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
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
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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 .
...
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