IEC 60601-1-2 4th Ed.
Why the new Edition?
Brodie C. Pedersen
Brodie.Pedersen@LogicPD.com
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Topics
• Introduction to IEC 60601-1-2
• Major philosophy of the fourth edition
– Environments
• Changes in testing limits
– ESD
– Radiated Immunity
– EFT
– Surge
– Conducted Immunity
– Magnetic Field
– Other
• Application
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Introduction to IEC 60601-1-2
• Medical Electrical Equipment Part 1-2:
General requirements for basic safety and essential
performance
• Collateral Standard:
–
Electromagnetic disturbances - Requirements and
Tests
•
Collateral to IEC 60601-1:2012
– Referenced in Clause 17, Electromagnetic Compatibility of ME EQUIPMENT and ME
SYSTEMS
– Interoperability of connected devices is covered by Clause 16 via the FUNCTIONAL
CONNECTION
•
Product Family EMC standard for medical electrical equipment
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The Fourth Edition of IEC 60601-1-2:2014
• Goals
– Address environments of use outside the hospital
• Home (See IEC 60601-1-11:2015)
• EMS (See IEC 60601-1-12:2014)
– These environments have reduced capability to control the EM
environment and a reduced level of medical supervision.
– To cover the Basic Safety and Essential Performance of ME Equipment in
the expected EM Environment
• Since the EM environment can be compared to temperature and
humidity it is considered a normal condition.
• Basic Safety with regard to Electromagnetic Disturbances is applicable
to all ME EQUIPMENT.
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IEC 60601-1-2 4th Ed. Environments
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The Fourth Edition of IEC 60601-1-2

To address EMI threats of today

Use in areas outside the hospital

Wireless

low frequency magnetic (EAS)

RFID

Other ME patient cables

HF Surgical
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Definitions
• Electromagnetic Disturbance
• Immunity
- ability of ME to perform without DEGRADATION in the presence of EM
Disturbance
• Port –
access to a device or network where EM energy or signals can be
supplied or received or where the device or network variables can be observed
or measured
• RF – audio frequency to Infrared
• Removed - Life supporting equipment
• Removed - Exclusion band
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Compliance Philosophy
• The immunity test levels specified in IEC 60601-1-2 represent the
general expected use environment
• In response, the medical device is expected to perform its intended
use and remain safe (essential performance and basic safety).
• Similar to normal ambient temperature, humidity, and atmospheric
pressure
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Testing
• ME Equipment shall be tested in representative
configurations, consistent with Intended Use, that are most
likely to result in unacceptable Risk.
• Most tests only require one voltage and frequency to be used
• The Artificial Hand is still utilized
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Emissions
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Emissions
• Radiated and conducted emissions
– Most ME will test to CISPR 11
• Multimedia Equipment in ME Systems can use CISPR 32
• ME Equipment that include RF transmitters are exempt from the
Emissions requirements in their transmission band
• Harmonics requirements
• IEC 61000-3-2 Harmonics
• IEC 61000-3-3 Voltage Fluctuations
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Immunity
• References IEC 61000-4 dated series
• Test conditions
– Device tested in mode most critical to intended use
– Risk Management must be provided for determining compliance, for functions
critical to patient: diagnosis, monitoring or treatment, that would not normally
be observed or verified during the test.
 Test
conditions are specified in tables and may be adjusted via a procedure in
Annex E depending on the operating environment.
 Testing
is only required at the highest test level specified
 Patient
simulation should be at 2 times the detection threshold
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Immunity Compliance Criteria
 The
Manufacturer shall determine specific, detailed Immunity pass/fail criteria,
based on applicable part two standards or Risk Management, for Basic Safety and
Essential Performance with regard to EM Disturbances.
 Immunity
pass/fail criteria may specify degradations that are acceptable because
they do not result in unacceptable Risk.
 ME
Equipment shall meet the Immunity pass/fail criteria before, during, and after
the Immunity tests.
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Table 4 – Enclosure Port
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Table 5 – Input a.c. power
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Table 6 – Input d.c. power
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Table 7 – Patient coupling port
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Table 8 – SIP/SOP port
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Table 9 – Enclosure port to RF
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ESD Immunity (IEC 61000-4-2)
• Contact discharge levels: +/- 8 kV
• Air Discharge levels: +/- 2 kV, 4 kV, 8 kV & 15 kV
• Compliance determined considering each discharge individually
• Conductive non-accessible portions of accessible parts(e.g., recessed connector
pins) tested with air discharge
• Isolated equipment is discharged between applications of ESD
» ESD gun generates up to 16KV of ESD.
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ESD Immunity (IEC 61000-4-2)
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Radiated RF Immunity (IEC 61000-4-3)
• New test level for Home Healthcare Environment
– 10 V/m from 80 MHz to 2.7 GHz
• Testing over full frequency range (80 MHz to 2.7 GHz) for all but
large, permanently installed equipment
• Intentional RF receivers are tested in their pass band (but may
have reduced performance if it does not impact Basic Safety or
Essential Performance)
• Patient-coupled equipment meets same requirements as other
equipment
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Radiated RF Immunity (IEC 61000-4-3)
• For all devices, modulation is 80% AM at 1 kHz
• Dwell time linked to device response time and test equipment
settling time.
• Large systems tested in situ, distance to communication. Sources
controlled to achieve test level
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Radiated RF Immunity (IEC 61000-4-3)
RF signal overview
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Radiated RF Immunity (IEC 61000-4-3)
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Transient Burst Immunity(IEC 61000-4-4)
• 2 kV to power lines for all devices
• 1 kV to signal and interconnecting cables with max. specified length
>3 m
• Test performed at any one nominal power input voltage
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Transient Burst Immunity (IEC 61000-4-4)
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Surge Immunity (IEC 61000-4-5)
• Power lines and SIP/SOPs (outdoor) are tested
• Compliance determined considering each surge individually
• Test performed at any one nominal power input voltage
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Surge Immunity (IEC 61000-4-5)
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Conducted RF Immunity (IEC 61000-4-6)
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Conducted RF Immunity (IEC 61000-4-6)
• 3V, 150kHz to 80MHz(start frequency dependant on equipment
size, including length of cables)
• Patient cables tested with current injection clamp at 150 ohms
• Artificial hand used for hand-held devices and patient end of patient
coupled cables
• Modulation and dwell time requirements identical to radiated RF
immunity test
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Power Frequency Magnetic Fields (IEC 61000-4-8)
• 30 A/m 10X higher level in Fourth Ed.
• Test performed at any one nominal power input frequency and
voltage.
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Voltage Dips, Interruptions, and Variations (IEC 61000-4-11)
• Low-power (< 1 kVA) and all life-supporting devices meet
compliance criteria, high power (> 1 kVA and < 16 A/phase)
remain safe during and after:
– 100% reduction (dropout) for 0.5 cycles
– 60% reduction for 5 cycles
– 30% reduction for 25 cycles
– All devices remain safe during and after 100% reduction for 5 sec.
– Test performed at each nominal power input voltage and
frequency (auto-ranging tested at minimum and maximum
threshold)
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Labeling
• For the Instructions the
– Environments of use;
– Essential performance expected;
– Warning for stacked equipment;
– List of cable and transducers;
– Portable RF transmitters simplified to 12” or 30 cm.
( Due to higher test limits)
– Class A emissions only suitable for hospitals.
– Former Tables are gone.
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Labeling
• Technical Description
– Shielded locations
– RF Transceivers
– Permanently installed ME Equipment
– HF Surgical Equipment compatibility
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Proposed future Edition Tests
• Magnetic field immunity test
• Close distance RF immunity test
• Patient cable CE test
• HF surgical Immunity test
• LF Magnetic field emissions test
• Wireless coexistence test
• Harmonics and flicker emissions test 3-11, 3-12
• Mains signaling immunity test 4-13.
• Increased immunity levels
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Schedule
• The standard was published in 2014.
• Regulatory authorities will decide how long to allow for transition to
the new edition.
• The FDA is already expecting these tests to have been completed.
The FDA has referenced this standard edition in:
• Design Considerations for Devices Intended for Home Use Guidance for Industry and Food and
Drug Administration Staff
• Document issued on August 5, 2014.
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM331681.pdf
–
Among others i.e. infusion pump guidance
• The EU and Canada have not yet recognized this new edition.
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Wrap up!
• The fourth edition of IEC 60601-1-2:
– Eliminate shortcomings of the third edition
– Outlines a comprehensive method for assuring EMC of medical
devices for alternative environments:
•
•
•
Testing limits specified for Home Healthcare environment and
Emergency Medical Services
Reliance on Risk Management for essential performance
increased over third edition.
Focus on Basic safety to assure all ME is tested.
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Thank You!
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