IEC 60601-1-2 4 th

Edition EMC

Nicholas Abbondante
Chief Engineer, EMC

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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) Nerve and Muscle Stimulators
IEC 60601-2-11 ed2.0 (1997-08) +am1 (2004-07) Gamma Beam Therapy Equipment
ISO 80601-2-12 ed1.0 (2011-04) 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, Nominal Any

Cispr 11
Radiated Emissions, Nominal Any
Cispr 11
Harmonics, 230V/50Hz (sometimes Rated single voltage
IEC 61000-3-2 100V/50Hz and or 230V for
100V/60Hz) or rated Single-phase
voltage 400V for 3-phase,
50 or 60 Hz
Voltage Fluctuations 230V/50Hz or rated Rated single voltage
and Flicker, voltage or 230V for
IEC 61000-3-3 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 Any Any
Discharge,
IEC 61000-4-2
Radiated RF Any Any
Immunity,
IEC 61000-4-3
Electrical Fast Lowest and Highest Any
Transients/Burst, Rated Voltage, any
IEC 61000-4-4 frequency
Surge, IEC 61000-4-5 Lowest and Highest Any
Rated Voltage, any
frequency

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 Test AC Voltage and Power Frequency

Test 3rd Edition 4th Edition

Conducted RF Any Any
Immunity,
IEC 61000-4-6
Power Frequency Any Voltage, 50 and Any Voltage, either 50 or
Magnetics, 60 Hz 60 Hz
IEC 61000-4-8
Voltage Dips, Min and Max Rated If rated voltage range
Dropouts, and Voltage, Minimum <25% of lowest rated
Interruptions, Power Frequency voltage, any one voltage.
IEC 61000-4-11 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
Test Band
Service Modulation Power Level
(MHz) (MHz)
(W) (V/m)
385 380 – 390 TETRA 400 Pulse 18 Hz 1.8 27
FM ±5 kHz
450 430 – 470 GMRS 460, FRS 460 2 28
1 kHz sine
710
Pulse
745 704 – 787 LTE Band 13, 17 0.2 9
217 Hz
780
810 GSM 800/900; TETRA 800;
870 800 – 960 iDEN 820; CDMA 850; LTE Pulse 18 Hz 2 28
930 Band 5

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 Radiated RF Immunity, IEC 61000-4-3
RF Wireless Communications Equipment

Max Test
Test Band
Service Modulation Power Level
(MHz) (MHz)
(W) (V/m)
1720 GSM 1800; CDMA 1900;
1700 – Pulse
1845 GSM 1900; DECT; LTE 2 28
1990 217 Hz
1970 Band 1, 3, 4, 25; UMTS

Bluetooth; WLAN;
2400 – Pulse
2450 802.11b/g/n; RFID 2450; 2 28
2570 217 Hz
LTE Band 7
5240
5100 – Pulse
5500 WLAN 802.11a/n 0.2 9
5800 217 Hz
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, ±0.5, 1, 2 kV ±0.5, 1, 2 kV

Line to Ground
AC Mains, ±0.5, 1 kV ±0.5, 1 kV
Line to Line
DC Input (>3m), No test ±0.5, 1, 2 kV
Line to Ground
DC Input (>3m), No test ±0.5, 1 kV
Line to Line
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 3V, Life Support: 10V ISM 3V with 6V ISM, Home: 6V Amateur
& Patient 1 kHz or 2 Hz 80% AM 80% AM at 1 kHz or risk frequency
Coupled 150 kHz – 80 MHz 150 kHz – 80 MHz
(>3m)

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, 100% drop, 0.5 periods,
0º and 180º 0º, 45º, 90º, 135º, 180º,
225º, 270º, 315º
60% dip, 5 periods 100% dip, 1 period
30% dip, 25 periods 30% dip, 25/30 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 “Testing Wireless Devices for

Based on Intertek’s EMC”, Medical Design Briefs
Recent Experience with th
FDA and 4th Edition Top 4 Edition FAQs

Or visit our website at

www.intertek.com/4thEdition
“Address Security & EMC Compliance
for the latest information in Your Connected Device”, Medical
Device Technology

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Questions

Valued Quality. Delivered.

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