Wolfgang Hofheinz serves on

the National Committees of the

German Commission for Electrical,
Electronic & Information Technologies
of the Deutsches Institut fr Normung
(DIN) and Association for Electrical,
Electronic & Information Technologies
(VDE). He has been with the Bender
Company since 1975, becoming the
companys Executive Vice-President
in 1995. He has been an invited
speaker at many national and
international conventions and is
the author of various publications
and books on the subject of
electrical safety. These include
Elektrische Sicherheit in Medizinisch
Genutzten Rumen (2001), Protective
Measures with Insulation Monitoring
(2000), Schutztechni k mi t
I sol ati ons - berwachung (2000)
and Fehl erstromberwachung i n
Elektrischen Anlage (1998). English
translations are pending. He is
the holder of two patents in the
field of insulation monitoring of
unearthed direct current systems:
Swiss Patent no. 613313 (1979)
and German Patent no. DE
2546997 C2 (1984). Mr Hofheinz
studied electrical engineering at the
University in Giessen, specialising
in communications engineering and
holds a Dipl.-Ing.
a report by
Wol f g a ng Hof he i nz
Member, National Committees of the German Commission for Electrical,
Electronic & Information Technologies of DIN and VDE
I nt r oduc t i on
Nowhere in daily life is there a more indispensable
relationship between safety and life than in the
medical profession. The multitude of accidents and
subsequent personal and material damage demonstrate
that safety cannot always be guaranteed by human
intervention. This is especially the case in the hospital
environment, where the application of electrical
devices in diagnostic and therapy, for example, means
exposure to increased electrical hazards, e.g. through
faults in the current supply or defective devices.
Ha z a r ds i n Me di c a l S i t e s
The safety degree is influenced by many factors that
can be categorised essentially into the following three
hazard groups:
hazards through faulty devices;
hazards through faulty application; and
hazards through procedural causes.
A risk always remains through unexpected or
unavoidable faults but, with consequent safety
responsibility, the risk can be reduced significantly.
Legislation has documented its responsibility for care
and safety when installing and applying electrical
devices and electrical installations through many regu-
lations and standards. This means that the constitutional
right of the patient in terms of physical and mental
protection in medical locations is safeguarded.
The responsibility of the electronic industry in this
area lies in the intricate knowledge of known and as-
yet-unknown single fault conditions of the total
electrical installation. The foremost aims of all safety
measures taken should therefore be:
patient safety to protect the patient from being
unsettled, damaged or subjected to unreasonable
and repeated therapy due to a single fault condition;
simple but effective operation to enable the
medical staff, who often are electro-technically
inexperienced, to simply and effectively deal with
a single fault condition and, henceforth, prevent
any additional workload; and
clear and comprehensive documentation to
supply clearly structured information on the
project and application of electrical installation in
medical locations to designers, architects and
operators, so that the occurrence of a single fault
condition is prevented to the best of their
technical know-how.
The reliability of power and reduction of current
leakage is also an essential safety aspect, which can be
responsible for the following:
abnormal or impaired responses of the patient and
organs;
body functions can be temporarily or permanently
taken over by machines;
fire and explosion hazards; and
electric and magnetic interference.
I nt e r na t i ona l E l e c t r ot e c hni c a l
Commi s s i on Re g ul a t i on 62A
In view of the application of a multitude of electro-
technical equipment in use in the medical
environment, measures must be taken to prevent
electrical accidents. This was the driving idea for the
International Electrotechnical Commission (IEC)
Regulation 62A (IEC 62A), Common Aspects of
Electrical Equipment used in Medical Practice, published
as a draft in 1976 by IEC Technical Committee
(TC) 62A. Besides numerous indications about
general installation, this draft contained two essential
arguments for the installation of ungrounded power
supply systems (information technology (IT)
systems) in hospitals:
reliability of power supply; and
reduction of leakage currents.
El ect r i cal Saf et y Ungr ounded Power Suppl y Sys t ems i n Medi cal Si t es
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Both aspects are still valid today; however, the
emphasis of the measures taken in this respect vary
from country to country. The application and
monitoring of ungrounded power supply systems in
hospitals are reflected in the different national
standards. The following are still valid basic statements
according to IEC TC 62A.
A patient may not be able to respond normally in
a hazardous event. This may be due to illness,
unconsciousness or anaesthesia or the patient may
be connected to electrical apparatus for
therapeutic reasons.
The natural electrical resistance of the skin
normally provides important protection against
electrical current. With some treatments, this
protection may be short-circuited, e.g. through
the insertion of a catheter into the patients body
or by treating the skin when an electrode has to
be placed on a patients body. The human heart
is more sensitive to electrical current than other
parts of the body. Electrical current could
inhibit natural heart activity and could lead to
heart failure.
Electro-medical equipment could be used to
partly or permanently support or substitute vital
bodily functions. A fault in the device or a power
failure could be life-threatening.
A mixture of flammable anaesthetics, disinfectant
or cleaning substances with air or with oxygen
and nitrous oxide may present fire/explosion
hazards.
Electrical and magnetic interference, e.g. from the
power supply, could disturb the reproduction of
action potentials, such as electrocardiogram or
electroencephalogram equipment.
The use of an ungrounded power supply system may
be desirable for the following reasons.
It improves the reliability of power supply in areas
where power failure may cause safety hazards for
patient and user.
It reduces the leakage currents of devices to a low
value, thus reducing the touch voltage of the
protective conductor through which the leakage
current may flow.
It reduces the leakage currents of devices to a low
value, if approximately balanced to earth.
It is necessary to maintain the impedance of the
system to earth as high as possible. This is achieved
by restricting the following:
the physical dimensions of the medical isolating
transformer;
the system supplied by this transformer;
the number of medical electrical devices
connected to the system; and
through high internal impedance to earth of the
insulation monitoring device (IMD) connected to
such a circuit.
S t r uc t ur e
The operation of the ungrounded power supply
system with isolation monitoring and alarm forms the
centre of the power supply of Group 2 locations (see
Figure 1). The base for the IT system is an insulating
power source against ground. An isolating
transformer is added, with a nominal power range set
to 3.15 kilovolt-amperes (kVA) to 8kVA, e.g.
according to the Deutsches Institut fr Normung
(DIN) standard VDE 0107: 1994-10. More set values
are: maximal secondary voltage alternating current
(AC) 230V, maximal inrush current under no load
conditions 8xI
n
, short-circuit voltage u
o
and no-load
current i
o
3%.
The ungrounded power supply system also bears the
following advantages:
it has no direct connection between live
conductors and earth;
in the case of an insulation fault, only a small
capacitive current will flow;
a fuse is not triggered;
the power supply is maintained; and
<U
PE
PA
>
MK
The ungrounded power supply has no direct connection between live conductors and earth
In case of an insulation fault, only a very small capacitive current will flow
A fuse is not triggered
Power supply is maintained
Insulation Monitoring Device (IMD) signals alarms
Group 2
Figure 1: Structure of an Ungrounded Power Supply System
El ect r i cal Saf et y Ungr ounded Power Suppl y Sys t ems i n Medi cal Si t es
IMD signals alarms.
The essential advantage of an IT system is already
evident in the event of a single fault condition.
Only a small current I
F
flows, the value of which
is determined through the system leakage
capacitance C
E
. This does not trigger a fuse, the
supply voltage is maintained and the operation of
the installation preserved.
Downtime safety is not the only argument for
the use of a medical IT system. It also reduces
the leakage currents of devices to a low value, if
the medical IT system is approximately balanced
to ground.
Moni t or i ng
Increasing the availability of supply a substantial
aspect is guaranteed with the IT system. When
operating an IT system at single fault condition,
attention has to be given to the fact that the original
ungrounded (IT) system has turned into a grounded
system. An additional fault could then lead to
triggering the short-circuit protection thereby
switching off the system. To prevent this
occurrence, the insulation resistance is permanently
monitored through an IMD. Internationally, the
following three measuring principles have proved
themselves here:
resistance monitoring with an IMD;
monitoring of impedance through a line isolation
monitor (LIM); and
monitoring of load and temperature.
Re s i s t anc e Moni t or i ng wi t h an I MD
The task of the IMD is to monitor the insulation
resistance between the active phase conductors and
earth and to report a certain drop below a set value
(<50kOhm (k). The IMD is connected between
the active phase conductors and earth and
superimposes a measuring voltage to the system. At
the occurrence of an insulation fault, the circuit
between the system and earth closes over the
insulation fault R
F
, so that a measuring current I
m
occurs that is proportional to the insulation fault. This
measuring current causes a voltage drop at the
measuring resistor R
m
, which is electronically
evaluated. If the voltage drop exceeds a set value,
which is equal to falling below a set insulation
resistance, an alarm is triggered via light-emitting
diode (LED) alarms and alarm contacts. The inherent
system leakage C
E
capacitance is only charged to
measuring voltage and, after a short transient reaction,
does not affect the measurement (see Figure 2).
The remote signalling and testing combination
required for the visual and audible alarms in medical
locations must be mounted in such a way that the
signal can be noticed by the staff on duty.
Moni t or i ng of I mpe danc e
Thr oug h an LI M
A device known as an LIM (an IMD to measure
impedance) should always be included in an
ungrounded power supply system. The LIM
monitors the impedance of the conductors to earth.
It is installed into an isolated power distribution
system, as illustrated in Figure 3. It is designed in such
a way that a green LED alarm, visible conspicuously
to the staff in locations for medical use, lights up
when the system has reached a sufficient impedance
to earth. The red LED alarm lights up and sounds an
audible warning signal as soon as the prospective fault
current (consisting of resis-tive and capacitive leakage
currents) of an ungrounded power supply system
reaches the threshold of 5mA (2mA in Canada).
Means are provided for resetting the audible warning
signal while leaving the read alarm LED activated. A
distinctive visual signal indicates that the audible
alarm has been reset. When the fault is eliminated
and the green LED alarm lights up again, the audible
alarm is automatically reset.
IMD connected between the phase conductor
and earth
Measuring voltage U
m
generated by G is
superimposed on the system via the coupling R
i
,
the measuring resistance R
m
and the low pass
An insulation fault R
F
between system and earth
closes the measuring circuit, measuring current
I
m
is flowing
I
m
causes a voltage drop U
m
proportional
to the insulation fault R
F
at the measuring
resistance R
m
Display indicates the ohmic insulation resistance
With an IMD
G
R
A
A-ISOMETER
R
I
R
m
R
i
R
F

Low pass
With a Line
Isolation
Monitor (LIM)
LIM monitors impedance of the ungrounded power supply
THC
C
Display indicates the total hazard current in mA
e1
R
F1
R
F2
I
mA
C
e2
U
N
Figure 2: Monitoring of an Ungrounded Power Supply System with an IMD
Figure 3: Monitoring of an Ungrounded Power Supply System with an LIM
3
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Moni t or i ng of Load and Te mpe r at ur e
To avoid overloading the isolating transformer, a
respective installation must be designated in order to
protect the transformer and supply conductors
between primary and secondary terminals and the
distribution bus from overloading or overheating.
When the rated current or the temperature is over
range, an acoustic or optical alarm is released.
Wor l dwi de De v e l opme nt
The application of ungrounded power supply
systems in hospitals began between 1920 and 1930 in
the US. Alarming numbers of fires and explosions in
operating theatres, in which flammable anaesthetics
were used, shocked the experts. In 1939 the National
Fire Protection Association (NFPA) began by
developing regulations for the safe application of
Box 1: E l e c t r i c a l S a f e t y i n Me di c a l S i t e s Ac c or di ng t o I E C 60364- 7- 710
After completion of IEC 62A, work was again taken up in Working Group 26 of IEC TC 64: Electrical
Installations of Buildings, Electrical Installations in Hospitals and Locations for Medical Use Outside
Hospitals. This working group, with members from Germany, the UK, France, the Netherlands, Italy
and Finland published Draft 364: Electrical Installations of Buildings, Part 7: Particular Requirements for
Special Installations or Locations, Section 710: Medical Locations.
Clause 710.413.1.5 describes the medical ungrounded power supply system as follows:
In Group 2 medical locations, the medical IT system shall be used for circuits supplying medical electrical
equipment and systems intended for life-support or surgical applications and other electrical equipment located
in the patient environment excluding equipment listed in 710.413.1.3
For each group of rooms serving the same function, at least one separate medical IT system is necessary. The
medical IT system is to be equipped with an insulation monitoring device in accordance with IEC 61557-8
with the following additional requirements:
the AC internal impedance shall be at least 100k;
the measuring voltage shall not be greater than 25V DC;
the measuring current shall, even under fault conditions, not be greater than 1mA DC;
the indication shall take place at the latest when the insulation resistance has decreased to 50k. A
measuring device shall be provided to test this facility;
the indication shall take place, if the earth or wiring connection is lost.
Monitoring of overload and high temperature for the medical IT transformer is required.
For each medical IT system, an acoustic and visual alarm system incorporating the following components shall
be arranged at a suitable place such that it can be permanently monitored (visual and audible signals) by the
medical staff:
a green signal lamp to indicate normal operation;
a yellow signal lamp, which lights when the minimum value set for the insulation resistance is reached.
It shall not be possible for this light to be cancelled or disconnected;.
an audible alarm, which sounds when the minimum value set for the insulations resistance is reached. The
signal may be silenced;
the yellow signal shall go out on removal of the fault and normal condition is restored.
Where an equipment is supplied from one single dedicated IT transformer, the latter can be installed without
an insulation monitoring device.
4
Country Standard Isolated Insulation Load Transformer Maximum Transformer Transformer
system monitoring monitoring temperature transformer regulation leakage
monitoring load current
yes no ohmic impedance yes no yes no
Australia AS 3003 X X X X X * AS 3100 25mA
Austria VE-EN7 X X X X 8kVA VE-M/EN60472 *
Belgium TN 013 X X X X X 8kVA NEN 3615 500 PF/35A
Brazil NBR13.543 X X **) X ***) IEC 742 *)
Canada CSA Z31.1 X X X X 5kVA CSA C22:1 15A
Chile N.SEG 4EP79 X X X X 5kVA * *
Finland SFS 4372 X X X X * IEC 601-1 0.5mA
France NF C15-211 X X X X 7.5kVA NF C74-010 0.5mA
Germany DIN VDE 0107 X X X X 8kVA DIN VDE 0551 *
Ireland TC10 X alt.x alt.x X X 8kVA IEC 742 *
Italy CEI 64.4 X X X X 7.5kVA CEI 11-11 0.5mA
Japan JIST 1022 X X X X 7.5kVA JIS C0702 0.1/0.5mA
The Netherlands NEN 3134 X X X X 1.6kVA NEN 3615 500 PF/35A
Norway NVE-1991-FEB X X X X IEC 742 *
Spain UNE20-615-80 X alt.x alt.x X X 6.3kVA UNE 20-399-78 0.5mA
Switzerland MED 4818 X X X X 8kVA EN60742 *
Hungary MSZ 2040 X X X X 4kVA 6.3kVA MSZ 9229 *)
US NFPA 99 X x X X 10kVA NFPA 99 50A
Table 1: Standards by Country
El ect r i cal Saf et y Ungr ounded Power Suppl y Sys t ems i n Medi cal Si t es
*) no regulations
**) the standard does not clearly define the method of measurement
***) the standard stipulates that the transformer must be built according to IEC 60742, but does not indicate the maximum capacity
alt.x) measuring of the ohmic resistance or impedance=20
electro-technical equipment in hospitals. In 1944 the
first regulation, Safe Practice in Hospital Operating
Rooms, was published in the US.
Through the increasing application of electrical med-
ical devices, the subject of micro-shock and non-stop
operation became increasingly popular and became
an integral part of the standards listed in Table 1.
S a f e t y Conc e pt s
A safe device is not the decisive factor in guaranteeing
sufficient electrical safety for patients, doctors and
medical staff. The requirement is foremost for the
optimal co-operation of the following:
safety of devices;
safety of the location; and
safety of the application.
In other words, the highest degree of safety for the
patient, doctors and their assistants is only achieved
when a sufficiently safe constructed and maintained
device is applied by a responsible operator in a medical
location with installations according to the regulations.
Furthermore, when problems in hospitals in terms of
technical safety are considered, the questions of
protection from radiation and fire, safety of the
environment, hygiene and electromagnetic tolerance
can no longer be disregarded.
S a f e t y Me a s ur e s f or Me di c a l E l e c t r i c a l
De v i c e s Ac c or di ng t o I E C 60601- 1
Regular testing of medical electrical devices is an
essential aspect of the safety concept in hospitals. It is
embodied in European law and the request for
testing is stipulated in the European Medical
Products Act (MPG), the implementation of
Regulation 93/94/EWG in June 1993.
Today, the international standard IEC 60601:1988
(European Standard EN 60601-1:1990) is used for
periodic tests. According to this standard the
following tests must be conducted:
resistance of protective conductor;
earth leakage current;
enclosure leakage current;
patient leakage current; and
patient auxiliary current.
It is requested that all leakage currents are measured
5
under the following normal and single fault
conditions:
Normal conditions:
normal and reverse polarity of the supply
system;
operational earth is or is not connected to
protective earth; and
applied part of type F is or is not connected to
protective earth.
Single fault conditions:
open circuit of the protective conductor (not
valid for earth leakage current);
break of one of the line conductors; and
voltage 110% of the highest nominal value of
the nominal voltage is applied to each applied
part of type F against earth.
IEC 60601 is a standard for type tests and production
tests that is used also for periodic tests since a
dedicated standard for periodic tests is not available in
many countries. For this purpose, a draft European
and IEC standard is currently being prepared.
Conc l us i on
The patient is the focus of attention in the hospital.
Even the slightest power failure can impair a successful
diagnosis and therapy and therefore be life threatening
to the patient. Therefore, the un-grounded power
supply system with insulation monitoring is used,
because it guarantees the comprehensive protection of
patients, doctors and medical staff. I
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