EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of IEC EN 61326-2-6 testing. In addition to the scope of IEC EN 61326-1, this part of the IEC EN 61326 series specifies minimum requirements for electromagnetic compatibility-related immunity and emissions for in vitro diagnostic medical equipment, taking into account the characteristics and specific aspects of this electrical equipment and their electromagnetic environment.
-tibbi-ekipman-testi.jpg "IEC EN 61326-2-6 Measurement - Control and Electrical Equipment for Laboratory Use - EMC Requirements - Part 2-6: In Vitro Diagnostic (IVD) Medical Equipment Testing")
Similar to conventional medical electrical equipment, in-vitro diagnostic medical equipment is used in a wide variety of electromagnetic environments. IVD devices will operate properly and safely in typical healthcare settings (hospitals, clinics, doctor's offices) as well as home environments. This means that the device will have the minimum level of immunity suitable for these areas.
Devices intended for use in other environments such as ambulances, airplanes, cars, or helicopters may require higher levels of immunity to ensure safe and effective device performance.
When different input power modes are available (e.g. battery, AC options), the manufacturer should specify those operating modes that cover the most severe case based on product risk analysis.
Strong sources of electromagnetic emissions can cause malfunctions in nearby medical equipment under certain conditions. Different types of medical electrical equipment have different levels of risk associated with failure. However, IVD medical equipment is not intended to keep patients alive or resurrect, so a failure would not directly cause death or serious injury to a patient. Such a malfunction in IVD medical electrical equipment can cause an inaccurate reading, which can lead to an incorrect therapeutic decision (misdiagnosis). For some analytes and in some cases an incorrect result can cause serious harm to the patient. In the case of larger IVD electrical equipment, electromagnetic disturbances can also cause malfunctions that pose a direct threat to the operator, for example through unexpected mechanical movements.
EUROLAB assists manufacturers with IEC EN 61326-2-6 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.
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