ISO 14708-6:2010
(Main)Implants for surgery — Active implantable medical devices — Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
Implants for surgery — Active implantable medical devices — Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
ISO 14708-6:2010 specifies requirements that are applicable to implantable cardioverter defibrillators and the functions of active implantable medical devices intended to treat tachyarrhythmia. ISO 14708-6:2010 is also applicable to some non-implantable parts and accessories of the devices.
Implants chirurgicaux — Dispositifs médicaux implantables actifs — Partie 6: Exigences particulières pour les dispositifs médicaux implantables actifs destinés à traiter la tachyarythmie (y compris les défibrillateurs implantables)
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Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 14708-6
First edition
2010-03-01
Implants for surgery — Active
implantable medical devices —
Part 6:
Particular requirements for active
implantable medical devices intended to
treat tachyarrhythmia (including
implantable defibrillators)
Implants chirurgicaux — Dispositifs médicaux implantables actifs —
Partie 6: Exigences particulières pour les dispositifs médicaux
implantables actifs destinés à traiter la tachyarythmie (y compris les
défibrillateurs implantables)
Reference number
ISO 14708-6:2010(E)
©
ISO 2010
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ISO 14708-6:2010(E)
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ii © ISO 2010 – All rights reserved
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ISO 14708-6:2010(E)
Contents Page
Foreword .v
Introduction.vii
1 Scope.1
2 Normative references.1
3 Terms and definitions .2
4 Symbols and abbreviated terms (optional).6
5 General requirements for non-implantable parts.6
6 Measurement of implantable pulse generator and lead characteristics .6
6.1 Measurement of IMPLANTABLE PULSE GENERATOR characteristics .6
6.2 Measurement of the electrical characteristic of a sensing/pacing LEAD.9
7 General arrangement of the packaging.9
8 General markings for active implantable medical devices .9
9 Markings on the sales packaging .9
10 Construction of the SALES PACKAGING .10
11 Markings on the STERILE PACK.10
12 Construction of the NON-REUSABLE PACK.11
13 Markings on the ACTIVE IMPLANTABLE MEDICAL DEVICE .11
14 Protection from unintended biological effects being caused by the ACTIVE IMPLANTABLE
MEDICAL DEVICE.12
15 Protection from HARM to the patient or user caused by external physical features of the
ACTIVE IMPLANTABLE MEDICAL DEVICE.12
16 Protection from HARM to the patient caused by electricity.12
17 Protection from HARM to the patient caused by heat .15
18 Protection from ionizing radiation released or emitted from the ACTIVE IMPLANTABLE
MEDICAL DEVICE.15
19 Protection from unintended effects caused by the device .15
20 Protection of the device from damage caused by external defibrillators .17
21 Protection of the device from changes caused by high power electrical fields applied
directly to the patient .21
21.2 Protection of the device from damage caused by HF surgical exposure .21
22 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from changes caused by
miscellaneous medical instruments.22
23 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from mechanical forces.22
24 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from damage caused by electrostatic
discharge.27
25 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from damage caused by atmospheric
pressure changes.27
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ISO 14708-6:2010(E)
26 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from changes caused by temperature
changes .27
27 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from electromagnetic non-ionizing
radiation.27
28 Accompanying documentation .49
Annex A (informative) Relationship between the fundamental principles in ISO/TR 14283 and the
clauses of this standard.55
Annex B (informative) Relationship between the clauses of this standard and the fundamental
principles listed in Annex A.77
Annex C (informative) Notes on ISO 14708-6 .79
Annex D (informative) Code for describing modes of IMPLANTABLE PULSE GENERATORS .99
Annex E (normative) Interface circuits .101
Annex F (informative) Selection of capacitor C .105
x
Annex G (normative) Calibration of injection network (Figure E.105); Test signal of inhibition
generator (Figure G.101) .106
Annex H (informative) Defined terms .108
Bibliography .110
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ISO 14708-6:2010(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 14708-6 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
⎯ Part 5: Circulatory support devices
⎯ Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia
(including implantable defibrillators)
In this International Standard, the following print types are used:
⎯ Requirements and definitions: roman type.
⎯ Test specifications: italic type.
⎯ Informative material appearing outside of tables, such as notes, examples and references: smaller type. Normative
text of tables is also in a smaller type.
⎯ TERMS DEFINED IN CLAUSE 3 OF ISO 14708-1, IN THIS PART OF ISO 14708 OR AS NOTED: SMALL CAPITALS
In referring to the structure of this standard, the term
⎯ “clause” means one of the seventeen numbered divisions within the table of contents, inclusive of all
subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
⎯ “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subclauses of
Clause 7).
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ISO 14708-6:2010(E)
References to clauses within this standard are preceded by the term “Clause” followed by the clause number.
References to subclauses within this collateral standard are by number only.
In this International Standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives,
Part 2. For the purposes of this standard, the auxiliary verb:
⎯ “shall” means that compliance with a requirement or a test is mandatory for compliance with this
standard;
⎯ “should” means that compliance with a requirement or a test is recommended but is not mandatory for
compliance with this standard;
⎯ “may” is used to describe a permissible way to achieve compliance with a requirement or test.
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ISO 14708-6:2010(E)
Introduction
This part of ISO 14708 specifies particular requirements for IMPLANTABLE CARDIOVERTER DEFIBRILLATORS and
the functions of ACTIVE IMPLANTABLE MEDICAL DEVICES intended to treat tachyarrhythmia, to provide basic
assurance of safety for both patients and users.
An external defibrillator is a MEDICAL DEVICE used, in the emergency setting, to deliver a high-energy shock to
the heart, by means of ELECTRODES applied to the external chest wall, in patients suffering ventricular
fibrillation (a rapid, disorganized and potentially lethal heart rhythm abnormality), to restore normal heart
action. External defibrillators may also be used, in emergency or elective settings, to terminate other
ventricular or atrial tachyarrhythmias by delivery of a high-energy shock, synchronized to the intrinsic cardiac
rhythm, a procedure known as CARDIOVERSION. In patients known to be at risk of such arrhythmias, due to the
occurrence of previous episodes or the presence of specific predisposing cardiac conditions, an IMPLANTABLE
CARDIOVERTER DEFIBRILLATOR may be implanted to perform similar functions. The implantable device, which is
much smaller than an external defibrillator, is contained within a sealed, encapsulating enclosure. It generates
high voltage PULSES from an enclosed, miniature, electrical battery. The PULSES are transmitted to the heart by
means of implanted, insulated conductors with ELECTRODES (LEADS). The IMPLANTABLE CARDIOVERTER
DEFIBRILLATOR may also incorporate other sensing and pacing functions, such as rate support for bradycardia
and ANTITACHYCARDIA PACING (ATP) to terminate certain tachyarrhythmias without the need of a high-energy
shock. The defibrillator may be adjusted non-invasively by means of an electronic device, known as a
programmer.
This part of ISO 14708 is relevant to all parts of ACTIVE IMPLANTABLE MEDICAL DEVICES intended to treat
tachyarrhythmia other than pacing functions to control bradyarrhythmia. Typical examples are IMPLANTABLE
PULSE GENERATORS, LEADS, ADAPTORS, ACCESSORIES, programmers and the related software (bradyarrhythmia
pacing functions are dealt with in ISO 14708-2).
The requirements of this part of ISO 14708 supplement or modify those of 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, hereinafter referred to as ISO 14708-1. The requirements of
this part of ISO 14708 take priority over those of ISO 14708-1.
Figures or tables that are additional to those of ISO 14708-1 are numbered starting from 101.
Annex D describes a coding system that may be used to designate tachyarrhythmia therapy modes. Annex E
defines the tissue equivalent interface circuits and low-pass filter required for some compliance tests. Annex F
describes a method for selecting the filter capacitor used in the tissue equivalent interface circuits defined by
Annex E. Annex G defines the method of calibrating the injection network defined by Annex E. All annexes
except Annex E and Annex G are informative.
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INTERNATIONAL STANDARD ISO 14708-6:2010(E)
Implants for surgery — Active implantable medical devices —
Part 6:
Particular requirements for active implantable medical devices
intended to treat tachyarrhythmia (including implantable
defibrillators)
1 Scope
This part of ISO 14708 specifies requirements that are applicable to IMPLANTABLE CARDIOVERTER
DEFIBRILLATORS and the functions of ACTIVE IMPLANTABLE MEDICAL DEVICES intended to treat tachyarrhythmia.
The tests that are specified in ISO 14708 are type tests and are to be carried out on samples of a device to
show compliance.
This part of ISO 14708 is also applicable to some non-implantable parts and accessories of the devices (see
Note 1).
The characteristics of the IMPLANTABLE PULSE GENERATOR or LEAD shall be determined by either the appropriate
method detailed in this part of ISO 14708 or by any other method demonstrated to have accuracy equal to, or
better than, the method specified. In the case of dispute, the method detailed in this part of ISO 14708 shall
apply.
Any aspect of an ACTIVE IMPLANTABLE MEDICAL DEVICE intended to treat bradyarrhythmias is covered by
ISO 14708-2.
NOTE 1 The device that is commonly referred to as an ACTIVE IMPLANTABLE MEDICAL DEVICE may in fact be a single
device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these
parts are required to be either partially or totally implantable, but there is a need to specify some requirements of non-
implantable parts and accessories if they could affect the safety or performance of the implantable device.
NOTE 2 The terminology used in this European Standard is intended to be consistent with the terminology of Directive
90/385/EEC.
NOTE 3 In this part of ISO 14708, terms printed in small capital letters are used as defined in Clause 3. Where a
defined term is used as a qualifier in another term, it is not printed in small capital letters unless the concept thus qualified
is also defined.
NOTE 4 Particular requirements for congestive heart failure devices are under consideration. These types of devices
are not covered by this part of ISO 14708.
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.
This clause of ISO 14708-1 applies except as follows:
Additional references:
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ISO 14708-6:2010(E)
ISO 5841-3 + corr. 1, Implants for surgery — Cardiac pacemakers — Part 3: Low-profile connectors (IS-1) for
implantable pacemakers
ISO 8601, Data elements and interchange formats — Information interchange — Representation of dates and
times
ISO 11318, Cardiac defibrillators — Connector assembly DF-1 for implantable defibrillators — Dimensions
and test requirements
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
ISO 14708-2, Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers
ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to
be supplied — Part 1: General requirements
IEC 60068-2-27, Environmental testing — Part 2-27: Tests — Test Ea and guidance: Shock
IEC 60068-2-47, Environmental testing — Part 2-47: Test — Mounting of specimens for vibration, impact and
similar dynamic tests
IEC 60068-2-64, Environmental testing — Part 2-64: Tests — Test Fh: Vibration, broadband random and
guidance
IEC 60878, Graphical symbols for electrical equipment in medical practice
ANSI/AAMI/ISO PC69, Active implantable medical devices — Electromagnetic compatibility — EMC test
protocols for implantable cardiac pacemakers and implantable cardioverter defibrillators
3 Terms and definitions
This clause of ISO 14708-1 applies except as follows:
Additional definitions:
3.3.1
adaptor
special connector used between an otherwise incompatible IMPLANTABLE PULSE GENERATOR and a LEAD
3.3.2
implantable cardioverter defibrillator (ICD)
ACTIVE IMPLANTABLE MEDICAL DEVICE comprising an IMPLANTABLE PULSE GENERATOR and LEAD(S) that is intended
to detect and correct tachycardias and fibrillation by application of CARDIOVERSION/DEFIBRILLATION PULSE(S) to
the heart
3.3.3
implantable pulse generator (IPG)
part of the ACTIVE IMPLANTABLE MEDICAL DEVICE, including the power supply and electronic circuit that produces
an electrical output
NOTE For purposes of this part of ISO 14708, the term IMPLANTABLE PULSE GENERATOR describes any ACTIVE
IMPLANTABLE MEDICAL DEVICE that incorporates functions intended to treat tachyarrhythmias.
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ISO 14708-6:2010(E)
3.3.4
sensitivity (sensing threshold)
minimum signal required to consistently control the function of the IMPLANTABLE PULSE GENERATOR
[see 6.1.5]
3.3.5
sensor
special part of an IMPLANTABLE PULSE GENERATOR that is designed to detect signals for the purpose of RATE
MODULATION or other control purposes
3.5.1
electrode
electrically conducting part (usually the termination of a LEAD), which is designed to form an interface with
body tissue or body fluid
3.5.2
endocardial lead
LEAD with an ELECTRODE designed to make a contact with the endocardium, or inner surface of the heart
3.5.3
epicardial lead
LEAD with an ELECTRODE designed to make a contact with the epicardium, or outer surface of the heart
3.5.4
transvenous
approach to the heart through the venous system
3.5.5
insertion diameter (of a lead)
minimum bore of a rigid cylindrical tube into which the LEAD (not including the connector) may be inserted
3.5.6
lead conductor resistance
R
c
ohmic resistance between the ELECTRODE and the corresponding LEAD connector TERMINAL
[see 6.2.1 of ISO 14708-2]
3.5.7
lead pacing impedance
Z
p
impedance that is formed by the ratio of a voltage PULSE to the resulting current [see 6.2.2 of ISO 14708-2].
The impedance is composed of the ELECTRODE/tissue interface and the LEAD CONDUCTOR RESISTANCE
3.5.8
lead sensing impedance
Z
s
source impedance of a LEAD as seen by an IMPLANTABLE PULSE GENERATOR
[see 6.2.3 of ISO 14708-2]
3.9.1
model designation
name and/or a combination of letters and numbers used by a manufacturer to distinguish, by function or type,
one device from another
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ISO 14708-6:2010(E)
3.9.2
serial number
unique combination of letters and/or numbers, selected by the manufacturer, intended to distinguish a device
from other devices with the same MODEL DESIGNATION
3.20.1
beat
ordered spontaneous activity of the heart
3.20.2
pulse
electrical output of an IMPLANTABLE PULSE GENERATOR other than CD PULSE [see 3.3.5] intended to stimulate the
myocardium
3.20.3
pulse amplitude
amplitude of the PULSE measured according to the procedure in 6.1.1 of ISO 14708-2
3.20.4
pulse duration
duration of the PULSE, measured between two reference points specified in this part of ISO 14708
[see 6.1.1 of ISO 14708-2]
3.20.5
pulse interval
interval between equivalent points of two consecutive PULSES
[see 6.1.1 of ISO 14708-2]
3.20.6
basic pulse interval
PULSE INTERVAL in absence of sensed cardiac or other electrical influence
3.20.7
automatic sensitivity control
automatic adjustment of the SENSITIVITY in response to available physiological signals
3.21.1
beginning of service; BOS
when an individual IMPLANTABLE PULSE GENERATOR is first released by the manufacturer as fit for being placed
on the market
3.21.2
end of service; EOS
when the PROLONGED SERVICE PERIOD has elapsed and no further pacing function is specified nor can be
expected
3.21.3
prolonged service period; PSP
period beyond the RECOMMENDED REPLACEMENT TIME during which the IMPLANTABLE PULSE GENERATOR
continues to function as specified by the manufacturer
[ISO 14708-2, 3.20.4, modified]
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ISO 14708-6:2010(E)
3.21.4
power source indicator
means of indicating the electrical status of the power source during the IMPLANTABLE PULSE GENERATOR'S
service life
3.21.5
recommended replacement time; RRT
when the POWER SOURCE INDICATOR reaches the value set by the manufacturer of the IMPLANTABLE PULSE
GENERATOR for its recommended replacement. This indicates entry into the PROLONGED SERVICE PERIOD
3.21.6
use-before date
date after which the manufacturer recommends that the ACTIVE IMPLANTABLE MEDICAL DEVICE should not be
implanted
3.22.1
antitachycardia pacing; ATP
cardiac pacing sequences intended to terminate re-entry tachycardias
3.22.2
arrhythmia detection interval
interval below which the IMPLANTABLE PULSE GENERATOR will classify a rhythm as a tachyarrhythmia
3.22.3
ATP only device
IMPLANTABLE PULSE GENERATOR capable of delivering rapid sequences of pacing PULSES to terminate
ventricular (VT) and atrial (AT) tachycardia and atrial fibrillation (AF)
3.22.4
cardioversion
termination of atrial tachyarrhythmia or ventricular tachycardia by PULSE(S) synchronized to cardiac events
3.22.5
cardioversion/defibrillation pulse (CD pulse)
high-energy monophasic, biphasic, or multiphasic PULSE intended to restore normal rhythm by shocking the
heart
3.22.6
capacitor formation
any charge to maximum-programmed energy that dissipates off the capacitors (is not dumped) for at least
10 min
3.22.7
cardioversion/defibrillation lead (CD lead)
LEAD used to conduct a CD PULSE from the IMPLANTABLE PULSE GENERATOR to the heart
3.22.8
charge time
the time required to charge the high-voltage capacitors to a specified CD PULSE ENERGY
3.22.9
delivered cardioversion/defibrillation pulse energy (delivered CD pulse energy)
total energy delivered to a standard load (50 Ω) by all phases of a CD PULSE, measured according to 6.1.3
3.22.10
defibrillation
termination of fibrillation
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ISO 14708-6:2010(E)
3.22.11
ICD output voltage
peak voltage of the CARDIOVERSION/DEFIBRILLATION PULSE(S), measured according to 6.1.2
3.22.12
terminal
electrically separate conductive device connection
4 Symbols and abbreviated terms (optional)
This clause of ISO 14708-1 applies.
5 General requirements for non-implantable parts
This clause of ISO 14708-1 applies.
6 (Vacant)
Replacement:
6 Measurement of implantable pulse generator and lead characteristics
6.1 Measurement of IMPLANTABLE PULSE GENERATOR characteristics
The values of the electrical characteristics for the IMPLANTABLE PULSE GENERATOR measured in accordance
with the methods described in this clause shall be within the range of values stated by the manufacturer in the
accompanying documentation [see 28.8.2].
CAUTION The tests in this subclause may employ the use of high voltage. Failure to use safe
laboratory practices may result in severe electrical shock, resulting in personal injury or death to the
persons handling the equipment or conducting the test. Also damage to electrical equipment is
possible.
The measurements shall be made with the IMPLANTABLE PULSE GENERATOR at a temperature of 37 ºC ± 2 ºC.
The overall measurement accuracy for each test shall be within the limits ± 5 %.
6.1.1 Measurement of the bradyarrhythmia characteristics
Measurement of the bradyarrhythmia characteristics of the IMPLANTABLE PULSE GENERATOR shall be performed
using the appropriate methods specified in 6.1 of ISO 14708-2. The bradyarrhythmia characteristics shall be
measured with the tachyarrhythmia therapies inactivated.
6.1.2 Measurement of icd output voltage
NOTE This clause does not apply to ATP ONLY DEVICES.
Procedure: use an oscilloscope, with input impedance of nominal 1 MΩ, ≤ 30 pF.
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ISO 14708-6:2010(E)
Figure 101 — Measurement of CD PULSE characteristics
The IMPLANTABLE PULSE GENERATOR shall be connected to the oscilloscope as shown in Figure 101. TERMINALS
of the IMPLANTABLE PULSE GENERATOR intended to deliver a CD PULSE shall be connected to a low-inductance
load of 50 Ω ± 1 % (R ). Other inputs/outputs shall be connected to loads of 500 Ω ± 5 % (R ). The
A B
oscilloscope shall be adjusted to display one phase of the CD PULSE.
The IMPLANTABLE PULSE GENERATOR shall be programmed to the maximum CD PULSE ENERGY setting.
The ICD OUTPUT VOLTAGE (V ) shall be determined by recording the peak amplitude of the voltage across the
max
resistor R [see Figure 101 and Figure 102].
A
The procedure shall be repeated for each type of CD PULSE (i.e. monophasic, biphasic waveform).
The entire procedure shall be repeated for the other required CD PULSE ENERGY settings
[see 28.8.2 d) 2)].
The results shall be expressed in volts (V) and shall be within the tolerance of disclosed data [see
28.8.2 d) 2)].
Figure 102 — Measurement of ICD OUTPUT VOLTAGE
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ISO 14708-6:2010(E)
6.1.3 Measurement of delivered CD PULSE ENERGY
NOTE This clause does not apply to ATP ONLY DEVICES.
Procedure:
...
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