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 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 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
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 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
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 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
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 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
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
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 unaccept-
able risk.
Gradient field-induced 13 Induced lead voltages shall not cause an unacceptable risk.
lead voltage
B field-induced device 14 Device malfunction shall not cause an unacceptable risk.
malfunction
RF field-induced device 15 Device malfunction shall not cause an unacceptable risk.
malfunction
Gradient field-induced 16 Device malfunction shall not cause an unacceptable risk.
device malfunction
Combined fields 17 The combined fields test outcome shall not result in an unaccept-
able risk.
23 Protection of the active implantable medical device from mechanical forces
This clause of ISO 14708-1 applies except as follows.
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
6 © ISO 2017 – All rights reserved
ISO 14708-3:2017(E)
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 The tests in this clause apply only to the implantable parts. Non-implantable parts are covered by
IEC 60601-1-2 (see ISO 14708-1:2014, 5.1).
Compliance is checked by review of the risk management file and test reports.
27.102 Test conditions
27.102.1 Acceptance criteria
During testing of all clauses, the acceptance criteria (pass/fail criteria) shall be based on the
manufacturer’s intended use of the INS and on a risk assessment, as follows:
— it is expected that the performance intended by the manufacturer will be maintained, and
— no hazardous situations occur that could lead to an unacceptable risk.
Prior to testing, risks shall be identified, taking into account the reasonably foreseeable electromagnetic
(EM) environment that is likely to occur during its intended use. Immunity test levels in Clause 27 are
based on the reasonably foreseeable maximum levels found in the general public EM environment. Each
risk shall be evaluated through a design analysis that takes account of any risk control, according to
ISO 14708-1:2014, 5.5.4.
The risk assessment process, performed in accordance with ISO 14971, could result in hazardous
situations being identified (see ISO 14971:2007, Figure E.1). Since actual risk cannot be observed
ISO 14708-3:2017(E)
during testing, it will be necessary to observe the performance of the device to see if any hazardous
situations occur.
Pass/fail criteria shall be defined prior to testing. Ideally, these criteria can be measurable or observable
during testing. If not, the manufacturer shall specify an alternative method for determining that the
DUT met the required pass/fail criteria during the test. The use of special hardware or software might
be necessary.
If the pass/fail acceptance criteria are not met during and after testing, the manufacturer shall
substantiate DUT behavioural responses and explain why the overall risk(s) are acceptable (see
Table 103). In no cases are irreversible changes in performance, outside of specification, allowed.
27.102.2 Test configuration and setup
The INS shall be tested in representative configurations, consistent with intended use, that are likely to
be the most susceptible to EM disturbances. This shall be determined using risk analysis, experience,
engineering analysis, or pretesting.
Unless specified otherwise in a particular test, the test setup shall include
— the IPG,
— attachment of patient leads to all ports as necessary to achieve the intended use,
— for devices that have more than one available electrode configuration for stimulation, such as bipolar
or unipolar, they shall be tested with the electrode configuration that is the most susceptible to
electromagnetic disturbances, provided that the circuit design and components are equivalent, and
— termination of the implantable parts of the INS as necessary to simulate normal impedance of the
patient.
For all tests, provision shall be made to determine the device’s behavioural responses, preferably during
testing. If the operation of the DUT cannot be observed or verified during the test, the manufacturer
shall specify an alternative method for determining that the DUT met the required pass/fail criteria
during the test. The use of special hardware or software might be necessary.
27.102.3 Operating functions, modes, and settings
The INS shall be tested using the functions, modes, and settings, consistent with intended use, that
are likely to be the most susceptible to EM disturbances. This shall be determined using risk analysis,
experience, engineering analysis, or pretesting.
Except for the requirements of 5.101, if the intended use includes a wireless communication channel, the
wireless communication function shall be evaluated and tested for EMC in accordance with IEC 60601-1-2.
NOTE A wireless communication function does not have to be tested twice for EMC, as it would be if it were
tested according to this document and IEC 60601-1-2.
27.102.4 Patient physiological simulation
If simulation of the patient is required to verify normal operation of the INS, it shall be provided during
immunity testing. Physiological simulation shall not provide an intentional conductive or capacitive
connection to earth other than that required by 27.102.2.
27.103 Risk management and test report documentation
The information listed in Table 103 shall be provided by the manufacturer.
8 © ISO 2017 – All rights reserved
ISO 14708-3:2017(E)
Table 103 — Minimum risk management and test report contents
No. Item
Description of the intended use, and any unacceptable risks and associated hazardous situations, result-
ing from the risk assessment.
2 Pass/fail criteria: how it was determined.
3 Pass/fail criteria: how it was monitored during testing.
Effects on the DUT that were observed during or after the application of the test disturbances, and the
duration for which these effects persisted.
If the intended use is not maintained during testing, or if a hazardous situation occurs, the manufactur-
er shall substantiate DUT behavioural responses and explain why they are not unacceptable.
Applicability/tests not performed. The decision and justification not to perform a measurement or test
shall be documented. Deviations and modifications to tests shall also be described.
DUT configuration during the test, including a block diagram of DUT configuration and all peripherals
and auxiliary equipment used.
8 DUT functions, settings, and operating modes listed by test.
9 Name and location of the test facility.
10 Names and functions or equivalent identification of the persons authorizing the test report.
Description of the DUT. For example, the device name, model number, manufacturer, and serial numbers,
or other means of identification.
12 DUT software/firmware version.
Prototype or production version of the DUT. For prototypes, describe the relationship to production
versions.
14 Compliance summary statement. Compliance of the DUT with each test.
15 Test data that support the compliance determination for each test performed.
16 Simulators, accessories and auxiliary equipment, including patient physiological and simulation.
17 Documentation of any special hardware or software needed to perform the tests.
18 Test equipment used, including calibration or maintenance dates.
19 Dwell time for each immunity test requiring a dwell time.
DUT modifications needed in order to pass any of the tests. A statement that they will all be incorporat-
ed into production units.
21 Photographs of each test setup including DUT and all peripherals and auxiliary equipment used.
27.104 Protection from static magnetic fields of flux density up to 50 mT
NOTE If the requirements of the B field-induced device malfunction test of 22.2 have been met, then this
test is not required. However, this test is not a substitute for any test in 22.2.
For this test, leads are not required and electrode configuration is not applicable.
Test equipment: A field coil capable of generating a magnetic field with a flux density of at least 50 mT in
the region to be occupied by the DUT.
Test procedure: The required magnetic field flux density shall be generated before placing the DUT in the
field. Then the DUT shall be placed into the centre of the test coil. After at least 15 s of exposure to the
magnetic field, the DUT shall be removed from the field. Reorient the DUT so that a second orthogonal
axis is aligned with the axis of the field coil, and again subject the DUT to the required field. Repeat with
the third orthogonal axis aligned with the axis of the field coil.
Evaluation of test results: The DUT shall meet the immunity pass/fail criteria determined by the
manufacturer.
ISO 14708-3:2017(E)
27.105 Protection from EM disturbances over the frequency range 16,6 Hz to 80 MHz
27.105.1 Voltage injection test for frequencies 16.6 Hz to 80 MHz
For this test, INS termination impedance requirement is accomplished through connection to the
injection network.
Test equipment: Injection network setup as illustrated in Figure 101. See Annex CC for a complete
description of the network and construction examples including good RF practices.
Key
A test signal input (V )
PP
B test signal monitor point
C stimulation waveform monitor point
Figure 101 — Injection network diagram for the range of frequencies from 16,6 Hz to 80 MHz
Port A is where the test signal generator, and if needed a suitable amplifier, is connected and is where
V is injected into the tissue interface board. The test signal generator shall have the ability to modulate
PP
a carrier waveform according to the modulation requirements listed later in this subclause.
Port B is where an oscilloscope (≥450 MHz, ≥1 Giga-sample per second) is connected in order to monitor
the V waveform delivered to the DUT.
PP
Port C is where an oscilloscope (≥450 MHz, ≥1 Giga-sample per second) is connected in order to monitor
the DUT output waveform during the immunity test.
In this document, the term “oscilloscope” may also be interpreted as including data acquisition systems
capable of performing similar measurements.
The tissue-electrode interface model simulates the impedance created by the tissue-electrode interface
and also matches signal generator output to the injection circuit. The injected test voltage (V ) is based
PP
on the theoretical open circuit voltage (V ) seen across the entire INS system. The interface model
OC
would not have to be used but then the entire test voltage would be applied across the IPG and leads. In
actual practice, the voltage presented to the IPG is less by a relative amount.
NOTE Annex BB describes the determination of V and V used in this subclause.
OC PP
10 © ISO 2017 – All rights reserved
ISO 14708-3:2017(E)
The low pass filter provides points where the monitoring oscilloscope can be connected to observe DUT
output stimulation waveforms during the test. Without this filter, it would be more difficult to separate
the injected signal from the DUT output waveform.
The lead interface simulates the therapy lead impedance. This may be accomplished by using an actual
lead or by circuit model simulation of an actual lead. Both approaches are represented in Figure 101.
Test procedure: A test signal generator, monitoring oscilloscopes, and the DUT are connected to the
injection network as indicated in Figure 101. DUT output stimulation will need to be selected so that
the output waveform can be reasonably monitored throughout the test. If the design of the DUT is
equivalent for all electrodes, then only one configuration needs to be tested (see 27.102.2). In that case,
it is not necessary to exercise several combinations of anodes and cathodes.
The frequency range of the applied test signals (V ) shall be stepped from 16,6 Hz to 80 MHz, pausing
PP
to adjust the signal level and to allow enough time for the DUT behavioural response to be observed.
Incremental steps are indicated in Table 104.
Test signal levels (V ) are shown in Table 105 and shall be applied to Port A (see Figure 101) according
PP
to the frequency ranges and lead lengths shown in Table 105. The amplitude of the test signal is defined
as the peak-peak amplitude, before modulation, as measured on Port B in Figure 101.
At low frequencies and short lead lengths, V might be very small. In these cases, the manufacturer may
PP
determine the start frequency based on voltages too low to cause a circuit response. For example, at
voltages lower than a forward bias diode voltage drop. Rationale shall be provided. The stop frequency
is always 80 MHz.
Table 104 — Frequency steps for the voltage injection test
Incremental frequency steps
Hz 16,6 20 30 40 50 60 70 80 90 — —
Hz 100 200 300 400 500 600 700 800 900 — —
kHz 1 2 3 4 5 6 7 8 9 — —
kHz 10 20 30 40 50 58 60 70 80 90 —
kHz 100 134 150 200 300 400 500 600 700 800 900
MHz 1 2 3 4 5 5,4 6 6,78 7 8 9
MHz 10,1 13,56 14,2 18,1 21 24,9 27,12 29 35 40,68 —
MHz 50 60 70 80 — — — — — — —
Table 105 — Peak-peak injected test levels V
PP
V (Volts peak-peak)
PP
Frequency range ( f )
Lead length (l) 70 cm to 50 cm Lead l
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