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Importance of medical device testing for EMC EMC testing evaluates a product to determine if it is compatible with its intended electromagnetic environment(s). Will it interfere with other nearby products and/or will it be negatively impacted by other nearby products?
Importance of medical device testing for EMC In health care applications electromagnetic incompatibility is not just a nuisance, it is potentially life-threatening. Most global regulatory bodies recognize a product cannot be safe and effective if it is not also compatible with its intended electromagnetic environment.
Electromagnetic compatibility, means a medical device is compatible with (no interference is caused by) its electromagnetic environment and it does not emit levels of electromagnetic energy that cause electromagnetic interference in other devices in the vicinity.
EN 60601-1-2 defines the basic and essential performance for medical equipment with regard to Electromagnetic (EM) disturbances associated with electromagnetic compatibility (EMC) emissions and immunity which the equipment manufacturer needs to show compliance with.
EN/IEC 60601-1-2 describes specific test methods for measuring electromagnetic compatibility (EMC) and sets limits to ensure that medical devices function reliably and do not cause dangerous interference with other devices, such as communication systems or vital equipment.
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EMI Testing measures the electromagnetic emissions from a device to ensure they do not interfere with other electronic equipment. This is important because excessive emissions can disrupt the operation of nearby devices, leading to malfunctions or failures.
What is electromagnetic compatibility (EMC) testing? Electromagnetic compatibility (EMC) testing measures the ability of equipment or systems to function satisfactorily in their electromagnetic environment without introducing intolerable electromagnetic disturbance to anything in that environment.
ANSI/AAMI/IEC 60601-1-2:2014/A1:2021; Medical electrical equipmentPart 1-2: General requirements for basic safety and essential performanceCollateral standard: Electromagnetic disturbancesRequirements and tests, Amendment 1.

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