The IEC 60601-1-2 standard published by the International Electrotechnical Commission (IEC) applies to basic safety and basic performance in the presence of electromagnetic disturbances radiated by medical equipment and systems. Complementing the IEC 60601-1 standard, this standard describes general requirements and defines test methods for basic safety and basic performance regarding electromagnetic disturbances and electromagnetic emissions of medical equipment and systems. These are in addition to the requirements of the general standard IEC 60601-1 and are the basis for specific standards.
The IEC 60601-1-2 standard represents the latest technology for all manufacturers whose medical devices or accessories fall within the scope of the IEC 60601-1 basic standard. The scope of this standard is limited to medical devices and accessories that are part of them. These are the parts of the medical equipment that, when used for their intended purpose, must come into physical contact with the patient. However, its applicability is not limited to medical equipment and systems. Manufacturers that provide electrical equipment for use in a medical environment, such as a ward computer in an intensive care unit or a wall monitor that is not intended to be a medical device in an operating room, must also comply with this standard so that other medical equipment is not affected.
While emission and immunity testing for medical products is very similar to that applied to other product types such as radio equipment, network equipment, and multimedia equipment, the IEC 60601-1-2 standard, unlike electromagnetic compatibility (EMC) for other types of products, requires that the fundamental safety and essential performance of the medical device be preserved.
Basic safety and fundamental performance are derived from the risk management process. The outcome of this process should define the performance associated with each function of the equipment necessary to keep risks within acceptable limits. After identifying the functions and their associated parameters that need to be evaluated during immunity testing, the next step is to develop a test plan and specify the functions to be evaluated.
Our organization also provides electromagnetic disturbances testing services for medical electrical equipment within the scope of IEC 60601-1-2 standard, with its trained and expert staff and advanced technological equipment, among the numerous test, measurement, analysis and evaluation studies it provides for businesses in various sectors.
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