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ORDER OF THE GOVERNMENT OF THE REPUBLIC OF MOLDOVA

of July 24, 2015 No. 451

About approval of the Regulations on radiation protection and radiation safety in diagnostic radiology and intervention radiology

Based on Item and) article 7 of the Law No. 132 of June 8, 2012 on safe implementation of nuclear and radiological activities (The official monitor of the Republic of Moldova, 2012, Art. No. 229-233, 739) DECIDES: the Government

1. Approve Regulations on radiation protection and radiation safety in diagnostic radiology and intervention radiology it (is applied).

2. Requirements to radiological safety during the designing, production and import of radiological installations will be applied to the acquired installations after entry into force of this provision.

Temporarily acting as Prime Minister

Natalia Hermann

Countersign:

minister of the environment

 

Sergey Palikhovich

Minister of Health

Mircha of Bug

Approved by the Order of the Government of the Republic of Moldova of July 24, 2015 No. 451

Regulations on radiation protection and radiation safety in diagnostic radiology and intervention radiology

Chapter I. Basic provisions

1. The this provision purpose about radiation protection and radiation safety in diagnostic radiology and intervention radiology (further - the Provision) consists in establishment of requirements radiation protection and radiation safety to practicians of diagnostic radiology and intervention radiology and partial transposition of the Directive of the Council of Europe 2013/59/Euratom of December 5, 2013, the safety establishing the main regulations for protection against the dangers arising from impact of ionizing radiation, and recognition voided Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and 2003/122/Euratom, published in the Official magazine of the European Union by L 13 of January 17, 2014.

2. This Provision is applied to the practicians of diagnostic radiology and intervention radiology integrated to risk of radiation by ionizing radiation when using x-ray installations and regulates radiation: medical, professional, the populations, including potential radiation.

3. In this Provision concepts of the following content are used:

the controlled area – rooms in which there are built-in x-ray installations and mobile x-ray installations which are subject to special regulation for the purpose of protection against ionizing radiation, access to which is controlled;

the observation zone – means the zone which is subject to observation for the purpose of protection against ionizing radiation;

practice of intervention radiology – means use the technician of x-ray visualization for simplification of introduction and the direction of devices in human body for the purpose of diagnostics or treatment;

practice of diagnostic radiology – means use of x-ray installations for the purpose of diagnostics;

radiodiagnosis – the practice connected with diagnostic nuclear medicine (in-vivo), medical diagnostic radiology with use of ionizing radiation, and also dental radiology.

Chapter II. Scope and responsibility

4. In each department of radiology and/or medical visualization in which practice of diagnostic radiology and intervention radiology is performed the culture of safety takes root.

5. For accomplishment of the relevant requirement the owner of the radiological permission issued by National agency on regulation of nuclear and radiological activities (in further - the National agency), develops and implements the quality assurance program of diagnostic radiology and intervention radiology (further - POK). Content of POK is provided in appendix No. 1 to this Provision.

6. Requirements of radiation protection concerning reasons for practice of radiology, limiting doses of radiation and optimization of protection and restriction of doses are applied to practicians of diagnostic radiology and intervention radiology by observance of the following conditions:

1) all practicians of medical radiation with use of x-ray radiation shall be proved by the comparative analysis of the diagnostic value received from this type of practice and harm which can put x-ray radiation, in view of advantage and risks of available alternative means without radiation with x-ray radiation;

2) limits of doses are applied to the personnel irradiated owing to professional activity, the trainees, expectant mothers irradiated owing to professional activity, and the population; limits of doses are not applied to medical radiation of patients;

3) in case of accomplishment of X-ray diagnostic testings, optimization of protection by application to the patient of the minimum doses of radiation necessary for required research.

7. The owner of radiological permission provides application of this provision by acceptance of qualified personnel to the sphere of radiation protection and the radiation safety having permission to the admission according to provisions of article 23 of the Law No. 132 of June 8, 2012 on safe implementation of nuclear and radiological activities (further - the Law No. 132 of June 8, 2012).

8. The owner of radiological permission at all stages of practice, from designing, construction, installation, operation, storage, before removal from operation:

Develops 1), implements and approves POK, according to nature and scale of the risks connected with radiological practice;

Appoints 2) the order for organization or for each certain controlled area responsible for radiation protection;

3) provides continuous professional training of personnel. The training of personnel corresponding to the appointed obligations comes to the end prior to accomplishment of professional radiological activity. Preparation is performed every time when the operated x-ray installations, functional obligations, regulating documents, conditions and terms of permission and the procedure of radiation safety significantly change;

4) provides necessary temporary resources, personnel and the budget for implementation of effective POK.

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