Introduction to

Electrical Safety Testing:

Part I
White Paper

Electro-Medical Devices are powered by the Electrical safety takes on added significance
mains or an internal power source (batteries) and in electrically-susceptible patients. For cardiac
often attached to the patient by wires. Some of procedures, electrically-conductive catheters may
these devices have active parts inserted into the be placed into the heart while the patient is con-
patient body and may come in direct contact with nected to medical equipment. This procedure puts
the heart. There is a risk to the patient in the patients at risk for ventricular fibrillation. Skin
event of current leaking from the device. Current exhibits a high electrical resistance, but internal
can also be transmitted through a caregiver such body components such as blood and muscle have
as a nurse in contact with an electronic device a low electrical resistance. In fact, currents as low
near the patient. Electrical shock can cause dis- as 20 microamps have caused ventricular fibrilla-
ruptions during health care procedures and result tion in experiments conducted with dogs when a
in injury or death. This makes electrical safety a conductor made direct contact to the heart.
topic of very high importance in medical device The term macroshock describes electrical cur-
quality assurance. rent applied externally. On the other hand, the
Physiological effects of electrical shock range term microshock is used to describe direct shocks
from a tingling sensation to serious burns and to the cardiac muscle. As a result of data collected
electrocution. Excitable human tissue is very sensi- regarding macroshock and microshock, world-
tive to current in the frequency range of electrical wide standards have been established to limit
power systems worldwide (50 Hz to 60 Hz). The leakage current.
figure below shows the effects of current flowing In equipment designed for low resistance
from one skin contact point to another. direct contact with patients, such as indwelling
catheters, electrical isolation techniques are used
to reduce the current flowing to the patient to
minimal levels. In the event of a device failure or
short-circuit condition, the patient is protected
Burns from microshock. These techniques may utilize
isolation transformers and optical circuits. Thus,
electrical safety standards specify low microam-
pere limits for direct patient contact equipment.
Cardiac fibrillation
To reduce leakage current to negligible levels,
chassis grounding is utilized to shunt any leak-
age or fault current to ground rather than to the
Muscle contraction, suffocation patient or staff. Figure 1 demonstrates the hazard
current from the electrical failure being safety
shunted to ground through this alternative path-
way. Effective grounding can only be achieved
Let-go current
with very low resistance pathways to ground
on the order of tenths of an ohm. Grounding is
another measurement specified in electrical safety
Sensitivity limit standards for medical devices.

1 mA 10 mA 100 mA 1A 10 A 100 A
Figure 1: Effects of current flowing from one skin contact point to another.
230 V
50 Hz

230 V standards for electro-medical equipment. There

Fuses
are general and specific standards for medical
device electrical safety.

IEC60601 AAMI/NFPA 99
10 Ω The primary standard for medical devices is
~22 A IEC 60601. General requirements for protection
against electric shock hazards are covered in IEC
60601.1, Section 3.
~11 V

In this standard, each instrument has a class:

0.5 Ω 0.5 to 200 kΩ • Class I—Live part covered by basic insulation
~22 A .055 to 22 mA
and protective earth
• Class II—Live part covered by double or
reinforced insulation
• Class IP—Internal power supply

Figure 2: Hazard current from electrical failure being safety shunted to ground
Each patient applied part or patient lead has a
through an alternative pathway. type:
• Type B—Patient applied part earthed
• Type BF—Patient applied part floating (surface
Basic electrical safety tests include: conductor)
• Type CF—Patient applied part floating for use
• Visual inspection of cables, plugs and
in direct contact with the heart
connectors
• Measurement of ground wire resistance
Leakage measurement limits have been developed
• Measurement of chassis and patient lead/
for equipment types and measurements. They
contact isolation
include:
• NC—normal conditions
Electrical safety standards • SFC—single fault conditions
To help verify the functionality and safety of med-
ical devices, electrical safety standards have been The terminology used in IEC 60601.1 3rd Edition
established in the United States, European coun- includes:
tries, and other parts of the world. The standards • Protective earth resistance
differ in criteria, measurements, and protocol. • Earth leakage current
The International Organization for Standardiza- • Touch current (formerly enclosure leakage
tion (ISO) and the International Electro-technical current)
Commission (IEC) organizations based in Europe • Patient leakage current
provide standards worldwide in partnership with • Patient auxiliary current
the World Trade Organization. These include • Mains on applied part (MAP)

Patient
leakage
Patient Patient current Patient Patient Patient
Earth Touch leakage leakage mains on auxiliary auxiliary auxiliary
Leakage leakage current current AC current DC applied current current current
current (µA) current mA (µA) (µA) (µA) (µA) (µA) (µA) (µA)
Type B NC 5 100 100 10 — 100 10 100
SFC 10 500 500 50 — 500 50 500
Type BF NC 5 100 100 10 — 100 10 100
SFC 10 500 500 50 5000 500 50 500
Type CF NC 5 100 10 10 — 10 10 10
SFC 10 500 50 50 50 50 50 50

2 Fluke Biomedical Introduction to Electrical Safety Testing: Part I

 10,000 Ω

0.015 µF
Milli-
Input 1,000 Ω voltmeter

Figure 3. Impedance of a patient

test load.

The figure above represents the impendence In the United States, there are several primary
of a patient test load. Leakage current mea- and secondary organizations setting standards:
suring devices use this impedance circuit for 1. National Fire Protection Association
measurements. (NFPA): NFPA 99 Standard for Health Care
Facilities is the primary standard addressing
Additional important points regarding IEC electrical safety testing required in health care
60601.1 include: institutions. Other publications include NFPA
• The use of up to 25 amperes ac for protective 70, National Electrical Code, and NFPA 70E,
earth testing (this is a type-test and generally Electrical Safety in the Workplace.
suitable for manufacturers) 2. Association for the Advancement of Medical
• Leakage current is measured at 100 percent of Instrumentation (AAMI): ANSI/AAMI ES1 Safe
mains voltage Current Limits for Electro-medical Apparatus is
• Performance of dielectric strength/insulation another commonly-accepted standard.
testing is measured at 110 percent of mains 3. Underwriters Laboratories (UL): UL544,
voltage. Medical Equipment requirements is a standard
A new IEC standard, IEC 62353, is used for medi- for manufacturers, not hospitals. These
cal device testing in hospitals. IEC 62353 was standards may be referenced by accreditation,
developed because IEC 60601.1 is a type-testing code or regulatory organizations such as the
standard with no risk management criteria and is Joint Commission, Occupational Health and
impractical for testing in the hospital environment. Safety Administration or other organizations
IEC 62353 tests are performed on equipment monitoring health care institutions in the
prior to use on patients, during schedule periodic United States.
testing, and after repair. Thus, this standard is 4. Canadian Standards Association (CSA):
for field (hospital) testing and does not address CAN/CSA C22.2 NO. 60601-1-08 Medical
equipment design. In Annex E of the document, Electrical Equipment Part 1: General
the manufacturer is requested to provide infor- Requirements for Basic Safety and Essential
mation on testing interval and procedure based Performance (Adopted IEC 60601-1:2005, third
on risk, typical usage, and device history. The edition, 2005-12)
minimum testing requirement for life support and
other critical equipment is every 24 months. Global harmonization of standards has led to the
development of worldwide standards. Equipment
in the regions listed below must be certified to the
IEC60601-1 standard or the device cannot be sold
in that country.
• USA uses UL2601-1 or ANSI/AAMI ES601
• Europe uses EN60601-1
• Canada uses CAN/CSA-C22.2 No. 601.1-M90

IEC60601 AAMI/NFPA 99
Protective Earth Resistance Ground Wire Resistance
Earth Leakage Current Ground Wire Leakage Current
Touch or Enclosure Leakage Current Chassis Leakage Current
Patient Leakage Current Lead to Ground Leakage Current
Patient Auxiliary Leakage Current Lead to Lead Leakage Current
Mains on Applied Part (MAP) Leakage Current Isolation Leakage Current

3 Fluke Biomedical Introduction to Electrical Safety Testing: Part I

 Start

Selection of the test Insulation resistance

Visual inspection Functional test

Protective earth resistance Reporting of results

Leakage current Evaluation

Check and prepare

for normal use

Figure 4: Testing requirements and sequence according to IEC 62353 Annex C.

Electrical safety testing

Testing requirements and sequence according
to IEC 62353 Annex C are shown below. Only
measurement equipment that meets IEC 61010-1
should be used. The sequence outlined in the
figure below should be followed. For example,
protective earth resistance should be measured
prior to leakage current measurements.
General connections to an electrical safety ana-
lyzer (ESA) are shown in Figure 5-5. Consult the
operational manual for specifics for your electrical
safety analyzer. Documentation requirements for
IEC 62353 include:
• Identification of the testing group (hospital
department, independent service organization,
manufacturer)
• Names of the person(s), who performed the Figure 5. General connections to an electrical safety analyzer.
testing and evaluation(s)
• Identification of the equipment/system (e.g.
Basic electrical safety testing with
type, serial number, inventory number) and the
accessories tested the ESA609
• Tests and measurements The ESA609 integrates all functions
• Date, type, and outcome/results of: needed to test medical devices when
– Visual inspections patient lead testing is not required,
–M  easurements (measured values, measuring including:
method, measuring equipment) • Line (mains) voltage
– Functional testing • Ground Wire (or protective earth)
• Concluding evaluation resistance
• Date and signature of the individual who • Equipment current
performed the evaluation • Ground wire (earth) leakage
• Chassis (enclosure) leakage
Computerized record-keeping systems are • Direct equipment leakage
greatly preferred for data storage, search, review, • Point to point leakage and resistance
and analysis. Note the device fields must be
standardized. Versatile to global electrical safety standards of
choice, the ESA609 tests to ANSI/AAMI ES1, NFPA-99,
and parts of IEC62353 and IEC60601-1. To learn
more about the ESA609 Electrical Safety Analyzer
or any other Fluke Biomedical analyzer, click here
or visit www.flukebiomedical.com/ESA609.

4 Fluke Biomedical Introduction to Electrical Safety Testing: Part I

 Do you want to learn more about electrical safety? Stay tuned
for Introduction to Electrical Safety—Part II.
Introduction to Introduction to Electrical Safety—Part II will cover:
• How to perform various required electrical safety tests using an Electrical Safety Analyzer
• How to test according to IEC62353
• How to select an electrical safety analyzer to perform prescribed tests

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without notice. Printed in U.S.A.
3/2014 6002127A_EN

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without written permission from Fluke Corporation.

5 Fluke Biomedical Introduction to Electrical Safety Testing: Part I