IEC 60601-1 VERSION 3.
2
AMENDMENT HIGHLIGHTS
Medical electrical systems and
equipment used to diagnose,
monitor, or treat a patient, or
alleviate or compensate for an
injury, disease, or disability fall
under IEC 60601 standards.
For this medical electrical
equipment, an applied part either
Why has detects an energy transfer or
transfers energy to or from the
60601-1 3.2
patient and provides up to one
been connection to supply mains. IEC
introduced? 60601-1 includes the general
requirements for all equipment
that fall under this umbrella
category.
For each version of the published standards, two
amendments can be included before a new version is
introduced. 60601-1 3.2 is version three of the 60601-1
standard, with Amendment 2 being published in August
2020 by the International Electrotechnical Commission
(IEC).
The FDA listed 6060-1 3.2 as a recognized standard on May
30, 2022. This new amendment includes updates that were
determined to be too urgent to wait for a new version to be
published – IEC has stated that version 4 won’t be
published until after 2024.
1
DIFFERENCES BETWEEN IEC 60601-1
3.1 AND 3.2
Amendment 2 of IEC standard 60601-1 Version 3 mainly
addresses the potential hazards that can happen to
patients or operators in both normal and fault conditions
when operating medical electrical equipment.
These hazards can be electrical, thermal, mechanical, or
functional, and are considered unacceptable risks. 78 items
were added in Amendment 2 and were determined too
urgent to wait until Version 4.
CLAUSE 2 - NORMATIVE REFERENCES
When applying an updated standard, it’s important to
interpret the guidelines alongside other documents that
provide supplementary information.
Version 3.2 includes more explicit language about making
the connection between documents, as well as paying
attention to subsequent collateral that comes out about
the 60601-1 series after the publication of Amendment 2.
2
10 normative references were
introduced or altered on the list
from 3.1 to 3.2.
One important change calls out
IEC 60950-1 and replaces it with
IEC 62368-1:2018 “Audio/video,
information and communication
technology equipment – Part 1:
IEC 60950-1 Safety requirements.”
reference
This new standard replaces IEC
replaced by 60950-1 as both a “hazard-based”
IEC 62368- standard and one that takes into
account the blurring of lines
1:2018 between Information and
Communications Technology
(ICT) and traditional AV devices.
The set of guidelines applies to all video, audio, information,
and communication technology.
IEC 62368-1:2018 is applicable to electronic and equipment
safety for these devices that don’t exceed 600 volts. The
standard works to outline safeguards against classified
energy sources and when to apply these safeguards.
3
CLAUSE 3 -
TERMINOLOGY AND
DEFINITIONS
Many of the definitions in
Amendment 2 reference
definitions included in ISO
14971:2019, including:
Harm
Hazard
Hazardous situations
Objective evidence
Procedure (Note 1 has been
deleted)
Process
Record
Residual
Risk definition
Risk analysis
Risk assessment
Risk control
Risk evaluation
Risk management
Risk management file
Severity
4
CLAUSE 3 -
TERMINOLOGY
& DEFINITIONS
The definition of harm was
also expanded to include
animals in this latest
version.
Intended use is separated
from normal use by
definition – intended use is
meant to describe the
medical purpose of a device,
whereas normal use could
also include non-medical
use such as transport and
maintenance.
5
CLAUSE 3 -
TERMINOLOGY &
DEFINITIONS
A manufacturer is defined as a
“natural or legal” person who is
responsible for:
Designing medical electrical
equipment (ME)
Manufacturing ME equipment
Packaging ME equipment
Labeling ME equipment
(which doesn’t include
shipping)
Assembling medical electrical
(ME) systems
Adapting ME equipment / ME
systems (substantially
modifying something already
being used)
Operations that could be
performed by the person or
on their behalf to be defined
as a manufacturer
The definition of verification was clarified to
include an explanation of what objective
evidence would be needed to verify and that
activities of verification are sometimes called a
“qualification process,” with “verified” being
the status of the outcome of that process. 6
CLAUSE 3 -
TERMINOLOGY
& DEFINITIONS
Definitions 3.148 to 3.154
were also introduced:
Electromagnetic
disturbance
High priority
Information signal
Low priority
Maximum equipment
pressure
Medium priority
Safety sign
7
Updates made to Clause 7 further
specify markings and lights that
should be used on devices.
Safety signs
The requirement for clearly
legible markings has been
extended to include safety signs
on ME equipment. Safety signs or
Clause 7 -
symbols should also be used to
Identification denote which accompanying
and Marking documents should be consulted
for additional safety information.
Several references in labeling
have been modified to specify
requirements for safety signs.
Clause 7.5 that addresses safety signs has also been modified
to include more clarification and specification on the definition
for safety signs, as well as what is required of safety signs on
different parts of equipment.
Alarm indicator and indicator lights
Clause 7 also includes a table (Table 2) that provides colors and
meanings for alarm indicator and indicator lights to be used on
ME equipment. This table offers details for the name of each
light, when it should be on, the color of the light, and whether
it should be accompanied by a sound.
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CLAUSE 7 -
IDENTIFICATION
AND MARKING
Other updates and additions in
Clause 7 include:
IP classification – Clarification
on when IP classification
needs to be marked or not
Batteries – Warnings via
proper markings and
references needed for
equipment that incorporates
lithium batteries or fuel cells
that could become a
hazardous situation if
replaced incorrectly
Power Switches:
Specification of symbols that can be used for
“on” and “off” on power parts of ME equipment,
as well as a symbol for “stand-by”
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CLAUSE 8
PROTECTION AGAINST
ELECTRICAL HAZARDS
10
MANY PARTS OF CLAUSE 8 HAVE BEEN
UPDATED, INCLUDING THE FOLLOWING:
Accessible Parts and Applied Parts
Gave instructions for measuring the voltage for ME
equipment with SIP/SOP connectors or separate power
supply outlet connectors and which currents need to be
measured based on different conditions.
Y Capacitors
A note has been added on fitting Y capacitors across barriers
and consideration of the dielectric strength requirement.
Means of Protection
Means of Protection will be categorized in accordance to the
parts that are being protected from surpassing permitted
limits. Figure 40 in the standards expands on this in a visual
way with a flowchart that determines when means of
protection (MOP), means of patient protection (MOPP), or
means of operator protection (MOOP) requirements apply to
certain parts of devices.
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CLAUSE 8
PROTECTION AGAINST
ELECTRICAL HAZARDS
Opto-Couplers
Opto-couplers that comply with IEC 60747-5-5:2007 or
later are deemed equivalent to 8.8.2 or 8.9.3 requirements
depending on the insulation used – air clearance,
creepage distance, and dielectric strength apply. This is
the first time opto-couplers have been mentioned in IEC
60601-1, making it a new requirement for version 3.2.
Previously, it was not necessary for opto-couplers to meet
IEC requirements.
Means of Operator Protection
Insulation coordination requirements need to be met for
solid insulation, creepage distances, and air clearances for
means of operator protection, citing specific IEC standards
for each. Additional requirements are listed for
compliance for protective earthing.
Working voltage measurement
There is a working voltage measurement requirement for
all circuits to be connected to the earth unless they are
floating parts, which would require one means of
protection to the earth. Figure 41 was also added for
greater specification. 12
CLAUSE 8
Single patient connection
A few notes were made about applied parts with multiple
patient connections all within the body and in close
proximity to one another being treated as a “single patient
connection.”
Impedance and current-carrying capability
Testing should be performed using a detachable power
supply cord provided or specified by the manufacturer. The
amendment also includes specification on how the highest
rated current should be determined.
Allowable values
The leakage current shouldn’t exceed 10 mA r.m.s. in either
normal conditions or single fault conditions.
Measuring supply circuits
Specifications were added for ME equipment when
connected to supply mains or internally powered.
Conductive surface coatings
If these coatings are applied to non-metallic surfaces, flaking
or peeling shouldn’t reduce air clearance or creepage
distance.
13
CLAUSE 11 – PROTECTION AGAINST
EXCESSIVE TEMPERATURES AND
OTHER HAZARDS
Clause 11 covers concerns about excessive temperatures
and protecting patients and operators from the hazards
that can come with these temperatures and similar
situations. The terminology “accessible parts” was added in
reference to allowable maximum temperatures for parts
on Table 23. The same term was added in other parts of the
clause as well.
A few updates were included for fire enclosure
requirements on ME equipment, including the
flammability classification requirement for insulated wire
and connectors within fire enclosure, as well as printed
circuit boards and insulating material that components are
mounted on.
Amendment 2 also made changes to the fire enclosure
requirements for the bottom and sides of the enclosure,
with a note included about other design solutions for
openings possibly being acceptable per solutions found in
other standards. 14
CLAUSE 13 -
HAZARDOUS
SITUATIONS AND FAULT
CONDITIONS
The biggest update in Clause
13 provided detail on
temperature excesses that
would be unacceptable and
would pose a hazard.
Table 34 in the standard is for
accessible parts that are not
likely to be touched. Table 23 is
for parts that are.
Additional details on how
compliance can be checked
are also provided.
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CLAUSE 14 -
PROGRAMMABLE
ELECTRICAL
MEDICAL
SYSTEMS (PEMS)
The main update made to
Clause 14 included a
definition of SOUP (software
of unknown provenance) as
found in IEC
62304:2006/AMD1:2015.
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WHAT ACTIONS SHOULD
MANUFACTURERS TAKE
WITH THIS SWITCH TO
60601-1 3.2?
60601-1 CERTIFIED PSUS
MAKE YOUR PATH TO MARKET SMOOTH
WITH A CERTIFIED VENDOR
Any manufacturers working on ME equipment and
expecting to seek clearance after December 17, 2023
should prepare to meet Version 3.2 standards.
RAM Technologies meets the requirements laid out by
Amendment 2, and we’re now certified. 17
CONTACT RAM
TECHNOLOGIES
29 SOUNDVIEW ROAD
GUILFORD, CT 06437
P:203-456-9792
RAMTECHNO.COM/CONTACT-US
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