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ou may already know or have international standard is IEC 60601-1. hazard in a normal operating or single
heard that medical compliance You might notice a common numbering fault condition (i.e., failure of one
testing involves a very stringent scheme. The main text is common with safety critical component) when
set of requirements and performance changes only in regard to country transported, stored, installed or
tests. The question is, how much more specific deviations. There are also a operated according to the
difficult are the medical requirements large number of “dash 2” (those ending manufacturer’s instructions. The
than those applicable to other in “-2-X”) standards to go along with definition of what constitutes a “safety
equipment? In this article, we will take the “dash 1” general requirements. hazard” is vague. The standard states
a look at a few of the key areas of These “dash 2” standards are written to that a safety hazard can be anything
Medical Product Safety Testing devoted modify the base standard to address having a “potentially detrimental effect
to protecting the user from electric safety issues of specific types of on the patient”.
shock. We will learn how each of the specialized medical equipment. For
tests are performed and their pass/fail example, IEC 601-2-32 is the standard In the world of product safety, the most
criteria. To illustrate the higher degree for “Particular requirements for the prominent hazard is electric shock. This
of performance required, comparisons safety of associated equipment of X-ray is emphasized with medical equipment
to Information Technology Equipment equipment”. because there is, in most cases, a
(ITE) will be made where appropriate. deliberate contact between the
But, before we start, let us identify the What is Medical Equipment? equipment and the patient and/or the
standards that apply to Medical Medical electrical equipment is defined user. We need to be concerned with the
Equipment. as equipment used to diagnose, treat or voltage and energy levels that can
monitor a patient by making physical contact the patient and the amount of
Medical Standards and electrical contact with the patient “leakage” current that could pass
and/or transferring energy to or from through their bodies.
The current U.S. Standard is UL
60601-1, 1st edition, dated April 25, the patient. Parts of the equipment that
come into contact with the patient or Three tests used to assess these hazards
2003. The effective date of this
those that the patient can touch are are the leakage current test, the
standard is June 30, 2003, with an
called applied parts. A patient can be capacitor discharge test and the
extension for clause 6.3 (g) until
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any living being, animal or human, that dielectric strength test. A class I piece
February 6, 2004. This standard
is having medical or dental treatment, of equipment will serve as our example
replaced the familiar UL 2601-1, 2nd
or is under medical investigation. The when describing these tests. Class I
edition dated October 24, 1997. UL
standard presumes at most one equipment provides connection to a
60601-1 includes all of the
connection to the mains supply for each protective earth conductor so that any
requirements of UL 2601-1, including
piece of equipment under investigation. accessible metal parts cannot become
issued amendments, “under one roof”.
live in the event of an insulation failure.
Generally Speaking In the event of such a failure, fault
As for the rest of world markets,
current would be diverted to earth.
Canada uses CSA 22.2 No 601.1, The key principle is that medical
Europe uses EN 60601-1, and the equipment shall not cause a safety
Leakage Current Tests ● Enclosure Leakage Current: In order to make these measurements, a
Electrical insulation in a product that Current flowing from the enclosure or measuring device as shown in Figure 1
provides protection against electric from parts accessible through an (Figure 15 of IEC/UL 60601-1) is used.
shock must be robust enough to limit external conductive connection to MD is the “measuring device”
the current flowing through it to safe another part of the enclosure. illustrated in the schematic. The
levels. There are four leakage current ● Patient Leakage Current: Current measuring impedance Z is connected to
tests associated with medical testing. flowing from the applied part through the points in the circuit you want to
They are defined as follows: the patient to earth. take your measurements. The voltage V
● Patient Auxiliary Current: Current across capacitor C1 will be read from a
● Earth Leakage Current: Current
flowing in the patient between parts digital multimeter. The voltage drop
flowing from the mains (part
of the applied part. divided by the input impedance Z will
conductively connected to the supply)
be the calculated current. Typically
through or across insulation into the
these values are on the order of
protective earth.
microamperes. The limits of leakage
current are based on the type of applied
part. Type B has a reference to ground,
type BF is floating and type CF is for
direct connection to the patients heart
(and is of course, floating!). Type CF
provides the highest degree of
protection against electric shock (i.e.,
lowest allowed leakage).
isolation transformer.
is only applicable to type BF and CF connections. The type Electric Strength Test
BF limit is 5 mA and the type CF limit is 50 µA. Insulation within a piece of equipment is subjected to an
applied voltage whose level is determined by the type of
Figure 6 (Figure 22 of IEC/UL 60601-1) shows mains voltage insulation and the working (or operating) voltage of the unit.
applied to the Sip/Sops, as in the alternate enclosure test, but Testing to a higher test voltage than is normally experienced
this time the patient leakage is measured with the external verifies that there is no insulation breakdown between the two
voltage applied. Leakage current measurements are made by points that the insulation is protecting. For the purposes of the
varying switches (S5, S9, S10, S13) in all possible test, insulation breakdown is defined as occurring when
combinations. S7 and S1 remain closed for this test. This test current flows uncontrollably. Momentary arcing is not
is only applicable to type B equipment. The limit for type B considered insulation breakdown.
is 5 mA in the single fault condition.
As for ITE, medical equipment insulation falls into four
categories:
Patient Auxiliary Current
● Basic insulation: Insulation applied to parts from which
Figure 7 (Figure 26 of IEC/UL 60601-1) shows the setup for electric shock could be drawn.
measuring patient auxiliary current. The unit is connected to a ● Supplementary insulation: Additional insulation provided
voltage source and operated at 110% of rated voltage. in case of a break down of the basic insulation.
Leakage current measurements are made by varying switches
● Double insulation: Encompasses the combination of basic
(S1, S5, S7, S10) in all possible combinations. Switch S1 and
and supplementary insulation.
S7 in the closed position is considered the normal condition.
Switch S1 and S7 in the open position is the single fault ● Reinforced insulation: A single layer of insulation which
condition. The limits for type B, BF and CF are 10 µA in provides the same degree of protection against electric
normal condition and 50 µA in single fault condition. shock as double insulation (for example, by being thicker
than a layer of basic insulation).
Capacitor Discharge Test
To ensure patients and equipment operators are not exposed
to hazardous energy levels, voltage levels are measured on all
mains terminals accessible after disconnection. With the unit
operating at 110 % of the rated voltage, power is
disconnected and the voltage decay at the mains connection is
recorded. The voltage should decay to a level of 60 VDC or
less within 1 second. The test is repeated ten times for each
pair of the measurement points. The theory is that in those ten
times, you will catch the AC waveform discharging at or
close to the peak of the mains voltage cycle. It is at the peak
where you will have the highest voltage and the longest decay
times. An alternative method of establishing the discharge
characteristics of the unit is simply just to monitor the
waveform on an oscilloscope and keep connecting and
disconnecting the power until a peak reading occurs. By this
method, you can see visually when the AC power waveform
has been shut off at the peak level and a single measurement
can be recorded and reported. Figure 8 shows an example of
discharging a piece of equipment at the peak of the waveform
cycle. In this plot it only took 13.4 mS for the waveform to
discharge to zero volts from a peak of 363.9 Volts. This easily
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The insulation breakdown test is 4000 VAC. In comparison, an ITE the two conductive parts or between
performed while the unit is warmed up. piece of equipment operating at the the conductive part and the outer
The test voltage, which may be AC or same supply voltage would have to surface of the enclosure, when the
DC, is increased from zero to the meet 1500 VAC for basic and path is measured along the surface of
specific test level. The voltage is supplementary and only 3000 VAC for the insulation.
applied, ramped up, and maintained at double or reinforced insulation. ● Solid insulation: Requires a
the maximum level for a period of measurement of thickness rather than
1 minute between the test points. All Insulation can be achieved by these space through air or across a surface.
switches, relays, contactors, triacs or methods:
equivalent components in the test ● Clearance: The shortest distance Obviously higher test voltages require
circuit are closed or shunted. A medical between two conductive parts or greater insulation, in the form of
product rated up to 250 VAC will have between a conductive part and the greater clearance and creepage distance
a basic insulation test voltage of 1500 outer surface of an enclosure, when or thicker solid insulation. For example,
VAC, a supplementary insulation test the distance is measured through air. larger distances on a PCB or the use of
voltage of 2500 VAC and a double or ● Creepage: The shortest path between more solid insulation can lead to bigger
reinforced insulation test voltage of boards, more layers to separate
circuitry and more expensive designs.
Figure 8