refer to the Bibliography
3.1
accompanying information
information accompanying or marked on a medical device or accessory for the user or those accountable
for the installation, use, processing, maintenance, decommissioning and disposal of the medical device
or accessory, particularly regarding safe useNote 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
3.2batch code
batch number
lot code
lot number
production control containing a combination of letters or numbers associated with a single batch or lot
[SOURCE: ISO 20417:---- [15], definition 3.15]3.3
catalogue number
commercial product code
commercial product name
value given by the manufacturer to identify a specific medical device or accessory as it relates to its
form/fit, function and process (i.e., manufacturing processes requiring differentiation for the end user)
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oSIST prEN ISO 15223-1:2020
ISO/DIS 15223-1:2020(E)
Note 1 to entry: A catalogue number shall consist of letters or numbers.
Note 2 to entry: For the purposes of this standard, commercial product code should not be confused with the US FDA, ‘product
code’ or procode classification.Note 3 to entry: See ISO 20417:2020 Figure 2.
[SOURCE: ISO 20417:---- [15], definition 3.3 - modified to make note 3 an external reference]
3.4characteristic 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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oSIST prEN ISO 15223-1:2020
ISO/DIS 15223-1:2020(E)
package insert
portion of the accompanying information that is essential for the safe and effective use of a medical
device or accessory directed to the user of the medical deviceNote 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 itemsNote 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.© ISO 2020 - All rights reserved
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oSIST prEN ISO 15223-1:2020
ISO/DIS 15223-1:2020(E)
Note 6 to entry: An authorized representative, distributor or importer who only adds its own address and contact details to the
medical device or the packaging, without covering or changing the existing labelling, is not considered a manufacturer.
Note 7 to entry: To the extent that an accessory is subject to the regulatory requirements of a medical device, the person
responsible for the design and/or manufacture of that accessory is considered to be a manufacturer.
[SOURCE: ISO 14971:2019 [3], definition 3.9]3.12
marking
information, in text or graphical format, durably affixed, printed, etched (or equivalent) to a medical
device or accessoryNote 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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ISO/DIS 15223-1:2020(E)
systematic process to collect and analyse experience gained from medical devices that have been placed
on the market[SOURCE: ISO 13485:2016 [16], definition 3.14]
3.15
risk
combination of the probability of occurrence of harm and the severity of that harm
[SOURCE: ISO 14971:2019 [3], definition 3.18]3.16
risk assessment
overall process comprising a risk analysis and a risk evaluation
[SOURCE: ISO 14971:2019 [3], definition 3.20]
3.17
serial number
production control containing a combination of letters or numbers, selected by the manufacturer,
intended for quality control and identification purposes to uniquely distinguish an individual medical
device from other medical devices with the same catalogue number or model number[SOURCE: ISO 20147:---- [15], definition 3.22]
3.18
single patient multiple use
intended by the manufacturer to be reused on an individual patient for
multiple usesNote 1 to entry: A single patient multiple use medical device or accessory may require processing
between uses.Note 2 to entry: For an implantable medical device, the duration of a single use is from implanting to
explanting the medical device.[SOURCE: ISO 20147:----[15], definition 3.25]
3.19
single use
do not re-use
use only once
intended by the manufacturer to be used on an individual patient or
specimen during a single procedure and then disposed ofNote 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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oSIST prEN ISO 15223-1:2020
ISO/DIS 15223-1:2020(E)
symbol
graphical representation appearing on the label (3.10) and/or associated documentation of a medical
device that communicates characteristic information (3.4) without the need for the supplier or receiver
of the information to have knowledge of the language of a particular nation or people
Note 1 to entry: The symbol can be an abstract pictorial or a graphical representation, or one that uses familiar objects,
including alphanumeric characters (with sufficient justification).3.22
title
unique name by which a graphical symbol is identified and referenced
[SOURCE: IEC 80416 -1:2008 [10], definition 3.9 – modified –replaced ‘spoken of’ with ‘referenced’.]
4 General requirements4.1 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.© ISO 2020 - All rights reserved
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oSIST prEN ISO 15223-1:2020
ISO/DIS 15223-1:2020(E)
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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oSIST prEN ISO 15223-1:2020
1 Table 1 — Symbols to convey information essential for proper 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
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 date2011-10-02
manufacturer by the name and information that is of manufacture
address of the required in Europe and precludes the use
manufacturer can be required by other of symbol 5.1.3
adjacent to the authorities having with a date of
symbol. jurisdiction. manufacture
NOTE 2 For use in
Europe the full definition
of “manufacturer” is
given in EU Regulations
2017/745 and
2017/746. Other
jurisdictions can have
unique definitions
...
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