Safety Testing of Medical Electrical Equipment

1 Hazards

2 Physiological Effects

3 Leakage Currents

4 Classes Types

5 Testing Requirements

6 Safety Tests

7 General Points on safety

1 Hazards of Medical Electrical 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. Listed below are various
types of common hazards.
1.1 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.

Such hazards may seem too obvious to warrant mentioning, but it is

unfortunately all too common for such mundane problems to be
overlooked while more exotic problems are addressed.
1.2 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 explosive anaesthetic gases is not common today, it should be
recognised that many of the medical gases in use vigorously support
combustion.
1.3 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.
1.4 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.
1.5 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.
1.6 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.
1.7 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
regimes which can be applied to all types of medical electrical equipment.
For these reasons, it is the electrical hazards that are the main topic of
this session.
2 Physiological effects of electricity

2.1 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.
2.2 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
common for internal electrical burns to be produced, which, if not fatal,
can cause long lasting and painful injury.
2.3 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.
2.4 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.
2.5 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.
2.6 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
20µA 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.
2.7 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, 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 neuro-muscular
response to current decreases almost exponentially.

Figure 1. Current required to prevent release of a live object.

2.8 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 are 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 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.
3 Leakage currents

3.1 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.
For medical electrical equipment, several different leakage currents are
defined according to the paths that the currents take.

3.2 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 2).

Figure 2. 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,
then 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 transformer primary and the enclosure needs
to be high. This would be evidenced when the equipment is in the normal
condition by 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 reduced.

3.3 Enclosure leakage current

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. However, 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 3). 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.

Figure 3. Enclosure leakage current path.

3.4 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 4a and 4b illustrate
the two scenarios.

Figure 4a. Patient leakage current path from equipment.

Figure 4b. Patient leakage current path to equipment.

3.5 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 5).

Figure 5. Patient auxiliary current path

4 Classes and types of medical electrical equipment
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.
4.1 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.
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 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.
Where any doubt exists, reference should be made to equipment manuals.
The symbols below may be seen on medical electrical equipment adjacent
to terminals.

Figure 6. Symbols seen on earthed equipment.

4.2 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.
Reinforced insulation is defined in standards as being a single layer of
insulation offering the same degree of protection as double insulation.
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 indicating
double insulation as shown below.

Figure 7. Symbol for class II equipment.

4.3 Class III equipment
Class III equipment is defined 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 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 standard relating to safety of
medical electrical equipment does not recognise Class III equipment since
limitation of voltage is not deemed sufficient to ensure safety of the
patient.
4.4 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.
Table 1 shows the symbols and definitions for each type classification of
medical electrical equipment.
Type Symbol Definition
Equipment providing a particular degree of protection
against electric shock, particularly regarding allowable
B
leakage currents and reliability of the protective earth
connection (if present).
 As type B but with isolated or floating (F - type) applied
BF
part or parts.
Equipment providing a higher degree of protection against
electric shock than type BF, particularly with regard to
CF
allowable leakage currents, and having floating applied
parts.
Table 1. Medical electrical equipment types

All medical electrical equipment should be marked by the manufacturer

with one of the type symbols above.
5 Testing regimes and relevant documentation
5.1 Type tests and routine tests
Before discussing the documentation relevant to electrical safety of
medical electrical equipment, it is important to distinguish between "type
tests" and routine tests.
Standards for the manufacture of equipment normally detail tests which
are intended to be carried out on a single representative sample of a piece
of equipment for which certification of compliance with a standard is being
sought. Such tests are carried out by approved test houses under tightly
specified environmental conditions. These tests are called "type tests" and
are not intended for routine use. Indeed, repetition of many of the tests
would certainly cause deterioration in performance and safety of the
equipment under test.
Routine tests have an entirely different purpose than that for type tests.
Routine tests are intended to provide good indicators to the safety of
equipment without subjecting it to undue stress that would be liable to
cause deterioration.
5.2 HTM 8
In 1963 the Department of Health and Social Security published Hospital
Technical Memorandum number 8 called "safety code for electro-medical
apparatus". The purpose of the document was to establish adequate
standards for the design and construction of electro-medical apparatus
since no other relevant national standard existed at the time. Although the
document was produced essentially for the guidance of manufacturers,
biomedical departments in hospitals were quick to adopt tests from the
document for the basis of their own medical electrical equipment safety
testing regimes. Although tests detailed in the code were type tests, many
of them could be fairly easily be repeated without adverse effects on the
equipment as routine tests. Performance of the electrical safety tests was
made easier by the development of specialised medical equipment safety
testers, specifically, the Liverpool tester.
5.3 BS 5724 or IEC 60601
In 1979, BS 5724 part 1 was published. This document is a
comprehensive specification for safety of medical electrical equipment.
Part 1 covers the general requirements, i.e requirements common to all
medical electrical equipment regardless of function. A series of part 2's
detailing particular requirements for specific categories of medical
electrical equipment followed publication of part 1.
BS 5724 is a far more detailed document than HTM 8, which it replaced.
Like the HTM, the tests contained in the standard are type tests. Some
guidance was given in the 1979 edition of the standard on recommended
testing during manufacture and/or installation. Unfortunately, some
routine test regimes based on BS 5724 tended to be too rigorous for such
application and in some cases caused damage to equipment.
BS 5724 part 1 was revised in 1989, making it identical to the
International Electro-technical Committee standard IEC 601 part 1.
References to routine tests were made even less specific than in the
previous edition. The standard was subsequently re-numbered as IEC
60601-1.
Any manufacturer obtaining compliance of an item of their equipment to
BS5724 or IEC 60601 will be in possession of a uniquely numbered
certificate issued by the test house verifying that fact. Compliance to the
standard is a commonly used route used by manufacturers to obtain CE
marking.
5.4 Hospital Equipment Information 95
In August 1981, the DHSS issued HEI 95 entitled "Code of practice for
acceptance testing of medical electrical equipment". The document was
produced partly to address the problems that had arisen due to the
misapplication of type tests from BS 5724 by some NHS biomedical
departments.
As indicated by the title of the document, the code of practice details
inspection and test procedures to be performed on newly acquired medical
electrical equipment before it is put into service. Inspection procedures
are clearly explained and the standard acceptance test log sheet given in
the appendix of the document contains references to the explanatory text.
The electrical safety testing recommendations offered in HEI 95 provided a
testing regime that was effective whilst being considerably simpler than
many test regimes that were developed from the recommendations of BS
5724. The reason for this is that the recommended electrical safety tests
are generally applied under worst-case conditions.
Although designed as a code of practice for acceptance testing the
document has been widely adopted and used as the basis of routine test
regimes by hospital biomedical departments.
The document was officially withdrawn in December 1999 on the
publication by the Medical Devices Agency of MDA DB9801 Supplement 1
(see below).
5.5 DB9801 Supplement 1
In December 1999, the Medical Devices Agency (now the Medicines and
Healthcare Products Regulatory Agency or MHRA) published Device
Bulletin 9801 Supplement 1 entitled "Checks and tests for newly delivered
medical devices". The document is a supplement to Device Bulletin 9801,
"Medical device and equipment management for hospital and community
based organisations", which was published by the Medical Devices Agency
in January 1998. The supplement supersedes HEI 95 as well as HEI 140
(see 5.9 below) for in vitro diagnostic medical devices.
The document is intended to be applicable to all newly delivered medical
devices, including equipment which is not electrical, before the equipment
is placed into service. Delivery checks detailed include paperwork checks,
visual inspection procedures and functional checks. Electrical safety checks
and tests as well as calibration checks are also recommended.
DB9801 Supplement 1 emphasises that new equipment under test should
not be subjected to currents or voltages exceeding those experienced
under normal operating conditions. Hence none of the recommended tests
involve shorting applied parts together or applying high voltages to
electrodes. It is also suggested that medical electrical equipment not
having applied parts can be safety tested satisfactorily using a non-
specialist portable appliance tester.
Specimen forms for recording the results of checks and tests are given in
the document. Rationales for the checks and tests prescribed are given in
the annexes of the document.
5.6 Medical Devices Directive
Since the Medical Devices Directive (Council Directive 93/42/EEC) became
law in the UK in 1994, it has been mandatory that all medical devices put
on to the market are appropriately CE marked to indicate compliance with
the directive. An important component of the directive is a list of
"essential requirements" to which all medical devices must comply.
Compliance with these requirements can be interpreted essentially as
meaning that the medical device is fit for purpose.
Depending on the risk class under which a particular medical device is
classified, there are various means by which a manufacturer is able to
demonstrate conformity with the directive. For devices in the lowest risk
category (class I), self declaration is acceptable, whilst for medium risk
devices (classes IIa and IIb), the assessment route normally includes
auditing of the manufacturers quality assurance system and independent
type testing to a recognised standard (e.g. IEC 60601) of a representative
production sample by a "notified body".
In each member state a "Competent Authority" is authorised by that
country's government to ensure that the requirements of the directive are
carried out. In the UK, the competent authority is the Secretary of State
for Health who has delegated day to day running of the competent
authority to the Medicines and Healthcare Products Regulatory Agency
(MHRA).
As far as the purchaser of equipment is concerned, all medical devices
purchased within any EEC member state should be appropriately CE
marked. Conformity to the directive should be confirmed by the equipment
supplier by means of a "declaration of conformity" prior to purchase.
5.7 ESCHLE
The Electrical Safety Code for Hospital Laboratory Equipment (ESCHLE)
was first published in 1977. It was produced by the Department of Health
in conjunction with industry as a minimum standard to ensure the safety
of laboratory equipment used in hospital pathology departments and
similar environments. This was done in response to pressure from industry
since prior to ESCHLE there was no strictly appropriate standard to form
the basis for design and assessment of hospital laboratory equipment.
Hospital Technical Memorandum 8, which was a safety code for
electromedical apparatus was used for this purpose prior to 1977. In 1986
the second edition of ESCHLE was published by the Department of Health
in Hospital Equipment Information 158 (HEI158). The title ESCHLE is
somewhat misleading since apart from electrical safety, the document is
also designed to ensure safety from overheating, fire, mechanical hazards,
and the provision of adequate documentation and clearly marked controls.
In HEI165 (March 1987) the DHSS recommended that as from January
1989, only laboratory equipment complying to ESCHLE II should be
purchased by the NHS. However, ESCHLE itself recognised that some
equipment used in hospital laboratories may comply to other standards
applicable to specific types of equipment (e.g. BS4743/IEC348 for
electronic measuring apparatus).
It was recognised that on publication of the IEC 1010 standard in 1990
(see below), ESCHLE would "die a natural death".
5.8 IEC 61010
In 1990 the International Electrotechnical Committee published IEC1010-1
(subsequently re-numbered as IEC 61010-1), which is a European
standard covering safety requirements for electrical equipment for
measurement control and laboratory use. Part 1 deals with requirements
relevant to all types of equipment under its remit and a series of part 2's
covers particular requirements for specific types of equipment. The
standard has been adopted by the British Standards Institution (BS EN
61010-1:2001 is the current edition) and has effectively replaced ESCHLE.
The purpose of the standard is to provide adequate protection to the
operator and the surrounding area against electric shock or burn,
mechanical hazards, excessive temperature, fire, effects of radiation,
liberated gases, explosion and implosion. However, it should be noted that
IEC61010-1 is not specifically intended for hospital applications of
laboratory equipment.
5.9 Hospital Equipment Information 140
Part II of HEI140 is virtually an equivalent to HEI95 except that it is
designed for hospital laboratory equipment. Part I of the document
summarised the implementation of the first edition of ESCHLE and added
some amendments to that standard.
Again, although HEI140 Part II is a code of practice for acceptance testing,
it is highly relevant to routine testing and has been widely used for this
purpose. The document was written with ESCHLE in mind but was still
considered to be a relevant code of practice for equipment complying to
IEC61010, since no equivalent document relating specifically to that
standard was produced.
MDA DB9801 Supplement 1 is stated to replace HEI 140 part II for in-vitro
medical diagnostic medical devices from December 1999, "pending further
guidance in this area". No guidance has been given by the Medical devices
Agency as to the status of HEI 140 with regard to hospital laboratory
equipment that is not classified as an in-vitro diagnostic device.
In March 2002, the MDA published Device Bulletin DB2002(02)
"Management of in-vitro diagnostic medical devices". Although this
document gives some general guidance on the need for acceptance
testing, it does provide any specific detail on appropriate electrical safety
tests.
5.10 When to test

Medical electrical equipment should be inspected and tested on the following occasions.

a.On newly acquired equipment prior to being accepted for use

 b.During routine planned preventative maintenance.

c.After repairs have been carried out on equipment.

A patient should never be connected to a piece of equipment that has not

been checked.
The testing regime used in the case of acceptance testing will be slightly
different to that used on other occasions particularly as regards condition
of packaging, presence of relevant documentation and accessories. Having
said this, the importance of visual inspection prior to all electrical testing
cannot be over stressed. Most equipment that has become hazardous or
defective due to damage exhibits visible signs of such.
5.11 Recording test results
The acceptance test log sheet given in appendix A of HEI 95 is a good
example of a comprehensive format for its purpose and many biomedical
departments have used it successfully or modified it slightly to suit their
own requirements.
Log sheets for routine safety testing are generally less extensive since the
bulk of the information they need to record relates purely to the electrical
safety tests. Examples of forms in use are given in appendix 2. One
important feature of such forms is that they should allow changes in
results over a period to be seen at a glance. This facility enhances the
usefulness of routine safety testing since it can often allow developing
problems to be spotted before they present a hazard.
5.12 Equipment Management Software Packages
There are on the market a number of equipment management software
packages suitable for use with medical electrical equipment. SEMS and
QA-MAP are some such packages.
Some software packages allow the downloading of test results from
automatic testers to a database and the production of hard copy test
result forms. These facilities can be very useful if used correctly although
there are also inherent dangers. Computers are able to handle large
amounts of information very quickly and the temptation exists with
automatic testers to perform large numbers of tests and store all results
on computer. Such information is of no use whatever if there is no human
contact with the information. This may seem to be stating the obvious, but
where large amounts of information are presented, it becomes very easy
to miss important details.
6 Electrical Safety Tests

6.1 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" (SFC's) 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). However, it is important to understand that in
this condition, the performance of certain tests may compromise the
means of protection against electric shock. For example, if earth leakage
current is measured in normal condition, the impedance of the measuring
device in series with the protective earth conductor means that there is no
effective supplementary protection against electric shock.
Many electrical safety tests are carried out under single fault conditions
since these 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. Personnel carrying out
electrical safety tests should be aware that the normal means for
protection against electric shock are not necessarily operative during
testing and should therefore exercise due precautions for their own safety
and that of others.

6.2 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 O 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 recommend 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.
Applicable to Class I, all types
Limit: 0.2
DB9801 recommended?: Yes, at 1A or less.
HEI 95 recommended?: Yes, at 1A or less.
Notes: Ensure probe is on a protectively earthed point
Figure 8. Measurement of protective earth continuity.

6.3 Insulation Tests

IEC 60601-1, 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 recommend that for class I equipment the insulation
resistance is measured at the mains plug between the live and neutral
pins connected together and the earth pin. Whereas HEI 95 recommends
using a 500V DC insulation tester, DB 9801 recommends the use of 350V
DC as the test voltage. In practice this last requirement could prove
difficult and it is 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 50MΩ but may be less in exceptional circumstances. For
example, equipment containing mineral insulated heaters may have an
insulation resistance as low as 1MΩ with no fault present. The test should
be conducted with all fuses intact and equipment switched on (see figure
9).

Applicable to Class I, all types

Limits: Not less than 50MΩ
DB9801
Yes
recommended?:
HEI 95
Yes
recommended?:
Equipment containing mineral insulated heaters may
Notes: give values down to 1MΩ. Check equipment is
switched on.
Figure 9. Measurement of insulation resistance for class I equipment

HEI 95 further recommends for class II equipment that the insulation

resistance be measured between all applied parts connected together and
any accessible conductive parts of the equipment. The value should not
normally be less than 50MΩ (see figure 10). DB9801 Supplement 1 does
not recommend any form of insulation test be applied to class II
equipment.

Applicable to Class II, all types having applied parts

Limits: not less than 50MΩ.
DB9801 recommended?: No
HEI 95 recommended?: Yes
Notes: Move probe to find worst case.

Figure 10. Measurement of insulation resistance for class II equipment.

Satisfactory earth continuity and insulation test results indicate that it is

safe to proceed to leakage current tests.

6.4 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 1 kO
and has a half power point at about 1kHz. The recommended measuring
device was changed slightly in detail between the 1979 and 1989 version
but remained functionally very similar. Figure 11 shows suitable
arrangements for the measuring device. The millivolt meter used should
be true RMS reading and should have an input impedance greater than 1
MΩ. In practice this is easily achievable with most good quality modern
multimeters. The meter in the arrangements shown measures 1mV for
each µA of leakage current.
 Figure 11. Suitable arrangements for measurement of leakage currents.

6.5 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. HEI 95 and DB9801 Supplement 1 recommend that the
earth leakage current be measured in normal condition (NC) only. Many
safety testers offer the opportunity to perform the test under a single fault
condition such as live or neutral conductor open circuit.

Applicable to Class I equipment, all types

0.5mA in NC, 1mA in SFC or 5mA and 10mA
Limits:
respectively for permanently installed equipment.
DB9801
Yes, in normal condition only.
recommended?:
HEI 95
Yes, in normal condition only.
recommended?:
Measure with mains normal and reversed. Ensure
Notes:
equipment is switched on.

Figure 12. Measurement of Earth Leakage Current.

6.6 Enclosure leakage 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. HEI 95 recommends that the test be performed under the SFC
protective earth open circuit for class I equipment and under normal
condition for class II equipment. DB9801 Supplement 1 recommends that
the test be carried out under normal condition only for both class I and
class II equipment. Many safety testers also allow the SFC's of interruption
of live or neutral conductors to be selected. Points on class I equipment
which are likely not to be protectively earthed may include front panel
fascias, handle assemblies etc.
Applicable to Class I and class II equipment, all types.
Limits: 0.1mA in NC, 0.5mA in SFC
DB9801
Yes, NC only
recommended?:
HEI 95
Yes, class I SFC earth open circuit, class II NC.
recommended?:
Ensure equipment switched on. Normal and reverse
Notes:
mains. Move probe to find worst case.

Figure 13. Measurement of Enclosure Leakage Current.

6.7 Patient leakage current

Under IEC 60601-1 and HEI 95, 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).
DB9801 Supplement 1 recommends that patient leakage current be
measured from each applied part in turn for all types of equipment,
although the recommended leakage current limits have not been revised
to take into account the changed test method for B and BF equipment.
Great care must be taken when performing patient leakage current
measurements that equipment outputs are inactive. In particular, outputs
of diathermy equipment and stimulators can be fatal and can damage test
equipment.

All classes, type B & BF equipment having applied

Applicable to
parts.
Limits: 0.1mA in NC, 0.5mA in SFC.
DB9801
No
recommended?:
HEI 95 Yes, class I SFC earth open circuit, class II normal
recommended?: condition.
Equipment on but outputs inactive. Normal and
Notes:
reverse mains.

Figure 14. Measurement of Patient Leakage Current with applied parts connected
together.

Class I and class II, type CF (B & BF for DB9801

Applicable to
only) equipment having applied parts.
Limits: 0.01mA in NC, 0.05mA in SFC.
DB9801
Yes, all types, normal condition only.
recommended?:
HEI 95 Yes, type CF only, class I SFC earth open circuit,
recommended?: class II normal condition.
Equipment on but outputs inactive. Normal and
Notes:
reverse mains. Limits are per electrode.

Figure 15. Measurement of patient leakage current for each applied part in turn

6.8 Patient auxiliary current

Patient auxiliary current as defined in section 3.5 is measured between
any single patient connection and all other patient connections of the
same module connected together. It is not usual to test all possible
combinations since together with all possible single fault conditions this
would give an exceedingly large amount of data of questionable value.

All classes and types of equipment having applied

Applicable to
parts.
Type B & BF - 0.1mA in NC, 0.5mA in SFC.
Limits:
Type CF - 0.01mA in NC, 0.05mA in SFC.
DB9801
No.
recommended?:
HEI 95 recommended?: No.
Ensure outputs are inactive. Normal and reverse
Notes:
mains.

Figure 16. Measurement of patient auxiliary current.

6.9 Mains on applied parts

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 18.
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 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".

Class I & class II, types BF & CF having applied

Applicable to
parts.
Limit: Type BF - 5mA; type CF - 0.05mA per electrode.
DB9801
No.
recommended?:
HEI 95
No
recommended?:
Ensure outputs are inactive. Normal and reverse
Notes: mains. Caution required, especially on physiological
measurement equipment.
 Figure 17. Mains on applied parts measurement arrangement.

6.10 Leakage current summary

The following table summarises the leakage current limits (in mA)
specified by IEC60601-1 for the tests most commonly performed as
routine tests. Limits for DB9801 recommended tests are underlined. Limits
for HEI 95 recommended tests are given in bold type.
Type B Type BF Type CF
Leakage current
NC SFC NC SFC NC SFC
Earth 0.5 1 0.5 1 0.5 1
Earth for fixed
5 10 5 10 5 10
equipment
Enclosure 0.1 0.5 0.1 0.5 0.1 0.5
Patient 0.1 0.5 0.1 0.5 0.01 0.05
Mains on applied
- - - 5 - 0.05
part
Patient auxiliary 0.1 0.5 0.1 0.5 0.01 0.05
* For class II type CF equipment HEI95 recommends a limit for enclosure
leakage current of 0.01mA as per the 1979 edition of BS 5724.
Table 2. Leakage current limits summary.

6.11 Comparison of HEI 95 and DB 9801 Supplement 1

recommendations
DB9801 Supplement
Test HEI 95
1
Use test current of 1A Use test current of 1A or
Earth continuity or less less
Limit 0.2ohm Limit 0.2ohm
Measure between L and Measure between L and
N connected together N connected together
Insulation for Class 1 and E using 500v DC and E using 350v DC
equipment tester. tester.
Limit > 50MΩ. Limit > 20MΩ.
Investigate lower values Investigate lower values
Measure between
applied parts and
Insulation for Class II accessible conductive
No recommendation.
equipment parts of the equipment.
Limit > 50MΩ.
Investigate lower values
 Measure in normal Measure in normal
Earth leakage current condition condition
Limit < 0.5mA Limit < 0.5mA
Measure in SFC, earth
open circuit for Class-1,
Enclosure leakage NC for Class-II Measure in NC only
current Limit <0.5 mA for Limit < 0.1 mA
Class1
<0.1 mA for class II
Measure from all applied Measure from each
parts connected applied part in turn, for
together for B & BF all types of equipment
equipment and from Measure under NC only
each applied part in turn Limits
for type CF.
Measure under SFC, • Type B & BF <0.1
eart open circuit for mA per electrode
Class 1, NC for classII.
Limits :
• Type CF < 0.01
• Class I, B& BF < per electrode
Patient leakage current 0.5 mA

• Class II, B& BF <

0.1 mA

• Class I, CF < 0.05

mA per electrode

• Class II, CF <

0.01 mA per
electrode
7 General points on safety
Many Electrical safety tests are performed under single fault conditions
such that a means for protection against electric shock has been removed.
In the case of patient leakage current with mains on applied parts, a
hazard is actually introduced. For these reasons no equipment under test
should be touched whilst tests are being undertaken, as parts of the
equipment may be hazardous live. For similar reasons, tests should be
conducted on suitable non-conductive surfaces and conductive objects
should be kept well clear of the equipment. The potential hazard is
exacerbated by the use of automatic testers when running in automatic or
semi-automatic modes since hazardous voltages may appear on the
equipment under test at any time without any warning.
Many categories of medical electrical equipment can produce outputs for
treatment purposes that, if applied incorrectly to a person can prove fatal,
or at least cause serious injuries. Examples of these categories include
surgical diathermy machines, nerve and muscle stimulators, short-wave
therapy units and defibrillators. Persons who have not had specific training
on such equipment sufficient to enable them to avoid the hazards should
not be allowed to perform electrical safety testing on it.
The tests applied in the course of routine safety testing can cause damage
to equipment if carried out incorrectly or inappropriately. Such damage
may lead directly or indirectly to patient injuries or death if the equipment
is put back into service in this condition. It is clear that only maintenance
personnel who are sufficiently trained to avoid such occurrences arising
should carry out electrical safety testing of medical equipment.
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