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.
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*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:
ãŧ Patient leakage current
ãŧ Ground leakage current (general electrical equipment, medical electrical equipment)
ãŧ Protective conductor current
ãŧ Contact current, external leakage current (general electrical equipment, medical electrical equipment)
ãŧ Patient measurement current (medical electrical equipment)
ãŧ 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
Compliance with | 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 | PWM method generates test voltage without power voltage dependency | Compliance with | ||||
ST5540 and ST5541 In Comparison
NetworkÂ
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 | ○ | - |