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Ministry of Justice of Ukraine

September 3, 2015

No. 1054/27499

ORDER OF THE STATE INSPECTION OF NUCLEAR REGULATION OF UKRAINE

of August 13, 2015 No. 148

About approval of Requirements and safety conditions (licensed conditions) of implementation of activities for production of sources of ionizing radiation

According to Articles 8, 24 Laws of Ukraine "About use of nuclear energy and radiation safety" and according to the subitem 7 of item 4 of the Regulations on the State inspection of the nuclear regulation of Ukraine approved by the resolution of the Cabinet of Ministers of Ukraine of August 20, 2014 No. 363, for the purpose of ensuring state regulation of safety of use of nuclear energy order:

1. Approve Requirements and safety conditions (licensed conditions) of implementation of activities for production of sources of ionizing radiation which are applied.

2. Declare invalid the order of the Ministry of Ecology and Natural Resources of Ukraine of March 20, 2001 No. 111 "About approval of Conditions and rules of implementation of activities for production of sources of ionizing radiation", registered in the Ministry of Justice of Ukraine on April 11, 2001 for No. 334/5525.

3. To management of radiation safety (Ryazantsev V. F.) provide submission of this order to the Ministry of Justice of Ukraine in the procedure established by the legislation.

4. This order becomes effective since January 01, 2016.

5. To impose control over the implementation of the order on the vice-chairman Kilochitskaya T. P.

Chairman

S. Bozhko

 

Approved by the Order of the State inspection of nuclear regulation of Ukraine of August 13, 2015 No. 148

Requirements and safety conditions (licensed conditions) of implementation of activities for production of sources of ionizing radiation

I. General provisions

1.1. These Licensed conditions (further - Conditions) establish the main requirements and safety conditions of implementation of activities for production of sources of ionizing radiation (further - III).

1.2. These Conditions are obligatory for accomplishment by the licensees performing activities for production of III.

1.3. Work types belong to activities for production of III:

practices of radioactive isotopes, the irradiated samples and materials, isotopes as radiopharmaceuticals;

production of the closed and open radio nuclide III, the generating devices of medical, industrial and scientific function;

production of devices, installations, the equipment which are completed with radio nuclide isotopes;

temporary storage of the made III;

sale of self-produced III;

maintenance and repair of self-produced III.

1.4. In these Conditions terms are used in the values given in the Laws of Ukraine "About use of nuclear energy and radiation safety", "About allowing activities in the field of use of nuclear energy", "About protection of the person against influence of ionizing radiation" and other regulatory legal acts in the field of use of nuclear energy.

II. Requirements of implementation of activities for production of sources of ionizing radiation

2.1. The licensee performs activities for production of III on condition of obtaining in the procedure for license for activities established by the legislation on production of III (further - the license).

2.2. The licensee carries out the analysis of safety of implementation of activities for production of III and prepares the report by results of this analysis according to the Requirements to the report on the analysis of safety of implementation of activities for production of sources of ionizing radiation approved by the order of the State committee of nuclear regulation of Ukraine of August 17, 2001 No. 62, registered in the Ministry of Justice of Ukraine on August 31, 2001 at No. 774/5965.

2.3. The licensee determines qualification requirements to personnel and provides carrying out training and examination concerning radiation safety according to the Procedure for carrying out training and examination concerning radiation safety at personnel and officials of subjects of separate types of activity in the field of use of nuclear energy (further - the Procedure) approved by the order of the State inspection of nuclear regulation of Ukraine of October 2, 2014 No. 143, registered in the Ministry of Justice of Ukraine on December 2, 2014 at No. 1549/26326.

2.4. The licensee develops, implements management system activities according to:

The general requirements to management system activities in the field of use of nuclear energy approved by the order of the State inspection of nuclear regulation of Ukraine of December 19, 2011 No. 190, registered in the Ministry of Justice of Ukraine on January 10, 2012 on No. 17/20330;

The requirements to quality management system of holding diagnostic and therapeutic procedures with use of sources of ionizing radiation approved by the order of the State committee of nuclear regulation of Ukraine of October 03, 2008 No. 166, registered in the Ministry of Justice of Ukraine on October 29, 2008 on No. 1054/15745 (in case of production of III of medical appointment).

2.5. The licensee according to management system activities (quality manual) creates and provides functioning:

information collection systems about safety of operation, technical maintenance, repair, dismantle and storage of III on objects of customers;

exchange of information with customers of III about information transfer about emergence of radiation accidents with III, suggestions for improvement of design and operational characteristics of III from the point of view of ensuring their safety.

2.6. The licensee when implementing activities provides availability:

organizational structure and qualified personnel for maintenance of proper level of safety of production of III;

financial, material and other resources for ensuring level of safety of production of III provided by regulations, rules and standards on radiation safety, physical protection and also the activities implementation conditions specified in the license.

2.7. The licensee the orders appoints persons responsible for:

observance of regulations, rules and standards on radiation safety;

development, implementation and efficiency analysis of management system activities for production of III (creation, implementation and functioning of the quality system), development of actions for its enhancement;

organization and conducting radiation control (including individual radiation control);

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