M20 - Chapter 1 - Medical Device Safety Standard PDF

MEDICAL DEVICE SAFETY STANDARD
UNIT 1: MEDICAL DEVICE SAFETY STANDARD
INTRODUCTION
The requirement for safety testing medical electronic (ME) equipment is regarded as
essential to ensure that apparatus does not pose any danger to users or patients. To
meet this need, many different standards have been published to describe what is
considered safe for the patients and operators of ME equipment.
The most widely used standard is IEC 60601. Although this is a type standard
associated with the design and development of ME equipment, most biomedical
engineering departments continue to use it as the basis for the regular testing of medical
devices, and/or after service or repair
LEARNING OBJECTIVES
The objectives of this unit are to:
1. Introduce Standard, Act and Regulation use in medical devices
2. Recognize hazard / risk that may arise from medical devices
3. Recognize safety aspect in managing medical devices
LEARNING OUTCOMES
After completing the unit, students should be able to:
1. Explain different type of standard used in medical devices
2. Identify hazard/risk produce by medical devices
3. Describe leakage current in relation to electrical safety standard
4. Describe safety aspect in managing medical devices
1.1
INTRODUCTION TO STANDARDS
Standards are published documents setting out specifications and procedures
designed to ensure products, services and systems are safe, reliable and
consistently perform the way they were intended to. They establish a common
language which defines quality and safety criteria.
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Some standards are national, others are international. Some national standard
are slightly alter versions of international ones.
Figure 1.1 Some National Standard are adopted from International Standard
Standards can be guidance documents including:
Malaysian Standards; eg MS
International Standards and Joint Standards; eg IEC,ISO
Codes;
Specifications;
Handbooks; and
Guidelines.
These documents are practical and don't set impossible goals. They are based
on sound industrial, scientific and consumer experience and are constantly
reviewed to ensure they keep pace with new technologies.
They cover everything from consumer products and services, construction,
healthcare, engineering, business, information technology, human services to
energy and water utilities, the environment and much more.
In general, Standard are documents which are usually prepared by expert in the
field, including from industry, which define the perceived best practice for the
equipment to which they relate.
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Standard are NOT usually legal document but can be made so by Governments
or by them being made part of a contract between buyer and seller.
Benefit of standard
Standards protect Malaysians at home, at play and at work are made

safer by standard
Standard support innovation reflect the latest technologies, innovation

and community needs.
Standard boost production and productivity save time and money, cut
production costs, use of common parts and specification.
Standard make business more competitive have more credibility, a

competitive edge over product that dont have standard.
Standard complement regulation and make markets work better help

make laws and regulations consistent.
Many standards are concerned with SAFETY, others with PERFORMANCE and
others still with PROCESS (usually the process of supplying goods or services
Quality Assurance Standards)
Most of the standards relating to Medical Equipment are concerned with SAFETY
and QUALITY. Only a few are concerned with PERFORMANCE
1.1.1 Safety Standard

The requirements for the electrical safety of medical equipment are much more
stringent than those for other electrical device. The reasons for increased
precautions include:
Patient may be connected to several medical devices simultaneously (e.g.

in intensive care)
Patient may be connected conductively to electronic circuitry (e.g. ECG

monitoring)
Contact with device may be directly to internal tissue that conducts well
(e.g. through natural orifices or breaks in the skin)
Example IEC601, UL544 BS5724
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1.1.2 Performance Standard

Performance Standards state what behaviors or results are expected for
performance to be considered satisfactory. Example AAMI Standard, AHA
standard, some part of IEC601
1.1.3 Quality Standard

Quality Standard state totally features and characteristic of the product or service
that bear on its ability to meet the stated standard. Example ISO9001
1.2
REFERENCE EQUIPMENT STANDARD, GUIDANCE AND

LEGISLATION
A code is a document that contains mandatory requirements. It uses the word
shall, is generally adopted into law by authority that has jurisdiction.
A standard is a document that contains mandatory requirements, but compliance
tends to be voluntary.
MALAYSIAN STANDARD
The Department of Standards Malaysia (STANDARDS MALAYSIA) is the
national standards and accreditation body of Malaysia established under
Standards of Malaysia Act 1996.
The main function of the Department is to foster and promote standards,

standardization and accreditation as a means of advancing the national
economy, promoting industrial efficiency and development, benefiting the health
and safety of the public, protecting the consumers, facilitating domestic and
international trade and furthering international cooperation in relation to standards
and standardisation.
Malaysian Standards are developed through consensus by committees which

comprise of balanced representation of producers, users, consumers and others
with relevant interests, as may be appropriate to the subject in hand. To the
greatest extent possible, Malaysian Standards are aligned to or are adoption of
international standards. Approval of a standard as a Malaysian Standard is
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governed by the Standards of Malaysia Act 1996 (Act 549). Malaysian Standards
are reviewed periodically. The use of Malaysian Standards is voluntary except in
so far as they are made mandatory by regulatory authorities by means of
regulations, local by-laws or any other similar ways.
The Department of Standards appoints SIRIM Berhad as the agent to develop

Malaysian Standards. The Department also appoints SIRIM Berhad as the agent
for distribution and sale of Malaysian Standards.
Figure 1.2
Department of Standards Malaysia
Standards policy development and implementation
Participation in International and Regional Bodies
Accreditation of laboratories and certification bodies
SIRIM Berhad
Managing the standards development infrastructure
Managing Malaysian representation in regional and
international
standards bodies
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Publishing, printing, selling and distributing Malaysian Standards
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Regulating Agencies: Malaysia has two regulatory bodies for medical devices:
The Medical Device Bureau, and the Atomic Energy Licensing Board of the
Malaysian Ministry of Science, Technology, and Innovation. The Medical Device
Bureau administers the Voluntary Registration of Medical Devices Establishments
(MeDVER) program, which will likely become mandatory under the Medical
Device Act. The licensing board exclusively regulates medical devices which emit
radiation.
Laws and Regulations: In August 2007, Malaysia issued a draft Medical Device
Act which indicated an intention to follow Global Harmonization Task Force
guidance documents. In November 2011 the Medical Device Act already table
into the parliament and being gazette in February 2012.However, the issuance of
implementing regulations will determine whether adherence to the Act will be
easy or problematic for medical device importers.
Registration Procedures: Devices emitting radiation are restricted, and any

such device must be examined by the Ministry of Health before it can be used in
Malaysia. Permits for radiation emitting devices can be obtained through the
Atomic Energy Licensing Board of the Malaysian Ministry of Science,
Technology, and Innovation:
1.2.1 IEC STANDARD

Millions of devices that contain electronics, and use or produce electricity, rely on
IEC International Standards and Conformity Assessment Systems to perform, fit
and work safely together.
Founded in 1906, the IEC (International Electrotechnical Commission) is the

worlds leading organization for the preparation and publication of International
Standards for all electrical, electronic and related technologies. These are known
collectively as electrotechnology
IEC provides a platform to companies, industries and governments for meeting,

discussing and developing the International Standards they require.
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The IEC is one of three global sister organizations (IEC, ISO and ITU) that
prepare International Standards for the world.
Figure 1.3 International Electrotechnical Commission
When appropriate IEC cooperates with ISO (International Organization for

Standardization) or ITU (International Telecommunication Union) to ensure that
International Standards fit together seamlessly and complement each other. Joint
committees ensure that International Standards combine all relevant knowledge
of experts working in related areas.
Currently IEC compromise:
Over 10,000 experts from industry, commerce, government, test and

research labs, academia and consumer groups participate in IEC
Standardization work.
174 Technical Committees with over 1,000 Working Groups
Over 6,000 International standards in IEC catalogue today
Over 500,000 Conformity Assessment certificates established
162 countries -81 Members and 81 Affiliates
An IEC International Standard is a normative document, developed according to

consensus procedures. It must be approved by the relevant IEC National
Committees and is finally published as an International Standard by the IEC
Central Office.
The word consensus is important. This means that the International Standard
represents a common point of view of concerned parties. Any member of the IEC
may participate in the preparatory work of an International Standard, and any
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international, governmental or nongovernmental organization liaising with the IEC

can also take part in this preparation.
Adoption of IEC International Standards by any country, whether it is a member

of the IEC or not, is entirely voluntary.
The IEC handles three Conformity Assessments Systems that enable it to

determine if a product or service is what it appears to be and if a systems
performs as it should.
Three IEC Conformity Assessment Systems are:

1. IECEE (IEC System of conformity assessment schemes for electrotechnical
equipment and components)
Covers conformity testing and certification for safety and performance of
home and office equipment, home entertainment, medical device, lighting,
portable tools, etc.
2. IECEx ( IEC System for certification to standards relating to equipment for
use in explosive atmospheres)
covers certification of
personnel
competencies (maintenance and repair), electrical and electronic products

and systems in the highly specialized field of explosion protection. This
includes all areas where inflammable gases, liquids, and combustible dusts
may be present, i.e., the oil and gas industry, mining, refuelling stations for
cars, trucks and planes, printing and paint industry, grain storage and
handling, sugar refineries, etc.
3. IECQ (IEC quality assessment system for electronic components) covers
business to business supply chain management systems for avionics,
management of electrostatic discharge and the use of hazardous substances
in the manufacturing process.
The ultimate goal is to provide one test, one global certification, one mark for
every product or system.
IEC Conformity Assessment Systems help accelerate access to markets and
reduce the need for multiple testing and approval. This cuts costs. They also
allow products to reach markets faster and knock down many barriers to trade
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Beyond electrotechnology, IEC work also covers:
Terminology and symbols that simply production and technology transfer,

because all partners communicate in a universally understood language.
Safety to make certain that products and systems perform as expected.
The environment to allow the safe production, use and end-life

destruction of electrotechnical goods.
Electromagnetic compatibility and interferences enabling undisturbed

performance of individual devices.
1.2.2 MS 838
MS 838:2007 -- Code of Practice for Radiation Protection -- Medical X-Ray
Diagnosis (First Revision), published by Standards Malaysia.
Part two of the code book, under the heading Radiological Safety, states that: "A
basic principle of protection in diagnostic radiology is that an X-ray examination
should not be performed unless the benefits accruing to the patient outweigh any
radiation risk.
1.2.3 ECRI
ECRI stand for Emergency Care Research Institute is an independent, nonprofit
organization that researches the best approaches to improving the safety, quality,
and cost-effectiveness of patient care. ECRI provide unbiased, evidence-based
healthcare research, information, and advice enable user to do:
Assess and address patient safety, quality, and risk management
Select the safest, most effective medical devices, procedures, and drugs
Procure healthcare technology in the most cost-effective manner
Develop evidence-based health coverage policies
Align hospital and health facility capital investments with user strategic
technology needs.
Establish in 1968, ECRI formally began operation focusing on research in

emergency medicine, resuscitation, and related biomedical engineering studies.
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The Institutes first evaluation of 18 brands of manually operated resuscitators

found nine to be ineffective and started ECRI as an independent evaluator and
provider of medical-device-related information and guidance.
Figure 1.4 Emergency Care Research Institute
Currently ECRI have more than 5,000 member and client list includes hospitals,
health systems, public and private, federal and state government agencies,
ministries of health, associations, and accrediting agencies worldwide.
1.2.4 AMMI
AAMI, the Association for the Advancement of Medical Instrumentation, is a
nonprofit organization founded in 1967. It is a unique alliance of more than 6,000
members from around the world united by one mission to increase the
understanding
and
beneficial
use
of
medical
instrumentation
through effective standards, educational programs, and publications.
Figure 1.5
AAMI is the primary source of consensus and timely information on medical
instrumentation and technology.
AAMI is the primary resource for the industry, the professions, and
government for national and international standards.
AAMI provides multidisciplinary leadership and programs that enhance

the ability of the professions, healthcare institutions, and industry to
understand, develop, manage, and use medical instrumentation and
related technologies safely and effectively.
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AAMI helps members:

o
contain costs
keep informed of new technology and policy developments
add value in healthcare organizations
improve professional skills and enhance patient care.
AAMI provides a unique and critical forum for members who cover a
complete range of interests, from clinical and biomedical engineers and
technicians, physicians, nurses, and hospital administrators, to educators
and researchers, manufacturers, distributors, government representatives
and other healthcare professionals with an interest in medical devices.
These diverse groups have been instrumental in making AAMI the leading
source of essential information on medical devices and equipment since
1967.
AAMI fulfills its mission through:

o
continuing education, conferences
certification of healthcare technical specialists
the publication
of
technical
documents,
periodicals,
books,
software.
1.2.5 FDA/CE
Figure 1.6
FDA is an agency within the U.S. Department of Health and Human Services. It
consists of six product centers, one research center, and two offices:
FDA is responsible for
Protecting the public health by assuring that foods are safe, wholesome,
sanitary and properly labeled; human and veterinary drugs, and vaccines
and other biological products and medical devices intended for human
use are safe and effective
Protecting the public from electronic product radiation
Assuring cosmetics and dietary supplements are safe and properly

labeled
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Regulating tobacco products
Advancing the public health by helping to speed product innovations
Helping the public get the accurate science-based information they need
to use medicines, devices, and foods to improve their health
FDA regulates
foods, except for most meat and poultry products, which are regulated by
the U.S. Department of Agriculture
food additives
infant formulas
dietary supplements
human drugs
vaccines, blood products, and other biologics
medical devices, from simple items like tongue depressors, to complex

technologies such as heart pacemakers
electronic products that give off radiation, such as microwave ovens and
X-ray equipment
cosmetics
feed, drugs, and devices used in pets, farm animals, and other animals
tobacco products
CE MARKING
The CE marking (an acronym for the French "Conformite Europeenne") certifies
that a product has met EU health, safety, and environmental requirements, which
ensure consumer safety.
Figure 1.7
Manufacturers in the European Union (EU) and abroad must meet CE marking
requirements where applicable in order to market their products in Europe. A
manufacturer who has gone through the conformity assessment process, may
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affix the CE marking to the product. With the CE marking, the product may be
marketed throughout the EU. CE marking now provides product access to 32
countries with a population of nearly 500 million.
Table 1.1 CE Marking Countries
Austria
Hungary
Poland
Belgium
Iceland
Portugal
Bulgaria
Ireland
Romania
Cyprus
Italy
Slovakia
Czech Republic
Latvia
Slovenia
Denmark
Liechtenstein
Spain
Estonia
Lithuania
Sweden
Finland
Luxembourg
Switzerland
France
Malta
Turkey
Germany
Netherlands
United Kingdom
Greece
Norway
Figure 1.8 CE Mark in product
1.3
HAZARD OF MEDICAL EQUIPMENT

Medical electrical equipment can present a range of hazards to the patient, the
user, or to service personnel. Many such hazards are common to many or all
types of medical electrical equipment, whilst others are peculiar to particular
categories of equipment.
For this reason, various hazards associated with medical electrical equipment are
discussed briefly below.
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Mechanical Hazards
All types of medical electrical equipment can present mechanical hazards. These
can range from insecure fittings of controls to loose fixings of wheels on
equipment trolleys. The former may prevent a piece of life supporting equipment
from being operated properly, whilst the latter could cause serious accidents in
the clinical environment.
Figure 1.9
Such hazards may seem too obvious to warrant mentioning, but it is unfortunately
all too common for such mundane problems to be overlooked whilst problems of
a more technical nature are addressed.
Risk of fire or explosion
All mains powered electrical equipment can present the risk of fire in the event of
certain faults occurring such as internal or external short circuits. In certain
environments such fires may cause explosions. Although the use of flammable
anaesthetics is not common today, it should be recognised that many of the
medical gases currently in use, such oxygen or nitrous oxide, vigorously support
combustion. Wherever there is an elevated concentration of such gases, there is
an increased risk of fire initiated by electrical faults.
Figure 1.10
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Absence of Function
Since many pieces of medical electrical equipment are life supporting or monitor
vital functions, the absence of function of such a piece of equipment would not be
merely inconvenient, but could threaten life.
Excessive or insufficient output

In order to perform its desired function equipment must deliver its specified
output. Too high an output, for example, in the case of surgical diathermy units,
would clearly be hazardous. Equally, too low an output would result in inadequate
therapy, which in turn may delay patient recovery, cause patient injury or even
death. This highlights the importance of correct calibration procedures.
Infection
Medical equipment that has been inadequately decontaminated after use may
cause infection through the transmission of microorganisms to any person who
subsequently comes into contact with it. Clearly, patients, nursing staff and
service personnel are potentially at risk here.
Figure 1.11
Misuse
Misuse of equipment is one of the most common causes of adverse incidents

involving medical devices. Such misuse may be a result of inadequate user
training or of poor user instructions.
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Risk of exposure to spurious electric currents
All electrical equipment has the potential to expose people to the risk of spurious
electric currents. In the case of medical electrical equipment, the risk is potentially
greater since patients are intentionally connected to such equipment and may not
benefit from the same natural protection factors that apply to people in other
circumstances. Whilst all of the hazards listed are important, the prevention of
many of them require methods peculiar to the particular type of equipment under
consideration. For example, in order to avoid the risk of excessive output of
surgical diathermy units, knowledge of radio frequency power measurement
techniques is required. However, the electrical hazards are common to all types
of medical electrical equipment and can minimised by the use of safety testing
and inspection regimes which can be applied to all types of medical electrical
equipment.
Figure 1.12
1.4
ELECTRIC SHOCK HAZARD

Three conditions occuring simultaneously can result in a shock
1. One part of the body is in contact with the conductive surface
2. A different part of the same body is in contact with a second conductive
surface
3. A voltage source drives current through the body between those two points of
contact.
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Figure 1.13
Electric current can flow through the human body either accidentally or
intentionally. Electrical currents are administered intentionally in the following
cases.
a. For the measurement of respiration rate by impedance method, a small
current at high frequency is made to flow between the electrodes applied
on the surface body.
b. High frequency currents are also passed through the body for the
therapeutic and surgical purpose.
c. When recording signal like ECG, the amplifiers used in the preamplifier
stage may deliver small currents due to defect in design.
The severity of electric shock depends on the current flowing through the body.
I=V/R to find out how much current will flow through the body.
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Figure 1.14
According to IEEE Std. 80, you can determine the maximum safe shock duration
by the formula, T=0.116/(VR),
For a 120V circuit, maximum shock duration =0.116(120V1,000)=1 sec
For a 277V circuit, maximum shock duration =0.116(277V1000)=0.43 sec
Factors that determine the form and severity of injury include:

a) the type and magnitude of current
b) the resistance of the body at the point of contact
different tissues in the body will offer different electrical resistance,
c) the current pathway through the body and
d) the duration of current flow.
AC Current
Particularly of the common 50-60 Hz variety, is three to five times more
dangerous than DC of the same voltage and amperage (current strength).
The effects of AC on the body depend to a great extent on the frequency: lowfrequency currents (50 60 Hz) are usually more dangerous than high-frequency
currents. AC causes muscle spasm, often 'freezing' the hand (the most common
part of the body to make contact) to the circuit. The fist clenches around the
current source resulting in prolonged exposure with severe burns. Burns from
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electricity are the result of extremely high temperatures (up to 5000 C) generated
at the point of skin contact with the conductor. They usually involve the skin and
the tissues beneath and may be of almost any size and depth. Generally the
higher the voltage and the amperage, the greater the damage from either type of
current.
DC Current
Tends to cause a convulsive contraction of the muscles, often forcing the victim
away from further current exposure.
Figure 1.15
1.4.1
SPECIAL ENVIRONMENT IN HOSPITAL
It is common experience that hazards due to electrical shocks are also

associated with the equipment other than that used in hospitals. However, the
equipments used in medical practice have to operate in special environment,
which differ in certain respects from the others. Some such special situations are
as follows
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a. A patient may not be usually able to react in the normal way. He is either
ill, unconscious, anaesthetized or strapped on the operating table. He may
not be able to withdraw himself from the electrified object, when feeling a
tingling in his skin, before any danger of electrocution occurs.
b. The patient or the operator may not realize that a potential hazard exists.
This is because potential differences are small and high frequency and
ionizing radiations are not directly indicated.
c. A considerable natural protection and barrier to electric currents is
provided by human skin. In certain applications of electromedical
equipments, the natural resistance of the skin may be by-passed. Such
situations arise when the tests are carried out on the subject with a
catheter in his heart or on large blood vessels.
d. Electromedical equipments, e.g. pacemakers may be used either
temporarily or permanently to support or replace functions of some organs
of the human body. An interruption in the power failure of the equipment
may give rise to hazards, which may cause permanent injuries or may
even prove fatal for the patient.
e. Medical instruments are quite often used in conjunction with several other
instruments and equipment. These combinations are often adhoc. Several
times there are combinations of high power equipment and extremely
sensitive low signal equipments. Each of these devices may be safe in
itself, but can become dangerous when used in conjunction with others.
f.
The environmental conditions in the hospitals, particularly in the operating

theatres, cause an explosion or fire hazards due to presence of anesthetic
agents, humidity and cleaning agents, etc.
The factor listed above indicate that the electromedical equipments may be used
in different places and under different circumstances. It is also obvious that an
optimum level of safety can only be achieved when efforts are made to include
safety measures in the equipment, in the installation as well as in the application.
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Figure 1.16
1.4.2 MICROSHOK AND MACROSHOCK

There are two situations which account for hazards from electrical shock. They
are microshock and macroshock.
Figure 1.17
Microshock
In micro current shock, the current passes directly through the heart wall. This is
the case when cardiac catheters may be present in the heart chambers. Here,
even very small amounts of currents can produce fatal results.
A physiological response to a current applied to the surface of the heart

that produced unwanted stimulation, muscle contraction or tissue injury.
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This often happens when cardiac catheters are intact with the patient.
Even small amount current can produce fatal injuries.
This makes microshock is more dangerous than macroshock with limits of 1uA
and 1mA respectively.
Figure 1.18
Macroshock
In macro current shock, the current flows through the body of the subject. E.g. as
from arm to arm.
A physiological response to a current applied to the surface of the body

that produced unwanted stimulation, muscle contraction or tissue injury
Figure 1.19
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Tissue Resistance
Skin - 5000 ohms/cm2
Blood - 100 ohms/cm2
Muscle - 200-400 ohms/cm2
Fat - 2000-3000 ohms/cm2
Bone - 3000+ ohms/cm2
Current goes to the path of least resistance
1.4.3 PHSIOLOGICAL EFFFECT OF ELECTRICITY

The electrical current induced to the body that causes unwanted physiological
effects
a) Electrolysis
The movement of ions of opposite polarities in opposite directions through
a medium is called electrolysis and can be made to occur by passing DC
current through body tissues or fluids. If a DC current is passed through
body tissues for a period of minutes, ulceration begins to occur. Such
ulcers, while not normally fatal, can be painful and take long periods to
heal.
b) Burns
When an electric current passes through any substance having electrical

resistance, heat is produced. The amount of heat depends on the power
dissipated (I2R). Whether or not the heat produces a burn depends on the
current density.
Human tissue is capable of carrying electric current quite successfully.
Skin normally has a fairly high electrical resistance while the moist tissue
underneath the skin has a much lower resistance. Electrical burns often
produce their most marked effects near to the skin, although it is fairly
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common for internal electrical burns to be produced, which, if not fatal,

can cause long lasting and painful injury.
c) Muscle cramps
When an electrical stimulus is applied to a motor nerve or a muscle, the

muscle does exactly what it is designed to do in the presence of such a
stimulus i.e. it contracts. The prolonged involuntary contraction of muscles
(tetanus) caused by an external electrical stimulus is responsible for the
phenomenon where a person who is holding an electrically live object can
be unable to let go.
d) Respiratory arrest
The muscles between the ribs (intercostal muscles) need to repeatedly

contract and relax in order to facilitate breathing. Prolonged tetanus of
these muscles can therefore prevent breathing.
e) Cardiac arrest
The heart is a muscular organ, which needs to be able to contract and

relax repetitively in order to perform its function as a pump for the blood.
Tetanus of the heart musculature will prevent the pumping process.
f) Ventricular fibrillation
The ventricles of the heart are the chambers responsible for pumping
blood out of the heart. When the heart is in ventricular fibrillation, the
musculature of the ventricles undergoes irregular, uncoordinated twitching
resulting in no net blood flow. The condition proves fatal if not corrected in
a very short space of time.
Ventricular fibrillation can be triggered by very small electrical stimuli. A
current as low as 70 mA flowing from hand to hand across the chest, or
20A directly through the heart may be sufficient. It is for this reason that
most deaths from electric shock are attributable to the occurrence of
ventricular fibrillation.
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Fig 1.20 Analogy for fibrillation

g) Effect of frequency on neuro-muscular stimulation
The amount of current required to stimulate muscles is dependent to
some extent on frequency. Referring to figure 1.21, it can be seen that the
smallest current required to prevent the release of an electrically live
object occurs at a frequency of around 50 Hz. Above 10 kHz the neuromuscular response to current decreases almost exponentially.
Figure 1.21 Current required to prevent release of a live object.

Research shows that the minimal let go current occurs for commercial
power line frequencies 50 60z
Skin resistance = 10k 1M ohm
If skin is wet or broken, body resistance may drop to 1% of its value.
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Electrical currents passing through surface electrodes from one arm to the other
have serious physiological effect consequences. At 60 Hz, such currents above
5mA are considered dangerous
Table 1.2
Type of
Current range
current
(mA)
Threshold
1-5
Tingling sensation
Pain
5 8
Intense or painful sensation
Physiological effect
Let go
8 20
Paralysis
>20
Respiratory paralysis and pain
Fibrillation
80 1000
Ventricular and heart fibrillation
Defibrillation
1000 10,000
Threshold of involuntary muscle contraction
Sustained
myocardial
contraction
and
possible tissue burns
Figure 1.22
Let go current
It is maximum current at which a person is still capable of hanging on to a
conductor by using his muscles that is directly stimulated by the current shock
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Hold on current
It is minimum current before a person losses ability to control his own muscle
actions and he is viable to grip on the electrical conductor
1.4.4 PRECAUTION TO MINIMISE ELECTRICAL SHOCK HAZARDS
The following precautions should be observed to prevent hazardous situations:
1. In the vicinity of the patient, use only apparatus or appliances with threewire power cords.
2. Provide isolated input circuits on monitoring equipment.
3. Have periodic checks of ground wire continuity of all equipment.
4. No other apparatus should be put where the patient monitoring equipment
is connected.
5. Staff should be trained to recognize potentially hazardous conditions.
6. Connectors for probes and leads should be standardized so that currents
intended for powering transducers are not given to the leads applied to
pick up physiologic electric impulses.
7. The functional controls should be clearly
marked and the operating instructions be
permanently and prominently displayed so
that they can be easily familiarized.
8. Many of the portable medical equipment
such as dialysis unit, hypothermia units,
physiotheraphy apparatus, respirators and humidifiers are used with
adapter plugs that do not ensure a proper grounding circuit. Particular
care should be taken in such cases.
9. The operating instructions should give directions on the proper use of the
equipments. In fact, for electromedical equipment, the operating
instructions should be regarded as an integral part of the unit.
10. The mechanical construction of the equipment must be such that the
patient or operator cannot be injured by the mechanical system of the
equipment, if properly operated.
11. A potential difference of not more than 5mV should exist between the
ground point at the outlet and the ground point at any of the outlets and
any conductive surface in the same area. If there is no voltage difference
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between two points or only an insignificant potential of a few millivolt

exists, the flow of possible leakage current between its source and ground
will be restricted to well below a level which could be dangerous.
12. The patient equipment grounding point should be connected individually
to all receptacle grounds, metal beds and any other conductive services.
The resistance of these connections individually should not exceed 0.15.
Figure 1.23
Natural protection factors

Many people have received electric shocks from mains potentials and above and
lived to tell the tale. Part of the reason for this is the existence of certain natural
protection factors.
Ordinarily, a person subject to an unexpected electrical stimulus is protected to
some extent by automatic and intentional reflex actions. The automatic
contraction of muscles on receiving an electrical stimulus often acts to disconnect
the person from the source of the stimulus. Intentional reactions of the person
receiving the shock normally serve the same purpose. It is important to realise
that a patient in the clinical environment who may have electrical equipment
intentionally connected to them and may also be anaesthetised is relatively
unprotected by these mechanisms.
Normally, a person who is subject to an electric shock receives the shock through
the skin, which has a high electrical resistance compared to the moist body
tissues below, and hence serves to reduce the amount of current that would
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otherwise flow. Again, a patient does not necessarily enjoy the same degree of
protection. The resistance of the skin may intentionally have been lowered in
order to allow good connections of monitoring electrodes to be made or, in the
case of a patient undergoing surgery, there may be no skin present in the current
path.
The absence of natural protection factors as described above highlights the need
for stringent electrical safety specifications for medical electrical equipment and
for routine test and inspection regimes aimed at verifying electrical safety.
1.5 LEAKAGE CURRENTS

Most safety testing regimes for medical electrical equipment involve the
measurement of certain "leakage currents", because the level of them can help to
verify whether or not a piece of equipment is electrically safe. In this section the
various leakage currents that are commonly measurable with medical equipment
safety testers are described and their significance discussed. The precise
methods of measurement along with applicable safe limits are discussed later
1.5.1 Causes of leakage currents
If any conductor is raised to a potential above that of earth, some current is
bound to flow from that conductor to earth. This is true even of conductors that
are well insulated from earth, since there is no such thing as perfect insulation or
infinite impedance. The amount of current that flows depends on:
a. the voltage on the conductor.
b. the capacitive reactance between the conductor and earth.
c. the resistance between the conductor and earth.
The currents that flow from or between conductors that are insulated from earth
and from each other are called leakage currents, and are normally small.
However, since the amount of current required to produce adverse physiological
effects is also small, such currents must be limited by the design of equipment to
safe values.
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For medical electrical equipment, several different leakage currents are defined
according to the paths that the currents take.
1.5.2 Earth leakage current
Earth leakage current is the current that normally flows in the earth conductor of a
protectively earthed piece of equipment. In medical electrical equipment, very
often, the mains is connected to a transformer having an earthed screen. Most of
the earth leakage current finds its way to earth via the impedance of the
insulation between the transformer primary and the inter-winding screen, since
this is the point at which the insulation impedance is at its lowest (see figure 1.24)
Figure 1.24 Earth leakage current path

Under normal conditions, a person who is in contact with the earthed metal
enclosure of the equipment and with another earthed object would suffer no
adverse effects even if a fairly large earth leakage current were to flow. This is
because the impedance to earth from the enclosure is much lower through the
protective earth conductor than it is through the person. However, if the protective
earth conductor becomes open circuited, then the situation changes. Now, if the
impedance between the transformer primary and the enclosure is of the same
order of magnitude as the impedance between the enclosure and earth through
the person, a shock hazard exists.
It is a fundamental safety requirement that in the event of a single fault occurring,
such as the earth becoming open circuit, no hazard should exist. It is clear that in
order for this to be the case in the above example, the impedance between the
mains part (the transformer primary and so on) and the enclosure needs to be
high. This would be evidenced when the equipment is in the normal condition by
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a low earth leakage current. In other words, if the earth leakage current is low
then the risk of electric shock in the event of a fault is minimised.
1.5.3 Enclosure leakage current or touch current

The terms "enclosure leakage current" and "touch current" should be taken to be
synonymous. Enclosure leakage current is defined as the current that flows from
an exposed conductive part of the enclosure to earth through a conductor other
than the protective earth conductor.
Figure 1.25 Enclosure leakage current path

If a protective earth conductor is connected to the enclosure, there is little point in
attempting to measure the enclosure leakage current from another protectively
earthed point on the enclosure, since any measuring device used is effectively
shorted out by the low resistance of the protective earth. Equally, there is little
point in measuring the enclosure leakage current from a protectively earthed
point on the enclosure with the protective earth open circuit, since this would give
the same reading as measurement of earth leakage current as described above.
For these reasons, it is usual when testing medical electrical equipment to
measure enclosure leakage current from points on the enclosure that are not
intended to be protectively earthed (see figure 1.25). On many pieces of
equipment, no such points exist. This is not a problem. The test is included in test
regimes to cover the eventuality where such points do exist and to ensure that no
hazardous leakage currents will flow from them.
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1.5.4 Patient leakage current

Patient leakage current is the leakage current that flows through a patient
connected to an applied part or parts. It can either flow from the applied parts via
the patient to earth or from an external source of high potential via the patient and
the applied parts to earth. Figures 1.26 and figure 1.27 illustrate the two
scenarios.
Figure 1.26. Patient leakage current path from equipment
Figure 1.27 Patient leakage current path to equipment
1.5.5 Patient auxiliary current

The patient auxiliary current is defined as the current that normally flows between
parts of the applied part through the patient, which is not intended to produce a
physiological effect (see figure 1.28).
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Figure 1.28 Patient auxiliary current path
1.6 EQUIPMENT CLASSIFICATION

All electrical equipment is categorised into classes according to the method of
protection against electric shock that is used. For mains powered electrical
equipment there are usually two levels of protection used, called "basic" and
"supplementary" protection. The supplementary protection is intended to come
into play in the event of failure of the basic protection.
1.6.1 Equipment Types
As described above, the class of equipment defines the method of protection

against electric shock. The degree of protection for medical electrical equipment
is defined by the type designation. The reason for the existence of type
designations is that different pieces of medical electrical equipment have different
areas of application and therefore different electrical safety requirements. For
example, it would not be necessary to make a particular piece medical electrical
equipment safe enough for direct cardiac connection if there is no possibility of
this situation arising.
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Table 1.3 shows the symbols and definitions for each type classification of
medical electrical equipment.
Type
Symbol
Definition
Non Isolated Applied Part
BF
Isolated Applied Part
Isolated Applied Part, suitable for
CF
direct cardiac application
Type BF Defib Protection
Type CF Defib Protection
Table 1.3 Medical electrical equipment types

All medical electrical equipment should be marked by the manufacturer with one
of the type symbols above.
1.6.2 Class
Class I Equipment
Class I equipment has a protective earth. The basic means of protection is the
insulation between live parts and exposed conductive parts such as the metal
enclosure. In the event of a fault that would otherwise cause an exposed
conductive part to become live, the supplementary protection (i.e. the protective
earth) comes into effect. A large fault current flows from the mains part to earth
via the protective earth conductor, which causes a protective device (usually a
fuse) in the mains circuit to disconnect the equipment from the supply.
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Figure 1.29
It is important to realise that not all equipment having an earth connection is
necessarily class I. The earth conductor may be for functional purposes only such
as screening. In this case the size of the conductor may not be large enough to
safely carry a fault current that would flow in the event of a mains short to earth
for the length of time required for the fuse to disconnect the supply.
Class I Grounded System

Live (L1)
Neutral (L2)
Ground
Figure 1.30
Class I medical electrical equipment should have fuses at the equipment end of
the mains supply lead in both the live and neutral conductors, so that the
supplementary protection is operative when the equipment is connected to an
incorrectly wired socket outlet.
Further confusion can arise due to the use of plastic laminates for finishing
equipment. A case that appears to be plastic does not necessarily indicate that
the equipment is not class I.
There is no agreed symbol in use to indicate that equipment is class I and it is not
mandatory to state on the equipment itself that it is class I. Where any doubt
exists, reference should be made to equipment manuals.
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The symbols below may be seen on medical electrical equipment adjacent to

terminals.
Figure 1.31 Symbols seen on earthed equipment.

Class II Equipment
The method of protection against electric shock in the case of class II equipment
is either double insulation or reinforced insulation. In double insulated equipment
the basic protection is afforded by the first layer of insulation. If the basic
protection fails then supplementary protection is provided by a second layer of
insulation preventing contact with live parts.
In practice, the basic insulation may be afforded by physical separation of live
conductors from the equipment enclosure, so that the basic insulation material is
air. The enclosure material then forms the supplementary insulation.
Figure 1.32
Reinforced insulation is defined in standards as being a single layer of insulation
offering the same degree of protection against electric shock as double
insulation.
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Hot (L1)
Class II Double
Insulated
System
Neutral (L2)
Figure 1.33
Class II medical electrical equipment should be fused at the equipment end of the
supply lead in either mains conductor or in both conductors if the equipment has
a functional earth.
The symbol for class II equipment is two concentric squares illustrating double
insulation as shown below.
Figure 1.34 Symbol for class II equipment double insulation (all plastic case)
Class III Equipment

Class III equipment is defined in some equipment standards as that in which
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.
In practice such equipment is either battery operated or supplied by a SELV
transformer.
If battery operated equipment is capable of being operated when connected to
the mains (for example, for battery charging) then it must be safety tested as
either class I or class II equipment. Similarly, equipment powered from a SELV
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transformer should be tested in conjunction with the transformer as class I or

class II equipment as appropriate.
It is interesting to note that the current IEC standards relating to safety of medical
electrical equipment do not recognise Class III equipment since limitation of
voltage is not deemed sufficient to ensure safety of the patient. All medical
electrical equipment that is capable of mains connection must be classified as
class I or class II. Medical electrical equipment having no mains connection is
simply referred to as "internally powered".
1.7 ELECTRICAL SAFETY TEST AND ANALYZERS

The following sub topic and diagrams describe the electrical safety tests
commonly available on medical equipment safety testers.
Why we perform safety test?
To ensure the medical equipment is safe to be used for all even the faulty
happen to the machine.
Who should do the testing?
An adequate knowledge and practical experience of electricity, its

hazards, the required safety standard and a clear understanding of the
precautions required to avoid danger.
These criteria will include:

o
Able to recognize whether it is safe for work to continue
Able to recommend the frequency of testing should this deviate

significantly from the guide book.
Adequate knowledge of the possible hazards of unfamiliar

equipment in unfamiliar locations.
When Electrical Safety Test is performed?
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After perform repair
After transportation
During routine PPM
Before apply to the patient
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Electrical Safety Test Parameters
Mains Voltage
o
Measure the voltage from the mains
Measure the voltage from pin to pin
Current Consumption
o
Measure the current consumption of the equipment
Insulation Resistance
o
Measure the dielectric strength from L to N, or applied part to

earth. >2 20M ohm
Protective Earth Resistance

o
Power cord resistance
Apply test current 1A or 25A for 5second
Limit : Less than 0.2 ohm
Leakage Current
o
Earth Leakage
Enclosure Leakage Current
Patient Leakage Current
Patient Auxillary Leakage Current
A range of electrical safety analyzers are commercially available for testing both
medical facility power systems and medical equipment. They vary in complexity
from simple volt-ohm-meter to computerized automatic measurement systems
that generate hard copies of test results.
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Terminology
Figure 1.35
ANALYSERS
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Figure 1.36
1.7.1 Normal condition and single fault conditions
A basic principle behind the philosophy of electrical safety is that in the event of
a single abnormal external condition arising or of the failure of a single means of
protection against a hazard, no safety hazard should arise. Such conditions are
called "single fault conditions" (SFCs) and include such situations as the
interruption of the protective earth conductor or of one supply conductor, the
appearance of an external voltage on an applied part, the failure of basic
insulation or of temperature limiting devices.
Where a single fault condition is not applied, the equipment is said to be in
"normal condition" (NC).
Many electrical safety tests are carried out under various single fault conditions in
order to verify that there is no hazard even should these conditions occur in
practice. It is often the case that single fault conditions represent the worst case
and will give the most adverse results. Clearly the safety of the equipment under
test may be compromised when such tests are performed.
Many electrical safety tests are carried out under single fault condition since
these represent the worst case and will give the most adverse results.
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Normal condition: condition in which all means for protection against hazards
are intact.
Single fault condition: condition in which one means for protection against
hazard is defective. If a single fault condition results unavoidably in another single
fault condition, the two failures are considered as one single fault condition.
1.7.2 Protective Earth Continuity
The resistance of the protective earth conductor is measured between the earth
pin on the mains plug and a protectively earthed point on the equipment
enclosure (see figure 6). The reading should not normally exceed 0.2 at any
such point. The test is obviously only applicable to class I equipment.
In IEC60601, the test is conducted using a 50Hz current between 10A and 25A
for a period of at least 5 seconds. Although this is a type test, some medical
equipment safety testers mimic this method. Damage to equipment can occur if
high currents are passed to points that are not protectively earthed, for example,
functional earths. Great care should be taken when high current testers are used
to ensure that the probe is connected to a point that is intended to be protectively
earthed.
HEI 95 and DB9801 Supplement 1 recommended that the test be carried out at a
current of 1A or less for the reason described above.
Where the instrument used does not do so automatically, the resistance of the
test leads used should be deducted from the reading.
If protective earth continuity is satisfactory then insulation tests can be performed.
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Applicable to
Class I, all types (B, BF and CF)
Limit:
0.2
Notes:
Ensure probe is on a protectively earthed point

Figure 1.37 Measurement of protective earth continuity.
230V
50Hz
230V
Fuses
10 Ohm
1,1-450 mA
225-230 V
0,5 - 200 kOhm

1,1-450 mA
Without protective earth
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230V
50Hz
230V
Fuses
10 Ohm
~22 A
~11 V
0,5 Ohm
0,5 - 200 kOhm
~22 A
,055-22 mA
With protective earth

Figure 1.38
1.7.3 Insulation Tests
This is a test of the breakdown strength of electrical insulating materials that

provide electrical isolation between certain electrical conductors and the ground
connection at the AC receptacle
At the AC line cord of the DUT, a high voltage (500VDC) between L1 and L2
shorted together and the ground.
IEC 60601-1 (second edition), clause 17, lays down specifications for electrical
separation of parts of medical electrical equipment compliance to which is
essentially verified by inspection and measurement of leakage currents. Further
tests on insulation are detailed under clause 20, "dielectric strength". These tests
use AC sources to test equipment that has been pre-conditioned to specified
levels of humidity. The tests described in the standard are type tests and are not
suitable for use as routine tests.
HEI 95 and DB9801 recommended that for class I equipment the insulation
resistance be measured at the mains plug between the live and neutral pins
connected together and the earth pin. Whereas HEI 95 recommended using a
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500V DC insulation tester, DB 9801 recommended the use of 350V DC as the

test voltage. In practice this last requirement could prove difficult and it was
acknowledged in a footnote that a 500 V DC test voltage is unlikely to cause any
harm. The value obtained should normally be in excess of 50M but may be less
in exceptional circumstances. For example, equipment containing mineral
insulated heaters may have an insulation resistance as low as 1M with no fault
present. The test should be conducted with all fuses intact and equipment
switched on where mechanical on/off switches are present (see figure 9).
Applicable to
Class I, all types
Limits:
Not less than 50M

Equipment containing mineral insulated heaters
Notes:
may give values down to 1M. Check

equipment is switched on.
Figure 1.39 Measurement of insulation resistance for class I equipment

Satisfactory earth continuity and insulation test results indicate that it is safe to
proceed to leakage current tests.
1.7.4 Leakage current measuring device
The leakage current measuring device recommended by IEC 60601-1 loads the
leakage current source with a resistive impedance of about 1k resistor in
parallel with the series combination of a 15nF capacitor and 10k resistor. This is
equivalent circuit that simulates impedance of the human body. Figure 11 shows
the arrangements for the measuring device. The millivolt meter used should be
true RMS reading and should have input impedance greater than 1 M. In
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practice this is easily achievable with most good quality modern multimeters. The
meter in the arrangements shown measures 1mV for each A of leakage current.
Figure 1.40 Arrangements for measurement of leakage currents.
1.7.5 Earth Leakage Current
For class I equipment, earth leakage current is measured as shown in figure 12.
The current should be measured with the mains polarity normal and reversed.
The earth leakage current is measured in normal condition (NC) and single fault
condition, neutral conductor open circuit.
Applicable to
Class I equipment, all types
Limits:
0.5mA in NC, 1mA in SFC
Notes:
Measure with mains normal and reversed.

Ensure equipment is switched on.
Figure 1.41 Measurement of earth leakage current.
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1.7.6 Enclosure leakage current or touch current

Enclosure leakage current is measured between an exposed part of the
equipment which is not intended to be protectively earthed and true earth as
shown in figure 13. The test is applicable to both class I and class II equipment
and should be performed with mains polarity both normal and reversed.
Applicable to
Class I and class II equipment, all types.
Limits:
0.1mA in NC, 0.5mA in SFC

Ensure equipment switched on. Normal and
Notes:
reverse mains. Move probe to find worst

case.
Figure 1.42 Measurement of enclosure leakage current
1.7.7 Patient leakage current

Under IEC 60601-1, for class I and class II type B and BF equipment, the patient
leakage current is measured from all applied parts having the same function
connected together and true earth (figure 14). For type CF equipment the current
is measured from each applied part in turn and the leakage current leakage must
not be exceeded at any one applied part (figure 15).
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Applicable to
Limits:
Notes:
All classes, type B & BF equipment having

applied parts.
0.1mA in NC, 0.5mA in SFC.
Equipment on, but outputs inactive. Normal
and reverse mains.
Figure 1.43 Measurement of patient leakage current with applied parts connected
together
Applicable to
Limits:
Notes:
Class I and class II, type CF (equipment having

applied parts.
0.01mA in NC, 0.05mA in SFC.
Equipment on, but outputs inactive. Normal and
reverse mains. Limits are per electrode.
Figure 1.44 Measurement of patient leakage current for each applied part in turn
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1.7.8 Patient auxiliary current

Patient auxiliary current is measured between any single patient connection and
all other patient connections of the same module or function connected together.
Where all possible combinations are tested together with all possible single fault
conditions this yields an exceedingly large amount of data of questionable value.
Applicable to
Limits:
Notes:
All classes and types of equipment having

applied parts.
Type B & BF - 0.1mA in NC, 0.5mA in SFC.
Type CF - 0.01mA in NC, 0.05mA in SFC.
Ensure outputs are inactive. Normal and
reverse mains.
Figure 1.45 Measurement of patient auxiliary current.
1.7.9 Mains on applied parts (patient leakage)

By applying mains voltage to the applied parts, the leakage current that would
flow from an external source into the patient circuits can be measured. The
measuring arrangement is illustrated in figure 1.46.
Although the safety tester normally places a current limiting resistor in series with
the measuring device for the performance of this test, a shock hazard still exists.
Therefore, great care should be taken if the test is carried out in order to avoid
the hazard presented by applying mains voltage to the applied parts.
Careful consideration should be given as to the necessity or usefulness of
performing this test on a routine basis when weighed against the associated
hazard and the possibility of causing problems with equipment. The purpose of
the test under IEC 60601-1 is to ensure that there is no danger of electric shock
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to a patient who for some unspecified reason is raised to a potential above earth
due to the connection of the applied parts of the equipment under test. The
standard requires that the leakage current limits specified are not exceeded.
There is no guarantee that equipment performance will not be adversely affected
by the performance of the test. In particular, caution should be exercised in the
case of sensitive physiological measurement equipment. In short, the test is a
"type test".
Most medical equipment safety testers refer to this test as "mains on applied
parts", although this is not universal. One manufacturer refers to the test simply
as "Patient leakage - F-type". In all cases there should be a hazard indication
visible where the test is selected.
Applicable to
Limit:
Class I & class II, types BF & CF having

applied parts.
Type BF - 5mA; type CF - 0.05mA per
electrode.
Ensure outputs are inactive. Normal and
Notes:
reverse
mains.
Caution
required,
especially on physiological measurement

equipment.
Figure 1.46 Mains on applied parts measurement arrangement
1.7.10 Leakage current summary

The following table summarises the leakage current limits (in mA) specified by
IEC60601-1 (second edition) for the most commonly performed tests. Most
equipment currently in use in hospitals today is likely to have been designed to
conform to this standard, but note that the allowable values of earth leakage
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current have been increased in the third edition of the standard as discussed
above.
The values stated are for d.c. or a.c. (r.m.s), although later amendments of the
standard included separate limits for the d.c. element of patient leakage and
patient auxiliary currents at one tenth of the values listed below. These have not
been included in the table since, in practice, it is rare that there is a problem
solely with d.c. leakage where that is not evidenced by a problem with combined
a.c and d.c. leakage.
Table 1.4. Leakage current limits summary.
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Figure 1.47
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IEC 62353 Medical Electrical Equipment

The most widely used standard is IEC 60601. Although this is a type standard
associated with the design and development of electro medical (EM) equipment,
most biomedical engineering departments continue to use it as the basis for the
regular testing of medical devices, and/or after service or repair.
Clearly, safety testing at the design stage and at the end of the production line
are vitally important, but what about when the equipment enters service? This
was the basis for the introduction of IEC 62353, the international standard for
medical electrical equipmentrecurrent test and test after repair of medical
electrical equipment.
IEC 62353 Medical Electrical Equipment defines the requirements of ensuring the
electrical safety for medical electronic devices used in the treatment, care, and
diagnosis of patients.
The main goal of IEC 62353 is to provide a uniform standard that ensures safe
practice and reduces the complexity of the current IEC 60601-1 standard.
IEC 62353 maintaining the relation to IEC 60601-1, and minimizing the risks to
the person conducting the assessment.
For example, one of the main differences is in ground bond testing. IEC 62353
proposes a minimum test current of 200 mA instead of the 25 A required in IEC
60601-1. This means that, provided sufficient consideration is given to potential
contact resistance, test equipment can be smaller and more lightweight
compared with current practices. Also, under insulation resistance testing, unlike
IEC 60601, IEC 62353 provides methods for testing the insulation of medical
devices. Three different test methods are detailed for assessing the insulation
between mains parts and ground, between applied parts and ground, and
between applied parts and mains parts.
Importantly, the new standard recognizes that the laboratory conditions described
in IEC 60601-1 cannot always be guaranteed when in-service testing of medical
devices is undertaken.
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In-Service Test Requirements

As a type-testing standard, the current IEC 60601 does not provide any guidance
to standardizing test requirements once an item of ME equipment has passed the
design phase.
Once a medical device enters into service, a number of potential test scenarios
arise, including:
Acceptance testing also referred to as initial or reference testing. This
test is carried out before a new medical device is authorized for use, and is
undertaken to ensure correct and complete delivery. Acceptance testing is often
not limited to electrical safety tests, with some basic function tests being applied
to verify correct performance.
Routine
testing
also
referred
to
as
PPM,
preventive
product
maintenance. This form of testing is often conducted at fixed intervals, which vary
among types of equipment, manufacturers' recommendations, and riskassessment procedures undertaken by individual biomed or medical physics
departments. Routine testing is not limited to safety testing and often includes the
verification of correct functionality.
After service and repair testingcarried out following a repair,
adaptation, or product upgrade. It is often part of a service carried out by inhospital mechanical or clinical engineering teams. In many cases, more rigorous
electrical safety testing is needed after the replacement of components or
reconfiguration of medical devices.
Visual inspection
In most cases, up to 70% of all potential faults in an item of ME equipment can be
detected during visual inspection. Although visual inspection is not clearly defined
in IEC 60601, its inclusion is a fundamental requirement of all routine test and
maintenance procedures.
Visual inspection is a relatively easy procedure to ensure that the medical
equipment in use still conforms to the manufacturers' specifications and has not
suffered from any external damage and/or contamination.
The following are typical visual checks that should be made:
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Housing enclosurelook for damage, cracks, etc;
Contaminationlook for obstruction of moving parts, connector pins, etc;
Cabling (supply, applied parts, etc)look for cuts, wrong connections, etc;
Fuse ratingcheck correct values after replacement;
Markings and labelingcheck the integrity of safety markings; and
Integrity of mechanical partscheck for any obstructions.
However, to identify all potentially dangerous faults, visual inspection should be

linked with a program of periodic inspection and testing that is capable of
revealing any "invisible" electrical faults such as insulation integrity, effective
ground bond connections, unacceptable leakage, and other potential problems.
IEC 62353 Insulation Resistance Test
Unlike the IEC 60601-1 tests, the new IEC 62353 includes a method of testing
the insulation of an EM device. Three different insulation test methods are
recommended for different types of ME equipment. The test methods are:
Insulation between mains parts and groundthis test is used to verify
that the mains parts are adequately insulated from ground (Class I) or the
enclosure (Class II).
Figure 1.47a: Insulation EUT on Class I Figure 1.47b : Insulation EUT on Class 2
equipment
equipment
Insulation between applied parts and groundthis test is used to verify that
the applied parts are adequately insulated from ground (Class I) or the enclosure
(Class II). It is designed for Class I and Class II, BF, and CF equipment only.
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Figure 1.48a : Insulation AP test on Figure 1.48b : Insulation AP Test on Class

Class I equipment
II equipment
Insulation between applied part and mainsthis test is used to verify
that the applied parts are adequately insulated from the mains parts and is
applicable to Class I and Class II BF and CF equipment only.
Figure 1.49 Insulation AP to Mains Test

on Class I and Class II equipment
IEC 62353 Ground Bond Test

The ground bond test proves the integrity of the low-resistance connection
between the ground conductor and any metal conductive parts, which may
become live in fault situations with Class I medical devices.
Although many Class I medical devices are supplied with an equipotential point,
most, if not all, medical devices require multiple ground bond tests to validate the
connections of additional metal accessible parts on the enclosure.
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Figure 1.50 : Ground Bond Test in Class

I equipment
Higher test currents of 25A or 10A have been traditionally favored, based largely
on IEC 60601-1 requirements. The assumption was made that higher currents
could best detect any damaged conductors present. In addition, when analog
instruments were widely used for low-resistance measurement, it was often
necessary to use high-test currents to produce sufficient voltage drop across the
sample to generate the necessary needle deflection.
However, higher test currentsof 10A or moremight potentially be destructive
to parts of the device under test, which are connected to the protective ground
but have a functional purpose, such as screening. As such, consideration should
be given to the test current.
With modern electronics and digital technology, the use of higher test currents is
regarded as no longer necessarya fact recognized by IEC62353 with its 200mA
minimum current.
On the other hand, low-test currentsof less than 8Amay not always overcome
problems associated with contact resistance caused by constriction, pressure, or
film resistance factors, and may therefore show a relatively higher reading than
there is and indicate unnecessary failures.
IEC 62353 Leakage Testing
Research has shown that it is current rather than voltage that is the source of
electricity-related injuries and deaths. As a result, there are stringent rules on the
design of medical equipment to ensure that the patient and operator are not
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exposed to those currents that do not form part of the functional operation of the
device. These are called leakage currents.
In the interests of helping to guarantee safer practice and the repeatability of test
measurements, IEC 62353 defines different types of leakage current testsone
for total equipment leakage and another for applied parts leakage currents.
IEC 62353 specifies three methods direct, differential, and alternativethat can
be used to determine the leakage of EM equipment.
a) Direct Leakage Method
The direct leakage method included in IEC62353 is the same as that in IEC
60601, measuring the true leakage through a body model measuring device to
ground.
The main benefits of this method include the ability to measure both AC and DC
components, allowing direct comparison with the manufacturer's IEC 60601-1
tests, and measuring lower leakage values typically of less than 100A.
However, one of the main disadvantages of this method is that the 1KV body
model resistor is connected in series with the protective ground conductor that
will form an "equal" parallel connection with the human body, thus presenting a
potential hazard to the operator.
Another disadvantage is that secondary ground connections will produce a lower
reading, thus potentially allowing faulty equipment to pass the test. The direct
method does therefore require a fully isolated device under test and must be
performed on a terre neutral supply and in each polarity of the incoming mains
supply to guarantee measurements are taken at the maximum potential leakage
current.
Keeping It Safe
Follow this checklist for safety testing and keep all the bases covered.
Ensure that the operator of safety test equipment is properly trained on both the
safety analyzer and the device under test to prevent unneccessary danger during
the safety test.
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Always ensure that the device under test does not pose any danger to the user
and/or people within the vicinity of the safety test. Stay aware of moving parts,
open conductors, live components, heat, etc.
Ensure that leakage measurements are performed while the equipment is in full
operation mode, including its subsystems and components.
Ensure high accuracy and repeatability of leakage measurement readings. Some

manufacturers might specify full-scale accuracy, which will affect the accuracy of
low-leakage measurements.
Ensure that contact resistance is taken into account when measuring the ground
continuity at low currents (<8A). Contact resistance can influence the readings
and cause unnecessary failures of the device under test.
When determining the correct means of testing a specific medical device, ensure
that the chosen safety test procedures are applicable to the device under test and
are clearly documented for future use.
b) Differential Leakage Method

The differential test method measures the leakage current as a result of
imbalance in current between the live and neutral conductors.
The main advantage of using the differential leakage method is that the ground
conductor remains intact during the measurement, thus providing safer working
conditions. Differential measurement of leakage also does not require an isolated
device under test because it relies on comparing the difference in current
between the live and neutral conductors to measure the complete leakage of the
device being tested, including leakage caused by secondary connections.
The main disadvantage of using the differential method is reduced accuracy on
lower leakage values, because typical leakage values of more than 100A are
required to obtain stable and reproducible readings. Measurements can also be
influenced by the presence of magnetic fieldsthe principle of measuring
differential currentand measurements must be done in both directions to
identify the worst-case scenario. The differential leakage measurement method is
also only able to measure the AC component.
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c) Alternative Leakage Method

The alternative method is similar to a dielectric strength test at mains potential,
using a current limited voltage source at mains frequency. The live and neutral
conductors are shorted together and the current limited voltage is applied
between the mains parts and other parts of the equipment.
The main advantage of using the alternative method included in IEC 62353 is that
the device under test is not connected to the mains supply and provides the
safest possible test conditions for the operator. In addition, this measurement is
only taken in a single polarity and is similar to a dielectric test at mains potential
using a current limited mains frequency supply.
Leakage measurements achieved using the alternative method are highly
repeatable and provide a good indication of deterioration in the dielectrics of the
medical device under test.
The disadvantages of using the alternative method are that measurements
cannot be compared with previous IEC 60601-1 tests, and those active parts of
the circuitry that require mains potential between live and neutral cannot be
tested for possible leakage. For this reason, the alternative leakage method is
only relevant for certain types of EM devices.
IEC 62353 defines two different kinds of leakage current tests for applied parts
equipment leakage current that tests for total leakage deriving from the applied
parts, enclosure, and mains parts combined to real ground; and applied part
leakage current that checks for total leakage deriving from the combined patient
connections within an applied part to ground and any conductive or
nonconductive parts on the enclosure.
Equipment Leakage
The equipment leakage test is applicable to both Class I and II, B, BF, and CF
equipment, and measures the total leakage (RMS) deriving from the applied
parts, enclosure, and mains parts combined to real ground.
All applied parts (B, BF and CF) and grounded (enclosure Class I), and
nongrounded accessible conductive parts or nonconductive accessible parts
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(enclosure Class II) are grouped together and connected to ground via the 1k
measuring device (body model).
Measurements are done in both polarities of the incoming mains, excluding
alternative method.
The IEC 62353 equipment leakage can be performed using a direct, differential,
or alternative method.
Figures 1, 2, and 3 provide a schematic representation of the equipment leakage
test on Class I (grounded) ME equipment.
Figure 1.51a: Equipment Leakage Direct Figure

Class I
Figure
1.51b:
Equipment
Leakage
Differential Class I
1.51c:
Equipment
Leakage
Alternative Class I
Applied Part Leakage

The applied part leakage test measures the RMS deriving from the combined
patient connections within an applied part to ground and any conductive or
nonconductive parts on the enclosure.
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This test is applicable to floating-type (BF and CF) applied parts onlyeither
Class I or II. All patient connections of a single function within an applied part
shall be connected together (BF and CF) and measured one at a time.
The test is conducted by applying a current limited (3.5mA) mains potential
sinusoidal 50Hz or 60Hz signal between the applied part and the enclosure and
ground connection of the EUT connected to real ground.
Measurements are done in both polarities of the incoming mainsdirect method
only.
The IEC 62353 applied part leakage test can be performed using a direct or
alternative method.
Figures 4 and 5 provide a schematic representation of the applied part leakage
test on Class I (grounded) ME equipment.
Figure 1.52a: Applied Part Leakage Direct Figure

Class I
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1.52b:
Applied
Part
Leakage
Alternative Class I
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Conclusion
Table 1.5
The electrical safety testing of ME equipment is a crucial part of the overall safety
validation of medical devices and requires specialized test equipment.
The introduction of the new IEC 62353 standard will provide:
A global test reference to allow uniform testing;
Development tools for safer and suitable test sequences; and
A method of record keeping and maintenance procedures.
Although the onus will remain on the manufacturers of medical devices to advise
on appropriate tests for their equipment, the new standard will clearly have a
significant impact on medical service companies and clinical engineering, EBME,
medical physics, and other technical departments.
In all cases, when choosing a suitable electrical safety analyzer, care should be
taken to ensure that it can be used to test in accordance with IEC 62353
requirements and that it is capable of performing accurate and repeatable test
routines.
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1.8 STATISCAL BASIS FOR SAFE LEVEL ASSESSMENT

Any current, however small, has some probability of inducing ventricular
fibrillation. A reasonable linear relationship exists between the log of this total
current and the probability of the occurrence of ventricular fibrillation. IEC60601
extrapolate this relationship to zero. Studies by Watson and Wright (1973)
applied an electrode area of 0.05cm2 over subjects with varying increment of
current and found the following:
i.
100% probability of fibrillation at 0.96mA
ii.
1% probability of fibrillation at 0.67mA
iii.
Worst case value is at 0.01mA that could be due to a weak heart
iv.
At least one (1) test resulted in fibrillation at 15uA
This showed that no current is perfectly safe and there is a near linear
relationship between log (I) and probability of ventricular fibrillation incident.
Evaluating the findings, IEC60601 extends the results down to an effective
probability of 0.001 for zero current. With a minimum normal condition current of
10uA in a small electrode, there is a probability of 0.2% or 2 patient in a 100 that
could be at risk to fibrillation.
Studies by Stramer and Whelan looks into the effect of electrode size on current
required to produce ventricular fibrillation, the current density required. They
found that as the area of electrode is reduced by 100:1, the current is only
reduced by 10:1. Stramer and Whelan kept the electrode spacing constant and
measured the voltage applied to electrode size, approximately 0.4V. In short,
they minimize variables and maximize constant to obtain a valid and reliable
outcome. The followings are further findings of their studies:
i.
The smaller the electrode size that is attached to or inside the

heart, the smaller the current required.
ii.
Current density in the bulk of the heart tissue is roughly constant.
iii.
A current density in heart tissue of approximately 20uAcm-2m

produced ventricular fibrillation in a significant number of trials.
iv.
Currents of 200-300 uA produced ventricular fibrillation in smaller

electrodes.
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The above two statistical conditions has been referred in setting the safe level
assessments of IEC60601. Current limits permitted in the standard are based on
currents needed to cause ventricular fibrillation with smaller electrodes. It is
concluded that larger electrodes are statistically safer. Table IV in IEC60601
defines allowable values of leakage current as follows:
Current
Earth Leakage Current Earthed Metal
Enclosure (Class I)
Earth Leakage Current No Accessible Earthed
Parts, but Earthed Internal Screens (Class I)
Earth Leakage Current Permanently Installed
Equipment (Class I)
Enclosure Leakage Current. Maybe Class I, II or
Internal Power Source
Normal
Single Fault
Condition (mA)
Condition (mA)
0.5
2.5
10
0.1
0.5
Table 1.6
These leakage current as per the above table, in the worst case would be flowing
through the thorax, not directly through the heart. In which case, type CF is
necessary. In IEC60601, for each amp of current flowing through the thorax,
approximately 5mAcm-2 will flow through cardiac tissue. This is the basis of
estimating the probability of ventricular fibrillation for the limits quoted in the
standard.
It can be seen that the limits quoted for different patient circuit types fit with the
general philosophy of negligible risk. Taking an example of the patient leakage
current for Type B and Type BF patients;
5mA when 240V is applied to either a single socket (Type B) or the patient
(Type BF)
If applied to the chest:
Produces 25uAcm-2 (above the negligible level), with a probability of 0.8.
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However, the probability of this particular type of fault condition, i.e. the
patient touching something at 240V and the current flowing through the
chest is regarded as very low.
Thus, the overall risk is negligible.
For Type CF, by definition, all currents flow through the heart. The limit is further
reduced to 50uA when mains are applied to the patient in normal and single fault
condition. This produces a probability of approximately 0.01 for ventricular
fibrillation which is again negligible.
Overall, the different current limits in IEC60601 are determined according to

probability that they will produce current in the heart big enough to produce
ventricular fibrillation. It is also noted that current flowing in the earth wire has a
different probability of doing this than current in isolated patient circuit. IEC60601
current limits are designed, in general terms, to ensure the probability of
ventricular fibrillation of 0.002 or less. The probability of mechanical stimulation
by a wire in the heart with zero current is set at 0.001.
R=1,5m
Bed
Figure 1.53 Distance1.5 m around the patient bed
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Figure 1.54 Definition of patient environment from IEC60601.1.1
1.9 SAFETY
ASPECT
EQUIPMENT
OF
INTERCONNECTION
OF
Equipment may be safe by itself but when there are connected together, there is a
risk that must be acknowledge. IEC60601 outlined permitted ways of equipment
interconnecting in its collateral standard, IEC60601-1-1 as per the following:
i.
Use an isolation system in the signal connection
ii. Use an isolated mains transformer

iii. Coupled the earth together, sometimes mounted on the trolley or double
the earth (unofficial).
Digital signals can be easily isolated by way of optical coupled. Other collateral
standards of IEC60601 include IEC60601-1-2 which is for Electromagnetic
Compatibility and IEC60601-1-4 which is for Software Integrating.
EFFECT OF ISOLATION TRANSFORMER

Live
Neutral
Earth
Figure 1.55 Without isolation transformer
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Live
Neutral
Earth
No current
Figure 1.56 One instrument on isolation transformer
Live
Neutral
Earth
No current
Equalisation current between instruments
Figure 1.57 Multiple instruments on isolation transformer
1.10
RISK MANAGEMENT / OSHA

IMPORTANCE OF SAFETY IN WORKPLACE
Works plays a central role in peoples lives.
Most workers spend at least 8 hours a day in workplace.
Therefore, work environments should be safe and healthy.
Every day workers all over the world are faced with multitude of health
hazards, such as:
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Dust
Gases
Noise
Vibration
Extreme temperatures.
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Some employers assume little responsibility for the protection of workers

health and safety.
As a result of the hazards and a lack of attention given to health and

safety, work-related accidents and diseases are common in all parts of the
world.
MAJOR SAFETY TERMINOLOGIES
SAFETY - The condition of being safe from undergoing or causing hurt, injury
or loss.
HAZARD - A hazard introduces the potential for an unsafe condition, possibly

leading to an accident.
RISK - The probability or likelihood of a Hazard resulting in an accident.
INCIDENT - Undesired circumstance that produces the potential for an

ACCIDENT.
ACCIDENT - An accident is an unplanned event, which could result in injury

to persons, or in damage to plant and equipment or both.(James,
D.W.B.,1983,5).
ACCIDENT COST - Accident cost includes medical Payments,

Compensation, overtime for replacement workers, production delays, product
or material damage, training of replacements, accident investigation cost,
building or complex damages, equipment damages and business
interruptions. (Boley, Jack W. 1977, 19).
What is occupational health and safety?

Occupational health and safety is a discipline with a broad scope involving many
specialized fields.
Should aim at:
The promotion and maintenance of the highest degree of physical, mental

and social well-being of workers in all occupations.
The prevention among workers of adverse effects on health caused by

their working conditions.
The protection of workers in their employment from risks resulting from

factors adverse to health.
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OSHA Act 1994
Occupational Safety and Health Act 1994 is aimed to foster and promote safety
awareness among health workers and also create organization with effective
safety and health regulations.
This is done through self-regulation scheme that relevant to the industry or
related organizations.
OSHA 1994 Requirement
For all industries
If >5 Employees - Safety & Health Policy
40 Employees (S30) - Safety & Health Policy + Safety & Health

Committee
For high risk industries (i.e. construction, ship building, gas etc.)
>100 Employees (Order 1997) - Safety & Health Policy + Safety &
Health Committee + a Certified Safety & Health Officer
For low risk industries (other than the above mentioned industries)
>500 Employees (Order 1997) - Safety & Health Policy + Safety &
Health Committee + a Certified Safety & Health Officer
Functions of Safety & Health Committee
Assist in the development of safety & health rules and safe systems of
work;
Review the effectiveness of safety & health programmes;
Carry out studies on the trends of accident, near-miss accident,

dangerous occurrence, occupational poisoning or disease, and shall
report to the employer together with recommendations for corrective
actions;
Review the safety & health policies.
Appointment of Committee
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Chairman : An employer or his authorized manager
Secretary: Safety and health officer at the place of work
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Employer representatives : Nominated by employer

(>100 employees 4 representatives)
Employees representatives : Nominated by employees

(>100 employees 4 representatives)
Duties of Safety and Health Officer
to advise employer on the safety and health measures;
to inspect and determine the safety of work place;
to investigate any accident which has happened in the work place;
to assist employer in organizing and implementing OSH programme;
to become secretary to the committee;
to assist the committee in any inspection of the work place;
to collect, analyze and maintain statistics on any accident, dangerous

occurrence, occupational poisoning and disease which have occurred
at the work place ;
to assist any officer in carrying out his duty under the Act;
to carry out other instruction made by the employer on any matters

pertaining to OSH.
Duties of an Employer
To ensure the safety, health and welfare at work of all his employees
and visitors.
To formulate safety and health policy.
Extra protection for the disabled etc.OSHA 1994
Penalty For Non Compliance
A fine not exceeding RM50,000 or
Imprisonment not exceeding 2 years
Or both
Other Penalty / Fine
Common Law:
Affected person (employee or public) may take legal action against the
organization under the Civil Law (Common Law).OSHA 1994
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Duties of third party (suppliers / contractors)
To provide sufficient information.
To eliminate or reduce hazard.
To build and fix the equipment with safety feature.
Penalty for non compliance.

A fine not exceeding RM20,000 or maximum 2 years imprisonment or
both
Duties of an Employee
To take reasonable safety and health measure for himself and other
persons;
To co-operate with his employer or any other persons in the discharge

of any duty;
To use and wear at all times, any protective equipment or clothing

provided by employer;
To comply with any instruction or measure on occupational safety and

health instituted by his employer.
Penalty for non compliance
A fine not exceeding RM1,000 or
Imprisonment not exceeding 3 months
Or both
The Regulations of OSHA 1994
Employers Safety and Health General Policy Statement (Exception)

Regulation 1995
Control of Industry Major Hazards (CIMAH) Regulations 1996
Safety and Health Committee Regulations 1996
Classification, Packaging and Labeling of Hazardous Chemicals (CPL)

Regulations 1997
Safety and Health Officer Regulations 1997
Safety and Health Officer Order 1997
Use and Standards of Exposure of Chemicals Hazardous to Health

(USECHH) Regulations 2000
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Notification of Accident, Dangerous Occurrence, Occupational

Poisoning and Occupational Disease (NADOOPOD) Regulation 2004
1.11
DISINFECTION / STERILISATION
The following are definition of the terminologies used in this subtopic:
i.
Cleaning: General removal of debris, i.e. dirt, food, feces, blood, saliva
and other body secretions. It shall reduce the amount of organic matter
that contributes to proliferation of bacteria and viruses.
ii.
Disinfection: The removal of all infective (pathogenic) microorganisms

usually by means of chemical agents. It will be necessary to remove all
spores.
iii.
Sterilisation: The killing or removal of all organisms.
1.11.1 Equipment Categorization and Reprocessing Level
In reference to the practice standards that are based on Spauldings

Classification System, healthcare devices and equipment are designated as per
the following, which would define the level of reprocessing (cleaning, disinfection,
sterilization) required:
i.
Critical
ii.
Semi-critical
iii.
Non-critical
Critical items would require sterilization which includes items that enter sterile
tissue or the vascular system. Examples include surgical instruments and
accessories, biopsy forceps, cardiac and urinary catheters, implants and needles.
For semi-critical items, a minimum high level of disinfection or sterilization is

required. All items that comes into contact with non-intact skin or mucous
membranes falls under this categories. Examples cover respiratory therapy
equipment,
anesthesia
equipment,
laryngoscopes,
bronchoscopes,
GI
endoscopes, cytoscopes and vaginal ultrasonic probes. Under the semi-critical

category, cleaning process must precede high level disinfection.
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Non-critical items require intermediate level or even low level disinfection where
necessary. This includes items in contact only with intact skin. A straightforward
example includes blood pressure cuffs, stethoscopes and durable mobile patient
equipment.
1.11.2 Cleaning, Disinfection and Sterilization of Medical Instruments

and Devices
One cannot achieve disinfection or sterilization without pre-cleaning as organic
material dilutes disinfectant and bioburden must be reduced for processes to be
effective. Thus, as a first step, all medical instruments and devices shall be clean
by removing all visible soil with any instrument parts are to be disconnected and
separated. One should also avoid organic material drying on equipment by
rinsing or soaking it in an enzymatic solution.
When cleaning soiled medical instruments, wear the necessary personal

protection equipment as per the following:
i.
Long sleeved impervious gown
ii.
Eyewear
iii.
Mask or mask with face shield
iv.
Gloves
v.
Cap
vi.
Chemical goggles (when mixing or changing solution)
Looking into disinfection, the goal is to eliminate or kills most bacteria, many virus
types and some spores. It is a time dependent process with a high, intermediate
or low level of disinfecting. Under the process of disinfection, it is important to
follow the manufacturers recommendations in order to achieve the desired
outcome and avoid from damaging the medical device. The following are
important points that have to be observed:
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i.
Use correct dilution (more is not better)
ii.
Use correct contact time
iii.
Use correct temperature
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The staff should not exceed the exposure limits and is in the know of permissible
exposure levels. The following table illustrates the types of available disinfectant.
Table 1.7
Type
Name
Description
Environmental Phenolics
Gold Standard in healthcare

Toxicity concerns prohibit use in nurseries,
NICU
Does not kill spores
Quaternary
Approved for specific pathogens (read the
Ammonium
label!)
Compound
Affected by water hardness

Affected by bioburden
Iodophors
Can be used in food preparation areas

Inactivated by organic materials, e.g. blood
Can stain surfaces
Chlorine
Inactivated by organic materials, e.g. blood
(Bleach)
Kills spores, e.g. C. difficile

Corrosive
Highly
toxic
(deadly)
if
combined
with
ammonia
Ultraviolet
Dependent on strength and duration of
Radiation
exposure to light, line of sight, how well

microorganism can withstand UV
Limited to destruction of airborne organisms,
inactivation of microorganisms on surfaces,
and water purification
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Sterilization is achieved through the following methods:
i.
Steam
ii.
Dry Heat
iii.
Ethylene Oxide
iv.
Peracetic Acid
v.
Plasma Gas (Vaporized hydrogem peroxide)
vi.
Glutaraldehyde (Using higher concentrations and exposure times)
In steam sterilization, it utilizes an autoclave to achieve rapid heating and

penetration in the process of eliminating microorganisms. It is applied in short
exposure time that is less than 20 minutes but a maintain temperature
throughout. The process pose no toxicity to workers and inexpensive. It is
however could be damaging to delicate instruments. As per the norm, items to be
sterilized must be clean and free of protein or other organic material. If a package
is used, it must allow the steam to penetrate to have the desired effect.
Rapid cycle or flash sterilization is a version of unwrapped steam sterilization. It

should only be applied when necessary and the following caution must be
observed:
i.
Do not flash whole trays of instruments
ii.
Items must be used immediately
iii.
Maintain records or flash logs
Flash sterilization can be avoided by keeping adequate supply of frequently

dropped items.
1.10.3 Environmental Cleaning

Patient environment, as per the figure below, can facilitate transmission of
bacteria and viruses, either by direct contact or on hands of healthcare
personnel. Contaminated surfaces increase potential for transmission of bacteria
and viruses between patients. Items categorized as non-critical (intermediate or
low disinfection( or require cleaning only.
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Figure 1.58
In reference to patient environment, the following policy should be taken into

consideration by a healthcare practitioner:
i.
Include in policy all surfaces and equipment that can reasonably

be expected to be contaminated by bacteria (high touch surfaces).
ii.
Define responsibility and frequency for cleaning and disinfection

patient care equipment and surfaces.
iii.
Monitor compliance with policy.
iv.
Cleaned/disinfected items should be labeled, date and time.
The following are high touch surfaces in patient rooms that are considered to be
non-critical. It must be cleaned then disinfected on a regular basis.
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i.
Bedrails
ii.
Call bell
iii.
Telephones
iv.
TV remote
v.
IV pump
vi.
IV poles
vii.
Toilet
viii.
Overbed table
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ix.
Light switches
x.
Doorknobs
xi.
Respiratory and other bedside equipments
xii.
Chairs
Items requiring only cleaning in a patient environment include floors, walls and
windows, chairs and other furniture used by individuals who are clothed, private
offices and other non-public and non-patient care areas.
Under the HICPAC Disinfection and Sterilization Guideline 2008, the use of
microfiber is recommended for cleaning. It shall be of densely constructed
synthetic strands 1/16th the diameter of a human hair. This attracts dust and
cleans approximately 50% better than comparable cotton and easier to use,
lighter and was designed for repeat usage.
Monitoring of environmental cleaning processes involves the following methods:
i.
Bioluminescence (Outcome measure): Monitors for light emissions

produced if organism present. Results are difficult to interpret
because it is unknown whether organism remains viable and
transmissible.
ii.
Fluorescence (Process measure): Monitors for chemical markers

that fluoresce with ultraviolet light if not removed during cleaning.
iii.
Culturing: Implemented during outbreak investigations.
iv.
Visual inspection: Routine rounds and provide feedback to

frontline staff.
1.10.4 Linens
The standard recommended procedure for all linen contaminated with blood or
body fluids are as follows:
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i.
Bag linen at point of use
ii.
Wear PPE when sorting and agitate minimally
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Laundry equipment must be maintained to prevent microbial contamination. New

laundry technologies allow linen washing without requirements for hot water and
chlorine but the following settings are the standard requirements:
i.
Hot water - 160F x 25 min
ii.
Cold water - 71-77F with 125 ppm chlorine bleach rinse or

equivalent detergent
1.12
MEDICAL DEVICES ACT (MALAYSIA)
The Medical Device Act 2012 (Act 737) has been gazetted on 9th February, 2012
by the Malaysian Government. The Act was effective on 1 July 2013 and
undergoes a transition period before it is fully enforced in 2014. The Act specifies
requirements for medical device product registration, establishment licensing and
conformity assessment body (CAB) registration through the Medical Device
Regulations 2012, the subsidiary legislations under the Medical Device Act 2012
that has been approved by the Minister of Health and has been published in the
Gazette on 31st December 2012.
The Act is the product of the efforts of the Ministry of Health to implement a
regulatory framework for medical devices, an area previously not regulated in
Malaysia. The Act seeks to address public health and safety issues and facilitate
medical device trade and industry. The Medical Device Authority Act 2012 (Act
738) which came into effect on 15 March 2012 established the Medical Device
Authority (Authority) which oversees the execution of the Act 737
.
Medical Device Authority (MDA) is charged with the role of regulating medical
device and its industry players.
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EXERCISE
1. Define standard
2. Explain the following standard
i.
Safety Standard
ii.
Performance Standard
iii.
Quality Standard
3. Discuss the benefit of standard

4. State the roles of Malaysia Standard
5. List three International Standard Organization
6. Explain hazard that may produce from medical equipment
7. State condition that can result electrical shock.
8. State factor to consider in determine form and severity of injury due to electrical
shock
9. Explain special environment in hospital that medical equipment need to operate.
10. Define microshock and macroshock.
11. Explain the physiological effect of electricity.
12. State precaution to minimize electrical shock hazards.
13. Explain 4 types of leakage current.
14. Define and sketches symbol for each type of medical equipment classification
according to method of protection against electrical shock.
15. Discuss similarities and differences between IEC60601 and IEC62353
SUMMARY
In this unit we have studied Medical Device Safety Standard. This chapter provides
information on standard being used in Malaysia and worldwide. Source of leakage
current and its physiological effect together with safety standard applied to protect
patient and user is presented.
UniKL BMI
80
BMD 22203

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MEDICAL DEVICE SAFETY STANDARD

UNIT 1: MEDICAL DEVICE SAFETY STANDARD

MEDICAL DEVICE SAFETY STANDARD

International Standards and Joint Standards; eg IEC,ISO

MEDICAL DEVICE SAFETY STANDARD

Standards protect Malaysians at home, at play and at work are made

Standard support innovation reflect the latest technologies, innovation

Standard make business more competitive have more credibility, a

Standard complement regulation and make markets work better help

1.1.1 Safety Standard

Patient may be connected to several medical devices simultaneously (e.g.

Patient may be connected conductively to electronic circuitry (e.g. ECG

Example IEC601, UL544 BS5724

MEDICAL DEVICE SAFETY STANDARD

1.1.2 Performance Standard

1.1.3 Quality Standard

REFERENCE EQUIPMENT STANDARD, GUIDANCE AND

The main function of the Department is to foster and promote standards,

Malaysian Standards are developed through consensus by committees which

MEDICAL DEVICE SAFETY STANDARD

The Department of Standards appoints SIRIM Berhad as the agent to develop

Department of Standards Malaysia

Standards policy development and implementation

Participation in International and Regional Bodies

Accreditation of laboratories and certification bodies

Managing the standards development infrastructure

Managing Malaysian representation in regional and

Publishing, printing, selling and distributing Malaysian Standards

MEDICAL DEVICE SAFETY STANDARD

Registration Procedures: Devices emitting radiation are restricted, and any

1.2.1 IEC STANDARD

Founded in 1906, the IEC (International Electrotechnical Commission) is the

IEC provides a platform to companies, industries and governments for meeting,

MEDICAL DEVICE SAFETY STANDARD

Figure 1.3 International Electrotechnical Commission

When appropriate IEC cooperates with ISO (International Organization for

Currently IEC compromise:

Over 10,000 experts from industry, commerce, government, test and

174 Technical Committees with over 1,000 Working Groups

Over 6,000 International standards in IEC catalogue today

Over 500,000 Conformity Assessment certificates established

162 countries -81 Members and 81 Affiliates

An IEC International Standard is a normative document, developed according to

MEDICAL DEVICE SAFETY STANDARD

international, governmental or nongovernmental organization liaising with the IEC

Adoption of IEC International Standards by any country, whether it is a member

The IEC handles three Conformity Assessments Systems that enable it to

Three IEC Conformity Assessment Systems are:

competencies (maintenance and repair), electrical and electronic products

MEDICAL DEVICE SAFETY STANDARD

Beyond electrotechnology, IEC work also covers:

Terminology and symbols that simply production and technology transfer,

Safety to make certain that products and systems perform as expected.

The environment to allow the safe production, use and end-life

Electromagnetic compatibility and interferences enabling undisturbed

Establish in 1968, ECRI formally began operation focusing on research in

MEDICAL DEVICE SAFETY STANDARD

The Institutes first evaluation of 18 brands of manually operated resuscitators

Figure 1.4 Emergency Care Research Institute

through effective standards, educational programs, and publications.

AAMI provides multidisciplinary leadership and programs that enhance

MEDICAL DEVICE SAFETY STANDARD