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OCTOBER 1, 2018 | MEDICAL | ELECTRONICS &
COMPUTERS | TEST & MEASUREMENT | FDA/REGULATORY
EMC for Medical Devices:
EN/IEC 60601-1-2, 4th
Edition
Page 1 of 2
The fourth edition IEC/EN 60601-1-2 (4th
Edition) will become a mandatory standard
covering safety for medical devices on
December 31, 2018.1,2 As with any new
standard edition, there are changes that
necessitate additional evaluations of the
product beyond those required by the
previous edition. Although emission and
immunity tests for medical products are very
similar to those applied to other product types,
such as radio equipment, networking
equipment and multimedia equipment, IEC
60601-1-2 requires that basic safety and
essential performance of the medical device
be maintained as opposed to the EMC
compliance for other type of products. This is
reflected in the title of 4th edition.
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A pulse oximeter. Basic safety and essential
performance requirements must be met for all devices.
INSIDE STORY
Basic safety and essential performance are
Zeus Industrial Products
derived from the risk management process.
Inc.
These terms are described in IEC 60601-1. The
outcome of this process should identify the
performance associated with each function of
the device that is necessary to maintain the
risks within acceptable limits.

Having determined the functions and their

associated parameters that need to be
evaluated during immunity tests, the next step
is to develop a test plan that addresses how
each function will be evaluated, identify those
functions that can be evaluated
simultaneously, and provide the cycle time for
each of these functions. These are only some
of the items that must be included in the test
plan. The form of the test plan is now specified
in Annex G of the 4th edition. Before testing
can begin, the test plan needs to be provided
to the test lab (section 6.2 of the 4th edition).

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Summary of the Changes in the 4th Edition

Below is a summary of the emission and

immunity test requirements in the standard.
The 4th edition includes three environments
based on intended use (professional
healthcare, home healthcare, and special).
Only the professional and home healthcare
environments are listed in Table 1. The use of
special environment is handled in the risk
management process and can result in using
different test levels than those indicated in the
4th edition. The items indicated with an
asterisk in Table 1 indicate that this is
something changed, is new, or was expanded
for the 4th edition.

The ESD levels have been increased from ±6 to

±8 kV for contact discharges and from ±8 to
±15 kV for air discharges.
The highest frequency for radiated immunity
has been increased from 2,500 to 2,700 MHz
and a new “proximity” test was added.
Additionally, the test levels have changed, and
the modulation frequency is specified only as
1 kHz. The 2 Hz modulation frequency that
was specified for certain equipment in the
previous edition is not in the 4th edition.
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Table 1. Immunity tests required by the 4th edition.

Note: 25/30 cycles means the test is per- formed over
10 cycles if tested with 50 Hz AC power and 12 cycles if
tested using 60 Hz AC power. Items indicated with an
asterisk indicate this is something changed, new, or
expanded for the 4th edition.

The EFT/B test is specified to be performed

using a 100 kHz repetition frequency. The
previous version of the standard did not
specify the rate, so it may be that 5 kHz was
used. A review of the existing test report
should be performed to determine the rate
that was used.

The AC power port surge test levels have not

changed from those in the previous edition.
DC power ports that are longer than 3 m and
signal ports that connect to outside cables are
now subject to a surge test.
The conducted immunity frequency range and
test levels did not change from the previous
edition. However, a new test level at certain
ISM and amateur band frequencies of 6 Vrms
has been added. The modulation frequency is
specified only at 1 kHz. The 2 Hz modulation
frequency that was specified for certain
equipment in the previous edition is not in the
4th edition. However, if the risk management
process identifies a different modulation
frequency, it should be used.

The power frequency magnetic fields test level

has been increased from 3 to 30 A/m.
However, the 4th edition states that the test
applies only to products with magnetically
sensitive components or circuitry.

Voltage dips have changed from those in the

previous edition, which were <5 percent for ½
cycle, 40 percent for 5 cycles, and 70 percent
for 25 cycles. Only the dip to 70 percent of
nominal voltage was not changed. Voltage
interruptions changed only in that the
previous edition allowed the interruption to
be performed with up to a 5 percent residual
voltage. If tests were performed for the
previous version at 0 percent, the results
comply with the 4th edition.

The transient conduction on DC power tests,

which are new in the 4th edition, only apply to
products intended to be installed in vehicles
with 12 or 24 V electrical systems.

It should also be noted that the 4th edition

includes a table delineating the voltage and
frequency of the AC supply mains to be used
during each test. Some of the tests specified in
the previous edition to be performed at
multiple voltages and frequencies are only
required to be tested at a single voltage and
frequency. It may be that other economies
require different voltages and/or frequencies
than those listed in the standard, so these
should be delineated in the test plan.
The other area in which the 4th edition is
different from the previous edition is in the
requirements for marking and instructions for
use contained in Clause 5 of the 4th edition.
Gone are the requirements for tables like
those in the previous edition. However, many
of the statements required to be included in
the instructions for use are similar. A test
laboratory can conduct a review of the
product and documentation provided to an
end user against these requirements.

RADIO FUNCTIONS
Addressing radio functions is not something
that is new in the 4th edition but it is often
overlooked. What do you do when a radio
module is incorporated in a medical device?
IEC/EN 60601-1-2 has wording that addresses
the use of radios in a medical device. An
exemption for the main transmit signal from
the radiated emissions limits (provided that
they meet the national requirements) is given,
but all other emissions must meet the radiated
emissions limits of IEC/EN 60601-1-2. Note:
There are many cases where the radio
standard's limits for transmitter radiated
spurious emissions are less restrictive than the
IEC/EN 60601-1-2 limits.

The radio function must be addressed during

the testing of the complete product. Some of
the tests that were likely performed on the
radio module alone would still be
representative of the use in the end product.
However, radiated emissions and immunity
tests performed on the radio module are
usually not performed or the results do not
consider the EMC effects of the integration, so
tests must be performed on the product with
the radio module operating as in normal use
and in a mode to make sure no unintentional
transmissions occur.
CYCLE TIME CONSIDERATIONS
Another tip that is not new in the 4th edition
addresses cycle time for each of the functions
to be evaluated, which can have a significant
impact on the time needed to perform
radiated and conducted immunity tests. The
standard requires that the dwell time at each
frequency step be long enough for the product
to be exercised and respond. For example, if a
device processes data by taking multiple
samples and averaging them and providing a
result every 60 seconds, the dwell time at each
frequency step would be 60 seconds. Note that
the dwell time must be specified in the test
plan.

Both radiated and conducted immunity tests

use a frequency step size of 1 percent and a
typical sweep rate of 1–3 s. Table 2 shows the
number of steps in the frequency ranges for
both conducted immunity (0.15–80 MHz) and
radiated immunity (80–2,700 MHz) and
compares the total test time for a nominal
sweep rate three seconds per frequency
versus a sweep rate requiring 60 seconds per
frequency.

The test times for conducted immunity in

Table 1 are compounded by the number of
interface cables, with the test typically applied
to each interface cable in turn.

For radiated immunity, the device is typically

tested four times (each side of the device
facing the transmitting antenna) sides, but
portable devices should be tested on all six
sides. Each side is tested twice, once with the
transmitting antenna vertically polarized and
once with the antenna horizontally polarized.
A portable device, therefore, would be tested a
total of 12 times. For transient immunity tests,
the issue of cycle time can also affect test times
since the application of the transient cannot
be synchronized to the “most susceptible”
 operating cycle of the device. Depending on
the function/process being evaluated, the test
may need to be applied over multiple cycles.

It may be possible to implement test modes in

advance of testing that use fewer samples
(thereby reducing the cycle time of the device)
or allow multiple functions to be monitored
simultaneously. It must be noted that test
modes have to be fully representative of the
real-world application, so it may not always be
possible to implement test-time-reducing
features and meet the requirements of the
notified body or government agency
responsible for reviewing the test data.

1 2

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