EN ISO 14708-6:2022

SLOVENSKI STANDARD
01-oktober-2022
Vsadki (implantati) za kirurgijo - Aktivni medicinski pripomočki za vsaditev - 6. del:
Posebne zahteve za aktivne vsadljive medicinske pripomočke, namenjene za
zdravljenje tahiaritmije (vključuje vsadljive defibrilatorje) (ISO 14708-6:2019)
Implants for surgery - Active implantable medical devices - Part 6: Particular
requirements for active implantable medical devices intended to treat tachyarrhythmia
(including implantable defibrillators) (ISO 14708-6:2019)
Chirurgische Implantate - Aktive implantierbare medizinische Geräte - Teil 6: Besondere
Festlegungen für aktive implantierbare medizinische Produkte zur Behandlung von
Tachyarrhythmie (einschließlich implantierbaren Defibrillatoren) (ISO 14708-6:2019)
Implants chirurgicaux - Dispositifs médicaux implantables actifs - Partie 6: Exigences
particulières pour les dispositifs médicaux implantables actifs destinés à traiter la
tachyarythmie (y compris les défibrillateurs implantables) (ISO 14708-6:2019)
Ta slovenski standard je istoveten z: EN ISO 14708-6:2022
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN ISO 14708-6

NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2022
ICS 11.040.40
English version
Implants for surgery - Active implantable medical devices -
Part 6: Particular requirements for active implantable
medical devices intended to treat tachyarrhythmia
(including implantable defibrillators) (ISO 14708-6:2019)
Implants chirurgicaux - Dispositifs médicaux Chirurgische Implantate - Aktive implantierbare
implantables actifs - Partie 6: Exigences particulières medizinische Geräte - Teil 6: Besondere Festlegungen
pour les dispositifs médicaux implantables actifs für aktive implantierbare medizinische Produkte zur
conçus pour traiter la tachyarythmie (y compris les Behandlung von Tachyarrhythmie (einschließlich
défibrillateurs implantables) (ISO 14708-6:2019) implantierbaren Defibrillatoren) (ISO 14708-6:2019)
This European Standard was approved by CEN on 6 July 2022.

CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for
giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical
references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to
any CEN and CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN and CENELEC member into its own language and notified to the CEN-CENELEC
Management Centre has the same status as the official versions.

CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium,
Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia,
Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and United Kingdom.

CEN-CENELEC Management Centre:
Rue de la Science 23, B-1040 Brussels
© 2022 CEN/CENELEC All rights of exploitation in any form and by any means
Ref. No. EN ISO 14708-6:2022 E
reserved worldwide for CEN national Members and for
CENELEC Members.
Contents Page
European foreword . 3

European foreword
This document (EN ISO 14708-6:2022) has been prepared by Technical Committee ISO/TC 150
"Implants for surgery" in collaboration with Technical Committee CEN-CENELEC/ JTC 16 “Active
Implantable Medical Devices” the secretariat of which is held by DKE.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by January 2023, and conflicting national standards shall
be withdrawn at the latest by January 2023.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN-CENELEC shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN and CENELEC
websites.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 14708-6:2019 has been approved by CEN-CENELEC as EN ISO 14708-6:2022 without
any modification.
INTERNATIONAL ISO
STANDARD 14708-6
Second edition
2019-09
Implants for surgery — Active
implantable medical devices —
Part 6:
Particular requirements for active
implantable medical devices intended
to treat tachyarrhythmia (including
implantable defibrillators)
Implants chirurgicaux — Dispositifs médicaux implantables actifs —
Partie 6: Exigences particulières pour les dispositifs médicaux
implantables actifs conçus pour traiter la tachyarythmie (y compris
les défibrillateurs implantables)
Reference number
ISO 14708-6:2019(E)
©
ISO 2019
ISO 14708-6:2019(E)
© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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Published in Switzerland
ii © ISO 2019 – All rights reserved

ISO 14708-6:2019(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Symbols and abbreviated terms . 6
5 General requirements for non-implantable parts . 6
5.1 General requirements for non-implantable parts . 6
5.2 General requirements for software . 6
5.3 Usability of non-implantable parts . 6
5.4 Data security and protection from harm caused by unauthorized information tampering 6
5.5 General requirements for risk management . 6
5.6 Misconnection of parts of the active implantable medical device . 6
6 Measurement of implantable pulse generator and lead characteristics .6
6.1 Measurement of implantable pulse generator characteristics . 6
6.1.1 General considerations . 6
6.1.2 Measurement of the bradyarrhythmia characteristics . 7
6.1.3 Measurement of ICD output voltage . 7
6.1.4 Measurement of delivered CD pulse energy . 8
6.1.5 Measurement of the antitachyarrhythmia pacing pulse amplitude . 8
6.1.6 Measurement of the sensitivity of an implantable pulse generator with
automatic sensitivity control. 8
6.1.7 Charge time. 9
6.1.8 Capacitor formation (capacitor maintenance) . 9
6.2 Measurement of the electrical characteristic of a sensing/pacing lead . 9
7 General arrangement of the packaging . 9
8 General markings for active implantable medical devices . 9
9 Markings on the sales packaging . 9
10 Construction of the sales packaging .11
11 Markings on the sterile pack.11
12 Construction of the non-reusable pack .13
13 Markings on the active implantable medical device .13
14 Protection from unintended biological effects being caused by the active
implantable medical device .13
15 Protection from harm to the patient or user caused by external physical features of
the active implantable medical device .14
16 Protection from harm to the patient caused by electricity .14
17 Protection from harm to the patient caused by heat .18
17.1 Protection from harm to the patient caused by heat .18
17.2 Active implantable medical device intended to supply heat .19
18 Protection from ionizing radiation released or emitted from the active implantable
medical device.19
19 Protection from unintended effects caused by the device .19
20 Protection of the device from damage caused by external defibrillators .20
ISO 14708-6:2019(E)
21 Protection of the device from changes caused by high-power electrical fields
applied directly to the patient .21
22 Protection of the active implantable medical device from changes caused by
miscellaneous medical treatments .21
23 Protection of the active implantable medical device from mechanical forces .21
24 Protection of the active implantable medical device from damage caused by
electrostatic discharge .25
25 Protection of the active implantable medical device from damage caused by
atmospheric pressure changes .26
26 Protection of the active implantable medical device from damage caused by
temperature changes .26
27 Protection of the active implantable medical device from electromagnetic non-
ionizing radiation .26
28 Accompanying documentation .26
Annex A (informative) Relationship between the fundamental principles in ISO/TR 14283
and the clauses of this document .32
Annex B (informative) Notes on ISO 14708-6.53
Annex C (informative) Code for describing modes of implantable pulse generators .64
Bibliography .66
iv © ISO 2019 – All rights reserved

ISO 14708-6:2019(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 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
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/directives).
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
on the ISO list of patent declarations received (see www .iso .org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, 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) principles in the Technical Barriers to Trade (TBT) see www .iso
.org/iso/foreword .html.
ISO 14708-6 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee
SC 6, Active implants.
This second edition cancels and replaces the first edition (ISO 14708-6:2010), which has been technically
revised.
The main changes compared to the previous edition are as follows.
— addition of requirements for congestive heart failure devices;
— introduction of nomenclature for devices having more than two channels of pacing/sensing/
defibrillation as shown in ISO 14117:2019, Annex N;
— inclusion of new temporary exposure criteria in 17.1 for outer surface temperatures exceeding 39 °C;
— revision of atmospheric pressure test requirements in Clause 25 to align with requirements of
ISO 14708-2;
— replacement of detailed requirements in Clause 27 by reference to ISO 14117.
Other changes include updates to selected definitions and incorporation of new measurement
equipment accuracy requirements.
A list of all parts in the ISO 14708 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/members .html.
ISO 14708-6:2019(E)
Introduction
This document specifies particular requirements for implantable cardioverter defibrillators and the
functions of active implantable medical devices intended to treat tachyarrhythmia, to provide basic
assurance of safety for both patients and users.
An external defibrillator is a medical device used, in the emergency setting, to deliver a high-energy
shock to the heart, by means of electrodes applied to the external chest wall, in patients suffering
ventricular fibrillation (a rapid, disorganized and potentially lethal heart rhythm abnormality),
to restore normal heart action. External defibrillators can also be used, in emergency or elective
settings, to terminate other ventricular or atrial tachyarrhythmias by delivery of a high-energy shock,
synchronized to the intrinsic cardiac rhythm, a procedure known as cardioversion. In patients known
to be at risk of such arrhythmias, due to the occurrence of previous episodes or the presence of specific
predisposing cardiac conditions, an implantable cardioverter defibrillator might be implanted to perform
similar functions. The implantable device, which is much smaller than an external defibrillator, is
contained within a sealed, encapsulating enclosure. It generates high voltage pulses from an enclosed,
miniature, electrical battery. The pulses are transmitted to the heart by means of implanted, insulated
conductors with electrodes (leads). The implantable cardioverter defibrillator can also incorporate other
sensing and pacing functions, such as rate support for bradycardia and antitachycardia pacing (ATP) to
terminate certain tachyarrhythmias without the need of a high-energy shock. The defibrillator can be
adjusted non-invasively by means of an electronic device, known as a programmer.
In recent years, other active implantable cardiovascular devices have emerged, most notably devices
that perform the function of improving cardiac output by optimizing ventricular synchrony, in addition
to performing ICD functions.
Although these devices can deliver an additional therapy with respect to ICD devices, most of their
requirements are similar so that, in most cases, the concepts that apply to ICDs also apply to CRT-D
devices, and the appropriate way to test a CRT-D device is similar to the way ICDs are tested.
This document is relevant to all parts of active implantable medical devices intended to treat
tachyarrhythmia other than pacing functions to control bradyarrhythmia or provide cardiac
resynchronization. Typical examples are implantable pulse generators, leads, adaptors, accessories,
programmers and the related software (bradyarrhythmia and cardiac resynchronization pacing
functions are dealt with in ISO 14708-2).
The requirements of this document supplement or modify those of ISO 14708-1, Implants for surgery —
Active implantable medical devices — Part 1: General requirements for safety, marking and for information
to be provided by the manufacturer, hereinafter referred to as ISO 14708-1. The requirements of this
document take priority over those of ISO 14708-1.
In this document, terms printed in italic letters are used as defined in Clause 3. Where a defined term is
used as a qualifier in another term, it is not printed in italic letters unless the concept thus qualified is
also defined.
Information is also provided in Annex A that explains the relationship between ISO/TR 14283, Implants
for surgery — Essential principles of safety and performance, ISO 14708-1 and this document.
Notes on this document are provided in Annex B for information.
Annex C describes a coding system that may be used to designate tachyarrhythmia therapy modes. All
annexes are informative.
vi © ISO 2019 – All rights reserved

INTERNATIONAL STANDARD ISO 14708-6:2019(E)
Implants for surgery — Active implantable medical
devices —
Part 6:
Particular requirements for active implantable medical
devices intended to treat tachyarrhythmia (including
implantable defibrillators)
1 Scope
This document specifies requirements that are applicable to implantable cardioverter defibrillators and
CRT-Ds and the functions of active implantable medical devices intended to treat tachyarrhythmia.
The tests that are specified in ISO 14708 are type tests and are to be carried out on samples of a device
to show compliance.
This document was designed for tachyarrhythmia pulse generators used with either endocardial leads
or epicardial leads. At the time of this edition, the authors recognized the emergence of technologies
that do not use endocardial or epicardial leads for which adaptations of this part will be required. Such
adaptations are left to the discretion of manufacturers incorporating these technologies.
This document is also applicable to some non-implantable parts and accessories of the devices (see
Note 1).
The characteristics of the implantable pulse generator or lead shall be determined by either the
appropriate method detailed in this document or by any other method demonstrated to have accuracy
equal to, or better than, the method specified. In the case of dispute, the method detailed in this
document shall apply.
Any aspect of an active implantable medical device intended to treat bradyarrhythmias or cardiac
resynchronization is covered by ISO 14708-2.
NOTE 1 The device that is commonly referred to as an active implantable medical device can in fact be
a single device, a combination of devices, or a combination of a device or devices and one or more accessories.
Not all of these parts are required to be either partially or totally implantable, but there is a need to specify
some requirements of non-implantable parts and accessories if they could affect the safety or performance of the
implantable device.
NOTE 2 In this document, terms printed in italics are used as defined in Clause 3. Where a defined term is
used as a qualifier in another term, it is not printed in italics unless the concept thus qualified is also defined.
2 Normative references
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 5841-3:2013, Implants for surgery — Cardiac pacemakers — Part 3: Low-profile connectors (IS-1) for
implantable pacemakers
ISO 11318:2002, Cardiac defibrillators — Connector assembly DF-1 for implantable defibrillators —
Dimensions and test requirements
ISO 14708-6:2019(E)
ISO 14117:2019, Active implantable medical devices — Electromagnetic compatibility — EMC test protocols
for implantable cardiac pacemakers and implantable cardioverter defibrillators
ISO 14708-1:2014, Implants for surgery — Active implantable medical devices — Part 1: General
requirements for safety, marking and for information to be provided by the manufacturer
ISO 14708-2:2019, Implants for surgery — Active implantable medical devices — Part 2: Cardiac
pacemakers
IEC/TR 60878:2015, Graphical symbols for electrical equipment in medical practice
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 14708-1 and the following apply.
— ISO Online browsing platform: available at http: //www .iso .org/obp
— IEC Electropedia: available at http: //www .electropedia .org/
3.1
adaptor
special connector used between an otherwise incompatible implantable pulse generator and a lead
[SOURCE: ISO 14708-2:2019, 3.2]
3.2
implantable cardioverter defibrillator
ICD
active implantable medical device comprising an implantable pulse generator and lead(s) that is intended
to detect and correct tachycardias and fibrillation by application of cardioversion/defibrillation pulse(s)
to the heart
3.3
implantable pulse generator
IPG
part of the active implantable medical device, including the power supply and electronic circuit that
produces an electrical output
Note 1 to entry: For purposes of this document, the term implantable pulse generator describes any active
implantable medical device that incorporates functions intended to treat tachyarrhythmias.
[SOURCE: ISO 14708-2:2019, 3.4, modified – “active implantable medical device” substituted for
“pacemaker”, NOTE 1 to entry added]
3.4
sensitivity
minimum signal required to control consistently the function of the implantable pulse generator
[SOURCE: ISO 14708-2:2019, 3.8]
3.5
electrode
electrically conducting part (usually the termination of a lead), which is designed to form an interface
with body tissue or body fluid
[SOURCE: ISO 14708-2:2019, 3.9]
3.6
endocardial lead
lead with an electrode designed to make contact with the endocardium, or inner surface of the heart
[SOURCE: ISO 14708-2:2019, 3.12]
2 © ISO 2019 – All rights reserved

ISO 14708-6:2019(E)
3.7
epicardial lead
lead with an electrode designed to make contact with the epicardium, or outer surface of the heart
[SOURCE: ISO 14708-2:2019, 3.13]
3.8
transvenous
approach to the heart through the venous system
[SOURCE: ISO 14708-2:2019, 3.14]
3.9
insertion diameter
minimum bore of a rigid cylindrical tube into which the lead (not including the connector) can be
inserted
[SOURCE: ISO 14708-2:2019, 3.15]
3.10
lead pacing impedance
Z
p
impedance that is formed by the ratio of a voltage pulse to the resulting current
Note 1 to entry: The impedance is composed of the electrode to tissue interface and the lead impedance.
[SOURCE: ISO 14708-2:2019, 3.16].
3.11
model designation
name and/or a combination of letters and numbers used by a manufacturer to distinguish, by function
or type, one device from another
[SOURCE: ISO 14708-2:2019, 3.17]
3.12
serial number
unique combination of letters and/or numbers, selected by the manufacturer, intended to distinguish a
device from other devices with the same model designation
[SOURCE: ISO 14708-2:2019, 3.18]
3.13
pulse
electrical output of an implantable pulse generator other than CD pulse intended to stimulate the
myocardium
[SOURCE: ISO 14708-2:2019, 3.20, modified – added “other than CD pulse”.]
3.14
pulse amplitude
amplitude of the pulse
[SOURCE: ISO 14708-2:2019, 3.21]
3.15
pulse duration
duration of the pulse
[SOURCE: ISO 14708-2:2019, 3.22]
ISO 14708-6:2019(E)
3.16
pulse interval
interval between equivalent points of two consecutive pulses
[SOURCE: ISO 14708-2:2019, 3.23]
3.17
automatic sensitivity control
automatic adjustment of the sensitivity in response to available physiological signals
3.18
beginning of service
BOS
time at which an individual implantable pulse generator is first released by the manufacturer as fit for
being placed on the market
[SOURCE: ISO 14708-2:2019, 3.35]
3.19
end of service
EOS
time at which the prolonged service period has elapsed and no further pacing function is specified nor
can be expected
[SOURCE: ISO 14708-2: 2019, 3.36]
3.20
prolonged service period
PSP
period beyond the recommended replacement time during which the implantable pulse generator
continues to function as specified by the manufacturer
[SOURCE: ISO 14708-2:2019, 3.38, modified – deleted “to prolong basic bradyarrhythmia pacing”]
3.21
power source indicator
means of indicating the electrical status of the power source during the implantable pulse generator's
service life
[SOURCE: ISO 14708-2:2019, 3.39]
3.22
recommended replacement time
RRT
time at which the power source indicator reaches the value set by the manufacturer of the implantable
pulse generator for its recommended replacement.
Note 1 to entry: This indicates entry into the prolonged service period
[SOURCE: ISO 14708-2:2019, 3.40]
3.23
antitachycardia pacing
ATP
cardiac pacing sequences intended to terminate re-entry tachycardias
3.24
ATP only device
implantable pulse generator capable of delivering rapid sequences of pacing pulses to terminate
ventricular (VT) and atrial (AT) tachycardia and atrial fibrillation (AF)
4 © ISO 2019 – All rights reserved

ISO 14708-6:2019(E)
3.25
cardioversion
termination of atrial tachyarrhythmia or ventricular tachycardia by pulse(s) synchronized to
cardiac events
3.26
cardioversion/defibrillation pulse
CD pulse
high-energy monophasic, biphasic, or multiphasic pulse intended to restore normal rhythm by shocking
the heart
3.27
capacitor formation
any charge to maximum-programmed energy that dissipates off the capacitors (is not dumped) for at
least 10 min
3.28
cardioversion/defibrillation lead
CD lead
lead used to conduct a CD pulse from the implantable pulse generator to the heart
3.29
charge time
the time required to charge the high-voltage capacitors to a specified CD pulse energy
3.30
delivered cardioversion/defibrillation pulse energy
delivered CD pulse energy
total energy delivered to a standard load (50 Ω) by all phases of a CD pulse, measured according to 6.1.4
3.31
defibrillation
termination of fibrillation
3.32
ICD output voltage
peak voltage of the cardioversion/defibrillation pulses, measured according to 6.1.3
3.33
terminal
electrically separate conductive device connection
3.34
implantable cardiac resynchronization therapy/defibrillator device
CRT-D
active implantable medical device intended to detect and correct tachycardias and fibrillation by
application of cardioversion/defibrillation pulses to the heart, and to provide improved ventricular
activation to optimize cardiac output, comprising an implantable pulse generator and leads
3.35
accessory
article which, while not being a device, is intended specifically by the manufacturer to be used together
with a device in accordance with the use of the device intended by the device manufacturer
[SOURCE: ISO 14708-2:2019, 3.1]
ISO 14708-6:2019(E)
3.36
pacemaker
active implantable medical device intended to treat bradyarrhythmias, comprising an implantable pulse
generator and lead(s)
[SOURCE: ISO 14708-2:2019, 3.3]
4 Symbols and abbreviated terms
The text in Clause 4 of ISO 14708-1:2014 applies.
NOTE See ISO 27185 for symbols to use when expressing information so as to reduce the need for multiple
languages on packaging and in manuals.
5 General requirements for non-implantable parts
5.1 General requirements for non-implantable parts
The text in 5.1 of ISO 14708-1:2014 applies.
5.2 General requirements for software
The text in 5.2 of ISO 14708-1:2014 applies.
5.3 Usability of non-implantable parts
The text in 5.3 of ISO 14708-1:2014 applies.
5.4 Data security and protection from harm caused by unauthorized information
tampering
The text in 5.4 of ISO 14708-1:2014 applies.
5.5 General requirements for risk management
The text in 5.5 of ISO 14708-1:2014 applies.
5.6 Misconnection of parts of the active implantable medical device
The text in 5.6 of ISO 14708-1:2014 applies.
6 Measurement of implantable pulse generator and lead characteristics
6.1 Measurement of implantable pulse generator characteristics
6.1.1 General considerations
The manufacturer shall ensure that measurement equipment accuracy is sufficient to support the
stated tolerances for the parameters being measured within this clause and stated by the manufacturer
in the accompanying documentation (see 28.8).
The values of the electrical characteristics for the implantable pulse generator measured in accordance
with the methods described in this clause shall be within the range of values stated by the manufacturer
in the accompanying documentation (see 28.8.2).
6 © ISO 2019 – All rights reserved

ISO 14708-6:2019(E)
CAUTION — The tests in this subclause can employ the use of high voltage. Failure to use safe
laboratory practices can result in severe electrical shock, resulting in personal injury or death to
the persons handling the equipment or conducting the test. Also damage to electrical equipment
is possible.
The measurements shall be made with the implantable pulse generator at a temperature of 37 °C ± 2 °C.
6.1.2 Measurement of the bradyarrhythmia characteristics
Measurement of the bradyarrhythmia and cardiac resynchronization characteristics of the implantable
pulse generator shall be performed using the appropriate methods specified in 6.1 of ISO 14708-2:2019.
The characteristics shall be measured with the tachyarrhythmia therapies inactivated.
6.1.3 Measurement of ICD output voltage
NOTE This clause does not apply to ATP only devices.
Procedure: Use an oscilloscope, with input impedance of nominal 1 MΩ, ≤ 30 pF.
Figure 1 — Measurement of CD pulse characteristics
The implantable pulse generator shall be connected to the oscilloscope as shown in Figure 1. terminals
of the implantable pulse generator intended to deliver a CD pulse shall be connected to a low-inductance
load of 50 Ω ± 1 % (R ). Other inputs/outputs shall be connected to loads of 500 Ω ± 5 % (R ). The
A B
oscilloscope shall be adjusted to display one phase of the CD pulse.
The implantable pulse generator shall be programmed to the maximum CD pulse energy setting.
The ICD output voltage (V ) shall be determined by recording the peak amplitude of the voltage across
max
the resistor R (see Figure 1 and Figure 2).
A
The procedure shall be repeated for each type of CD pulse (i.e. monophasic, biphasic waveform).
The entire procedure shall be repeated for the other required CD pulse energy settings [see 28.8.2 d) 2)].
The results shall be expressed in volts (V) and shall be within the tolerance of disclosed data [see
28.8.2 d) 2)].
ISO 14708-6:2019(E)
Figure 2 — Measurement of ICD output voltage
6.1.4 Measurement of delivered CD pulse energy
NOTE This clause does not apply to ATP only devices.
Procedure: Use the oscilloscope and measurement set-up specified in 6.1.3.
The oscilloscope shall be adjusted to display one CD pulse. The implantable pulse generator shall be
programmed to deliver the maximum CD pulse energy setting.
The CD pulse shall be determined by recording the voltage waveform V (see Figure 2) across the
(t)
resistor R (see Figure 1). The delivered CD pulse energy, W, shall be calculated by applying the formula:
A
Tp
Vt()
W = dt
∫
R
A
where
T = duration (all phases) of the CD pulse;
p
V = instantaneous voltage;
(t)
R = 50 Ω.
A
For devices with more than two output terminals, the delivered CD pulse energy (W) shall
be determined by the sum of the energies delivered from each terminal, as measured by the
manufacturer's disclosed method.
The entire procedure shall be repeated for the other required CD pulse energy settings [see 28.8.2 d) 2)].
The result shall be expressed in joules (J) and shall be within the tolerance of disclosed data [see
28.8.2 d) 2)].
6.1.5 Measurement of the antitachyarrhythmia pacing pulse amplitude
The low-voltage antitachyarrhythmia pacing pulse amplitude of an implantable pulse generator shall be
measured with the device set in the as-shipped mode or as recommended by the manufacturer using
the procedure in 6.1.2 of ISO 14708-2:2019 [see 28.8.2 d) 3)].
6.1.6 Measurement of the sensitivity of an implantable pulse generator with automatic
sensitivity control
The lowest (most sensitive) sensing threshold for both positive and negative polarities shall be measured
using a method as specified by the manufacturer [see 28.8.2 d) 4)].
8 © ISO 2019 – All rights reserved

ISO 14708-6:2019(E)
6.1.7 Charge time
NOTE This clause does not apply to ATP only devices.
The values of typical charge times (when the capacitors are fully formed) for maximum CD pulse energy
shall be disclosed at BOS and at RRT, as a minimum [see 28.8.2 d) 5)].
6.1.8 Capacitor formation (capacitor maintenance)
NOTE This clause does not apply to ATP only devices.
If applicable the manufacturer shall provide instructions for periodic capacitor formation to be
performed at least in connection with patient follow-up sessions, unless the implantable pulse generator
provides a feature of fully automatic capacitor formation.
6.2 Measurement of the electrical characteristic of a sensing/pacing lead
The values of the electrical characteristics of any sensing/pacing lead of the implantable cardioverter
defibrillator measured in accordance with the appropriate method specified in 6.2 of ISO 14708-2 shall
be within the range of values stated by the manufacturer in the accompanying documentation (see
28.8.3).
7 General arrangement of the packaging
7.1 The text in 7.1 of ISO 14708-1:2014 applies.
7.2 The text in 7.2 of ISO 14708-1:2014 applies.
7.3 The implantable pulse generator shall be shipped with the antitachycardia pacing and/or
cardioversion and/or defibrillation inactivated.
Compliance is checked by inspection.
NOTE When cardioversion and/or defibrillation are inactivated the implantable pulse generator is not capable
of delivering any CD pulse(s).
8 General markings for active implantable medical devices
8.1 The text in 8.1 of ISO 14708-1:2014 applies.
8.2 The text in 8.2 of ISO 14708-1:2014 applies.
9 Markings on the sales packaging
9.1 The text in 9.1 of ISO 14708-1:2014 applies.
9.2 The text in 9.2 of ISO 14708-1:2014 applies.
9.3 The text in 9.3 of ISO 14708-1:2014 applies.
ISO 14708-6:2019(E)
9.4 The text in 9.4 of ISO 14708-1:2014 applies.
9.4.1 The sales packaging containing an implantable pulse generator shall bear a list of the
tachyarrhythmia therapies available.
Instead of using words to describe the tachyarrhythmia therapies, the mode codes in Annex C may
be used.
Compliance is checked by inspection.
9.4.2 The sales packaging containing an implantable pulse generator shall bear a statement that the
tachyarrhythmia therapies of the implantable pulse generator, as shipped, are inactive.
NOTE 1 See 7.3 for the shipping requirements for antitachycardia pacing, cardioversion and defibrillation.
NOTE 2 For ATP only devices, the CD terminals part of the requirement is not applicable.
Compliance is checked by inspection.
9.4.3 If applicable, the sales packaging containing an implantable pulse generator shall bear a
description of the most comprehensive bradyarrhythmia pacing mode available and, if different, the
pacing mode as shipped.
NOTE The pacing mode as shipped is meant to be the pacing mode of the device available when first removed
from its packaging if the device is shipped in a ready-to-implant state, or the mode first available upon activation
without any additional programming.
Instead of describing the bradyarrhythmia pacing mode in words, the mode codes defined in Annex C
of ISO 14708-2:2019 may be used in the markings and accompanying documentation to designate the
bradyarrhythmia pacing mode of the implantable pulse generator.
Compliance is checked by inspection.
9.4.4 The sales packaging containing a lead shall bear the following information necessary to
appropriately prescribe the lead:
a) Identifying information as applicable: e.g. epicardial or endocardial; straight or shaped; unipolar,
bipolar or multipolar; drug eluting; passive or active fixation; recommended anatomical placement.
b) Physical dimensions, including:
1) the length (in centimetres);
2) for a transvenous lead, the insertion diameter (in millimetres) and the size of the corresponding
introducer (in French gauge);
3) connector geometry shall be provided by a refere
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