SIST 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 (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
SIST EN ISO 14708-7:2022
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
SIST EN ISO 14708-7:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 14708-7:2022
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SIST EN ISO 14708-7:2022
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.
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SIST EN ISO 14708-7:2022
EN ISO 14708-7:2022 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 14708-7:2022
EN ISO 14708-7:2022 (E)
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.
3
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SIST EN ISO 14708-7:2022
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SIST EN ISO 14708-7:2022
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
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SIST EN ISO 14708-7:2022
ISO 14708-7:2019(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 14708-7:2022
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 2019 – All rights reserved iii
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SIST EN ISO 14708-7:2022
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 active implantable medical device from electromagnetic non-
ionising radiation .23
27.1 Protection from static magnetic fields .23
27.2 Radiated magnetic field test for frequencies 16,6 Hz to 27 MHz .23
27.3 Radiated electric field test for frequencies 10 MHz to 2,7 GHz .25
27.4 General test configuration and setup .25
27.4.1 Test configuration and setup .25
27.4.2 Operating functions, modes and settings .26
27.4.3 Patient physiological simulation .26
27.5 Acceptance Criteria .26
28 Accompanying documentation .27
Annex A (informative) General guidance and rationale .31
Annex B (informative) Relationship between the fundamental principles in ISO/TR 14283
and the clauses of this document .42
Annex C (informative) Notes on EN 45502-2-3 (basis for this document) .61
Annex D (informative) Notes on EMI measurements to demonstrate compliance with Clause 27 .62
Bibliography .66
iv © ISO 2019 – All rights reserved
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SIST EN ISO 14708-7:2022
ISO 14708-7:2019(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.
This document was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee
SC 6, Active implants.
This second edition cancels and replaces the first edition (ISO 14708-7:2013), which has been technically
revised. The main changes compared to the previous edition are as follows:
— alignment to the revised ISO 14708-1:2014;
— significant changes to Clauses 17, 22 and 27;
— many clauses have been replaced by references to ANSI/AAMI CI86: 2017.
A list of all part 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.
This corrected version of ISO 7063:2018 incorporates the following correction: in 16.2, the word
"direct" was added in the following sentence: "The maximum direct current density at the electrode
2
contact opening shall be no more than 0,75 μA/mm ".
© ISO 2019 – All rights reserved v
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SIST EN ISO 14708-7:2022
ISO 14708-7:2019(E)
Introduction
This document specifies particular requirements for active implantable medical devices used to
treat hearing impairment via electrical stimulation (for example, cochlear implant systems or auditory
brainstem implant systems), to provide basic assurance of safety for both patients and users.
A cochlear implant system or auditory brainstem implant system is an active implantable medical device
comprising implantable and non-implantable parts (external parts). The power source can be externally
derived or from an internal battery. The implant system is designed to restore hearing via electrical
stimulation of the auditory pathways. Externally or internally processed acoustic information is
converted to electrical stimulation signals which are delivered via one or more electrodes. The working
parameters of the device may be adjusted via a non-implantable accessory.
This document is relevant to all parts of implant systems, including accessories.
The requirements of this document supplement or modify those of ISO 14708-1:2014.
In this document, terms printed in italic letters are used as defined in Clause 3. Where a defined term is
used as a qualifier in another term, it is not printed in italic letters unless the concept thus qualified is
also defined.
Information is also provided in Annex B that explains the relationship between ISO/TR 14283,
ISO 14708-1:2014 and this document.
Notes on EN 45502-2-3 (basis for this document) is provided in Annex C for information.
vi © ISO 2019 – All rights reserved
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SIST EN ISO 14708-7:2022
INTERNATIONAL STANDARD ISO 14708-7:2019(E)
Implants for surgery — Active implantable medical
devices —
Part 7:
Particular requirements for cochlear and auditory
brainstem implant systems
1 Scope
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.
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/TS 10974, Assessment of the safety of magnetic resonance imaging for patients with an active
implantable medical device
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
IEC 60068-2-31, Environmental testing — Part 2-31: Tests — Test Ec: Rough handling shocks, primarily for
equipment-type specimens
IEC 60601-1-2, Medical electrical equipment — Part 1-2: General requirements for basic safety and essential
performance — Collateral standard: Electromagnetic compatibility — Requirements and tests
IEC 61000-4-2, Electromagnetic compatibility (EMC) — Part 4-2: Testing and measurement techniques —
Electrostatic discharge immunity test
EN 1593, Non-destructive testing — Leak testing — Bubble emission techniques
EN 13185, Non-destructive testing — Leak testing — Tracer gas method
© ISO 2019 – All rights reserved 1
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SIST EN ISO 14708-7:2022
ISO 14708-7:2019(E)
ANSI/AAMI CI86: 2017, Cochlear implant systems: Requirements for safety, functional verification, labeling
and reliability reporting
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 14708-1:2014 and the
following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at http:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
cochlear implant system
CIS
active implantable medical device, comprising implantable and non-implantable parts (3.4), intended to
treat hearing impairment via electrical stimulation of the cochlea
3.2
auditory brainstem implant system
ABIS
active implantable medical device, comprising implantable and non-implantable parts (3.4), intended to
treat hearing impairment via electrical stimulation of the auditory brainstem
3.3
implant system
either cochlear implant system (3.1) or auditory brainstem implant system (3.2)
3.4
non-implantable part
external part of the implant system (3.3)
Note 1 to entry: Examples would include, but are not limited to, sound processor, microphone, coil or power source.
3.5
stimulator
implantable part of the implant system (3.3) containing electronic circuitry required to produce
electrical stimulation
3.6
body-worn
non-implantable part (3.4) of the implant system (3.3) and worn on the body (e.g. belt or ear level)
3.7
electrode contact
electrically conducting part which is designed to form an interface with body tissue or body fluid
3.8
electrode array
distal part of a lead containing more than one electrode contact (3.7)
3.9
reference electrode
electrically conducting part designed as return path for electrical stimulation current
3.10
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
2 © ISO 2019 – All rights reserved
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SIST EN ISO 14708-7:2022
ISO 14708-7:2019(E)
3.11
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 (3.10)
3.12
output signal
electrical output, either pulsatile or analogue, of an implant system (3.3) intended to stimulate the
auditory pathways
3.13
use-before-date
date after which the manufacturer recommends that the implant system (3.3) should not be implanted
4 Symbols and abbreviations
There are no requirements specified in this document. However, this does not preclude the use of
symbols defined in other standards nor special symbols defined in the accompanying documentation.
5 General requirements for non-implantable parts
5.1 General requirements for non-implantable parts
The text in ISO 14708-1:2014, 5.1 applies.
5.2 General requirements for software
The text in ISO 14708-1:2014, 5.2 applies.
5.3 Usability of non-implantable parts
The text in ISO 14708-1:2014, 5.3 applies.
5.4 Data security and protection from harm caused by unauthorized information
tampering
The text in ISO 14708-1:2014, 5.4 applies.
5.5 General requirements for risk management
The text in ISO 14708-1:2014, 5.5 applies.
5.6 Misconnection of parts of the active implantable medical device
The text in ISO 14708-1:2014, 5.6 applies.
5.7 Protection against external electrical hazards for fully implantable systems
The text in ANSI/AAMI CI86: 2017, 5.7 applies.
© ISO 2019 – All rights reserved 3
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SIST EN ISO 14708-7:2022
ISO 14708-7:2019(E)
6 Inspection and measurement
6.1 General
If this document refers to inspection of design analysis documentation provided by the manufacturer, it
shall include an inspection of the risk management file as required by ISO 14971.
6.2 Measurement of output signal characteristics
The text in ANSI/AAMI CI86: 2017, 8.1 applies.
NOTE This ANSI/AAMI CI86 subclause is not a measurement step but describes the test configuration for
the measurement steps in 6.3 to 6.5.
6.3 Measurement of the output signal amplitude and pulse width
The text in ANSI/AAMI CI86: 2017, 8.2 applies.
6.4 Impedance measurement accuracy
The text in ANSI/AAMI CI86: 2017, 8.3 applies.
6.5 Inductive link characterization
The text in ANSI/AAMI CI86: 2017, 8.4 applies.
6.6 Sound processor battery testing
The text in ANSI/AAMI CI86: 2017, 8.5 applies.
7 General arrangement of the packaging
The text in ISO 14708-1:2014, Clause 7 applies.
8 General markings for active implantable medical devices
The text in ISO 14708-1:2014, Clause 8 app
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SLOVENSKI STANDARD
oSIST prEN ISO 14708-7:2018
01-junij-2018
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Implants for surgery - Active implantable medical devices - Part 7: Particular
requirements for cochlear implant systems (ISO/DIS 14708-7:2018)
Implants chirurgicaux - Dispositifs médicaux implantables actifs - Partie 7: Exigences
particulières pour les systèmes d'implant cochléaire (ISO/DIS 14708-7:2018)
Ta slovenski standard je istoveten z: prEN ISO 14708-7
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
oSIST prEN ISO 14708-7:2018 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 14708-7:2018
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oSIST prEN ISO 14708-7:2018
DRAFT INTERNATIONAL STANDARD
ISO/DIS 14708-7
ISO/TC 150/SC 6 Secretariat: ANSI
Voting begins on: Voting terminates on:
2018-03-27 2018-06-19
Implants for surgery — Active implantable medical
devices —
Part 7:
Particular requirements for cochlear implant systems
Implants chirurgicaux — Dispositifs médicaux implantables actifs —
Partie 7: Exigences particulières pour les systèmes d'implant cochléaire
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 14708-7:2018(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 14708-7:2018
ISO/DIS 14708-7:2018(E)
ISO 14708-7:201x
27 Contents
28 Foreword . 5
29 Introduction. 6
30 1 Scope. 7
31 2 Normative references . 7
32 3 Terms and definitions . 8
33 4 Symbols and abbreviations. 10
34 5 General requirements for non-implantable parts. 10
35 6 Inspection and measurement. 10
36 7 General arrangement of the packaging . 11
37 8 General markings for active implantable medical devices . 11
38 9 Markings on the SALES PACKAGING. 11
39 10 Construction of the SALES PACKAGING. 12
40 11 Markings on the sterile pack. 12
41 12 Construction of the non-reusable pack . 13
42 13 Markings on the active implantable medical device . 13
43 14 Protection from unintentional biological effects being caused by the active implantable
44 medical device. 13
45 15 Protection from harm to the patient or user caused by external physical features of the active
46 implantable medical device . 14
COPYRIGHT PROTECTED DOCUMENT 47 16 Protection from harm to the patient caused by electricity. 14
© ISO 2018
48 17 Protection from harm to the patient caused by heat. 14
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 49 18 Protection from ionizing radiation released or emitted from the active implantable medical
below or ISO’s member body in the country of the requester.
50 device. 15
ISO copyright office
CP 401 • Ch. de Blandonnet 8
51 19 Protection from unintended effects caused by the device. 16
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
52 20 Protection of the device from damage caused by external defibrillators . 16
copyright@iso.org
www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved © ISO 2017 – All rights reserved 3
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oSIST prEN ISO 14708-7:2018
ISO/DIS 14708-7:2018(E)
27 Contents
28 Foreword . 5
29 Introduction . 6
30 1 Scope . 7
31 2 Normative references . 7
32 3 Terms and definitions . 8
33 4 Symbols and abbreviations . 10
34 5 General requirements for non-implantable parts . 10
35 6 Inspection and measurement . 10
36 7 General arrangement of the packaging . 11
37 8 General markings for active implantable medical devices . 11
38 9 Markings on the SALES PACKAGING . 11
39 10 Construction of the SALES PACKAGING . 12
40 11 Markings on the sterile pack . 12
41 12 Construction of the non-reusable pack . 13
42 13 Markings on the active implantable medical device . 13
43 14 Protection from unintentional biological effects being caused by the active implantable
44 medical device . 13
45 15 Protection from harm to the patient or user caused by external physical features of the active
46 implantable medical device . 14
47 16 Protection from harm to the patient caused by electricity . 14
48 17 Protection from harm to the patient caused by heat . 14
49 18 Protection from ionizing radiation released or emitted from the active implantable medical
50 device . 15
51 19 Protection from unintended effects caused by the device . 16
52 20 Protection of the device from damage caused by external defibrillators . 16
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oSIST prEN ISO 14708-7:2018
ISO/DIS 14708-7:2018(E)
53 21 Protection of the device from changes caused by high power electrical fields applied directly
54 to the patient . 17
55 22 Protection of the active implantable medical device from changes caused by miscellaneous
56 medical treatments . 17
57 23 Protection of the active implantable medical device from mechanical forces . 26
58 24 Protection of the active implantable medical device from damage caused by electrostatic
59 discharge . 30
60 25 Protection of the active implantable medical device from damage caused by atmospheric
61 pressure changes . 30
62 26 Protection of the active implantable medical device from damage caused by temperature
63 changes . 30
64 27 Protection of the active implantable medical device from electromagnetic non-ionising
65 radiation . 31
66 28 Accompanying documentation . 37
67 Annex AA (informative) General guidance and rationale . 41
68 Annex BB (informative) Relationship between the fundamental principles in ISO/TR 14283 and
69 the clauses of this part of ISO 14708 . 53
70 Annex CC (informative) Notes on EN 45502-2-3 (basis for this part of ISO 14708) . 67
71 Annex DD (informative) Notes on EMI measurements to demonstrate compliance with Clause 27
72 . 68
73 Bibliography . 72
74
4 © ISO 2018 – All rights reserved
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oSIST prEN ISO 14708-7:2018
ISO/DIS 14708-7:2018(E)
75 Foreword
76 ISO (the International Organization for Standardization) is a worldwide federation of national
77 standards bodies (ISO member bodies). The work of preparing International Standards is normally
78 carried out through ISO technical committees. Each member body interested in a subject for which a
79 technical committee has been established has the right to be represented on that committee.
80 International organizations, governmental and non-governmental, in liaison with ISO, also take part in
81 the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all
82 matters of electrotechnical standardization.
83 The procedures used to develop this document and those intended for its further maintenance are
84 described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
85 different types of ISO documents should be noted. This document was drafted in accordance with the
86 editorial rules of the ISO/IEC Directives, Part 2. www.iso.org/directives
87 Attention is drawn to the possibility that some of the elements of this document may be the subject of
88 patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
89 any patent rights identified during the development of the document will be in the Introduction and/or
90 on the ISO list of patent declarations received. www.iso.org/patents
91 Any trade name used in this document is information given for the convenience of users and does not
92 constitute an endorsement.
93 For an explanation on the meaning of ISO specific terms and expressions related to conformity
94 assessment, as well as information about ISO’s adherence to the World Trade Organization (WTO)
95 principles in the Technical Barriers to Trade (TBT) see the following URL:
96 www.iso.org/iso/foreword.html.
97 This document was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee
98 SC 6, Active implants.
99 This second edition cancels and replaces the first edition (ISO 14708-7:2013), which has been
100 technically revised.
101 The main changes compared to the previous edition are:
102 alignment to the updated ISO 14708-1:2014
103 significant changes to clauses 17, 22, 27
104 many clauses have been replaced by references to the ANSI/AAMI CI86:2017 standard
105 A list of all part in the ISO 14708 series can be found on the ISO website.
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oSIST prEN ISO 14708-7:2018
ISO/DIS 14708-7:2018(E)
106 Introduction
107 This document specifies particular requirements for ACTIVE IMPLANTABLE MEDICAL DEVICES used to treat
108 hearing impairment via electrical stimulation (for example cochlear implant systems or auditory
109 brainstem implant systems), to provide basic assurance of safety for both patients and users.
110 A COCHLEAR IMPLANT SYSTEM or AUDITORY BRAINSTEM IMPLANT SYSTEM is an ACTIVE IMPLANTABLE MEDICAL
111 DEVICE comprising implantable and NON-IMPLANTABLE PARTS (external parts). The power source may be
112 externally derived or from an internal battery. The IMPLANT SYSTEM is designed to restore hearing via
113 electrical stimulation of the auditory pathways. Externally or internally processed acoustic information
114 is converted to electrical stimulation signals which are delivered via one or more electrodes. The
115 working parameters of the device may be adjusted via a non-implantable accessory.
116 This document is relevant to all parts of IMPLANT SYSTEMS, including accessories.
117 The requirements of this document supplement or modify those of ISO 14708-1, Implants for surgery —
118 Active implantable medical devices — Part 1: General requirements for safety, marking and for
119 information to be provided by the manufacturer.
120 Figures or tables that are additional to those of Part 1 are numbered starting from 101; additional
121 annexes are lettered AA, BB, etc.
122 In this part of ISO 14708, terms printed in small capital letters are used as defined in Clause 3. Where a
123 defined term is used as a qualifier in another term, it is not printed in small capital letters unless the
124 concept thus qualified is also defined.
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oSIST prEN ISO 14708-7:2018
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125 Implants for surgery — Active implantable medical devices —
126 Part 7: Particular requirements for cochlear implant systems
127 1 Scope
128 This part of ISO 14708 specifies requirements that are applicable to those ACTIVE IMPLANTABLE MEDICAL
129 DEVICES that are intended to treat hearing impairment via electrical stimulation of the auditory
130 pathways. Devices which treat hearing impairment via means other than electrical stimulation are not
131 covered by this part of ISO 14708.
132 The tests that are specified in this part of ISO 14708 are type tests and are to be carried out on samples
133 of a device to show compliance.
134 This part of ISO 14708 is also applicable to NON-IMPLANTABLE PARTS and accessories of the devices (see
135 NOTE).
136 The electrical characteristics of the IMPLANTABLE PART are determined by either the appropriate method
137 detailed in this part of ISO 14708 or by any other method demonstrated to have an accuracy equal to, or
138 better than, the method specified. In the case of dispute, the method detailed in this part of ISO 14708
139 applies.
140 NOTE A device that is commonly referred to as an active implantable medical device can in fact be a single
141 device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of
142 these parts are required to be either partially or totally implantable, this standard specifies those requirements of
143 NON-IMPLANTABLE PARTS and accessories which could affect the safety or performance of the implantable part.
144 2 Normative references
145 The following documents are referred to in the text in such a way that some or all of their content
146 constitutes requirements of this document. For dated references, only the edition cited applies. For
147 undated references, the latest edition of the referenced document (including any amendments) applies.
148 This clause of ISO 14708-1 applies except as follows:
149 Additional references:
150 ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
151 management process
152 ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials,
153 sterile barrier systems and packaging systems
154 ISO 14155, Clinical investigation of medical devices for human subjects — Good clinical practice
155 ISO 14971, Medical devices — Application of risk management to medical devices
156 IEC 60068-2-27, Environmental testing — Part 2-27: Tests — Test Ea and guidance: Shock
157 IEC 60068-2-31, Environmental testing — Part 2-31: Tests — Test Ec: Rough handling shocks, primarily
158 for equipment-type specimens
159 IEC 60068-2-47, Environmental testing — Part 2-47: Test — Mounting of specimens for vibration, impact
160 and similar dynamic tests
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oSIST prEN ISO 14708-7:2018
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161 IEC 60068-2-64, Environmental testing — Part 2-64: Tests — Test Fh: Vibration, broadband random and
162 guidance
163 IEC 60068-2-75, Environmental testing — Part 2-75: Tests — Test Eh: Hammer tests
164 IEC 60118-6, Hearing aids — Part 6: Characteristics of electrical input circuits for hearing aids
165 IEC 60601-1:2012, Medical electrical equipment — Part 1: General requirements for basic safety and
166 essential performance
167 IEC 60601-1-2, Medical electrical equipment — Part 1-2: General requirements for basic safety and
168 essential performance — Collateral standard: Electromagnetic compatibility — Requirements and tests
169 IEC 61000-4-2, Electromagnetic compatibility (EMC) — Part 4-2: Testing and measurement techniques —
170 Electrostatic discharge immunity test
171 IEC 62304, Medical device software — Software life cycle processes
172 EN 1593, Non-destructive testing — Leak testing — Bubble emission techniques
173 EN 13185, Non-destructive testing — Leak testing — Tracer gas method
174 ANSI/AAMI CI86:2017, Cochlear implant systems: Requirements for safety, functional verification,
175 labeling and reliability reporting
176 3 Terms and definitions
177 For the purposes of this document, the terms and definitions given in ISO 14708-1 and the following
178 apply.
179 ISO and IEC maintain terminological databases for use in standardization at the following addresses:
180 — ISO Online browsing platform: available at http://www.iso.org/obp
181 — IEC Electropedia: available at http://www.electropedia.org/
182 3.101
183 cochlear implant system
184 CIS
185 active implantable medical device, comprising implantable and NON-IMPLANTABLE PARTS, intended to
186 treat hearing impairment via electrical stimulation of the cochlea
187 3.102
188 auditory brainstem implant system
189 ABIS
190 ACTIVE IMPLANTABLE MEDICAL DEVICE, comprising implantable and NON-IMPLANTABLE PARTS, intended to
191 treat hearing impairment via electrical stimulation of the auditory brainstem
192 3.103
193 implant system
194 either COCHLEAR IMPLANT SYSTEM or AUDITORY BRAINSTEM IMPLANT SYSTEM
195 3.104
196 non-implantable part
197 external part of the IMPLANT SYSTEM
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oSIST prEN ISO 14708-7:2018
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198 Note 1 to entry Examples would include, but are not limited to, sound processor, microphone, coil or power
199 source.
200 3.105
201 stimulator
202 implantable part of the IMPLANT SYSTEM containing electronic circuitry required to produce electrical
203 stimulation
204 3.106
205 body-worn
206 NON-IMPLANTABLE PART of the IMPLANT SYSTEM and worn on the body (e.g. belt or ear level)
207 3.107
208 electrode contact
209 electrically conducting part which is designed to form an interface with body tissue or body fluid
210 3.108
211 electrode array
212 DISTAL part of a LEAD containing more than one ELECTRODE CONTACT
213 3.109
214 reference electrode
215 electrically conducting part designed as return path for electrical stimulation current
216 3.110
217 distal
218 located away from the point of attachment to the STIMULATOR
219 3.111
220 proximal
221 located closest to the point of attachment to the STIMULATOR
222 3.112
223 model designation
224 name and/or a combination of letters and numbers used by a manufacturer to distinguish, by function
225 or type, one device from another
226 3.113
227 serial number
228 unique combination of letters and/or numbers, selected by the manufacturer, intended to distinguish a
229 device from other devices with the same MODEL DESIGNATION
230 3.114
231 output signal
232 electrical output, either pulsatile or analogue, of an IMPLANT SYSTEM intended to stimulate the auditory
233 pathways
234 3.115
235 pulse
236 specified electrical OUTPUT SIGNAL (voltage or current) of a specified amplitude and duration
237 3.116
238 biphasic pulse
239 PULSE which has both negative and positive going phases
240 3.117
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oSIST prEN ISO 14708-7:2018
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241 use-before-date
242 date after which the manufacturer recommends that the IMPLANT SYSTEM should not be implanted
243 3.118
244 magnet
245 component producing an external magnetic flux
246 3.119
247 SAR value
248 SAR = Specific Absorption Rate
249 3.120
RF
250
251 Radio Frequency
252 4 Symbols and abbreviations
253 There are no requirements specified in this part of ISO 14708. However this does not preclude the use
254 of symbols defined in other standards nor special symbols defined in the accompanying documentation.
255 5 General requirements for non-implantable parts
256 5.1 This subclause of ISO 14708-1 applies.
257 5.2 This subclause of ISO 14708-1 applies.
258 5.3 This subclause of ISO 14708-1 applies.
259 5.4 This subclause of ISO 14708-1 applies.
260 5.5 This subclause of ISO 14708-1 applies.
261 5.6 This subclause of ISO 14708-1 applies.
262 Additional subclauses:
263 5.7 Protection against external electrical hazards for fully implantable systems
264 Clause 6.5 of ANSI/AAMI CI86:2017 applies.
265 6 Inspection and measurement
266 If this part of ISO 14708 refers to inspection of design analysis documentation provided by the
267 manufacturer, it shall include an inspection of the risk management file as required by ISO 14971.
268 6.1 Measurement of output signal characteristics
269 Clause 8.1 of ANSI/AAMI CI86:2017 applies.
270 6.2 Measurement of the output SIGNAL amplitude and pulse width
271 Clause 8.2 of ANSI/AAMI CI86:2017 applies
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272 6.3 Impedance measurement accuracy
273 Clause 8.3 of ANSI/AAMI CI86:2017 applies.
274 6.4 Inductive link characterization
275 Clause 8.4 of ANSI/AAMI CI86:2017 applies.
276 6.5 Sound processor battery testing
277 Clause 8.5 of ANSI/AAMI CI86:2017 applies.
278 7 General arrangement of the packaging
279 7.1 This subclause of ISO 14708-1 applies.
280 7.2 This subclause of ISO 14708-1 applies.
281 8 General markings for active implantable medical devices
282 8.1 This subclause of ISO 14708-1 applies.
283 8.2 This subclause of ISO 14708-1 applies.
284 9 Markings on the SALES PACKAGING
285 9.1 This subclause of ISO 14708-1 applies.
286 9.2 This subclause of ISO 14708-1 applies except as follows:
287 Replacement:
288 The sales packaging shall bear the name and full address of the manufacturer.
289 The SALES PACKAGING shall also bear the name and address of the authorized representative, if the
290 manufacturer does not have a registered place of business in the European Community.
291 Compliance is checked by inspection.
292 9.3 Replacement
293 Where an IMPLANT SYSTEM is supplied in separate sub-assembly packaging, each individual SALES
294 PACKAGING shall bear a description of the contents of the packaging, the model designation or part
295 number and, if applicable the batch number or the serial number.
296 Compliance is checked by inspection.
297 9.4 This subclause of ISO 14708-1 applies.
298 9.5 This subclause of ISO 14708-1 applies.
299 9.6 This subclause of ISO 14708-1 applies.
300 9.7 Replacement
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oSIST prEN ISO 14708-7:2018
ISO/DIS 14708-7:2018(E)
301 The SALES PACKAGING of implantable parts of an ACTIVE IMPLANTABLE MEDICAL DEVICE shall bear the USE-
302 BEFORE-DATE, as expressed in 9.6.
303 Compliance shall be checked by inspection.
304 9.8 This subclause of ISO 14708-1 applies.
305 9.9 This subclause of ISO 14708-1 applies.
306 9.10 This subclause of ISO 14708-1 applies.
307 9.11 This subclause of ISO 14708-1 applies.
308 9.12 This subclause of ISO 14708-1 applies.
309 9.13 This subclause of ISO 14708-1 applies.
310 9.14 This subclause of ISO 14708-1 applies.
311 10 Construction of the SALES PACKAGING
312 10.1 This subclause of ISO 14708-1 applies.
313 10.2 This subclause of ISO 14708-1 applies.
314 10.3 This subclause of ISO 14708-1 applies.
315 Additional note:
316 NOTE Removable stickers, which provide supplementary information exceeding the information specified in
317 Clause 9 need not to be subjected to the test specified in 10.3.
318 10.4 This subclause of ISO 14708-1 applies.
319 11 Markings on the sterile pack
320 11.1 This subclause of ISO 14708-1 applies.
321 11.2 This subclause of ISO 14708-1 applies.
322 11.3 This subclause of ISO 14708-1 applies.
323 11.4 This subclause of ISO 14708-1 applies.
324 11.5 This subclause of ISO 14708-1 applies.
325 11.6 This subclause of ISO 14708-1 applies.
326 11.7 This subclause of ISO 14708-1 applies.
327 11.8 This subclause of ISO 14708-1 applies.
328 11.9 This subclause of
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