ISO 14708-3:2008

INTERNATIONAL ISO
STANDARD 14708-3
First edition
2008-11-15
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 2008
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©  ISO 2008
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ii © ISO 2008 – All rights reserved

Contents Page
Foreword. v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 2
4 Symbols and abbreviated terms . 3
5 General requirements for non-implantable parts . 3
6 Requirements for particular active implantable medical devices . 3
7 General arrangement of the packaging. 6
8 General markings for active implantable medical devices . 6
9 Markings on the sales packaging . 6
10 Construction of the sales packaging. 7
11 Markings on the sterile pack . 8
12 Construction of the non-reusable pack. 8
13 Markings on the active implantable medical device . 9
14 Protection from unintentional biological effects 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. 10
16 Protection from harm to the patient caused by electricity. 10
17 Protection from harm to the patient caused by heat . 11
18 Protection from ionizing radiation released or emitted from the active implantable
medical device . 11
19 Protection from unintended effects caused by the device. 11
20 Protection of the device from damage caused by external defibrillators. 12
21 Protection of the device from changes caused by high-power electrical fields applied
directly to the patient. 12
22 Protection of the active implantable medical device from changes caused by
miscellaneous medical treatments . 12
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. 21
[8]
Annex AA (informative) Relationship between the fundamental principles in ISO/TR 14283 and
the clauses of this part of ISO 14708 . 23
Annex BB (informative) Relationship between the clauses of this part of ISO 14708 and the
fundamental principles listed in Annex AA. 33
Annex CC (informative) Rationale. 35
Bibliography . 44

iv © ISO 2008 – All rights reserved

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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 14708-3 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 6,
Active implants.
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
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 14708-1:2000, 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 device
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. (See Clause 3 for
device type definitions used throughout this part of ISO 14708.)
This part of ISO 14708 is relevant to all parts and accessories of implantable neurostimulators, including
programmers, trial screeners, 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.
Requirements for physiologic sensing functions of implantable neurostimulators are not included in this edition
of this part of ISO 14708 but might be considered in future editions.
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.

vi © ISO 2008 – All rights reserved

INTERNATIONAL STANDARD ISO 14708-3:2008(E)

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.
This part of ISO 14708 is also applicable to all non-implantable parts and accessories of the devices as
defined in Clause 3.
The tests that are specified in this part of ISO 14708 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.
NOTE This part of ISO 14708 is not intended to apply to non-implantable neurostimulation devices. However, it does
apply to devices intended to be used as trial screeners because of their close affiliation with implantable neurostimulators.
2 Normative references
The following referenced documents are indispensable for the application 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 14708-1, Implants for surgery — Active implantable medical devices — Part 1: General requirements for
safety, marking and for information to be provided by the manufacturer
IEC 60601-1:2005, Medical electrical equipment — Part 1: General requirements for basic safety and
essential performance
IEC 60601-1-2:2007, Medical electrical equipment — Part 1-2: General requirements for basic safety and
essential performance — Collateral standard: Electromagnetic compatibility — Requirements and tests
IEC 61000-4-3:2002, Electromagnetic compatibility (EMC) — Part 4-3: Testing and measurement
techniques — Radiated, radio-frequency, electromagnetic field immunity test
ANSI/AAMI PC69:2000, Active implantable medical devices — Electromagnetic compatibility — EMC test
protocols for implantable cardiac pacemakers and implantable cardioverter defibrillators
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
NOTE For purposes of this part o
...