Safety Solutions For The Medical Industry

 

Compliant with International Standards.
Measure Patient Leakage Current According to IEC60601-1.

 

During this global pandemic, the need for medical equipment such as ventilators cannot be overstated, and manufacturers all over the world are rushing to meet the demand. As with most electrical equipment, medical devices must also be tested for safety, especially since the devices often come into direct contact with the patient or healthcare worker. IEC 60601-1 Ed. 3 is a widely accepted safety standard for medical electrical equipment.

Part of the standard addresses patient leakage current, i.e., leakage current that flows through a patient connected to an applied part or parts. Here, we outline and introduce Hioki electrical safety testers in the following orders:

1.  Frequently Asked Questions
2. Our Answer
3. Learn More About Hioki Leak Current HiTester ST5540
4. Types of Leakage Current
5. Types of Leakage Current Testing
6. Other Critical Safety Test
7. Hioki Electrical Safety Testers At A Glance
8. ST5540 and ST5541 In Comparison
9. Contact Us

 

Frequently Asked Question

We are manufacturing medical equipment such as ventilators, artificial cardiopulmonary devices and extracorporeal membrane oxygenation machines (ECMO). Do you have any instruments that comply with safety standards for leakage current testing (patient leakage current) or insulation withstand voltage testing?

Our Answer

To test the safety of medical equipment such as ventilators, artificial cardiopulmonary devices and ECMO, we recommend the Hioki ST5540 Leak Current HiTester, which complies with the IEC60601-1:(2005) 3rd Standard.

Hioki Leak Current HiTester
ST5540

Learn more about the innovative product.

 

 

*Learn How To Use Hioki Leak Current HiTester ST5540 For Medical Use.

Types Of Leakage Current

The main types of leakage current are as follows:

・ Patient leakage current

・ Ground leakage current (general electrical equipment, medical electrical equipment)

・ Protective conductor current

・ Contact current, external leakage current (general electrical equipment, medical electrical equipment)

・ Patient measurement current (medical electrical equipment)

・ Total patient leakage current (medical electrical equipment)

Types Of Leakage Current Testing

Other Critical Safety Tests

To verify the safety of medical devices, protective continuity testing (or earth continuity testing) is also necessary, as well as withstanding voltage testing.

For these tests, please consider the following Hioki products:

 

Complies with IEC60601-1 and other safety electrical safety laws :
3157 AC Grounding HiTester

 

Test according to electrical safety laws and various safety standards
3153 Automatic Insulation/Withstanding HiTester
3174 AC Automatic Insulation/Withstanding HiTester

Hioki Electrical Safety Testers At A Glance

Compliance with
IEC 60601-1 Ed 3.0,
JIS T 0601-1:2017,
IEC62353.


For medical-use electrical devices

Complies with Electrical Appliances and Materials Safety Act, JIS/IEC/UL standards. 

For non-medical use equipment 

All-in-one tester that combines withstand voltage and insulation resistance (AC/DC) measurement

Insulation resistance testing: up to 9999 MΩ

PWM method generates test voltage without power voltage dependency


Insulation resistance test: up to 2000 MΩ

Compliance with
IEC 60601-1 Ed 3.0, IEC60950-1


Designed for protection circuit testing of a wide range of electrical equipment, including industrial machinery and medical equipment

ST5540 and ST5541 In Comparison

Network 

Item

ST5540

ST5541

Electrical Appliance and Material Safety Law Network A

Network B for medical electrical equipment

-

Network C for IEC60990

Network D for UL

General purpose 1 network E

General purpose 2 network F

Network G for IEC61010-1

Main functions

Item

ST5540

ST5541

Non-stop polarity switching function

Rated current 20A

Fuse disconnection check function

Frequency band switching

-

110% voltage output terminal (T3 terminal)

-

S10, S12, S13, E terminal

-

Leakage Current Test Mode

Item

ST5540

ST5541

Ground leakage current

Contact current

Patient measured current

-

Patient leakage current

-

Total patient leakage current

-

Free current

Leakage current between exterior and ground

Leakage current between exterior and exterior

Exterior-line leakage current

Patient leakage current I

-

Patient leakage current II

-

Patient leakage current III

-


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