The medical leakage current test

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Safety tests are mandatory and are part of every final inspection of your electrical product.
Learn the most important facts about medical leakage current test in a nutshell.
We explain the WHY, WHERE, and HOW.
And if you want to learn even more, you can download more detailed information at the bottom of this page for free!

As with the "classic" leakage current test, the focus of the medical leakage current test is leakage current test the quality and safety insulation. In addition, special attention is also paid to the occurrence of various faults.

The danger

The danger is obvious at first glance:

A malfunction or weak insulation in a medical device inevitably leads to the highest risk for the patient.

Dangerous currents must therefore not flow to the patient connections under any circumstances. This risk must be ruled out by means of a test. The medical leakage current test therefore carried out not only on the protective earth conductor on the housing, but also on all patient connections. This results in a large number of possible malfunctions.

It is therefore not just a question of classic insulation weaknesses in electrical conductors, but essentially of possible electrical malfunctions of the medical device in as many conceivable fault states as possible.

In order to detect malfunctions, a wide variety of possible—and even seemingly impossible—malfunctions are simulated during operation, e.g.:

What happens at the patient connections when ...?

  • ... the printer connection of the medical device is connected to the mains voltage?
  • ... there is a sudden interruption in the medical device between the power supply and the application part?
  • ... accidentally connect unused patient connections to ground or mains voltage?
  • ... the power supply is partially or completely interrupted?
  • ... etc.

In the event of malfunctions at and between patient connections, currents must never flow that could endanger the patient during an examination or operation.

DIN EN 60990
All possible faults are described in detail in this standard. When studying the standard, the manufacturer of the medical device recognizes the complexity and the very extensive requirements for the tests to be carried out.

To avoid making mistakes when creating the test plan for your testing device, SCHLEICH offers a wizard SCHLEICH the GLP2 device class. This makes creating the test plan much easier.

Based on a wide variety of inputs, it reliably and quickly generates the complete test sequence.

And what about the other security checks?

SCHLEICH are designed to combine all safety and functional tests in a single testing device.

Your advantage: connect all test leads, including patient connections, application part connections, and functional earth to the test device—and then the test, often involving hundreds of test steps, runs fully automatically.

 

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– Dipl. Ing. Martin Lahrmann

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