FprEN ISO 15223-1

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

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

Dispositifs médicaux — Symboles à utiliser avec les étiquettes, l'étiquetage et les informations à fournir

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

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

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

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

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

Any trade name used in this document is information given for the convenience of users and does not

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)

The committee responsible for this document is ISO/TC 210, Quality management and corresponding

This fourth edition cancels and replaces the third edition (ISO 15223-1:2016), which has been

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

The symbols included in this document have been published in ISO 7000, ISO 7010, IEC 60417 or have

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 verbal forms used in this document conform to usage described in ISO/IEC Directives, 129 Part 2.

− “shall” means that conformance with a requirement or a test is mandatory for conformance with

− “should” means that conformance with a requirement or a test is recommended but is not

− “may” is used to describe permission (e.g. a permissible way to achieve conformance with a

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.

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

This document is applicable to symbols used in a broad spectrum of medical devices, which are marketed

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

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 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 80416-1:2008, Basic principles for graphical symbols for use on equipment — Part 1: Creation of

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

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

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,

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).

Figure 1 – Relationship of terms used to describe information supplied by the manufacturer

production control containing a combination of letters or numbers associated with a single batch or lot

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)

Note 2 to entry: For the purposes of this standard, commercial product code should not be confused with the US FDA, ‘product

[SOURCE: ISO 20417:---- [15], definition 3.3 - modified to make note 3 an external reference]

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 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.

natural or legal person who imports a medical device or accessory into a locale, which was

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

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

portion of the accompanying information that is essential for the safe and effective use of a medical

Note 1 to entry: For the purposes of this document, a user can be either a lay user or professional user with relevant

Note 2 to entry: For the purposes of this document, instructions for the professional processing between uses of a medical

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

written, printed or graphic information marked on the item itself, or on the packaging of each item, or

Note 1 to entry: For the purposes of this document, the term labelled is used to designate the corresponding act.

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

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

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

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

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.

information, in text or graphical format, durably affixed, printed, etched (or equivalent) to a medical

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

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, monitoring, treatment, alleviation of or compensation for an injury;

— investigation, replacement, modification, or support of the anatomy or of a physiological process;

— 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:

systematic process to collect and analyse experience gained from medical devices that have been placed

combination of the probability of occurrence of harm and the severity of that harm

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

intended by the manufacturer to be reused on an individual patient for

Note 1 to entry: A single patient multiple use medical device or accessory may require processing

Note 2 to entry: For an implantable medical device, the duration of a single use is from implanting to

intended by the manufacturer to be used on an individual patient or

Note 1 to entry: A single use medical device or accessory is not intended by its manufacturer to be used

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,

[SOURCE: IEC 80416 -1:2008 [10], definition 3.9 – modified –replaced ‘spoken of’ with ‘referenced’.]

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

b) Any symbol proposed for adoption in this document shall be applicable to a range of medical

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

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

b) The manufacturer should determine the appropriate size for the symbol to be legible for its

NOTE This document does not specify colours or minimum size for the symbols in Table 1, nor does it specify the

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

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

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

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.

Reference Title of symbol Description of Requirements Informative notes Restrictions of Additional Symbol

5.1.1. Manufacturer Indicates the This symbol shall NOTE 1 This symbol is The use of this ISO 7000-3082