Principles of Electrical

Safety in Medical
Equipment
Management
Electricity – The Basics

• Three basic units of electricity:

– Voltage (V) measured in Volts (V)
– Current (I) measured in Amperes/Amps,(A)
– Resistance (R) measured in Ohms (Ω)

• Ohm’s Law:
Voltage = Current x Resistance
V = I x R or V = A x Ω
 Healthcare Technology

• Medical technology has greatly

improved. Increased use and
complexity has resulted in more
related patient injuries. Some
causes include:
– Improper device use
– Failure of equipment
– Electrical hazards
Healthcare Technology
• Why the stringent electrical safety requirements for
medical equipment?

• Medical procedures expose the patient to more hazards

e.g. electricity, fire, water, chemicals, drugs etc.

• Increased risk of electric shock/injury:

– Patients in contact with equipment
– Some equipment require invasive contact with patients in
order to achieve their function i.e. protective skin and
mucous membranes breached
– Patients unconscious/unresponsive so unable to detect
potentially harmful faults
Physiological Effects of Electricity
• Electricity travels in a closed circuit
• If a person becomes part of a
circuit and is standing on the
ground, the person will receive an
electric shock

• Current travels from high to low

potential
• Ground is at zero potential
• Body has ions dissolved in water
which conduct electricity
• Would a bird resting on a power
line get electric shock?
Physiological Effects of Electricity
Threshold of perception:
• Minimal current that can be detected
• Usually ranges between 0.5mA to 10mA
• Stimulates nerve endings in
skin which is felt as a tingling
sensation

Approximate range of currents to produce a certain electrical effect

Physiological Effects of Electricity
Let-go current
• 10mA – 100mA
• Maximal current at which subject can
withdraw voluntarily
• As current amplitude increases nerves
and muscles get vigorously stimulated
resulting in pain & fatigue
• Involuntary muscle contractions leading
to inability to let-go of live conductor

Approximate range of currents to produce a certain electrical effect

Physiological Effects of Electricity
Respiratory paralysis, fatigue, pain
• Higher currents cause respiratory arrest
• Chest muscles contract involuntarily resulting
in breathing difficulties leading to asphyxiation
– body does not receive adequate oxygen
• Respiratory arrest observed to at 18mA to
22mA

Approximate range of currents to produce a certain electrical effect

Physiological Effects of Electricity
Ventricular Fibrillation (VF)
• Major cause of death due to electric
shock
• Threshold: 75mA to 400mA

Approximate range of currents to produce a certain electrical effect

Physiological Effects of Electricity
• Sustained myocardial contraction
• Entire heart muscle contracts
• Heart stops beating

Approximate range of currents to produce a certain electrical effect

Physiological Effects of Electricity
Burns, physical injury
• Local to full-thickness burns
• Severity of burn depends on surface
area, intensity of current and duration of
exposure
• Serious burns require 75mA/mm
• Most burns on skin
• For low skin R, burns occur internally in
tissues

Approximate range of currents to produce a certain electrical effect

Physiological Effects of Electricity
Summary of Main Effects
Current Effect
Magnitude
1mA Barely perceptible
1 – 3mA Threshold of perception (most cases)
3 – 9mA Painful sensations
9 – 25mA Muscular contractions (can’t let-go)
25 – 60mA Respiratory paralysis (may be fatal)
60mA or more Ventricular fibrillation (probably fatal)
4A or more Heart paralysis (probably fatal)
5A or more Tissue burning (fatal if vital organ)
Susceptibility Factors
• Amount of current flowing through the body:
– Larger magnitude current causes more damage
• Body Resistance:
– External resistance – skin (40kΩ to 100kΩ in adult
depending on thickness). Primary resistor against
current
– Internal resistance – tissue resistance e.g. blood
vessels, nerves, muscles. Low resistance, very good
conductors of current due to high water content so get
damaged easily
– Exposure of different parts of the body to the same
voltage will generate a different current
• Moisture on skin:
– sweat reduces skin resistance to <1000 Ω
Susceptibility Factors
• Circuit Voltage:
– Low voltage does not mean no hazard
– Degree of injury depends on amount of current and duration
of contact with circuit
What is the typical defibrillation energy & does it cause
myocardium damage?
2500V over 4ms

• Path of current through the body (from entry to exit point):

– Determines number of organs affected, therefore type and
severity of injury
– Vertical pathway most dangerous
– Horizontal pathway from hand to hand also fatal but spares
brain
– Path of current through body determines type of electric shock
Macroshock
• Only a small fraction of the
total applied current flows
through the heart

• Externally applied current

spreads throughout the
body

• If entry and exit points are

on same extremity, risk of
fibrillation is small
Macroshock Hazards
• Any medical procedure that
reduces/eliminates skin resistance makes
the patient vulnerable to macroshocks e.g.
electrode gel

• Medical equipment can malfunction

• Metallic case (or chassis) can become live

and person can simultaneously touch
chassis and any grounded object resulting
in a macroshock
Microshock
• Invasive devices placed in direct
contact with the heart

• If device provides a conductive

path to the heart that is insulated
except at the heart, then very
small currents called
microshocks can induce VF

• All current flows through heart

• Currents as low as 10µA can

cause VF
Microshock Hazards
• Microshocks can either flow into or out of the electric connection
to the heart

• Generally caused by leakage currents in mains-powered

equipment. What is leakage current & what causes it?

• Leakage currents – “stray currents”, very small in magnitude (µA),

flow between any adjacent insulated conductors that are at
different potentials

• Various sources of leakage currents, each defined according to

path current takes:
– Earth Leakage Current
– Enclosure Leakage Current
– Patient Leakage Current
– Patient Auxiliary Current
 Earth Leakage Current
 Current that
flows in the earth
conductor of a
protectively
earthed piece of
equipment

• Under normal conditions, person who touches metal part of

equipment and an earthed object does not receive an electric shock
• Why?
• Resistance of earth conductor much lower than person and current
takes the path of least resistance
• Shock hazard exists if earth conductor becomes open
 Enclosure Leakage Current

• Touch current
• Current that flows from an exposed conductive part of the
enclosure to earth through a conductor other than the
protective earth conductor e.g. points on enclosure not
protectively earth
• For protectively earthed equipment, enclosure leakage
current flows through earth conductor
 Patient Leakage Current

• Leakage current that flows through a patient connected to

an applied part or parts
• Applied part: Part or parts of medical equipment, which is
designed to come into physical contact with the patient e.g.
BP cuff, ECG electrodes, ultrasound probe etc
• Can flow from the applied parts through the patient to earth
or from an external high voltage source through the patient
and the applied parts then to the earth conductor
Patient Auxiliary Current

• Current that normally flows between parts

of the applied part through the patient
• Not intended to produce a physiological
effect
Conformance Directives & Standards
• How do we know medical equipment is safe to use?

• Council of European Communities issued Medical Devices

Directive (93/42/EEC)

• Sets the regulatory requirements for medical devices

throughout EU which manufacturers have to meet in order to
legally place a medical device on the European market

• To comply, manufacturers have to meet certain harmonised

standards

• Standard: an agreed way of doing

something. Its a technical document
designed to be used as a rule,
 Conformance Directives & Standards

• Main Standards: BS EN 60601 Series of Standards for

Electrical Medical Equipment

• Specifies:
– Set of requirements for safety
– Means of demonstrating compliance with these requirements,
generally by inspection or testing

• Type tests: carried out on a single representative sample and

are potentially destructive in nature

• Safety under a single fault condition (sfc), which tests whether

the equipment is still safe if any one component of the system
fails
Classes of Medical Equipment
• Purpose of 60601: Medical equipment should provide
sufficient degree of protection from electric shock to both
patients and staff

• What protection methods could you use?

• Medical equipment powered through mains electricity

should have two levels of protection:
– Basic
– Supplementary – comes into effect if basic protection fails

• Standard categorises equipment into classes & types:

– CLASS: define method of protection against electric shock
– TYPE: define degree of protection against electric shock
 Class I Medical Equipment
• Basic Protection: Insulation between live parts and exposed
conductive parts

• Supplementary Protection: Protective earth conductor:

– Large fault current flow to earth via the protective earth conductor
– Protective device (usually a fuse) disconnects the equipment from the
supply

• No symbol for Class I equipment

• Symbols for protective earth conductor:

 Class II Medical Equipment
• Basic Protection: Insulation between live parts and
exposed conductive parts

• Supplementary Protection: Double or reinforced insulation

• In practice, basic insulation may be a physical separation of

live conductors from equipment enclosure i.e. insulation
material is air

• Enclosure material then forms the supplementary insulation

• Symbol for Class II Equipment:

Class III
• Not defined in 60601 standard

• For Class III, protection against electric shock relies on the

fact that no voltages higher than safety extra low voltage
(SELV) are present

• SELV is defined in turn in the relevant standard as a voltage

not exceeding 25V ac or 60V dc

• Such equipment is battery operated

• No symbols for Class III equipment

• Note: If battery operated equipment can also operate when

connected to mains power e.g. for battery charging then it
 Equipment Types
• Define degree of protection against electric shock

• Different pieces of medical electrical equipment have

different areas of application and therefore different
electrical safety requirements

• Types are defined according to Applied Parts

• Applied Parts: parts of the medical equipment that are

intended to come into contact with the patient in order for
the equipment to perform its function
Equipment Types
TYPE SYMBOL DEFINITION

TYPE B: Indicates patient-connected equipment

B and applied parts that are not isolated from earth
or the case of the equipment

TYPE BF: Indicates patient-connected equipment

and applied parts that are separated from earth
BF and the case of the equipment by means that give
the patient general protection against electrical
hazards. An isolation barrier is involved
TYPE CF: Indicates patient-connected equipment
and applied parts provide a higher degree of
CF isolation from earth and the case of the
equipment in keeping with requirements for direct
cardiac applications
Equipment Types
Defibrillator-protected versions
TYPE B TYPE BF TYPE CF
IEC 60601-1 uses the term applied part to refer to the part of
the medical device which come into physical contact with the
patient in order for the device to carry out its intended
function.
Applied parts are classified as Type B, Type BF or Type CF
according to the nature of the device and the type of contact.
Each classification has differing requirements from the point
of view of protection against electrical shock.
Type CF is the most stringent classification, being required for
those applications where the applied part is in direct
conductive contact with the heart or other applications as
considered necessary.
Type BF is less stringent than CF, and is generally for devices
that have conductive contact with the patient, or having
medium or long term contact with the patient.
• Type B is the least stringent classification, and is
used for applied parts that are generally not
conductive and can be immediately released from
the patient.
• Type B applied parts may be connected to earth,
while Type BF and CF are 'floating' and must be
separated from earth.
• Although IEC 60601-1 doesn't stipulate which
classification is to be used for specific devices, the
particular standards, IEC 60601-2-XX, generally
do specify which classification is required.
Electrical Safety Tests
• IEC 60601 type tests: manufacturer carries out
majority of tests
• Engineering services carry out electrical safety tests
as part of functional testing of equipment to ensure
equipment conforms to standards and is safe
• Equipment should still be safe even after failure of a
single means of protection against a hazard i.e.
single fault conditions (SFC) e.g. disconnection of
protective earth connector
• Many electrical safety tests are carried out under
various SFCs to verify no hazard exists
• When SFC not applied, equipment said to be in
normal condition (NC)
Protective Earth Resistance

• A measure of the resistance between the earth pin on

the mains plug and a protectively earthed point on the
equipment enclosure
• Should this resistance be high or low & why?
• Reading should not exceed 0.2Ω
•
Class I: Insulation Resistance

• Checks for the electrical separation of parts of medical electrical

equipment
• Measured as a resistance at the mains plug between the live and
neutral pins connected together and the earth pin
• Should not be less than 50MΩ
• Test only applicable to Class I equipment (all types).
Why? What might happen if Live or Neutral is linked to an Earthed
metallic part?
Class II: Insulation Resistance

• Insulation resistance is measured between all applied parts

connected together and any accessible conductive parts of
the equipment
• What do you do if you have more applied parts that
connection points on the electrical safety tester?
Earth Leakage Current

• Test only applicable to Class I equipment (all types)

• Why?
• For NC, leakage current should not exceed 0.5mA
• For SFC, leakage current should not exceed 1mA
Enclosure Leakage / Touch Current

• Measured between an exposed part of the equipment which is not

intended to be protectively earthed and true earth
• Test applies to both Class I and Class II equipment (all types)
• For NC, leakage current should not exceed 0.1mA
• For SFC, leakage current should not exceed 0.5mA
Patient Leakage Current

• Class I & II, Type B & BF

• Measured from all applied parts having the same
function connected together and true earth
• NC limits: 0.1mA
• SFC limits: 0.5mA
Patient Leakage Current

• Patient Leakage Current –Class I, II Type CF

• Measured from each applied part in turn against true
earth
• Must not be exceeded at any one applied part
• NC limits: 0.01mA
Patient Leakage Current

• Patient Leakage Current – Mains on Applied Part

• Main purpose of test is to ensure that there is no danger of
electric shock to a patient who may be at a higher potential
than earth due to connection to applied parts
• Caution: shock hazard exists as you are applying a high
voltage to the applied parts
• Applicable to all classes, mainly types BF and CF
Electrical Safety Tests

Patient Auxiliary Current

• Measured between any single patient connection and all
other patient connections of the same module or function
connected together

• Applies to all classes and types

• Limits for NC and SFC same as patient leakage currents
Electrical Safety Tests
• Leakage Current Summary: For Class I, II
Types B, BF and CF (all values are in mA)
Type B Type BF Type CF
Leakage current
NC SFC NC SFC NC SFC
Earth 0.5 1 0.5 1 0.5 1
Enclosure 0.1 0.5 0.1 0.5 0.1 0.5
Patient 0.1 0.5 0.1 0.5 0.01 0.05
Mains on applied
- - - 5 - 0.05
part
Patient Auxiliary 0.1 0.5 0.1 0.5 0.01 0.05
EST – In Practice
• Identify the Class:
– Class I
– Class II
• Identify Applied Part Types:
– Type B
– Type BF
– Type CF
• Apply the Electrical Safety Test (ERIC):
– ER – Protective Earth Resistance measurements
– I – Insulation resistance measurements
– C – Measurement of various leakage Currents
• Check Results
 EST – In Practice
• When to do EST:
– Commissioning
– After repair or servicing
– Adverse incident investigation
• Visual Inspection
– Check the moulded on plug-
top for signs of damage, fluid
ingress or thermal or
mechanical stress
– Appropriate fuse rating (3A)
– Mains cord is free from cuts,
abrasions, kinks http://www.londonpattesting.co.uk/advice-pat-testing-
dangerous-items.html
Mains-powered Equipment
• Mains electricity is supplied over three main
conductors:
• Live (L): Carries alternating current
connected fuse
• Neutral (N): Completes the circuit and returns
electricity back to the generator after it has
passed through the appliance. Also connected
to ground
• Earth (E): connected to ground. Used for
safety purposes to carry any fault current
• Safety precautions:
– Long earth wire and short live so that to prevent
disconnection
– Earth plug pin longer – plug is securely
grounded to earth before any live connection
Mains Plug: Spot the Hazards
Mains Plug: Spot the Hazards
General Points on Electrical Safety

Multiple Socket Outlet (MSOs) /

Extension Lead Hazards

• Overloading of
MSOs/Extension leads:
– Genuine fire risk
– Increases leakage current

• Medical grade Olson

distribution boards:
– High-Integrity dual earth
bonding for maximum safety
 Trip Hazards

http://www.sciencedirect.com/science/article/pii/S000120920700261X
References
• http://www.leonics.com/support/article2_2j/articles2_2j_en.php
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f
• http://www.need.org/needpdf/infobook_activities/SecInfo/Elec3S.pdf
• http://safetycom.hst.aau.dk/elsafetyathst2005.pdf
• http://www.allaboutcircuits.com/vol_1/chpt_3/3.html
• http://www.ubccriticalcaremedicine.ca/academic/jc_article/Electrical%20Injuries%20-%20CCM%2020
02%20(Feb-05-09).pdf
• http://www.mauvila.com/ECG/ecg_fundamentals.htm
• http://www.antonine-education.co.uk/Pages/Physics_GCSE/Unit_1/Core_08_NG/core_8.htm
• http://www.bbc.co.uk/bitesize/standard/physics/using_electricity/from_the_wall_socket/revision/1/
• Safety of Medical Electrical Equipment, Liverpool Course
http://www.docstoc.com/docs/70043946/Electrical-Test-Certificates
• http://www.flukebiomedical.com/biomedical/usen/Electrical-Safety-Analyzers/601-Pro-SeriesXL.htm?
PID=55069
• http://www.s-cool.co.uk/category/subjects/gcse/physics/static-and-current-electricity
• http://www.londonpattesting.co.uk/advice-pat-testing-dangerous-items.html
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• http://www.auberelectrical.co.uk/lighting_sockets.html
• Biomedical Technician Training Notes, Medical Room Medical Engineering Training Centre
 Course work
• What engineering controls are necessary to
ensure safe working clinical environment?
• Write brief notes about the various types of
medical inventories.