IEC 60601-1-2
Edition EMC
th
4
Nicholas Abbondante
Chief Engineer, EMC
1
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Overview
What is it? What are the changes? When does it matter?
Home use and Life Supporting, Special Environment
Risk Management
Product Configuration for Testing and Operating Modes
Marking and Information to User
Test Voltages in 4th edition
Testing – Emissions and Immunity, 3rd to 4th comparison
Radiated RF Immunity
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What is it?
IEC 60601-1-2 is a collateral standard to IEC 60601-1, which applies to
the BASIC SAFETY and ESSENTIAL PERFORMANCE of Medical
Electrical EQUIPMENT and Medical Electrical SYSTEMS in the
presence of ELECTROMAGNETIC DISTURBANCES and to
ELECTROMAGNETIC DISTURBANCES emitted by Medical Electrical
EQUIPMENT and Medical Electrical SYSTEMS.
It applies to all medical electrical devices!
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Why does EMC matter?
July 29th, 1967 – USS Forrestal –
134 Killed, 161 Injured
21 aircraft destroyed, aircraft
carrier damaged ($72 million;
$509 million inflation adjusted)
Surge caused Zuni missile to fire
(but not detonate)
Yes, there is a risk on aircraft…
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Potential Medical Device EMC Problems
Surgical Table actuates during surgery
Cardiac Defibrillator activates unexpectedly
Infusion Pump changes rate of infusion
ECG or BP reading changes during surgery
Ventilator stops
Incubator temperature incorrect
Pacemaker reprogrammed
Tonometer pokes patient in the eye
Device gives incorrect information,
- even useless!
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FDA Medical Device EMC Problems
Can search FDA ‘MAUDE’ database for records of EMC issues
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM
Many categories which are EMC related
Many cases go unreported or are not identified as EMC
EMC problems are sometimes difficult to reproduce
EAS systems causing defibs, to R/C cars causing implants to beep
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ME Equipment and Systems
MEDICAL ELECTRICAL EQUIPMENT “ME EQUIPMENT”
electrical equipment having an applied part or transferring energy to or from
the patient or detecting such energy transfer to or from the patient and
which is:
a) provided with not more than one connection to a particular supply mains;
and b) intended by its manufacturer to be used:
1) in the diagnosis, treatment, or monitoring of a patient; or
2) for compensation or alleviation of disease, injury or disability
MEDICAL ELECTRICAL SYSTEM “ME SYSTEM”
combination, as specified by its manufacturer, of items of equipment, at
least one of which is ME EQUIPMENT to be inter-connected by functional
connection or by use of a Multiple Socket-Outlet
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Historical Editions
IEC 60601-1-2:2007 3rd Edition
IEC 60601-1-2:2001+A1:2004 2nd Edition
CENELEC EN 60601-1-2:2007 (with AC:2010)
CENELEC EN 60601-1-2:2001+A1:2006
3rd edition harmonized in EU under Medical Device Directive,
can be used for USA, 2nd edition no longer used without
additional explanation
2nd edition still used in Japan, Brazil, some other countries
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60601-2-X Particular Standards
60601-1-2 is modified by Particular Standards that apply to
certain product types
Check the scope of the particular standard to see if it applies
Some contain modifications to the EMC requirements. Clause
numbering varies from standard to standard.
If a particular standard was written for a previous edition, it
should still be considered when testing to newer editions,
even though the clause numbering is different.
Also appearing under ISO 80601-2-XX and IEC 80601-2-XX
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60601-2-X Particular Standards (from 08/2012)
Particular Standard
Description
IEC 60601-2-1 ed3.0 (2009-10)
Electron Accelerators 1-50 Mev
IEC 60601-2-2 ed5.0 (2009-02)
HF Surgical Equipment
IEC 60601-2-3 ed3.0 (2012-04)
Short-wave Therapy Equipment
IEC 60601-2-4 ed3.0 (2010-12)
Cardiac Defibrillators
IEC 60601-2-5 ed3.0 (2009-07)
Ultrasonic Physiotherapy Equipment
IEC 60601-2-6 ed2.0 (2012-04)
Microwave Therapy Equipment
IEC 60601-2-7 ed2.0 (1998-02)
X-ray Generators
IEC 60601-2-8 ed2.0 (2010-11)
Therapeutic X-ray 10kV to 1 MV
IEC 60601-2-10 ed2.0 (2012-06)
IEC 60601-2-11 ed2.0 (1997-08) +am1 (2004-07)
ISO 80601-2-12 ed1.0 (2011-04)
Nerve and Muscle Stimulators
Gamma Beam Therapy Equipment
Critical Care Ventilators
ISO 80601-2-13 ed1.0 (2011-08)
Anaesthetic Systems
IEC 60601-2-16 ed4.0 (2012-03)
Haemodialysis Equipment
IEC 60601-2-17 ed2.0 (2004-01)
Brachytherapy Afterloading Equipment
IEC 60601-2-18 ed3.0 (2009-08)
Endoscopic Equipment
IEC 60601-2-19 ed2.0 (2009-02)
Infant Incubators
IEC 60601-2-20 ed2.0 (2009-02)
Infant Transport Incubators
IEC 60601-2-21 ed2.0 (2009-02)
Infant Radiant Warmers
IEC 60601-2-22 ed3.0 (2007-05)
Laser Equipment
IEC 60601-2-23 ed3.0 (2011-02)
Transcutaneous Partial Pressure Monitoring
IEC 60601-2-24 ed1.0 (1998-02)
Infusion Pumps and Controllers
IEC 60601-2-25 ed2.0 (2011-10)
Electrocardiographs
IEC 60601-2-26 ed3.0 (2012-05)
Electroencephalographs
IEC 60601-2-27 ed3.0 (2011-03)
Electrocardiographic Monitoring Equipment
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60601-2-X Particular Standards (from 08/2012)
IEC 60601-2-28 ed2.0 (2010-03)
X-ray Tube Assemblies
IEC 60601-2-29 ed3.0 (2008-06)
Radiotherapy Simulators
IEC 80601-2-30 ed1.0 (2009-01)
Automated Non-Invasive Sphygmomanometers
IEC 60601-2-31 ed2.1 (2011-09)
External Cardiac Pacemakers internally powered
IEC 60601-2-32 ed1.0 (1994-03)
Associated Equipment to X-ray Systems
IEC 60601-2-33 ed3.0 (2010-03)
MR Equipment
IEC 60601-2-34 ed3.0 (2011-05)
IBP Monitoring Equipment
IEC 80601-2-35 ed2.0 (2009-10)
Blankets, Pads and Matresses, Intended for Heating in Medical Use
IEC 60601-2-36 ed1.0 (1997-03)
Extracorporeally Induced Lithotripsy
IEC 60601-2-37 ed2.0 (2007-08)
Ultrasonic Medical Diagnostic and Monitoring
IEC 60601-2-39 ed2.0 (2007-11)
Peritoneal Dialysis Equipment
IEC 60601-2-40 ed1.0 (1998-02)
Electromyographs and Evoked Response Systems
IEC 60601-2-41 ed2.0 (2009-08)
Surgical Luminaires
IEC 60601-2-43 ed2.0 (2010-03)
X-ray for Interventional Procedures
IEC 60601-2-44 ed3.0 (2009-02)
X-ray for CT
IEC 60601-2-45 ed3.0 (2011-02)
X-ray for Mammomagraphic Steriotactic Devices
IEC 60601-2-46 ed2.0 (2010-12)
Operating Tables
IEC 60601-2-47 ed2.0 (2012-02)
Ambulatory ECG Systems
IEC 60601-2-49 ed2.0 (2011-02)
Multifunction Patient Monitoring Equipment
IEC 60601-2-50 ed2.0 (2009-03)
Infant Phototherapy Equipment
IEC 60601-2-52 ed1.0 (2009-12)
Medical Beds
IEC 60601-2-54 ed1.0 (2009-06)
X-ray for Radiography and Radioscopy
ISO 80601-2-55 ed1.0 (2011-12)
Respiratory Gas Monitors
ISO 80601-2-56 ed1.0 (2009-10)
Clinical Thermometers for Body Temperature Measurement
IEC 60601-2-57 ed1.0 (2011-01)
Non-laser Light Source Equipment
ISO 80601-2-61 ed1.0 (2011-04)
Pulse Oximeters
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What are the differences?
Removal of the “Life-Supporting” device category
Introduction of the “Home Healthcare”, “Professional
Healthcare Facility”, and “Special” environments
Reformatting the immunity test requirements into tables by
port to align with other immunity standards
Increased test levels for various immunity tests
Increased immunity test levels to take into account radio
devices used in close proximity and guidance on
determination of immunity levels in the “Special”
environment
Guidance on adjustment of immunity test levels, determining
immunity pass/fail criteria, and risk management
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When does it matter?
Date of Withdrawal of EN 60601-1-2:2007 3rd
Edition: December 31st, 2018
FDA is currently accepting and prefers 4th edition;
4th edition will be required after April 1, 2017.
All versions including 4th edition operative under
CB Scheme, but only certain versions accepted
by specific CB Scheme members
• Austria, Belgium, France, Germany, Hungary
Singapore, Spain, Sweden, Switzerland, and USA
have NCBs who are accepting 4th edition
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Life-Supporting ME Equipment
LIFE-SUPPORTING ME EQUIPMENT or ME SYSTEM
ME EQUIPMENT or ME SYSTEM that includes at least one
FUNCTION that is intended to actively keep alive or
resuscitate PATIENTS and the failure of which to comply with
the requirements of 6.2.1.10 is likely to lead to serious injury
or death of a PATIENT
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Professional Healthcare Facility Environment
PROFESSIONAL ME EQUIPMENT or ME SYSTEM
ME EQUIPMENT or ME SYSTEM for use by healthcare
professionals and that is not intended for sale to the general
public (3rd edition)
Examples (4th edition): Physician offices, dental offices, clinics,
limited care facilities, freestanding surgical centers,
freestanding birthing centers, multiple treatment facilities,
hospitals (emergency rooms, patient rooms, intensive care,
surgery rooms except near HF SURGICAL EQUIPMENT,
outside the RF shielded room of an ME SYSTEM for
magnetic resonance imaging)
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Home Healthcare Environment
HOME HEALTHCARE ENVIRONMENT (IEC 60601-1-11)
dwelling place in which a PATIENT lives or other places where
PATIENTS are present, excluding professional healthcare
facility environments where OPERATORS with medical
training are continually available when PATIENTS are
present
Examples: Restaurants, cafes, shops, stores, markets,
schools, churches, libraries, outdoors (streets, sidewalks,
parks), domiciles (residences, homes, nursing homes),
vehicles (cars, buses, trains, boats, planes, helicopters), train
stations, bus stations, airports, hotels, hostels, pensions,
museums, theatres
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Special Environment
SPECIAL ENVIRONMENT
ELECTROMAGNETIC ENVIRONMENT with electromagnetic
characteristics different from those specified in this collateral standard
in Table 2 through Table 9 or that requires EMISSIONS limits,
IMMUNITY TEST LEVELS or test methods that are different from those
specified for the professional healthcare facility environment and the
HOME HEALTHCARE ENVIRONMENT
Military areas (submarines, near radar installations, near weapons
control systems), heavy industrial areas (power plants, steel and paper
mills, foundries, automotive and appliance manufacturing, smelting and
mining operations, oil and gas refineries), medical treatment areas with
high-powered ME EQUIPMENT (HF SURGICAL EQUIPMENT,
SHORT-WAVE THERAPY EQUIPMENT, inside the RF shielded room
of an ME SYSTEM for magnetic resonance imaging)
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Risk Management
RISKS resulting from reasonably foreseeable
ELECTROMAGNETIC DISTURBANCES shall be taken into
account in the RISK MANAGEMENT PROCESS.
• Specific, detailed immunity pass/fail criteria based on part two
standards or risk management for basic safety and essential
performance related to EMC
• Determination of how the product will be monitored to
demonstrate compliance with the Immunity pass/fail criteria
• Immunity pass/fail criteria may specify degradations that are
acceptable because they do not result in unacceptable risk
• Justification for any special increased or reduced test levels
Risk Management Guidance: Annex F
Test Plan Guidance: Annex G
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Operating Modes
Emissions Testing
 Modes that maximize emissions
 Active and standby modes should be considered
Immunity Testing
 Modes and settings most likely to result in unacceptable
risk, as determined by the manufacturer via risk analysis,
experience, engineering analysis, or pretesting
 Standby mode should be considered
 Devices not rated for continuous use can use a duty cycle
Documented in Test Plan and Test Report
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Product Configuration for Testing
• Representative configuration consistent with intended use
• Most likely to result in unacceptable risk
• Determined by the manufacturer using risk analysis, experience,
engineering analysis, or pretesting
• All cables, tubing, and fluid containers necessary for the intended use
must be attached and full, including system grounds when present
• Terminated with the intended equipment or by an appropriate simulator
• Artificial hand circuit (220pF + 510Ω) attached to all handheld and
patient coupled parts, consistent with intended use
• AC Line Conducted Emissions, Electrical Fast Transients, and Conducted
RF Immunity
• Special hardware or software may be required
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Permanently Installed Systems
Approaches to testing
• Tested on a test site as a system
• Tested on a test site on a subsystem basis
• Test in situ
Group 1 devices may meet the emissions limits specified for a
test site when tested in situ
Some permanently installed systems are exempt from full
Radiated RF Immunity testing, testing with walkie-talkies,
cellphones, RFID, and ISM bands in situ
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Markings
A warning is required for devices specified for use in a shielded
location stating this fact
The intentional radiator mark has been removed
The ESD mark has been removed
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Information to User
Instructions for Use
• Intended environment and exclusions for that environment
• Essential performance and user expectation during loss of performance
• Portable RF communications equipment safe distance warning
• Class A device warning
Technical Description
• Compliance for each EMC test, all deviations, and all necessary
instructions for maintaining basic safety and essential performance for
the expected service life
• Frequency of operation, modulation, radiated power
• Additional statements for shielded rooms, large systems, and HF surgical
compatibility
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Test AC Voltage and Power Frequency
Test
3rd Edition
4th Edition
AC Emissions,
Cispr 11
Nominal
Any
Radiated Emissions,
Cispr 11
Nominal
Any
Harmonics,
IEC 61000-3-2
230V/50Hz (sometimes
100V/50Hz and
100V/60Hz) or rated
voltage
Rated single voltage
or 230V for
Single-phase
400V for 3-phase,
50 or 60 Hz
Voltage Fluctuations
and Flicker,
IEC 61000-3-3
230V/50Hz or rated
voltage
Rated single voltage
or 230V for
Single-phase
400V for 3-phase,
50 or 60 Hz
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Test AC Voltage and Power Frequency
Test
3rd Edition
4th Edition
Electrostatic
Discharge,
IEC 61000-4-2
Any
Any
Radiated RF
Immunity,
IEC 61000-4-3
Any
Any
Electrical Fast
Transients/Burst,
IEC 61000-4-4
Lowest and Highest
Rated Voltage, any
frequency
Any
Surge, IEC 61000-4-5
Lowest and Highest
Rated Voltage, any
frequency
Any
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Test AC Voltage and Power Frequency
Test
3rd Edition
4th Edition
Conducted RF
Immunity,
IEC 61000-4-6
Any
Any
Power Frequency
Magnetics,
IEC 61000-4-8
Any Voltage, 50 and
60 Hz
Any Voltage, either 50 or
60 Hz
Voltage Dips,
Dropouts, and
Interruptions,
IEC 61000-4-11
Min and Max Rated
Voltage, Minimum
Power Frequency
If rated voltage range
<25% of lowest rated
voltage, any one voltage.
Otherwise, lowest and
highest rated voltage
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A Note about Voltages…
Regulators can supersede the standard!
Notable examples:
Korea – 220V/60Hz
Japan – 100V/50Hz and 100V/60Hz
Brazil – 127V/60Hz and 220V/60Hz
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Testing, Emissions –
Professional Medical Equipment
Radiated and Conducted RF Emissions – Cispr 11
• Shielded locations: increase Cispr limit based on shielding effectiveness
• X-rays in intermittent mode can increase quasi-peak limits by 20 dB
• Professional Medical Equipment can meet Class A or B
• Type A Medical Professional Devices – removed!
Simple Electrical components (Motors, drills, switches) – Cispr 14
• Only standalone devices – systems must meet Cispr 11
Lighting Equipment – Cispr 15 – Removed!
Multimedia Equipment – Cispr 32
Exempt from IEC 61000-3-2 Harmonics and IEC 61000-3-3 Flicker
unless it is intended to be connected to a publics mains network
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Testing, Emissions –
Home Healthcare Devices
Radiated and Conducted RF Emissions – Cispr 11
• Equipment intended for use in aircraft
• ISO 7137
• RTCA DO-160
• EUROCAE ED-14
• Equipment intended for automotive use
• Cispr 25
• ISO 7637-2
• Other standards may apply based on environment
Harmonics per IEC 61000-3-2, Flicker per IEC 61000-3-3
• >220V, <16A only
• Japan: 100V/50Hz and 100V/60Hz, <16A
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Immunity Testing
IEC 61000-4-2 Electrostatic Discharge
IEC 61000-4-3 Radiated RF Immunity
IEC 61000-4-4 Electrical Fast Transients/Bursts
IEC 61000-4-5 Surge
IEC 61000-4-6 Conducted RF Immunity
IEC 61000-4-8 Magnetics
IEC 61000-4-11 Voltage Dips and Interruptions
ISO 7637-2 Electrical Transient Conduction Along Supply Lines (DC)
Emergency Medical Services devices classified as home healthcare
Devices used in aircraft or other environments should meet additional
standards such as RTCA DO-160G, ISO 7637-2, etc
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Electrostatic Discharge, IEC 61000-4-2
Test
3rd Edition
4th Edition
Contact Discharges
±2, 4, 6 kV
±2, 4, 8 kV
Air Discharges
±2, 4, 8 kV
±2, 4, 8, 15 kV
Discharges are applied to the patient coupling port with no
connection to artificial hand or patient simulation; device
checked afterwards for pass/fail
On I/O ports, contact discharges are applied to the connector
shell, and for insulated connector shells, air discharges are
applied only to the shell and any pins which can be contacted
or touched
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Radiated RF Immunity, IEC 61000-4-3
Test
3rd Edition
4th Edition
Enclosure 3V/m, Life Support: 10V/m 3V/m, Home: 10V/m
80% AM at 1 kHz or 2 Hz
80% AM at 1 kHz or risk frequency
80 MHz – 2500 MHz
80 MHz – 2700 MHz
Test voltage is before modulation is applied
Dwell time is based on the settling time of the test system and the
adequate time for the device under test to be exercised and be affected
Exclusion band for RF receivers applies, but basic safety and essential
performance must be maintained
Proximity fields from RF wireless communications equipment and special
environments must be considered
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Radiated RF Immunity, IEC 61000-4-3
RF Wireless Communications Equipment
Max
Test
Modulation Power Level
(W)
(V/m)
Test
(MHz)
Band
(MHz)
Service
385
380 – 390
TETRA 400
Pulse 18 Hz
1.8
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450
430 – 470
GMRS 460, FRS 460
FM ±5 kHz
1 kHz sine
2
28
704 – 787
LTE Band 13, 17
Pulse
217 Hz
0.2
9
800 – 960
GSM 800/900; TETRA 800;
iDEN 820; CDMA 850; LTE
Band 5
Pulse 18 Hz
2
28
710
745
780
810
870
930
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Radiated RF Immunity, IEC 61000-4-3
RF Wireless Communications Equipment
Test
(MHz)
1720
1845
Service
1700 –
1990
GSM 1800; CDMA 1900;
GSM 1900; DECT; LTE
Band 1, 3, 4, 25; UMTS
Pulse
217 Hz
2
28
2400 –
2570
Bluetooth; WLAN;
802.11b/g/n; RFID 2450;
LTE Band 7
Pulse
217 Hz
2
28
5100 –
5800
WLAN 802.11a/n
Pulse
217 Hz
0.2
9
1970
2450
5240
5500
Max
Test
Modulation Power Level
(W)
(V/m)
Band
(MHz)
5785
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Radiated RF Immunity, IEC 61000-4-3
RF Wireless Communications Equipment
Not all radio services are included. Risk Management should determine
which services are applicable to a particular device.
Automotive and Aircraft standards can include higher levels
To declare closer distances than 30cm, testing at higher levels is required
using
2 Watt radiated power P converted to 10 cm distance d gives E = 84 V/m
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Electrical Fast Transients/Bursts, IEC 61000-4-4
Test
3rd Edition
4th Edition
AC Mains or DC Input
±2kV, 5 kHz PRF
±2 kV, 100 kHz PRF
I/O Ports
±1 kV, 5 kHz PRF
±1 kV, 100 kHz PRF
Artificial hand attached to all handheld and patient coupled
parts, consistent with intended use
Cables less than 3m in length are exempt
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Surges, IEC 61000-4-5
Test
3rd Edition
4th Edition
AC Mains,
Line to Ground
±0.5, 1, 2 kV
±0.5, 1, 2 kV
AC Mains,
Line to Line
±0.5, 1 kV
±0.5, 1 kV
DC Input (>3m),
Line to Ground
No test
±0.5, 1, 2 kV
DC Input (>3m),
Line to Line
No test
±0.5, 1 kV
I/O, Line to Ground
No test
±2 kV (outdoor lines
only)
The option to test only at 0º, 90º, 270º, or 90º, 180º, 270º phase angles
was not carried over to the 4th edition!
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Conducted RF Immunity, IEC 61000-4-6
Test
3rd Edition
4th Edition
AC Mains 3V, Life Support: 10V ISM 3V with 6V ISM, Home: 6V Amateur
1 kHz or 2 Hz 80% AM
80% AM at 1 kHz or risk frequency
150 kHz – 80 MHz
150 kHz – 80 MHz
DC & I/O
& Patient
Coupled
(>3m)
3V, Life Support: 10V ISM 3V with 6V ISM, Home: 6V Amateur
1 kHz or 2 Hz 80% AM
80% AM at 1 kHz or risk frequency
150 kHz – 80 MHz
150 kHz – 80 MHz
RMS voltage, before modulation is applied. FDA has not accepted 3m exclusion
Artificial hand attached to all handheld and patient coupled parts, consistent with
intended use
Patient tubes intentionally filled with a conductive liquid are patient coupled cables
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Power Frequency Magnetics, IEC 61000-4-8
Test
3rd Edition
4th Edition
Enclosure
3 A/m, 50 and 60 Hz
30 A/m, 50 or 60 Hz
Tested in X, Y, and Z axes
Can be waived due to a justification that there are no magnetic
components
Assumes a minimum distance of 15 cm to magnetic source in actual
usage
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Voltage Dips, Dropouts, and Interruptions,
IEC 61000-4-11
Test
3rd Edition
4th Edition
Voltage Dips (<16A)
>95% dip, 0.5 periods,
0º and 180º
100% drop, 0.5 periods,
0º, 45º, 90º, 135º, 180º,
225º, 270º, 315º
100% dip, 1 period
30% dip, 25/30 periods
60% dip, 5 periods
30% dip, 25 periods
Voltage Interruptions >95% drop, 5 seconds 100% drop, 5 seconds
(all input current)
Voltage interruptions shall be applied to all phases
simultaneously
Systems intended for use with an AC to DC converter shall be
tested with a converter which meets the manufacturer’s
specification
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Conclusions
4th edition compliance is not required yet, but will be by the end
of a 2-3 year development cycle
Retesting is necessary as many requirements have been
increased
Testing for 4th edition is not completely backwards compatible
with 3rd edition
It is important to consider EMC during the risk management
process and to make sure that the EMC testing addresses
basic safety and all identified risks
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Resources on EMC and 4th Edition
Right click on the IMAGE and select “open link” to access:
Learn Market Trends
Based on Intertek’s
Recent Experience with
FDA and 4th Edition
“Testing Wireless Devices for
EMC”, Medical Design Briefs
Or visit our website at
www.intertek.com/4thEdition
for the latest information
42
th
Top 4 Edition FAQs
“Address Security & EMC Compliance
in Your Connected Device”, Medical
Device Technology
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Questions
Valued Quality. Delivered.
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