SIST EN ISO 14708-2:2022
(Main)Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers (ISO 14708-2:2019)
Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers (ISO 14708-2:2019)
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
Chirurgische Implantate - Aktive implantierbare medizinische Geräte - Teil 2: Herzschrittmacher (ISO 14708-2:2019)
Das vorliegende Dokument legt Anforderungen für jene aktiven implantierbaren medizinischen Geräte fest, die dafür vorgesehen sind, Bradyarrhythmie zu behandeln, sowie für Geräte, die kardiale Resynchronisationstherapien bereitstellen.
Die Prüfungen, die in diesem Dokument festgelegt sind, sind Typprüfungen und an Prüflingen eines Geräts durchzuführen, um die Einhaltung der Anforderungen festzustellen.
Dieses Dokument ist auf Bradyarrhythmie-Impulsgeneratoren anwendbar, die zusammen mit endokardialen oder epikardialen Elektroden eingesetzt werden. Zum Zeitpunkt der Veröffentlichung dieser Ausgabe begann die Entwicklung anschlussloser Technologien, für die dieser Teil zukünftig angepasst werden muss. Solche Anpassungen liegen im Ermessen von Herstellern, die diese Technologien integrieren.
Das vorliegende Dokument gilt auch für einige nicht implantierbare Teile und Zubehörteile der Geräte (siehe Anmerkung 1).
Die elektrischen Leistungsmerkmale eines implantierbaren Impulsgenerators oder einer Elektrode werden entweder durch das in diesen Besonderen Festlegungen beschriebene Prüfverfahren bestimmt oder durch eine andere Prüfung, deren Genauigkeit der des beschriebenen Verfahrens nachweislich entspricht oder überlegen ist. Bei Meinungsverschiedenheiten muss das in diesen Besonderen Festlegungen beschriebene Prüfverfahren angewandt werden.
Alle Funktionen eines aktiven implantierbaren medizinischen Geräts zur Behandlung von Tachyarrhythmien werden durch ISO 14708-6 abgedeckt.
ANMERKUNG 1 Ein Gerät, das üblicherweise als aktives implantierbares medizinisches Gerät bezeichnet wird, kann tatsächlich ein einzelnes Gerät, eine Kombination von Geräten oder eine Kombination von einem Gerät oder Geräten und einem einzelnen Zubehörteil oder mehreren Zubehörteilen sein. Nicht alle diese Teile müssen teilweise oder komplett implantierbar sein, aber es ist notwendig, einige Anforderungen von nicht-implantierbaren Teilen und Zubehörteilen festzulegen, die einen Einfluss auf die Sicherheit oder die Leistungsmerkmale von implantierbaren Geräten haben könnten.
ANMERKUNG 2 In diesem Dokument werden Begriffe, die in Abschnitt 3 definiert werden, in kursiver Schrift gedruckt. Wo ein definierter Begriffe als Merkmal eines anderen Begriffes dient, wird dieser nicht in kursiver Schrift gedruckt, es sei denn, der fragliche Begriff ist auch definiert.
Implants chirurgicaux - Dispositifs médicaux implantables actifs - Partie 2: Stimulateurs cardiaques (ISO 14708-2:2019)
Le présent document spécifie les exigences applicables aux dispositifs médicaux implantables actifs destinés au traitement des bradyarythmies, ainsi qu'aux dispositifs qui fournissent des thérapies de resynchronisation cardiaque.
Les essais spécifiés dans le présent document sont des essais de type, qui sont à réaliser sur des échantillons d'un dispositif pour en prouver la conformité.
Le présent document a été conçu pour les générateurs d'impulsions destinés au traitement des bradyarythmies, équipés de sondes endocardiques ou épicardiques. Au moment de la rédaction de la présente édition, les auteurs ont reconnu l'émergence de technologies sans sonde, pour lesquelles des adaptations de la présente partie seront exigées. Lesdites adaptations sont laissées à la discrétion des fabricants qui ont recours à ces technologies.
Le présent document est aussi applicable à certaines parties et à certains accessoires non implantables des dispositifs (voir Note 1).
Les caractéristiques électriques du générateur d'impulsions implantable ou des sondes sont déterminées, soit par la méthode appropriée décrite dans la présente norme particulière, soit par toute autre méthode dont il a été prouvé qu'elle présentait une exactitude supérieure ou égale à celle de la méthode spécifiée. En cas de contradiction, la méthode décrite dans la présente norme particulière s'applique.
Toutes les fonctionnalités des dispositifs médicaux implantables actifs destinées au traitement des tachyarythmies sont couvertes par l'ISO 14708-6.
NOTE 1 Le dispositif communément appelé dispositif médical implantable actif peut en fait se composer d'un seul dispositif, d'une combinaison de plusieurs dispositifs ou d'une combinaison d'un ou plusieurs dispositifs avec un ou plusieurs accessoires. Il n'est pas exigé que toutes ces parties soient totalement ou partiellement implantables, mais il est nécessaire de spécifier certaines exigences des pièces et accessoires non implantables si elles peuvent avoir une influence sur la sécurité ou les performances du dispositif implantable.
NOTE 2 Dans le présent document, les termes imprimés en italique sont utilisés selon les définitions de l'Article 3. Si un terme défini est utilisé pour qualifier un autre terme, il n'est pas imprimé en italique, sauf si le concept ainsi qualifié est aussi défini.
Vsadki (implantati) za kirurgijo - Aktivni medicinski pripomočki za vsaditev - 2. del: Srčni spodbujevalniki (ISO 14708-2:2019)
Ta dokument določa zahteve, ki se uporabljajo za aktivne medicinske pripomočke za vsaditev, namenjene zdravljenju bradiaritmij, in pripomočke za izvajanje terapij za srčno resinhronizacijo. Preskusi, ki so določeni v tem dokumentu, so tipski preskusi in jih je treba za dokaz skladnosti opraviti na vzorcih pripomočka. Ta dokument je zasnovan za pulzne generatorje za zdravljenje bradiaritmije, ki se uporabljajo z endokardialnimi ali epikardialnimi elektrodami. Avtorji so v času te izdaje upoštevali razvoj brezžičnih tehnologij, zaradi katerih bodo potrebne spremembe tega dela. Za te spremembe so odgovorni proizvajalci, ki v svojih izdelkih uporabljajo omenjene tehnologije. Ta dokument se uporablja tudi za nekatere dele in dodatno opremo pripomočkov, ki niso namenjeni vsaditvi (glej opombo 1). Električne karakteristike pulznega generatorja ali elektrod za vsaditev se določijo z ustrezno metodo, opisano v tem standardu, ali katero koli drugo metodo, ki je dokazano enako ali bolj natančna od opisane metode. V primeru spora se uporabi metoda, opisana v tem standardu. Značilnosti aktivnih medicinskih pripomočkov za vsaditev, namenjenih zdravljenju tahiaritmije, so obravnavane v standardu ISO 14708-6. OPOMBA 1: Pripomoček, ki se običajno imenuje aktivni medicinski pripomoček za vsaditev, je dejansko lahko posamezen pripomoček, skupek pripomočkov ali kombinacija pripomočka ali pripomočkov in enega ali več kosov dodatne opreme. Za nobenega od teh delov ni zahtevano, da jih je mogoče delno ali povsem vsaditi, vendar obstaja potreba po določanju nekaterih zahtev za dele in dodatno opremo, ki ni namenjena vsaditvi, če bi lahko vplivala na varnost ali delovanje pripomočka za vsaditev. OPOMBA 2: V tem dokumentu so izrazi, natisnjeni v poševnem tisku, uporabljeni, kot je določeno v 3. točki. Če je določen izraz uporabljen kot oznaka v drugem izrazu, ni natisnjen v poševnem tisku, razen če je določen tudi tako kvalificiran koncept.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 14708-2:2022
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
SIST EN ISO 14708-2:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 14708-2:2022
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SIST EN ISO 14708-2:2022
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.
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SIST EN ISO 14708-2:2022
EN ISO 14708-2:2022 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 14708-2:2022
EN ISO 14708-2:2022 (E)
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.
3
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SIST EN ISO 14708-2:2022
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SIST EN ISO 14708-2:2022
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
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SIST EN ISO 14708-2:2022
ISO 14708-2:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© 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
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SIST EN ISO 14708-2:2022
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 2019 – All rights reserved iii
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SIST EN ISO 14708-2:2022
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
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SIST EN ISO 14708-2:2022
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 2019 – All rights reserved v
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SIST EN ISO 14708-2:2022
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
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SIST EN ISO 14708-2:2022
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 2019 – All rights reserved 1
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SIST EN ISO 14708-2:2022
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
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SIST EN ISO 14708-2:2022
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 2019 – All rights reserved 3
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SLOVENSKI STANDARD
oSIST prEN ISO 14708-2:2018
01-julij-2018
9VDGNL LPSODQWDWL ]DNLUXUJLMR$NWLYQLPHGLFLQVNLSULSRPRþNL]DYVDGLWHYGHO
6UþQLVSRGEXMHYDOQLNL ,62',6
Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers
(ISO/DIS 14708-2:2018)
Implants chirurgicaux - Dispositifs médicaux implantables actifs - Partie 2: Stimulateurs
cardiaques (ISO/DIS 14708-2:2018)
Ta slovenski standard je istoveten z: prEN ISO 14708-2
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
oSIST prEN ISO 14708-2:2018 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 14708-2:2018
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oSIST prEN ISO 14708-2:2018
DRAFT INTERNATIONAL STANDARD
ISO/DIS 14708-2
ISO/TC 150/SC 6 Secretariat: ANSI
Voting begins on: Voting terminates on:
2018-05-04 2018-07-27
Implants for surgery — Active implantable medical
devices —
Part 2:
Cardiac pacemakers
Implants chirurgicaux — Dispositifs médicaux implantables actifs —
Partie 2: Stimulateurs cardiaques
ICS: 11.040.40
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 14708-2:2018(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2018
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oSIST prEN ISO 14708-2:2018
ISO/DIS 14708-2:2018(E)
ISO 14708-2:201x
22 Contents
23 Foreword . 5
24 Introduction. 6
25 1 Scope . 7
26 2 Normative references . 7
27 3 Terms and definitions . 8
28 4 Symbols and abbreviated terms . 13
29 5 General requirements for non-implantable parts . 13
30 6 Measurements of IMPLANTABLE PULSE GENERATOR and LEAD characteristics . 13
31 7 General arrangement of the packaging . 26
32 8 General MARKINGS for ACTIVE IMPLANTABLE MEDICAL DEVICES . 26
33 9 MARKINGS on the SALES PACKAGING . 26
34 10 Construction of the SALES PACKAGING . 27
35 11 MARKINGS on the STERILE PACK . 27
36 12 Construction of the NON-REUSABLE PACK . 29
37 13 MARKINGS on the ACTIVE IMPLANTABLE MEDICAL DEVICE . 29
38 14 Protection from unintentional biological effects being caused by the ACTIVE IMPLANTABLE
39 MEDICAL DEVICE . 30
40 15 Protection from HARM to the patient or user caused by external physical features of the ACTIVE
41 IMPLANTABLE MEDICAL DEVICE . 30
42 16 Protection from HARM to the patient caused by electricity . 30
43 17 Protection from HARM to the patient caused by heat . 32
COPYRIGHT PROTECTED DOCUMENT
44 18 Protection from ionizing radiation released or emitted from the ACTIVE IMPLANTABLE MEDICAL
© ISO 2018
45 DEVICE . 33
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
46 19 Protection from unintended effects caused by the device. 33
below or ISO’s member body in the country of the requester.
ISO copyright office
47 20 Protection of the device from damage caused by external defibrillators . 34
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
48 21 Protection of the device from changes caused by high power electrical fields applied directly
Fax: +41 22 749 09 47
Email: copyright@iso.org
49 to the patient . 35
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved © ISO 2018 – All rights reserved 3
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oSIST prEN ISO 14708-2:2018
ISO/DIS 14708-2:2018(E)
ISO 14708-2:201x
22 Contents
23 Foreword . 5
24 Introduction. 6
25 1 Scope . 7
26 2 Normative references . 7
27 3 Terms and definitions . 8
28 4 Symbols and abbreviated terms . 13
29 5 General requirements for non-implantable parts . 13
30 6 Measurements of IMPLANTABLE PULSE GENERATOR and LEAD characteristics . 13
31 7 General arrangement of the packaging . 26
32 8 General MARKINGS for ACTIVE IMPLANTABLE MEDICAL DEVICES . 26
33 9 MARKINGS on the SALES PACKAGING . 26
34 10 Construction of the SALES PACKAGING . 27
35 11 MARKINGS on the STERILE PACK . 27
36 12 Construction of the NON-REUSABLE PACK . 29
37 13 MARKINGS on the ACTIVE IMPLANTABLE MEDICAL DEVICE . 29
38 14 Protection from unintentional biological effects being caused by the ACTIVE IMPLANTABLE
39 MEDICAL DEVICE . 30
40 15 Protection from HARM to the patient or user caused by external physical features of the ACTIVE
41 IMPLANTABLE MEDICAL DEVICE . 30
42 16 Protection from HARM to the patient caused by electricity . 30
43 17 Protection from HARM to the patient caused by heat . 32
44 18 Protection from ionizing radiation released or emitted from the ACTIVE IMPLANTABLE MEDICAL
45 DEVICE . 33
46 19 Protection from unintended effects caused by the device. 33
47 20 Protection of the device from damage caused by external defibrillators . 34
48 21 Protection of the device from changes caused by high power electrical fields applied directly
49 to the patient . 35
© ISO 2018 – All rights reserved 3
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oSIST prEN ISO 14708-2:2018
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ISO 14708-2:201x
50 22 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from changes caused by miscellaneous
51 medical treatments . 35
52 23 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from mechanical forces . 35
53 24 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from damage caused by electrostatic
54 discharge . 39
55 25 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from damage caused by atmospheric
56 pressure changes . 39
57 26 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from damage caused by temperature
58 changes . 40
59 27 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from electromagnetic non-ionizing
60 radiation . 40
61 28 Accompanying documentation . 40
62 Annex AA (informative) Relationship between the fundamental principles in ISO/TR 14283 and
63 the clauses of this International Standard. 45
64 Annex BB (informative) Relationship between the clauses of ISO 14708-1 and the fundamental
65 principles in Annex A . 59
66 Annex CC (informative) Rationale . 60
67 Annex DD (informative) Code for describing modes of IMPLANTABLE PULSE GENERATORS . 70
68 Annex EE (normative) PULSE forms . 74
69 Bibliography . 76
70
4 © ISO 2018 – All rights reserved
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oSIST prEN ISO 14708-2:2018
ISO/DIS 14708-2:2018(E)
ISO 14708-2:201x
71 Foreword
72 ISO (the International Organization for Standardization) is a worldwide federation of national
73 standards bodies (ISO member bodies). The work of preparing International Standards is normally
74 carried out through ISO technical committees. Each member body interested in a subject for which a
75 technical committee has been established has the right to be represented on that committee.
76 International organizations, governmental and non-governmental, in liaison with ISO, also take part in
77 the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all
78 matters of electrotechnical standardization.
79 The procedures used to develop this document and those intended for its further maintenance are
80 described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
81 different types of ISO documents should be noted. This document was drafted in accordance with the
82 editorial rules of the ISO/IEC Directives, Part 2. www.iso.org/directives
83 Attention is drawn to the possibility that some of the elements of this document may be the subject of
84 patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
85 any patent rights identified during the development of the document will be in the Introduction and/or
86 on the ISO list of patent declarations received. www.iso.org/patents
87 Any trade name used in this document is information given for the convenience of users and does not
88 constitute an endorsement.
89 ISO 14708-2 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee
90 SC 6, Active implants.
91 This third edition cancels and replaces the second edition (ISO 14708-2:2012), which has been
92 technically revised.
93 A list of all parts in the ISO 14708 series can be found on the ISO website.
94 NOTE The attention of Member Bodies is drawn to the fact that equipment MANUFACTURERS and testing
95 organizations might need a transitional period following publication of a new, amended, or revised ISO
96 publication in which to make products in accordance with the new requirements and to equip them for
97 conducting new or revised tests. It is the recommendation of the committee that the content of this publication
98 not be adopted for mandatory implementation nationally earlier than three years from the date of publication.
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oSIST prEN ISO 14708-2:2018
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ISO 14708-2:201x
99 Introduction
100 This document specifies particular requirements for those ACTIVE IMPLANTABLE MEDICAL DEVICES intended
101 to treat bradyarrhythmias (PACEMAKERS), to provide basic assurance of safety to both patients and users.
102 In recent years, other active implantable cardiovascular devices have emerged, most notably devices
103 that perform the function of improving cardiac output by optimizing ventricular synchrony, in addition
104 to performing PACEMAKER functions.
105 Although these devices can deliver an additional therapy with respect to PACEMAKERS, most of their
106 requirements are similar so that, in most cases, the concepts that apply to PACEMAKERS also apply to CRT-
107 P devices, and the appropriate way to test a CRT-P device is similar to the way PACEMAKERS are tested.
108 An implantable cardiac PACEMAKER is essentially a powered electronic device within a sealed,
109 encapsulating enclosure (an IMPLANTABLE PULSE GENERATOR). The device can stimulate heart BEATs by
110 generating electrical impulses which are transmitted to the heart along implanted, insulated conductors
111 with ELECTRODES (LEADS). The PACEMAKER can be adjusted non-invasively by an electronic device, known
112 as a programmer.
113 This document is relevant to all parts of implantable PACEMAKERS, including all ACCESSORIES. Typical
114 examples are IMPLANTABLE PULSE GENERATORS, LEADS, ADAPTORS, programmers and the related software.
115 The requirements of this part of ISO 14708 supplement or modify those of ISO 14708-1, referred to as
116 the General Standard. The requirements of this document take priority over those of ISO 14708-1.
117 Figures or tables that are additional to those of ISO 14708-1 are numbered starting from 101;
118 additional annexes are lettered AA, BB, etc.
119 Although both this document and the Directive 90/385/EEC deal with the same products, the structure
120 and purpose of the two documents are different. Annex AA correlates the requirements of the Directive
121 with the subclauses of ISO 14708-1 and this document. Annex BB provides reference in the other
122 direction, from this document to the Directive. Annex CC is a rationale providing further explanation of
123 the subclauses of this document.
124 Annex DD describes a coding system that may be used to designate bradyarrhythmia pacing modes.
125 Annex EE defines reference points for measurements of PULSE AMPLITUDE and PULSE DURATION, and the
126 form of test signal used to determine SENSITIVITY.
127 All annexes except Annex EE are informative.
6 © ISO 2018 – All rights reserved
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ISO 14708-2:201x
128 Implants for surgery — Active implantable medical devices —
129 Part 2: Cardiac PACEMAKERS
130 1 Scope
131 This document specifies requirements that are applicable to those ACTIVE IMPLANTABLE MEDICAL DEVICES
132 intended to treat bradyarrhythmias and devices that provide therapies for cardiac resynchronization.
133 The tests that are specified in this document are type tests, and are to be carried out on samples of a
134 device to show compliance.
135 This document was designed for Bradyarrhythmia PULSE generators used with endocardial or epicardial
136 LEADS. At the time of this edition, the authors recognized the emergence of leadless technologies for
137 which adaptations of this part will be required. Such adaptations are left to the discretion of
138 MANUFACTURERS incorporating these technologies.
139 This document is also applicable to some non-implantable parts and ACCESSORIES of the devices (see
140 NOTE 1).
141 The electrical characteristics of the IMPLANTABLE PULSE GENERATOR or LEAD are determined either by the
142 appropriate method detailed in this particular standard or by any other method demonstrated to have
143 an accuracy equal to, or better than, the method specified. In case of dispute, the method detailed in this
144 particular standard applies.
145 Any features of an ACTIVE IMPLANTABLE MEDICAL DEVICE intended to treat tachyarrhythmias are covered by
146 ISO 14708-6.
147 NOTE 1 The device that is commonly referred to as an ACTIVE IMPLANTABLE MEDICAL DEVICE can in fact be a single
148 device, a combination of devices, or a combination of a device or devices and one or more ACCESSORIES. Not all of
149 these parts are required to be either partially or totally implantable, but there is a need to specify some
150 requirements of non-implantable parts and ACCESSORIES if they could affect the safety or performance of the
151 implantable device.
152 NOTE 2 In this document, terms printed in small capital letters are used as defined in Clause 3. Where a defined
153 term is used as a qualifier in another term, it is not printed in small capital letters unless the concept thus qualified
154 is also defined.
155 2 Normative references
156 The following documents, in whole or in part, are normatively referenced in this document and are
157 indispensable for its application. For dated references, only the edition cited applies. For undated
158 references, the latest edition of the referenced document (including any amendments) applies.
159 ISO 5841-3:2013, Implants for surgery — Cardiac pacemakers — Part 3: Low-profile connectors (IS-1) for
160 implantable pacemakers
161 ISO 8601:2004, Data elements and interchange formats — Information interchange — Representation of
162 dates and times
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163 ISO 11318:2002, Cardiac defibrillators — Connector assembly DF-1 for implantable defibrillators —
164 Dimensions and test requirements
1
165 ISO 14117:— , Active implantable medical devices — Electromagnetic compatibility — EMC test
166 protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac
167 resynchronization devices, Second Edition
168 ISO 14708-1:2014, Implants for surgery — Active implantable medical devices — Part 1: General
169 requirements for safety, marking and for information to be provided by the manufacturer
170 ISO 27186:2010, Active implantable medical devices - Four-pole connector system for implantable cardiac
171 rhythm management devices - Dimensional and test requirements
172 3 Terms and definitions
173 For the purposes of this document, the terms and definitions given in ISO 14708-1 and the following
174 apply.
175 ISO and IEC maintain terminological databases for use in standardization at the following addresses:
176 ISO Online browsing platform: available at http://www.iso.org/obp
177 IEC Electropedia: available at http://www.electropedia.org/
178 3.101
179 accessories
180 articles which, while not being a device, are intended specifically by the MANUFACTURER to be used
181 together with a device in accordance with the use of the device intended by the device MANUFACTURER
182 3.102
183 adaptor
184 special connector used between an otherwise incompatible active IMPLANTABLE PULSE GENERATOR and a
185 LEAD
186 3.103
187 pacemaker
188 ACTIVE IMPLANTABLE MEDICAL DEVICE intended to treat bradyarrhythmias, comprising an IMPLANTABLE
189 PULSE GENERATOR and LEAD(S)
190 3.104
191 implantable pulse generator
192 part of the PACEMAKER, including the power supply and electronic circuit that produces an electrical
193 output
194 3.105
195 sensor
196 part of a PACEMAKER that is designed to detect signals for the purpose of RATE MODULATION or other
197 control purposes
1
In development.
8 © ISO 2018 – All rights reserved
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ISO 14708-2:201x
198 3.106
199 dual-chamber
200 condition of relating both to the atrium and ventricle
201 3.107
202 implantable cardiac resynchronization therapy pacing device
203 CRT-P
204 ACTIVE IMPLANTABLE MEDICAL DEVICE intended to provide improved ventricular activation to optimize
205 cardiac output, comprising an IMPLANTABLE PULSE GENERATOR and LEADS
206 [SOURCE: ISO 14117:201x, 3.3, modified – PULSE GENERATOR substituted for “DUT”]
207 3.108
208 sensitivity
209 minimum signal required to control consistently the function of the IMPLANTABLE PULSE GENERATOR
210 3.109
211 electrode
212 electrically conducting part (usually the termination of a LEAD), which is designed to form an interface
213 with body tissue or body fluid
214 3.110
215 bipolar lead
216 LEAD with two ELECTRODES, electrically isolated from each other
217 3.111
218 unipolar lead
219 LEAD with one ELECTRODE
220 3.112
221 endocardial lead
222 LEAD with an ELECTRODE designed to make contact with the endocardium, or inner surface of the heart
223 3.113
224 epicardial lead
225 LEAD with an ELECTRODE designed to make contact with the epicardium, or outer surface of the heart
226 3.114
227 transvenous
228 approach to the heart through the venous system
229 3.115
230 insertion diameter
231 LEAD minimum bore of a rigid cylindrical tube into which the LEAD (not including the connector) can be
232 inserted
233 3.117
234 lead pacing impedance
235 Z
p
236 impedance that is formed by the ratio of a voltage PULSE to the resulting current
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oSIST prEN ISO 14708-2:2018
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ISO 14708-2:201x
237 Note 1 to entry: The impedance is composed of the ELECTRODE to tissue interface and the LEAD impedance.
238 3.119
239 model designation
240 name and/or a combination of letters and numbers used by a MANUFACTURER to distinguish, by function
241 or type, one device from another
242 3.120
243 serial number
244 unique combination of letters and/or numbers, selected by the MANUFACTURER, intended to distinguish a
245 device from other devices with the same MODEL DESIGNATION
246 3.121
247 beat
248 ordered spontaneous or paced activity of the heart
249 3.122
250 pulse
251 electrical output of an IMPLANTABLE PULSE GENERATOR intended to stimulate the myocardium
252 3.123
253 pulse amplitude
254 amplitude of the PULSE
255 Note 1 to entry: The PULSE AMPLITUDE is measured according to the procedure in 6.1.2
256 3.124
257 pulse duration
258 duration of the PULSE
259 Note 1 to entry: The PULSE DURATION is measured according to the procedure in 6.1.2
260 3.125
261 pulse interval
262 interval between equivalent points of two consecutive PULSES
263 Note 1 to entry: The PULSE INTERVAL is measured according to the procedure in 6.1.2
264
265 3.126
266 basic pulse interval
267 PULSE INTERVAL in absence of sensed cardiac or other electrical influence
268 3.127
269 pulse rate
270 number of PULSES per minute
10 © ISO 2018 – All rights reserved
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oSIST prEN ISO 14708-2:2018
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ISO 14708-2:201x
271 Note 1 to entry: The PULSE RATE is measured according to the procedure in 6.1.2
272
273 3.128
274 basic rate
275 PULSE RATE of an IMPLANTABLE PULSE GENERATOR, either atrial or ventricular, unmodified by sensed cardiac
276 or other electrical influence
277 3.129
278 atrioventricular interval
279 AV interval
280 delay between an atrial PULSE or the sensing of an atrial depolarization and the subsequent ventricular
281 PULSE or the sensing of a ventricular depolarization
282 Note 1 to entry: The AV INTERVAL is measured according to the procedure in 6.1.8
283
284 3.130
285 escape interval
286 time elapsing between the sensing of a spontaneous BEAT and the succeeding non-triggered PULSE of an
287 IMPLANTABLE PULSE GENERATOR
288 Note 1 to entry: The ESCAPE INTERVAL is measured according to the procedure in 6.1.5
289
290 3.131
291 hysteresis
292 characteristic of an IMPLANTABLE PULSE GENERATOR defined by the difference between the ESCAPE INTERVAL
293 and the BASIC PULSE INTERVAL
294 Note 1 to entry: The ESCAPE INTERVAL is normally longer than the BASIC PULSE INTERVAL; this is “positive” HYSTERESIS.
295 3.132
296 interference pulse rate
297 PULSE RATE with which the IMPLANTABLE PULSE GENERATOR responds when it senses electrical activity that
298 it recognizes as interference
299 3.133
300 maximum tracking rate
301 maximum PULSE RATE at which the IMPLANTABLE PULSE GENERATOR will respond on a 1:1 basis to a
302 triggering signal
303 3.134
304 rate modulation
305 altering of the PULSE INTERVAL as a function of a control parameter other than a sensed BEAT
306 3.135
307 refractory period
308 period of time during which atrial or ventricular PACEMAKER timing is unaffected by sensed spontaneous
309 depolarizations, although sensing is not completely disabled
© ISO 2018 – All rights reserved 11
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