SIST EN ISO 14708-2:2022

SLOVENSKI STANDARD
01-oktober-2022
Vsadki (implantati) za kirurgijo - Aktivni medicinski pripomočki za vsaditev - 2. del:
Srčni spodbujevalniki (ISO 14708-2:2019)
Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers
(ISO 14708-2:2019)
Chirurgische Implantate - Aktive implantierbare medizinische Geräte - Teil 2:
Herzschrittmacher (ISO 14708-2:2019)
Implants chirurgicaux - Dispositifs médicaux implantables actifs - Partie 2: Stimulateurs
cardiaques (ISO 14708-2:2019)
Ta slovenski standard je istoveten z: EN ISO 14708-2:2022
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 14708-2

NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2022
ICS 11.040.40
English version
Implants for surgery - Active implantable medical devices -
Part 2: Cardiac pacemakers (ISO 14708-2:2019)
Implants chirurgicaux - Dispositifs médicaux Chirurgische Implantate - Aktive implantierbare
implantables actifs - Partie 2: Stimulateurs cardiaques medizinische Geräte - Teil 2: Herzschrittmacher (ISO
(ISO 14708-2:2019) 14708-2:2019)
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 14708-2:2022 E
reserved worldwide for CEN national Members and for
CENELEC Members.
Contents Page
European foreword . 3

European foreword
This document (EN ISO 14708-2:2022) 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 14708-2:2019 has been approved by CEN-CENELEC as EN ISO 14708-2:2022 without
any modification.
INTERNATIONAL ISO
STANDARD 14708-2
Third edition
2019-09
Implants for surgery — Active
implantable medical devices —
Part 2:
Cardiac pacemakers
Implants chirurgicaux — Dispositifs médicaux implantables actifs —
Partie 2: Stimulateurs cardiaques
Reference number
ISO 14708-2:2019(E)
©
ISO 2019
ISO 14708-2:2019(E)
© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved

ISO 14708-2:2019(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Symbols and abbreviated terms . 5
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 Measurements 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 pulse amplitude, pulse duration, pulse interval, and
pulse rate . 6
6.1.3 Measurement of sensitivity (e and e ) . 7
pos neg
6.1.4 Measurement of input impedance (Z ) . 8
in
6.1.5 Measurement of escape interval (t ) . 8
e
6.1.6 Measurement of sensing refractory period (t ) .10
sr
6.1.7 Measurement of pacing refractory period (t ) (applicable only to
pr
inhibited implantable pulse generators).13
6.1.8 Measurement of AV interval (applicable only to dual-chamber
implantable pulse generators) .13
6.1.9 Measurement of the post-ventricular atrial refractory period (PVARP)
(applicable only to implantable pulse generators with atrial sensing and
ventricular pacing) .14
6.1.10 Measurement of the atrial-ventricular (AV) interval after sensing
(applicable only to implantable pulse generators with atrial sensing and
ventricular pacing) .15
6.2 Measurement of the lead pacing impedance (Z ) .16
p
6.2.1 Measurement equipment accuracy.16
6.2.2 Methods of measuring lead pacing impedance .16
6.2.3 In vitro method for measurement of lead pacing impedance .17
7 General arrangement of the packaging .18
8 General markings for active implantable medical devices .18
9 Markings on the sales packaging .18
10 Construction of the sales packaging .20
11 Markings on the sterile pack.20
12 Construction of the non-reusable pack .22
13 Markings on the active implantable medical device .22
14 Protection from unintentional biological effects being caused by the active
implantable medical device .23
15 Protection from harm to the patient or user caused by external physical features of
the active implantable medical device .23
ISO 14708-2:2019(E)
16 Protection from harm to the patient caused by electricity .23
17 Protection from harm to the patient caused by heat .25
18 Protection from ionizing radiation released or emitted from the active implantable
medical device.25
19 Protection from unintended effects caused by the device .26
20 Protection of the device from damage caused by external defibrillators .27
21 Protection of the device from changes caused by high power electrical fields
applied directly to the patient .27
22 Protection of the active implantable medical device from changes caused by
miscellaneous medical treatments .27
23 Protection of the active implantable medical device from mechanical forces .27
24 Protection of the active implantable medical device from damage caused by
electrostatic discharge .31
25 Protection of the active implantable medical device from damage caused by
atmospheric pressure changes .31
26 Protection of the active implantable medical device from damage caused by
temperature changes .32
27 Protection of the active implantable medical device from electromagnetic non-
ionizing radiation .32
28 Accompanying documentation .32
Annex A (informative) Relationship between the fundamental principles in ISO/TR 14283
and the clauses of this document .37
Annex B (informative) Rationale .57
Annex C (informative) Code for describing modes of implantable pulse generators .65
Annex D (normative) Pulse forms .68
Bibliography .70
iv © ISO 2019 – All rights reserved

ISO 14708-2:2019(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 14708-2 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee
SC 6, Active implants.
This third edition cancels and replaces the second edition (ISO 14708-2:2012), 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 as
shown in ISO 14117:2019, Annex N;
— revision of the method for measurement of pulse amplitude and pulse duration in 6.1.2;
— removal of measurement requirements for input impedance in 6.1.4;
— inclusion of new temporary exposure criteria in 17.1 for outer surface temperatures exceeding
39 °C. 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 14708-2:2019(E)
Introduction
This document specifies particular requirements for those active implantable medical devices intended
to treat bradyarrhythmias (pacemakers), to provide basic assurance of safety to both patients and users.
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 pacemaker functions.
Although these devices can deliver an additional therapy with respect to pacemakers, most of their
requirements are similar so that, in most cases, the concepts that apply to pacemakers also apply to
CRT-P device, and the appropriate way to test a CRT-P device is similar to the way pacemakers are tested.
An implantable cardiac pacemaker is essentially a powered electronic device within a sealed,
encapsulating enclosure (an implantable pulse generator). The device can stimulate heart beats by
generating electrical impulses which are transmitted to the heart along implanted, insulated conductors
with electrodes (leads). The pacemaker can be adjusted non-invasively by an electronic device, known
as a programmer.
This document is relevant to all parts of implantable pacemakers, including all accessories. Typical
examples are implantable pulse generators, leads, adaptors, programmers and the related software.
The requirements of this document supplement or modify those of ISO 14708-1. The requirements of
this document take priority over those of ISO 14708-1.
Although both this document and the Directive 90/385/EEC deal with the same products, the structure
and purpose of the two documents are different. Annex A correlates the requirements of the Directive
with the subclauses of ISO 14708-1 and this document. Annex B is a rationale providing further
explanation of the subclauses of this document.
Annex C describes a coding system that may be used to designate bradyarrhythmia pacing modes.
Annex D defines reference points for measurements of pulse amplitude and pulse duration, and the form
of test signal used to determine sensitivity.
All annexes except Annex D are informative.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
vi © ISO 2019 – All rights reserved

INTERNATIONAL STANDARD ISO 14708-2:2019(E)
Implants for surgery — Active implantable medical
devices —
Part 2:
Cardiac pacemakers
1 Scope
This document specifies requirements that are applicable to those active implantable medical devices
intended to treat bradyarrhythmias and devices that provide therapies for cardiac resynchronization.
The tests that are specified in this document are type tests, and are to be carried out on samples of a
device to show compliance.
This document was designed for bradyarrhythmia pulse generators used with endocardial leads
or epicardial leads. At the time of this edition, the authors recognized the emergence of leadless
technologies 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 electrical characteristics of the implantable pulse generator or lead are determined either by the
appropriate method detailed in this particular standard or by any other method demonstrated to have
an accuracy equal to, or better than, the method specified. In case of dispute, the method detailed in
this particular standard applies.
Any features of an active implantable medical device intended to treat tachyarrhythmias are covered
by ISO 14708-6.
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 14117:2019, Active implantable medical devices — Electromagnetic compatibility — EMC test protocols
for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization
devices, Second Edition
ISO 14708-2:2019(E)
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 27186:2010, Active implantable medical devices — Four-pole connector system for implantable cardiac
rhythm management devices — Dimensional and test requirements
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 14708-1 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https: //www .iso .org/obp
— IEC Electropedia: available at http: //www .electropedia .org/
3.1
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
3.2
adaptor
special connector used between an otherwise incompatible implantable pulse generator and a lead
3.3
pacemaker
active implantable medical device intended to treat bradyarrhythmias, comprising an implantable pulse
generator and lead(s)
3.4
implantable pulse generator
part of the pacemaker, including the power supply and electronic circuit that produces an electrical output
3.5
sensor
part of a pacemaker that is designed to detect signals for the purpose of rate modulation or other control
purposes
3.6
dual-chamber
condition of relating both to the atrium and ventricle
3.7
implantable cardiac resynchronization therapy pacing device
CRT-P
active implantable medical device intended to provide improved ventricular activation to optimize
cardiac output, comprising an implantable pulse generator and leads
3.8
sensitivity
minimum signal required to control consistently the function of the implantable pulse generator
3.9
electrode
electrically conducting part (usually the termination of a lead), which is designed to form an interface
with body tissue or body fluid
3.10
bipolar lead
lead with two electrodes, electrically isolated from each other
2 © ISO 2019 – All rights reserved

ISO 14708-2:2019(E)
3.11
unipolar lead
lead with one electrode
3.12
endocardial lead
lead with an electrode designed to make contact with the endocardium, or inner surface of the heart
3.13
epicardial lead
lead with an electrode designed to make contact with the epicardium, or outer surface of the heart
3.14
transvenous
approach to the heart through the venous system
3.15
insertion diameter
minimum bore of a rigid cylindrical tube into which the lead (not including the connector) can
be inserted
3.16
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.
3.17
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
3.18
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
3.19
beat
ordered spontaneous or paced activity of the heart
3.20
pulse
electrical output of an implantable pulse generator intended to stimulate the myocardium
3.21
pulse amplitude
amplitude of the pulse
3.22
pulse duration
duration of the pulse
3.23
pulse interval
interval between equivalent points of two consecutive pulses
3.24
basic pulse interval
pulse interval in absence of sensed cardiac or other electrical influence
ISO 14708-2:2019(E)
3.25
pulse rate
number of pulses per minute
3.26
basic rate
pulse rate of an implantable pulse generator, either atrial or ventricular, unmodified by sensed cardiac or
other electrical influence
3.27
AV interval
atrioventricular interval
delay between an atrial pulse or the sensing of an atrial depolarization and the subsequent ventricular
pulse or the sensing of a ventricular depolarization
3.28
escape interval
time elapsing between the sensing of a spontaneous beat and the succeeding non-triggered pulse of an
implantable pulse generator
3.29
interference pulse rate
pulse rate with which the implantable pulse generator responds when it senses electrical activity that it
recognizes as interference
3.30
maximum tracking rate
maximum pulse rate at which the implantable pulse generator will respond on a 1:1 basis to a
triggering signal
3.31
rate modulation
altering of the pulse interval as a function of a control parameter other than a sensed beat
3.32
refractory period
period of time during which atrial or ventricular pacemaker timing is unaffected by sensed spontaneous
depolarizations, although sensing is not completely disabled
3.33
test pulse interval
pulse interval of an implantable pulse generator when directly influenced by a testing device
3.34
test pulse rate
pulse rate of an implantable pulse generator when directly influenced by a testing device
3.35
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 14708-1:2014, 3.4, modified – “time” substituted for “point”]
4 © ISO 2019 – All rights reserved

ISO 14708-2:2019(E)
3.36
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 14708-1:2014, 3.7, modified – existing definition entirely replaced]
3.37
projected service life
period from the implantation of the implantable pulse generator to the recommended replacement time
under defined conditions
3.38
prolonged service period
PSP
period beyond the recommended replacement time during which the implantable pulse generator
continues to function as specified by the manufacturer to prolong basic bradyarrhythmia pacing
[SOURCE: ISO 14708-1:2014, 3.23, modified – existing definition entirely replaced]
3.39
power source indicator
means of indicating the electrical status of the power source during the implantable pulse generator's
service life
3.40
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 14708-1:2014, 3.25, modified – “time” substituted for “point” and “implantable pulse
generator” substituted for “active implantable medical device”]
3.41
stoichiometric capacity
capacity as defined by the active materials contents in the power source
3.42
usable capacity
portion of the stoichiometric capacity of the power source that can be utilized by the implantable pulse
generator until end of service is reached
3.43
terminal
electrically separate conductive device connection
[SOURCE: ISO 14708-6:2019, 3.39]
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.
ISO 14708-2:2019(E)
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 Measurements 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 implantable pulse generator characteristics 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).
The procedures shall be performed with the implantable pulse generator at a temperature of 37 °C ± 2 °C,
connected to a load of 500 Ω ± 1 % and set to the nominal settings recommended by the manufacturer
(the factory recommended settings), unless otherwise stated.
If the implantable pulse generator has multichannel functionality, each channel's characteristics shall
be determined separately. For simplicity, all the measurement procedures provided show bipolar
implantable pulse generators. For unipolar implantable pulse generators, the case is properly incorporated
in the set-up as the indifferent terminal.
In this document, the term “oscilloscope” may also be interpreted as including data acquisition systems
capable of performing similar measurements.
6.1.2 Measurement of pulse amplitude, pulse duration, pulse interval, and pulse rate
Procedure: Use an interval counter and an oscilloscope.
6 © ISO 2019 – All rights reserved

ISO 14708-2:2019(E)
The implantable pulse generator shall be connected to a 500 Ω ± 1 % load resistor (R ), and the test
L
equipment as shown in Figure 1. The oscilloscope shall be adjusted to display one pulse in full.
The pulse duration (D) shall be measured between the points on the pulse equal to one-third of the peak
pulse amplitude (A ) (see Figure D.1).
max
The pulse amplitude (A) shall be calculated from the time integral over current or voltage, as appropriate,
divided by the pulse duration (see Figure D.2).
The pulse interval (t ) shall be recorded from the display on the interval counter when set to trigger on
p
the leading edge of each pulse.
The pulse rate shall be calculated from the mean interval over at least 20 pulses.
Figure 1 — Measurement of pulse amplitude, pulse duration, pulse interval, and pulse rate
The procedures shall be repeated with load resistors R of 240 Ω ± 1 % and 2 kΩ ± 1 % to determine
L
any change in the values as functions of load resistance.
The results shall be expressed in the following units:
— Pulse duration: milliseconds (ms);
— Pulse amplitude: volts or milliamperes (V or mA);
— Pulse interval: milliseconds (ms);
−1
— Pulse rate: reciprocal minutes (min ).
Whenever the result is recorded, the operating settings of the implantable pulse generator (programmed
pulse rate, etc.) shall also be noted.
6.1.3 Measurement of sensitivity (e and e )
pos neg
Procedure: Use an oscilloscope, nominal input impedance ≥1 MΩ, and a test signal generator, output
impedance ≤1 kΩ, which provides a signal in the form defined by Figure D.3.
The implantable pulse generator shall be connected to a 500 Ω ± 1 % load resistor (R ) and the test
L
equipment as shown in Figure 2. Apply positive polarity test signals from the test signal generator
through a 100 kΩ ± 1 % feed resistor (R ) to point A. Adjust the pulse interval of the test signal generator
F
so that it is at least 50 ms less than the basic pulse interval of the implantable generator. The test signal
amplitude (A ) shall be adjusted to zero, and the oscilloscope shall be adjusted to display several pulses.
T
ISO 14708-2:2019(E)
The test signal amplitude shall be slowly increased until either: for an inhibited-mode implantable
pulse generator, the pulse shall be consistently suppressed; or, for a triggered-mode implantable pulse
generator, the pulse always occurs synchronously with the test signal.
The test signal amplitude shall then be measured. The positive sensitivity, designated e , shall be
pos
calculated by dividing the measured test signal voltage by 201.
Figure 2 — Sensitivity measurement
The procedure shall be repeated with negative polarity test signals applied at point A and the negative
sensitivity designated e shall be similarly calculated.
neg
The results shall be expressed in millivolts (mV).
6.1.4 Measurement of input impedance (Z )
in
The text in 6.1.4 of ISO 14708-2:2012 no longer applies in this document.
6.1.5 Measurement of escape interval (t )
e
Procedure: Use an oscilloscope and a triggerable pulse test signal generator.
The implantable pulse generator shall be connected to a 500 Ω ± 1 % load resistor (R ) and the test
L
equipment as shown in Figure 3. Apply the test signal generator through a 100 kΩ ± 1 % feed resistor
(R ) to point A.
F
Figure 3 — Escape interval measurement
8 © ISO 2019 – All rights reserved

ISO 14708-2:2019(E)
The test signal generator shall be adjusted until the amplitude of the test signal is approximately twice
the value of the positive sensitivity e as determined according to 6.1.3.
pos
The test signal generator shall be adjusted to provide a single pulse with delay, t, between being
triggered and generating the pulse, where t is between 5 % and 10 % greater than the basic pulse
interval (t ) of the implantable pulse generator.
p
The oscilloscope shall be adjusted so that a display similar to that shown in Figure 4 is obtained (the
test signals and the pulses both appear as lines).
Figure 4 — Initial oscilloscope display, when measuring the escape interval
The test signal delay, t, shall be reduced until the test signal no longer falls in the implantable pulse
generator's refractory period. If an inhibited type of implantable pulse generator is being tested, the
oscilloscope display is then similar to that shown in Figure 5. If a triggered (synchronous) implantable
pulse generator is being tested, then the display will be similar to that shown in Figure 6.
Figure 5 — Measurement of escape interval (t ) in inhibited mode
e
ISO 14708-2:2019(E)
Figure 6 — Measurement of escape interval (t ) in triggered (synchronized) mode
e
Measure the time between the test signal (or the output that is triggered by the test signal) and the next
output pulse. This is the escape interval (t ).
e
The result shall be expressed in milliseconds (ms).
6.1.6 Measurement of sensing refractory period (t )
sr
Procedure: Use an oscilloscope and a triggerable double pulse test signal generator.
The implantable pulse generator shall be connected to a 500 Ω ± 1 % load resistor (R ) and the test
L
equipment as shown in Figure 7. Apply the test signal through the series feed resistor (R ) to point A. R
F F
shall be 100 kΩ ± 1 %.
Figure 7 — Refractory period measurement
The test signal generator shall be adjusted until the amplitude of the test signal is approximately twice
the value of positive sensitivity e as determined in 6.1.3.
pos
The test signal generator shall be adjusted to provide a delay, t , between being triggered and generating
the test signal, where t is between 5 % and 10 % greater than the basic pulse interval of the implantable
pulse generator.
10 © ISO 2019 – All rights reserved

ISO 14708-2:2019(E)
The test signal generator shall be set so that the test signal is in the form of a double-pulse with a small
separation, s, between the leading edges of the two components of the test signal (see Figure 8).
Figure 8 — Initial oscilloscope displays when measuring sensing and pacing refractory period
The delay (t ) of the test signal shall be reduced (keeping s constant) until the implantable pulse
generator senses the test signal 1.
Then, in the case of an inhibited implantable pulse generator, test signal 1 causes inhibition of one
pulse from the implantable pulse generator as shown in Figure 9. Then, keeping t constant, t shall
1 2
be increased until the test signal 2 in Figure 9 is delayed as shown in Figure 10. The second pulse in
Figure 10 is displaced from test signal 2 by the escape interval (t ).
e
Figure 9 — Measurement of sensing refractory period in inhibited mode – A
ISO 14708-2:2019(E)
Figure 10 — Measurement of sensing refractory period in inhibited mode – B
In the case of a triggered implantable pulse generator, sensing test signal 1 triggers the implantable
pulse generator (see Figure 11). Then, keeping t constant, t shall be increased until the third pulse in
1 2
Figure 11 occurs simultaneously with test signal 2, as shown in Figure 12.
Figure 11 — Measurement of sensing refractory period in triggered (synchronous) mode – A
Figure 12 — Measurement of sensing refractory period in triggered (synchronous) mode – B
The interval, t t , shall be measured. This interval corresponds to the sensing refractory period (t )
2 − 1 sr .
The result shall be expressed in milliseconds (ms).
12 © ISO 2019 – All rights reserved

ISO 14708-2:2019(E)
6.1.7 Measurement of pacing refractory period (t ) (applicable only to inhibited implantable
pr
pulse generators)
Procedure: Use the equipment and connections required by 6.1.5 and Figure 3.
The test signal generator shall be adjusted until the amplitude of the test signal is approximately twice
the value of positive sensitivity e as determined according to 6.1.3.
pos
The test signal generator shall be adjusted to provide a delayed test pulse, the delay t between triggering
and generating the test signal between 5 % and 10 % greater than the basic pulse interval (t ) of the
p
implantable pulse generator.
The oscilloscope shall be adjusted so that a display similar to that shown in Figure 4 is obtained (the
test signals and the pulses both appear as li
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