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

Status
Published
Publication Date
26-Jul-2022
Withdrawal Date
30-Jan-2023
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
27-Jul-2022
Completion Date
27-Jul-2022

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SLOVENSKI STANDARD
SIST EN ISO 14708-3:2023
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
SIST EN ISO 14708-3:2023 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 14708-3:2023

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SIST EN ISO 14708-3:2023


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.

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SIST EN ISO 14708-3:2023
EN ISO 14708-3:2022 (E)
Contents Page
European foreword . 3

2

---------------------- Page: 4 ----------------------
SIST EN ISO 14708-3:2023
EN ISO 14708-3:2022 (E)
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 app
...

SLOVENSKI STANDARD
oSIST prEN ISO 14708-3:2015
01-november-2015
9VDGNL LPSODQWDWL ]DNLUXUJLMR$NWLYQLPHGLFLQVNLSULSRPRþNL]DYVDGLWHYGHO
9VDGOMLYLQHYURVWLPXODWRUML ,62',6
Implants for surgery - Active implantable medical devices - Part 3: Implantable
neurostimulators (ISO/DIS 14708-3:2015)
Chirurgische Implantate - Aktive implantierbare medizinische Geräte - Teil 3:
Implantierbare Neurostimulatoren (ISO/DIS 14708-3:2015)
Implants chirurgicaux - Dispositifs médicaux implantables actifs - Partie 3:
Neurostimulateurs en implant (ISO/DIS 14708-3:2015)
Ta slovenski standard je istoveten z: prEN ISO 14708-3
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
oSIST prEN ISO 14708-3:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 14708-3:2015

---------------------- Page: 2 ----------------------
oSIST prEN ISO 14708-3:2015
DRAFT INTERNATIONAL STANDARD
ISO/DIS 14708-3
ISO/TC 150/SC 6 Secretariat: ANSI
Voting begins on: Voting terminates on:
2015-08-13 2015-11-13
Implants for surgery — Active implantable medical devices —
Part 3:
Implantable neurostimulators
Implants chirurgicaux — Dispositifs médicaux implantables actifs —
Partie 3: Neurostimulateurs en implant
ICS: 11.040.40
ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for
Standardization (ISO), and processed under the ISO lead mode of collaboration
as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member
bodies for a parallel five month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments
received, will be submitted to a parallel two-month approval vote in ISO and
THIS DOCUMENT IS A DRAFT CIRCULATED
formal vote in CEN.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
To expedite distribution, this document is circulated as received from the
IN ADDITION TO THEIR EVALUATION AS
committee secretariat. ISO Central Secretariat work of editing and text
BEING ACCEPTABLE FOR INDUSTRIAL,
composition will be undertaken at publication stage.
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 14708-3:2015(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 2015

---------------------- Page: 3 ----------------------
oSIST prEN ISO 14708-3:2015
ISO/DIS 14708-3:2015(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2015, 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
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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2015 – All rights reserved

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oSIST prEN ISO 14708-3:2015
Contents
Foreword . 5
Introduction. 6
1 Scope . 7
2 Normative references . 7
3 Terms and definitions . 7
4 Symbols (and abbreviated terms). 8
5 General requirements for ACTIVE IMPLANTABLE MEDICAL DEVICES . 8
6 Requirements for particular ACTIVE IMPLANTABLE MEDICAL DEVICES .
...

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