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HIOKI EE CORPORATION

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.

Product Information

Product Catalog

User’s Guide

Application Note 1

Application Note 2

*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
Leak Current HiTester ST5540
Download Catalogue

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

For non-medical use equipment
Leak Current HiTester ST5541
Download Catalogue

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

Insulation resistance testing: up to 9999 MΩ
Automatic Insulation/ Withstanding HiTester 3153
Download Catalogue

PWM method generates test voltage without power voltage dependency

Insulation resistance test: up to 2000 MΩ
AC Automatic Insulation/ Withstanding HiTester 3174
Download Catalogue
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
AC Grounding HiTester 3157
Download Catalogue

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 currentContact 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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  • E-mail: Marketing@hioki.com.sg
  • LINE Official ID: @hiokith

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