Medical Devices Test Standard According to IEC 60601-1-2

Medical Device Tests

Medical Devices Test Standard According to IEC 60601-1-2

IEC 60601-1-2 applies to the basic safety and essential performance of Medical Equipment(ME) and medical equipment systems in the presence of electromagnetic disturbances and electromagnetic disturbances emitted by medical equipment systems.

Medical Devices Test Standard According to IEC 60601-1-2

This standard specifies requirements and tests for electromagnetic compatibility of equipment and systems and forms the basis of electromagnetic compatibility requirements and tests in certain standards. A level less than or equal to the immunity level at which the equipment or system meets the applicable regulatory requirements.

The existence of electromagnetic emission standards is essential for the protection of:

  • Security services;
  • Other equipment and systems;
  • non-medical electrical equipment (eg computers);
  • Telecommunications (eg radio/TV, telephone, radio-navigation);


The presence of electromagnetic immunity requirements is essential to ensure the safety of equipment and systems. The immunity test levels specified in this standard (IEC 60601 test levels) represent the range found in the general medical use environment.

In the 4th century, a number of changes were made regarding electromagnetic immunity. Implementation of higher immunity levels compared to 60601rd edition of IEC 1-2-3, including harmonizations and changes in procedures.

As IEC 60601-1-2 is a complementary standard to the International Medical Safety Standard IEC, 60601-1-2 has been adopted by many countries. Therefore, the mismatch
Bringing ME equipment to market in a significant part of the world increases the potential return on investment of the manufacturer.


IEC60601-1-2 testing services are provided by EUROLAB to businesses within the scope of medical device tests.

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