ISO/TR 15223:1998

TECHNICAL ISO/TR
REPORT 15223
First edition
1998-10-01
Medical devices — Symbols to be used with
medical device labels, labelling and
information to be supplied
Dispositifs médicaux — Symboles à utiliser avec les étiquettes, l’étiquetage
et les informations à fournir relatifs aux dispositifs médicaux
A
Reference number
ISO/TR 15223:1998(E)

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ISO/TR 15223:1998(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 main task of technical committees is to prepare International
Standards, but in exceptional circumstances a technical committee may
propose the publication of a Technical Report of one of the following types:
 type 1, when the required support cannot be obtained for the
publication of an International Standard, despite repeated efforts;
 type 2, when the subject is still under technical development or
where for any other reason there is the future but not immediate
possibility of an agreement on an International Standard;
 type 3, when a technical committee has collected data of a different
kind from that which is normally published as an International
Standard ("state of the art", for example).
Technical Reports of types 1 and 2 are subject to review within three years of
publication, to decide whether they can be transformed into International
Standards. Technical Reports of type 3 do not necessarily have to be
reviewed until the data they provide are considered to be no longer valid or
useful.
ISO/TR 15223, which is a Technical Report of type 3, was prepared by
Technical Committee ISO/TC 210, Quality management and corresponding
general aspects for medical devices.
This document is being published as an ISO Technical Report at this time
because it is urgently needed in the marketplace, however it is simul-
taneously being circulated for adoption as an International Standard. When
ISO/TC 210 began work on this item several years ago, the technical
committee was incorrectly informed that a document such as this, consisting
entirely of symbols, could not be published as an International Standard. It
was subsequently learned that publication as a standard was permissible,
and given the already wide acceptance of the symbols contained herein,
the decision was made to proceed immediately to circulation as a draft
International Standard so that an International Standard will replace the
Technical Report as soon as possible.
©  ISO 1998
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced
or utilized in any form or by any means, electronic or mechanical, including photocopying and
microfilm, without permission in writing from the publisher.
International Organization for Standardization
Case postale 56 • CH-1211 Genève 20 • Switzerland
Internet iso@iso.ch
Printed in Switzerland
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© ISO
ISO/TR 15223:1998(E)
Introduction
This Technical Report (type 3) considers certain items of information which
may be considered by regulatory authorities to be essential for the safe and
proper use of medical devices. As such, the items are required by laws and
regulations of certain political jurisdictions to be presented with the device.
This information may be required on the device itself, part of the label of the
device on its packaging, or provided with the device in an information
document.
These items of information are subject to international harmonization to the
end that there is agreement on information to be provided. However, there is
no harmonization with regard to language to be used when presenting this
information. This presents potential problems to manufacturers, users and
regulatory authorities.
Device manufacturers, desiring to minimize the indirect costs not associated
with healthcare purposes, seek to minimize costs of labelling by reducing or
rationalizing labelling variants. In the European Union alone, there are
thirteen languages which may be required. This presents a major problem of
design and logistics. In addition, technical translation can present difficulties
in transferring the precise meaning from one language to another.
Users may be presented with devices labelled in a number of different
languages. This can cause confusion and delay in locating the appropriate
language. It may also create confusion as to precise meanings for
multilingual users.
Regulatory authorities may be presented with labelling not in their national
language and have difficulty in ascertaining the safety and fitness for use of a
device required in emergencies or other exceptional circumstances.
This Technical Report proposes solutions to these problems through the use
of internationally recognized symbols, with precisely defined meanings that
transcend language.
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TECHNICAL REPORT  © ISO ISO/TR 15223:1998(E)
Medical devices — Symbols to be used with medical device
labels, labelling and information to be supplied
1 Scope
This Technical Report identifies symbols and their meanings which may be used to convey information essential to the
user and others for safe and effective use of medical devices. The report is primarily intended to be used by the
following:
 manufacturers of medical devices who market their products in a number of countries having different language
requirements for medical device labelling;
 users of medical devices who draw their supplies from a number of sources and may have varied language
capabilities;
 those responsible for postmarket surveillance;
 health care regulatory authorities, testing organizations, certif
...