What X-ray machine is required in the emergency room? What are the rules and regulations for the new SanPiN for x-rays? Here we draw your attention to the main ones

SanPin provisions define specific requirements for the condition of x-ray and dental rooms, based on concern for the health of patients. They are based on relevant federal laws. In addition to general cleaning and cleaning equipment after use, the rules establish safety parameters for patients and staff.

The rules developed in SanPin 2.6.1.1192-03 apply to all organizations using X-ray installations. Amended new rules were released in 2006. All medical centers must obey them, regardless of who owns them. The rules come into force at the stage of designing a house and are valid during the construction of a medical building, modernization of its parts and operation of offices.

One-time amount of radiation and motivation for radiography

Radiation doses for doctors and patients are subject to restrictions according to SanPin:

1. A radiologist has no right to receive a radiation dose of more than 20 m3 per 12 months. A dose of 50 m3 is acceptable, but the annual dosage must be maintained.
2. Women under 45 years of age should not take more than 1 m 3 x-ray per month.
3. A single dose for the patient being examined should be kept in the amount of no more than 1 m 3 in.

SanPin 2003 says that the patient receiving a dose of X-ray radiation must be justified. Motivation includes:

• if possible, use other diagnostic methods that do not involve irradiation of the patient;
• prescribing radiography only for serious indications;
• least choice dangerous species radiography;
• an unfavorable outcome of the disease should exceed the risk of an x-ray examination.

The same conditions apply when prescribing x-ray therapy. The benefit from it must be greater than the harm from radiation.

Concern for the safety of the subject

Minimizing harm to patients in SanPin contains the following provisions:

• examination of the patient in x-ray rooms is carried out on the direction of the doctor;
• the subject receives all the information about a single dose of X-ray irradiation and its possible negative consequences;
• X-ray equipment complies with established standards;
• the optimal dosage for the study is used;
• X-rays are carried out by specially trained personnel;
• the office is kept in proper condition;
• the rules for using the equipment are followed;
• work is monitored x-ray room.

Responsibility for the consequences of the examination lies with the radiologist. He decides whether x-rays can be taken. If, in his opinion, the referral for an x-ray is not justified, he has the right to refuse the examination.

Rules for placing x-ray units and establishing their functioning

There are strict requirements for the installation of X-ray machines in new centers in SanPin:

• devices must not be placed in residential buildings;
• It is recommended to organize special x-ray departments;
• X-ray rooms are installed at the end of the houses of medical centers or hospitals;
• at the top (on the next floor) there should be no rooms with the possibility of water leakage;
• X-rays should not be adjacent to the children's department and rooms for expectant mothers;
• cabinets should be used only for their intended purpose, there should be no other equipment there;
• The gaps between the radiologist's table, the protective screen, the X-ray machine, walls and windows are strictly regulated.

The floor covering in the radiography room must be antistatic and prevent sparks. It is suitable for frequent washing with detergents. The walls are being finished matte materials so that there is no glare. The window is equipped with light protection. X-ray installation it is installed so that the beam of rays falls on the main wall.

X-ray machine

The wall partitions of the darkroom are finished with a tiled apron. When using static x-ray installations, it is recommended to organize work in two rooms - the control room and the examination room. A window is provided from the control room to the examination room for visual communication with the patient. The installation is located in the examination room, and in the control room there is a remote control and a screen.

Temperature and air exchange requirements

The temperature in the X-ray room according to SanPin is allowed to range from 18 to 22 degrees. Air extraction occurs once every 60 minutes. The influx of fresh air into the examination room occurs once every 20 minutes, in the control room - once every half hour. The intensity of lighting in the department is also regulated.

Concern for the safety of medical workers

Employees of the radiographic department are provided with radiation protection items. Employees over 17 years of age can conduct radiation examinations. Radiographers and technicians must undergo an annual physical examination. Expectant mothers at all stages and women breastfeeding a baby are not allowed to work with emitting equipment.

Operating conditions for dental offices with an X-ray machine

The room intended for x-rays in a dental clinic according to SanPin must have a minimum size of 8 m 2. In 60 minutes, old air is extracted three times and oxygen is supplied twice. The room temperature is allowed within 18 - 20 degrees. The equipment is registered with the Ministry of Health. The question of whether radiography can be performed is resolved simply - the clinic must have a licensing permit. Radiation protection items must be present in the office. Radiography is performed by a certified specialist.

After the end of the appointment time, all devices in the radiography room are turned off. A technician performs wet cleaning - wipes wall coverings, washes the floors. Trained personnel conduct disinfection measures with an X-ray machine and component materials.

Once a month it is necessary to carry out general cleaning with a 2% solution. acetic acid. General cleaning and the usual one cannot be carried out in the morning before the start of patients’ appointments - only in the evening.

The developed operating conditions for the radiography room ensure the safety of patients and staff. They cannot be neglected.

The new X-ray Sanpin represents the main normative document, which is aimed at regulating requirements relating to radiation safety in the field of radiology, as well as compliance with sanitary rules in dental clinics.

What is the document?

SanPiN is deciphered verbatim like this: sanitary rules and standards. This document is a vault certain rules, which are presented to x-ray rooms. It regulates sanitary and hygiene requirements regarding the design and use of x-ray rooms, specialized equipment and the implementation of x-ray examinations. Compliance with the rules and regulations specified in the presented document is an indispensable condition for obtaining a license for each clinic.

The rules and regulations presented in the document are intended to comply with and ensure radiation safety of both patients and medical personnel, who works in them during X-ray studies.

SanPiN sets the maximum acceptable standards and radiation dosages, exceeding which can pose a serious threat to human health and life, and therefore is strictly prohibited.

The document also specifies certain requirements for the design of rooms and the rules for operating specialized X-ray equipment.

Cabinet design rules

According to SanPiNA standards, there are certain requirements regarding the design and equipment of dental offices that provide X-ray procedures to the population:

1. The X-ray department is prohibited from being located in children's institutions or residential buildings. The exception is clinics that are built into residential buildings, where the premises are not considered private property and people do not live on its territory.
2. It is strictly forbidden to place the X-ray room in areas where there is a possibility of water leakage. That is, if the office is located in a residential building, then rooms such as a bathroom, shower room, and toilet should not be located above it.
3. If dental office intended exclusively for servicing a clinic, hospital, hospital, it should be located at the end of the building.
4. It is prohibited to locate an X-ray room next to wards intended for children or pregnant women.
5. The room in which the dental office with the X-ray department is located should not be a walk-through area.

If, during a routine or specialized inspection, specialists of the sanitary and hygienic service discover non-compliance with the requirements regarding the location and equipment in the X-ray room, its activity and operation is terminated

Security measures

Given the fact that radiographic procedures are associated with the risk of excessive radiation exposure, the rules for using specialized equipment and ensuring maximum safety during its operation are considered one of the key ones in modern dentistry.

Let's look at them in more detail:

1. The flooring in the office must be made of materials with electrical insulating properties. It is best to give preference ceramic tiles or porcelain stoneware.
2. Walls and ceilings in X-ray room must be covered with materials intended for frequent use wet cleaning and disinfection without glare.
3. The procedural room must be protected from direct penetration sun rays. Therefore, according to SanPiN rules, it is equipped with special light-protective devices.
4. Before entering the room for radiography, there must certainly be a white-red light table with the inscription “Do not enter!”, which will automatically light up in response to the switching on of the anode voltage.
5. The X-ray machine, according to the requirements of SanPiN, must be located in the office so that its main radiation is aimed towards the wall behind which there is a room with a small number of visitors.
6. When operating equipment and carrying out procedures of a research, therapeutic or preventive nature, the use of special protective clothing is mandatory.
7. To use any type of sources ionizing radiation an appropriate permit must be obtained in accordance with SanPiN standards.
8. Personnel must be specially trained to operate the equipment and strictly follow the rules for its operation.

How to ensure safety?

The SanPiN rules governing the radiographic industry of dentistry were created specifically to protect the population and ensure their maximum safety.

How can these goals be achieved?

1. Comply with the requirements regulated in the document when equipping the office and conducting procedures.
2. Use equipment that complies with the established sanitary standards and radiation safety rules.
3. When performing radiographic procedures, use optimal parameters operation of the equipment, allowing not to exceed the maximum permissible dose of radiation, in accordance with the established requirement.
4. Strictly control radiation doses to patients and dental office staff.

Compliance with SanPiN rules for x-rays contributes to the most effective and efficient safe operation X-ray rooms and conducting relevant studies.

03.02.2018

Basic requirements for the premises of the X-ray room and for placement in it x-ray equipment

The placement of the X-ray room and equipment in it is carried out on the basis of a project completed by an organization that has a license to operate in the placement of ionizing radiation sources (generating) and the design of radiation protection equipment.

An X-ray room, unlike other rooms in medical institutions, is not one room, but several rooms (rooms isolated from each other), each of which has its own purpose and corresponds in area to the established regulatory requirements, and also meets all other sanitary and hygienic requirements. We will dwell on the latter in detail.

Composition and area of ​​the X-ray room/rooms of the X-ray room

The X-ray room includes at least 3 isolated rooms, one of which serves as a treatment room (the room in which work is directly carried out using sources of ionizing radiation), the second is a control room (the room in which the equipment that controls the radiation source is located) and the third is an office doctor Depending on the purpose of the X-ray equipment or the specifics of the activity medical institution The X-ray room may include a darkroom, a waiting room, a dressing room, a staff room, etc. ( detailed information the types of X-ray rooms are described in the article “Project of an X-ray room”).

Appendix 5 to SanPiN 2.6.1.1192-03 establishes the composition and area of ​​X-ray rooms. Thus, based on the information in Appendix 5 to SanPiN 2.6.1.1192-03, we present below in Table 1 the area of ​​the treatment room with different X-ray machines, in Table 2 the composition and area of ​​the rooms of the X-ray diagnostic room, in Table 3 - the composition and area of ​​the rooms of the X-ray therapy room.

Table 1

Treatment room area with different x-ray machines

table 2

Composition and area of ​​the premises of the X-ray diagnostic room

* Not necessary.
** Not needed when using devices for digital radiography and fluorography.

Table 3

Composition and area of ​​premises of the X-ray therapy room

The use of premises of a smaller area or a reduced set of premises is possible in cases where the equipment used, the organization of work, the number of personnel, etc. ensure compliance with general hygienic requirements (microclimate, bacterial contamination, sanitary and epidemiological regime, etc.).

X-ray room in the building: basic requirements

According to the hygienic requirements of SanPiN 2.6.1.1192-03, it is advisable to place x-ray rooms centrally, as part of the x-ray department, at the junction of the hospital and the clinic. X-ray rooms of infectious diseases, tuberculosis and obstetric departments of hospitals and, if necessary, fluorography rooms of emergency departments and outpatient departments can be located separately.

By general rule The X-ray department (office) is not allowed to be located in residential buildings and children's institutions. The exception is X-ray dental rooms (devices), the possibility of placing which in residential buildings is regulated by a special chapter of rules SanPiN 2.6.1.1192-03, as well as the “Basic sanitary rules for ensuring radiation safety (OSPORB-99/2010” SP 2.6.1.2612-10 and Amendment 1 to SP 2.6.1.2612-10. It is not allowed to place dental X-ray machines with a film image receiver in residential buildings.

In dental and X-ray rooms adjacent to residential apartments, it is allowed to place X-ray diagnostic devices with digital image processing, the total rated workload of which does not exceed 40 mA-min/week. (detailed information on this issue is described in the article “Placement of X-ray equipment in a dental clinic”).

It is allowed to operate X-ray rooms in clinics built into residential buildings if the vertically and horizontally adjacent rooms are not residential. It is also allowed to place X-ray rooms in an extension to a residential building, as well as in the basement, if the entrance to the X-ray department (room) is separate from the entrance to the residential building.

As stated in clause 3.3 of SanPiN 2.6.1.1192-03, an X-ray department serving only a hospital or only a clinic should be located in the end parts of the building. In this case, the department should not be a walk-through. Entrances to the X-ray department for inpatient and outpatient department patients are separate.

Important: by virtue of clause 3.4 of SanPiN 2.6.1.1192-03, it is not allowed:

• Place X-ray rooms under rooms where water can leak through the ceiling (swimming pools, showers, restrooms, etc.);
• Place the X-ray treatment room adjacent to the wards for pregnant women and children.

Room for x-ray equipment

According to clause 2 of Appendix 7 to SanPiN 2.6.1.1192-03, the selection of premises included in the X-ray room (department) is carried out by the administration of the medical institution together with the X-ray and radiological department (RRO) (or another organization similar in function to the RRO) of the region and is consistent with institution of sanitary and epidemiological surveillance. At the same time, in relation to individual rooms of the X-ray room, the medical organization must comply with special requirements, established by SanPiN 2.6.1.1192-03. However, in practice, such coordination of the selected premises with Rospotrebnadzor no longer exists and applications for approval of the placement of the X-ray room are no longer submitted.

X-ray room

A treatment room is a specially equipped room in an x-ray room in which an x-ray emitter is located and x-ray examinations or x-ray therapy are carried out.

According to clause 3.11 of SanPiN 2.6.1.1192-03, the height of the X-ray treatment room must ensure the functioning of technical equipment, for example, ceiling mounting of an X-ray emitter, tripod, television monitor, shadowless lamp, etc. X-ray equipment with ceiling suspension emitter, screen-imaging device or X-ray image intensifier requires a room height of at least 3 m (2.6 meters according to the newer SanPiN 2.1.3.2630-10). The height of the X-ray treatment room in the case of rotational irradiation must be at least 3 m. The width of the doorway in the X-ray diagnostic room, RCT room and cath lab must be at least 1.2 m with a height of 2.0 m, the size of the rest doorways- 0.9 x 1.8 m.

Requirements for the treatment room area, including depending on the X-ray machine, are given in Tables 1, 2 and 3 above. At the same time, as stated in clause 3.9, the area of ​​the procedural room can be adjusted in agreement with the body exercising federal sanitary and epidemiological supervision, taking into account the following requirements:

• The distance from the personnel workplace behind a small protective screen to the walls of the room is at least 1.5 m;
• The distance from the personnel workplace behind a large protective screen to the walls of the room is at least 0.6 m;
• The distance from the rotating tripod table or from the imaging table to the walls of the room is at least 1.0 m;
• The distance from the photo stand to the nearest wall is at least 0.1 m;
• The distance from the X-ray tube to the viewing window is at least 2 m (for mammography and dental devices - at least 1 m);
• The technological passage for personnel between elements of stationary equipment is at least 0.8 m;
• The area where the gurney is placed for the patient is at least 1.5 x 2 m;
• Additional area in case of technological need to bring a gurney into the treatment room - 6 m 2.

In accordance with clause 3.30 of SanPiN 2.6.1.1192-03, in the treatment room, in addition to the procedure room for fluorography and the X-ray operating room, it is provided for the installation of a sink with a supply of cold and hot water. In a procedural room designed for urological studies, a viduar should be installed.

In the treatment room for the study of children, the presence of toys (washed in a soap and soda solution and disinfected) and distracting design is allowed.

Important: Placement in procedural equipment, which is not included in the project, as well as carrying out work not related to x-ray examinations.

X-ray machine placement

The X-ray machine is placed in the treatment room in such a way that the primary beam of radiation is directed towards main wall, behind which there is a less visited room. The direct beam of radiation should not be directed towards the viewing window (control room of the protective screen). When the office is located on the first or ground floor, the windows of the treatment room are screened with protective shutters to a height of at least 2 m from the level of the building's blind area. When placing the X-ray room above the first floor at a distance from the treatment room to residential and office premises of a neighboring building less than 30 m away, the windows of the treatment room are screened with protective shutters to a height of at least 2 m from the finished floor level.

Information about controlling the X-ray machine is presented in the article “X-ray room project”.

Photo lab

In accordance with clause 3.23 of SanPiN 2.6.1.1192-03, a photo laboratory can consist of one room - a “dark room”. When equipping a laboratory with a developing machine, an additional “light” room should be provided for sorting, marking and trimming dry photographs.

The minimum area of ​​a darkroom (“dark room”) for small-format photographs is 6 m2, for large-format photographs - 8 m2. The minimum width of the passage for personnel between elements of equipment in a dark room is 1.0 m. The width of the doorway is 0.9 - 1.0 m.

The walls of the darkroom are finished with light-colored tiles, primarily at the sink and photo processing device (tiled apron). It is allowed to finish with tiles to a height of 2 m with the overlying finishing materials allowing for repeated wet sanitization.

The door from the darkroom, as well as the treatment room and control room to the corridor, should, for reasons fire safety open “to the exit” (during the evacuation), and from the control room to the treatment room - towards the treatment room.

Window, transfer hatch and front door darkrooms are protected with light-proof curtains to prevent exposure of photographic materials.

However, it is worth noting that a darkroom is necessary when using film X-ray machines, which have actually already been replaced by modern digital technology.

Other requirements for X-ray room premises

SanPiN 2.6.1.1192-03 contains a number special rules in relation to the X-ray room premises. Thus, the floor of the treatment room, control room, except for the X-ray operating room and darkroom, is made of natural or artificial electrical insulating materials. Application artificial surfaces and floor structures is possible if they have a conclusion on their electrical safety. In the X-ray operating room, preoperative room, and darkroom, the floors are covered with waterproof materials that are easy to clean and allow frequent washing and disinfection. The floor of the cath lab must be antistatic and spark-free. When making a floor from antistatic linoleum, it is necessary to ground the base of the linoleum.

The surfaces of the walls and ceilings in the treatment room and control room should be smooth, easy to clean and allow wet cleaning. Decoration Materials must have a sanitary and epidemiological certificate allowing their use in residential and public buildings.

The walls in the X-ray operating room are finished with materials that do not produce light reflections, for example, matte tiles.

The orientation of the windows of the X-ray room for fluoroscopy and the control room is preferable to the north-west directions.

The treatment room window for fluoroscopy, if necessary, is equipped with light-protective devices to darken it from natural light(direct sunlight).

An important requirement to comply with is the requirement to place a light sign (signal) “Do not enter!” white-red color, automatically lighting up when the anode voltage is turned on, at the entrance to the procedure room of the X-ray diagnostics, fluorography room and to the control room of the X-ray therapy room at a height of 1.6 - 1.8 m from the floor or above the door. In this case, it is allowed to apply a sign to the light signal radiation hazard.

The regulated air exchange rate, calculated values ​​of illumination and temperature in the premises of the X-ray department (room) are given in Appendix 6 to SanPiN 2.6.1.1192-03. The inflow should be carried out into the upper zone, the exhaust - from the lower and upper zones in a ratio of 50 +/- 10%.

Ventilation of X-ray rooms in newly constructed buildings general purpose must be autonomous. In existing departments, the presence of non-autonomous general supply and exhaust ventilation is allowed, with the exception of computed tomography departments and X-ray departments of infectious diseases hospitals. It is allowed to equip X-ray rooms (departments) with air conditioners.

Start and end of work in the X-ray room

In accordance with clause 3.32 of SanPiN 2.6.1.1192-03, before starting work, personnel check the serviceability of equipment and reagents with mandatory registration of the results in a technical control log. If malfunctions are detected, it is necessary to suspend work and call a representative of the organization carrying out Maintenance and equipment repair.

After the end of the working day, the X-ray machine, electrical appliances, desk lamp, electric lighting, ventilation, wet cleaning of walls with washing of floors and thorough disinfection of elements and accessories of the X-ray machine are carried out. Wet cleaning is carried out monthly using a 1 - 2% acetic acid solution. Wet cleaning of the treatment room and control room of the X-ray room is not allowed immediately before and during X-ray examinations.

Necessary formalities

According to the general rule, enshrined in clause 3.31 of SanPiN 2.6.1.1192-03, an institution that has an X-ray room or an X-ray machine must have the following documentation related to the premises of the X-ray room and the placement of X-ray equipment in it:

• Sanitary and epidemiological conclusion on the type of activity (operation, storage, etc.) (see also “Sanitary and epidemiological conclusion on types of activity”);
• technical certificate for an X-ray room (more details in the article “Technical passport for an X-ray room”);
• Project documentation for the placement of X-ray equipment;
• The act of putting the X-ray machine into operation, signed by representatives of the organization carrying out commissioning works, And medical organization(for newly supplied devices) and an act for hidden work.

Relevance of the issue

Medicine has many modern diagnostic methods. However, this does not detract from the value of the X-ray examination. X-ray methods make it possible to study the structure and functions of organs and systems, as well as diagnose diseases. They have proven their value in gynecological, urological, oncological and surgical practice.

The examination is carried out in a specially equipped room. High demands are placed on him. They are approved in Appendix No. 12 to the Order of the Ministry of Health and Social Development No. 149n dated December 7, 2011 and SanPiN 2.6.1.1192-03 “Hygienic requirements for the design and operation of X-ray rooms, devices and the conduct of X-ray examinations.”

Where to open an office

It is recommended to open it on the basis of a medical institution. The Ministry of Health prohibits placing it in residential complexes, child care institutions, as well as under premises with high level humidity - swimming pools, baths, etc.

You can place an office in a clinic, which is located in a residential building. But in this case, it is necessary to equip a separate entrance, not to combine the office with living quarters and extensions to them, and also to locate it on the ground floors.

If the office operates on the basis of a medical institution, it should not be located near wards where pregnant women or newborns are lying.

Staff units

The X-ray room has at least 2 employees - a doctor and an X-ray technician.

The radiologist conducts the examination, makes conclusions on the examinations, monitors and is responsible for the serviceability of the equipment, and also advises doctors on how to prepare patients for the examination.

The X-ray technician prepares contrast agents and patients for the procedure, performs radiographs, tomograms and photo processing, takes part in fluoroscopy, monitors the radiation dose, and maintains documentation.

Premises requirements

Several rooms are allocated for the office: a treatment room, a control room (control room), and a darkroom. Ideally, equip a separate room for storing film archives.

Usually, workplace The radiologist is equipped in the control room or separately.

SanPin sets requirements for each of the rooms in the office:

• Minimum area. In the treatment room - at least 16 square meters. m, width - 3.5 m; in the control room - at least 6 sq. m;
• Ceiling height- minimum 3 m;
• Floor. Made from electrical insulating materials. The X-ray machine must stand on a concrete base 1x1 m and a thickness of 1 m 20 cm to 1 m 50 cm. The edges of the base are covered with linoleum. The floor and base levels must be the same;
• Net. Single-phase 220 V. It is necessary to have a neutral and an autonomous grounding that is not connected to it;
• Distance from concrete base to the power supply - maximum 3.5 m;
• Sockets. They are installed near the workstations of each employee in the control room. European standard sockets (220V, 10A).

The laboratory assistant's workplace is positioned so that he can see the patient through the viewing window while the image is being taken.

If the office is open in a hospital, it is necessary to allocate additional area 6 sq. m for transporting patients on a gurney.

Safety and Security Issues

X-ray rooms belong to the 4th class of radiation hazard. Therefore, SanPiN imposes strict requirements for radiation protection of people and the environment.

For this purpose, the floor, windows, doors, walls, ceiling of the treatment room are finished with X-ray protective materials - barite plaster, gypsum panels, leaded materials (for example, glass and metal sheets for windows and doors).

Treatment room equipment

The main equipment that is installed in the treatment room: mobile and stationary X-ray units, orthopantomograph or dental apparatus. If necessary, a digital radiovisiograph is installed.

If there are 2 devices installed in the office, you need to prevent them from being turned on at the same time. For this purpose, a special blocker is installed.

Important! X-ray installations must be placed so as to direct the main radiation to the main wall.

If the office does not provide separate room for a control room, the control panel can be placed in the treatment room, enclosing it with a protective screen.

The office requires a supply and exhaust ventilation system.

The door to the treatment room is locked from the inside and is equipped with a patient warning light from the outside.

Additional equipment

Must have:

• Facilities personal protection - aprons, gloves, aprons, skirts, collars made of leaded rubber, glasses and plates;
• Dosimeters-radiometers. They need to be periodically checked for the radiation dose that the worker may have received;
• Furniture: screw chair, child seat with clamps;
• Consumables: scissors, containers for disinfection.

Masks, examination gloves, paper and sanitary napkins and towels, and dressings may also be required.

Darkroom equipment

List of necessary things equipment: a developing machine or installation for manual film processing, flashlights for developing, negatoscopes, a darkroom clock with a timer, a set of cassettes.

From furniture cabinets are needed for storing film and drying it, Consumables: film, barium, photo reagents.

It is necessary to provide a photo laboratory supply and exhaust ventilation and water supply.

Equipping a doctor's workplace

It is equipped either in a control room or in an autonomous room.

List of necessary devices: fluoroscope, negatoscope, intercom (through which the doctor gives commands to the patient while taking the picture), video device or viewing window for monitoring the patient.

Necessary furniture: workplaces for doctors and laboratory assistants - tables, chairs, as well as cabinets for documentation, reagents, medical clothing, medicines, a cabinet for drying film.

The work of a modern hospital cannot be imagined without a specially equipped X-ray room. The X-ray room can be one of the following types:

• diagnostic x-ray room – fluorographic, mammographic,
• dental, computed tomography room, radiographic;
• therapeutic x-ray room;
• operating x-ray room;
• stationary, portable and portable x-ray machines.

In the article we will consider the basic requirements for X-ray rooms as sources of increased danger in accordance with the requirements of the current SanPiN.

The dangers of X-ray machines

X-ray machines are sources of increased danger because they project ionizing radiation, which is generated when turned on high voltage. In this regard, owners of X-ray machines must exercise special caution and caution when using them. All X-ray rooms belong to radiation hazard class 4, so they are subject to special requirements in order to protect patients, medical staff and the environment from ionizing radiation.

Licensing of activities

One of the conditions for compliance with radiation safety is the licensing of activities related to the operation of sources of ionizing radiation. In general terms, licensing is the process of obtaining special permission to carry out certain activities from the regulatory authority.

It is obtaining a license when organizing an X-ray room that is the main requirement for admission to activity. This is due to the fact that the operation of an X-ray room in a medical institution should bring maximum benefit from the procedure, but at the same time guarantee radiation safety to the patient and medical staff. This is guaranteed by obtaining the appropriate license.

Algorithm for organizing the work of the X-ray room

In order to make the procedure for organizing the work of the office clear, let’s imagine this process in the form of several stages:

• choosing an X-ray machine that is suitable for work in a medical institution;
• development and implementation of a project for the future office;
• obtaining a sanitary and epidemiological certificate for carrying out activities;
• obtaining a license for activities with sources of ionizing radiation;

Let's consider these stages in detail.

Choosing an X-ray machine
First of all, the management of a medical institution must determine the tasks that are of primary importance to the radiology department of the hospital, determine the composition of the studies performed and the purpose of the device. Based on this, it is determined specifications of the future device, as well as the possibility of placing it in a hospital. There are a number general requirements, which are presented to X-ray machines for medical use. In particular, they must have:

• registration certificate from the Ministry of Health of the Russian Federation;
• sanitary and epidemiological conclusion that the device complies with SanPiN 2.6.1.1192-03 (X-ray rooms), as well as radiation safety requirements;
• certificate of compliance with regulatory and technical documents.

Let us note that the sanitary-epidemiological report must contain an indication of whether the device must be equipped with a means for changing the individual radiation dose during research. This requirement is contained in SapPiN 2.1.6.1192-03.

In addition, the use of fluoroscopy machines is not permitted unless the machine is equipped with an X-ray image intensifier.

After the required model of the device has been selected, its documentation has been studied, it is necessary to coordinate its purchase with the authorized organization - the territorial governing body of the State Sanitary and Epidemiological Supervision.

Coordination will subsequently help you correctly draw up medical and technical specifications for the installation and design of an X-ray room and avoid problems when coordinating many other details: choosing a room, approving a project, etc.

After purchasing an X-ray machine, the medical institution must ensure its safety, as well as monitor compliance with the conditions for its receipt, use, storage, and write-off. The conditions must be such that the possibility of damage, loss and uncontrolled use of devices is completely excluded.

If the X-ray machine is not yet in use, it must be stored in a specially equipped room (storage) in which their safety will be ensured and access by third parties will be excluded.

Development of an X-ray room project
The project must be developed in the following cases:

• during the construction of a new hospital, department, etc.;
• when organizing a new X-ray room in a hospital;
• at major renovation, refurbishment or redevelopment of an existing office;
• when changing examination technology and replacing equipment.

If a new hospital or department is being built, the X-ray room design is developed within the framework common project hospitals according to medical and technical specifications. Institutions that have a license giving the right to design sources of ionizing radiation may be allowed to create a project. The administration of the medical institution issues a medical project to a specialized organization. terms of reference, on the basis of which the cabinet design is developed. The assignment from the medical institution must contain the following information:

• for which object it is necessary to draw up a project;
• what area is allocated for the project;
• what equipment is planned to be placed in the X-ray room;
• what technological procedures will be used in the work of the office.

Requirements for the placement of an X-ray room
When drawing up technical specifications, it is necessary to take into account the requirements for the placement of the office, the area of ​​the premises, etc.

The premises for the X-ray room are selected by the hospital management in agreement with the authorized organization (State Sanitary and Epidemiological Supervision).
X-ray rooms cannot be placed in children's institutions and residential buildings, but the operation of the office is permissible in clinics that are built into residential buildings. In this case, the premises adjacent to the office should not be residential or located on ground floor or in an extension to a residential building.
In this case, the entrance to the X-ray room must be separate.
Let us note that SanPiN 2.6.1.1192-03 and SNiP 31-01-2003 contain contradictory norms: the first document says that X-ray and dental rooms can be placed in residential buildings, and the second document says that any X-ray rooms.
Please note that the requirements for X-ray rooms contained in these documents must, in any case, be carefully studied before drawing up the project.
Therefore, we believe that the decision on the location of an x-ray and dental office should be made by the controlling organization. Cabinets cannot be placed under rooms with increased level humidity, which includes swimming pools, bathtubs and toilet rooms, baths
X-ray treatment rooms should not be adjacent to wards for pregnant women and newborns.

Office area and set of premises
All requirements for X-ray rooms in terms of their area and set of premises are set out in Appendix No. 5 to SanPiN No. 2.6.1.1192-03.

In addition, when drawing up a project for operating X-ray rooms, it is also necessary to take into account the requirements of SanPiN No. 2.1.3.2630-10, SNiP 06/31/2009. The following requirements are imposed on the X-ray room:

• The distance from the walls of the room to the medical staff’s workplace behind a small screen should be at least 1.5 meters;
• at least 0.6 meters should be the distance from the walls of the room to the medical staff’s workplace behind a large screen;
• The distance from the walls of the room to the image table or tripod table must be at least 1 meter;
• The distance from the nearest wall to the photo stand must be at least 10 centimeters;
• The distance from the viewing window to the X-ray tube must be at least 2 meters;
• the distance from the equipment elements to the technological passage for the medic must be at least 80 centimeters;
• gurneys must be placed in an area of ​​at least 1.5-2 meters;
• the additional area required to bring the gurney into the treatment room must be at least 6 square meters. m.

The equipment manufacturer's design proposals contained in the technical documentation to devices, however they do not replace the development of your own project.

• prevention of possible radiation accidents;
• calculation of stationary radiation protection.

Further finished project must undergo a sanitary-epidemiological examination, which decides whether its content meets the requirements of sanitary standards.
Such an examination is carried out by a special body - the territorial center of hygiene and epidemiology.

More information about sanitary and epidemiological examination
The essence of the examination is to establish compliance of design and other documentation, products, services, works (Federal Law “On the Sanitary and Epidemiological Welfare of the Population”) with state rules, standards and technical regulations.
Experts are given 2 months to review the project and document the results of the examination, after which they accept a positive or negative expert opinion.
If the experts’ decision is negative, it should list the complete deficiencies that the medical institution must eliminate in the project.
If the terms of the examination are violated, the medical institution has the right to file a complaint with a higher organization.
After approval of the project, the authorized organization issues a “Sanitary and Epidemiological Conclusion” on the compliance of the project sanitary requirements. After this, the project can be implemented.

Equipment installation
As we have already said, after receiving a positive sanitary and epidemiological conclusion for the X-ray room project, the medical institution can carry out all the necessary measures.
In particular, the premises are being repaired or reconstructed, and other activities provided for by the project are being implemented. After this, you can begin installing the equipment. Installation activities are carried out by a specialized organization or representatives of the equipment manufacturer.
Please note that equipment that was not provided for in the design documentation cannot be placed in the office.
All organizations that are involved in construction and installation work, must have appropriate licenses and other permits provided for by law.

Commissioning of the X-ray room
Before accepting the X-ray room, it is necessary to check the compliance sanitary rules ventilation systems, sewerage, lighting, noise, microclimate systems, radiation control of the premises and other systems.
Such checks are carried out by organizations that are accredited to conduct such studies. They carry out the necessary research and measurements, after which they draw up the appropriate act.
After all the work is completed, it is necessary to assemble a commission that will commission the X-ray room into operation. The commission includes:

• representatives of the medical institution (chief physician, his deputies, etc.);
• representatives of the State Sanitary and Epidemiological Supervision Service;
• representatives of the X-ray center;
• representatives of the construction and installation organization.

The commission establishes the compliance of the actual work performed with the content of the project, studies the acts and protocols of the studies and measurements carried out, establishes the presence of all necessary documents listed in Appendix No. 7 to SanPiN No. 2.6.1.1192-03. After a successful inspection, the commission signs an acceptance certificate for the x-ray room in triplicate (for the medical institution, x-ray center and authorized organization).

Obtaining a technical passport for the office
The medical institution must obtain a technical passport for the office. This document certifies the technical condition of all equipment located in the X-ray room.
In addition, it confirms that staff workplaces and premises comply with legal requirements.
A passport must be obtained for each room for tomography, diagnostics, x-ray therapy, osteometry, etc. It is filled out by the chief X-ray radiologist of the territory, after which it is certified by his signature and seal.
The passport has a validity period of 3 years, which can be renewed no more than three times.
If insignificant deviations of the devices from the passport data are identified, it can be issued from six months to a year.
If serious violations are detected in the operation of the equipment, the work of the office and equipment is suspended until completion. repair work or replacement of equipment.
In addition, the technical passport can be replaced before the expiration date if the complete set of the device changes, if the design of the X-ray room changes, as well as in case of wear and tear of the equipment and the emergency condition of the room.

Effect of sanitary-epidemiological conclusion
This document gives the right to operate and store X-ray equipment and is issued for the first time on the basis of the act of acceptance of the X-ray room into operation. This document is valid for 5 years from the date of its issuance; after expiration of the validity period, the medical institution is required to issue a new conclusion. In order to obtain a new conclusion, the medical institution contacts the Center for Hygiene and Epidemiology so that the agency conducts a new sanitary and epidemiological examination. One conclusion is issued per medical institution. It indicates all X-ray rooms and devices (stationary and mobile) to which it applies. The annex to the sanitary-epidemiological report specifies the restrictive conditions for the use of equipment and the conditions for its operation. If control organizations subsequently reveal a violation of the requirements of sanitary and epidemiological rules, the current conclusion must be revoked.

Obtaining a license to operate with sources of ionizing radiation
After passing all the previous stages (not earlier), the medical institution must obtain a license to carry out activities related to sources of ionizing radiation.
Such a license is issued by executive authorities authorized to carry out state sanitary and epidemiological supervision.
To obtain a license, a medical institution submits a package of documents to the licensing authority:

• application for a license. The application must indicate: the name of the medical institution, its location and other contact information;
• copies of the constituent documents of the medical institution;
• copies of medical institution licenses to carry out medical activities;
• a list of specific sources of radiation that are planned to be used in a medical institution. This list is accompanied by copies of documents for these sources, as well as a sanitary and epidemiological certificate for working with such sources;
• copies of educational documents of medical workers that confirm their qualifications to work with sources of radiation;
• receipt of payment of the license fee for consideration of the application for issuance of a permit.

All provided copies must be notarized.

License terms

• compliance with the legislation of the Russian Federation and SanPiN requirements;
• the presence in the medical institution of structures and premises that meet the requirements for placing X-ray rooms in them;
• compliance of design and other documentation, operating conditions, storage and operation of ionizing radiation sources with radiation safety requirements;
• the presence of employees who have the appropriate qualifications to carry out work in the field of using ionizing radiation sources;
• conducting radiation safety certification for all employees who work with radiation sources;
• existence of an action plan aimed at protecting medical institution employees and citizens in the event of a radiation accident.

The licensing authority reviews the documents, conducts the necessary studies, examinations and other activities, after which, within a period not exceeding 60 days, it makes a decision to issue a license. A license for a medical institution is issued for a period of 5 years, after which it, in the absence of changes in licensing conditions and requirements, can be extended. If a medical institution has violated licensing requirements, the licensing authority has the right to suspend the license to eliminate these violations or go to court to cancel it.