ISO 14708-3:2008

Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators

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.

Implants chirurgicaux — Dispositifs médicaux implantables actifs — Partie 3: Neurostimulateurs en implant

General Information

• Status: Withdrawn
• Publication Date: 04-Nov-2008
• Withdrawal Date: 04-Nov-2008
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: ISO/TC 150/SC 6 - Active implants
• Drafting Committee: ISO/TC 150/SC 6 - Active implants
• Current Stage: 9599 - Withdrawal of International Standard
• Completion Date: 12-Apr-2017

Relations

• Revised: ISO 14708-3:2017 - Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators
• Effective Date: 08-Oct-2011

Standards Content (Sample)

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 14708-3:2008(E)
©
ISO 2008

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ISO 14708-3:2008(E)
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ISO 14708-3:2008(E)
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
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ISO 14708-3:2008(E)
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

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ISO 14708-3:2008(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.
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
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ISO 14708-3:2008(E)
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.

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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
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ISO 14708-3:2008(E)
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 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, screeners and RF transmitters.
3.102
implantable pulse generator
IPG
implantable part of a particular type of implantable neurostimulator, typically consisting of a power source and
electronic circuit, which produces a stimulation voltage or current pulse
NOTE The complete neurostimulator includes a means for conveying the output pulse to the stimulation site.
3.103
RF transmitter
non-implantable part of a particular type of implantable neurostimulator, typically consisting of a power source
and electronic circuit, which produces an electrical output pulse transmitted through an antenna to an
implanted RF receiver
3.104
RF receiver
implantable part of a particular type of implantable neurostimulator which converts an electrical pulse received
from an external RF transmitter into a stimulation voltage or current pulse
3.105
trial screener
non-implantable neurostimulator, used during a trial period of stimulation, typically consisting of a power
source and electronic circuit, which produces a stimulation voltage or current pulse conveyed to the
stimulation site through a lead or leads
NOTE Although a medical device in its own right, a screener is considered by this part of ISO 14708 as an accessory
to an implantable neurostimulator.
3.106
projected service life
period after implantation when the implantable neurostimulator remains within stated specifications and
characteristics
3.107
DUT
device under test, including conductive leads
3.108
essential performance
performance necessary to achieve freedom from unacceptable risk
NOTE For guidance on essential performance concepts, see IEC 60601-1.
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ISO 14708-3:2008(E)
4 Symbols and abbreviated terms
This clause of ISO 14708-1 applies.
5 General requirements for non-implantable parts
This clause of ISO 14708-1 applies except as follows.
Addition:
NOTE 3 This clause applies to RF transmitters, trial screeners, and programmers, for example. A percutaneous lead,
such as might be used with screeners, is considered to be an implantable part.
6 Requirements for particular active implantable medical devices
Additional subclauses:
6.101 Measurement of stimulation pulse characteristics
This subclause describes a uniform method of measurement for certain stimulation pulse characteristics
(amplitude, pulse width, pulse rate and pulse shape). The related specifications and characteristics stated by
the manufacturer in the accompanying documentation (see 28.8) shall correspond with the results obtained in
accordance with this method.
If the neurostimulator has multiple channels or output modes (e.g. bipolar or unipolar), the characteristics of
each channel or mode shall be determined. Consideration shall be given to all states of operation,
i.e. channels or modes operating individually or simultaneously.
Test conditions and device settings applicable to the stimulation pulse characteristics stated in the
accompanying documentation shall also be stated (see 28.8).
NOTE 1 Test conditions refer, for example, to ambient temperature and any special circumstances that existed during
the measurements. Device settings refer, for example, to the rate and pulse width values that were set during the
amplitude measurement.
The test sample shall be representative of production units, be in normal working condition, and shall not have
reached the elective replacement indication (see 19.2).
⎯ Method: The pulse generator (i.e. IPG, RF receiver, trial screener) shall be connected to a load resistor,
R , and test equipment as shown in Figure 101. Resister values for R shall be determined by the
L L
manufacturer based on appropriate tissue impedances for use of the product. Measurements shall be
replicated to characterize operation at minimum, typical and maximum load impedances. More complex
impedances may be used if they better represent actual use. In addition, the measurements shall be
performed using a nominal impedance, R , of 499 Ω ± 1 %. The load impedances used to obtain the
L
stimulation pulse characteristics stated in the accompanying documentation (see 28.8) shall also be
stated.
Points A and B, as shown in Figure 101, represent either the direct electrical output of the pulse generator
or the electrodes at the distal end of a lead (or lead-extension combination), if applicable. The
manufacturer shall unequivocally state the configuration(s) that are applicable to the stimulation pulse
characteristics stated in the accompanying documentation (see 28.8).
NOTE 2 Configuration refers to the point of measurement and to the model mix of pulse generator, and leads and
extensions, (if applicable).
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ISO 14708-3:2008(E)
While performing these measurements, the pulse shapes associated with each channel shall be
characterized and described in the accompanying documentation (see 28.8). Any variations in pulse
shapes, between channels, output modes, states of operation or load conditions, shall also be described.
The measurement accuracy of the test set-up shall be within ± 5 %. Test equipment and test sample shall
be at room temperature.

Key
1 oscilloscope
2 channel 1
3 trigger
4 pulse generator
5 load (as specified)
Figure 101 — Test set-up for measuring stimulation pulse characteristics

The pulse amplitude shall be measured from the base (just prior to the pulse transition) to the peak of the
pulse as shown in Figure 102. The result shall be expressed in volts or milliamperes, as appropriate. In
addition, other units may be used at the manufacturer’s discretion.

Key
1 amplitude
Figure 102 — Measurement of pulse amplitude

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ISO 14708-3:2008(E)
The pulse width shall be measured between the points on the pulse equal to one-half of the peak pulse
amplitude as shown in Figure 103. The result shall be expressed in microseconds. In addition, other units may
be used at the manufacturer’s discretion.

Key
1 pulse width (at ½ amplitude point)
Figure 103 — Measurement of pulse width
The pulse rate shall be determined by measuring the interval from the leading edge of one pulse to the
leading edge of the next pulse from the same point on the pulse used to measure pulse width
(see Figure 104). The actual rate is calculated from the reciprocal of the interval measurement. The result
shall be expressed in Hertz (Hz). In addition, other units may be used at the manufacturer’s discretion.

Key
1 pulse interval (at ½ amplitude point)
Figure 104 — Measurement of pulse interval to determine rate
6.102 Measurement of lead or extension d.c. resistance
This subclause describes a uniform method of measurement for lead or extension d.c. resistance. The related
specifications and characteristics stated by the manufacturer in the accompanying documentation (see 28.8)
shall correspond with the results obtained in accordance with this method.
If the lead or extension has multiple conductors, the d.c. resistance of each conductor shall be determined.
Test conditions applicable to the lead or extension d.c. resistance stated in the accompanying documentation
shall also be stated (see 28.8).
NOTE Test conditions refer, for example, to ambient temperature and any special circumstances that existed during
the measurements.
The test sample shall be representative of production units and be in normal working condition.
⎯ Method: The d.c. resistance of lead and extension conductors shall be measured by applying a four
terminal ohmmeter (offset compensated) between the proximal and distal end of each conductive element.
The results shall be expressed in ohms. In addition, other units may be used at the manufacturer’s
discretion.
The measurement accuracy of the test setup shall be within ± 5 %. Test equipment and test sample shall
be at room temperature.
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ISO 14708-3:2008(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 except as follows.
8.2
Addition:
NOTE For leads that are not intended to be implanted and are used only temporarily, this requirement does not apply.
Additional subclauses:
8.101 If special handling measures have to be taken during transport, the transport packaging shall be
[1] [2]
marked accordingly (see ISO 780 or ISO 15223 ).
Compliance shall be checked by inspection.
8.102 The permissible environmental conditions for transport shall be marked on the outside of the transport
packaging.
Compliance shall be checked by inspection.
9 Markings on the sales packaging
This clause of ISO 14708-1 applies except as follows.
9.4
Addition:
Specific additional information shall be provided for the following components:
a) Implantable pulse generator (IPG) and trial screener
⎯ number of electrodes and channels,
⎯ if the output is constant voltage or constant current,
⎯ any additional information and relevant characteristics, as necessary, to identify the device.
b) Lead
⎯ type of lead (e.g. surgical, percutaneous, cuff, CNS, peripheral),
⎯ number of electrodes per lead,
⎯ lead length (in centimetres),
⎯ any additional information and relevant characteristics, as necessary, to identify the device.
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ISO 14708-3:2008(E)
c) Extension
⎯ type of extension (e.g. low profile, bifurcated),
⎯ number of electrodes per extension,
⎯ extension length (in centimetres),
⎯ any additional information and relevant characteristics, as necessary, to identify the device.
d) RF receiver
⎯ number of electrodes and channels,
⎯ if the output is constant voltage or constant current
⎯ maximum recommended implant depth,
⎯ a means of identifying the corresponding RF transmitter,
⎯ a means of identifying the corresponding lead, if not permanently attached,
⎯ any additional information and relevant characteristics, as necessary, to identify the device.
e) RF transmitter
⎯ number of channels,
⎯ maximum recommended transmission distance,
⎯ a means of identifying the corresponding RF receiver,
⎯ any additional information and relevant characteristics, as necessary, to identify the device.
Additional subclause:
9.101 The sales packaging shall, when appropriate, bear an indication that the contents are intended for
single use only.
Compliance shall be checked by inspection.
10 Construction of the sales packaging
This clause of ISO 14708-1 applies except as follows.
10.3
Amendment:
The test is replaced by subclause 7.1.3 b) of IEC 60601-1:2005.
NOTE Removable stickers (e.g. temporary stickers used in the manufacturing process), which provide
supplementary information exceeding the information specified in Clause 9, need not be subjected to this test.
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ISO 14708-3:2008(E)
11 Markings on the sterile pack
This clause of ISO 14708-1 applies except as follows.
Additional subclause:
11.101 The sterile pack shall bear specific additional information for the following components:
a) Implantable pulse generator (IPG)
⎯ number of electrodes and/or channels,
⎯ if the output is constant voltage or constant current,
⎯ maximum recommended implant depth, if applicable,
⎯ any additional information and relevant characteristics, as necessary, to identify the device.
b) Lead
⎯ type of lead (e.g. surgical, percutaneous, cuff, CNS, peripheral),
⎯ number of electrodes per lead,
⎯ lead length (in centimetres),
⎯ any additional information and relevant characteristics, as necessary, to identify the device.
c) Extension
⎯ type of extension (e.g. low profile, bifurcated),
⎯ number of electrodes per extension,
⎯ extension length (in centimetres),
⎯ any additional information and relevant characteristics, as necessary, to identify the device.
d) RF receiver
⎯ maximum recommended implant depth
⎯ a means of identifying the corresponding RF transmitter
⎯ a means of identifying the corresponding lead, if not permanently attached
⎯ any additional information and relevant characteristics, as necessary, to identify the device.
Compliance shall be checked by inspection.
12 Construction of the non-reusable pack
This clause of ISO 14708-1 applies.
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ISO 14708-3:2008(E)
13 Markings on the active implantable medical device
This clause of ISO 14708-1 applies except as follows.
13.1
Amendment:
The wet rub test is replaced by subclause 7.1.3 b) of IEC 60601-1:2005, after which the markings shall remain
clearly legible.
14 Protection from unintentional biological effects caused by the active implantable
medical device
This clause of ISO 14708-1 applies except as follows.
14.2
Replacement:
Any part of the implantable neurostimulator, intended in normal use to be in contact with body fluids, shall be
evaluated to determine if the release of particulate matter is hazardous.
⎯ Test: Remove the implantable part aseptically from the non-re-usable pack. Immerse the implantable part
in a bath of approximately 9 g/l saline solution, suitable for injection, or filtered saline or ultra-pure water,
in a neutral glass container. The volume of the saline in millilitres shall be (5 ± 0,5) times the numerical
2
value of the surface area of the implantable part expressed in cm . The container shall be covered with a
glass lid and maintained at 37 °C ± 2 °C for between 8 h and 18 h, the bath being agitated throughout the
period. A reference sample of similar volume shall be prepared from the same batch of saline, maintained
and agitated in a similar way to the specimen. A sample of liquid from the specimen bath and from the
reference bath shall be compared using apparatus suitable for measurement of particle size, such as
apparatus operating on the light blockage principle [see method 2.9.19 of the European Pharmacopoeia,
[3]
3rd edition, 1977, (Council of Europe) ].
The excess average count of particles from the specimen compared to the reference sample shall not exceed
the amount determined, by the manufacturer, to be hazardous. If the manufacturer does not make this
determination then the excess average co
...