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Reference Section

Electrical Safety – Ungrounded Power Supply Systems in Medical Sites
a report by

Wolfgang Hofheinz
Member, National Committees of the German Commission for Electrical,
Electronic & Information Technologies of DIN and VDE

Introduction

Wolfgang Hofheinz serves on
the National Committees of the
German Commission for Electrical,
Electronic & Information Technologies
of the Deutsches Institut für Normung
(DIN) and Association for Electrical,
Electronic & Information Technologies
(VDE). He has been with the Bender
Company since 1975, becoming the
company’s 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 Räumen (2001), Protective
Measures with Insulation Monitoring
(2000), Schutztechnik mit
Isolations -Überwachung (2000)
and Fehlerstromüberwachung in
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.

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.
Hazards in Medical Sites

The safety degree is influenced by many factors that
can be categorised essentially into the following three
hazard groups:

• 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;

• hazards through faulty devices;
• hazards through faulty application; and

• body functions can be temporarily or permanently
taken over by machines;

• hazards through procedural causes.

• fire and explosion hazards; and

A risk always remains through unexpected or
unavoidable faults but, with consequent safety
responsibility, the risk can be reduced significantly.

• electric and magnetic interference.

Legislation has documented its responsibility for care
and safety when installing and applying electrical
devices and electrical installations through many regulations 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 asyet-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;

1

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

• simple but effective operation – to enable the

International Electrotechnical
Commission Regulation 62A

In view of the application of a multitude of electrotechnical 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.

BUSINESS BRIEFING: HOSPITAL ENGINEERING & FACILITIES MANAGEMENT 2003

however. thus reducing the touch voltage of the protective conductor through which the leakage current may flow. Electrical current could inhibit natural heart activity and could lead to heart failure. The base for the IT system is an insulating power source against ground. More set values are: maximal secondary voltage alternating current (AC) 230V. • A mixture of flammable anaesthetics. An isolating transformer is added. unconsciousness or anaesthesia or the patient may be connected to electrical apparatus for therapeutic reasons. • In case of an insulation fault. 2 • Electrical and magnetic interference. and BUSINESS BRIEFING: HOSPITAL ENGINEERING & FACILITIES MANAGEMENT 2003 . • the system supplied by this transformer. only a very small capacitive current will flow It is necessary to maintain the impedance of the system to earth as high as possible. could disturb the reproduction of action potentials. Figure 1: Structure of an Ungrounded Power Supply System >θ <U Group 2 • It reduces the leakage currents of devices to a low value.g. maximal inrush current under no load conditions 8xIn. short-circuit voltage uo and no-load current io ≤ 3%. A fault in the device or a power failure could be life-threatening. through the insertion of a catheter into the patient’s body or by treating the skin when an electrode has to be placed on a patient’s body. With some treatments. according to the Deutsches Institut für Normung (DIN) standard VDE 0107: 1994-10. e. from the power supply. • in the case of an insulation fault. • Electro-medical equipment could be used to partly or permanently support or substitute vital bodily functions. and Structure The ungrounded power supply system also bears the following advantages: • it has no direct connection between live conductors and earth. if approximately balanced to earth.g.Reference Section The use of an ungrounded power supply system may be desirable for the following reasons. • the power supply is maintained. • the physical dimensions of the medical isolating transformer. • through high internal impedance to earth of the insulation monitoring device (IMD) connected to such a circuit. • The natural electrical resistance of the skin normally provides important protection against electrical current. this protection may be short-circuited. The application and monitoring of ungrounded power supply systems in hospitals are reflected in the different national standards. MK PE PA • It improves the reliability of power supply in areas where power failure may cause safety hazards for patient and user.15 kilovolt-amperes (kVA) to 8kVA. The following are still valid basic statements according to IEC TC 62A. with a nominal power range set to 3. This is achieved by restricting the following: • A fuse is not triggered • Power supply is maintained • Insulation Monitoring Device (IMD) signals alarms Both aspects are still valid today. 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 human heart is more sensitive to electrical current than other parts of the body.g. • The ungrounded power supply has no direct connection between live conductors and earth • It reduces the leakage currents of devices to a low value. • A patient may not be able to respond normally in a hazardous event. disinfectant or cleaning substances with air or with oxygen and nitrous oxide may present fire/explosion hazards. e. • a fuse is not triggered. • the number of medical electrical devices connected to the system. only a small capacitive current will flow. This may be due to illness. such as electrocardiogram or electroencephalogram equipment. e. the emphasis of the measures taken in this respect vary from country to country.

3 . This measuring current causes a voltage drop at the measuring resistor Rm. The inherent system leakage CE capacitance is only charged to measuring voltage and. The essential advantage of an IT system is already evident in the event of a single fault condition. attention has to be given to the fact that the original ungrounded (IT) system has turned into a grounded system. as illustrated in Figure 3. 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). an alarm is triggered via light-emitting diode (LED) alarms and alarm contacts. the insulation resistance is permanently monitored through an IMD. At the occurrence of an insulation fault. When operating an IT system at single fault condition. An additional fault could then lead to triggering the short-circuit protection thereby switching off the system. Monitoring of Impedance Through an LIM Resistance Monitoring with an IMD 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 (kΩ). the audible alarm is automatically reset. the circuit between the system and earth closes over the insulation fault RF. which is equal to falling below a set insulation resistance. the value of which is determined through the system leakage capacitance CE. visible conspicuously to the staff in locations for medical use. Ri Low pass Rm Downtime safety is not the only argument for the use of a medical IT system. A distinctive visual signal indicates that the audible alarm has been reset. To prevent this occurrence. lights up when the system has reached a sufficient impedance to earth. the measuring resistance Rm and the low pass • An insulation fault RF between system and earth closes the measuring circuit. Only a small current IF flows. The LIM monitors the impedance of the conductors to earth. after a short transient reaction. This does not trigger a fuse. if the medical IT system is approximately balanced to ground. It is installed into an isolated power distribution system. the supply voltage is maintained and the operation of the installation preserved. Means are provided for resetting the audible warning signal while leaving the read alarm LED activated. does not affect the measurement (see Figure 2). and • monitoring of load and temperature. measuring current Im is flowing • Im causes a voltage drop Um proportional to the insulation fault RF at the measuring resistance Rm • Display indicates the ohmic insulation resistance RF G With an IMD Figure 3: Monitoring of an Ungrounded Power Supply System with an LIM With a Line Isolation Monitor (LIM) UN THC C e1 I mA C e2 R F1 R F2 • LIM monitors impedance of the ungrounded power supply • Display indicates the total hazard current in mA 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. The IMD is connected between the active phase conductors and earth and superimposes a measuring voltage to the system. It also reduces the leakage currents of devices to a low value. • monitoring of impedance through a line isolation monitor (LIM). so that a measuring current Im occurs that is proportional to the insulation fault. If the voltage drop exceeds a set value. which is electronically evaluated. A device known as an LIM (an IMD to measure impedance) should always be included in an ungrounded power supply system. It is designed in such a way that a green LED alarm. the following three measuring principles have proved themselves here: • resistance monitoring with an IMD.Electrical Safety – Ungrounded Power Supply Systems in Medical Sites • IMD signals alarms. When the fault is eliminated and the green LED alarm lights up again. Monitoring A-ISOMETER ® RA RI • IMD connected between the phase conductor and earth • Measuring voltage Um generated by G is superimposed on the system via the coupling Ri. Internationally. Figure 2: Monitoring of an Ungrounded Power Supply System with an IMD Increasing the availability of supply – a substantial aspect – is guaranteed with the IT system.

Clause 710. not be greater than 1mA DC. at least one separate medical IT system is necessary. with members from Germany.413. even under fault conditions. the Netherlands. 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. 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. the latter can be installed without an insulation monitoring device. Monitoring of overload and high temperature for the medical IT transformer is required. which sounds when the minimum value set for the insulations resistance is reached. Where an equipment is supplied from one single dedicated IT transformer.5 describes the medical ungrounded power supply system as follows: “In Group 2 medical locations.1.” 4 Monitoring of Load and Temperature Worldwide Development To avoid overloading the isolating transformer. • the yellow signal shall go out on removal of the fault and normal condition is restored. This working group. • the indication shall take place. • a yellow signal lamp. France. For each medical IT system.3 For each group of rooms serving the same function.. 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. • the indication shall take place at the latest when the insulation resistance has decreased to 50kΩ. Italy and Finland published Draft 364: Electrical Installations of Buildings. • the measuring current shall. 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 100kΩ. work was again taken up in Working Group 26 of IEC TC 64: Electrical Installations of Buildings. in which flammable anaesthetics were used. Part 7: Particular Requirements for Special Installations or Locations. When the rated current or the temperature is over range. Alarming numbers of fires and explosions in operating theatres. • the measuring voltage shall not be greater than 25V DC. the UK. The signal may be silenced. an acoustic or optical alarm is released. A measuring device shall be provided to test this facility. which lights when the minimum value set for the insulation resistance is reached.Reference Section Box 1: Electrical Safety in Medical Sites According to IEC 60364-7-710 After completion of IEC 62A. In 1939 the National Fire Protection Association (NFPA) began by developing regulations for the safe application of BUSINESS BRIEFING: HOSPITAL ENGINEERING & FACILITIES MANAGEMENT 2003 . • an audible alarm. It shall not be possible for this light to be cancelled or disconnected. Electrical Installations in Hospitals and Locations for Medical Use Outside Hospitals.413. shocked the experts. if the earth or wiring connection is lost. The application of ungrounded power supply systems in hospitals began between 1920 and 1930 in the US.1. Section 710: Medical Locations.

The requirement is foremost for the optimal co-operation of the following: • safety of devices. In other words.Electrical Safety – Ungrounded Power Supply Systems in Medical Sites Table 1: Standards by Country Country Standard Isolated Insulation Load Transformer Maximum Transformer Transformer system monitoring monitoring temperature transformer regulation leakage monitoring load ohmic impedance yes yes X X yes no no Australia AS 3003 X Austria ÖVE-EN7 X Belgium TN 013 X X X Brazil NBR13. • patient leakage current. doctors and medical staff.x alt. the subject of micro-shock and non-stop operation became increasingly popular and became an integral part of the standards listed in Table 1.6kVA NEN 3615 500 PF/35µA Norway NVE-1991-FEB X X X X IEC 742 * Spain UNE20-615-80 X alt.SEG 4EP79 X X X X 5kVA * * Finland SFS 4372 X X X X * IEC 601-1 0. • safety of the application.4 X X X X 7. According to this standard the following tests must be conducted: • safety of the location.5kVA JIS C0702 0.5mA France NF C15-211 X X X X 7. protection from radiation and fire. the questions of It is requested that all leakage currents are measured 5 . 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.5mA The Netherlands NEN 3134 X X X X 1. Safety Measures for Medical Electrical Devices According to IEC 60601-1 Safety Concepts A safe device is not the decisive factor in guaranteeing sufficient electrical safety for patients.x x X X X AS 3100 25mA ÖVE-M/EN60472 * X 8kVA NEN 3615 500 PF/35µA X ***) IEC 742 *) X X * 8kVA *) 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. and • patient auxiliary current. but does not indicate the maximum capacity alt. and • resistance of protective conductor.1 X X X X 5kVA CSA C22:1 15µA Chile N.3kVA MSZ 9229 *) US NFPA 99 X X X 10kVA NFPA 99 50µA X X current no X alt. hygiene and electromagnetic tolerance can no longer be disregarded.5kVA NF C74-010 0.5mA Switzerland MED 4818 X X X X 8kVA EN60742 * Hungary MSZ 2040 X X X X 4kVA 6.543 X X **) Canada CSA Z31. Safe Practice in Hospital Operating Rooms. • earth leakage current. the highest degree of safety for the patient. when problems in hospitals in terms of technical safety are considered. 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.x X 8kVA IEC 742 * Italy CEI 64. In 1944 the first regulation.5mA Japan JIST 1022 X X X X 7. was published in the US. Furthermore. Today.5mA Germany DIN VDE 0107 X X X 8kVA DIN VDE 0551 * Ireland TC10 X alt.3kVA UNE 20-399-78 0. Through the increasing application of electrical medical devices.1/0. Regular testing of medical electrical devices is an essential aspect of the safety concept in hospitals. safety of the environment. the international standard IEC 60601:1988 (European Standard EN 60601-1:1990) is used for periodic tests.x X X 6.5kVA CEI 11-11 0. • enclosure leakage current.x) measuring of the ohmic resistance or impedance=20 electro-technical equipment in hospitals.

– operational earth is or is not connected to protective earth.Reference Section under the following ‘normal’ and ‘single fault’ conditions: – voltage ≤110% of the highest nominal value of the nominal voltage is applied to each applied part of type F against earth. For this purpose. • Single fault conditions: – open circuit of the protective conductor (not valid for earth leakage current). • Normal conditions: – normal and reverse polarity of the supply system. doctors and medical staff. Even the slightest power failure can impair a successful diagnosis and therapy and therefore be life threatening to the patient. because it guarantees the comprehensive protection of patients. a draft European and IEC standard is currently being prepared. – break of one of the line conductors. and 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. Therefore. and The patient is the focus of attention in the hospital. the un-grounded power supply system with insulation monitoring is used. ■ 6 BUSINESS BRIEFING: HOSPITAL ENGINEERING & FACILITIES MANAGEMENT 2003 . Conclusion – applied part of type F is or is not connected to protective earth.