Leak Current Measurement of Medical Equipment Compliant with the IEC60601-1 Ed.3.2:2020

Automatically measure the leak current of medical equipment using a method compliant with IEC60601-1 Ed.3.2:2020


Medical electric equipment should always be assured safety to the operator and patient. Therefore, a safety test is necessary, and the testing conditions are specified by various standards and laws. The test methods also differ according to the type of equipment.

The international standard IEC60601-1 Ed.3.2:2020 stipulates requirements concerning basic safety and essential performance that are generally applicable to medical electrical equipment.  When developing and commercializing medical equipment, many manufacturers view compliance to IEC60601-1 as a requirement, and most countries call for mandatory implementation.


Leakage Current Testing

Leakage current testing is one of the main components of IEC60601-1 Ed.3.2:2020.  Medical equipment must exhibit good insulation performance, and to verify this parameter, leakage current must be tested.

Leak current tests are defined so as to allow verification of how much leak current would flow under a variety of circumstances.  Consequently, the tests must be carried out under a number of test conditions with leakage measurement limits, including:
Normal Conditions: A state representing a completely normal set of conditions in which no malfunction has occurred.
Single-fault Conditions: A state in which a single malfunction has occurred, such as a power wire malfunction, connection to a malfunctioning device, or a break in a connecting wire.

Key Benefits of the ST5540 Leak Current HiTester

A measuring instrument that is designed to meet the requirements stipulated by IEC60601-1 Ed.3.2:2020 is indispensable in carrying out the electrical safety tests needed in order to ensure that faulty medical equipment does not flow into the market.
The ST5540 Leak Current HiTester contributes to the validation of medical equipment safety by providing the following key advantages:


・Leak current in normal conditions and single fault conditions can be automatically measured without the troublesome switching of power supply polarity


・Networks (body dummy load) fully compliant with JIS, IEC, UL, and Electrical Appliance and Material Safety Law are available as standard
・ Store up to 30 measurement conditions in memory. Once a measurement condition is set up, the same measurement can be easily launched by just calling up the measurement condition stored in memory

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