ORDER OF THE GOVERNMENT OF THE REPUBLIC OF MOLDOVA

of November 3, 2016 No. 1210

About approval of Sanitary regulations on ensuring radiation protection and radiological safety in practicians of nuclear medicine

For the purpose of accomplishment of provisions of part (2) Article 6 and article 72 of the Law on the state supervision of public health No. 10-XVI of February 3, 2009 (The official monitor of the Republic of Moldova, 2009, No. 67, the Art. 183), with subsequent changes and amendments, article 7 of the Law on safe implementation of nuclear and radiological activities No. 132 of June 8, 2012 (The official monitor of the Republic of Moldova, 2012, Art. No. 229-233, 739), and also for ensuring high level of protection of health of the population the Government DECIDES:

1. Approve Sanitary regulations on ensuring radiation protection and radiological safety in practicians of nuclear medicine it (is applied).

2. The regulation and supervision of safe implementation the practician of nuclear medicine are performed by the National agency on regulation of nuclear and radiological activities.

3. The state supervision of public health and radiation by ionizing radiation within the practician of nuclear medicine is performed by the Ministry of Health through the National agency of public health.

4. This resolution becomes effective after 30 days from the date of publication.

Prime Minister

Paweê Phillip

Countersign: Minister of Health

Ruksanda Glavan

minister of the environment

To Valeriu Muntyan

 

Approved by the Order of the Government of the Republic of Moldova of November 3, 2016, No. 1210

Sanitary regulations on ensuring radiation protection and radiological safety in practicians of nuclear medicine

The sanitary regulations on ensuring radiation protection and radiological safety in practicians of nuclear medicine (further – Regulations) create necessary base for application of the Directive 2013/59 Euroatom of the Council of Europe of December 5, 2013 establishing basic regulations of safety for protection against the risks connected with ionizing radiation and the canceling Directive 89/618/Evroatom, 90/641/Евроатом, 96/29/Евроатом, 97/43/Евроатом and 2003/122/Евроатом published in the Official magazine of the European Union (IO) No. L13/1 of January 17, 2014 and application of Regulations of Council No. 1493/93/Evroatom of the June 8, 1993 about transportations of radioactive materials between state members published in the Official magazine of the European Union (IO) No. L148/1 of June 19, 1993.

Chapter I. General provisions

1. These Regulations establish special requirements to ensuring radiation protection of patients, personnel, the population and the environment when conducting diagnostic testings of in vivo with introduction of radio pharmaceutical medicines in organism of patients. The regulations establish also use of set of reagents for the radio immune analysis of in vitro for the purpose of diagnostics.

2. The regulations are intended for establishment of requirements for ensuring radiation protection and radiological safety of patients, to prevention of impact of ionizing radiation on professionally irradiated workers and the population, to the prevention of environmental pollution when carrying out researches using radiopharmaceuticals.

3. Provisions of these Regulations extend on:

1) departments, laboratories of nuclear medicine of medical and sanitary organizations, research establishments, organizations of university and professional education and profile medical institutions where methods of nuclear medicine are applied;

2) the regulating body for supervision and control in the field of nuclear and radiological activities; public institutions and bodies in the field of safety in nuclear and radiological activities; the organizations using the open sources of ionizing radiation applied in nuclear medicine; the public institutions and bodies equipped with functions of supervision and control in the field of nuclear and radiological activities; central and local state bodies; project organizations; the organizations and the companies, irrespective of type of property and form of business;

3) the organizations performing assessment, accounting and control of doses of radiation of patients and professionally irradiated personnel from ionizing radiation.

4. Provisions of these Regulations are applied at design stages, placements, constructions, reconstruction and operation of departments, laboratories, rooms of nuclear medicine.

5. The concepts and determinations used in these Regulations are established by the Law on the state supervision of public health No. 10-XVI of February 3, 2009 and the Law on safe implementation of nuclear and radiological activities No. 132 of June 8, 2012.

6. The concepts used in these Regulations have the following values:

quality assurance in nuclear medicine – set of the events planned and held by the owner of radiological authorization (permission) which purpose is achievement of the set researches with radiopharmaceuticals in the conditions of the ensuring radiological safety, radiation protection of personnel and patients aimed at providing guarantee of appropriate level of quality in structure, system or component;

the room of deactivation – the room intended for the deactivation of ware, medical tools and other objects used during the work with radiopharmaceuticals;

procedural – the room intended for introduction of radiopharmaceuticals in the patient's organism;

the radiometric room – the room intended for radiometry of separate bodies, fabrics and all body of the patient;

packing – the room intended for accomplishment of technological procedures, preparation, packing and preparation of the radiopharmaceuticals intended for introduction in the patient's organism including procedures with use of radio nuclide generators;

The PET-center – the specialized division of radio nuclide diagnostics of in vivo intended for holding procedures of PET-diagnostics and production of pozitronnoizluchayushchy radiopharmaceuticals with control of their quality;

quality control – system of organizational actions, technical means and technological procedures for quantitative determination, monitoring and maintenance at optimum levels of work characteristics of the radio diagnostic equipment, the modes of radio diagnostic testings, and also parameters of quality of radiopharmaceuticals.

diagnostics radio nuclide in vivo – establishment of availability, nature and prevalence of pathological process in the patient's organism on the basis of visualization of images and/or determination of characteristics of existential distribution of the radiopharmaceutical entered into the patient's body;

storage of radioactive waste – set of all rooms, intended for temporary storage of solid and liquid radioactive waste for the purpose of their endurance on radioactive decay and/or their accumulatings for the subsequent centralized removal;

storage of radiopharmaceuticals – the room intended for temporary storage of the radiopharmaceuticals prepared for introduction, arriving in finished form or prepared in laboratory of radiopharmaceuticals for the purpose of diagnostics of in vivo;

the gamma camera – the stationary or portable installation for stsintigrafiya which is turning on the position sensitive detector for gamma radiation, the shtativny device, the patient's bed, electronic path of transformation of signals of the detector and the computer for reconstruction and visualization of scintigraphic images;

the gamma tomograph – the stationary installation for one-photon issued computer tomography containing one or several sensitive detectors of gamma radiation, the shtativny device with the mechanism of rotation of detectors around longitudinal axis, the patient's bed, electronic path of transformation of signals of detectors and the computer for reconstruction and visualization of tomographic images;

generators radio nuclide – portable devices with local radiation protection for bystry receipt of short-lived radionuclides in the conditions of medical institution;

means of radiation protection stationary – the elements, building constructions and the protective equipment intended for protection of personnel and patients from external radiation, inhalation or intake of radioactive materials in organism;

means radiation individual protection – the technical means intended for protection of personnel when carrying out radiological inspections for protection of body or separate bodies during the profile researches;

radiopharmaceuticals – the pharmaceutical medicines and connections with radionuclides registered by the Ministry of Health, work and social protection, allowed for use for diagnosis of various diseases according to Article 24 and part (2) article 43 of the Law No. 10-XVI of February 3, 2009 on the state supervision of public health;

procedures in nuclear medicine – diagnostic procedures with introduction in organism of the patient of radiopharmaceuticals;

stsintigrafiya – the diagnostic procedure performed on the gamma camera for visualization of images, projections, spatial distribution of radiopharmaceuticals in the patient's body (static stsintigrafiya) or registration of the characteristics of stationary (existential) distribution of radiopharmaceuticals changing in time in the patient's body;

tomography positron issued PET – (positron and issued tomography) – the reduced name of tomography on the basis of positron issue. PET is one of the most modern methods of visualization of images in the medical purposes. It is the diagnostic procedure of visualization of spatial distribution of the positron radiating radiopharmaceutical in the patient's body at the annihilation radiation.

7. The system of ensuring radiation protection at design stages and operation of departments of nuclear medicine shall provide implementation in practice of the following basic principles of radiological safety: regulation, reasons and optimization.

8. The principle of regulation is performed by setting standards (maximum-permissible doses of radiation, admissible levels and reference levels) of radiation exposure of personnel and the population.

The Limit of admissible effective dose of radiation for personnel constitutes 1) 20 m3v in year. Nevertheless in particular cases or in case of certain situations of radiation higher effective dose to 50 m3v can be resolved by competent authority within one year provided that average annual dose for any period within five next years including in years when the limit of doses was exceeded, shall not exceed 20 m3v.

2) Along with limits of the effective doses provided by the subitem 1) limits of equivalent dose are applied:

a) the limit of equivalent dose for crystalline lens constitutes 20 m3v in one year or 100 m3v for any period within five next years in case of the maximum dose 50 m3v within one year;

b) the limit of equivalent dose for skin constitutes 500 m3v in year; this limit is applied to average dose to any surface in 1 cm 2, irrespective of the irradiated surface;

c) the limit of equivalent dose for extremities constitutes 500 m3v in year.

The limit of effective dose constitutes 3) For radiation of the population 1 m3v in year.

4) Along with limit of the doses provided by the subitem (3), the following limits of equivalent dose are applied:

a) the limit of equivalent dose for crystalline lens constitutes 15 m3v/year;

b) the limit of equivalent dose for skin constitutes 50 m3v in year, calculated as average for any surface in 1 cm 2, irrespective of the irradiated surface.

5) the Owner of radiological authorization provides limit of effective dose for pupils at the age of 16-18 years and for students at the age of 16-18 years which shall work with radiation sources in laboratories of nuclear medicine during study, 6 m3v/year.

6) Along with limit of the effective dose provided by the subitem (5), the following limits of equivalent dose are applied:

a) the limit of equivalent dose for crystalline lens constitutes 15 m3v/year;

b) the limit of equivalent dose for skin constitutes 150 m3v in year, calculated as average for any surface in 1 cm 2, irrespective of the irradiated surface;

c) the limit of equivalent dose for extremities constitutes 150 m3v/year.

7) the Owner of radiological authorization shall provide protection of fruit, comparable with protection which is provided for the population. Since that moment when the permanent worker or the external worker reports to administration of organization about pregnancy, organization or the employer provide such working conditions for the expectant mother that the equivalent dose of radiation of fruit was minimum and did not exceed 1 m3v for the remained pregnancy period.

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