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 2

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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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