Electromagnetic Compatibility (EMC)

for Active Implantable Medical Devices

Roland Gubisch
 Electromagnetic Compatibility (EMC)
for Active Implantable Medical Devices

Table of Contents

Introduction ..................................................................................................................... 2

EMC Background ............................................................................................................. 2

EMC definition ..................................................................................................................... 2
EMC and medical devices ..................................................................................................... 3
Sources of electromagnetic disturbances .............................................................................. 4

Active Implantable Medical Devices .............................................................................. 6

Types ................................................................................................................................... 6
EMC considerations.............................................................................................................. 6
How much field attenuation does the human body provide? ................................................ 7
Environments and EMC threats........................................................................................... 10

Regulatory considerations: EMC .................................................................................. 14

United States of America.................................................................................................... 14
European Union ................................................................................................................. 15
Rest of world ..................................................................................................................... 15

Test requirements: EMC ................................................................................................ 16

Cardiac pacemaker and defibrillator ................................................................................... 17
Radio standards: Programming the implant ........................................................................ 20

EMC design considerations........................................................................................... 22

Summary ........................................................................................................................ 23

About the author........................................................................................................... 23

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 Electromagnetic Compatibility (EMC)
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Introduction

The role of electromagnetic compatibility in implantable medical device design and testing
has become increasingly important as we rely more and more on electronics in our lives.

During the course of a normal day, our human body can experience a large number of
different electromagnetic environments. Our homes can be relatively benign. But when we
put a mobile phone to our ears, or pass through a department store security check, we are
exposing our body to high levels of electromagnetic fields.

We are not normally aware of this invisible aspect of our surroundings, nor is it harmful. But
when we carry an active implantable medical device with us, the results can be serious.
That’s why manufacturers of such devices must anticipate the environments we visit - and
test their devices to assure continuous, reliable operation.

The electromagnetic environments experienced by implanted medical devices are quite

different from those encountered by common types of other medical electrical equipment.
In this paper we will start from the basic issues of medical EMC and analyze the unique
circumstances affecting active implanted devices.

EMC Background

EMC definition

Electromagnetic Compatibility (EMC) is defined as:

The condition which exists when equipment is performing its designed functions without
causing or suffering unacceptable degradation due to electromagnetic interference to or
from other equipment.

EMC refers to a kind of environmental equilibrium. In this case, the environment is an

electromagnetic one - consisting of invisible disturbances which travel through the air or
through metal cabinets or wires. Most electrical and electronic devices generate such
disturbances. And, as we have seen, many electronic devices can be upset by these
disturbances.

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When a particular piece of equipment is not generating excessive disturbances, and when it
is operating correctly in the presence of such disturbances, the condition of electromagnetic
compatibility is satisfied.

The illustration below illustrates graphically that electromagnetic compatibility is comprised

of the two parts: emissions that are not excessive for the intended environment, and a level
of susceptibility that permits normal operation in that environment. Note that there is a
wide gap between the typical levels of emissions and immunity – a factor of roughly 10,000
to 1. This arises because the emission limits are set to protect radio/TV broadcast receivers
and other sensitive radio services, whereas the immunity limits protect the normal function
of most other electronic devices.

Electromagnetic
compatibility

Electromagnetic Electromagnetic
emissions susceptibility

Radiated emission limits RF susceptibility levels

100-224 μV/m
Residential 3 V/m
CISPR 11Class B (3m)
316-708 μV/m
Industrial 10 V/m
CISPR 11 Class A (3m)

EMC and medical devices

Electrical and electronic medical devices often operate in well-defined electromagnetic

environments – hospitals, clinics, doctors’ offices and our homes. For these locations the
circumstances of electromagnetic compatibility are fairly well-defined. The medical EMC
standard IEC 60601-1-2 has been adopted internationally to cover both life-supporting
equipment and other types. It draws on the IEC 61000-4-x series of basic EMC standards
(below). It also defines the immunity “compliance criteria” – emission limits and changes in
equipment performance that are not allowed unless specific precautions are provided to the
user.

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Table 1 – Basic EMC standards in IEC 60601-1-2

emissions phenomenon standard typical source

Radiated emissions CISPR 11 Digital electronics
AC conducted emissions CISPR 11 Switching power supply
Harmonic distortion IEC 61000-3-2 Switching power supply
Voltage fluctuations/flicker IEC 61000-3-3 Internal load switching
immunity phenomenon standard typical source
Electrostatic discharge IEC 61000-4-2 Static buildup on person or object
RF radiated immunity IEC 61000-4-3 radio transmitters above 80 MHz
Fast transient burst (EFT/B) IEC 61000-4-4 Switching noise in AC line
Lightning induced surge IEC 61000-4-5 Lightning near power line
RF conducted immunity IEC 61000-4-6 AM and HF mobile radio stations
Radiated magnetic immunity IEC 61000-4-8 Nearby power cord
Voltage dips/interrupts IEC 61000-4-11 Loads switching in AC branches

Sources of electromagnetic disturbances

Electromagnetic disturbances can be generated by natural events (ESD, lightning), AC

power installations (magnetic fields, fast transients, dropouts) or nearby electrical
equipment. Equipment sources of interference can be intentional or unintentional radiators.
The word intentional here does not mean a deliberate source of interference. Rather, it
means a device that intentionally emits radio waves for communications or therapy or other
useful purpose. Unintentional radiators emit radio waves as a byproduct of their normal
operation. Examples of both types are given below.

Intentional radiators Unintentional radiators

• Radio/TV stations • Digital electronics
• Remote controls • Microwave ovens
• Cell phones and pagers • Appliances
• Perimeter protection (anti-theft) systems • Lamp dimmers
• RFID scanners • FM radio receivers

Radiated emissions are essential for the operation of broadcast radio and TV, public
telecommunications (such as cellular telephony and paging), and private uses (such as
walkie-talkies, remote controls and wireless car door keys). Each of these intentional

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radiators is subject to rules for preventing interference and maximizing the efficient use of
limited spectrum.

Unintentional radiators, such as digital electronics and microwave ovens, are also governed
by standards which limit the permitted emissions. These are products which are not
designed to generate RF energy, but do so anyway. As a result, they can interfere with
broadcast reception or the operation of other nearby electronic devices.

In the United States, FCC rules govern permissible emissions from both unintentional and
intentional radiators. Part 15 establishes limits for digital devices, radio receivers and low-
power transmitters such as remote controls, perimeter protection systems and WiFi
networks. Other FCC parts regulate higher-power equipment such as cellular radio (Parts 22,
24 and 27), mobile radio (Part 90) and microwave communications (Part 101). With few
exceptions, the FCC does not regulate product immunity.

Medical product emissions and immunity are of concern to the US Food and Drug
Administration (FDA), through its responsibility for medical device safety. It has recognized
IEC 60601-1-2 as an acceptable medical EMC standard, with exceptions for specific devices
such as electric wheelchairs or equipment in ambulances where high-power mobile radios
may be in use. Medical equipment that uses wireless technology presents special risks for
both life-supporting and other applications, and the FDA provides additional guidance here
(www.fda.gov/cdrh/osel/guidance/1618.pdf).

In the European Union, unintentional radiators are regulated under the EMC Directive
2004/108/EC. Intentional radiators are regulated under the Radio and Telecommunications
Terminal Equipment (R&TTE) Directive 1999/5/EC. In both cases, standards harmonized to
these directives include both emission limits and immunity levels for typical environments.
The emission limits are similar to FCC rules in most cases.

Medical devices in the European Union are regulated under the Medical Device Directive
(MDD) 93/42/EC and by standards harmonized to it. EN 60601-1-2 (IEC 60601-1-2 as
adopted by CENELEC) has been harmonized to the MDD. Both the R&TTE and MDD
Directives are applied to medical equipment containing wireless devices. But the MDD
supersedes the EMC Directive with respect to EMC standards for unintentional radiators in
medical applications. These directives, and lists of all their harmonized standards, can be
found at the EU web site www.newapproach.org.

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Active Implantable Medical Devices

Types

Against this background of general and medical EMC and radio considerations, we are now
ready to consider active implantable medical devices. These are electrically-powered
therapeutic or monitoring devices situated wholly (or, in special cases, partially) within the
human body. Here are some typical active implantable medical device types:

Implantable cardiac pacemakers

Implantable defibrillators
Cochlear implants
Implantable nerve stimulators
Limb function stimulation
Bladder stimulators
Sphincter stimulators
Diaphragm stimulators
Analgesia (pain reduction)
Implantable infusion pumps
Implantable active monitoring devices

EMC considerations

Because active implantable medical devices are generally contained completely within the
human body, they do not have many of the provisions, or “ports,” through which
electromagnetic disturbances can enter or exit:

• There are no connections to other devices or to the AC power network; thus, AC

power line conducted emissions and conducted immunity are not a factor in EMC;

• Owing to the conductive tissues surrounding the implant, ESD events on the
surface of the body are not a factor after the device is implanted. However, some
EMC precautions (such as ESD handling) still apply until the device is implanted.

Thus most of the basic EMC standards referenced in IEC 60601-1-2 do not apply. In fact,
the FDA’s recognition of 60601-1-2 specifically excludes active implants. We are left with
only the radiated disturbances to consider:

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Table 2 – Basic standards for active implantable medical devices

phenomenon standard typical source

RF radiated immunity IEC 61000-4-3 Cell phone, walkie-talkie
RF conducted immunity IEC 61000-4-6 AM and HF mobile radio stations
IEC 61000-4-8 Perimeter protection (anti-theft)
Radiated magnetic immunity
(extended > 60 Hz) systems

Although the diversity of electromagnetic disturbances is reduced from general medical

electrical devices to implants, the magnitude of the immunity levels must be increased. The
patient is likely to transport the implant through a much harsher and more varied
electromagnetic environment than that encountered by typical medical equipment, without
even being aware of it. For example, the FDA has recognized as long ago as 2000 the
threat to active implants from perimeter protection (anti-theft) systems, and has
encouraged manufacturers and users to provide cautionary labeling for installations
(www.fda.gov/cdrh/com/guidance/1170.pdf).

RF emissions from implants are generally not a major concern. The active implant is
designed to use as little battery power as possible, so that internal digital circuitry will not
radiate significant energy. Any leads emerging from the implant housing will be thoroughly
bypassed or attenuated to prevent the ingress of RF emissions from the outside world; this
bypassing works in both directions to also reduce RF emissions from the implant.

Additionally, the dielectric properties of human tissue act to attenuate RF signals entering or
exiting the body. This attenuation serves to immunize the active implant from external
radiated electromagnetic disturbances, but it works against the use of implanted radio
transmitters.

How much field attenuation does the human body provide?

The dielectric properties of various tissue types

constituting the human body have been extensively
analyzed to arrive at threshold values of harm from
external electric and magnetic fields (ICNIRP Guidelines
for limiting exposure to time-varying electric, magnetic,
and electromagnetic fields up to 300 GHz (1998); IEEE
Std. C95.1-2005 Standard for safety levels with respect

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to human exposure to radio frequency electromagnetic fields, 3 kHz to 300 Hz). These
dielectric values have been used to approximate the power density within the human body
resulting from various external radio transmitters, especially cellular handsets.

The measurement of power density (termed Specific Absorption Rate or SAR) in the human
head or body from an external radio source uses a “phantom” or plastic shell in the shape
of a typical human head and/or trunk. This shell is filled with a liquid whose dielectric
properties are very similar to the human tissue such as brain or muscle.

With the radio transmitter placed below the phantom, an electric field probe immersed in
the dielectric fluid then scans inside the phantom to find the location of maximum power
density or peak SAR. A typical SAR measurement setup, using a precise robot arm to move
the probe, is shown in Figure 1 below.

Figure 1
SAR measurement setup

During the course of SAR measurement, the probe is moved in the dielectric fluid toward
the surface of the phantom and away from it. It can never measure SAR precisely at the
inside surface of the phantom, because the probe has a finite thickness. The value of SAR at
the inside surface of the phantom is extrapolated from the measurements further away.
This family of measurements reflects the attenuation of the RF field inside the human body,
and a typical curve is shown in Figure 2 below.

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Figure 2 – Attenuation of RF field inside human body phantom

By compiling these attenuation curves for various transmitter RF frequencies, we can build a
picture of how RF fields diminish as they propagate through the human body. The data
points in Figure 3 below were taken from a number of published SAR studies, and from
SAR reports accompanying radio certification filings in the FCC authorization database at
https://fjallfoss.fcc.gov/oetcf/eas/index.cfm.

RF field attenuation vs. body penetration

1.00
relative field strength

13.56 MHz
1900 MHz
0.10 2450 MHz
5.2 GHz
5.8 GHz

0.01
0 1 2 3 4 5 6
penetration distance, cm

Figure 3 – RF field attenuation in human body, from SAR reports.

Note that field attenuation in the first 1 cm of penetration varies from about 35% at 13.56
MHz, to over 80% above 5 GHz. Implanted radio transmitters will suffer correspondingly
from reduced range, and implanted receivers from loss of sensitivity. Lower frequencies
would be attenuated to lesser extents.

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Environments and EMC threats

We navigate through a world increasingly populated by radio devices – some visible, and
some not. Perhaps the most visible, and powerful, radio in personal use today is the cell
phone. Cell phones operate around the world in two common frequency bands, 800-900
MHz and 1800-2000 MHz, at about 0.6 W. Other bands are used by face-held personal
radios (450-470 MHz), at about 0.5 W. New WiMAX mobile data services occupy the
spectrum from 2.3 to around 3.5 GHz.

Cell phones
Because cell phones are generally held to the ear, or worn in pockets or holsters, they are
potential threats to cochlear implants, pacemakers and infusion pumps. Studies
summarized in Table 3 demonstrate a moderate incidence of interference to the normal
operation of pacemakers. In response, EMC standards have evolved to assure that
pacemakers have adequate immunity.

Table 3 – Impact of cell phones on pacemakers

In Vivo Studies
Power Frequency In Vitro
Device Type (W) (MHz)
Health Univ. of U.S. Studies
Canada Oklahoma FDA

Analog Cellular
0.6 828 0% 0% 0 0.5%
Phone

TDMA-50 0.6 835 3.4% 4.7% 10% 4.2%

TDMA-11 0.6 — — — 36.7% 10.5%

CDMA 0.6 — — 2.8% — 3.1%

PCS 0.6 1810 0% 0.6% — 0.2%

GSM 0.6 — — — 0 —

FRS 0.1 468 0% — — —

Number of 975
— — 20 29 30
Pacemakers patients

Incidence of
— — 3.4% 4.7% — 20%
Interference

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Security systems
Less widespread than cell phones but of equal concern are the myriad of security screening
devices in use that employ varying electromagnetic fields. The frequencies are much lower
than cell phones and, below 9 kHz, fall outside of the normal definition of RF energy. Such
screening devices are common in airports, department stores and libraries, to detect either
special passive tags or any sizeable metal object. The data summarized in Table 4 were
originally published by Kok-Swang Tan and Irwin Hinberg, Medical Devices Bureau,
Therapeutic Products Directorate, Health Products and Food Branch, Health Canada in
International Journal of Bioelectromagnetism, 2002, Vol. 4, No. 2.

Table 4 – Security system effects on pacemakers

Magnetic Effects on Pacemakers

Type Mode Carrier Frequency Field
Strength Inhibition Re-activation
(μT) *

Continuous 535 Hz 450 23 % 55 %

EAS carrier: 58.4 KHz

Modulated Pulse 400 36 % 68 %
modulation: 60 Hz

Sweep 7.4 - 9.1 MHz 0.1 0% 0%

Pulse 250 - 500 Hz 4.5 - 10 5% 9%

Pulse 89 Hz 45 36 % 64 %
WTMD
Modulated Pulse 250 - 909 Hz 18 - 22 5% 9%

Modulated Pulse 210 Hz 12 9% 14 %

HHMD Continuous 14 kHz - 1.8 MHz 0.2 - 10 0% 0%

*Measured at 15 cm from the transmission panel of EAS and WTMD systems, and 2.5 cm from
HHMDs; 0 % indicates no interference effects.

EAS: Electronic Article Surveillance

WTMD: Walk Through Metal Detector
HHMD: Hand Held Metal Detector

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RFID systems
The maximum field strengths emitted by security systems are higher than from RFID (Radio
Frequency IDentification) scanners, which detect and read encoded tags but at closer
distances and typical frequencies shown in Table 5 below.

Table 5 – RFID system field strengths: From ISO/IEC JTC1 SC31 study, January 2006

Carrier frequency Peak field Modulation

134 kHz 65 A/m (~ 80 μT) 10 – 14 Hz
13.56 MHz 7 A/m (~ 9 μT) 2 – 11 Hz
915 MHz – 56 kHz

However, many security systems generate lesser magnetic fields which are comparable to
RFID systems.

Magnetic Resonance Imaging (MRI)

MRI lies at the extreme end of the continuum of EMC threats to implanted devices. It is a
clinical technique for imaging different types of tissues in the body. It uses extremely high
transient magnetic fields to temporarily re-orient atomic nuclei, which then return to their
normal positions and emit detectable signals for imaging. Fortunately, the patient has prior
knowledge of the process, so that proper precautions can be taken with regard to implants.
This may not be the case for security systems that may be hidden from view.

Typical characteristics of MRI systems are:

• Magnetic field strengths of 0.3T to 3T (earth’s magnetic field is ~50 μT).

• Magnetic field gradients of 20 mT/m to 100 mT/m.
• Pulse repetition time 16 – 500 ms.

Owing to the very high magnetic field strengths attained by MRI systems, patients with
active implants have been generally advised to avoid MRI exposure, even when the implant
has been deactivated (see Table 6). One of the hazards of exposure is the overheating of
internal patient leads from magnetic induction.

More recent observations with cardiac pacemakers manufactured in the last ten years
indicates that exposure to lower levels of MRI exposure (< 1.5T) may not cause any adverse
outcomes (for example, see Martin et. al., J. Am. Col. Cardiology, vol. 43, 2004).

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Table 6 – Indications between implants and common

diagnostic/therapeutic devices

Type of AIMDS
Procedure Implanted Cardiac Implanted Cardiac Implanted
Pacemaker Defibrillator Neurostimulator
Absolute Absolute Absolute
Shortwave and Microwave Diathermy
contraindication contraindication contraindication
Relative Relative Absolute
Therapeutic Ultrasound Diathermy
contraindication contraindication contraindication
Relative Relative Absolute
Electromagnetic Stimulation
contraindication contraindication contraindication
MRI with transmit/receive radio-frequency (RF) Absolute Absolute Relative
head coil contraindication contraindication contraindication*
Absolute Absolute Absolute
MRI (all other)
contraindication contraindication contraindication
Relative Relative Relative
Electrosurgery
contraindication contraindication contraindication
Relative Relative Relative
External Defibrillation
contraindication contraindication contraindication
Relative Relative Relative
Radiotherapy
contraindication contraindication contraindication
Relative Relative Relative
Lithotripsy or Ultrasound Therapy
contraindication contraindication contraindication
Fluoroscopy or other X-ray procedures No contraindication No contraindication No contraindication
Echography No contraindication No contraindication No contraindication
From: Agence française de sécurité sanitaire des produits de santé (AFSSAPS) (1995), as adopted by
Health Canada.
* This type only of MRI is allowed if both of the following conditions are met:
1) The gradient magnetic field must be 20 T/s or less;
2) The transmit/receive radio-frequency (RF) head coil must have a specific absorption rate (SAR)
rating less than the maximum permissible SAR as given in the manufacturer's specifications for
the neurostimulator, for all possible radio-frequency (RF) pulse sequences.

The categories of “No contraindication,” “Relative contraindication” and “Absolute

contraindication” have corresponding 2006 classifications for implant and ancillary device
safety (ASTM/FDA):

MR-Safe – device or implant is completely non-magnetic, non-electrically conductive, and

non-RF reactive.
MR-conditional – may contain magnetic, electrically-conductive or RF-reactive components
found safe in tested conditions (“tested safe to 1.5T”)
MR-unsafe

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Regulatory considerations: EMC

United States of America

In the USA, the FDA has recognized IEC 60601-1-2 as a consensus standard for medical
devices. Its recognition is restricted by the FDA from applying to active implanted devices. In
spite of this restriction, it is nevertheless cited in conjunction with ANSI C63.19 Methods of
Measurement of Compatibility between Wireless Communications Devices and Hearing Aids
for cochlear implants.

FDA standards guidance for EMC on cardiac pacemakers (pulse generators) cites no
particular EMC standards, but encourages compatibility testing with likely interference
sources. Filings submitted to the FDA, and its draft guidance regarding wireless
technologies, reference AAMI (Association for the Advancement of Medical
Instrumentation) PC69 Active implantable medical devices—Electromagnetic compatibility—
EMC test protocols for implantable cardiac pacemakers and implantable cardioverter
defibrillators.

Table 7 – Implant Safety and EMC standards

U.S. FDA EU AIMDD International

General
- EN 45502-1 ISO 14708-1
requirements
Implantable Pacemaker
Cardiac
Testing Guidance EN 45502-2-1 ISO 14708-2
pacemakers
AAMI PC69
Cardiac
- EN 45502-2-2 ISO/DIS 14708-6
defibrillators
IEC 60601-1-2
ANSI C63.19
FprEN 45502-2-3
Cochlear implants FDA Guidance 8-1-03, -
(AIMDD)
Implantable middle ear
hearing device
Neurostimulators - - ISO 14708-3
BSR/AAMI/ISO 14708-4:
Infusion pumps Fpr ISO 14708-4 ISO 14708-4
200x (AAMI)
Standards harmonized to AIMDD in italics.

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ANSI is poised to adopt the recently-published ISO 14708-4 Implants for surgery -- Active
implantable medical devices -- Part 4: Implantable infusion pumps, after which it will likely
be recognized by the FDA.

European Union

In the EU, the Active Implantable Medical Device (AIMDD) Directive 90/385/EC regulates the
evaluation and approval of active implants. It is a “New Approach” directive, requiring CE-
marking of the compliant product. Notified Bodies are required to evaluate the
manufacturer’s quality system or to provide type-examination of the product. Although any
method acceptable to the Notified Body may be used to demonstrate conformity of the
implant to the “essential requirements” of the AIMDD, the use of “harmonized” standards
gives a presumption of conformity. Standards are “harmonized” when they are published
in the Official Journal of the European Union under the particular directive. Although
CENELEC has published a number of standards intended for application to the AIMDD
(listed below), only two (shown in italics) have been harmonized to it to date.

EN 45502-1:1997 Active implantable medical devices -- Part 1: General

requirements for safety, marking and information to be provided
by the manufacturer

EN 45502-2-1:2003 Active implantable medical devices -- Part 2-1: Particular

requirements for active implantable medical devices intended to
treat bradyarrhythmia (cardiac pacemakers)

EN 45502-2-2:2008 Active implantable medical devices -- Part 2-2: Particular

requirements for active implantable medical devices intended to
treat tachyarrhythmia (includes implantable defibrillators)

FprEN 45502-2-3:2008 Active implantable medical devices -- Part 2-3: Particular

(Draft) requirements for cochlear implant systems

Rest of world

Outside of the jurisdiction of the USA and EU, countries generally adopt international EMC
standards or amended versions thereof. The most common sources of international EMC
standards are the IEC and CISPR, but their standards are limited in scope to exclude
implantable devices. For example, external cardiac pacemakers and infusion pumps are
covered by particular standards in the IEC 60601-1 family, specifically -2-10 and -2-24.

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Thus for international active implant EMC standards we must look to the ISO – which does
provide a list roughly parallel to existing and draft CENELEC standards:

ISO 14708-1:2000 Implants for surgery -- Active implantable medical devices -- Part 1:
General requirements for safety, marking and for information to be
provided by the manufacturer
ISO 14708-2:2005 Implants for surgery -- Active implantable medical devices -- Part 2:
Cardiac pacemakers
ISO 14708-3:2008 Implants for surgery -- Active implantable medical devices -- Part 3:
Implantable neurostimulators
ISO 14708-4:2008 Implants for surgery -- Active implantable medical devices -- Part 4:
Implantable infusion pumps
ISO/DIS 14708-5 Implants for surgery -- Active implantable medical devices -- Part 5:
(Draft) Circulatory support devices
ISO/DIS 14708-6 Implants for surgery -- Active implantable medical devices -- Part 6:
(Draft) Particular requirements for active implantable medical devices
intended to treat tachyarrhythmia (including implantable
defibrillators)

Test requirements: EMC

The safety and EMC standard for each type of implant imposes its own unique test
requirements appropriate to the purpose and function of the device, and there are too
many variations among the standards to detail them here. Nevertheless, there are common
EMC considerations among them, specifically:

• The immunity disturbances are limited to the types given in Table 2 above.
• RF disturbances below ~ 450 MHz are applied to implant leads by direct coupling.
• RF disturbances above ~450 MHz are applied with radiated fields.
• In addition, radiated magnetic fields 0 – 140 kHz are applied.

We will look at an example of implant EMC test requirements, including setup and
disturbance levels, below.

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Cardiac pacemaker and defibrillator

Numerous cardiac pacemakers and

defibrillators filed with the FDA cite EMC
compliance with AAMI PC69:2000. The
only EMC test in this version of the
standard is immunity to a radiated, pulse-
modulated RF field applied to the implant
immersed in a saline solution in a torso
simulator. The test setup is shown in
Figure 4 at left. Thirteen test frequencies
from 450 MHz to 3000 MHz are applied
to the implant using a series of 13
resonant dipole antennas. The implant
Figure 4 – RF immunity setup
surface is positioned 2.5 cm from the
dipole. The applied power is 40 mW prior
to modulation, with optional levels of 8 W (450 – 1000 MHz) and 2 W (1000 – 3000 MHz).
Conformance is determined both with and without a simulated ECG (electrocardiogram)
signal applied to the implant.

Annex A.1 of PC69:2000 contains an extensive list of common RF sources including Family
Radio Service (FRS) transmitters operating around 460 MHz, cellular radios in the 800 MHz,
1500 MHz and 1900 MHz bands, and WiFi services around 2.45 GHz. Potential interferers
below 450 MHz are not noted in the Annex, but have since become quite widespread (see
Tables 4 and 5 in this paper).

The 2007 edition of AAMI PC69 addresses this change in the electromagnetic environment.
It retains the 450-3000 MHz RF radiated test (but increases the mandatory applied power
from 40 mW to 150 mW prior to modulation); the optional power levels are unchanged.
Numerous directly-coupled test signals are added, as well as a magnetic radiated immunity
test. The informative annex B.1 of the 2007 edition lists many types of electromagnetic
emitters below 450 MHz.

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Table 8 – Defibrillator test parameter comparison

AAMI PC69:2007 EN 45502-2-2:2008

Conducted differential mode lead current immunity during test
16.6 Hz – 1 kHz 50 μA
1 kHz – 20 kHz 50 μA x f/1 kHz
Conducted common mode lead voltage immunity during test
16.6 Hz – 1 kHz 2 mV
1 kHz – 3 kHz 2 mV x (f/1 kHz)2
3 kHz – 150 kHz 6 mV x f/1 kHz
150 kHz – 167 kHz 6 mV x f/1 kHz
167 kHz – 1 MHz 1V
1 MHz – 10 MHz 1 V x f/1 MHz
10 MHz – 450 MHz - 10 V
Conducted common mode lead voltage immunity after test
16.6 Hz – 20 kHz - 1V
20 kHz – 140 kHz - 1 V x (f/20 kHz)
140 kHz – 10 MHz - 7 V x (f/140 kHz)0.1624
Radiated magnetic immunity
DC, operates during - 1 mT
DC, operates after - 50 mT
1 kHz – 100 kHz 150 A/m
100 kHz – 140 kHz 150 A/m x 100 kHz/f
Radiated electric immunity during test
150 mW into dipole;
40 mW per AAMI
optional 8 W (450 –
450 MHz – 3 GHz PC69:2000 or 30 dB of
1000 MHz) and 2 W (1 –
feed-through insertion loss
3 GHz)

The two standards detailed above are very similar, with additional requirements in EN
45502-2-2:2008 that are not included in PC69:2007. Test signals in both are identically
modulated, at the higher frequencies with burst modulation selected to test implant
immunity to demodulated signals which mimic cardiac events.

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Test signals are applied through a tissue equivalent R-C interface circuit whose connections
to the implant depends on the lead configurations available, whether single-channel or
multi-channel sense/pace leads.

defibrillator

Figure 5 – Tissue equivalent interface circuit (left) and implanted pulse generator
(right) test setup for differential-mode current immunity test. C = test
signal input; D = test point; K = monitoring point. F, G, J = implant
sensing inputs. R, RL = pulse generator output loads.

Component values for the tissue equivalent interface circuits specified in the two standards
compared in Table 8 are generally identical, but there are differences. For example, AAMI
PC69:2007 requires a bypass capacitor across R3 in the interface circuit, which is absent in
EN 45502-2-2:2008.

Magnetic immunity test levels in these standards approach the levels noted in actual field
measurements shown in Tables 4 and 5 in this paper. High-frequency, high strength
magnetic fields are not easily reproduced in the test laboratory. Normally a Helmholtz coil
configuration would be chosen to assure field uniformity over the extent of the test object,
but the inductive impedance of a Helmholtz coil precludes its use at high frequencies.
Hence the magnetic field for testing in these standards is generated by a single coil whose
field is calibrated only in the plane of the coil.

The static magnetic field tests shown in Table 8 and specified in EN 45502-2-2:2008 but
not in AAMI PC69:2007 may be critical. A recent study indicates that the field from the
strong permanent magnet in some audio headphones can not only affect cardiac
pacemakers – which are generally reset using an external magnet – but they can inhibit
proper defibrillator performance. Reference: American Heart Association (2008, November

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 Electromagnetic Compatibility (EMC)
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10). MP3 Headphones Interfere With Implantable Defibrillators, Pacemakers, Study Suggests.
ScienceDaily. Retrieved November 10, 2008, from
http://www.sciencedaily.com/releases/2008/11/081109122525.htm

Radio standards: Programming the implant

If the active implant also contains a radio transmitter for remote programming and/or
telemetry, emissions at the operating frequency and spurious emissions associated with the
transmitter will be governed by applicable radio standards. There are a number of low-
power transmitter frequency bands available almost universally around the world shown in
Table 9 below. Not all are suitable for implant communications, owing to factors such as
spectrum congestion or signal attenuation in tissue.

Table 9 – Common global communication frequency bands

Global
FCC
frequency Category Comments EU regulation
regulation
bands
15.209
not so general EN 302 195-1, -2 (radio)
EU medical
9 – 315 kHz allocated
implant (not 90-110 EN 301 489-1, -31 (EMC)
outside EU
kHz)
RFID 15.225 EN 300 330-1, -2 (radio)
13.56 MHz ISM and SRD
frequency* general EN 302 291-1, -2 (inductive)
15.227 and EN 300 220-1, -2 (radio)
27.12 MHz ISM and R/C congested
95C EN 301 489-1, -3 (EMC)
protocol EN 300 220-1, -2 (radio)
40.68 MHz ISM and SRD restrictions in 15.231
USA EN 301 489-1, -3 (EMC)

Medical
Reserved for
402 – 405 MHz Implant 95I EN 301 839-1, -2
implants
Comm.
ISM and SRD
802.11b/g 14.247, EN 300 440-1, -2;
2.45 GHz and microwave
(BT, Wi-Fi) 15.249 EN 300 328
oven
15.247; EN 300 440-1, -2;
5.8 GHz ISM 802.11a
15.407 EN 301 893
* See FDA Guidance 12-10-2004 on RFID transponders for patient ID.

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Fortunately, the 402-405 MHz band is allocated worldwide for Medical Implant
Communications (MICS); see Tables 10 and 11 below. The spectrum is shared with
radiosondes and some satellite communications, but coexistence is not usually a problem.
Where they are established, the MICS rules are identical in countries around the world.

Table 10 - Radio standards: Medical Implant Communications

(MICS), 402 – 405 MHz

Jurisdiction Regulation
USA 47 CFR Part 95 subpart I
Radio per EN 301 839-1, -2
EU
EMC per EN 301 489-1, -27
Japan Ordinance regulating radio equipment, article 49.14
Australia Radiocommunications (Low Interference Potential) Class License, item 48
LP0002 Low-power Radio-frequency Devices,
Taiwan
Technical Regulations

The MICS band is also known as Ultra Low Power radio, because the RF power limit is 25
μW, compared to typical values for short-range radios of 10 mW up to 100 mW or higher,
for remote controls and WiFi or similar wireless data services.

Table 11 – MICS radio key parameters

Frequency band 402 – 405 MHz
25 μW or 9.1 mV/m at 3m on anechoic site (if implant,
Transmitter power
measured in torso simulator)
Bandwidth 300 kHz maximum
Frequency stability 100 ppm
Programmer access protocol Listen-before-talk

In addition to its low operating power to avoid interference, the MICS radio rules also
specify a “listen-before-talk” access protocol to assure that ongoing implant dialog is not
interrupted by other MICS users nearby.

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Figure 6 – MICS implant torso simulator

FCC, EU and other MICS rules such as FCC

Part 95I and EN 301 489-27 specify the use
of a torso simulator to measure the
emissions from a radio implant. The torso
simulator is an upright plastic cylinder 30 cm
in diameter, filled with a fluid that
approximates the dielectric properties of the
human torso. The fluid is not a simple saline
solution.

The radio implant is positioned vertically in

the center of the torso simulator and 6 cm
from the inside surface of the cylinder, as
shown in Figure 6. During field strength
measurements, the torso is rotated through
360º about a vertical axis, and the
measurement antenna is raised and lowered from 1 m to 4 m to maximize the readings.

Devices using the MICS frequency band that are not implanted must meet the same power
and protocol requirements as implants, but they are tested on a supporting table without
the use of the torso simulator.

EMC design considerations

EM disturbances for implants are much more severe than non-medical industrial ones - but
there may be some mitigation of high-frequency RF fields owing to body attenuation.

EM disturbances are limited in type to RF electric and magnetic fields, DC and suitably
modulated. (Be careful: EN 45502-2-1/ISO 14708-2 for pacemakers use special coupling
networks.)

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The influence of MRI on patients can arise from the presence of implant leads, separate
from any direct effect on the implant.

In many cases, the recognized EMC tests for a given active implant will differ between
jurisdictions. Be careful to cover all tests, or obtain prior regulatory assent to a single
method of testing.

RF communications with implants takes place with lowest loss at lowest RF frequencies –
but operation at these frequencies is also most susceptible to ambient disturbances such as
RFID. Therefore, a robust protocol is needed. See FDA draft guidance “Radio-Frequency
Wireless Technology in Medical Devices” (www.fda.gov/cdrh/osel/guidance/1618.pdf) to
augment IEC 60601-1-2 compliance testing.

Summary

Active implanted medical devices are subject to a more limited palette of electromagnetic
disturbances than most other medical equipment that resides outside of the body. However,
the levels of disturbances can be much more severe than those specified in the collateral
medical EMC standard IEC 60601-1-2, owing to the portability of the implant and the
growing number of RF devices in the environment. The dielectric properties of human tissue
provide some shielding of the implant from these external disturbances.

Many of the EMC standards for implanted medical devices are recent, or have been recently
revised, to account for newer EMC threats such as wireless handsets and anti-theft systems.
These standards either simulate the effect of external fields by direct coupling to the patient
leads, or generate the strong electric and magnetic fields which have been observed in the
environment.

About the author

Roland Gubisch is Intertek’s Chief Engineer for EMC and Telecommunications. He has been
with Intertek for 18 years. He holds domestic and international patents in the fields of

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 Electromagnetic Compatibility (EMC)
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optical and chemical instrumentation, and network test apparatus. He is a member of the
IEEE, and IEEE Communications and EMC Societies. His education includes a B.S.E.E from
Northwestern University (Evanston, Illinois) and Ph.D. studies in visual physiology at
Cambridge University (England).

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