Electrical Safety Essentials & Test Tools

Presented by: Fareed Hassan

SVAE / EBMC / BEng(Hons) / CBET
Senior Medical Equipment Engineer – Hampshire Hospital NHS
Foundation Trust - UK
 Electrical current

Electrical current do have effects on Human muscles

 Involuntary Muscle Contraction (Tetanus)

 Paralyse Respiratory system (heart / lungs)
 AC / DC have different effects (shock, fib, heat)
 Importance?

 Current of 10uA (too small to perceived), can have serious

affects on the cardiac rhythm.
 The skin of the Patients can be burned by the current.
 Patients can be weakened, skin resistance reduced,
connected to Med. Equipment, or anaesthetised.

Testing the Electrical Safety of a MD is to ensure there is no

danger for patients / users.
Electrical Safety Essentials
 Terminology.
 IEC60601
 IEC62353
 Single Fault Condition and Normal Condition
 Medical device class and type
 Leakage Currents
 The leakage limits, obscure values
 Test tools
What Electrical Safety means?
TYPE TESTING IEC 60601-1
• Ground Wire Resistance / Earth
Bond Test.
• Leakage Test:
1. Earth
2. Enclosure / Chassis
3. Patient (AC / DC)
4. Patient Auxiliary (AC / DC)
5. Patient F-Type
TYPE TESTING IEC 62353
• Earth Bond Test
• Leakage Test:
• A) Equipment Leakage (Direct,
Alternative and Differential)
• B) Applied Part Leakage
(Direct and Alternative)
TYPE TESTING IEC 61010-1
 Safety requirements for Electrical Equipment for measurement,
control, and Laboratory use.
 Clinical Laboratories.
 Research Laboratories.
 Normal Conditions (NC)
• Reverse AC Line. (RM)

• Functional Earth Grounded

• Isolated metal parts grounded

 Single Fault Conditions (SFC)

• Open Safety Earth. (SFC)

• Open Neutral

• Mains voltage on applied part

Medical Equipment Class

 ME class I (Protection relying on fault currents to Earth)

 ME class II (Double Insulated, protection relying on

additional insulation)

 ME class III (Protection is based on the use of SELV,

Battery operated device with no main voltage)
Device types
 Degree of Protection

SYMBOL TITLE

TYPE B APPLIED PART (Earth reference)

TYPE BF APPLIED PART (Non Cardiac)

TYPE CF APPLIED PART (Cardiac)

Device types
 Degree of Protection
SYMBOL TITLE

Defibrillator Proof - TYPE B APPLIED PART

Defibrillator Proof - TYPE BF APPLIED PART

Defibrillator Proof - TYPE CF APPLIED PART

 IEC60601 Leakage current Limits summary table
Leakage Current TYPE B TYPE BF TYPE CF
(µA)
NC SFC NC SFC NC SFC

Earth Leakage 5000µA 10000µA 5000µA 10000µA 5000µA 10000µA

(Pre 3rd edition 2005) 500µA 1000µA 500µA 1000µA 500µA 1000µA

Enclosure Leakage 100µA 500µA 100µA 500µA 100µA 500µA

Patient Leakage 100µA 500µA 100µA 500µA 10µA 50µA

Mains on applied part - - - 5000µA - 50µA

Patient auxiliary 100µA 500µA 100µA 500µA 10µA 50µA

Sample test procedure
Safety testing
Physical Inspection
Mains Voltage

Ground wire resistance

Ground wire leakage

Configure Safety
Analyzer Chassis leakage

Patient leakage

Auxiliary leakage

Documentation Isolation leakage

Visual inspection for electrical safety

 Visual inspection forms a critical part of safety inspections

 Up to 70% of all faults are detected during visual inspection

 Housing / enclosure; Look for damage, spillage, cracks etc.

 Cabling (supply, applied parts etc.) cuts, wrong connections
 Fuse Rating; check correct values after replacement
 Markings and Labeling; Check integrity
 Integrity of Mechanical Parts; check for any obstruction
Leakage Currents what causes them
 If a conductor is raised to a potential above that of earth, current will
flow from the conductor to earth.

 The amount of current that flows depends on the voltage on the

conductor.

 The capacitive reactance between the conductor and earth.

 The resistance between the conductor and earth.

 Electrical Safety Tests IEC60601
 Protective Earth Test • Ground Wire Resistance

 Earth Leakage Current • Earth Leakage Current or Ground Wire

Leakage

 Enclosure Leakage Current, updated to

Touch Current
• Chassis Leakage Current

• Ground Leakage Current

 Patient Leakage Current

• Interlead Leakage or Lead – Lead Leakage

 Patient Auxiliary Current
• Lead Isolation (Iso)
 Mains on Applied Part

IEC60601 AAMI / NFPA-99

IEC 60601-1 tests
Protective Earth Resistance / Ground Wire Resistance /
Earth Bond Test.

 Resistance between Main Earth conductor and Earth

reference point.
 Proving the protective earth integrity
 Protective earth provides current path in case of leakage and
fault currents
 25 Amp AC (on a 0 to 200 Ω circuit)
 Limit : 200mΩ
IEC 60601-1 tests
Earth Leakage current / Ground Wire Leakage current
Applicable to B / BF / CF (Class 1 only)
Conditions
1. Normal Supply
2. Normal Supply, Open Neutral
3. Reversed Supply
4. Reversed Supply, Open Neutral
IEC 60601-1
Enclosure leakage current / Chassis leakage current

• Applicable to B / BF / CF
• Conditions
1. Normal Supply
2. Normal Supply, Open Neutral
3. Normal Supply, Open Earth (Class 1 only)
4. Reversed Supply
5. Reversed Supply, Open Neutral
6. Reversed Supply, Open Earth (Class 1 only)
IEC 60601-1 tests
Patient Leakage current “Lead to Ground”

• Applicable to B / BF / CF
• Conditions
1. Normal Supply
2. Normal Supply, Open Neutral
3. Normal Supply, Open Earth (Class 1 only)
4. Reversed Supply
5. Reversed Supply, Open Neutral
6. Reversed Supply, Open Earth (Class 1 only)
• AC and DC reading
IEC 60601-1 test
Patient Auxiliary leakage current “Lead to Lead”

• Applicable to B / BF / CF
• Conditions
1. Normal Supply
2. Normal Supply, Open Neutral
3. Normal Supply, Open Earth (Class 1 only)
4. Reversed Supply
5. Reversed Supply, Open Neutral
6. Reversed Supply, Open Earth (Class 1 only)
• AC and DC reading
IEC 60601-1 tests
Patient F - Type leakage current “Mains on Applied Parts”

• Applicable to BF & CF only

• Current Limited to 5mA max at 110% of mains
• Conditions
1. Normal Supply, Source Normal
2. Normal Supply, Source Reversed
3. Reversed Supply, Source Normal
4. Reversed Supply, Source Reversed
• RMS reading
IEC 62353 tests
Earthbond test / Groundbond test

• Minimum 200mA AC / DC into 500m Ω

• Reversed Polarity for DC

• Maximum 24 V o.c. voltage

• Limites: 100mΩ / 300mΩ / 500mΩ

IEC 62353 tests
Equipment Leakage

• Total leakage deriving from all the Applied parts, Enclosure and
Mains Parts combined to real Earth.

• Equipment Class I & II.

• AP type B, BF and CF.

• All the Applied Parts are connected together.

• RMS Value (Route Mean Square).

• Method Direct, Differential and Alternative

IEC 62353 tests
Applied Parts Leakage

• Total leakage deriving from combined Patient Connections within

Applied Part to earth and any conductive or non conductive parts on
the enclosure).
• Test Current: 3.5mA limited (Main Frequency).
• Equipment Class I and II.
• AP type BF & CF (Grouped by type).
• RMS Value.
• Method Direct & Alternative.
Limits of IEC 62353
APPLIED PART
Current in μA (RMS)
B BF CF
Equipment Leakage – alternative method
Class I Equipment 1000μA 1000μA 1000μA
Class II Equipment 500μA 500μA 500μA
Equipment leakage – direct or differential method
Class I Equipment 500μA 500μA 500μA
Class II Equipment (touch current) 100μA 100μA 100μA
Patient leakage current – alternative method (AC)
Class I & II 5000μA 50μA
Patient leakage current – direct method (AC)
Class I & II 5000μA 50μA
Test Tools
Electrical Safety Analyzer

• Consider what standard tests your facility required

• Manual or Full automated

• Documentation and recording is so crucial

Electrosurgical Analyzer

• Consider the manufacturer recommendation of your ESU

• HF leakage measurement test
• Output waveforms (Continuous or Pulsed)
• REM test and Crest factor test
• Comply with IEC60601-2-2
 Gas Flow Analyzer

• Measure flow, pressure, temperature, humidity and O2 concentrations bi-directionally

• Measure Adult, Pediatric and high frequency Ventilation
• Measure all ventilator parameters (PEEP, MV, TV, IT, ET, I:E ratio…etc)
• Measure Anesthetic agents, O2, CO2 & N2O
• Calibration tool
 Defibrillator Analyzer

• Measure AED out-put and Defibrillator energy.

• Measure Non-invasive pacing
• Measure synchronized Cardioversion & Testing ECG
• Simulate several waveforms and cardiac rhythms
• Calibration tool
 Infusion Pump Analyzer
• Comply with Standards IEC 60601-2-24.

• Calibration in Flow Module.

• Can do simulation

Incubator Analyzer & Radiant warmer Tester

• Can test baby incubators, transport incubators, and
infant radiant warmers.
• Can measure temperature, airflow, sound, humidity.
• Comply with standards IEC 60601-2-19, IEC 60601-
2-20 & IEC 60601-2-21
 Patient Simulator
• Able to simulate NiBP, SpO2, ECG, Temperature, IBP,
Cardiac output and respiration.
• Battery operated
• Comply with standards IEC60601-2-49, IEC60601-
2-34 and IEC6060-2-27

Digital Pressure Meter

• Measure both gas and liquid pressures
• Measure both negative and positive pressure
• Calibration tool
 Tachometer
• Can provide contact and noncontact measurement of
rational and linear motions

Phototherapy and Radiometer

• Can measure light radiation
• Comply with IEC60601-2-50

Ultrasound Wattmeter
• Measures pulsed or continuous power

• measure the ultrasonic power output of diagnostic or therapeutic

transducers

• Comply with IEC60601-2-5

 X-ray meter / Mass meter / Dosimeter
• Can measure KVp and mAs

• Can measure exposure time

• Comply with IEC60601-2-54

Collimator & Beam Alignment Test tool

• Provides test of the x-ray beams alignment

• Show misalignment of Collimator

 Ultrasound Phantom
• Reference part of a quality assurance program for clinical B-Mode,
M Mode and Doppler Ultrasound systems.

• Be used to perform a QC survey of Doppler ultrasound systems at

installation

• Test the flow velocities from constant flow rates to pulsatile flow
rates

• Be used to perform annual QC surveys

• Mimic the speed of sound, attenuation and echogenicity in blood

and tissue
 MRI Phantom
• Geometric Distortion
• Spatial Resolution
• Slice thickness and position
• Interslice Gap
• T1 and T2 values
• Estimate of Image Bandwidth
• Low Contrast Detectability
• Image Uniformity
• Signal-to-Noise Ratio (SNR)
• Physical and Electronic Slice Offset
• Point of reference
• Bandwidth: water-fat shift
Questions & Answers