X-ray license

Who regulates the activities of X-ray rooms?

The procedure for operating X-ray rooms in Ukraine is regulated by a number of regulations that establish permissible radiation doses for personnel and patients, requirements for the placement of X-ray equipment.

At the first stage, you need to decide on the premise for the X-ray room, work out the room structure, make the list of the necessary equipment, establish the list of tasks and develop the plan for their implementation.

Further, it is necessary to obtain an appropriate license, since the use of an X-ray machine in a diagnostic room requires a special permit. A license for the provision of X-ray services can be issued for an active legal entity or individual entrepreneur, and must be tied to the territorial location of the object. To obtain it, it is necessary to maintain compliance in the size of the room, its equipment and security measures.

In this case, obtaining a license is possible subject to certain other conditions. For example, there must be a medical worker in the staff, a radiologist, admitted to the X-ray machine, who must have permission to work with this equipment. In addition, a prerequisite for issuing a license is the presence of an X-ray room project.

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Premises for an X-ray room

Before opening an X-ray room, it is necessary to rent or purchase a premise in which the space will be allocated for:

  • control room, from 10 m2.
  • procedural room, from 10 m2.
  • radiologist’s room, from 10 m2.

Also note that the X-ray machine in the room should be placed in such a way that the primary beam is directed towards the main wall, behind which, at the same time, there is no room where patients or staff would be constantly. The control panel for X-ray equipment must be located in the next room, in compliance with safety rules.

At the same time, the room area for the placement of digital equipment should be at least 6 m2 per equipment unit, however, even if the area allows, it is unacceptable to use two or more X-ray machines at the same time in one room.

Therefore, the best option for dentistry would be the availability of such equipment:

– stationary wall-mounted machine;

– stationary ceiling x-ray machine;

– portable visiograph (tomograph).

In this case, it will be easy and convenient for you to arrange this equipment for the comfortable work of the doctor and the reception of patients.

Documentation of X-ray room licensing

When licensing the activity of an X-ray room, it must be remembered that the equipment is a source of radiation. In this regard, when opening a room, it is necessary to obtain a sanitary passport allowing the storage and use of X-ray equipment. Also, it is necessary to submit the following package of documents to the state authorities to legalize the activities of the X-ray room:

  • application for a license;
  • notarized copy of statutory documents or its electronic version;
  • document confirming the ownership or lease of real estate (X-ray room);
  • documents confirming the ownership or lease of the equipment;
  • registration certificate for the X-ray machine, as well as the set of protocols for measuring parameters;
  • sanitary passport confirming the compliance of the X-ray equipment with the standards approved in the regulatory documents;
  • conclusion on the fulfillment of all requirements for the preparation of the X-ray room project;
  • act confirming the effectiveness of the ventilation system in the dental (X-ray) office.
  • data on the institution structure and the personnel;
  • certificate confirming that the medical staff has passed the commission and that employees have no contraindications for working with medical X-ray equipment.

Opening in a residential building and a dental office

First of all, when opening an X-ray room, you need to understand that the placement of X-ray equipment must comply with safety standards.

So, for example, the only type of X-ray that can be in a residential building is X-ray for dentistry. Moreover – of a certain type – U 60-90 mV and I 7-10 mA.

Also, the X-ray room can be located only on the first floor of the non-residential part of the building, or in the basement.

In dental offices, no more than 100 pictures per week should be taken when conducting targeted X-ray examinations and no more than 50 when using an orthopantomograph. This will avoid exceeding the annual radiation dose of medical personnel. The operator’s workplace should be at least 4 m2, equipped with a protective cabin or screen.

The requirements for the equipment operation increase the safety not only of medical personnel, but also of citizens living in houses where there are dental offices and clinics. If dental offices are located in older residential buildings, materials and floor thickness must be considered. If necessary, you need to make a special ceiling protection to ensure reliable anti-radiation protection. It is forbidden to direct the primary beam of the X-ray machine towards the front door or first floor window without protective shutters.

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