TOPIC 1 STANDARD AND

QUALITY ASSURANCE OF
MEDICAL EQUIPMENT
• IEC
• CLASS & TYPES
When to test?
IEC 60601

• Introduced by the International Electrotechnical

Commission to govern the design and development of
medical equipment (mandatory)
• Design / final test (type) standard
• Standard is hazards specific
• Requires two levels of protection be employed – if one
fails, the other protects
• Insulation
• Protective grounding or earthing
• Protective impedance
Background on IEC60601
• IEC60601 is an international electrical safety standard
recognized in almost all developed countries as a
complete set of regulations for the design of
electrically safe medical equipment.
• Prior to this standard, different countries had different
standards, so manufacturers were forced to comply to
many different standards.
• Recently, the IEC601-1 standard has been adopted in
most all developed countries, and may appear with
different numbers such as UL2601, EN60601, or
equivalent.
Purpose of Safety Testing
• The basic purpose of safety testing medical electrical equipment is to
be sure that a device is safe for the patient and the caregiver.
• There are basically three stages of a product where safety testing is
important: product development, production line, service
department.
• The IEC601-1 standard is mainly intended for product development,
but can also be applied on the production line and eventually in the
service area.
Terminology
• Protective Earth is the ground conductor in the line cord or ground
wire used for protectively grounding the piece of equipment.
• Mains Voltage is the line or supply voltage. Usually 120VAC or
230VAC.
• Single Fault Condition is where a single problem has occurred, such
as an open ground wire.
• Enclosure is the outer surface of the device.
• Functional Earth is a ground on the DUT not intended for protective
grounding purposes.
• Applied Part is any part that intentionally comes in contact with the
patient.
• Accessible Part is a part of the equipment that can be touched
without the use of a tool.
• SIP/SOP is a signal input part/signal output part. Generally jacks on
the exterior of the device.
 Basic Areas of Safety Testing
• 1. Earth leakage current. This is essentially the current
flowing down through the ground conductor in the line cord
back to earth.
• 2. Enclosure leakage current. This is essentially the current
that flows from any enclosure part if you were to touch it.
• 3. Applied part leakage. Commonly known as patient lead
leakage. This is any leakage that flows from an applied part,
between applied parts, or into an applied part.
• 4. Dielectric withstand. Commonly known as hipot testing. A
high voltage is applied between insulated parts to be sure
insulation will withstand the high voltage for a specified
time.
• 5. Ground bond continuity. Commonly known as the high
current ground continuity test. A current of 25 amps or more is
run through the ground system to be sure the connections will
handle it.
• 6. Residual voltage. Sometimes called the plug discharge test.
This is the voltage present between any plug conductor 1
second after the plug is disconnected from power.
• 7. Accessible parts voltage. This is the voltage present on any
accessible part, including those covered by service or access
doors.
• 8. Retained energy. The energy that is stored in an accessible
part.
• 9. Current draw. Current consumed by the product.
• 10. Power consumption. Power that is consumed by the
product.
Single Faults & Normal Conditions
• During the leakage tests, single faults and normal
conditions are used to simulate all electrical possibilities
that may occur in the field.
• If a equipment is said to be in normal condition which
mean without any single fault condition has been
setting.
• Single faults are essentially problem conditions that
could occur. Since it is very unlikely that two faults
would occur at one time, faults are tested one at a
time.
• Single fault condition means worst case or the most
adverse results occurred to the equipment.
 Examples of SFC

Many electrical safety tests are carried out under various SFC in order
to verify that there is no hazard when using it in real time condition.

• Interruption of the protective earth conductor/ one supply conductor

• An external voltage on applied part
• The failure of basic insulation
• Temperature limiting devices
Test Condition

SINGLE FAULT CONDITIONS (SFC)

short circuit of any one insulation that complies with the
requirements for one means of protection
Short circuit any one creepage distant or air clearance that
complies with the requirements for one means of protection
Open circuit any protective earth conductor or internal
protective earth connection that complies with the
requirements
Interruption of any one supply conductor
Below is a list of the single faults used in
IEC601-1
a. Open safety ground.
b. Open neutral.
c. Mains voltage on SIP/SOP.
d. Mains voltage on applied part.
e. Insulation shorting.
f. Open external power supply ground.
g. Open external power supply neutral.
• Normal conditions are electrical conditions that normally occur on a
daily basis and are not considered to be a problem. For example,
grounding an patient applied part would not be a fault, since this
happens anytime an ECG lead touches a metal bed frame.
Below are a list of the normal conditions used
in IEC601-1.
a. Reversed AC line.
b. Functional earth grounded.
c. Patient lead grounded.
d. Isolated metal parts grounded.
e. Reversed mains voltage on SIP/SOP polarity.
f. Reversed mains voltage on applied part polarity.
g. External power supply functional earth grounded.
Example of Class I
CLASS II
Example of Class II
Type B (body – Non – Isolated Applied Part) is the least stringent classification,
and is used for applied parts that are normally not conductive and can be
immediately released from the patient. Examples would be LED operating
lighting, medical lasers, MRI body scanners, hospital beds and phototherapy
equipment. Type B applied parts may be connected to earth ground.

Type BF (body floating) is generally used for applied parts that have conductive
contact with the patient, or have medium or long term contact with the patient.
Examples of this type of equipment are blood pressure monitors, incubators
and ultrasound equipment. Type BF is separated from earth and are
considered floating. ( connect to skin – body protection)

Type CF (cardiac floating) is the most stringent classification, and is used for
applied parts that may come into direct contact with the heart, such as dialysis
machines. Type CF is separated from earth and are considered floating.
(connect to cardiac – cardiac protection)
 Examples of Applied Parts – Patient Touch Points – Patient Leads

• ECG module (CF)

• Patient connections are the leads 3-10

• Defib paddle module (BF)

• Patient connections are the paddles

• SPO2 (BF)
• Infusion Device (CF)
• Hospital Bed (B)
Type BF & CF, all class I, 500microA
Class I, II.
Type B & BF 100 microA.
Type CF 10 microA
Type B, BF 100microA
Type CF 10 microA Per part of apply part
Class I, II
Type B, BF, CF 10 microA
IEC60601 – Test
• Earthbond Bond Test/Protective Earth Continuity/Ground Bond Test
• HIPOT Test /Insulation test/ Hight Potential test (Poor conductor –check resistance in
earth)
(Creepage / Clearance for dielectric voltage design to verify that the insulation of a
product is adequate enough to withstand high voltage.)
• Leakage Test (SFC’s)
• Earth
• Enclosure / Touch
• Patient (AC / DC)
• Patient Auxiliary (AC / DC)
• Patient Type F
• SIP / SOP SFC
Allowable Leakage
Current
Earth Leakage Current
5 mA in Normal Condition
10 mA in Single Fault Condition
Touch Current
100 µA in Normal Condition
500 µA in Single Fault Condition
Patient Leakage Current
10 µA in Normal Condition
500 µA in Single Fault Condition
50 µA in Single Fault Condition (TYPE CF)
Total Patient Leakage Current
100 µA in Normal Condition
1000 µA in Single Fault Condition
100 µA in Single Fault Condition (TYPE CF)
Applicable to Class I, all types
Limit: 0.2Ω
Ensure probe is on a protectively earthed
Notes:
point
MSO – MULTIPLE SOCKET OUTLET

• msy
 INSULATION TEST
• Measurement of insulation resistance for class I equipment

• Measurement of insulation resistance for class II equipment.

Applicable to Class I, all types
Limits: Not less than 50MΩ Applicable to Class II, all types having applied parts
Equipment containing mineral insulated Limits: not less than 50MΩ.
Notes: heaters may give values down to 1MΩ. Check Notes: Move probe to find worst case.
• equipment is switched on.
LEAKAGE TEST (SFC) - 1. EARTH
Earth Leakage
Earth Leakage
• Applicable to B / BF / CF (class I only)
• Conditions
• Normal supply
• Normal supply, open neutral
• Reversed supply
• Reversed supply, open neutral
• Limits 0.5mA / 1mA (SFC)2nd edition
• Limits 5mA / 10mA (SFC)3rd edition
LEAKAGE TEST (SFC) - 2. ENCLOSURE (
TOUCH/CHASSIS)
Enclosure Leakage
Enclosure Leakage
• Applicable to B / BF / CF
• Conditions
• Normal supply
• Normal supply, Open Neutral
• Normal supply, Open Earth (class I only)
• Reversed supply
• Reversed supply, Open Neutral
• Reversed supply, Open Earth (class I only)
• Limits 0.1mA/0.5mA (SFC)
LEAKAGE TEST (SFC) - 3. PATIENT ( APPLIED
PART/LEAD)
Patient Leakage
Patient Leakage
Applicable to B / BF /CF
Condition
Normal supply
Normal supply, Open Neutral
Normal supply, Open Earth
(class I only)
Reversed supply
Reversed supply, Open
Neutral
Reversed supply, Open Earth
(class I only)
AC and DC reading
 Patient connection shorted
within applied part for B
and BF.
 Patient connection
measured separately within
applied part for CF.
 Limits B / BF (AC)
0.1mA / 0.5mA (SFC)
 Limits CF (AC) 0.01mA /
0.05mA (SFC)
 Limits B / BF / CF (AC)
0.01mA / 0.05mA (SFC)
LEAKAGE TEST (SFC) - 4. PATIENT AUXILIARY
( LEAD TO LEAD)
Patient AUX Leakage
Patient AUX Leakage
Applicable to B / BF /CF
Conditions
Normal supply
Normal supply, Open Neutral
Normal supply, Open Earth
(class I only)
Reversed supply
Reversed supply, Open
Neutral
Reversed supply, Open Earth
(class I only)
AC and DC reading
 Each Patient Connection to all
other Connection shorted
within Applied Part.
 Limits B / BF (AC) 0.1mA /
0.5mA (SFC)
 Limits CF (AC) 0.01mA /
0.05mA (SFC)
 Limits B / BF / CF (AC)
0.01mA / 0.05mA (SFC)
Patient F-type Leakage
Patient F-type Leakage
Applicable to BF / CF only  Patient Connection shorted
Current Limited to 5mA max at within Applied Part for BF
110% of mains  Patient Connection measured
Condition separately within Applied Part
Normal Supply, Source for CF
Normal  Limits BF (AC) 5mA
Normal Supply, Source
Reversed  Limits CF (AC) 0.05mA
Reversed Supply, Source
Normal
Reversed Supply, Source
Reversed
RMS reading
NOTES: TYPE OF IEC62353 TESTS
• Protective earth test
• Insulation test
• Leakage test: 1. Direct; 2. Alternative; 3. Differential
 Visual Inspection
The process of visual inspection is not clearly defined by IEC 60601. In most cases, 70% of
all faults are detected during visual an inspection.

A visual inspection is a relatively easy procedure, which is carried  out  to  ensure that 
the  ME equipment  in use, still conforms to the specifications released by the
manufacturer and has not suffered from any external damage and / or contamination.

The following inspections can be included:

•Housing / Enclosure - Look for damage, cracks etc.
•Integrity - Look for obstruction, moving parts, connector pins etc.
•Cabling (supply, applied parts etc.) Look for cuts, wrong connections etc.
•Fuse rating - check correct values after replacement.
•Markings and labelling - check the integrity of safety markings.
•Integrity of mechanical parts - check for any obstructions.
 Technical Considerations
The aim of IEC 62353 is to provide a uniform standard that ensures safe practices and reduces
the complexity of the current IEC60601-1 standard. All tests are based on leakage testing to IEC
60601, but a number of aspects to improve safety and practicality have been removed. The most
significant changes are:

• No pre-conditioning of equipment under test

• No elevated mains
• No destructive testing
• Testing under single fault condition only
• Summarizing leakage into input and output safety
• Testing at applied part level rather than at patient connection
• Different methods for conducting leakage tests subject to practicality
• Many IEC 62353 tests are directly related to IEC60601 tests, which is shown in figure 6 below.
COMPARING IEC60601 VS 62353
GROUND BOND TEST
The ground bond test (also called PE resistance test, ground continuity test), is the first test required by the
electrical safety testing standards.
The ground bond test consists in testing whether the ground points of a device under test are well connected in
between each other, and also to the mains ground.
The measure result of a ground bond test is a resistance value, which has to be lower than the indicated limit