EN ISO 14708-3:2022
(Main)Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators (ISO 14708-3:2017)
Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators (ISO 14708-3:2017)
ISO 14708-3:2017 is applicable to active implantable medical devices intended for electrical stimulation of the central or peripheral nervous system.
The tests that are specified in this document are type tests and are to be carried out on a sample of a device to assess device behavioural responses, and are not intended to be used for the routine testing of manufactured products.
Chirurgische Implantate - Aktive implantierbare medizinische Geräte - Teil 3: Implantierbare Neurostimulatoren (ISO 14708-3:2017)
Dieses Dokument gilt für AKTIVE IMPLANTIERBARE MEDIZINISCHE GERÄTE (AIMD), die zur elektrischen Stimulation des zentralen oder peripheren Nervensystems vorgesehen sind.
Die in diesem Dokument festgelegten Prüfungen sind Typprüfungen und müssen an einem Prüfling eines Gerätes durchgeführt werden, um das Betriebsverhalten des Geräts zu beurteilen, sind jedoch nicht dafür vorgesehen, zur Stückprüfung der hergestellten Produkte angewendet zu werden.
Implants chirurgicaux - Dispositifs médicaux implantables actifs - Partie 3: Neurostimulateurs en implant (ISO 14708-3:2017)
ISO 14708-3:2017 s'applique aux dispositifs médicaux implantables actifs destinés à la stimulation électrique du système nerveux central ou périphérique.
Les essais qui sont spécifiés dans le présent document sont des essais de type et doivent être effectués sur un échantillon du dispositif afin d'évaluer les réactions comportementales du dispositif, et ne sont pas destinés à être utilisés pour les essais de routine sur les produits manufacturés.
Vsadki (implantati) za kirurgijo - Aktivni medicinski pripomočki za vsaditev - 3. del: Vsadljivi nevrostimulatorji (ISO 14708-3:2017)
Standard ISO 14708-3:2008 se uporablja za aktivne medicinske pripomočke za vsaditev, namenjene električni stimulaciji centralnega ali perifernega živčevja.
Standard ISO 14708-3:2008 se uporablja tudi za vse dele in dodatno opremo pripomočkov, ki niso namenjeni vsaditvi.
Preskusi, določeni v standardu ISO 14708-3:2008, so tipski preskusi, ki jih je treba za dokaz skladnosti opraviti na vzorcih pripomočka in niso namenjeni za rutinsko preskušanje proizvedenih izdelkov.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-junij-2023
Vsadki (implantati) za kirurgijo - Aktivni medicinski pripomočki za vsaditev - 3. del:
Vsadljivi nevrostimulatorji (ISO 14708-3:2017)
Implants for surgery - Active implantable medical devices - Part 3: Implantable
neurostimulators (ISO 14708-3:2017)
Chirurgische Implantate - Aktive implantierbare medizinische Geräte - Teil 3:
Implantierbare Neurostimulatoren (ISO 14708-3:2017)
Implants chirurgicaux - Dispositifs médicaux implantables actifs - Partie 3:
Neurostimulateurs en implant (ISO 14708-3:2017)
Ta slovenski standard je istoveten z: EN ISO 14708-3:2022
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 14708-3
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2022
ICS 11.040.40
English version
Implants for surgery - Active implantable medical devices -
Part 3: Implantable neurostimulators (ISO 14708-3:2017)
Implants chirurgicaux - Dispositifs médicaux Chirurgische Implantate - Aktive implantierbare
implantables actifs - Partie 3: Neurostimulateurs en medizinische Geräte - Teil 3: Implantierbare
implant (ISO 14708-3:2017) Neurostimulatoren (ISO 14708-3:2017)
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 14708-3:2022 E
reserved worldwide for CEN national Members and for
CENELEC Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 14708-3:2022) 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 14708-3:2017 has been approved by CEN-CENELEC as EN ISO 14708-3:2022 without
any modification.
INTERNATIONAL ISO
STANDARD 14708-3
Second edition
2017-04
Implants for surgery — Active
implantable medical devices —
Part 3:
Implantable neurostimulators
Implants chirurgicaux — Dispositifs médicaux implantables actifs —
Partie 3: Neurostimulateurs en implant
Reference number
ISO 14708-3:2017(E)
©
ISO 2017
ISO 14708-3:2017(E)
© ISO 2017, Published in Switzerland
All rights reserved. Unless otherwise specified, 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
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ii © ISO 2017 – All rights reserved
ISO 14708-3:2017(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Symbols and abbreviated terms . 2
5 General requirements for active implantable medical devices . 2
6 Requirements for particular active implantable medical devices .2
7 General arrangement of the packaging . 3
8 General markings for active implantable medical devices . 3
9 Markings on the sales packaging . 3
10 Construction of the sales packaging . 3
11 Markings on the sterile pack. 3
12 Construction of the non-reusable pack . 3
13 Markings on the active implantable medical device . 3
14 Protection from unintentional biological effects being caused by the active
implantable medical device . 3
15 Protection from harm to the patient or user caused by external physical features of
the active implantable medical device. 3
16 Protection from harm to the patient caused by electricity . 3
17 Protection from harm to the patient caused by heat . 3
18 Protection from ionizing radiation released or emitted from the active implantable
medical device. 4
19 Protection from unintended effects caused by the active implantable medical device .4
20 Protection of the active implantable medical device from damage caused by
external defibrillators . 5
21 Protection of the active implantable medical device from changes caused by
electrical fields applied directly to the patient . 5
22 Protection of the active implantable medical device from changes caused by
miscellaneous medical treatments . 5
23 Protection of the active implantable medical device from mechanical forces.6
24 Protection of the active implantable medical device from damage caused by
electrostatic discharge . 6
25 Protection of the active implantable medical device from damage caused by
atmospheric pressure changes . 7
26 Protection of the active implantable medical device from damage caused by
temperature changes . 7
27 Protection of the active implantable medical device from electromagnetic non-
ionizing radiation . 7
28 Accompanying documentation .16
ISO 14708-3:2017(E)
Annex AA (normative) Relationship between the fundamental principles in ISO/
[1]
TR 14283 and the clauses of this document .18
Annex BB (informative) Rationale .30
Annex CC (informative) Injection network example and board layout guidance .41
Bibliography .53
iv © ISO 2017 – All rights reserved
ISO 14708-3:2017(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 respons
...
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