ISO 27185:2012

Cardiac rhythm management devices — Symbols to be used with cardiac rhythm management device labels, and information to be supplied — General requirements

ISO 27185:2011 specifies requirements for the use of symbols conveying information on the safe and effective use of cardiac rhythm management medical devices. A listing is given of existing symbols that comply with the requirements of ISO 27185:2011. ISO 27185:2011 is applicable to, and limited to, symbols for cardiac rhythm management medical devices that can be marketed globally. These symbols can be used on the devices themselves or their labelling.

Dispositifs de gestion du rythme cardiaque — Symboles à utiliser avec les marquages de dispositif de rythme cardiaque et informations à fournir — Exigences générales

General Information

• Status: Published
• Publication Date: 12-Feb-2012
• ICS: 01.080.20 - Graphical symbols for use on specific equipment
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: ISO/TC 150/SC 6 - Active implants
• Drafting Committee: ISO/TC 150/SC 6/JWG 1 - Joint ISO/TC 150/SC 6 - IEC/SC 62D WG: Cardiac pacemakers and implantable defibrillators
• Current Stage: 9093 - International Standard confirmed
• Completion Date: 24-Nov-2023

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 27185
First edition
2012-02-15

Cardiac rhythm management devices —
Symbols to be used with cardiac rhythm
management device labels, and
information to be supplied — General
requirements
Dispositifs de gestion du rythme cardiaque — Symboles à utiliser avec
les marquages de dispositif de rythme cardiaque et informations à
fournir — Exigences générales




Reference number
ISO 27185:2012(E)
©
ISO 2012

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ISO 27185:2012(E)

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©  ISO 2012
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ii © ISO 2012 – All rights reserved

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ISO 27185:2012(E)
Contents Page
Foreword . iv
Introduction . v
1  Scope . 1
2  Normative references . 1
3  Terms and definitions . 1
4  Abbreviated terms . 2
5  General requirements . 3
5.1  Proposal of symbols for adoption . 3
5.2  Requirements for usage . 3
6  Symbols . 4
Annex A (informative) Examples of use of symbols . 16
Annex B (informative) Graphical symbol system for implantable cardiac devices . 19
Annex C (informative) Validation report for symbols included in this International Standard . 24
Annex D (informative) ISO 27185 response to comment in DIS . 30
Bibliography . 31

© ISO 2012 – All rights reserved iii

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ISO 27185:2012(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 2.
The main task of technical committees is to prepare International Standards. 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 document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 27185 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 6,
Active implants.

iv © ISO 2012 – All rights reserved

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