FprEN ISO 14708-3

Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators (ISO/FDIS 14708-3:2016)

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/FDIS 14708-3:2016)

Implants chirurgicaux - Dispositifs médicaux implantables actifs - Partie 3: Neurostimulateurs en implant (ISO/FDIS 14708-3:2016)

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/FDIS 14708-3:2016)

General Information

• Status: Not Published
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: CEN/CLC/JTC 16 - CEN/CENELEC Joint Working Group on Active Implantable Medical Devices
• Current Stage: 6055 - CEN Ratification completed (DOR) - Publishing
• Due Date: 11-Jul-2012
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Directive: 90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: kSIST prEN ISO 14708-3:2017 - Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators (ISO/FDIS 14708-3:2016)

Standards Content (sample)

SLOVENSKI STANDARD
oSIST prEN ISO 14708-3:2015
01-november-2015

9VDGNLLPSODQWDWL]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.

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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

written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of

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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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oSIST prEN ISO 14708-3:2015
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.
6 © ISO 2015 – All rights reserved
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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

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
Second edition is under development.
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oSIST prEN ISO 14708-3:2015
ISO 14708-3:201(X)

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.
8 © ISO 2015 – All rights reserved
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oSIST prEN ISO 14708-3:2015
ISO 14708-3:201(X)
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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oSIST prEN ISO 14708-3:2015
ISO 14708-3:201(X)
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.
10 © ISO 2015 – All rights reserved
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oSIST prEN ISO 14708-3:2015
ISO 14708-3:201(X)
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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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

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.

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.
12 © ISO 2015 – All rights reserved
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oSIST prEN ISO 14708-3:2015
ISO 14708-3:201(X)
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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oSIST prEN ISO 14708-3:2015
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27.102 Test conditions
27.102.1 Acceptance criteria
...