IEC 60601-1-2 Medical Device EMC Testing

Keystone Compliance provides laboratory certification testing for IEC 60601-1-2 per the European Union Medical Device Directive (93/42/EEC) and/or FDA 510k requirements.

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Summary of IEC 60601-1-2 EMC Testing of Medical Devices

The IEC 60601-1-2 standard applies to the basic safety and performance of medical electrical equipment and systems. Risks resulting from reasonably foreseeable electromagnetic disturbances must always be taken into account before testing.

Medical Equipment and systems are tested in representative configurations. Meaning they are tested consistently for their intended use. These configurations are the ones that are most likely to result in unacceptable risk.

IEC 60601-1-2 Laboratory and Certification Testing Procedures

The documentation of the tests must contain all of the necessary information to facilitate adequate planning and execution. Before testing, a detailed test plan is prepared. Any deviations from the test plan are documented in the test report.

By understanding and complying with these standards, manufacturers help ensure that medical devices can be trusted to perform reliably in the diverse and complex electronic landscapes of modern hospitals, clinics, and homes.

Emission Requirements

Emissions refer to the electromagnetic energy that a device emits.

Conducted Emissions Test: Measures the electromagnetic energy traveling along the power lines. IEC 60601-1-2 conducted emissions testing ensures that a device doesn’t send disruptive energy back into the power lines.

To conduct this test, the device is connected to a Line Impedance Stabilization Network (LISN), which isolates the device and allows precise measurement of the conducted emissions.

Radiated Emissions Test: Measures the electromagnetic energy radiated into the air. Radiated emissions assure that the device doesn’t interfere with other electronic devices nearby.

The device is placed in a specialized anechoic chamber, and antennas are used to measure the radiated emissions.

Immunity Requirements

Immunity refers to a device’s ability to function correctly even when exposed to electromagnetic disturbances.

Electrostatic Discharge (ESD) Test: Simulates static electricity shocks. Electrostatic discharge testing ensures that the device can handle static electricity without malfunctioning.

To conduct ESD testing, an ESD simulator is used to apply controlled static electricity shocks to the device.

Radiated RF Immunity Test: Exposes the device to radio frequency (RF) electromagnetic fields. This ensures that the device can operate near other devices emitting RF energy.

For radiated RF immunity testing, the medical device under testing is exposed to controlled RF fields using a signal generator, power amplifier, and antennas.

Electrical Fast Transient/Burst Immunity Test: Simulates quick changes in voltage. Electrical fast transient/burst immunity testing helps ensure that the device can handle sudden voltage changes.

For most electrical fast transient/burst immunity tests, a specialized generator creates fast voltage transients that are applied to the power lines of the device.

Expert IEC/EN Medical Device Certification Testing Laboratory

IEC 60601-1-2 EMC testing is recognized around the globe to ensure that Electromagnetic Compatibility failures do not create unnecessary risks to patients, medical professionals, and/or Medical Equipment/Systems. Keystone Compliance is recognized as an industry-leading EN 60601-1-2 EMC test lab because of our experience in identifying, communicating, and resolving failures during compliance testing.

Unprecedented consultative engineering has made Keystone Compliance one of the fastest-growing companies in the country. Whether your EMC testing requirements are to the IEC 60601-1-2 4th edition, 3rd edition, 2nd edition, or 1st edition, Keystone Compliance is the best EMC compliance lab to meet your EMC testing needs.

Contact Keystone Compliance to partner with the experts who offer short lead times, thorough reports, unprecedented consultative guidance, and the best IEC 60601-1-2 and EN 60601-1-2 test experience in the industry.

For more information on IEC 60601-1-2 testing and its respective standards, please visit the following links: