EN ISO 14708-7:2022
(Main)Implants for surgery - Active implantable medical devices - Part 7: Particular requirements for cochlear and auditory brainstem implant systems (ISO 14708-7:2019)
Implants for surgery - Active implantable medical devices - Part 7: Particular requirements for cochlear and auditory brainstem implant systems (ISO 14708-7:2019)
This document specifies requirements that are applicable to those active implantable medical devices that are intended to treat hearing impairment via electrical stimulation of the auditory pathways. Devices which treat hearing impairment via means other than electrical stimulation are not covered by this document.
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 is also applicable to non-implantable parts and accessories of the devices (see NOTE).
The electrical characteristics of the implantable part are determined by either the appropriate method detailed in this document or by any other method demonstrated to have an accuracy equal to, or better than, the method specified. In the case of dispute, the method detailed in this document applies.
NOTE A 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, this document specifies those requirements of non-implantable parts and accessories which could affect the safety or performance of the implantable part.
Chirurgische Implantate - Aktive implantierbare medizinische Geräte - Teil 7: Besondere Anforderungen an Cochlea-Implantat Systeme (ISO 14708-7:2019)
Das vorliegende Dokument legt Anforderungen fest, die für diejenigen aktiven implantierbaren medizinischen
Geräte gelten, die zum Behandeln von Gehörbeeinträchtigungen mittels elektrischer Stimulation der Hörbahn
vorgesehen sind. Geräte, die die Gehörbeeinträchtigung in anderer Weise als mittels elektrischer Stimulation
behandeln, werden im vorliegenden Dokument nicht behandelt.
Die Prüfungen, die im vorliegenden Dokument festgelegt sind, sind Typprüfungen und an Prüflingen eines
Gerätes durchzuführen, um die Einhaltung der Anforderungen nachzuweisen.
Das vorliegende Dokument gilt auch für einige nicht implantierbare Teile und Zubehörteile der Geräte (siehe
ANMERKUNG).
Die elektrischen Kennwerte des implantierbaren Teils werden entweder nach dem geeigneten, im
vorliegenden Dokument beschriebenen Verfahren bestimmt oder nach einem beliebigen anderen Verfahren,
dessen im Vergleich zum festgelegten Verfahren gleichwertige oder höhere Genauigkeit nachgewiesen
wurde. Im Zweifelsfall gilt das im vorliegenden Dokument beschriebene Verfahren.
ANMERKUNG Ein Gerät, das allgemein als aktives implantierbares medizinisches Gerät bezeichnet wird, kann ein
einzelnes Gerät, eine Kombination von Geräten oder eine Kombination von einem Gerät oder Geräten mit einem oder
mehreren Zubehörteilen sein. Es ist nicht erforderlich, dass alle diese Teile entweder teilweise oder ganz implantierbar
sind, im vorliegenden Dokument sind einige Anforderungen für nicht implantierbare Teile und Zubehörteile festgelegt, die
sich auf die Sicherheit oder Leistungsmerkmale des implantierbaren Teils auswirken können.
Implants chirurgicaux - Dispositifs médicaux implantables actifs - Partie 7: Exigences particulières pour les systèmes d'implant cochléaire et d'implant auditif du tronc cérébral (ISO 14708-7:2019)
Le présent document spécifie les exigences applicables aux dispositifs médicaux implantables actifs qui sont destinés au traitement des altérations auditives par la stimulation électrique des voies auditives. Les dispositifs qui traitent les altérations auditives par des moyens autres que la stimulation électrique ne sont pas couverts par le présent document.
Les essais qui sont spécifiés dans le présent document sont des essais de type et doivent être réalisés sur des échantillons d'un dispositif afin d'en démontrer la conformité.
Le présent document est également applicable aux parties non implantables et aux accessoires des dispositifs (voir NOTE).
Les caractéristiques électriques de la partie implantable sont déterminées soit par la méthode appropriée détaillée dans le présent document, soit par toute autre méthode connue pour avoir une exactitude égale ou supérieure à la méthode spécifiée. En cas de litige, la méthode détaillée dans le présent document s'applique.
NOTE Un dispositif couramment désigné comme dispositif médical implantable actif peut en fait être un dispositif individuel, une combinaison de dispositifs ou une combinaison d'un ou de plusieurs dispositifs avec un ou plusieurs accessoires. Ces parties ne sont pas nécessairement toutes implantables, en partie ou en totalité; le présent document spécifie les exigences applicables aux accessoires et parties non implantables qui peuvent affecter la sécurité ou les performances de la partie implantable.
Vsadki (implantati) za kirurgijo - Aktivni medicinski pripomočki za vsaditev - 7. del: Posebne zahteve za sisteme s polžkovim vsadkom (ISO 14708-7:2019, popravljena verzija 2020-05)
Ta dokument določa zahteve, ki se uporabljajo za aktivne medicinske pripomočke za vsaditev, namenjene zdravljenju okvar sluha z električno stimulacijo slušnih poti. Pripomočki, namenjeni zdravljenju slušnih okvar brez električne stimulacije, niso zajeti v tem dokumentu. Preskusi, ki so določeni v tem dokumentu, so tipski preskusi in jih je treba za dokaz skladnosti opraviti na vzorcih pripomočka. Ta dokument se uporablja tudi za dele in dodatno opremo pripomočkov, ki niso namenjeni vsaditvi (glej opombo). Električne karakteristike dela 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 je treba uporabiti metodo, opisano v tem standardu. OPOMBA: 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, ta dokument pa določa zahteve za tiste nevsadne dele in dodatno opremo, ki bi lahko vplivali na varnost ali delovanje pripomočka za vsaditev.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-oktober-2022
Vsadki (implantati) za kirurgijo - Aktivni medicinski pripomočki za vsaditev - 7. del:
Posebne zahteve za sisteme s polžkovim vsadkom (ISO 14708-7:2019, popravljena
verzija 2020-05)
Implants for surgery - Active implantable medical devices - Part 7: Particular
requirements for cochlear and auditory brainstem implant systems (ISO 14708-7:2019)
Chirurgische Implantate - Aktive implantierbare medizinische Geräte - Teil 7: Besondere
Anforderungen an Cochlea-Implantat Systeme (ISO 14708-7:2019)
Implants chirurgicaux - Dispositifs médicaux implantables actifs - Partie 7: Exigences
particulières pour les systèmes d'implant cochléaire (ISO 14708-7:2019)
Ta slovenski standard je istoveten z: EN ISO 14708-7:2022
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 14708-7
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2022
ICS 11.040.40
English version
Implants for surgery - Active implantable medical devices -
Part 7: Particular requirements for cochlear and auditory
brainstem implant systems (ISO 14708-7:2019)
Implants chirurgicaux - Dispositifs médicaux Chirurgische Implantate - Aktive implantierbare
implantables actifs - Partie 7: Exigences particulières medizinische Geräte - Teil 7: Besondere
pour les systèmes d'implant cochléaire et d'implant Anforderungen an Cochlea-Implantat Systeme (ISO
auditif du tronc cérébral (ISO 14708-7:2019) 14708-7:2019)
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 14708-7:2022 E
reserved worldwide for CEN national Members and for
CENELEC Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 14708-7:2022) 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 14708-7:2019 has been approved by CEN-CENELEC as EN ISO 14708-7:2022 without
any modification.
INTERNATIONAL ISO
STANDARD 14708-7
Second edition
2019-12
Corrected version
2020-05
Implants for surgery — Active
implantable medical devices —
Part 7:
Particular requirements for cochlear
and auditory brainstem implant
systems
Implants chirurgicaux — Dispositifs médicaux implantables actifs —
Partie 7: Exigences particulières pour les systèmes d'implant
cochléaire et d'implant auditif du tronc cérébral
Reference number
ISO 14708-7:2019(E)
©
ISO 2019
ISO 14708-7:2019(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 14708-7:2019(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Symbols and abbreviations . 3
5 General requirements for non-implantable parts . 3
5.1 General requirements for non-implantable parts . 3
5.2 General requirements for software . 3
5.3 Usability of non-implantable parts . 3
5.4 Data security and protection from harm caused by unauthorized information tampering 3
5.5 General requirements for risk management . 3
5.6 Misconnection of parts of the active implantable medical device . 3
5.7 Protection against external electrical hazards for fully implantable systems. 3
6 Inspection and measurement . 4
6.1 General . 4
6.2 Measurement of output signal characteristics . 4
6.3 Measurement of the output signal amplitude and pulse width . 4
6.4 Impedance measurement accuracy . 4
6.5 Inductive link characterization . 4
6.6 Sound processor battery testing . 4
7 General arrangement of the packaging . 4
8 General markings for active implantable medical devices . 4
9 Markings on the sales packaging . 4
10 Construction of the sales packaging . 5
11 Markings on the sterile pack. 5
12 Construction of the non-reusable pack . 5
13 Markings on the active implantable medical device . 5
14 Protection from unintentional biological effects being caused by the active
implantable medical device . 6
15 Protection from harm to the patient or user caused by external physical features of
the active implantable medical device . 6
16 Protection from harm to the patient caused by electricity . 6
17 Protection from harm to the patient caused by heat . 7
18 Protection from ionizing radiation released or emitted from the active implantable
medical device. 8
19 Protection from unintended effects caused by the device . 8
20 Protection of the device from damage caused by external defibrillators .9
21 Protection of the device from changes caused by high power electrical fields
applied directly to the patient . 9
22 Protection of the active implantable medical device from changes caused by
miscellaneous medical treatments .10
23 Protection of the active implantable medical device from mechanical forces .18
ISO 14708-7:2019(E)
24 Protection of the active implantable medical device from damage caused by
electrostatic discharge .22
25 Protection of the active implantable medical device from damage caused by
atmospheric pressure changes .22
26 Protection of the active implantable medical device from damage caused by
temperature changes .23
27 Protection of the ac
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