ISO 14117:2012
(Main)Active implantable medical devices — Electromagnetic compatibility — EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
Active implantable medical devices — Electromagnetic compatibility — EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
ISO 14117:2012 specifies test methodologies for the evaluation of the electromagnetic compatibility (EMC) of active implantable cardiovascular devices that provide one or more therapies for bradycardia, tachycardia and cardiac resynchronization. It specifies performance limits of these devices, which are subject to interactions with EM emitters operating across the EM spectrum in the two following ranges: 0 Hz ≤ f 450 MHz ≤ f ≤ 3 000 MHz. ISO 14117:2012 also specifies requirements for the protection of these devices from EM fields encountered in a therapeutic environment and defines their required accompanying documentation, providing manufacturers of EM emitters with information about their expected level of immunity.
Dispositifs médicaux implantables actifs — Compatibilité électromagnétique — Protocoles d'essai EMC pour pacemakers cardiaques implantables, défibrillateurs implantables et dispositifs de resynchronisation cardiaque
General Information
Relations
Buy Standard
Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 14117
First edition
2012-07-15
Active implantable medical devices —
Electromagnetic compatibility —
EMC test protocols for implantable
cardiac pacemakers, implantable
cardioverter defibrillators and cardiac
resynchronization devices
Dispositifs médicaux implantables actifs — Compatibilité
électromagnétique — Protocoles d’essai EMC pour pacemakers
cardiaques implantables, défibrillateurs implantables et dispositifs de
resynchronisation cardiaque
Reference number
ISO 14117:2012(E)
©
ISO 2012
---------------------- Page: 1 ----------------------
ISO 14117:2012(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2012
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO’s
member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2012 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 14117:2012(E)
Contents Page
Foreword .iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions, symbols and abbreviations . 1
4 Test requirements for the frequency band 0 Hz ≤ ƒ ≤ 3 000 MHz . 3
4.1 General . 3
4.2 Induced lead current . 4
4.3 Protection from persisting malfunction attributable to ambient electromagnetic fields . 11
4.4 Temporary response to continuous wave sources .21
4.5 Protection from sensing EMI as cardiac signals .24
4.6 Protection from static magnetic fields of flux density up to 1 mT .34
4.7 Protection from static magnetic fields of flux density up to 50 mT .35
4.8 Protection from AC magnetic field exposure in the range of 1 kHz to 140 kHz .36
4.9 Test requirements for the frequency range of 450 MHz ≤ ƒ ≤ 3 000 MHz .37
5 Testing above frequency of 3 000 MHz .41
6 Protection of devices from EM fields encountered in a therapeutic environment .41
6.1 Protection of the device from damage caused by high-frequency surgical exposure .41
6.2 Protection of the device from damage caused by external defibrillators .42
7 Additional accompanying documentation.46
7.1 Disclosure of permanently programmable sensitivity settings .46
7.2 Descriptions of reversion modes .46
7.3 Known potential hazardous behaviour.46
Annex A (informative) Rationale .47
Annex B (informative) Rationale for test frequency ranges .58
Annex C (informative) Code for describing modes of implantable generators .63
Annex D (normative) Interface circuits .65
Annex E (informative) Selection of capacitor C .70
x
Annex F (normative) Calibration of the injection network (Figure D.5) .71
Annex G (normative) Torso simulator .73
Annex H (normative) Dipole antennas .76
Annex I (normative) Pacemaker/ICD programming settings .78
Annex J (normative) Simulated cardiac signal .80
Annex K (normative) Calculation of net power into dipole antenna .81
Annex L (informative) Loop area calculations .85
Annex M (informative) Correlation between levels of test voltages used in this International Standard
and strengths of radiated fields .90
Bibliography .96
© ISO 2012 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO 14117:2012(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 14117 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 6,
Active implants.
ISO 14117 is based on ANSI/AAMI PC69:2007. The relationship between the documents is addressed in A.2.4.
iv © ISO 2012 – All rights reserved
---------------------- Page: 4 ----------------------
ISO 14117:2012(E)
Introduction
The number and the types of electromagnetic (EM) emitters to which patients with active implantable
cardiovascular devices are exposed in their day-to-day activities have proliferated over the past two decades.
This trend is expected to continue. The interaction between these emitters and active implantable cardiovascular
devices (pacemakers and implantable cardioverter defibrillators, or ICDs) is an ongoing concern of patients,
industry and regulators, given the potential life-sustaining nature of these devices. The risks associated with
such interactions include device inhibition or delivery of inappropriate therapy that, in the worst case, could
result in serious injury or patient death.
In recent years, other active implantable cardiovascular devices have emerged, most notably devices that
perform the function of improving cardiac output by optimizing ventricular synchrony, in addition to performing
pacemaker or ICD function.
Although these devices can deliver an additional therapy with respect to pacemakers and ICD devices, most
of their requirements concerning EM compatibility are similar so that, in most cases, the concepts that apply
to pacemakers also apply to CRT-P devices, and the appropriate way to test a CRT-P device is similar to the
way pacemakers are tested. Similarly, the concepts that apply to ICD devices mostly apply to CRT-D devices
as well, so the appropriate way to test a CRT-D device is similar to the way ICD devices are tested.
Standard test methodologies allow manufacturers to evaluate the EM compatibility performance of a product
and demonstrate that the product achieves an appropriate level of EM compatibility in uncontrolled EM
environments that patients may encounter.
It is important that manufacturers of transmitters and any other equipment that produces EM fields (intentional
or unintentional) understand that such equipment may interfere with the proper operation of active implantable
cardiovascular devices.
It is important to understand that these interactions may occur despite the conformance of the device to this
International Standard and the conformance of emitters to the relevant human exposure safety standards and
pertinent regulatory emission requirements, e.g. those of the U.S. Federal Communications Commission (FCC).
Compliance with biological safety guidelines does not necessarily guarantee EM compatibility with active
implantable cardiovascular devices. In some cases, the reasonably achievable EM immunity performance for
these devices falls below these biological safety limits.
The potential for emitter equipment to interfere with active implantable cardiovascular devices is complex and
depends on the following factors:
— frequency content of the emitter,
— modulation format,
— power of the signal,
— proximity to the patient,
— coupling factors, and
— duration of exposure.
Devices within the scope of this International Standard are life-sustaining and are designed to sense low-level
physiological signals (as low as 0,1 mV) that have frequency content up to several hundred Hertz. For patient
safety and comfort, these devices are small, offer many therapeutic features, and have a long battery life. These
highly desired features, combined with the intrinsic functionality, limit the size and number of components and
thus place practical constraints on the capability to control electromagnetic interference (EMI).
An emitter with a fundamental carrier frequency up to several hundred Hertz has the potential to be sensed
directly by the pacemaker or ICD. Also, higher-frequency carriers that are modulated up to several hundred
Hertz and that have sufficient proximity and power may be sensed by the pacemaker or ICD.
Additional details regarding this issue can be found in Annex M.
© ISO 2012 – All rights reserved v
---------------------- Page: 5 ----------------------
ISO 14117:2012(E)
This International Standard addresses the EM compatibility of pacemakers and ICDs up to 3 000 MHz and is
divided in several sections.
a) 0 Hz ≤ ƒ < 450 MHz
In the lower-frequency bands (<450 MHz), there are many EM emitters, such as broadcast radio and television,
and a number of new technologies or novel applications of established technologies that may increase the
likelihood of interaction between the emitters and patients’ pacemakers and ICDs. A few examples:
— electronic article surveillance (EAS) systems;
— access control systems (radio-frequency identification, or RFID);
— new wireless service in the ultra-high-frequency and very-high-frequency bands;
— magnetic levitation rail systems;
— radio-frequency (RF) medical procedures, such as high-frequency surgery and ablation therapy;
— metal detectors;
— magnetic resonance imaging; and
— experimental use of transponders for traffic control.
b) 450 MHz ≤ ƒ < 3 000 MHz
These are the frequencies, ƒ, that are typically associated with personal hand-held communication devices
(e.g. wireless telephones and two-way radios).
Two decades ago, relatively few pacemaker patients used hand-held transmitters or were exposed to EM
fields from portable transmitters. Hand-held, frequency-modulated transceivers for business, public safety,
and amateur radio communications represented the predominant applications. However, the environment has
changed rapidly during the past 15 years, with wireless phone systems becoming increasingly common as this
technology matured and received widespread public acceptance. Thus, it is becoming increasingly likely that a
large portion of the pacemaker and ICD patient population will be exposed to EM fields from portable wireless
phone transmitters operated either by themselves or by others. Also, it should be expected that the wireless
technology revolution will continue to evolve new applications using increasingly higher microwave frequencies.
Most electronic equipment, including external medical devices, has been designed for compatibility with
relatively low-amplitude EM conditions. Recognizing the wide range of EM environments that patients could
encounter, implantable devices have been designed to tolerate much higher-amplitude EM conditions than
most other electronic products. However, in some instances, even this enhanced immunity is not sufficient to
achieve compatibility with the complex electric and magnetic fields generated by low-power emitters located
within a few centimetres of the implantable device. Studies in the mid-1990s demonstrated that some models
of pacemakers and ICDs had insufficient immunity to allow unrestricted use when in close proximity to some
hand-held emitters (e.g. wireless telephones and two-way radios). Although operating restrictions can help
prevent EM interaction with implantable devices, this approach is not viewed as an optimum long-term solution.
Rather, improved EM compatibility is the preferred method for meeting patient expectations for using wireless
services with minimal operating restrictions.
Some technological factors are contributing to the expanding variety of emitters to which patients may
now be exposed:
— smaller wireless phones,
— the introduction of digital technology, and
— peak transmitter power.
Wireless phone size has now been reduced sufficiently so that it is possible for patients to carry a phone that
is communicating or in standby mode in a breast pocket immediately adjacent to a pectorally implanted device.
vi © ISO 2012 – All rights reserved
---------------------- Page: 6 ----------------------
ISO 14117:2012(E)
Since 1994, reported studies have indicated that interference effects in pacemakers are more severe from
digital phones than from analog phones. As of September 2010, there were more than 5 billion digital
subscriptions worldwide.
The various wireless phone standards allow for a range of power levels and modulation schemes. Most digital
wireless phones are capable of producing greater peak transmitted power than analog phones are capable of
producing. Those factors contribute to greater potential interactions with pacemakers and ICDs.
For frequencies of 450 MHz ≤ ƒ ≤ 3 000 MHz, this International Standard specifies testing at 120 mW net power into
a dipole antenna to simulate a hand-held wireless transmitter 15 cm from the implant. An optional characterization
test is described that uses higher power levels to simulate a hand-held wireless transmitter placed much closer to the
implant. Claims that the manufacturer may wish to make on the basis of the results of the optional characterization
are to be negotiated between the manufacturer and the appropriate regulatory authorities.
c) ƒ ≥ 3,000 MHz
This International Standard does not require testing of devices above 3 GHz. The upper-frequency limit chosen
for this International Standard reflects consideration of the following factors:
1) the types of radiators of frequencies above 3 GHz,
2) the increased device protection afforded by the attenuation of the enclosure and body tissue at
microwave frequencies,
3) the expected performance of EMI control features that typically are implemented to meet the lower-
frequency requirements of this International Standard, and
4) the reduced sensitivity of circuits at microwave frequencies.
Additional details can be found in Clause 5.
In conclusion, it is reasonable to expect that patients with pacemakers and ICDs will be exposed to increasingly
complex EM environments. Also, the rapid evolution of new technologies and their acceptance by patients
will lead to growing expectations for unrestricted use. In view of the changing EM environment and customer
expectations, manufacturers will need to evaluate their product designs to assess compatibility with the
complex fields, broad range of frequencies, and variety of modulation schemes associated with existing and
future applications.
© ISO 2012 – All rights reserved vii
---------------------- Page: 7 ----------------------
INTERNATIONAL STANDARD ISO 14117:2012(E)
Active implantable medical devices — Electromagnetic
compatibility — EMC test protocols for implantable cardiac
pacemakers, implantable cardioverter defibrillators and cardiac
resynchronization devices
1 Scope
This International Standard specifies test methodologies for the evaluation of the electromagnetic compatibility
(EMC) of active implantable cardiovascular devices that provide one or more therapies for bradycardia,
tachycardia and cardiac resynchronization.
It specifies performance limits of these devices, which are subject to interactions with EM emitters operating
across the EM spectrum in the two following ranges:
0 Hz ≤ ƒ < 450 MHz;
450 MHz ≤ ƒ ≤ 3 000 MHz
This International Standard also specifies requirements for the protection of these devices from EM fields
encountered in a therapeutic environment and defines their required accompanying documentation, providing
manufacturers of EM emitters with information about their expected level of immunity.
2 Normative references
There are currently no standards normatively referenced within this International Standard. However, future
editions are likely to include normative references as new emitters or test methods are identified.
NOTE It is also expected that future revisions of the related product standards ISO 14708-2 and ISO 14708-6 will
normatively reference this standard.
3 Terms and definitions, symbols and abbreviations
For the purposes of this document, the following terms and definitions apply.
3.1
implantable pacemaker
active implantable medical device intended to treat bradyarrhythmias, comprising an implantable DUT and leads
3.2
implantable cardioverter defibrillator
ICD
active implantable medical device intended to detect and correct tachycardias and fibrillation by application of
cardioversion/defibrillation pulses to the heart, comprising an implantable DUT and leads
3.3
implantable cardiac resynchronization therapy pacing device
CRT-P
active implantable medical device intended to provide improved ventricular activation to optimize cardiac
output, comprising an implantable DUT and leads
© ISO 2012 – All rights reserved 1
---------------------- Page: 8 ----------------------
ISO 14117:2012(E)
3.4
implantable cardiac resynchronization therapy/defibrillator device
CRT-D
active implantable medical device intended to detect and correct tachycardias and fibrillation by application
of cardioversion/defibrillation pulses to the heart, and to provide improved ventricular activation to optimize
cardiac output, comprising an implantable DUT and leads
3.5
inhibition generator
equipment that generates a simulated heart signal for devices within the scope of this International Standard
3.6
harm
physical injury or damage to the health of people, or damage to property and environment
[ISO/IEC Guide 51:1999, definition 3.3]
3.7
maximum permanently programmable sensitivity
condition where the sensing channels of an ICD or pacemaker are set, either automatically by the device or
programmed by a clinician, to detect the lowest amplitude signals
NOTE 1 These settings are intended for use without direct medical supervision.
NOTE 2 Sensitivity settings are usually expressed in terms of the minimum voltage that can be sensed. Therefore, a
sensitivity of 1mV is actually more sensitive than a setting of 2mV.
NOTE 3 An AIMD may have settings, including those for sensitivity, that by design of the device or its software, are
only temporarily available for use during diagnostic testing (such as during manufacture) or for testing at the time of
implantation. Such settings are therefore unavailable for use by patients when not under immediate medical care and are
not intended to be encompassed by the testing herein.
Table 1 shows acronyms and abbreviations used in this International Standard.
Table 1 — List of acronyms and abbreviations
Acronym or abbreviation Description
A atrial
AAMI Association for the Advancement of Medical Instrumentation
ACA antenna cable attenuation (+dB)
AdBm power meter “A” reading (dBm)
ASIC Application Specific Integration Circuit
ATP antitachycardia pacing
BdBm power meter “B” reading (dBm)
BPEG British Pacing and Electrophysiology Group
bpm beats per minute
CENELEC European Committee for Electrotechnical Standardization
CW continuous wave
dB decibel
dBm decibels above a milliwatt
DCF directional coupler forward port coupling factor (+dB)
DCR directional coupler reflected port coupling factor (+dB)
DUT device under test
EAS electronic article surveillance
ECG electrocardiogram
EGM electrogram
2 © ISO 2012 – All rights reserved
---------------------- Page: 9 ----------------------
ISO 14117:2012(E)
Table 1 (continued)
Acronym or abbreviation Description
EM electromagnetic
EMC electromagnetic compatibility
EMI electromagnetic interference
EN European Norm
ESMR enhanced specialized mobile radio
ƒ frequency
FCC Federal Communications Commission
FP forward dipole power (mW)
FPdBm forward dipole power (dBm)
ICD implantable cardioverter defibrillator
ICNIRP International Commission on Non-Ionizing Radiation Protection
IEC International Electrotechnical Commission
IEEE Institute of Electrical and Electronics Engineers
λ wavelength
NASPE North American Society of Pacing and Electrophysiology
NP net dipole power (mW)
o.d. outside diameter
Ωcm measure of resistivity (Ohm-cm)
PCS personal communication services
PVARP post ventricular atrial refractory period
RF radio frequency
RFID radio-frequency identification
rms root mean square
RP reflected dipole power (mW)
RPdBm reflected dipole power (dBm)
SMA subminiature “A”
T simulated heart signal interval
shs
V ventricular
VF ventricular fibrillation
VSWR voltage standing wave ratio
VT ventricular tachycardia
NOTE Throughout this International Standard, DUT has been used to designate all devices within the scope of this
International Standard. When a certain test or requirement applies only to a specific type of device, that designation is used.
4 Test requirements for the frequency band 0 Hz ≤ ƒ ≤ 3 000 MHz
4.1 General
Implantable pacemakers, ICDs and CRT devices shall not cause any harm because of susceptibility to electrical
influences due to external EM fields, whether through malfunction of the device, damage to the device, heating
of the device, or by causing local increase of induced electrical current density within the patient.
© ISO 2012 – All rights reserved 3
---------------------- Page: 10 ----------------------
ISO 14117:2012(E)
Compliance shall be confirmed if, after performance of the appropriate procedures described in 4.2 to 4.9, the
values of the characteristics when measured are as stated by the manufacturer specification of the DUT. All
requirements shall be met for all settings of the DUT, except as follows.
— For pacemakers and CRT-P devices: those settings that the manufacturer specifies in the accompanying
documentation as not meeting the requirements of 4.4 and 4.5.2.1.
— For ICDs and CRT-D devices: those settings that the manufacturer specifies in the accompanying
documentation as not meeting the requirements of 4.5.2.2.
NOTE 1 This does not mean that all combinations of settings are tested, but at least the setting to which the device is
preset by the manufacturer should be tested completely.
NOTE 2 If the case of the DUT is covered with an insulating material, the DUT (or part of it) should be immersed in a 9
g/l saline bath held in a metal container; the metal container should be connected directly to the test circuit as applicable
in each test set up.
NOTE 3 Manufacturers that use an automatic gain control function (or similar feature) for sensing purposes should
include a detailed test method.
NOTE 4 Some of the tests described in the following sections may require modifications of the testing fixtures to allow
for the tests to be applied to devices having three or more channels, e.g. CRT-P and CRT-D.
NOTE 5 The following tests are generally intended to address the compatibility of the intracardiac signal sensing. Any
additional physiological sensors may be turned off during testing unless otherwise specified. Tests for these additional
sensors are under consideration.
4.2 Induced lead current
4.2.1 General considerations
The DUT shall be constructed so that ambient EM fields are unlikely to cause hazardous local increases of
induced electrical current density within the patient.
4.2.2 Pacemakers and CRT-P devices
Test equipment: Use the test setup defined in Figure 2; the tissue-equivalent interface circuit defined in
Figure D.1 and Table D.1a; the low-pass filter defined by Figure D.4; two oscilloscopes, input impedance
nominal 1 MΩ; and test signal generators, output impedance 50 Ω.
Test signal: Two forms of test signal shall be used.
Test signal 1 shall be a sinusoidal signal of 1 V peak-to-peak amplitude. The frequency shall be either swept
over the range 16,6 Hz to 20 kHz at a rate of 1 decade per minute or applied at a minimum of four distinct,
well-spaced frequencies per decade between 16,6 Hz and 20 kHz, with an evenly distributed dwell time of at
least 60 s per decade.
Test signal 2 shall be a sinusoidal carrier signal, frequency 500 kHz, with continuous amplitude modulation at
130 Hz (double sideband with carrier) (see Figure 1).
Figure 1 — Test signal 2
4 © ISO 2012 – All rights reserved
---------------------- Page: 11 ----------------------
ISO 14117:2012(E)
The maximum peak-to-peak voltage of the modulated signal shall be 2 V. The modulation index, M, shall
be 95 %, where
Vv-
pp
M = * 100
V +ν
pp
Test procedure: The test signal generator shall be connected through input C of the interface circuit as shown
in Figure 2. The test signal shall be measured on the oscilloscope connected to monitoring point D.
Figure 2 — Test setup for measurement of induced current
The induced electrical current is measured by the oscilloscope connected to test point K through the low-pass
filter (as defined in Figure D.4), as shown in Figure 2. When test signal 1 is being used, the low-pass filter shall
be switched to bypass mode.
The capacitor C of the interface circuit (see Figure D.1) shall be bypassed unless required to eliminate spurious
x
low-frequency signals produced by the interference signal generator (see Annex E).
NOTE 1 It is not mandatory that a current measurement be made in the period from 10 milliseconds (ms) preceding a
stimulation pulse to 150 ms after the stimulation pulse.
The pacemaker or CRT-P shall be categorized into one or more of four groups as appropriate:
— single-channel unipolar devices shall be Group a);
— multichannel unipolar devices shall be Group b);
— single-channel bipolar devices shall be Group c);
— multichannel bipolar devices shall be Group d).
NOTE 2 The bipolar channel should be tested in unipolar or bipolar mode, or both, according to the programmability of
the device and should be changed where applicable.
Any terminal of the DUT not being tested shall be connected to the channel under test through a resistor of
value R ≥ 10 kΩ, as specified by the manufacturer.
Group a): the DUT shall be connected to the coupled outputs F and G of the tissue-equivalent interface (as
shown in Figure 3), with output J connected to the case.
© ISO 2012 – All rights reserved 5
---------------------- Page: 12 ----------------------
ISO 14117:2012(E)
Figure 3 — Connection to a single-channel unipolar device
Group b): every input/output of the DUT shall be connected, in turn, to the coupled
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.