University of Zagreb

Faculty of Electrical Engineering and

Computing

Biomedical Instrumentation
Safety of electrical medical devices

prof.dr.sc. Ratko Magjarević

1
 Medical technology
• Achievements
– Significant improvement of health care in all medical
specialties
– Reducing the number of seriously ill people
– Reduction of mortality
• Consequences
– increased complexity of medical devices and their
applications
– increased incidence of adverse effects of
implementation of MT
– in the U.S. approx. 10,000 cases of patient injury due
to the application of MT
2
 Medical technology
• Causes of unintended consequences:
– improper handling
– insufficient or improper staff practice (training) in
handling with MT
– insufficient experience
• example, medical staff rarely read manuals for the users
(User Manual)
– equipment malfunction
• Demand for MT developers
– developement of safe devices (failure-safe)

3
 Danger to patients
• In a clinical environment patient is exposed to
various risks, more than a typical workplace or at
home
– frequent invasive (blood) operations - penetration
through skin or mucous membranes
– presence of potentially hazardous chemicals and
substances - anesthetics, medicines, medical gases
– sources of infection - particularly "hospital infection"
– various sources of energy that penetrate into or
through the patient: current, voltage, ionizing and
non-ionizing radiation, sound and ultrasound, electric
and magnetic field, UV radiation, lasers, microwave
radiation, mechanical stress, etc.
4
 Safe MT development
• Electrical MT security is considered:
– physiological effects of electricity
– possibility (risk) of failures and their consequences
– methods of patients and staff protection
– standards describing electrical safety
– electrical safety testing modes
• Understanding the possible dangers and risks
• Implementation in achieving security

5
 Physiological effects of electricity
• Body (tissue) becoming a part of an electrical circuit
• The amount (amplitude) of electricity often depends
on the ratio of voltage present and the sum of all
(serially connected) impedance
• Usually, the highest impedance is the impedance of
the skin
• The consequence of current flow:
– nerve and/or muscle tissue stimulation
– heating of tissues (a result of tissue resistance)
– burns

6
 Pulsed current
• I – t curves for sensory and motor responses

7
Physiological effects of current

8
 Electricity
• Unintended consequences are usually a result of
human involvement in the circuit, in some way
connecting to the power network (inattention,
failure)
• Several levels of action
– perception
– contractions (let-go)
– paralysis (respiratory), pain, fatigue
– ventricular fibrillation
– tetanic contraction
– burns and physical injuries

9
Consequences of dangerous voltage
• Consequences
depend on the
voltage – current
relation, but also on
individual
Fibrilation susceptibility
• Expected values
– Intact skin,
RK = 2-5 kΩ
– Damaged skin -
Convulsion injuries, surgical
procedures,
RO = 100 Ω – 1 kΩ

10
Consequences of dangerous voltage
• Focus on the worst
possible scenario, for
example, a person holding
two conductors at
different potentials in his
hands  resulting muscle
spasms, inability to release
captured conductors
• In case of intact skin, RK =
2-5 kΩ, cramps can occur
even at a voltage of few
dozen mA
• In case of damaged skin -
injuries, surgical
procedures, RO = 100 Ω – 1
kΩ, fibrillation may occur
at voltages of several volts
and current of few dozen
mA
11
 Excitability dependence of the
pulse waveforms
• Monopolar vs. bipolar pulses, sinusoidal current

Extrapolation of sinusoidal
current

What is the duration of the

half-cycle sine current to
achieve
maximum excitability?

12
 Safe voltages - AC
• Security measures in design of medical
electrical devices
– defining voltage values ​that may not appear on
the conductive parts of instruments or
equipment coming into contact with the patients
skin or user
– for alternating current:
• safety extra low voltage, SELV of 50V, 50/60Hz
• medical safety extra low voltage, MSELV of 25V,
50/60Hz
13
 Safe voltages - DC
• Security measures in designing
– defining voltage values ​that may not appear on
the conductive parts of instruments or
equipment coming into contact with the patients
skin or user
– for direct current:
• safety extra low voltage, SELV of 120V,
• medical safety extra low voltage, MSELV of 60V

14
 Ventricular fibrillation
In cases of shock due to
unwanted
connection to power network
voltage, current passing
through the heart is
considered the most
dangerous effect and can
cause ventricular fibrillation
(ventricles) with fatal
consequences
• Ventricular fibrillation is completely irregular, asynchronous
heartbeat; no synchronism in ventricular contractions,
blood flow stops and if such heart work does not stop, it
leads to death within a few minutes 15
 Microshock vs. macroshock
• The consequences of current passage through
the tissue depend on the contact point with
the source of voltage

Even greater power

will not necessarily
cause fatal
consequences, eg.
fibrillation, when
going through the
limbs
16
 Microshock vs. macroshock

• Macroshock is caused by current passing through the body through the

skin, and the current that can cause harmful effects is relatively high and
significantly depends on the point of contact
• Microshock is caused by the passage of relatively low current, but the
source of electricity was brought directly into contact with the heart, for
example, during cardiac catheterization (catheter in the heart is a
diagnostic procedure). Electricity sufficient to induce fibrillation is of
n x 10μA. Another point of contact can be anywhere on the body (eg 17
limbs). Current of 10 μA is considered safe limit to prevent microshock
 Protective grounding
• Generally, patients are only occasionally and accidentally exposed
to risk of getting in touching with devices whose conductive parts may be
energized
• In hospitals, especially in intensive care units,
patients are deliberately connected to the
diagnostic and/or therapeutic electrical devices/equipment
– particularly careful with the isolation of
any conductive parts connected to the heart or its vicinity from all
other conductive parts
– all conductive parts in the vicinity of the patient must be connected
to a single point grounding (eg, metal bed, cupboard, etc.)
– periodic testing of the grounding impedance must be provided
• Tolerable difference in potential between the grounded conductive parts
in clinical areas:
– in the general - of 500 mV
– intensive care and other critical cases- of 40 mV 18
 Power in clinical environments
• Under normal conditions, increasing patient safety is
provided by:
– isolating parts of the power network
– installation of automatic monitoring of grounding
impedance (line isolation monitor)

19
 Power failure
• In case of power failure, in critical areas in
hospitals power is automatically provided
within 10s after stoppage
• Critical systems/devices are:
– lighting
– alarms
– equipment in intensive care

20
Equipment safe during the first
failure • The principle of
redundancy can be
applied to the safety of
medical devices and
equipment (KEU)
• For example, it is
required that electrical
medical equipment is
safe even in case of a
breakdown on the
conductive contact with
patient
• Grounding impedance
must be sufficiently low
so that the patient may
not get in touch with
any dangerous voltage

21
 Leakage currents
• Occur between conductors that are not in direct
contact (touch) and are at different potentials
• For devices that are powered from the power
network, leakage currents are:
– capacitive character (stray capacitance)
– resistive character (current through the
insulation, dust, humidity ...)
•

22
Leakage currents pathways

• Pathways of leakage current

through the patient
a) Intact ground lead
b) Broken protective ground
lead, patien connected to
ground through a catheter
c) Broken protective ground lead,
patien connected to ground by
an electrode or unintentianally.
23
Leakage currents

24
Conductive paths to / from the heart
• Current flow pathways that cause heart
microshock (in clinical settings ):
– The external pacemaker connected to epicardial
(heart surface) or endocardial (inside heart)
electrodes
– Intracardial ECG measuring electrodes
– Catheters for invasive
• heart pressure measurment
• taking blood samples
• injection of contrast or medication into the heart

25
 Medical products evaluation
• The European Medicines Agency (EMA) is a European Union agency for
the evaluation of medicinal products.
• The Food and Drug Administration (FDA or USFDA) is a federal agency of
the United States Department of Health and Human Services, one of the
United States federal executive departments. The FDA is responsible for
protecting and promoting public health through the control and
supervision of food safety, tobacco products, dietary supplements,
prescription and over-the-counter pharmaceutical drugs (medications),
vaccines, biopharmaceuticals, blood transfusions, medical devices,
electromagnetic radiation emitting devices (ERED), cosmetics, animal
foods & feed[4] and veterinary products.

26
 Regulations, standards and
recommendations
• Regulations are by-laws which are obligatory and
are related to the characteristics of devices and
equipment that must be assured
• Standards define technical characteristics that
must be met, but their application is voluntary.
Standards contain detailed instructions on how to
accomplish / verify compliance with the standard
• Recommendations (usually from manufacturers)
stipulate how to ensure the safety and prescribe
procedures and frequency of testing the device
safety
27
 International Electrotechnical Commission
(IEC)
• a non‐governmental organization that prepares and
publishes International Standards for all electrical, electronic
and related technologies.
• Utilizes over 10,000 experts from industry, commerce,
government, test and research labs, and academia and
consumer groups.
• When appropriate, IEC cooperates with ISO to ensure that
International Standards are congruent.
• For example, IEC 60601 is a series of technical standards for
the safety and effectiveness of medical electrical equipment.
First published in 1977 and regularly updated and
restructured, it consists of a general standard, collateral
standards, and particular standards.

28
 Standards 60601
• Various standard organizations/institutes define standards
for electromedical devices and equipment
• These standards are mostly harmonized, due to the needs of
global market
• The fundamental standard for electronedical devices
in Europe: IEC 60601-1 , Medical Electrical Equipment, Part 1: General
requirements for basic safety and essential
performances
• These codes are followed by the standard 60601 -2-xxx, Particular
requirements for ........
• Compliance with IEC60601-1 has become a requirement for the
commercialisation of electrical medical equipment

29
 Colateral Standards 60601
define the requirements for certain aspects of safety and performance

Full name:
• 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

Short name:
• IEC 60601-1-2 : Electromagnetic disturbances - Requirements and tests
• IEC 60601-1-3 : Radiation protection in diagnostic X-ray equipment
• IEC 60601-1-6 : Usability
• IEC 60601-1-8 : General requirements, tests and guidance for alarm systems in medical electrical
equipment and medical electrical systems
• IEC 60601-1-9 : Requirements for environmentally conscious design
• IEC 60601-1-10 : Requirements for the development of physiologic closed-loop controllers
• IEC 60601-1-11 : Requirements for medical electrical equipment and medical electrical systems used
in the home healthcare environment
• IEC 60601-1-12 : Requirements for medical electrical equipment and medical electrical systems
intended for use in the emergency medical services environment

30
 Particular Standards 60601
define the requirements for specific products

Full name:
• 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

Short name:
• IEC 60601-2-1 … electron accelerators in the range 1 MeV to 50 MeV
• IEC 60601-2-2 ... high frequency surgical equipment and high frequency surgical accessories
• IEC 60601-2-3 ... short-wave therapy equipment
• IEC 60601-2-4 ... cardiac defibrillators
• IEC 60601-2-5 ... ultrasonic physiotherapy equipment
• IEC 60601-2-6 ... microwave therapy equipment
• IEC 60601-2-8 … therapeutic X-ray equipment operating in the range 10 kV to 1 MV
• IEC 60601-2-10 ... nerve and muscle stimulators
• IEC 60601-2-11 ... gamma beam therapy equipment
• IEC 60601-2-16 … haemodialysis, haemodiafiltration and haemofiltration equipment
.
.
• 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

31
 International Organization for
Standardization (ISO)
• a non‐governmental organization that develops and publishes international standards on a
wide range of subject, including medical equipment. For the consumer, ISO International
Standards ensure that products and services are safe, reliable and of good quality. For
business, they are strategic tools that reduce costs by minimizing waste and errors, and
increasing productivity. These standards are very relevant for medical devices and encompass
virtually every aspect of device design and implementation – from device inspection
requirements to guidelines for medical device labels.
For example, ISO 13485 establishes the requirements for a quality management system for
both the design and manufacture of medical devices.
Covers aspects including risk management, design control during product development, and
verification and validation systems.
http://www.iso.org/iso/home/standards.htm

32
 Design Recommendations for Safety
• Reliable grounding for equipment
• Reduction of leakage current
• Double – insulated equipment
• Operation at low voltages
• Driven right leg circuit
• Current limiters
• Electrical isolationisolated heart connectors

33
 Safety checking
• Electrical Safety Analysis:
– general
– for certain types of electrical medical devices and
equipment
• Demo practice:
– "General" analyzer according to 60601-1
– Defibrillator analyzing operation

34
Determination of device categories

35
 Price/performance
• Mind the costs,
but satisfy safety
requirements !

36
 Literature
• J. Webster: Medical Instrumentation, Chapter
14, Electrical Safety

37