LAW OF THE REPUBLIC OF MOLDOVA

of October 20, 2022 No. 289

About the main requirements in the field of radiation safety

This law partially shifts the Directive of Council 2013/59/Evratom of December 5, 2013, establishing the main regulations of safety for protection against ionizing radiation and canceling Directives 89/618/Evratom, 90/641/Evrat, 96/29/Evrat, 97/43/Evrat and 2003/122/Evrat, published in the Official magazine of the European Union by L 13 of January 17, 2014.

The Parliament adopts this organic law.

Chapter I General provisions

Article 1. Subject of the law

This law establishes the main safety requirements on protection of human health as a result of professional and medical radiation and radiation of the population, and also from the dangers caused by ionizing radiation.

Article 2. Scope of application

(1) Provisions of this law are applied to all planned, existing or to the emergencies of radiation attracting the risk caused by impact of ionizing radiation which cannot be neglected from the point of view of radiation protection or environmental protection for the purpose of long-term health protection of the person.

(2) This law is applied, in particular, in the relation:

1) all types of activity listed in article 3 of the Law on safe implementation of nuclear and radiological activities No. 132/2012 (further - the Law No. 132/2012), and also concerning the types of activity established by the regulations approved by the Government;

2) production and operation of any electric equipment emitting ionizing radiation and containing the components operating in case of potential difference more than 5 kilovolts (kV);

3) the activities of the person connected with availability of natural sources of ionizing radiation which lead to significant increase in level of radiation of workers or the populations, in particular:

a) operation of aircrafts and spaceships from the point of view of radiation of crew;

b) conversion of the materials containing natural radionuclides;

4) radiations of workers or the population radon in rooms, external radiation from construction materials and cases of long radiation owing to long-term effects of emergency or the previous activities of the person;

5) readiness for the emergency situations connected with radiation, planning of reaction and management of situations, acknowledged proved for protection of health of the population or workers.

Article 3. Exception of scope of application

This law is not applied in case:

a) radiations as a result of natural radiation background, as, for example, availability of radionuclides in human body and the dominating space radiations at the surface of the soil;

b) radiations of the population or workers, except for crews of aircrafts or spaceships owing to impact of space radiation in flight or in space;

c) radiations at the surface of the soil radionuclides from the raw crust.

Chapter II of the Concept

Article 4. Concepts

For the purposes of this law in addition to the concepts determined in article 4 of the Law No. 132/2012, the following concepts are used:

the accelerator of particles - the equipment or installation in which charged particles accelerate, emitting ionizing radiation with energy more than 1 mega-electron-volt (MEV);

activation - process of transformation of stable nuclide to radionuclide by radiation of material in which it contains, high-energy particles or photons;

practical aspects of medical radiological procedures - physical carrying out medical radiation and any adjacent aspects, including the handling of the medical radiological equipment and its use, assessment of technical and physical parameters (including radiation doses), calibration of measuring devices and maintenance of the equipment, production and introduction of radio pharmaceutical medicines and processing of pictures;

boundary dose - the restriction set in the form of the predicted extreme value of individual dose, used for determination of the range of the options considered in the course of optimization of certain source of radiation in situation of the planned radiation;

source container - set of components which are not integral part of source and are intended for ensuring sealing of the closed radioactive source and for protection of source during transportation and the treatment of him;

pollution - inadvertent or undesirable availability of radioactive materials on surfaces or in solid bodies, liquids or gases or in human body;

quality control - set of the transactions (planning, coordination, realization) directed to maintenance or improvement of quality. Includes monitoring, assessment and maintenance at the required level of all operational characteristics of the equipment which can be determined, measured and checked. Quality control is part of system of quality assurance;

regulating control - any form of control or regulation applied to activities of the person to ensuring compliance with radiation protection;

physical examination (medical screening) - the procedure using medical radiological installations for early diagnosing of the groups of persons subject to risk;

the absorbed dose (D) - for the purpose of this law represents average dose of radiation of fabric or body. Unit of measure of the absorbed dose is heat (Гр);

equivalent dose (HT) - the dose absorbed by fabric or body increased by the corresponding weighing coefficient for this type of radiation. Unit of measure of equivalent dose is sievert (Stars);

the effective dose (E) is the amount of the weighed equivalent doses absorbed by all fabrics and bodies of organism received in case of internal and external radiation. Unit of measure of effective dose is sievert (Stars);

evacuation (emission) in the environment - the planned and controlled (permitted) emission of radionuclides in the environment answering to all conditions provided by regulations;

significant event - the situation connected with accidental or inadvertent radiation;

the medical physicist expert - person who has necessary knowledge, professional training and experience for provision of consultations in the field of radiation physics in relation to medical radiation and whose competence is acknowledged as National agency on regulation of nuclear and radiological activities (further - the National agency);

radiation - action or conditions of impact of ionizing radiation from the source which is out of body (external radiation) or in body (internal radiation);

accidental radiation - radiation of persons who are not employees of emergency services as a result of accident;

radiation by radon - radiation by products of disintegration of radioactive gas of radon;

medical radiation - impact to which the patients or persons who are not finding disease symptoms within medical diagnostics or the treatment which is carried out for the purpose of improvement of the state of health and also radiation to which persons performing care of patients and support of patients or volunteers within the medical or medicobiological researches are exposed are exposed;

potential radiation - radiation which cannot be expected with absolute confidence, but which can become result of event or series of events of probable nature, including consequence of equipment failure or mistake in case of operation;

extremities - palm, forearm, foot and anklebone;

the radiation generator - the device capable to generate ionizing radiation, such as gamma-rays (x-ray emission), neutrons, electrons or other charged particles;

medical radiological installation - installation on which medical radiological procedures are performed;

implementation - general activity of the radionuclide getting to organism from external environment;

dose limit - the size of effective dose (where it is applicable, the expected effective dose) or equivalent dose for certain period which is not exceeded for person;

the irradiated worker - the person working on hiring or performing independent activities who is exposed to radiation on workplace as a result of the practice falling under operation of this law and who can be exposed to radiation in the doses exceeding one of the limits of dose set for radiation of the population;

the freelance employee - any worker subject to radiation who is not hired by the authorized physical person or legal entity responsible for zones of observation and control, but which performs activities in these zones, including pupils and students;

the emergency worker - any person to whom accurately certain part in emergency is assigned and who can be affected by radiation during taking measures in case of response to the corresponding emergency;

construction material - any construction products intended for inclusion on permanent basis in structure of the building or in its part which characteristics influence characteristics of the building from the point of view of impact on living in it ionizing radiation;

protective measures - measures others, than recovery, undertaken in avoidance or for reducing doses which could be received for lack of adequate measures, in situation of emergency radiation or in situation of the existing radiation;

recovery measures - removal of source of radiation or reduction of its intensity (in values of activity or quantity) either suppression of ways of radiation or decrease in extent of its impact in avoidance or for the purpose of reducing doses to which subjects could be exposed for lack of these measures in situation of the existing radiation;

radiation monitoring of the environment - measurement of capacities of dose of the external radiation caused by radioactive materials in the environment, or concentration of radionuclides in the main components of the environment;

the spaceship - the piloted aircraft intended for functioning at the height more than 100 km above sea level;

index level - in situation of emergency radiation or the existing radiation is the level of effective or equivalent dose or the absorbed dose or concentration of activity, is higher than which it is considered unacceptable to allow radiation as a result of the corresponding situation of radiation even if it is not limit which cannot be exceeded;

withdrawal levels - the values established by competent authorities or regulations, expressed in terms of concentration of activity in case of which and below which the materials received as a result of the activities which are subject to the notification or authorization can be exempted from observance of the requirements established by this law;

diagnostic index levels - levels of doses in radio diagnostic or intervention medical practicians or, in case of radio pharmaceutical medicines, activity levels for regular inspections of groups of standard patients or standard medical phantoms simulators for wide range of types of the equipment;

the authorized physical person or legal entity - any physical person or legal entity which according to regulations bears legal responsibility for implementation of practice or for radioactive source (including cases when the owner or the holder of radioactive source does not perform the activities connected with radiation of the person);

representative person - person receiving representative dose among the most irradiated persons of the population, except for persons with extreme or unusual occupations;

persons performing leaving and support of patients, - persons, consciously and voluntarily affected by ionizing radiation in case of assistance outside the profession, with support and care of persons which are exposed or exposed to medical radiation;

personnel of category A - persons as they are determined in the Law No. 132/2012;

personnel of category B - the workers who are exposed to radiation who do not fall under category A;

the plan of reaction in emergencies - measures for planning of the corresponding reaction in the situations of emergency radiation based on the simulated events and the accompanying scenarios;

the population - persons who can be subjected to mass radiation;

practice - activities of the person when which implementing radiation of persons from source of ionizing radiation can increase and which is controlled as situation of the planned radiation;

the practicing doctor - the doctor, the stomatologist or other person with medical qualification, authorized to undertake clinical responsibility for individual medical radiation according to national requirements;

conversion - chemical, physical or other transactions with radioactive materials, including production, conversion, enrichment of the sharing or reproduced nuclear materials and secondary conversion of spent fuel;

the medical radiological procedure - any procedure attracting medical radiation;

consumer goods - any manufactured device or element into which are purposely entered one or more radionuclides or are manufactured by activation one or several radionuclides or which generate ionizing radiation and which can be on sale or be provided to the population without special supervision or after-sale regulating control;

radiodiagnosis - the activities connected with in-vivo the diagnostic nuclear medicine, medical diagnostic radiology using ionizing radiation including with dental radiology;

intervention radiology - use the technician of x-ray visualization for simplification of introduction of devices and management of them in body of the person for the diagnostic or medical purposes;

medical radiology - the activities connected with radio diagnostic and radiotherapeutic procedures, with intervention radiology or other types of medical use of ionizing radiation for the purpose of planning, management and check;

radiotherapeutic - connected with radiotheraphy, including with nuclear medicine for the therapeutic purposes;

radon - Rn-222 radionuclide and on circumstances products of its disintegration;

service of medicine of work - the health worker or body of health care, competent to perform medical observation of the irradiated workers and whose powers in this plan are acknowledged as body of the central public management in the field of health care;

dosimetric service - any organization or physical person or legal entity which competences include setup, reading or interpretation of indicators of devices of individual monitoring, measurement of radioactivity of body of the person or biological samples or determination of doses whose powers are in this respect acknowledged the National agency;

management system radiation emergency - the legal or administrative basis establishing obligations on readiness and reaction in emergency and also procedure for decision making in situations of emergency radiation;

the situation of the existing radiation - radiation situation which already exists for a moment when it is necessary to make the decision on establishment of control over it and which does not require or does not require acceptance of urgent measures any more;

situation of the planned radiation - radiation situation as a result of the planned use of source of radiation or owing to activities of the person which change ways of radiation, leading thus to radiation or potential radiation of the population or the environment. Situations of the planned radiation can include both normal radiation, and potential radiation;

situation of emergency radiation - radiation situation as a result of radiation accident;

storage - storage of radioactive materials, including the fulfilled nuclear fuel, radioactive sources or radioactive waste in installation, with recuperation intention;

natural source of radiation - source of ionizing radiation of terrestrial or space origin;

the closed radioactive source - radioactive source in which radioactive material is constantly put into the capsule or is included in structure of firm form for the purpose of prevention, under normal conditions uses, any dispersion of radioactive materials;

the closed radioactive source of high activity - the closed radioactive source for which activity of the containing radionuclide exceeds or is equal to the value of activity referred to categories I-III;

the closed radioactive source (the fulfilled source) withdrawn from the use - the closed radioactive source which was any more not used or not planned to use for authorized practicians, but concerning which need of safe management remains;

control zone - zone in which the special rules developed for protection against ionizing radiation or spread of radioactive infection, and access to which is controlled, are effective;

observation zone - zone in which observation for protection against ionizing radiation is performed;

the pupil - person taking course of professional training or instructing on the authorized nuclear/radiation object for the purpose of occupation professional activity in the field.

Chapter III System of radiation protection

Article 5. General principles of radiation protection

The general principles of radiation protection established by this law, the following:

a) justification - decisions on implementation of certain practice come true in the sense that relevant decisions are accepted with intention to provide the fact that the advantages got in result of this practice for individuals and society in general will exceed possible negative effects for health. Decisions on implementation or change of way of radiation in situations of the existing radiation and in situations of emergency radiation are justified in the sense that they shall bring more benefit, than harm;

b) optimization - radiation protection of persons which are exposed to professional radiation or the populations is optimized with the purpose to keep values of individual doses, probability of radiation and the number of persons subject to radiation at the lowest level, taking into account the current level of technical knowledge, economic and social factors. Optimization of protection of persons which are exposed to medical radiation is applied to value of individual doses and answers the medical purpose of radiation as it is provided by Article 56 provisions. This principle is applied not only in that, as for effective doses, but if necessary and to equivalent doses as precautionary measure for accounting of some uncertainty connected with adverse effect is one health lower than extreme value for fabric reactions;

c) restriction or standardization of doses - in situations of the planned radiation the amount of doses to which the person is exposed shall not exceed the dose limits provided for professional radiation or radiation of the population. Limits of dose (standardization) are not applied in case of radiation to the medical purposes.

Part 1 Instruments of optimization

Article 6. Boundary dose for professional radiation, radiation of the population and medical radiation

(1) the Boundary dose is applied for the purpose of the predicted protection optimization as follows:

a) for professional radiation the boundary dose is established as the operational tool for protection optimization by the authorized physical person or legal entity under general supervision of competent authority. In case of freelance employees the boundary dose is established in cooperation between the employer and the authorized physical person or legal entity;

b) for radiation of the population the boundary dose is established for the individual dose received by the population as a result of the planned operation of specific source of radiation. The national agency guarantees that boundary doses correspond to dose limit by total quantity of the doses received by the same person from all authorized the practician;

c) to medical radiation the boundary dose is applied only to protection of persons involved in leaving and support of patients, and the volunteers participating in medical or biomedical researches.

(2) Boundary doses are established depending on indicators of the effective or equivalent individual doses received by the person for certain corresponding period of time.

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