SIST EN ISO 14708-3:2023
(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 14708-3:2008 is applicable to active implantable medical devices intended for electrical stimulation of the central or peripheral nervous system.
ISO 14708-3:2008 is also applicable to all non-implantable parts and accessories of the devices.
The tests that are specified in ISO 14708-3:2008 are type tests intended to be carried out on a sample of a device to show compliance, 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
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
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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 approved by CEN-CENELEC as EN ISO 14708-3:2022 without
any modification.
3
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SIST EN ISO 14708-3:2023
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SIST EN ISO 14708-3:2023
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
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SIST EN ISO 14708-3:2023
ISO 14708-3:2017(E)
COPYRIGHT PROTECTED DOCUMENT
© 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
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 2017 – All rights reserved
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SIST EN ISO 14708-3:2023
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 2017 – All rights reserved iii
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SIST EN ISO 14708-3:2023
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
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SIST EN ISO 14708-3:2023
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 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 on 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 the following
URL: w w w . i s o .org/ iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 150, Implants for surgery, SC 6, Active
implants.
This second edition cancels and replaces the first edition (ISO 14708-3:2008), which has been
technically revised.
A list of all parts in the ISO 14708 series can be found on the ISO website.
© ISO 2017 – All rights reserved v
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SIST EN ISO 14708-3:2023
ISO 14708-3:2017(E)
Introduction
This document specifies particular requirements for active implantable medical devices intended for
electrical stimulation of the central or peripheral nervous system, to provide basic assurance of safety
for both patients and users. It amends and supplements ISO 14708-1:2014, hereinafter referred to as
ISO 14708-1.
The requirements of this document take priority over those of ISO 14708-1.
Devices that use electricity to stimulate the nervous system are commonly called “neurostimulators.”
They produce controlled electrical pulses that are delivered through electrodes in contact with a specific
target area. Whether or not a neurostimulator is totally or partially implantable, a lead or extension is
usually required to convey stimulation pulses from a form of pulse generator to the electrodes, although
newer forms of devices might not utilize leads or extensions. An external programmer might be used to
adjust device parameters.
Currently, several types of neurostimulators exist for treating the central or peripheral nervous system.
This document is intended to apply to these neurostimulator types regardless of therapy.
This document is relevant to all parts and accessories of implantable neurostimulators, including
programmers, software, and technical manuals. Not all parts or accessories might be intended to be
totally or partially implanted, but there is a need to specify some requirements of non-implantable
parts and accessories if they could affect the safety or performance intended by the manufacturer.
Not included in the scope of this document are non-implantable medical devices, such as external
neurostimulators and RF-coupled neurostimulators, even though such devices might have implantable
parts, because they are covered under the IEC 60601-1 series of standards.
Within this document, the following terms are used to amend and supplement ISO 14708-1:
“Replacement”: the clause of ISO 14708-1 is replaced completely by the text of this document.
“Addition”: the text of this document is additional to the requirements of ISO 14708-1.
“Amendment”: the clause of ISO 14708-1 is amended as indicated by the text of this document.
“Not used”: the clause of ISO 14708-1 is not applied in this document.
Subclauses, figures, or tables that are additional to those of ISO 14708-1 are numbered starting from
101; additional annexes are lettered AA, BB, etc.
vi © ISO 2017 – All rights reserved
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SIST EN ISO 14708-3:2023
INTERNATIONAL STANDARD ISO 14708-3:2017(E)
Implants for surgery — Active implantable medical
devices —
Part 3:
Implantable neurostimulators
1 Scope
This document 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.
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 14117:2012, Active implantable medical devices — Electromagnetic compatibility — EMC test
protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac
resynchronization devices
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
ISO 14971, Medical devices — Application of risk management to medical devices
1)
ISO/TS 10974:— , Assessment of the safety of magnetic resonance imaging for patients with an active
implantable medical device
IEC 60601-1:2005+A1: 2012, Medical electrical equipment — Part 1: General requirements for basic safety
and essential performance
IEC 60601-1-2:2014, Medical electrical equipment — Part 1-2: General requirements for basic safety and
essential performance — Collateral standard: Electromagnetic disturbances — Requirements and tests
I EC 61000 - 4 -3:2006 +A 1: 2007+A 2: 2010, Electromagnetic compatibility (EMC) — Part 4-3: Testing and
measurement techniques — Radiated, radio-frequency, electromagnetic field immunity test
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 14708-1 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http:// www .electropedia .org/
— ISO Online browsing platform: available at http:// www .iso .org/ obp
1) Under preparation.
© ISO 2017 – All rights reserved 1
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SIST EN ISO 14708-3:2023
ISO 14708-3:2017(E)
3.101
implantable neurostimulator
INS
active implantable medical device intended for electrical stimulation of the central or peripheral
nervous system
Note 1 to entry: For the purposes of this document, an implantable neurostimulator can be a single article, or a
system consisting of a set of components and accessories which interact to achieve the performance intended
by the manufacturer. Not all of these components or accessories might be required to be partially or totally
implanted, e.g. programmers.
3.102
implantable pulse generator
IPG
part of an implantable neurostimulator (3.101), consisting of a power source and electronic circuit,
which produces a stimulation voltage or current pulse
3.103
MR Conditional
item with demonstrated safety in the MR environment within defined conditions
Note 1 to entry: Adapted from ASTM F2503, 3.1.11.
3.104
projected service life
period after implantation when the implantable neurostimulator (3.101) remains within stated
specifications and characteristics
3.105
DUT
device under test
device being tested, including conductive leads
Note 1 to entry: Not all tests require conductive leads.
4 Symbols and abbreviated terms
This clause of ISO 14708-1 applies.
5 General requirements for active implantable medical devices
This clause of ISO 14708-1 applies, except as follows.
Additional subclause:
5.101 Wireless coexistence and wireless quality of service
When communication with the implantable part of an active implantable medical device is provided
through wireless communication channels, the manufacturer shall evaluate wireless coexistence
and wireless quality of service through the risk management process and apply the appropriate risk
control measures to protect the patient from harm (see 28.105).
Compliance is checked by the inspection of the risk management file.
6 Requirements for particular active implantable medical devices
No additional requirements are specified in this clause.
2 © ISO 2017 – All rights reserved
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SIST EN ISO 14708-3:2023
ISO 14708-3:2017(E)
7 General arrangement of the packaging
This clause of ISO 14708-1 applies.
8 General markings for active implantable medical devices
This clause of ISO 14708-1 applies.
9 Markings on the sales packaging
This clause of ISO 14708-1 applies.
10 Construction of the sales packaging
This clause of ISO 14708-1 applies.
11 Markings on the sterile pack
This clause of ISO 14708-1 applies.
12 Construction of the non-reusable pack
This clause of ISO 14708-1 applies.
13 Markings on the active implantable medical device
This clause of ISO 14708-1 applies.
14 Protection from unintentional biological effects being caused by the active
implantable medical device
This clause of ISO 14708-1 applies.
15 Protection from harm to the patient or user caused by external physical
features of the active implantable medical device
This clause of ISO 14708-1 applies.
16 Protection from harm to the patient caused by electricity
This clause of ISO 14708-1 applies.
17 Protection from harm to the patient caused by heat
This clause of ISO 14708-1 applies except as follows.
17.1
Replacement:
© ISO 2017 – All rights reserved 3
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SIST EN ISO 14708-3:2023
ISO 14708-3:2017(E)
In the absence of external influence, an implantable part of the INS, not intended to supply heat to the
patient, shall comply with at least one of the following conditions (a, b, or c) when implanted, and when
in normal operation, including recharge:
NOTE Examples of external influences include exposure to MRI, electrosurgery, external defibrillation,
ultrasound, and electromagnetic fields.
a) no outer surface greater than 39 °C,
b) no tissue receives a thermal dose greater than the CEM43 dose thresholds in Table 101, or
c) manufacturer’s evidence that a higher temperature rise, than indicated in Table 101, is justified for
a particular application.
Because the values in Table 101 represent tissue dose thresholds, the manufacturer’s risk assessment
shall include an analysis of any effects to the patient due to the time/temperature relationship.
Table 101 — CEM43 dose thresholds for various tissues
Tissue CEM43 dose threshold
muscle 40
fat 40
peripheral nerve 40
skin 21
bone 16
brain 2
BBB (blood brain barrier) 15
The CEM43 value is calculated using Formula (1):
n
()43−T
i
CEM43=×tR (1)
∑
i
i=1
where
t is the i-th time interval in minutes;
i
T is the average temperature of the tissue in degrees Centigrade during the interval t ;
i i
R is 0,25 for T <43 °C and 0,5 for T ≥ 43 °C;
n is the number of samples taken during the heating duration.
Formula (1) is valid for temperatures between 39 °C and 57 °C.
Compliance is checked by inspection of a design analysis provided by the manufacturer, supported by
the manufacturer’s calculations and data from test studies as appropriate.
18 Protection from ionizing radiation released or emitted from the active
implantable medical device
This clause of ISO 14708-1 applies.
19 Protection from unintended effects caused by the active implantable
medical device
This clause of ISO 14708-1 applies.
4 © ISO 2017 – All rights reserved
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SIST EN ISO 14708-3:2023
ISO 14708-3:2017(E)
20 Protection of the active implantable medical device from damage caused by
external defibrillators
This clause of ISO 14708-1 applies except as follows.
20.1
Not used.
21 Protection of the active implantable medical device from changes caused by
electrical fields applied directly to the patient
This clause of ISO 14708-1 applies.
22 Protection of the active implantable medical device from changes caused by
miscellaneous medical treatments
22.1 Ultrasonic energy
This clause of ISO 14708-1 applies.
22.2 MRI
NOTE 1 This clause does not apply to devices that are not labelled mr conditional.
Implantable parts of an INS and any non-implantable components and accessories, which are labelled
mr conditional, shall be designed and constructed so that no irreversible change to the device or
unacceptable risk to the patient results from exposure to MRI.
Assessment: For an implantable part of an INS intended to be used in patients who undergo a magnetic
resonance scan in 1,5 T, cylindrical bore, whole body MR scanners, the requirements of ISO/TS 10974
shall apply. For non-implantable components and accessories, or as an alternative for implantable parts,
the manufacturer may demonstrate safety using similar or equivalent means.
NOTE 2 Other MR environments will require manufacturer evaluation by similar or other means.
The outcome of each test shall not result in an unacceptable risk to the patient. Additional acceptance
criteria are listed in Table 102.
If device samples are used for testing, they shall meet all manufacturer specifications after testing is
completed.
Compliance is checked by inspection of test reports and the risk management file.
© ISO 2017 – All rights reserved 5
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SIST EN ISO 14708-3:2023
ISO 14708-3:2017(E)
Table 102 — Acceptance criteria for test requirements of ISO/TS 10974
Test requirement ISO/TS 10974 Acceptance criteria to protect patient from harm
Clause #
RF field-induced heating 8 RF-induced heating of adjacent tissue(s) shall not cause an unac-
of the AIMD ceptable risk. This heating value shall be below a limit support-
ed by scientific rationale linked to clinical significance for the
adjacent tissue(s). The value used for assessment could be CEM43,
applied RF power, temperature, or any other measurable and
relevant parameter. If temperature rise is ≤2 °C, then no further
scientific rationale is needed.
Gradient field-induced 9 Gradient induced heating of adjacent tissue(s) shall not cause an
device heating unacceptable risk. This heating value shall be below a limit sup-
ported by scientific rationale linked to clinical significance for the
adjacent tissue(s). The value used for assessment could be CEM43,
applied RF power, temperature, or any other measurable and
relevant parameter. If temperature rise is ≤2 °C, then no further
scientific rationale is needed.
Gradient field-induced 10 Gradient induced vibration shall not cause an unacceptable risk.
vibration
B -induced force 11 Magnetically induced force shall be less than the weight of the
0
device or less than a greater specified value that is supported by
a scientific-based rationale that the force of this specified value
shall not cause an unacceptable risk.
B -induced torque 12 Magnetically induced torque shall be less than the worst case
0
gravity-induced torque, which is defined as the product of the
weig
...
SLOVENSKI STANDARD
oSIST prEN ISO 14708-3:2015
01-november-2015
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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
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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
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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
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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 . 8
7 General arrangement of the packaging . 8
8 General markings for ACTIVE IMPLANTABLE MEDICAL DEVICES . 9
9 Markings on the sales packaging . 9
10 Construction of the sales packaging . 9
11 Markings on the sterile pack . 9
12 Construction of the non-reusable pack . 9
13 Markings on the ACTIVE IMPLANTABLE MEDICAL DEVICE . 9
14 Protection from unintentional biological effects being caused by the ACTIVE IMPLANTABLE
MEDICAL DEVICE . 9
15 Protection from harm to the patient or user caused by external physical features of the ACTIVE
IMPLANTABLE MEDICAL DEVICE . 9
16 Protection from harm to the patient caused by electricity . 9
17 Protection from harm to the patient caused by heat . 9
18 Protection from ionizing radiation released or emitted from the active implantable medical
device . 10
19 Protection from unintended effects caused by the ACTIVE IMPLANTABLE MEDICAL DEVICE . 10
20 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from damage caused by external
defibrillators . 11
21 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from changes caused by electrical fields
applied directly to the patient . 11
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oSIST prEN ISO 14708-3:2015
22 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from changes caused by miscellaneous
medical treatments . 11
23 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from mechanical forces . 12
24 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from damage caused by electrostatic
discharge . 13
25 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from damage caused by atmospheric
pressure changes . 13
26 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from damage caused by temperature
changes . 13
27 Protection of the active implantable medical device from electromagnetic non-ionizing
radiation . 13
28 Accompanying documentation . 24
Annex AA (normative) Relationship between the fundamental principles in ISO/TR 14283 and
the clauses of this part of ISO 14708. 26
Annex BB (informative) Rationale . 35
Annex CC (informative) Guidance — Test plan . 45
Bibliography . 46
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oSIST prEN ISO 14708-3:2015
ISO 14708-3:201(X)
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. 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. 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 on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO's adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL:
The committee responsible for this document is ISO/TC 150/SC 6.
This second edition cancels and replaces the first edition (ISO 14708-3:2008), which has been
technically revised.
ISO 14708 consists of the following parts, under the general title Implants for surgery — Active
implantable medical devices:
— Part 1: General requirements for safety, marking and for information to be provided by the
manufacturer
— Part 2: Cardiac pacemakers
— Part 3: Implantable neurostimulators
— Part 4: Implantable infusion pumps
— Part 5: Circulatory support devices
— Part 6: Particular requirements for active implantable medical devices intended to treat
tachyarrhythmia (including implantable defibrillators)
— Part 7: Particular requirements for cochlear implant systems
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ISO 14708-3:201(X)
Introduction
This part of ISO 14708 specifies particular requirements for active implantable medical devices
intended for electrical stimulation of the central or peripheral nervous system, to provide basic
assurance of safety for both patients and users. It amends and supplements ISO 14708-1:2014,
hereinafter referred to as ISO 14708-1.
The requirements of this part of ISO 14708 take priority over those of ISO 14708-1.
Devices that use electricity to stimulate the nervous system are commonly called neurostimulators.
They produce controlled electrical pulses that are delivered through electrodes in contact with a
specific target area. Whether or not a neurostimulator is totally or partially implantable, a lead or
extension is usually required to convey stimulation pulses from a form of pulse generator to the
electrodes, although newer forms of devices might not utilize leads or extensions. An external
programmer might be used to adjust device parameters.
Currently, several types of neurostimulators exist for treating the central or peripheral nervous system.
This part of ISO 14708 is intended to apply to these neurostimulator types regardless of therapy.
This part of ISO 14708 is relevant to all parts and accessories of implantable neurostimulators,
including programmers, software, and technical manuals. Not all parts or accessories might be intended
to be totally or partially implanted, but there is a need to specify some requirements of non-implantable
parts and accessories if they could affect the safety or performance intended by the manufacturer.
Not included in the scope of this document are non-implantable medical devices, such as external
neurostimulators and RF coupled neurostimulators, even though such devices might have implantable
parts, because they are covered under the IEC 60601-1 series of standards.
Within this part of ISO 14708 the following terms are used to amend and supplement ISO 14708-1:
“Replacement”: the clause of ISO 14708-1 is replaced completely by the text of this part of ISO 14708.
“Addition”: the text of this part of ISO 14708 is additional to the requirements of ISO 14708-1.
“Amendment”: the clause of ISO 14708-1 is amended as indicated by the text of this part ISO 14708.
“Not used”: the clause of ISO 14708-1 is not applied in this part ISO 14708.
Subclauses, figures, or tables that are additional to those of ISO 14708-1 are numbered starting from
101; additional annexes are lettered AA, BB, etc.
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oSIST prEN ISO 14708-3:2015
ISO 14708-3:201(X)
Implants for surgery — Active implantable medical devices —
Part 3: Implantable neurostimulators
1 Scope
This part of ISO 14708 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 part of ISO 14708 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.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 14117:2012, Active implantable medical devices — Electromagnetic compatibility — EMC test
protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac
resynchronization devices
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
1
ISO/TS 10974:— , Assessment of the safety of magnetic resonance imaging for patients with an active
implantable medical device
IEC 60601-1:2005+A1:2012, Medical electrical equipment — Part 1: General requirements for basic
safety and essential performance
IEC 60601-1-2:2014, Medical electrical equipment — Part 1-2: General requirements for basic safety and
essential performance — Collateral standard: Electromagnetic disturbances — Requirements and tests
IEC 61000-4-3:2006+A1:2007+A2:2010, Electromagnetic compatibility (EMC) — Part 4-3: Testing and
measurement techniques — Radiated, radio-frequency, electromagnetic field immunity test
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 14708-1 and the following
apply.
3.101
implantable neurostimulator
INS
active implantable medical device intended for electrical stimulation of the central or peripheral
nervous system
1
Second edition is under development.
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Note 1 to entry For purposes of this part of ISO 14708, an implantable neurostimulator can be a single article, or
a system consisting of a set of components and accessories which interact to achieve the performance intended by
the manufacturer. Not all of these components or accessories might be required to be partially or totally
implanted, e.g. programmers.
3.102
implantable pulse generator
IPG
part of an implantable neurostimulator (INS), consisting of a power source and electronic circuit, which
produces a stimulation voltage or current pulse
3.103
MR Conditional
an item with demonstrated safety in the MR environment within defined conditions
Note 1 to entry Adapted from 3.1.11 of ASTM F2503.
3.104
projected service life
period after implantation when the implantable neurostimulator remains within stated specifications
and characteristics
3.105
DUT
device under test
4 Symbols (and abbreviated terms)
This clause of ISO 14708-1 applies.
5 General requirements for ACTIVE IMPLANTABLE MEDICAL DEVICES
This clause of ISO 14708-1 applies, except as follows.
Additional subclause:
5.101 Wireless coexistence and wireless quality of service
When communication with the implantable part of an ACTIVE IMPLANTABLE MEDICAL DEVICE is provided
through wireless communication channels, the MANUFACTURER shall evaluate wireless coexistence and
wireless quality of service through the RISK MANAGEMENT PROCESS and apply the appropriate RISK CONTROL
measures to protect the patient from HARM (see 28.105).
Compliance is checked by the inspection of the RISK MANAGEMENT FILE.
6 Requirements for particular ACTIVE IMPLANTABLE MEDICAL DEVICES
No additional requirements are specified in this clause.
7 General arrangement of the packaging
This clause of ISO 14708-1 applies.
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8 General markings for ACTIVE IMPLANTABLE MEDICAL DEVICES
This clause of ISO 14708-1 applies.
9 Markings on the sales packaging
This clause of ISO 14708-1 applies.
10 Construction of the sales packaging
This clause of ISO 14708-1 applies.
11 Markings on the sterile pack
This clause of ISO 14708-1 applies.
12 Construction of the non-reusable pack
This clause of ISO 14708-1 applies.
13 Markings on the ACTIVE IMPLANTABLE MEDICAL DEVICE
This clause of ISO 14708-1 applies.
14 Protection from unintentional biological effects being caused by the ACTIVE
IMPLANTABLE MEDICAL DEVICE
This clause of ISO 14708-1 applies.
15 Protection from harm to the patient or user caused by external physical
features of the ACTIVE IMPLANTABLE MEDICAL DEVICE
This clause of ISO 14708-1 applies.
16 Protection from harm to the patient caused by electricity
This clause of ISO 14708-1 applies.
17 Protection from harm to the patient caused by heat
This clause of ISO 14708-1 applies except as follows.
17.1
Replacement:
In the absence of external influence, an implantable part of the INS, not intended to supply heat to the
patient, shall comply with at least one of the following conditions (a, b or c) when implanted, and
whether in normal operation, including recharge.
NOTE Examples of external influences include exposure to MRI, electrosurgery, external defibrillation,
ultrasound and electromagnetic fields.
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a) no outer surface greater than 39 °C; or
b) no tissue receives a thermal dose greater than the CEM43 dose thresholds in Table 101; or
c) manufacturer’s evidence that a higher temperature rise, than indicated in Table 101, is justified for
a particular application.
Because the values in Table 101 represent tissue dose thresholds, the manufacturer’s risk assessment
shall include an analysis of any effects to the patient due to the time/temperature relationship.
Table 101 – CEM43 dose thresholds for various tissues
Tissue CEM43 dose threshold
muscle 40
fat 40
peripheral nerve 40
skin 21
bone 16
brain 2
BBB (blood brain 15
barrier)
The CEM43 value is calculated using the following formula:
(1)
where
ti is the i-th time interval in minutes;
T is the average temperature of the tissue in degrees Centigrade during the interval t ;
i i
R is 0,25 for T <43 °C and 0,5 for T ≥ 43 °C;
n is the number of samples taken during the heating duration.
This formula is valid for temperatures between 39 °C and 57 °C.
Compliance is checked by inspection of a design analysis provided by the manufacturer, supported by
the manufacturer’s calculations and data from test studies as appropriate.
18 Protection from ionizing radiation released or emitted from the active
implantable medical device
This clause of ISO 14708-1 applies.
19 Protection from unintended effects caused by the ACTIVE IMPLANTABLE MEDICAL
DEVICE
This clause of ISO 14708-1 applies.
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20 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from damage caused by
external defibrillators
This clause of ISO 14708-1 applies except as follows.
20.1
Not used.
21 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from changes caused by
electrical fields applied directly to the patient
This clause of ISO 14708-1 applies.
22 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from changes caused by
miscellaneous medical treatments
22.1 Ultrasonic energy
This clause of ISO 14708-1 applies.
22.2 MRI
NOTE 1 This clause does not apply to devices that are not labeled MR CONDITIONAL.
Implantable parts of an INS and any non-implantable components and accessories, which are labeled MR
CONDITIONAL, shall be designed and constructed so that no irreversible change to the device or
unacceptable risk to the patient results from exposure to MRI.
Assessment: For an implantable part of an INS intended to be used in patients who undergo a
magnetic resonance scan in 1,5 T, cylindrical bore, whole body MR scanners, the requirements of
ISO/TS 10974 shall apply. For non-implantable components and accessories, or as an alternative for
implantable parts, the manufacturer may demonstrate safety using similar or equivalent means.
NOTE 2 Other MR environments will require manufacturer evaluation by similar or other means.
The outcome of each test shall not result in an unacceptable risk to the patient. Additional acceptance
criteria are listed in Table 102.
If device samples are used for testing, they shall meet all manufacturer specifications after testing is
completed.
Compliance is checked by inspection of test reports and the risk management file.
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nd
Table 102 – Acceptance criteria for test requirements of ISO/TS 10974, 2 ed
Test requirement ISO/TS 10974 Acceptance Criteria to protect patient from harm
Clause #
RF field-induced heating TBD after ED2 RF induced heating of adjacent tissue(s) shall not cause an
of the AIMD is published unacceptable risk. This heating value shall be below a limit
supported by scientific rationale linked to clinical significance for
the adjacent tissue(s). The value used for assessment could be
CEM43, applied RF power, temperature, or any other measurable
and relevant parameter. If temperature rise is ≤ 2 °C, then no
further scientific rationale is needed.
Gradient field-induced TBD after ED2 Gradient induced heating of adjacent tissue(s) shall not cause an
device heating is published unacceptable risk. This heating value shall be below a limit
supported by scientific rationale linked to clinical significance for
the adjacent tissue(s). The value used for assessment could be
CEM43, applied RF power, temperature, or any other measurable
and relevant parameter. If temperature rise is ≤ 2 °C, then no
further scientific rationale is needed.
Gradient field-induced TBD after ED2 Gradient induced vibration shall not cause an unacceptable risk.
vibration is published
B -induced force
0 TBD after ED2 Magnetically induced force shall be less than the weight of the
is published device or less than a greater specified value that is supported by a
scientific based rationale that the force of this specified value shall
not cause an unacceptable risk.
B -induced torque TBD after ED2 Magnetically induced torque shall be less than the worst case
0
is published gravity induced torque, which is defined as the product of the
weight of the device and the longest linear dimension or less than a
greater specified value supported by a scientific based rationale
that the force of this specified value shall not cause an unacceptable
risk.
RF field induced lead TBD after ED2 Induced lead voltages shall not cause an unacceptable risk.
voltage is published
Gradient field induced TBD after ED2 Induced lead voltages shall not cause an unacceptable risk.
lead voltage is published
B field induced device TBD after ED2 Device malfunction shall not cause an unacceptable risk.
0
malfunction is published
RF field induced device TBD after ED2 Device malfunction shall not cause an unacceptable risk.
malfunction is published
Gradient field induced TBD after ED2 Device malfunction shall not cause an unacceptable risk.
device malfunction is published
Combined fields TBD after ED2 The combined fields test outcome shall not result in an
is published unacceptable risk.
23 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from mechanical forces
This clause of ISO 14708-1 applies except as follows.
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23.1
Amendment:
Following the test, the non-implantable part of the active implantable medical device shall operate as
specified in IEC 60601-1.
24 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from damage caused by
electrostatic discharge
This clause of ISO 14708-1 applies except as follows.
24.1
Replacement:
The requirements of IEC 60601-1-2 shall apply to the non-implantable parts.
NOTE While the electrostatic discharge is applied only to the non-implantable parts, operation of the ACTIVE
IMPLANTABLE MEDICAL DEVICE is evaluated as a system following the test.
Compliance is checked as specified in IEC 60601-1-2.
25 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from damage caused by
atmospheric pressure changes
This clause of ISO 14708-1 applies.
26 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from damage caused by
temperature changes
This clause of ISO 14708-1 applies.
27 Protection of the active implantable medical device from electromagnetic non-
ionizing radiation
Replacement:
27.101 General
Implantable parts of the implantable neurostimulator (INS) are expected to maintain their intended use
and shall not result in an unacceptable risk because of susceptibility to electrical influences due to
external electromagnetic fields.
Assessment: The tests of this clause shall be used to assess device behavioural responses when exposed
to electromagnetic (EM) fields representing the general public environment.
NOTE 1 The tests in this clause apply only to the implantable parts. Non-implantable parts are covered by IEC
60601-1-2 (see 5.1 of ISO 14708-1).
Compliance is checked by review of the risk management file and test reports.
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27.102 Test conditions
27.102.1 Acceptance criteria
Du
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