IEC 60601-1-2 EDITION 4.1
What are the changes?
Nicholas Abbondante, Global Chief Engineer, EMC
January 2021
IEC 60601-1-2 EDITION 4.1
01
What is it?
02
What is new in edition 4.1?
03
Radio-Frequency Identification (RFID) Immunity
Testing
04
What does the testing apply to?
05
When does it take effect?
IEC 60601-1-2 Edition 4.1
2
IEC 60601-1-2 Edition 4.1
includes amendment 1,
published September 2020
It is the EMC compliance
standard for Medical
Electrical Equipment
IEC 60601-1-2 Edition 4.1
3
UPDATES FROM AMENDMENT 1
References:
Test Voltage Changes in Table 1:
• Reference is made to IEC 60601-1:2005
+A1:2012+A2:2020, as well as 2020 versions of
other collateral standards and ISO 14971
• Conducted Emissions changed from “any one
voltage” to “minimum and maximum rated
voltage”, any power frequency.
• Reference added to IEC 61000-4-39 for proximity
RF fields testing
• IEC 61000-4-8 magnetic field testing had a wording
update for clarity but no substantive change has
occurred
• References to Aircraft standards in Table 2 have
been removed and replaced with generic examples
• EMC References updated to latest amendments:
• CISPR 11:2015+A1:2016+A2:2019 ISM Emissions
• IEC 61000-4-11 voltage dips had a wording update
for clarity. For dips, there is no change, but for
short interruptions and voltage variations the
standard now allows any one voltage to be tested
• CISPR 14-1:2016 Appliance Emissions
• CISPR 32:2015 Multimedia Emissions
• IEC 61000-4-5:2014+A1:2017 Surge Immunity
• IEC 61000-4-11:2004+A1:2017 Voltage dips
IEC 60601-1-2 Edition 4.1
4
TESTING UPDATES
• The exemption for Conducted RF Immunity
(IEC 61000-4-6) testing of I/O cables <3m in
length has been replaced by an exclusion
for cables <1m in length and a reference to
IEC 61000-4-6:2013 Annex B for a modified
start frequency based on cable length
• Warning: The FDA does not accept the <1m
cable exemption for IEC 61000-4-6!
• Section 8.11 has been added covering RFID
immunity in the range 9 kHz – 13.56 MHz
using IEC 61000-4-39 methods
IEC 60601-1-2 Edition 4.1
5
TABLE 11 TEST FREQUENCIES AND TEST LEVELS
• IEC 61000-4-39 methods are specified using 12cm and 10cm transmit loop antennas based on MILSTD 461
• The entire product need not be tested if the magnetically sensitive components can be identified
and tested, but test locations must be documented in the test report
• Communication may not be possible if in the passband of the radio, but basic safety and essential
performance must be maintained
• Decision tree allows for cases where testing may not be applicable
Frequency
Signal Type
Level
30 kHz (home healthcare)
Continuous Wave
8 A/m
134.2 kHz
2.1 kHz 50 % duty cycle
Square wave pulse
65 A/m RMS prior to
modulation
13.56 MHz
50 kHz 50 % duty cycle
Square wave pulse
7.5 A/m RMS prior to
modulation
IEC 60601-1-2 Edition 4.1
6
DECISION STEPS FOR RFID TESTING
8.11
a)
Does the entire device contain magnetically sensitive components anywhere? If not, no need to test
8.11
b)
Is a separation distance of at least 15 cm between the magnetically sensitive components ensured
by the enclosure or physical design? If so, no need to test
8.11
c)
If separation of at least 15 cm cannot be guaranteed, then a risk analysis is performed and if the risk
is deemed accepted, there is no need to test
8.11
d)
Otherwise, testing is required. The standard also allows manufacturers to simply perform the
testing rather than perform the steps above. The result for each step shall be documented in the
risk management file or test report, as applicable.
IEC 60601-1-2 Edition 4.1
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WHEN DOES IT TAKE EFFECT?
Timelines will depend on adoption and transitions
specified by individual regulators
• IEC version operative under CB Scheme since
September 5th, 2020
• EN not yet published, target date of September
19, 2021
USA FDA:
• Already recognized as an FDA consensus
standard
• Already operative under the FDA ASCA Pilot
Program
• Similar to AIM 7351731 which the FDA already
asks for on 510k reviews
IEC 60601-1-2 Edition 4.1
Recognized by FDA on
December 21, 2020
Three
Year
Transition
IEC 60601-1-2 Edition 4.0 may be
used until December 17, 2023
The FDA routinely asks for
equivalent compliance in 510k
reviews prior to transition dates
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