TS EN 60601-2-54 Electrical Medical Equipment - Part 2-54: Special Rules for Basic Safety and Required Performance of X-Ray Equipment Used in Radiography and Radioscopy

Medical Device Tests

TS EN 60601-2-54 Electrical Medical Equipment - Part 2-54: Special Rules for Basic Safety and Required Performance of X-Ray Equipment Used in Radiography and Radioscopy

The IEC 60601-2-54 standard, prepared by the International Electrotechnical Commission (IEC), an affiliate of the International Organization for Standardization (ISO), describes the specific requirements for the basic safety and basic performance of X-ray equipment for radiography and radioscopy operations. This standard has been published in our country by the Turkish Standards Institute with the following title: TS EN 60601-2-54 Electrical medical equipment - Part 2-54: Special rules for the basic safety and required performance of X-ray equipment used in radiography and radioscopy.

TS EN 60601-2-54 Electrical Medical Equipment - Part 2-54: Special Rules for Basic Safety and Required Performance of X-Ray Equipment Used in Radiography and Radioscopy

The lowest safety requirements described in this specific standard are believed to provide a practical level of safety in the operation of medical devices used for radiography and radioscopy. The standard is part of a number of international standards on medical electrical devices that cover basic safety and basic performance for both medical devices and medical systems. This standard contains guidelines specific to the safe operation of X-ray devices used in radiography and radioscopy studies.

This special standard complements the IEC 60601-1 standard for medical electrical equipment.

The IEC 60601-2-54 standard covers companies that produce radiography and radioscopy devices, suppliers and organizations using these devices, hospitals and all health institutions, people working in the field of health and safety, and health regulatory organizations.

This standard is systematically reviewed by experts to ensure market continuity and adherence to clinical best practice.

X-rays are invisible beams containing ionizing radiation and are mainly used in radiographic examinations, computed tomography, angiography and mammography examinations. Ultrasonography and magnetic resonance imaging methods are non-X-ray imaging methods.

Tests in accordance with IEC 60601-2-54 standard are also carried out by our organization within the scope of medical device tests.

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