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.
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 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:
|IEC 60417||Graphical symbols for use on equipment|
|IEC 60601-1||2005 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance|
|IEC 60601-1-8||2006 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems|
|IEC 61000-3-2||Limits – Limits for harmonic current emissions (equipment input current ? 16 A per phase)|
|IEC 61000-3-3||Limits – Limitation of voltage fluctuations and flicker in low-voltage supply systems for equipment with rated current ? 16 A|
|IEC 61000-4-2||Testing and measurement techniques – Electrostatic discharge immunity test|
|IEC 61000-4-3||Testing and measurement techniques – Radiated, radio-frequency, electromagnetic field immunity test|
|IEC 61000-4-4||Testing and measurement techniques – Electrical fast transient/burst immunity test|
|IEC 61000-4-5||Testing and measurement techniques – Surge immunity test|
|IEC 61000-4-6||Testing and measurement techniques – Immunity to conducted disturbances, induced by radio-frequency fields|
|IEC 61000-4-8||Testing and measurement techniques – Power frequency magnetic field immunity test|
|IEC 6100-4-11||Testing and measuring techniques – Voltage dips, short interruptions and variations immunity tests|
|CISPR 11||Industrial, scientific and medical (ISM) radio-frequency equipment – Electromagnetic disturbance characteristics – Limits and methods of measurement|
|CISPR 14||Electromagnetic compatibility – Requirements for household appliances, electric tools and similar apparatus – Part 1: Emission|
|CISPR 15||Limits and methods of measurement of radio disturbance characteristics of electrical lighting and similar equipment|
|CISPR 16||Specification for radio disturbance and immunity measuring apparatus and methods – Part 1-2: Radio disturbance and immunity measuring apparatus – Ancillary equipment – Conducted disturbances CISPR 22, Information technology equipment – Radio disturbance characteristics – Limits and methods of measurement|