TS EN 60601-2-43 Electrical Medical Equipment - Part 2-43: Specific Features for Basic Safety and Required Performance of X-Ray Equipment for Interventional Operations

The IEC 60601-2-43 standard prepared by the International Electrotechnical Commission (IEC), an affiliate of the International Organization for Standardization (ISO), is addressed in the design and manufacture of X-ray devices for radioscopically directed interventional procedures. It describes the safety and performance criteria and test methods that should be taken.

This standard has been published in our country by the Turkish Standards Institute with the following title: TS EN 60601-2-43 Electrical medical equipment - Part 2-43: Specific features for the basic safety and required performance of X-ray equipment for interventional procedures.

This standard describes the information to be provided by such interventional X-ray devices to reduce the risk of radiation and equipment failure from employees, patients or procedures that may affect them.

The following medical equipment is excluded from the standard IEC 60601-2-43: radiotherapy equipment, equipment for computed tomography, implantable accessories, mammographic X-ray equipment, and dental x-ray equipment.

Several standards that have been referred to during the implementation of the IEC 60601-2-43 standard and are in an indispensable position are: IEC 60601-1-2 (assurance standard: electromagnetic compatibility), IEC 60601-1-3 (assurance standard: radiation protection in diagnostic X-ray equipment ), IEC 60580 (medical electrical devices, dose area product counters), IEC 60601-2-54 (specific rules for basic safety and basic performance of the x-ray device for radiography and radioscopy) and IEC 62220-1 (determination of quantum efficiency).

Interventional radiology is a field of radiology that includes diagnostic and therapeutic methods in many fields of medicine. Generally, local anesthesia is applied to the patient, and diagnosis and treatment methods are applied by entering the body in the size of a pinhole. The most widely used interventional radiology applications in diagnosis and treatment are imaging methods such as angiography, ultrasound and computed tomography.

Tests in accordance with IEC 60601-2-43 standard are also carried out by our organization within the scope of medical device tests.