The IEC 61326-2-6 standard prepared by the International Electrotechnical Commission (IEC), an organization affiliated to the International Organization for Standardization (ISO), for in vitro diagnostic medical equipment, taking into account the characteristics and specific features of an electrical equipment and electromagnetic environment, electromagnetic compatibility It describes the minimum requirements for immunity and emission related to
-tibbi-donanim.jpg "TS EN 61326-2-6 Electrical Equipment for Measurement, Control and Laboratory Use - EMU Requirements - Part 2-6: Special Conditions - Intrabody Diagnosis (IVD) Medical Equipment")
This standard has been published in our country by the Turkish Standards Institute with the following title: TS EN 61326-2-6 Electrical equipment for measurement, control and laboratory use - EMU requirements - Part 2-6: Special requirements - In-body diagnosis (IVD) medical equipment.
The main standard that was referred to during the implementation of the IEC 61326-2-6 standard and is in an indispensable position is ISO 14971 (medical devices, application of risk management to medical devices).
In vitro diagnostic devices (IVD) must comply with the In Vitro Diagnostics directive 98/79 / EC published in the European Union countries.
The Regulation on Active Implantable Medical Devices published by the Ministry of Health determines the basic requirements for such devices and regulates the principles for design, production and use against health and safety risks that may arise during use. Accordingly, active implantable medical devices are active medical devices that are fully or partially implanted in the human body with a surgical intervention and must remain where it is placed. In this context, the most widely used devices, pacemakers, insulin pumps, Implantable hearing aids are implantable sensory devices, active medical devices for application in clinical tests and active medical devices that can be implanted in the body with special production.
IEC 61326-2-6 is a special standard and complements the IEC 61326-1 standard for sensitive test and measurement equipment that is vulnerable to EMC.
Within the scope of measurement, control and laboratory equipment tests, our company also conducts tests in accordance with the IEC 61326-2-6 standard.
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