of August 24, 2011 No. 632
About approval of Sanitary regulations about radiation protection and radiation safety when performing radiation therapy
1. Approve Sanitary regulations about radiation protection and radiation safety when performing radiation therapy it (is applied).
2. The state supervision of public health and radiation safety in case of procedures for radiation therapy performs the Ministry of Health by means of Service of the state supervision of public health.
3. Supervision of safe activities in case of procedures for radiation therapy is exercised by the Ministry of the environment by means of the National agency on regulation of nuclear and radiological activities.
Minister of Health
minister of the environment
Approved by the Order of the Government of the Republic of Moldova of August 24, 2011, No. 632
The sanitary regulations about radiation protection and radiation safety when performing radiation therapy (further - Regulations) are harmonized with the Directive 96/29 of Council Euroatom of May 13, 1996 establishing the main regulations of safety for protection of health of workers and the population against the dangers connected with ionizing radiation, the Directive 97/43 of June 30, 1997 of Council Euroatom on public health care from harmful effects of ionizing radiation in connection with medical radiation, the Directive 2003/122 of Council Euroatom of December 22, 2003 on control over the highly active closed and ownerless sources and also Regulations No. 1493/93 of Council Euroatom of June 8, 1993 about transportations of radioactive materials between state members.
1. These Regulations establish special requirements to ensuring radiation protection of patients, prevention of unreasonable professional radiation of workers and the population from impact of ionizing radiation, to prevention of environmental pollution when holding procedures in radiation therapy.
2. Requirements of these Regulations are applied in departments and offices of radiation therapy of medical and sanitary organizations, research medical institutes, higher educational institutions, professional medical and other specialized agencies which use methods of remote, intracavitary and interstitsialny therapy with technogenic sources and generators of ionizing radiation.
1) Requirements of Regulations extend to activities for designing, construction or reconstruction of departments, offices of radiation therapy and to the actions connected with operation of the existing departments of radiation therapy.
2) Provisions of this regulation are intended for the organizations using the radioactive sources applied in radiation therapy, the public institutions and bodies exercising supervision and control in the field of safety of nuclear and radiological activities, project organizations, the central and local state bodies, the organizations of all patterns of ownership, individual entrepreneurs, the populations.
3) These Regulations are applied to the following types of medical radiation:
a) radiation of patients within medical diagnostics or treatment;
b) radiation of personnel within work medicine;
c) radiation of the population within the program of physical examinations;
d) radiation of the healthy people or patients who are voluntarily participating in medical or medicobiological, diagnostic or therapeutic testings;
e) radiation of the population in case of medicolegal procedures.
4) Accomplishment of provisions of these Regulations is performed within the assignments provided by funds of compulsory medical insurance.
4. The terms applied in these Regulations mean the following:
the accelerator of electrons (further - the accelerator) - electrophysical installation which generates flow of electrons or brake radiation with the maximum energy of more 0,1 of MEV;
the subsequent introduction (afterloading) - method by means of which applicators or the directing tubes are located on the patient before placement (introduction) of radioactive sources to receive exact placement of radioactive sources, and also exact movement of radioactive sources;
quality assurance in radiation therapy - complex of the measures planned and carried out by the owner of permission which purpose is achievement of the expected results of radiation therapy in the conditions of radiation protection and radiation safety of professionally irradiated workers and patients who guarantee the sufficient level of reliability of certain structure, system or component;
interstitsialny method - method of radiation therapy in case of which radioactive material is implanted in volume of target;
superficial application - method of radiation therapy in case of which radioactive material is on the surface of skin or other bodies;
intracavitary application - the radiotherapeutic procedure in case of which radioactive material is placed in anatomic cavity;
permission - the permission issued by competent authorities in document type according to the statement, for accomplishment of the transactions connected with use of radioactive source;
office of dosimetric planning - set of the rooms and the equipment intended for processing of topographical data and calculation of distribution of dose and preparation of plans of radiation by sources of ionizing radiation;
office for simulars of bunch of radiation and individual means of immobilization of the patient - set of the rooms and the equipment intended for forming of bunch of radiation and individual means of immobilization of the patient;
the management room - the room of office of radiation therapy where the control panel, systems of radiation control of radiation and in which audio-video communication with the patient is provided during procedure of radiation therapy, is established;
the room for storage - the room intended for storage, preparation, control and sterilization of radioactive sources. Depending on situation, in the room for storage also the warehouse for storage of radioactive sources can be provided;
procedural office - the room where there is installation for radiation therapy and procedures of radiation therapy are performed;
quality control - package of measures, the carried-out medical institutions or persons authorized for inspection and assessment of parameters of programming, the coordination or implementation of practice aimed at quality assurance the practician of radiation therapy and maintenance or improvement of quality of this control;
professionally irradiated worker - the worker or the employee who performs independent operations and is exposed to the radiation on workplace connected with the practice falling under action of these Regulations and which can receive radiation doses above the limits of doses set for the population;
the operating room - the room intended for implementation of endostat and applicators in the patient's body with monitoring of the correct placement of the available catheters, endostat and applicators by means of use of X-rays or ultrasonography;
department (office) of radiation therapy - set of the premises of medical institution which are specially equipped for holding procedures of radiation therapy;
sievert - the special name for unit of measure of equivalent or effective dose. One sievert is equivalent to one joule on kilogram: 1 Stars = 1 J/kg-1;
system of blocking - functional part of installation which provides immediate shutdown of its functional parts for the purpose of ensuring protection of workers;
system of the alarm system - functional part of installation which provides informing on radiation process, values of capacity of dose in radiation danger areas (workplaces), condition of functional components of installation;
source - the device, radioactive material or installation capable to radiate ionizing radiation or radioactive material;
the closed source is source which structure is executed so that in normal service conditions to interfere with any dispersion of the radioactive material containing in the environment;
the prohibition period - the minimum time between completion of radiation and permission of entrance to procedural office, necessary for decrease in concentration of hazardous substances to the specified levels thanks to ventilation, and also for reducing levels of impact from the induced activity of structural materials and other materials in procedural office to admissible values;
the pupil - the person who has training or professional training within medical institution to perform professional activity;
the controlled area - any area in which is or special measures of protection and safety can be taken for: control of normal radiation and prevention of distribution of pollution under normal conditions work; on prevention and restriction of distribution of potential radiation;
target amount - the geometrical concept used in radiation therapy for the plan of treatment which takes into account effect of movement of the patient and movement of the irradiated fabric, changes of the size and form of fabric, change in bunch geometry, such as the size and the direction of bunch.
5. Provisions of Regulations extend to all types of the equipment used in radiation therapy. Installations for radiation therapy are medical radiological installations, such as:
a) installations with X-rays for teletherapy (external radiation), for contact therapy with the anode voltage up to 100 kV (kilovolts), for superficial therapy with anode voltage about 100 kV, ortovoltazhny therapy with anode voltage of 150-300 kV;
b) gamma-ray irradiation plants for teletherapy (external radiation) with the closed radioactive sources (installations for telekobalto-therapy with source of Kobalt-60);
c) medical linear accelerators (linak) which make bunch of low energy in 4-8 MV (megavolt), bunch of photons of average energy of 10-15 MV and electrons, bunch of photons of high energy of 18-25 MV and electrons;
d) simulators and simulators of computer tomography (further - KT) in radiation therapy on implementation of the plan of treatment;
e) installations for brachytherapy (kyuriterapiya) with the closed sources.
1) Classification by loading types:
a) installations for brachytherapy with manual loading - when the applicator is previously loaded and contains radioactive sources at the time of placement of the applicator on the patient;
b) installations for brachytherapy with the subsequent loading - when establish previously the applicator in target line item on the patient and radioactive sources are loaded later manually (the subsequent manual loading) or automatic installation (installation with remote control).
2) Classification by capacity of dose:
a) installation of brachytherapy with low power of dose (further - LDR);
b) installation of brachytherapy with average capacity of dose (further - MDR);
c) installation of brachytherapy with high capacity of dose (further - HDR);
d) installation of brachytherapy with the pulsing capacity of dose (further - PDR).
3) Classification by the equipment:
a) temporary implant;
b) permanent implant.
4) Classification by contact type:
a) installations with contact radiation;
b) installations with remote radiation.
6. Requirements of Regulations do not extend to activities in radiation therapy with open sources of ionizing radiation.
7. The system of ensuring radiation protection at design stages and operation of departments (offices) of radiation therapy shall provide accomplishment when implementing activities of three basic principles of radiation safety - regulation, reasons and optimization.
8. The principle of regulation is carried out by installation of sanitary standards (within admissible dose of radiation, admissible levels and reference levels) radiation exposure of professional workers and the population.
1) Radiation of each worker shall not exceed the following levels:
a) effective dose 20 mzv (millisievert) a year, average in 5 next years;
b) effective dose 50 mzv in any year on condition that within 5 next years the average dose will not exceed 20 mzv in year;
c) for eye crystalline lens - equivalent dose 150 mzv in year;
d) for skin, hands, hands, foot of legs and shins - equivalent dose 500 mzv in year. This limit is applied to average dose on the area of 1 quarter of cm irrespective of the fact which the surface was irradiated.
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