Leak Current HiTester Medical IEC Standard

Why is leak current testing necessary?

Electrical devices are typically designed with sufficient insulation so that operators do not experience electric shock. However, equipment deteriorates over time, and current leaks may develop and worsen gradually when equipment is used over an extended period of time. Such leak currents are extremely dangerous for the human body. Leak currents generated by medical-use electrical devices are particularly problematic as they may cause prolonged electric shock and significant tissue damage in unconscious patients.

The ST5540 and ST5541 allow operators to comply with specific leak current testing requirements that have been put in place by international and Japanese standards to address these risks.

Advanced Features

• Support for all standard test types for medical-use and general-use electrical devices (ST5540)
  • Electrical devices, including those intended for use in medical applications, are typically designed with sufficient insulation so that operators do not experience electrical shock.
  • However, insulation may deteriorate over time. The ST5540 and ST5541 are capable of standards-compliant leak current testing to detect such degradation before it becomes problematic. (Only the ST5540 is specifically engineered to test medical-use devices.)
• Reduced testing time thanks to a new measurement method
  • Previous models (specifically, the LEAK CURRENT HiTESTER 3156) required that the device being tested be turned off when conducting tests under certain standards. In contrast, the ST5540 allows these tests to be performed without turning off the device under test, reducing testing time.
• More testable products thanks to support for rated currents of up to 20A
  • HIOKI responded to requests from customers in the field by increasing the new products’ rated current to 20A (previous models topped out at 15A). The ability to accommodate larger currents allows the ST5540 and ST5541 to perform leak testing of newly designed products such as industrial equipment and household appliances. The instruments support voltages of up to 240V (max. 264V).
• Compliance with the IEC 60601-1:2005 international standard
  • Unlike previous models, the ST5540 complies with the IEC 60601-1:2005 3rd Edition international standard, allowing leak current measurement from 0.1 Hz to 1 MHz.

Standards Compliance - The ST5540 complies with the following standards:

• International standards
  • IEC 60601-1:2005 3rd Edition (Medical electrical equipment – Part 1: General requirements for basic safety and essential performance)
• Japanese standards
  • JIS T 1001:1992 (General rules of testing methods for safety of medical electrical equipment), JIS T 1002:1992 (General requirements for safety of medical electrical equipment)
  • JIS T 0601-1:1999 (Medical electrical equipment: General requirements for safety)