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
Current Stage
9093 - International Standard confirmed
Start Date
24-Nov-2023
Completion Date
13-Dec-2025
Ref Project
Standard
ISO 27185:2012 - Cardiac rhythm management devices -- Symbols to be used with cardiac rhythm management device labels, and information to be supplied -- General requirements
English language
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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 2012
©  ISO 2012
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 either ISO at the address below or
ISO's member body in the country of the requester.
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Published in Switzerland
ii © ISO 2012 – All rights reserved

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

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

Introduction
This International Standard addresses the presentation of certain items of information that are considered by
regulatory authorities to be essential for the safe and proper use of cardiac rhythm management medical
devices. As such, the items are required to be presented with the device in most regulatory domains. The
information can be required on the device itself, as part of the label, or provided with the device.
Many countries require the use of their own language to present textual information with medical devices. This
presents problems to device manufacturers and users.
Manufacturers seek to take costs out of labelling by reducing or rationalizing variants. This presents a major
problem of translation, design and logistics when multiple languages are included on a single label or piece of
documentation.
Users, presented with devices labelled in a number of different languages, can experience confusion and
delay in locating the appropriate language.
This International Standard proposes solutions to these problems through the use of internationally
recognized symbols, with precisely defined meanings, that are independent of language.
This International Standard is primarily intended to be used by:
 manufacturers of cardiac rhythm management medical devices who market identical products in countries
having different language requirements for labelling;
 users of cardiac rhythm management medical devices who draw their supplies from a number of sources
and can have varied language capabilities.
This International Standard can also be of assistance to
 distributors of cardiac rhythm management medical devices or other representatives of manufacturers;
 health care providers responsible for training as well as those being trained;
 those responsible for post-market vigilance;
 health care regulatory authorities, testing organizations, certification bodies and other organizations
responsible for implementing regulations affecting medical devices and having responsibility for
post-market surveillance.
INTERNATIONAL STANDARD ISO 27185:2012(E)

Cardiac rhythm management devices — Symbols to be used
with cardiac rhythm management device labels, and
information to be supplied — General requirements
1 Scope
This International Standard specifies requirements for the use of symbols conveying information on the safe
and effective use of cardiac rhythm management medical devices. Table 1 gives a list of existing symbols that
comply with the requirements of this International Standard.
This International Standard 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.
NOTE Other standards specify additional symbols that are applicable to particular kinds or groups of devices or to
particular situations. Examples of such sources are identified in the Bibliography. This listing is not exhaustive.
2 Normative references
The following referenced documents are indispensable for the application 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 15223-2, Medical devices — Symbols to be used with medical device labels, labelling and information to
be supplied — Symbol development, selection and validation
ISO 80416-2, Basic principles for graphical symbols for use on equipment — Part 2: Form and use of arrows
IEC 80416-1:2008, Basic principles for graphical symbols for use on equipment — Part 1: Creation of
graphical symbols for registration
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
characteristic information
mental representation of a property or properties of an object or set of objects
3.2
compound symbol
series of individual symbols linked together to form a piece of information that it is intended to read as a single
unit
3.3
description
normative text that defines the purpose, the application, and the use of the symbol
[IEC 80416-1:2008, 3.2]
3.4
graphical symbol
graphical object that communicates characteristic information (3.1) without relying on language to
communicate the information
3.5
graphical symbol element
graphical object that has a particular meaning and that is used in combination with other graphical symbol
elements to create a graphical symbol (3.4) which communicates more complete meaning
3.6
iconic presentation
pictorial or graphical representation using familiar objects including alphanumeric characters
3.7
non-programmable
device parameter that cannot be modified by the physician
3.8
programmable
device parameter that can be modified by the physician
3.9
symbol original
drawing of a symbol, prepared in accordance with IEC 80416-1, used for reference or reproduction purposes
[IEC 80416-1:2008, 3.3]
3.10
symbol used in medical device labelling
object presented on the label and/or associated documentation of a medical device that communicates
characteristic information (3.1) without relying on knowledge of the language of a particular nation or people
by the supplier or receiver of the information
NOTE The symbol can utilize symbolic or iconic presentation.
3.11
title
unique name by which a symbol is identified and spoken of
[IEC 80416-1:2008, 3.5]
4 Abbreviated terms
ATP Anti-tachycardia pacing
A-V Atrial-ventricular
CRT-D Cardiac resynchronization therapy — defibrillation
CRT-P Cardiac resynchronization therapy — pacing
ICD Implantable cardioverter defibrillator
2 © ISO 2012 – All rights reserved

IPG Implantable pulse generator
LV Left ventricular
PVARP Post-ventricular atrial refractory period
RA Right atrial
RV Right ventricular
NOTE The definitions for these terms are provided in the respective standards for the product. See the Bibliography
for a list of these standards.
5 General requirements
5.1 Proposal of symbols for adoption
Proposals for symbols for adoption into ISO 27185 shall be submitted to the secretariat of ISO/TC 150/SC 6.
Symbols being proposed shall be presented following the dimensional criteria and design principles set out in
IEC 80416-1 and ISO 80416-2. Where the presentation is symbolic, alphanumeric characters shall not be part
of the symbol. Alphanumeric characters may be used when appropriate and relevant in a symbol with iconic
presentation.
Symbols presented for advice on acceptability or procedural details may be presented as symbol concepts.
Symbols presented for formal adoption shall be symbol originals (see 3.9).
Any symbol proposed for adoption into this International Standard shall be applicable to cardiac rhythm
management devices and have global applicability.
5.2 Requirements for usage
When risk management shows that it is appropriate to use symbols to convey information essential for proper
use on the cardiac rhythm management medical devices, on its package, or in associated documentation, the
symbols provided in Table 1 should be used.
NOTE 1 Other symbols can be used to convey different information. Many other standards specify symbols for
particular purposes and/or for particular kinds of devices. The Bibliography lists some of these standards.
In use, the graphical representation of symbols shall comply with that shown in this International Standard,
especially with respect to relative dimensions including line thickness, orientation and the absence or
presence of filled or shaded areas.
As part of risk management and taking account of the specifics and size of the product and its packaging, the
manufacturer shall determine the appropriate size necessary for the symbol to be legible for its intended
function. Symbols are designed as specified in the requirements of IEC 80416-1 and ISO 80416-2 in order to
maximize the clarity of the symbol in a reduced form.
NOTE 2 Colours and minimum dimensions are not specified in this International Standard.
The manufacturer shall ensure that no additional risk is incurred before using symbols. Alternatively,
appropriate strategies shall be adopted to negate the risk.
NOTE 3 Additional information regarding risk is available in ISO 14971.
Symbols may be used without accompanying text. When this is not permitted by statute or regulation, the
minimum text in all required languages associated with the symbol should be the referent of this International
Standard. Refer to the “Title” column in Table 1 for the minimum text to accompany the symbol. The
information under “Informative notes” provides synonyms for titles.
When one or more values are associated with a particular symbol, they should be placed immediately
adjacent to the primary graphical element in the symbol most closely related to the value. Examples of
associating values with particular symbols are provided in Annex A.
6 Symbols
When appropriate, certain information essential for proper use, as required in the appropriate standard, shall
be indicated on the medical device, on its package, or in the associated documentation by using the
corresponding symbols given in Table 1. Examples are provided in Annex A.
Table 1 — Symbols to convey information essential for proper use
No. Graphical symbol Title Description Informative notes Related subclause ISO 7000
of symbol in AIMD product registration
standards number
6.1 Pacemaker, To indicate NOTE  A synonym 9.3 ISO 7000-3038
single chamber, implantable for “Pacemaker, (ISO 14708-1:2000,
right ventricular pacemakers that are single chamber, right EN 45502-1:1998)
intended to stimulate ventricular” is Description of the
and sense in the “Pacemaker (single device
right ventricle of the chamber, RV)”.
heart
6.2 Pacemaker, To indicate an NOTE  A synonym 9.3 ISO 7000-3039
single chamber, implantable for “Pacemaker, (ISO 14708-1:2000,
right atrial pacemaker that is single chamber, right EN 45502-1:1998)
intended to stimulate atrial” is “Pacemaker Description of the
and sense in the (single chamber, device
right atrium of the RA)”.
heart
6.3 Pacemaker, dual To indicate an NOTE  Synonyms 9.3 ISO 7000-3040
chamber, right implantable for “Pacemaker, dual (ISO 14708-1:2000,
atrial, right pacemaker that is chamber, right atrial, EN 45502-1:1998)
ventricular intended to stimulate right ventricular” are Description of the
and sense in both “Pacemaker (dual device
the right atrium and chamber, RA, RV)”
right ventricle of the or “Pacemaker (dual

heart chamber)”.
6.4 Implantable To indicate an NOTE  A synonym 9.3 ISO 7000-3041
cardioverter implantable for “Implantable (ISO 14708-1:2000,
defibrillator, cardioverter cardioverter EN 45502-1:1998)
single chamber, defibrillator that is defibrillator, single Description of the
right ventricular intended to stimulate chamber, right device
and sense in the ventricular” is “ICD
right ventricle and to (single chamber,

shock the heart RV)”.
6.5 Implantable To indicate an NOTE  Synonyms 9.3 ISO 7000-3042
cardioverter implantable for “Implantable (ISO 14708-1:2000,
defibrillator, dual cardioverter cardioverter EN 45502-1:1998)
chamber, right defibrillator that is defibrillator, dual Description of the
atrial, right intended to stimulate chamber, right atrial, device
ventricular and sense in the right ventricular” are
right atrium and right “ICD (dual chamber,
ventricle and to RA, RV)” or “ICD

shock the heart (dual chamber)”.
4 © ISO 2012 – All rights reserved

Table 1 (continued)
No. Graphical symbol Title Description Informative notes Related subclause ISO 7000
of symbol in AIMD product registration
standards number
6.6 Cardiac To indicate an NOTE  Synonyms 9.3 ISO 7000-3043
resynchronization implantable for “Cardiac (ISO 14708-1:2000,
therapy pacemaker that is resynchronization EN 45502-1:1998)
pacemaker, right intended to stimulate therapy pacemaker, Description of the
atrial, right and sense in the right atrial, right device
ventricular, left right atrium, right ventricular, left
ventricular ventricle and left ventricular” are
ventricle of the heart “CRT-P, RA, RV, LV”

or “CRT-P”.
6.7 Cardiac To indicate an NOTE  Synonyms 9.3 ISO 7000-3044
resynchronization implantable for “Cardiac (ISO 14708-1:2000,
therapy cardioverter resynchronization EN 45502-1:1998)
defibrillator, right defibrillator that is therapy defibrillator, Description of the
atrial, right intended to stimulate right atrial, right device
ventricular, left and sense in the ventricular, left
ventricular right atrium, right ventricular” are
ventricle and left “CRT-D, RA, RV, LV”

ventricle; and to or “CRT-D”.
shock the heart
6.8 Implantable To indicate an 9.3 ISO 7000-3045
device implantable device (ISO 14708-1:2000,
EN 45502-1:1998)
Description of the
device
6.9 Implantable To indicate an 9.3 ISO 7000-3046
device (coated) implantable device (ISO 14708-1:2000,
with coating for EN 45502-1:1998)
allergies or to Description of the
prevent unintended device
muscle stimulation
6.10 Maximum To indicate the NOTE  Synonyms 9.4.1 ISO 7000-3047
tracking rate and shipping parameters for “Maximum (ISO 14708-2:2005,
minimum rate for maximum tracking rate and EN 45502-2-1:2003)
tracking rate and minimum rate” are The IPGs
minimum rate “Upper tracking rate/ non-programmable
lower rate”, “Max characteristics for
tracking rate/ each input/output
minimum rate”, or terminal, as
“Max track applicable: the basic
rate/minimum rate”. rate in reciprocal
minutes
This symbol may
be used for
programmable as
well as non-
programmable
parameters.
Table 1 (continued)
No. Graphical symbol Title Description Informative notes Related subclause ISO 7000
of symbol in AIMD product registration
standards number
6.11 Minimum rate To indicate the NOTE  Synonyms 9.4.1 ISO 7000-3048
shipping parameters for “Minimum rate” (ISO 14708-2:2005,
for minimum rate are “Lower rate” or EN 45502-2-1:2003)
“Rest rate”. The IPGs non-
programmable
characteristics for
each input/output
terminal, as
applicable: the basic
rate in reciprocal
minutes
This symbol may
be used for
programmable as
well as non-
programmable
parameters.
6.12 Amplitude and To indicate the NOTE  Synonyms 9.4.1 ISO 7000-3049
pulse width, general shipping for “Amplitude and (ISO 14708-2:2005,
general parameters for pulse width, general” EN 45502-2-1:2003)
amplitude and pulse are “Amplitude and The IPGs non-
width pulse width” or programmable
“Amplitude/pulse characteristics for
width”. each input/output
terminal, as
applicable: the pulse
amplitude (in volts or
milliamperes)
This symbol may
be used for
programmable as
well as non-
programmable
parameters.
6.13 Amplitude and To indicate the NOTE  Synonyms 9.4.1 ISO 7000-3050
pulse width, right shipping parameters for “Amplitude and (ISO 14708-2:2005,
atrial for atrial amplitude pulse width, right EN 45502-2-1:2003)
and pulse width atrial” are “Atrial The IPGs non-
amplitude/pulse programmable
width” or “Amplitude characteristics for
and pulse width, RA” each input/output
or “Amplitude/pulse terminal, as
width, RA” or applicable: the pulse
“Amplitude/pulse amplitude (in volts or
width, right atrial”. milliamperes)
This symbol may
be used for
programmable as
well as non-
programmable
parameters.
6 © ISO 2012 – All rights reserved

Table 1 (continued)
No. Graphical symbol Title Description Informative notes Related subclause ISO 7000
of symbol in AIMD product registration
standards number
6.14 Amplitude and To indicate the NOTE  Synonyms 9.4.1 ISO 7000-3051
pulse width, left shipping parameters for “Amplitude and (ISO 14708-2:2005,
ventricular for left-ventricular pulse width, left EN 45502-2-1:2003)
amplitude and pulse ventricular” are “LV The IPGs
width amplitude/pulse non-programmable
width” or characteristics for
“Amplitude/pulse each input/output
width, LV” or terminal, as
“Amplitude and pulse applicable: the pulse
width, LV” or amplitude (in volts or
“Amplitude/pulse milliamperes)
width, left
This symbol may
ventricular”.
be used for
programmable as
well as
non-programmable
parameters.
6.15 Amplitude and To indicate the NOTE  Synonyms 9.4.1 ISO 7000-3052
pulse width, right shipping parameters for “Amplitude and (ISO 14708-2:2005,
ventricular for right-ventricular pulse width, right EN 45502-2-1:2003)
amplitude and pulse ventricular” are “RV The IPGs
width amplitude/pulse non-programmable
width” or characteristics for
“Amplitude/pulse each input/output
width, RV” or terminal, as
“Amplitude and pulse applicable: the pulse
width, RV” or amplitude (in volts or
“Amplitude/pulse milliamperes)
width, right
This symbol may
ventricular”.
be used for
programmable as
well as
non-programmable
parameters.
6.16 Sensitivity To indicate the 9.4.1 ISO 7000-3053
shipping parameter (ISO 14708-2:2005,
for sensitivity EN 45502-2-1:2003)
(defined as the size The IPGs
of the signal to non-programmable
which the characteristics for
pacemaker ought to each input/output
respond). terminal, as
applicable: the
sensitivity (in
millivolts)
This symbol may
be used for
programmable as
well as
non-programmable
parameters.
Table 1 (continued)
No. Graphical symbol Title Description Informative notes Related subclause ISO 7000
of symbol in AIMD product registration
standards number
6.17 Sensitivity, right To indicate the NOTE  Synonyms 9.4.1 ISO 7000-3054
atrial shipping parameters for “Sensitivity, right (ISO 14708-2:2005,
for right-atrial atrial” are “Atrial EN 45502-2-1:2003)
sensitivity sensitivity” or The IPGs
“Sensitivity, RA” or non-programmable
“Right atrial characteristics for
sensitivity”. each input/output
terminal, as
applicable: the
sensitivity (in
millivolts)
This symbol may
be used for
programmable as
well as
non-programmable
parameters.
6.18 Sensitivity, right To indicate the NOTE  Synonyms 9.4.1 ISO 7000-3055
ventricular shipping parameters for “Sensitivity, right (ISO 14708-2:2005,
for right-ventricular ventricular” are EN 45502-2-1:2003)
sensitivity “Sensitivity, RV” or The IPGs
“Right ventricular non-programmable
sensitivity” or characteristics for
“Ventricular each input/output
sensitivity”. terminal, as
applicable: the
sensitivity (in
millivolts)
This symbol may
be used for
programmable as
well as
non-programmable
parameters.
6.19 Refractory period, To indicate the NOTE  Synonyms 9.4.1 ISO 7000-3056
right atrial shipping parameters for “Refractory (ISO 14708-2:2005,
for atrial refractory period, right atrial” EN 45502-2-1:2003)
period are “Refractory The IPGs
period, RA” or “Right non-programmable
atrial refractory characteristics for
period” or “RA, each input/output
refractory period” or terminal, as
“Atrial refractory applicable: the
period”. refractory period (in
milliseconds)
This symbol may
be used for
programmable as
well as
non-programmable
parameters.
8 © ISO 2012 – All rights reserved

Table 1 (continued)
No. Graphical symbol Title Description Informative notes Related subclause ISO 7000
of symbol in AIMD product registration
standards number
6.20 Refractory period, To indicate the NOTE  Synonyms 9.4.1 ISO 7000-3057
right ventricular shipping parameters for “Refractory (ISO 14708-2:2005,
for ventricular period, right EN 45502-2-1:2003)
refractory period ventricular” are The IPGs
“Refractory period, non-programmable
RV” or “Right characteristics for
ventricular refractory each input/output
period” or “RV, terminal, as
refractory period” or applicable: the
“Ventricular refractory period (in
refractory period”. milliseconds)
This symbol may
be used for
programmable as
well as
non-programmable
parameters.
6.21 Atrial refractory To indicate the NOTE  Synonyms 9.4.1 ISO 7000-3058
period, post shipping parameters for “Atrial refractory (ISO 14708-2:2005,
ventricular for post ventricular period, post EN 45502-2-1:2003)
atrial refractory ventricular” are “Post The IPGs
period ventricular atrial non-programmable
refractory period” or characteristics for
“PVARP”. each input/output
terminal, as
applicable: the
refractory period (in
milliseconds)
This symbol may
be used for
programmable as
well as
non-programmable
parameters.
6.22 Refractory period To indicate the 9.4.1 ISO 7000-3059
shipping parameters (ISO 14708-2:2005,
for refractory period EN 45502-2-1:2003)
The IPGs
non-programmable
characteristics for
each input/output
terminal, as
applicable: the
refractory period (in
milliseconds)
This symbol may
be used for
programmable as
well as
non-programmable
parameters.
Table 1 (continued)
No. Graphical symbol Title Description Informative notes Related subclause ISO 7000
of symbol in AIMD product registration
standards number
6.23 Atrial to To indicate the NOTE  Synonyms 9.4.1 ISO 7000-3060
ventricular shipping parameters for “Atrial to (ISO 14708-2:2005,
interval, paced for paced and ventricular interval, EN 45502-2-1:2003)
and sensed sensed atrial to paced and sensed” The IPGs
ventricular interval are “A-V interval non-programmable
(paced/sensed)” or characteristics for
“AV interval each input/output
(paced/sensed)”. terminal, as
applicable: the A/V
interval, if applicable
(in milliseconds)
This symbol may
be used for
programmable as
well as
non-programmable
parameters.
6.24 Sensed atrial to To indicate the NOTE  Synonyms 9.4.1 ISO 7000-3061
ventricular shipping parameters for “Sensed atrial to (ISO 14708-2:2005,
interval for sensed atrial to ventricular interval” EN 45502-2-1:2003)
ventricular interval are “Sensed A-V The IPGs
interval” or “Sensed non-programmable
AV interval”. characteristics for
each input/output
terminal, as
applicable: the A/V
interval, if applicable
(in milliseconds)
This symbol may
be used for
programmable as
well as
non-programmable
parameters.
6.25 Header face To indicate the 9.4.1 ISO 7000-3062
header face to be (ISO 14708-2:2005,
used for identifying EN 45502-2-1:2003)
connector bore The connector
locations geometry, or provide
a reference by
symbols defined in
published connector
standards
10 © ISO 2012 – All rights reserved

Table 1 (continued)
No. Graphical symbol Title Description Informative notes Related subclause ISO 7000
of symbol in AIMD product registration
standards number
6.26 Single pole high To indicate the NOTE 1  Synonyms 9.4.1 ISO 7000-3063
voltage connector shape to be used for for “Single pole high (ISO 14708-2:2005,
cavity for identifying single voltage connector EN 45502-2-1:2003)
defibrillator pole high voltage cavity for defibrillator” The connector
(DF-1) connector are “DF-1” or “DF-1 geometry, or provide
cavity locations for connector cavity” a reference by
defibrillators employing terms symbols defined in
familiar to the published connector
discipline. standards
NOTE 2  The
header shape is
included in this
symbol to show
perspective. See
Annex A for
examples of this
symbol's usage.
NOTE 3  Unipolar or
bipolar may be
identified using text.
See Annex A for an
example of how this
identification is
accomplished.
6.27 Four pole high To indicate the NOTE 1  Synonyms 9.4.1 ISO 7000-3064
voltage connector shape to be used for for “Four pole high (ISO 14708-2:2005,
cavity for identifying four pole voltage connector EN 45502-2-1:2003)
defibrillator high voltage (DF4) cavity for defibrillator” The connector
connector cavity are “DF4” or “DF4 geometry, or provide
locations for connector cavity”. a reference by
defibrillators symbols defined in
NOTE 2  The
published connector
header shape is
standards
included in this
symbol to show
perspective. See
Annex A for
examples of this
symbol's usage.
NOTE 3  Unipolar or
bipolar may be
identified using text.
See Annex A for an
example of how this
identification is
accomplished.
Table 1 (continued)
No. Graphical symbol Title Description Informative notes Related subclause ISO 7000
of symbol in AIMD product registration
standards number
6.28 Single pole low To indicate the NOTE 1  Synonyms 9.4.1 ISO 7000-3065
voltage connector shape to be used for for “Single pole low (ISO 14708-2:2005,
cavity for identifying single voltage connector EN 45502-2-1:2003)
pacemaker and pole low voltage cavity for pacemaker The connector
defibrillator (IS-1) connector and defibrillator” are geometry, or provide
cavity locations “IS-1” or “IS-1 a reference by
connector cavity”. symbols defined in
published connector
NOTE 2  The
standards
header shape is
included in this
symbol to show
perspective. See
Annex A for
examples of this
symbol's usage.
NOTE 3  Unipolar or
bipolar may be
identified using text.
See Annex A for an
example of how this
identification is
accomplished.
6.29 Four pole low To indicate the NOTE 1  Synonyms 9.4.1 ISO 7000-3066
voltage connector shape to be used for for “Four pole low (ISO 14708-2:2005,
cavity for identifying four pole voltage connector EN 45502-2-1:2003)
pacemaker and low voltage (IS4) cavity for pacemaker The connector
defibrillator connector cavity and defibrillator” are geometry, or provide
locations “IS4” or “IS4 a reference by
connector cavity”. symbols defined in
published connector
NOTE 2  The
standards
header shape is
included in this
symbol to show
perspective. See
Annex A for
examples of this
symbol's usage.
NOTE 3  Unipolar or
bipolar may be
identified using text.
See Annex A for an
example of how this
identification is
accomplished.
12 © ISO 2012 – All rights reserved

Table 1 (continued)
No. Graphical symbol Title Description Informative notes Related subclause ISO 7000
of symbol in AIMD product registration
standards number
6.30 Non-standard To indicate the NOTE 1  A synonym 9.4.1 ISO 7000-3067
connector cavity shape to be used for for “Non-standard (ISO 14708-2:2005,
identifying non- connector cavity” is EN 45502-2-1:2003)
standard connector “Non-standard”. The connector
cavity locations geometry, or provide
NOTE 2  The
a reference by
header shape is
symbols defined in
included in this
published connector
symbol to show
standards
perspective. See
Annex A for
examples of this
symbol's usage.
NOTE 3  Unipolar or
bipolar may be
identified using text.
See Annex A for an
example of how this
identification is
accomplished.
6.31 Legacy connector To indicate the NOTE 1  A synonym 9.4.1 ISO 7000-3068
cavity shape to be used for for “Legacy (ISO 14708-2:2005,
identifying legacy connector cavity” is EN 45502-2-1:2003)
connector cavity “Legacy cavity”. The connector
locations geometry, or prov
...

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