IONIZING RADIATION, RADIATION SAFETY

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2.6.1. IONIZING RADIOTION,
RADIATING SAFETY

THE HYGIENIC REQUIREMENTS TO THE DEVICE
AND OPERATION OF X-RAY LABORATORIES, DEVICES
AND REALIZATION OF X-RAY RESEARCHES.

Sanitary rules and specifications
SanR&N 2.6.1.1192-03

I. Area of application

1.1. The present Sanitary rules and specifications (further - Rules) are developed in conformity with the Federal laws " About sanitary – epidemiologic well-being of the population " N 52-FR from March 30, 1999 (Assembly of the legislation
of the Russian Federation, 1999, N 14, item 1650), " About radiating safety of
the population " N 3-FR from January 9, 1996 (Assembly of the legislation of the Russian Federation, 1996, N 3, item 141), " About using of atomic energy " N 170-FR from November 21, 1995 (Assembly of the legislation of the Russian Federation, 1995, N 48, item 4552), the decision of the Government of the Russian Federation from July 24, 2000 N 554 " About the statement of a Rule about state sanitary - epidemiologic service of the Russian Federation and the Rule about state sanitary - epidemilogocal norming " (The assembly of the legislation of the Russian Federation, 2000, N 31, item 3295). The rules are the normative document establishing the basic requirements and norms on
maintenance of radiating safety of the personnel, the patients and the population at realization of medical rentgenological procedures with diagnostic, preventive, therapeutics or research purposes.

1.2. The rules are obligatory for execution by the organizations, irrespective of their subordination and forms of ownership, and by physical persons, whose activities is connected with X-ray researches.

1.3. The rules are distributed to the designing, construction, reconstruction
(modernization) and operation of X-ray laboratories, devices, including
the mobile X-ray laboratories, devices.

II. The general provisions

2.1. According to the classification of radiating objects concering there potential danger the X-ray diagnostic and X-ray therapeutic laboratories are related to the IV category.

2.2. The system of maintenance of radiating safety during fulfilling of medical X-ray researches should provide practical realization of three basic principles of radiating safety – norminating, substantion and optimization.

2.2.1. The principle of norming is realized by an establishment of the hygienic specifications (allowable limits of the dozes) of radiation. For the personnel the average annual effective doze is equal to 20 mZv (0,02 zivert) or an effective doze for the period of labour activity (50 years) - 1000 mZv (1 zivert); the radiation in an annual effective doze up to 50 mZv (0,05 ziveret) is allowable at the condition that an average annual effective doze estimated for five consecutive years, will not exceed 20 mZv (0,02 zivert). For women of the age till 45 years the equivalent doze on a surface of the bottom part of the area of the stomach should not exceed 1 mZv (0,001 zivert) per one month. For practically healthy persons an annual effective doze at fulfilling preventive medical X-ray of procedures and scientific researches should not exceed 1 mZv (0,001 zivert).

2.2.2. The principle of substantiation at realization of X-ray researches is realized according to the following requirements:

- priority of using the alternative (not radiating) methods;
- fulfilling of X-ray researches only according to clinical indications;
- choice of the most sparing methods of X-ray researches;
- the risk of refusal from X-ray research should obviously exceed risk from irradiation at it’s realization.
The principle of substantiations at realization of X-ray therapeutic is realized in view of the following requirements:

- using of the method only in the cases, when the expected efficiency of the treatment with the account of preservation of functions of the vital necessary bodies surpasses the efficiency of alternative (not radiating) methods;
- the risk of refusal from X-ray therapeutic should obviously exceed the risk from the radiation during at It’s realization.

2.2.3. The principle of optimization or restriction of levels of irradiation at realization X-ray researches is carried out by the maintenance of the dozes of irradiation at such low levels, which it is possible to achieve under the condition of maintenance the necessary volume and quality of the diagnostic information or therapeutic effect.

2.3. Maintenance of radiating safety at realization of X-ray researches includes:

- realization of a complex of measures of technical, sanitary - hygienic, medical -
preventive and organizational character;
- realization of measures on observance of the rules, norms and specifications in the area of radiating safety;
- informing the population (patients) about dosage loadings, possible consequences of irradiation, accepted measures on maintenance of radiating safety;
- training of the persons nominating and carrying out X-ray researches, to the bases of radiating safety, the methods and means of maintenance ofradiating safety.

2.4. Safety of working in X-ray laboratory is provided by means of:

- application of the X-ray equipment and the equipment adequate to technical and sanitary - hygienic specifications creating required clinical productivity at maintenance of the requirements of radiating safety;
- the proved set of premises, their arrangement and furnishing;
- using of optimum phisic - technical parameters of functioning of X-ray devices at X-ray researches;
- applications of the stationary, mobile and individual means of radiating protection of the personnel, patients and population;
- training of the personnel to safe methods and receptions of fulfilling of X-ray researches;
- observance the service regulations of the communications and the equipment;
- the control of the dozes of irradiation of the personnel and patients;
- realization of the industrial control for the performance of the norms and rules on ensuring of safety at X-ray researches and X-ray therapeutics.

2.5. The realization of X-ray researches and X-ray therapeutic by medical-preventive establishments, other legal and physical persons is carried out when they have a sanitary - epidemiologic conclusion about conformity of working conditions with sources of ionizing radiations to the rules of sanitary.

2.6. The methods of diagnostics, preventive maintenance and treatments based on the using of X-ray radiation, should be authorized by the Ministry of the Health and social development of the Russion Federation.

2.7. In medical practice the X-ray devices can be addopted to application under the condition of their registration by the Ministry of the Health and social development of the Russion Federation and having a sanitary - epidemiologic conclusion about their conformity to sanitary rules in the area of the radiating safety.

2.8. At modificating of new domestic, purchasing import and operation of the existing X-ray devices the definition of individual dozes of irradiation of the patients at realization of X-ray searches should be stipulated. In the sanitary - epidemiologic conclusion on the X-ray device the necessity (or absence of the necessitie) of the complictation of the set by the means of definition of individual dozes of irradiations of the patients is underlined. Methods and means of definition of the dozes of irradiation of the patients, used for these purposes, should correspond to the requirements of normative and methodical documents authorized in a defenit order.

2.9. During testing of operational parameters of X-ray devices and at realization of the radiating control, including definition of the individual dozes of irradiation of the patients, the means having working certificates about it’s testing are used. The means for definition of individual dozes of irradiation of the patients can be both independent, and entered in to the design of the X-ray device or in Workstation of the radiologist.

2.10. At the manipulation with the X-ray medical devices the organizations (medical - preventive establishments, stomatological clinics, other legal persons) provide:

- planning and realization of measures on maintenance of radiating safety;
- realization of the industrial control about radiating conditions on the working
places, in the premises, on the territories;
- realization of the individual control and account of individual dozes for the personnel and the patients. The control and account of the individual dozes of irradiation is carried out in the frameworks of the common state monitoring system of control and account of individual dozes of irradiation;
- realization of preparation and certification of the chiefs and executors of the works, the experts who carry out the industrial control, other persons, who constantly or temporarily carry out the jobs with the X-ray devices, on the questions concerning maintenance of radiating safety;
- organization, realization of preliminary (at receipt on the job) and periodical physical examinations of the personnel;
- regular informing of the personnel about the levels of ionizing radiation at the workplaces and the size of the received individual dozes of irradiation;
- duly informing the federal bodies of executive authorities, carrying out the state management, the state supervision and control in the area of radiating safety, and also the bodies of the executive authority of the subjects of the Russian Federation about emergencies;
- fulfilling of the conclusions, instructions of the official bodies, authorized to that which carry out state management, state supervision and control in the field of maintenance of radiating safety;
- realization of the rights of the citizens in the area of maintenance of radiating safety.

2.11. The administration of the establishment is responsible for radiating safety, for maintenance, safety precautions and industrial sanitation at the operation of X-ray devices and laboratories.

2.12. Designing, construction, manufacturing of the process equipment and
the means of radiating protection of X-ray study are carried out by the organizations having the special licenses, given by the authorized bodies.

2.13. The organization which has received the medical X-ray device, should inform about it the body of sanitary - epidemiologic supervision in 10-day's term. Delivery and installation of X-ray devices for rentgenoscopy, not equipped with the amplifier of the X-ray image, is not supposed.

2.14. The X-ray devices are taken into account in an account-book.
2.15. The administration of the establishment provides safety of the X-ray devices and such conditions of their reception, storage, using and writing off, at which the opportunity of their loss or unattended use is excluded.

2.16. The administration of the establishment conducts X-ray - hygienic passport of the organization in the established order.

2.17. At estimation of working conditions in X-ray laboratories the following dangerous and harmful production factors should be taken into account:

- the increased level of ionizing radiation;
- the dangerous level of voltage in the electrical high-current circuits, in which short circuit can pass through a body of the man;
- the raised temperature of the elements of the hardware;
- the raised physical efforts at operation of the X-ray equipment;
- the opportunity of air and contact transfer of infection;
- the presence of traces of leaden dust on a surface of the equipment and walls;
- the increased noise level created by the hardware;
- the danger of fire.

2.18. At operation of the photo laboratory the influence of additional dangerous and harmful factors should be taken into account:

- the low level of light exposure;
- contact to chemically active substances (oxidizers such as metol, hydrohenon etc.);
- conducting of poisoning connections at ignition of photofilm materials.

2.19. The dozes of irradiation of the personnel of A&B groups and the population should not exceed the basic limits of the dozes established by NRB-99, which are given in the table 2.1.