ISO 15223:2000

INTERNATIONAL ISO
STANDARD 15223
Second edition
2000-04-15
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
Reference number
ISO 15223:2000(E)
©
ISO 2000

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ISO 15223:2000(E)
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ISO 15223:2000(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.
Draft International Standards adopted by the technical committees are circulated to the member bodies for voting.
Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this International Standard may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
International Standard ISO 15223 was prepared by Technical Committee ISO/TC 210, Quality management and
corresponding general aspects for medical devices.
This first edition cancels and replaces ISO/TR 15223:1998.
Annex A of this International Standard is for information only.
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ISO 15223:2000(E)
Introduction
This International Standard considers certain items of information that 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, as part of the label of the device on its packaging, or provided with the device in an information
document.
There is a considerable degree of international harmonization of the information to be provided. However, there is
no harmonization with regard to the 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 that 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 may 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 International Standard proposes solutions to these problems through the use of internationally recognized
symbols, with precisely defined meanings that transcend language.
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INTERNATIONAL STANDARD ISO 15223:2000(E)
Medical devices — Symbols to be used with medical device labels,
labelling and information to be supplied
1 Scope
This International Standard identifies symbols conventionally used to convey information essential for proper use to
the user and others for safe and effective use of medical devices. This International Standard is primarily intended
to be used by:
� 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, certification bodies and other organizations
responsible for implementing regulations affecting medical devices and having responsibility for postmarket
surveillance.
This International Standard may also be of assistance to:
� manufacturers having to cope with space limitations on small labels;
� distributors of medical devices or other representatives of manufacturers;
� health care authorities responsible for training as well as those being trained.
NOTE This International Standard deals with a small number of symbols that may be used when appropriate on the device
itself, its package or in the accompanying documentation. Many other standards, such as IEC 60601-1, specify additional
symbols that are applicable to particular kinds or groups of devices, or to particular situations.
2 Terms and definitions
For the purposes of this International Standard, the following terms and definitions apply.
NOTE This International Standard does not introduce new concepts. The following terms and definitions are provided for
guidance. In particular circumstances, the legal definitions expressed by relevant statutes should be applied.
2.1
information essential for proper use
information that is essential for the safe use of the device for the patient, user or others
NOTE This information could, for example, include the degree of microbial cleanliness, up to and including sterility, when
this is necessary with regard to the essential purpose. It could also include information that would facilitate traceability in the
interest of postmarket surveillance by manufacturers and postmarket vigilance
...