College of Engineering and Information Technology
Department of Biomedical Engineering
Academic Year 2024/2025
Spring Semester (20242)
BME403: Medical Instrumentation II
Project report (3):
Electrical Safety Analyzer
Student Name & ID: Ali Hasan Shanableh - 202111460
Section (Day/Time): M1 (Tuesday / 5:30 - 7:30)
Date of Submission: February 11, 2025
Laboratory Instructor: Eng. Mohamed Agam
Comments & Marks:
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Contents
Objective...................................................................................................................................... 3
Introduction ................................................................................................................................. 3
Discussion.................................................................................................................................... 4
Instrument Description ................................................................................................................ 6
Conclusion ................................................................................................................................... 9
References ................................................................................................................................. 10
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Objective
• To understand the safe ranges of electrical current exposure for human beings.
• To review international standards for designing safe medical devices.
• To examine leakage currents and their types in medical devices.
• To classify medical devices by their safety methods and protection types.
Introduction
In biomedical engineering, ensuring the safety of both patients and healthcare professionals is
a top priority. Medical devices, particularly those used for diagnostic imaging, frequently
involve electrical systems that interact with the human body. These systems, when improperly
designed or maintained, can pose significant risks, including electric shock, burns, and, in
extreme cases, cardiac arrest. As such, designing safe biomedical devices requires a thorough
understanding of electrical safety, careful control of leakage currents, and strict adherence to
international safety standards.
Electrical shock risks in medical settings are unique because patients often have lowered
resistance due to exposure to conductive environments, invasive procedures, or compromised
health. Medical imaging systems, such as MRI, CT scanners, and ultrasound devices, involve
direct contact with the patient, increasing the potential for electrical current to flow through
the body. Therefore, electrical safety in these systems is of paramount importance, particularly
in applications involving the heart or sensitive tissues [1].
Leakage current, which refers to unintended electrical current that escapes its designated path,
poses an additional threat in medical devices. Even small leakage currents can be harmful in
high-risk environments, where patients are exposed to multiple devices simultaneously.
Biomedical devices must be designed to limit leakage current to safe levels, especially in
systems that directly interact with the cardiovascular system [2].
To ensure the safety of medical equipment, standards such as IEC 60601 and AAMI/ANSI
ES60601-1 provide guidelines for the design, testing, and performance of electrical medical
devices. These standards focus on minimizing risks associated with electrical, mechanical, and
radiation hazards, ensuring that devices are safe for patients and operators in various medical
environments [3]. By understanding these safety parameters and applying stringent safety
regulations, engineers can create biomedical imaging systems that perform reliably without
compromising patient safety.
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Discussion
1. Range of Currents Producing Shocks
The severity of an electrical shock depends on the magnitude of the current that flows through
the body, as well as the path it takes and the duration of exposure. The following ranges are
critical in understanding electrical safety in medical devices:
• 0.5 mA: Safe for humans, no perception.
• 1 mA – 2 mA: Tingling sensation is felt; however, this is not harmful and is typically
tolerated by most individuals.
• 6 mA – 60 mA: Falls within the "let-go range," meaning muscle control may be lost,
but serious injury can still be avoided if contact is broken quickly.
• 100 mA: Can cause severe burns and potential damage to tissues.
• 200 mA – 2,000 mA: Results in severe burns and tissue damage, with the risk of heart
arrhythmia and fibrillation.
• >2,000 mA (2A): Cardiac arrest is highly likely, and survival depends on immediate
medical intervention.
As per safety standards, 1 mA is the maximum current that can pass through the human body
without causing any harm, which is critical in designing electrical safety features in
biomedical equipment [4].
2. Standards for Designing Medical Devices
The design and manufacturing of medical devices are governed by stringent standards that
ensure safety, efficacy, and reliability:
• IEC 60601: The International Electrotechnical Commission (IEC) provides global
standards for electrical medical equipment, specifically focusing on the safety and
essential performance of these devices. IEC 60601 addresses risks like electrical shock,
mechanical hazards, and radiation exposure [5].
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• AAMI/ANSI: The Association for the Advancement of Medical Instrumentation
(AAMI) and the American National Standards Institute (ANSI) work together to create
standards like ANSI/AAMI ES60601-1, which closely align with international IEC
standards but are tailored for the U.S. market [6].
These standards ensure that medical devices function correctly under normal conditions and
during potential failures or emergencies.
3. Leakage Current
Leakage currents are unintended currents that flow through the device casing or other
conductive surfaces instead of the designed current paths. They are a significant safety
concern in medical devices, as even small amounts of leakage can harm patients with
compromised health. Common types of leakage currents include:
• Earth Leakage Current: A small amount of current that leaks from the live parts of
the device into the protective earth. Proper grounding is crucial to mitigate this risk.
• Touch or Enclosure Leakage Current: This type of leakage occurs when current
flows through the enclosure of the device, posing a risk if someone touches the
surface.
• Patient Auxiliary Leakage Current: Current leakage between applied parts
(electrodes or sensors) and the device body. These currents must be minimal to prevent
injury.
• Patient Leakage Current: Current leakage that flows directly from the patient into
other parts of the system, which must be kept extremely low, especially in critical
applications like cardiology [7].
4. Classes and Types of Medical Devices
Medical devices are classified based on their method of protection against electrical hazards
and their degree of protection for patients:
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• Classes (Method of Protection):
o Class I: Devices that use protective earth to prevent electrical shock, such as
operating tables.
o Class II: Devices without protective earth, relying on reinforced insulation, like
handheld diagnostic tools.
o Class III: Devices using Safety Extra Low Voltage (SELV), which operate at
voltages less than 25V AC or 60V DC, reducing the risk of electrical injury.
• Types (Degree of Protection):
o Type B: Devices with direct patient contact but not intended for high-risk
applications, such as ultrasound machines.
o Type BF: Devices with conductive connections to the patient, like monitoring
equipment. Special isolation measures are used.
o Type CF: Devices directly affecting the heart (e.g., pacemakers). The most
stringent leakage current requirements apply.
o Type C: Devices with less common uses and special risk factors.
These classifications guide device design, ensuring that appropriate safety measures are
implemented depending on how the device interacts with the patient.
Instrument Description
Ensuring Device Safety in Healthcare Settings with an Electrical Safety Analyzer
The electrical safety analyzer is a critical tool in healthcare, primarily used by biomedical
departments and medical device service firms. Its primary function is to ensure the safety of
medical equipment by detecting and addressing potential electrical hazards, such as leakage
currents. Below is an overview of its key features and significance:
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Features and Importance
1. Usage and Importance:
The electrical safety analyzer is essential for verifying the safety and performance of medical
devices, ensuring compliance with regulatory standards.
It is widely used in biomedical engineering departments to detect abnormal leakage currents
and measure the resistance of primary power connections in medical equipment.
2. Leakage Current Measurement:
Procedure: The analyzer evaluates the leakage current of a medical device by applying a
small test current and measuring the return value.
Theoretical vs. Practical Perspective: Ideally, a perfect device should have zero leakage
current, but in practice, every device exhibits some degree of leakage.
3. Types of Electrical Safety Analyzers:
Automatic Analyzers:
Utilize a built-in database to assess cord resistance and leakage currents automatically.
Identify connected medical devices and provide automated pass/fail results based on
predefined safety thresholds.
Manual Analyzers:
Require manual operation for testing and recording acceptable values for cord resistance and
leakage current.
4. Resistance Measurement:
Method: The Kelvin Test Cable is connected to the metallic casing of a device to measure the
resistance of its main power line.
Importance: Ensuring low resistance helps prevent power losses, ensuring efficient current
flow and minimizing electrical hazards.
5. Netech Electrical Safety Analyzer:
Equipment Used: The Netech electrical safety analyzer, available in the biomedical
laboratory, is used to measure resistance and case leakage through button-operated controls.
Display: Results are displayed on an LCD screen for easy interpretation.
6. Documentation and Compliance:
Proper documentation is crucial, especially in case of medical accidents.
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The biomedical engineering department must maintain records that include:
Measurement readings
Acceptable safety ranges
Date of safety checks
7. Kelvin Test Cable Connection:
The Kelvin Test Cable is attached to the analyzer and clamped to a metallic part of the
medical device to facilitate resistance measurement.
NETECH multi-pro 2000:
Key Functions
ESC (Escape): Returns to the previous menu.
MENU: Navigates back to the main menu from any submenu.
READ: Used for measuring operations and storing test data.
CASE LEAKAGE: Initiates case leakage measurement. Displays the "CASE LEAKAGE"
menu, prompting polarity selection for further testing.
MEASURING RESISTANCE:
Guides users to connect the Kelvin Test Cable to the chassis or earth ground of the device
under test (DUT).
Ensures accurate resistance measurements of power cords.
LEADS LEAKAGE: Activates the leads leakage test menu.
SIMULATOR: Allows waveform selection using function keys F1–F5.
F1, F2, F3, F4, F5, F6: Interactive keys corresponding to various menu options for user
control.
Manual vs. Automatic Safety Analyzers
Manual safety analyzers require human intervention for test execution and data recording.
Automatic safety analyzers streamline testing processes, improving efficiency and accuracy
by automating test procedures.
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Figure 1:NETECH multi-pro-2000.
Conclusion
Electrical safety in biomedical medical devices is paramount, as electrical currents can pose
serious risks to the human body. Ensuring safe operation requires a thorough understanding of
safe current ranges, controlling leakage currents, and adhering to international safety
standards such as those established by the International Electrotechnical Commission (IEC)
and the Association for the Advancement of Medical Instrumentation (AAMI/ANSI). These
standards provide a regulatory framework to ensure that medical devices function safely and
effectively in clinical environments.
Medical device classifications further guide manufacturers and healthcare providers in
implementing adequate safety measures to protect patients, operators, and healthcare facilities.
Compliance with these regulations ensures that medical devices are reliable, pose minimal
risks, and function within safe operational limits.
Electrical safety analyzers play a crucial role in this process by evaluating the safety and
reliability of both medical and industrial electrical equipment. These analyzers adhere to IEC
and National Electrical Manufacturers Association (NEMA) standards, helping to detect
leakage currents, measure resistance, and verify compliance with electrical safety
requirements. By minimizing risks and ensuring regulatory compliance, these devices
safeguard both users and equipment, contributing to a safer healthcare environment.
By adhering to established safety protocols and recognizing potential electrical hazards,
healthcare providers and biomedical engineers can ensure that medical equipment remains
safe, reliable, and effective. This commitment to electrical safety not only protects patients
and medical personnel but also enhances overall healthcare quality and improves patient
outcomes.
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References
[1] D. L. Jones and E. P. Green, "Electrical safety in biomedical engineering," J. Med.
Devices, vol. 45, no. 2, pp. 18-25, Apr. 2020.
[2] R. V. Oommen, "Leakage currents in medical devices: Safety considerations and testing
requirements," IEEE Trans. Med. Instrum., vol. 39, no. 6, pp. 789-795, Dec. 2017.
[3] IEC 60601, "Medical electrical equipment – Part 1: General requirements for basic safety
and essential performance," IEC Standard, 2012.
[4] N. H. Lovell and J. A. Mortimer, "Electrical safety in medical equipment," Biomed.
Instrum. Technol., vol. 43, no. 1, pp. 35-42, Jan. 2009.
[5] ANSI/AAMI ES60601-1, "Medical electrical equipment – Part 1: General requirements for
basic safety and essential performance," ANSI/AAMI Standard, 2015.
[6] W. G. Kester, "Leakage currents in electrical devices," J. Med. Eng. Technol., vol. 38, no.
4, pp. 120-126, May 2014.
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