Guide To IEC 62353 Uk
Guide To IEC 62353 Uk
Guide To IEC 62353 Uk
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CONTENTS
03 Foreword 43 Appendix D: Patient
environment
04 Introduction
44 Appendix E: Example
07 Medical electronic
documentation
equipment
18 Insulation resistance
test
33 Record keeping
34 Conclusion
36 Appendix A: Pass/fail
limits of IEC 62353
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P=VxI P = I2 x R P = V2 / R
E=Pxt E = (V x t) / R
2
E = I2 x R x t
A Electrical current (I) B
Water Electricity
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z (f = 10)
z (f) f
Note: The network and voltage measuring instrument above are replaced by the symbol
in the following figures:
a) Non-inductive components
b) Impedance >> measuring impedance Z
c) Z (f) is the transfer impedance of the network, i.e. V out/in, for a current frequency f
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medical electronic system. To ensure safety of F-Type applied part - Applied part which is
patient and operator, this system must meet electrically isolated from earth and other parts
the design requirements of IEC 60601. of the medical equipment, i.e. floating. F-Type
applied parts are either type BF or type CF
The definition of a medical electronic system is: applied parts.
Protective earth - Dedicated circuit intended medical systems, accessories and other related
to carry the fault and leakage current in Class parts. A full overview of the symbols used in IEC
I equipment and to be connected to the 60601 is provided in table D1 of the standard.
protective earth terminal.
For the purpose of this booklet, a selection of
Functional earth - Dedicated circuit intended the most commonly used symbols is displayed
to provide an electrical screening and to be below:
connected to a functional earth terminal.
Earth
Protective reference
Line to earth voltage - Applied voltage Earth point
between the live wire and earth conductor,
affecting the leakage current.
Functional
Class II
Leakage current - Current that is not functional. Earth
Defibrillation-
Type CF
Note: Class II equipment may be provided proof type BF
applied part
with a functional earth terminal or a applied part
functional earth conductor.
Defibrillation-
proof type CF
Symbols and markings applied part
The IEC 60601 defines the requirements for
information/data to be present on the medical
equipment’s nameplate, in order to form an Product lifecycle
unambiguous identification of the equipment. For many years, ME equipment has been
subject to extensive approval processes from
Information must include; manufacturers clinical trials, to type testing all the way through
name, model number, serial number, electrical to end of production line testing, to ensure it
requirements. operates properly before leaving the factory.
In addition, manufacturers recommend
The IEC 60601 standard refers to a large variety that regular electrical safety and essential
of symbols for use on medical equipment, performance checks are carried out to ensure
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REPAIR
(IEC 62353) SAFETY END OF LINE
TEST Operator training
Maintenance
Planned Preventative Maintenance (PPM) is
MAINTENANCE
(IEC 62353)
ACCEPTANCE a process whereby the device is subject to
scheduled inspections and tests in order to
OPERATOR
TRAINING verify that the safety and operation are within
acceptable levels and criteria. This is referred to
as proactive maintenance.
Figure 5 - Safety stages through product lifecycle
Repair
Design Should a device create a fault or require an
During this stage a concept is subject to initial upgrade, the device will be susceptible to
and clinical trials. Electronic and mechanical further inspections and testing. This is referred
design of the product (where applicable) must to as reactive maintenance.
be in line with the IEC 60601 standard.
Decommissioning
Type test At the end of a product lifecycle, is the
During this stage the product is expected decommissioning stage. The device, depending
to have completed the clinical trials and, on its function and material content may
subject to type testing, is ready for marketing. be required to follow a set process (i.e. An
The hardware and software of the product is environmentally hazardous product will need
verified against the design standards. When CE to follow a recycling process. Under certain
marking is obtained, the medical product can conditions, the device can be made available to
be marketed in the European Economic Area. other organisations in which a second lifecycle
can start at the acceptance stage.
End of line test
During this stage the products are being
assembled, tested and inspected for release
into the market place.
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manufacturing and marketing, a subset of tests After service and repair testing this is carried
will suffice to ensure the product has been out following a repair or product upgrade
built and assembled to the required product and is often part of a service carried out by
quality and safety requirements. This subset of in-hospital mechanical or clinical engineering
tests is commonly referred to as routine tests teams. In many cases, more rigorous electrical
and are not clearly defined in IEC 60601, and safety testing is needed after the replacement
can therefore vary between manufacturers and of components or reconfiguration of medical
product designs. It’s for this reason that the IEC devices.
62353:2014 makes a recommendation that IEC
62353 is used during final testing and before
putting a piece of ME equipment into service.
Introduction to
IEC 62353: 2014
In-service test requirements
IEC 60601-1 does not provide any guidance As its full name implies, IEC 62353 Medical
on routine test requirements. This has led to Electrical Equipment - recurrent test and
different interpretations on how to apply IEC test after repair of ME equipment defines the
60601 to routine test scenarios. requirements for electrical safety testing of
medical electrical (ME) equipment and systems
Once a medical device leaves the factory, during routine intervals.
a number of potential test scenarios arise,
including: Following the need for a unified approach to
routine testing, the first edition of IEC 62353
Acceptance testing also referred to as an initial brought together a set number of tests to allow
or reference test. This test is carried out prior its users to test the MOOP and MOPP dielectric
to a new medical device being authorised for integrity via two distinct leakage current tests:
use and is undertaken to ensure correct and
complete delivery. Acceptance testing is often ∙∙ Equipment leakage - Testing the total
not limited to an electrical safety test, with leakage generated from the incoming
some basic function tests also being applied to mains to the rest of the equipment
verify correct performance. (confirming integrity of the MOOP)
∙∙ Applied part leakage - Testing that floating
Routine testing also referred to as planned applied parts (Type BF and Type CF) remain
preventative maintenance (PPM). This form at an acceptable floating level (confirming
of testing is often conducted at fixed time integrity of the MOPP)
intervals, which vary between types of
equipment, manufacturers’ recommendations In meeting this requirement the IEC 62353
and risk assessment procedures undertaken incorporates tests beyond those of type testing.
by individual biomedical/clinical engineering Specifically, it seeks to provide a uniformed and
or medical physics departments. Routine unambiguous means of assessing the safety
testing is not limited to safety testing and often of medical equipment, whilst maintaining the
includes the verification of correct functionality. relevance to IEC 60601-1 and minimising the
risks to the person conducting the assessment. pass/fail limits, taken from internationally
accepted practices for insulation testing of
Importantly, the IEC 62353 standard recognises electrical equipment. While insulation tests
that the laboratory conditions described are optional, it’s recommended to check with
in the IEC 60601, such as elevated mains, the equipment manufacturer if this can be
isolated TN (terre neutral) supply, temperature conducted without damaging the equipment
and humidity conditions cannot always be under test.
guaranteed when in-service testing of medical
devices is undertaken. More commonly, The strength of IEC 62353 enables those who
secondary earth connections caused by data carry out testing to conduct a summary of tests
cables and systems, provided measurement on the input of medical devices (equipment
errors that can now be overcome by IEC 62353. leakage) and on the output of the medical
Another factor raised is that equipment could equipment (applied part leakage). As will
potentially be damaged by applying type test become evident from the following chapters,
specifications (IEC 60601) when in service and the time saving associated with IEC 62353 will
could therefore represent a potential danger to also allow for more time to be spent on visual
users. and functional testing.
One of the most significant changes to the How does IEC 62353 compare with
2014 edition is the recommendation to test IEC 60601?
according to IEC 62353 at the final production Although IEC 60601 is a type test standard
line stage and also before equipment goes governing the safety of the design and
into service. This will allow recurrent testing manufacture of ME equipment, for decades
to be directly comparable with factory tests, biomedical and clinical engineers have used
providing for easier greater observation of the IEC 60601 as the basis for regular testing
any variations in leakage measurement. New or after service/repair of medical devices. Local
in the IEC 62353:2014 edition is a number of variants of IEC 60601 have also been adopted
suggested leakage tests that would isolate and used as a basis for routine testing.
the touch leakage current or patient leakage
current. Both tests form part of the equipment It is clear that most commonly used electrical
leakage current. safety analysers will only provide means of
testing to a subset of tests described in IEC
However, if a manufacturer wants to provide 60601 and often exclude destructive tests such
a specific measurement, the IEC 62353:2014 as high voltage dielectric testing, constant
now provides guidance for these tests to current 25A testing and SIP/SOP fault condition
be conducted in the informative section of testing to aid portability and safety of the
the standard, which might be considered operator.
when the equipment leakage values have
changed from previous measurements. The So what are the main implications of testing to
500V DC insulation tests in the 2014 edition IEC 62353 and how does it differ from the very
have also been supplied with recommended well established and widely understood
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Although many Class I medical devices are The open circuit voltage of the current source
supplied with an earth reference point, most should not exceed 24V.
if not all medical devices require multiple
earth bond tests to validate the connections The test limits in IEC 62353 are set to:
of additional metal accessible parts on the
enclosure.
100mΩ For a detachable power cable up to
3 metres.
A test current is applied between the earth pin
of the mains supply plug and any accessible
300mΩ For a Class I device including power
metal part (including the earth reference point)
cable (not exceeding 3 metres).
via a dedicated earth bond test lead (clip/
probe). Figure 7 shows a representation of the
500mΩ For a medical system consisting of
earth bond test.
several medical and non-medical pieces
of equipment. See definition of a medical
system in IEC 60601-1:2005.
L
The IEC 62353 requires a minimum test current 1. Restriction resistance (where the
of 200mA, either AC or DC. When using a DC conductive cross section is reduced)
test current, the resistance must be tested in 2. Film resistance (the possible resistive layer
both polarities of the test current. The highest between the two conductive surfaces due
reading will determine the pass or fail result of to film oxidation, dust etc.)
this test.
(High resistance)
(Low resistance)
Lower test currents, typically less than 8A the protective earth path.
RMS, are unable to temporarily overcome
contact resistance (both film and restriction Precision vs accuracy
resistance) and therefore highlight problems When performing an earth bond test,
as a result of aging: increased restriction remember that accuracy must take
resistance due to softening of spring loaded precedence over precision as having a
force on the contacts typically found in consistently wrong measurement is precise
removable power cords, as illustrated in Figure but not very accurate.
8.
Using a high test current might provide a
High test currents (10A or more) tend to higher precision (see Figure 9), but would
provide a more constant reading (high not necessarily give you a more accurate
precision) even if there is a potential representation of the quality of the protective
constriction in the protective earth path. earth circuit due to its capability to temporarily
High test currents might also be destructive repair constriction resistance.
to parts of the DUT which are connected to
the protective earth but have a functional Lower currents are not able to provide a false
purpose (e.g. screening). positive and are therefore fail-safe.
Therefore, IEC 62353 recommends that Low test current only (see Figure 9) - Possible
protective earth connections are tested with low accuracy and low precision as high
a 200mA test current to highlight aging readings could be due to film or constriction
power cords, although high readings could resistance.
be as a result of film resistance which can be
removed. High test current only (see Figure 10) - Possible
high precision but low accuracy as aging cables
Combining a high pre-pulse (to clean the film with poor contact resistance will give the same
resistance) and measuring with a low current readings as a brand new good cable.
to show up any restriction resistance is the
most accurate way to determine the quality of
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Figure 9 - Low accuracy - low precision Figure 10 - Low accuracy - high precision Figure 11 - High accuracy - high precision
∙∙ Input (phase and neutral) and output not provide a real indication of the effectiveness
(applied parts) for floating type applied of the insulation in modern medical devices
parts (BF and CF). (See Insulation resistance: or the expected leakage values that may be
applied parts to mains). experienced during normal or typical operation.
This is due to the increased use of switch
The resistance is measured and then compared mode power supplies that may indicate very
with the minimum acceptable value to high DC insulation resistance (>100MΩ), when
assess pass or fail conditions, which can vary measured with AC indicate high leakage. This is
greatly depending on design and test voltage due to the greater influence of capacitive and
variations. inductive leakage experienced in these devices
rather than resistive leakage as in a heating
With all measurements of insulation resistance, element.
the appliance under test must have the power
switch in the “ON” position before performing Infinity readings are common when performing
the test otherwise the test voltage does not DC insulation tests and provide no information
pass beyond the mains switch, in which case as to whether the unit was actually switched on
only the mains in the cord will be tested. or off. This makes the test results meaningless
from a safety point of view.
However, since the insulation resistance test
does not power up the appliance, which could It is a matter of debate as to whether a 50 MΩ
be seen as an advantage (reducing the time (higher) result is ‘safer’ than a 10 MΩ (lower)
taken to test and eliminating the danger of result, considering the equipment has been
moving hazardous parts), extra care should be exposed to a voltage it was not designed to
taken to ensure the equipment switch is in the operate at. Furthermore, the 50 MΩ (higher)
‘on’ position to complete a meaningful test. device might have been designed to measure
100 MΩ and has therefore lost 50% of its
In addition, appliances fitted with electronic insulation level. This could lead to higher
mains switches or RCD plugs cannot be tested leakage currents and unsafe conditions.
in this manner because it is not possible to
close the mains switch (as they require mains Finally, in some electrical equipment,
to be present). components connected to the live/neutral
conductors for EMC filtering or surge protection
In some cases, sensitive electronic devices and can significantly influence the measurement,
particularly older IT equipment, which does not indicating an erroneous failure of the test. On
comply with EN60950, may be damaged by the plus side, the insulation resistance test is
500V. However, in practice, this may not be a relatively quick and easy to perform, which is
significant issue as EN 60950 has been around why it is probably the most widely used.
longer than most IT equipment currently in use.
Insulation resistance test: EUT to earth
While the outcome of a 500V DC insulation test This test is used to verify that the mains parts
is quick and safe to do, in most cases it does are adequately insulated from earth (Class I)
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or the enclosure (Class II). Figure 12 and Insulation resistance: applied parts
Figure 13 below show a representation of the This test is used to verify that the applied parts
insulation test. are adequately insulated from earth (Class I) or
the enclosure (Class II). This test is applicable to
Class I and Class II, BF and CF equipment only.
Figure 14 and Figure 15 show a representation
MP AP
L of this insulation test.
MΩ
N
MP AP AP1
L
PE
MΩ
MP AP
L
PE
MP AP AP1
L
For both Class I and Class II appliances, plug During this test, 500V DC is applied
the DUT into the safety analyser. Class II between the earth pin (Class I) or
equipment requires an auxiliary lead to be the enclosure (Class II) and all the applied
connected to the enclosure of the equipment. parts combined.
This can be done by wrapping the enclosure
in aluminium foil and connecting it to the
auxiliary lead via a crocodile clip.
Figure Class B BF CF
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IEC 62353 leakage the live and neutral wire (see Alternative
method)
measurements
Direct leakage
As covered in The human body, it is the level The direct leakage method is identical to the
of electrical current rather than level of voltage method used in the IEC 60601-1 standard;
which is the criteria for safety due to the measuring the true leakage through a body
impact of electrical currents on the human model (measuring device) to earth.
tissues. Small amounts of current which
are undetectable by sensation can have a
significant impact on our safety. Benefits:
∙∙ Means of measuring both AC and DC
IEC 62353 defines two different kinds of leakage current
leakage current tests: ∙∙ Highest accuracy compared to other
methods
∙∙ Equipment leakage current - total leakage ∙∙ Potential leakage through a human body
deriving from the power supply to earth via measuring device
via the applied parts and enclosure, see ∙∙ Direct comparison with measurements
Equipment leakage made in accordance with IEC 60601-1
∙∙ Applied part leakage current - leakage
current flowing from an applied part to the To consider:
enclosure or earth as a result of an external ∙∙ The 1kΩ resistor forming the measuring
voltage on the applied part, see Applied device is interrupting the low resistance
part leakage protective earth conductor, therefore
causing a potential hazard when testing
Method characteristics faulty equipment
To ensure that a valid leakage measurement ∙∙ Secondary earth path(s) could lead
can be obtained, the IEC 62353 describes the to zero current readings (see Method
following methods: characteristics)
∙∙ A difference in polarity of the live and
∙∙ Direct leakage - measurement of leakage neutral conductors might alter the
current via a measuring device, placed leakage readings, as such leakage
directly in the path of the leakage current measurements must be done in each
(see Direct leakage) polarity of mains supply
∙∙ Differential leakage - measuring the ∙∙ A TN (terre – neutral) system is required
imbalance between current in the live to ensure that the measurements are
conductor and the neutral conductor as a done at maximum live to earth voltage.
result of leakage current (see Differential Any voltage between neutral and
method) earth might result in a lower reading,
∙∙ Alternative Method - measurement of potentially passing faulty equipment
leakage when mains voltage is both on
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RI= 66kΩ
∙∙ Both direct and alternative methods
provide higher accuracy and broader
frequency response which is required
for measuring trends in low leakage U=230V
50HZ ±2.2mA 83V
conditions
Alternative method
The alternative method is, in effect, similar to
a dielectric strength test at mains potential, or Figure 18 - Example of current limited mains supply during
alternative leakage
an insulation test at AC voltage, using a current
limited voltage source at mains frequency. The
IEC 62353 requires you to scale the measured
maximum short circuit current is limited to
leakage value up, equivalent to having 230V
3.5mA through a current limiting resistor of
over the applied part;
66kΩ (see Figure 18).
Benefits:
In Figure 18, a resistance (37kΩ) has been
∙∙ As live and neutral are combined, the
allocated to an applied part type BF. The total
mains polarity has no influence and only
resistance connected to the mains voltage
one measurement is required
is 103kΩ, which results in a fault current of
∙∙ The DUT is disconnected from mains,
2.23mA measured at a voltage of only 83V over
therefore providing a high level of safety
the applied part.
for the test engineer
∙∙ TN system is not required due to mains-
free application
∙∙ Measurements are not influenced by
secondary earth connections
under test
To consider: MD
Equipment leakage N
N(L)
The IEC 62353 specifies three different All applied parts (B, BF & CF) and earthed (e.g.
methods for measuring the equipment leakage enclosure class I) and non-earthed accessible
current: conductive parts or non-conductive accessible
parts (enclosure class II) are grouped together
∙∙ Direct method and connected to the earth via the 1kΩ
∙∙ Differential method measuring device (body model).
∙∙ Alternative method
The 1kΩ measuring device (MD – equivalent to
Equipment leakage: Direct method that used in the IEC 60601 standard – see IEC
The direct method is identical to the method 60601 body model) is positioned in the leakage
used in the IEC 60601-1. return path to earth.
Figure 19 and Figure 20 show a representation The test is conducted with the protective earth
of the direct method. connection ‘interrupted’, to ensure the
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Applied part
Current in µA (RMS) B BF CF
M M
L(N) MP AP L(N) MP AP
L L
N N
N(L) N(L)
PE PE
Figure 22 - Equipment leakage differential - Class I Figure 23 - Equipment leakage differential – Class II
Unlike the direct method, the differential Measurements are done in both polarities of
method does not measure the earth the incoming mains with the protective earth
conductor via the standard IEC 60601 body to the EUT interrupted.
model. The MD is part of a differential current
measurement between the live and neutral Low leakage currents of less than 75µA are
conductors. The frequency response of the difficult to measure using the differential
measurement shall be similar to the body leakage method. As such the differential
model used in the IEC 60601. leakage method is unsuitable when measuring
conductive un-earthed parts and in instances
The test is conducted with the protective earth where leakages are expected to be below
connection closed for protection of the user. 75µA.
Applied part
Current in µA (RMS) B BF CF
MP AP MP AP
MD MD
Figure 25 - Equipment leakage alternative - Class I Figure 26 - Equipment leakage alternative - Class II
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The test is performed using a current limited All applied parts, and earthed (e.g. enclosure
(3.5mA) mains potential sinusoidal 50Hz signal Class I) and non-earthed accessible conductive
(60Hz where this is the mains frequency). parts or non-conductive accessible parts
(enclosure Class II) are grouped together and
As live and neutral are shortened, the DUT is connected to the mains parts via the 1kΩ
not directly connected to the mains potential. measuring device (body model) and voltage
As such, mains reversal is not applicable and source.
the EUT is not required to be positioned
isolated from earth.
Applied part
Current in µA (RMS) B BF CF
∙∙ Direct method
∙∙ Alternative method
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A PRACTICAL GUIDE TO IEC 62353
Applied part leakage: Direct method Applied parts and patient connections not part
Figure 28 and Figure 29 show a representation of the measurement shall be left floating.
of the direct method.
The 1kΩ (MD - equivalent to that used in the
IEC 60601 standard – see IEC 60601 body
L(N) MP
model) is positioned between the applied part
AP AP1
L and voltage source.
Warning:
L(N) MP AP AP1 This applied part direct leakage test is similar
L
to that of the F-Type leakage test according
to IEC 60601, using an equivalent current
N
N(L) AP2 limited voltage source to produce the
mains potential. Both sources depend on a
current limiting resistor which could cause a
significant voltage drop. See Figure 18.
PE MD
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Applied part
Current in µA (RMS) B BF CF
Applied part leakage: Alternative method As live and neutral are shortened, the DUT is
This method is in fact similar to a dielectric not directly connected to the mains potential.
test between the applied part, and all As such, mains reversal is not applicable and
mains parts, EUT earth and enclosure all the EUT is not required to be positioned
connected together. Figures 31 and 32 show isolated from earth.
representations of the alternative method.
All floating type patient connections in each
applied part (BF & CF) are connected together.
MP AP AP1
Each individual applied part is measured in
turn and connected via the 1kΩ measuring
device (body model) to the voltage source
and earthed (e.g. enclosure Class I) and
AP2
non-earthed accessible conductive parts or
non-conductive accessible parts (enclosure
Class II) grouped together.
MD
Applied parts and patient connections not part
Figure 31 - Applied part leakage direct - Class I of the measurement shall be left floating.
MD
Applied part
Current in µA (RMS) B BF CF
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E
0V
L
Figure 37 - Leakage measurement on a TN system
AP
N
L
Differential 230V
Display
<5Ω
130V
N
Live to earth voltage 0V
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Going forward, determining the appropriate Additional test setups such as the differential
levels of both electrical and functional testing method and alternative method give the user a
will be central to the introduction of cost valid measurement when circumstances might
effective yet reliable preventative maintenance not allow for a valid test measurement under
campaigns. IEC 60601 (direct method).
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Current in µA (RMS) B BF CF
Note 1: This IEC 62353 standard does not provide measuring methods and allowable values
for equipment producing DC leakage currents. In such a case the manufacturer should give
information in accompanying documents.
Note 2: Particular standards may allow different values of leakage current. For a list of particular
standards, please refer to Appendix C .
IEC 60601-1
Medical electrical equipment - Part 1: General requirements for basic safety and essential
performance
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
IEC 60601-1-3
Medical electrical equipment - Part 1-3: General requirements for basic safety and essential
performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
EC 60601-1-6
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential
performance - Collateral standard: Usability
IEC 60601-1-8
Medical electrical equipment - Part 1-8: General requirements for basic safety and essential
performance - Collateral Standard: General requirements, tests and guidance for alarm systems in
medical electrical equipment and medical electrical systems
IEC 60601-1-9
Medical electrical equipment - Part 1-9: General requirements for basic safety and essential
performance - Collateral Standard: Requirements for environmentally conscious design
IEC 60601-1-10
Medical electrical equipment - Part 1-10: General requirements for basic safety and essential
performance - Collateral Standard: Requirements for the development of physiologic closed-loop
controllers
IEC 60601-1-11
Medical electrical equipment – Part 1-11: General requirements for basic safety and essential
performance – Collateral Standard: Requirements for medical electrical equipment and medical
electrical systems used in the home healthcare environment
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IEC 60601-1-12
Medical electrical equipment - Part 1-12: General requirements for basic safety and essential
performance - Collateral Standard: Requirements for medical electrical equipment and medical
electrical systems intended for use in the emergency medical services environment
IEC 60601-2-1
Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential
performance of electron accelerators in the range 1 MeV to 50 MeV
IEC 60601-2-2
Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential
performance of high frequency surgical equipment and high frequency surgical accessories
IEC 60601-2-3
Medical electrical equipment - Part 2-3: Particular requirements for the basic safety and essential
performance of short-wave therapy equipment
IEC 60601-2-4
Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential
performance of cardiac defibrillators
IEC 60601-2-5
Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential
performance of ultrasonic physiotherapy equipment
IEC 60601-2-6
Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential
performance of microwave therapy equipment
IEC 60601-2-8
Medical electrical equipment - Part 2-8: Particular requirements for the basic safety and essential
performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
IEC 60601-2-10
Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential
performance of nerve and muscle stimulators
IEC 60601-2-11
Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential
performance of gamma beam therapy equipment
IEC 60601-2-16
Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential
performance of haemodialysis, haemodiafiltration and haemofiltration equipment
IEC 60601-2-17
Medical electrical equipment - Part 2-17: Particular requirements for the basic safety and essential
performance of automatically-controlled brachytherapy after loading equipment
IEC 60601-2-18
Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential
performance of endoscopic equipment
IEC 60601-2-19
Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential
performance of infant incubators
IEC 60601-2-20
Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential
performance of infant transport incubators
IEC 60601-2-21
Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential
performance of infant radiant warmers
IEC 60601-2-22
Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential
performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
IEC 60601-2-23
Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential
performance of transcutaneous partial pressure monitoring equipment
IEC 60601-2-24
Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential
performance of infusion pumps and controllers
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IEC 60601-2-25
Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential
performance of electrocardiographs
IEC 60601-2-26
Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential
performance of electroencephalographs
IEC 60601-2-27
Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential
performance of electrocardiographic monitoring equipment
IEC 60601-2-28
Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential
performance of X-ray tube assemblies for medical diagnosis
IEC 60601-2-29
Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential
performance of radiotherapy simulators
IEC 60601-2-31
Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential
performance of external cardiac pacemakers with internal power source
IEC 60601-2-33
Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential
performance of magnetic resonance equipment for medical diagnosis
IEC 60601-2-34
Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential
performance of invasive blood pressure monitoring equipment
IEC 60601-2-36
Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential
performance of equipment for extra corporeally induced lithotripsy
IEC 60601-2-37
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential
performance of ultrasonic medical diagnostic and monitoring equipment
IEC 60601-2-39
Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential
performance of peritoneal dialysis equipment
IEC 60601-2-40
Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential
performance of electromyographs and evoked response equipment
IEC 60601-2-41
Medical electrical equipment - Part 2-41: Particular requirements for the basic safety and essential
performance of surgical luminaires and luminaires for diagnosis
IEC 60601-2-43
Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential
performance of X-ray equipment for interventional procedures
IEC 60601-2-44
Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential
performance of X-ray equipment for computed tomography
IEC 60601-2-45
Medical electrical equipment - Part 2-45: Particular requirements for basic safety and essential
performance of mammographic X-ray equipment and mammomagraphic stereotactic devices
IEC 60601-2-46
Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential
performance of operating tables
IEC 60601-2-47
Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential
performance of ambulatory electrocardiographic systems
IEC 60601-2-50
Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential
performance of infant phototherapy equipment
EC 60601-2-52
Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential
performance of medical beds
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RIGEL MEDICAL
IEC 60601-2-54
Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential
performance of X-ray equipment for radiography and radioscopy
IEC 60601-2-57
Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential
performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring
and cosmetic/aesthetic use
IEC 60601-2-62
Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential
performance of high intensity therapeutic ultrasound (HITU) equipment
IEC 60601-2-63
Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential
performance of dental extra-oral X-ray equipment
IEC 60601-2-64
Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and essential
performance of light ion beam medical electrical equipment
IEC 60601-2-65
Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential
performance of dental intra-oral X-ray equipment
IEC 60601-2-66
Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential
performance of hearing instruments and hearing instrument systems
IEC 60601-2-68
Electrical medical equipment - Part 2-68: Particular requirements for the basic safety and
essential performance of X-ray-based image-guided radiotherapy equipment for use with electron
accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment
IEC 60601-2-75
Medical electrical equipment - Part 2-75: Particular requirements for the basic safety and essential
performance of photodynamic therapy and photodynamic diagnosis equipment
IEC 60601-2-76
Medical electrical equipment - Part 2-76: Particular requirements for the basic safety and essential
performance of low energy ionized gas haemostasis equipment
PG 43
RIGEL MEDICAL
i
“Harm” is a defined term in ISO 14971:2000 as “physical injury or damage to the health of
people or animals, or damage to property or the Environment”
In IEC 60601, safe levels of current are defined as 10µA AC / DC for CF applied parts and 100µA
ii
AC / DC for B / BF applied parts and touch current. Earth leakage limits are higher at 500µA RMS
for equipment with conductive accessible parts that may become live under a fault condition
and 5000µA RMS for earthed devices with no conductive accessible parts. Under fault conditions,
higher values are allowed.
iii
A free application note on this subject is available at; www.rigelmedical.com/rigel-downloads
iv Comparing the tests of a 12 lead ECG (CF) monitor which requires 290 AC and DC leakage
readings under IEC 60601 (excluding SIP-SOP) and only 4 leakage readings in IEC 62353.
v
Information gathered by Rigel Medical during over 40 international seminars on IEC 62353.
62353+
Accurate and fast electrical safety tester
288+
Accurate and fast electrical safety tester
SafeTest 60
A robust medical safety tester
Download our free Rigel Medical product brochure to see the full
range: www.rigelmedical.com/rigel-downloads
PG 45
RIGEL MEDICAL
Accessories
Having the right accessories can streamline your testing processes and help you get the most from
your instrument. Our range of accessories includes scanners, Bluetooth enabled printers, a variety
of leads and adaptors, pass/fail labels and verification units.
To see the full range of Rigel Medical accessories available, visit www.rigelmedical.com/accessories
Training
Alongside our commitment to quality, we also offer peace of mind to our customers who know
that help and advice is always available. Part of that offering includes training to support and help
you get the most from your instrument.
www.rigelmedical.com/support
www.rigelmedical.com/service-centre
Notes
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