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The following paragraphs and diagrams describe the electrical safety tests commonly available on
medical equipment safety testers. Please note that although HEI 95 and DB9801 are no longer current,
they are referred to in the text since many medical electronics departments have used them as a basis for
local acceptance testing and even routine testing protocols. Protocols based on both sets of guidance are
also available on many medical equipment safety testers.
Applicable to
Limit:
0.2
DB9801 recommended?:
Yes, at 1A or less.
HEI 95 recommended?:
Yes, at 1A or less.
Notes:
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 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
Limits:
DB9801
recommended?:
Yes
HEI 95
recommended?:
Yes
Notes:
Equipment containing mineral insulated heaters may give values down to 1M.
Check equipment is switched on.
Figure 9. Measurement of insulation resistance for class I equipment
HEI 95 further recommended 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 50M (see figure 10). DB9801 Supplement 1 did not recommend any
form of insulation test be applied to class II equipment.
Applicable to
Limits:
DB9801 recommended?:
No
HEI 95 recommended?:
Yes
Notes:
Satisfactory earth continuity and insulation test results indicate that it is safe to proceed to leakage current
tests.
Applicable to
Limits:
0.5mA in NC, 1mA in SFC or 5mA and 10mA respectively for equipment designed to
IEC60601-1:2005.
DB9801
recommended?:
HEI 95
recommended?:
Notes:
Measure with mains normal and reversed. Ensure equipment is switched on.
Figure 12. Measurement of earth leakage current.
Applicable to
Limits:
DB9801
recommended?:
Yes, NC only
HEI 95 recommended?: Yes, class I SFC earth open circuit, class II NC.
Ensure equipment switched on. Normal and reverse mains. Move probe to find
worst case.
Notes:
Applicable to
Limits:
DB9801 recommended?:
No
HEI 95 recommended?:
Notes:
Figure 14. Measurement of patient leakage current with applied parts connected together
Applicable to
Class I and class II, type CF (B & BF for DB9801 only) equipment having applied
parts.
Limits:
DB9801
recommended?:
HEI 95 recommended?: Yes, type CF only, class I SFC earth open circuit, class II normal condition.
quipment on, but outputs inactive. Normal and reverse mains. Limits are per
electrode.
Notes:
Figure 15. Measurement of patient leakage current for each applied part in turn
Applicable to
Limits:
Type B & BF - 0.1mA in NC, 0.5mA in SFC. Type CF - 0.01mA in NC, 0.05mA in
SFC.
DB9801
recommended?:
No.
Applicable to
Limit:
DB9801 recommended?:
No.
HEI 95 recommended?:
No
Ensure outputs are inactive. Normal and reverse mains. Caution required,
especially on physiological measurement equipment.
Notes:
Type B
NC
Leakage current
Earth
Earth for fixed equipment
Enclosure
Patient
Mains on applied part
Patient auxiliary
Type BF
SFC
NC
Type CF
SFC
NC
SFC
0.5
0.5
0.5
10
10
10
0.1
0.5
0.1
0.5
0.1
0.5
0.1
0.5
0.1
0.5
0.01
0.05
0.05
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.
HEI 95
DB9801 Supplement 1
Earth continuity
No recommendation.
Measure in normal condition Limit < Measure in normal condition Limit <
0.5mA
0.5mA
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b.
c.
Annex 3 contains a test record sheet that is used to record inspection and test results produced by a
simple electrical safety protocol. It is not intended to be in any way prescriptive, but is included here
simply to illustrate many of the important features of an effective protocol.
Details of the equipment under test are recorded at the top of the form including the device serial number
and a plant number ascribed by the user organisation. This ensures that the record can be linked to the
particular item of equipment. The class and type/s of the equipment under test are also recorded here to
ensure that appropriate test limits are applied.
The details of the test equipment used are also recorded at the top of the form together with the
calibration date. This information is important for traceability since test results can only be proved to be
accurate if it can be demonstrated that the test equipment was in calibration.
The visual inspection checklist provides a record that the relevant parts of the equipment have been
inspected. This is very important since, in practice, the visual inspection is likely to flag up problems far
more often than the electrical safety tests themselves. It is also important that a record of visual
inspection is kept. Where user organisations use electronic means to record data downloaded from
electrical safety testers, it is important to add information on visual inspection to the record.
The electrical safety tests that are used in this particular protocol are few in number and are the same
tests, derived from IEC60601-1, that were selected for HEI 95. The earth continuity test is obviously
important for all class I equipment. The insulation test is intended to look at the insulation between the
mains part and the earth of the equipment under test, and may be regarded as a pre-test to verify that it is
safe to apply mains power in order to measure leakage currents.
Earth leakage current here is only measured under normal condition (NC). Note that "normal" and
"reverse" here mean that the leakage current is measured with L1 and L2 the right way round and the
wrong way round. Both of these conditions are defined as "normal condition". This test will not usually
produce as high a reading as if the test is conducted with under single fault condition, neutral open circuit.
However, in most cases, if there is no problem with earth leakage current under normal condition, there is
unlikely to be one under the single fault condition.
Enclosure leakage and patient leakage currents are both recommended under this protocol to measured
under single fault condition, earth open circuit (EOC). The rationale behind this is that any problems are
likely to be evident under this condition and it is not improbable that the fault condition may arise when the
equipment is in use.
At the foot of the form, it is recorded whether the equipment has passed or failed in the light of the visual
inspection and the electrical safety test results. The date of the test and the identity of the person who
performed the test must also be recorded.
The comments field below the table is a useful feature of any recording system. It allows any observations
to be recorded, for example, of peculiarities of the equipment under test or concerns about test results.
The record should be referred to by the person performing the next test and inspection on the equipment
prior to carrying out the inspection and test.
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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.
Even under normal condition, the equipment under test cannot be regarded as safe, since the
supplementary protection may have been compromised by the test arrangement. 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 semiautomatic modes since hazardous voltages may appear on the equipment under test at any time without
any warning. Where it is not possible to remove equipment to a workshop facility for testing, particular
care must be taken to ensure that there is no possibility of any other persons coming into contact with the
equipment under test.
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.
AND LEGISLATION
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However, any tests that are used for the latter purposes should ideally be consistent with the standards to
which the equipment has been manufactured. Routine tests and test limits may therefore be derived (in
modified form) from the standards, with the strict proviso that any such tests should not damage or even
stress the equipment under test.
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. The
HTM was withdrawn on publication of BS5724 part 1 (see below).
The third edition of IEC60601-1 was introduced in December 2005. The standard has been renamed
"General requirements for basic safety and essential performance" to reflect the fact that inadequate
equipment performance may give rise to hazards. The new standard is stated to replace the second
edition, although it is recognised that, in practice, due to the references made to the general standard by
particular standards (part twos), there is likely to be a fairly long transitionary period for compliance by
equipment manufacturers.
There are some significant changes in the new standard, some of which are worth noting here.
The new standard states that the manufacturer must have in place a risk management process that
complies to the requirements of ISO 14971 in order to ensure that the equipment design process results
in equipment that is suitable for its intended purpose and that any risks associated with its use are
acceptable.
Certain changes in terminology and numbering systems have been introduced in order to make the
standard more compatible with other IEC standards, in particular IEC 60950-1 (Information technology
equipment).
Collateral standards for medical electrical systems (IEC 60601-1-1) and programmable electrical medical
systems (IEC 60601-1-4) have been incorporated into the body of the new standard as new clauses.
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).
DB9801 Supplement 1. Having said that, much of the basic philosophy behind, and recommendations
from, the latter document have been retained.
The guidance stresses the importance of acceptance checks as a means of improving efficiency and
reducing risk. It also emphasises the necessity of recording checks and test results in order to meet
health and safety requirements, possible litigation demands and to enable safe and effective future device
management.
Delivery checks relevant to medical electrical equipment on delivery are divided into administrative tasks
("paperwork/database") and visual inspection. Recommended administrative checks and tasks include:
check for special requirements such as need for decontamination before use
The guidance further recommends that functional checks, electrical safety tests and calibration checks
(where appropriate) should be carried out prior to the equipment being placed into service.
No specific detail is given on safety tests, other than to emphasise that "pre-use tests should not exceed
the bounds of normal use". In connection with this, it states that the tests described in IEC 60601-1 are
"type tests" and are therefore not suitable for pre-use or maintenance tests (see paragraphs at 5.1
above).
The guidance does, however, point out the legal requirements for electrical safety testing under the
Health and Safety at Work etc Act 1974 and the Electricity at Work Regulations 1989. The guidance
states that "Responsible organisations should ensure that they have implemented electrical safety testing
procedures to comply with this legislation". The legal requirements are further discussed in these notes
under paragraphs at 5.6 below.
The full text of DB2006(05) is available free of charge on the MHRA website at www.mhra.gov.uk
5.6 UK LEGISLATION
There are a number of items of legislation applicable in the UK that impact in a fairly direct way on
maintenance procedures for medical electrical devices. These are discussed briefly below.
There are many sets of Regulations that are made under the act that spell out in detail what must be done
to meet the requirements of the act. The Regulations are said to be "made under the Act", and nonconformity to any such regulations is therefore an offence under the HASAWA.
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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.
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.
The symbols below may be seen on medical electrical equipment adjacent to terminals.
Definition
Equipment providing a particular degree of protection against electric
shock, particularly regarding allowable leakage currents and reliability of
the protective earth connection (if present).
BF
CF
All medical electrical equipment should be marked by the manufacturer with one of the type symbols
above.
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John Backes, Product Manager at Rigel Medical, part of the Seaward Group, considers the merits of 25A
and 200mA test currents for testing protective earthing conductors in electromedical devices.
Debate in the medical industry on the most appropriate test current for checking the integrity of the
protective earthing conductor of medical devices has been around for many years.
Historically, some have traditionally favoured a higher test current of 25A or 10A originating from the IEC
60601-1 requirements on the premise that it will best detect any damaged conductors present. In addition,
when analogue 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.
With modern electronics and digital technology, this is no longer necessary and more recently, given the
growth in hand held test instruments, others have come to favour a lower test current of 1A or less as a
means of eliminating any risk of damage to the equipment under test.
In reality, the different test currents both have their merits. Various International Standards and Code of
Practices for In-service Testing and Inspection of Medical Electrical Equipment recommend a variety of
test currents from 25A down to 200mA. However, for routine testing and testing after repair of nonmedical appliances and testing of fixed installations, the majority of European standards now specify a
test current of 200mA.
Bulk resistance is the material along the conductors' path. This will tend to be constant although it will be
affected by temperature and in certain cases by physical pressure.
Contact resistance, however, is a variable resistance that occurs at the interface between two conducting
surfaces. Contact resistance is made up of constriction resistance and film resistance and will be
dependent on the contact force between the two surfaces in contact.
Careful inspection of the contact interface between two conducting materials will show that surfaces that
may appear flat and uniform to the naked eye will invariably comprise a series of rough peaks and valleys
when viewed under a microscope.
In reality, the two mating surfaces will therefore only make contact with each other where the surface
peaks (asperites) meet and the actual surface area of this real contact area is typically much smaller than
may be apparent.
In these circumstances constriction resistance occurs as the electrical current is channelled through small
point contacts that occur at these peak points or interfaces. Layers of oxide and dirt that are formed on
the material's surface also create film resistance. These oxides have higher resistance than the
conducting material on either side of the junction.
Constriction resistance could be reduced by increasing the force applied between the two surfaces as
shown in Figure 2 below.
Film resistance is typically overcome by cleaning the surfaces between the two contacts although this is
not always practical and oxidation might occur again immediately after a connection has been cleaned.
Figure 3 shows the effects on the total resistance by reducing the constriction resistance. Unlike film
resistance, constriction resistance and therefore the total resistance is reduced by increasing the force
applied between the two surfaces. Bulk resistance is assumed as constant.
Test done at our laboratory demonstrate the effects of film resistance in relation to the level of current
passing through the contacts.
Figure 4 shows the effect of film resistance in relation to the test current in a connection within a typical
IEC lead. At each stage of the test, the test current was increased and the total resistance was measured.
As the test current is rising (shown in blue - rising), the film resistance is being reduced as a result. In this
test, the film resistance was completely eliminated at a test current of 8 Ampere and ones this point was
reached, the test current was reduced in steps (Shown in red - Falling).
Tests demonstrated that once film resistance was cleared in an existing connection; film resistance no
longer effected the total resistance measurement.
During our tests, bulk resistance and constriction resistance were kept as a constant.
The impact of these different types of resistance can therefore have significant impact on the results
obtained from varying levels of test current. It follows, therefore that the level of test current will affect the
measurement when film resistance is considered.
The temperature rise and hence the ability to fuse a damaged cable depends upon the test current and
the test duration. In protective fuses this is referred to as the I2t rating. The higher the current or the
longer the test duration the higher the probability of fusing the damaged cable.
The probability of the test fusing a cable with broken strands will therefore depend on:
a.
b.
c.
200MA TESTING
A 200mA test current is rapidly becoming the European standard for inservice testing and testing after
repair. In particular, those test instruments that comply with the requirements of the VDE 0751 (German
standard) and the imminent IEC 62353 (Standard for in-service and routine testing of Medical Electronic
Equipment) are capable of making accurate resistance measurements using a 200mA test current.
The use of a lower test current such as 200mA also reduces or eliminates the risk of damage to the
equipment under test caused by passing high test currents through paths to ground that are not intended
to provide protective earthing.
One of the reasons often provided for the use of a higher test current is that the resistance values being
measured are in the order of 0.1 ohms and, in principle a higher test current will aid the measurement
process. However, this particular argument loses some of its merits, with modern advances in test
technology enabling very accurate resistance measurements to be made using low test currents.
Recently new test technology has been pioneered in the form of a newpatented low energy, high current
test that overcomes the previous contact resistance problems that inhibited the wider application of
protective earth testing using 1A or 200mA test currents.
As a result the new concept successfully conquers variations in measurement that can be caused by high
film resistance between the test probe and the electromedical equipment under test, for example, when
measuring continuity of tarnished parts in detachable IEC power cables.
Importantly, the new low current test technology enables valid earth continuity tests to be carried out
using battery powered testers, significantly increasing the portability and versatility of hand held safety
analysers and speeding up the testing process.
SUMMARY
Both 25A and 200mA are recommended internationally as a valid test current for in-service testing and
inspection of medical electrical equipment and both are of value to biomedical engineers and technicians.
However, a high test current doesn't necessarily detect a damaged protective earth path and does not
always give better accuracy. In addition, modern electronic technology means that low current testing can
now be applied more effectively than may have been the case in the past.
Whatever the test current, contact resistance is an ever present variable. However, a low energy, high
current pulse prior to a 200mA test can overcome such problems. Furthermore, low current 200mA earth
continuity testing has a further advantage in that it can be undertaken with battery power rather than
mains supply, enabling significant design and practical improvements to be incorporated in modern
electromedical safety testers.
CONCLUSION
Provided modern techniques are used to measure the ground resistance during routine testing and
contact resistance is properly addressed, for example by using a low energy high current pulse prior to
200mA test current, the lower test current is preferred for routine field maintenance as this would provide
you with the benefits of:
John Backes is active as UK representative in working group 14 (testing to the general standard) of IEC
subcommittee 62A: Common Aspects of Electrical Equipment in Medical Practise.
Rigel Medical, part of the Seaward Group is a market-leading manufacturer of portable biomedical test
equipment. The company has pioneered the introduction of a range of test instruments and technical
innovations to make the safety testing of medical devices faster and easier for contractors and service
engineers.
Seaward Electronic Ltd. is based at Bracken Hill, South West Industrial Estate, Peterlee, County Durham,
SR8 2SW
Tel. (0191) 586 3511 Fax. (0191) 586 0227
E mail: sales@seaward.co.uk Web : www.seaward.co.uk
EQUIPMENT
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experience and risk assessments. The information in these notes is intended to assist in the development
of suitable procedures to this end.
Any test and inspection regime intended to minimise the electrical risks from medical electrical equipment
should take into account the likely degree of risk from electrical hazards compared to other hazards of
medical equipment. For this reason, various hazards associated with medical electrical equipment are
discussed briefly below.
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.
LEAKAGE CURRENTS
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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 under paragraphs at 6.
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.
b.
c.
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 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.
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.
PHYSIOLOGICAL EFFECTS OF
ELECTRICITY
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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.
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.
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.
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Reference has been made to the following documents in the preparation of these notes.
IEC 60601-1 Third edition: 2005 - International standard - Medical electrical equipment - Part 1:
General requirements for basic safety and essential performance
Health Equipment Information Number 95 (HEI95) August 1981: Code of practice for acceptance
testing of medical electrical equipment (withdrawn Dec 1999)
MDA Device Bulletin DB9801 Supplement 1: December 1999 - Checks and tests for newly
delivered medical devices (replaced November 2006)
MHRA Device Bulletin DB2006(05): Managing Medical Devices - Guidance for healthcare and
social services organisations
HSE memorandum of guidance on the Electricity at Work Regulations 1989 (ISBN 0-11-8839632)
IEE Code of Practice for In-service Inspection and Testing of Electrical Equipment (ISBN 085296-776-4)