21BM3022

MEDICAL ETHICS AND

SAFETY

Handled By
Dr.S.Gnana Saravanan
Assistant Professor
Department of Biomedical Engineering
Module 3:Electrical Safety
1. Safety Mechanics
2. Electrical Safety – Biological aspect
3. Limitation of Voltages
4. Macroshock and Microshock
5. Earth and Protection – Leakage currents
6. Magnetic fields and compatibility
7. Basic assumptions in safety technology
8. Safety classes.
1.Safety Mechanics
• There are basically 21 safety rules to be followed in working with
electrical / medical equipment.
1. Avoid contact with energized electrical circuits
2. Treat all electrical devices as if they are live or energized. You never
know.
3. Disconnect the power source before servicing or repairing electrical
equipment. (The only way to be sure)
4. Use only tools and equipment with non-conducting handles when
working on electrical devices. (Easy to check)
https://electrical-engineering-portal.com/21-safety-rules-for-
working-with-electrical-equipment
1.Safety Mechanics (Cont..)
5. Never use metallic pencils or rulers, or wear rings or metal
watchbands when working with electrical equipment. (Always be
aware)
6. When it is necessary to handle equipment that is plugged in, be
sure hands are dry and when possible, wear nonconductive gloves,
protective clothes and shoes with insulated soles
7. If it is safe to do so, work with only one hand, keeping the other
hand at your side or in your pocket, away from all conductive
material. This precaution reduces the likelihood of accidents that
result in current passing through the chest cavity.
1.Safety Mechanics (Cont..)
8. Minimize the use of electrical equipment in cold rooms or other
areas where condensation is likely.
9. If water/chemical is spilled into the equipment shutoff the power at
mains and unplug the equipment
10. If an individual comes in contact with a live electrical conductor,
do not touch the equipment, cord or person. Disconnect the power
source from the circuit breaker or pull out the plug using a leather
belt. Tricky situation, and you must be very calm in order not to
make the situation even worse.
1.Safety Mechanics (Cont..)
11. Equipment producing a “tingle” should be disconnected and
reported promptly for repair
12. Do not rely on grounding to mask a defective circuit nor attempt to
correct a fault by insertion of another fuse or breaker, particularly
one of larger capacity
13. Drain capacitors before working near them and keep the short
circuit on the terminals during the work to prevent electrical shock
14. Never touch another person’s equipment or electrical control
devices unless instructed to do so.
1.Safety Mechanics (Cont..)
15. Enclose all electric contacts and conductors so that no one can
accidentally come into contact with them
16. Never handle electrical equipment when hands, feet, or body are
wet or perspiring, or when standing on a wet floor.
17. When it is necessary to touch electrical equipment (for example,
when checking for overheated motors), use the back of the hand.
Thus, if accidental shock were to cause muscular contraction, you
would not “freeze” to the conductor.
18. Do not store highly flammable liquids near electrical equipment.
1.Safety Mechanics (Cont..)
19. Be aware that interlocks on equipment disconnect the high voltage
source when a cabinet door is open but power for control circuits
may remain on
20. De-energize open experimental circuits and equipment to be left
unattended.
21. Do not wear loose clothing or ties near electrical equipment. Act
like an electrical engineer, you are not on the beach.
Module 3:Electrical Safety
1. Safety Mechanics
2. Electrical Safety – Biological aspect
3. Limitation of Voltages
4. Earth and Protection
5. Leakage currents
6. Macroshock and Microshock
7. Magnetic fields and compatibility
8. Basic assumptions in safety technology
9. Safety classes.
2.Electrical Safety – Biological aspect
1. Body resistance:
• If somebody touches live parts, the
body resistance determines whether
electric currents flowing across the
body can reach dangerous values or
not.
• At the beginning of the 20th century
first measurements of the electric body
resistance ware made on dead bodies

Reference : Text book – Page no- 109

 2.Electrical Safety–Biological aspect (Cont..)
• It is the resistance of the skin that considerably
contributes to electric shock protection. The
different layers, the dry horny skin, followed by
the epidermis, the dermis and subcutaneous
insulating fat layer
• It is the resistance of the skin that considerably
contributes to electric shock protection. Equivalent circuit diagram of the whole-body impedance

• The different layers the dry horny skin,

followed by the epidermis, the dermis and
subcutaneous insulating fat layer
• wet skin exhibits a lower impedance than dry
skin
2.Electrical Safety–Biological aspect (Cont..)

• Skin impedance critically depends

also on the size of the contact area
• low-frequency range the internal
body impedance is not dependent on
frequency. Since an electric resistance
increases with decreasing cross-
sectional area
 2.Electrical Safety–Biological aspect (Cont..)

2. Cellular excitation
• It was the year 1780, on Galvani’s experiment A
dead frog’s thigh seemed to have regained life and
performed a convulsive movement when an
electric spark jumped over to it.
• our cells are like small batteries exhibiting a
potential difference between the interior and
exterior (membrane potential) of about –90mV
• A small external disturbance can change this
potential to 20mv which we call it as “Action
Potential”
3.Limitation of Voltages
• The question, which voltages must be considered as dangerous, does
not only depend on their absolute value but also on body impedance,
kind of contact and electric current pathway
• The probability of cardiac fibrillation caused by currents of 10 μA
directly introduced to the heart is about 0.2%. Since the electric
resistance of the heart is only a few Ohms, directly coupled voltages
of only several 10 μV could be dangerous.
• In case of indirect hand – hand contacts and a body resistance of
1,000 Ω potential differences of about 10 mV could already cause
cardiac fibrillation
3.Limitation of Voltages
• SELV (safety extra low voltage): Earth-free voltages of 50 V~ and
120 V
• MSELV (medical safety extra low voltage): Earth-free voltages of
half the SELV values, namely 25 V~ and 60 V
 3.1. Leakage currents
• There is no material capable of insulating a voltage source
infinitely good
• This means that when touching a device leakage currents
are unavoidably flowing across our body irrespective of the
devices construction
• For safety checks leakage currents are not assessed by
directly measuring them with ampere meters in a short-
circuit situation.
• Instead of this, those leakage currents are assessed which
would flow, if a person would touch the device.
3.2 Touch current:
• Touch currents (previously known as enclosure leakage current) are
those currents that flow from an accessible part across a person to
another part of the device
• 3.5 mA for permanently installed devices (e. g. electric range or
washer).
• The safety factor to dangerous effects such as to the let-go threshold
which is 5 mA for the general population
• In daily life the protecting impedance is usually considerably higher
than assumed for safety considerations because of additional
contributions from stockings, socks and shoes. Their additional
impedances reduce the actual touch currents amplitudes and increase
the safety margin.
3.3. Patient leakage current
• Patient leakage currents are those that flow from
applied parts (which intentionally are brought into
contact with the patient) across the patient to earth
• Applied parts of equipment (e.g. ultrasonic
transducers or biosignal electrodes) can contact the
patient’s skin only or even be brought into the body’s
interior (e. g. endoscopes, catheters or surgical
instruments)
• In normal condition patient leakage currents are
limited to 100 μA (AC).
3.4. Patient Auxiliary current
• These are kind of current intentionally flowing
across the patient, in particular from one applied
part to another.
• These auxiliary currents are not intended for
treatment nor to cause biological or therapeutic
effects.
• They are just necessary to enable the functioning of
a method or device such as for assessing body
impedance from measured currents and voltages (e.
g. impedance cardiography, impedance
plethysmography or impedance imaging)
3.5. Earth leakage currents

• These leakage currents only exist in safety

class I devices
• Leakage Current is the residual flow of
current through insulation after a high
voltage has been applied for a period of time
Module 3:Electrical Safety
1. Safety Mechanics
2. Electrical Safety – Biological aspect
3. Limitation of Voltages
4. Earth and Protection
5. Leakage currents
6. Macroshock and Microshock
7. Magnetic fields and compatibility
8. Safety classes
4.Macroshock and Microshock
Microshock :
• It is a very small-scale shock.
• A small electric current passing directly through the heart, sending the patient directly
into ventricular fibrillation
• Death by micro-shock is known as Micro-electrocution
• Both Catheters And Pacemakers carry this risk.
• It has been repeatedly estimated that currents of over 20 microamps can lead to micro-
electrocution.
• Patients in medical environments are uniquely vulnerable to the risks from micro-shock.
• A major cause of microshock is a leakage current, i.e. a small current passing between
circuits or to earth because of incomplete insulation
https://www.rigelmedical.com/gb/support/electrical-safety-testing/
faqs/94-what-is-the-difference-between-macroshock-and-microshock/
4.Macroshock and Microshock
Macroshock:
• Macroshocks are usually the result of malfunctioning equipment.
• In the case of micro current shock, the current passes directly through the heart
wall.
• Macro shock is experienced by the person by an accidental contact with the
electrical wiring at any point on the surface of the body. Macro shock hazards are
usually caused by electrical wiring failures.
• This type of hazard is dangerous to the patient as well as to the medical and
attending staffs.
• Voltages of more than 50 Volts connected crosswise over dry unbroken human skin
are fit for delivering heart fibrillation if they create electric streams in the body
tissues which happen to go through the chest zone.
Macroshock and Microshock
Magnetic fields and compatibility
• Electromagnetic compatibility (EMC) is the ability of electrical
equipment and systems to function acceptably in
their electromagnetic environment
• In general electromagnetic energy may cause unwanted effects such
as electromagnetic interference (EMI) or even physical damage in
operational equipment
• The goal of EMC is the correct operation of different equipment in a
common electromagnetic environment
• EMC pursues three main classes of issue (i) Emission (ii) susceptibility
(iii) coupling
Electromagnetic compatibility (EMC)
• Emission is the generation of electromagnetic energy, whether
deliberate or accidental, by some source and its release into the
environment
• Susceptibility is the tendency of electrical equipment, to malfunction
or break down in the presence of unwanted emissions, which are
known as Radio frequency interference (RFI)
• A third class studied is coupling, which is the mechanism by which
emitted interference reaches the equipment
Techniques to Reduce EMC:
• Grounding and shielding aim to reduce emissions or divert EMI away from the
victim by providing an alternative, low-impedance path.
• Decoupling or filtering at critical points such as cable entries and high-speed
switches, using RF chokes and/or RC elements. A line filter implements these
measures between a device and a line.
• Avoidance of antenna structures such as loops of circulating current, resonant
mechanical structures, unbalanced cable impedances or poorly grounded shielding.
• Eliminating Spurious rectifying junctions that can form between metal structures
around and near transmitter installations. Such junctions in combination with
unintentional antenna structures can radiate harmonics of the transmitter
frequency.
Safety classes:
There are 3 classes of medical devices:
• Class I devices are low-risk devices. Examples include bandages,
handheld surgical instruments, and nonelectric wheelchairs.
• Class II devices are intermediate-risk devices
• Class III devices are high-risk devices that are very important to
health or sustaining life.
Class I medical Devices
• Class I devices are low-risk devices.
• Examples include bandages, handheld surgical instruments, and
nonelectric wheelchairs.
Class II Medical devices:
• Class II – Most medical devices are considered Class II devices.
• Examples of Class II devices include powered wheelchairs and some
pregnancy test kits.
• 43% of medical devices fall under this category.
Class III devices:
• These devices usually sustain or support life are implanted, or
present potential unreasonable risk of illness or injury.
• Examples of Class III devices include implantable pacemakers and
breast implants
Thank You