TS EN 60601-2-65 Electrical Medical Devices - Part 2-65: Special Rules for Basic Safety and Required Performance of Dental Intra-Oral X-Ray Equipment

The IEC 60601-2-65 standard, prepared by the International Electrotechnical Commission (IEC), an affiliate of the International Standards Organization (ISO), describes the criteria for the basic safety and basic performance of dental intra-oral X-ray devices. This standard has been published in our country by the Turkish Standards Institute with the following title: TS EN 60601-2-65 Electrical medical devices - Part 2-65: Special rules for the basic safety and required performance of dental intra-oral X-ray equipment.

Dental radiography is generally known as dental x-ray. Dental structures that are not easily visible with a standard visual inspection are monitored with this diagnostic device. This device is also used to detect cavities in the mouth, bone loss in teeth and jawbones, and benign or malignant masses in the mouth. Dental x-rays are not limited to images of the patient's teeth. Soft tissue and bone structures are also monitored with this equipment.

Typically, a dental x-ray is taken during the initial dental examination. These images are important in making the correct diagnosis. Generally, two types of dental x-rays are used: intra-oral and extra-oral. These are classified according to the area where the x-ray images are taken. Intra-oral X-rays are the most common and provide images of the tooth structure and the jawbone to which they are attached. Extra-oral X-rays are for observing skull and jaw structures. Meanwhile, the teeth are also seen in the movie. Intra-oral X-rays are usually extra-more detailed than oral x-rays.

The operation of these devices with the expected accuracy and performance depends on having inspections according to domestic and foreign standards. Authorized organizations carry out these tests within the framework of special rules for basic safety and required performance in the IEC 60601-2-65 standard.

Tests in accordance with IEC 60601-2-65 standard are also carried out by our organization within the scope of medical device tests.