of December 5, 2007 No. 1382
About approval of the Technical regulation of the closed sources of ionizing radiation
According to article 14 of the Law of Ukraine "About standards, technical regulations and assessment procedures of compliance" the Cabinet of Ministers of Ukraine decides:
1. Approve the Technical regulation of the closed sources ionizing the radiation and the actions plan on application of the Technical regulation of the closed sources of ionizing radiation which are applied.
2. Determine that the Technical regulation of the closed sources of ionizing radiation is applied by subjects of activities in the field of use of nuclear energy in voluntary procedure till 2011 inclusive, and since 2012 surely.
Prime Minister of Ukraine
V. Yanukovych
Approved by the Resolution of the Cabinet of Ministers of Ukraine of December 5, 2007, No. 1382
General provisions
1. This Technical regulation determines the main requirements to the closed sources ionizing radiation concerning ensuring radiation protection of personnel and the population, the surrounding environment from influence of ionizing radiation, and also assessment procedure of compliance of such sources to the established requirements and procedure for their appendix.
2. In this Technical regulation terms are used in the following value:
the closed source ionizing radiations (further - the closed source) - the radioactive material which is completely packed into firm protective cover from the non-radioactive material and/or the vytoka of substance encapsulated in rather strong protective cover for prevention under the corresponding service conditions during fixed term of service and also in unexpected conditions is also component of such source;
the module of assessment procedure of compliance (further - the module) - complex of the approved assessment procedures of compliance of products to the established requirements.
Service life of the closed source - the term of possible use of the specific closed source established by the producer from the moment of its production in case of which end use of such source shall be stopped. In case of confirmation of the fact of preserving radiation characteristics, hermeticity and lack of defects, their signs on the closed source its service life can be prolonged in the procedure established by the legislation.
Other terms are applied in the value given in the Laws of Ukraine "About use of nuclear energy and radiation safety", "About standardization", "About confirmation of conformity", "About standards, technical regulations and assessment procedures of compliance", "About accreditation of conformity assessment bodies".
3. Action of the Technical regulation extends to all closed sources of national or foreign production which are not exempted in the procedure established by the legislation from the regulating control.
4. The closed sources are introduced into circulation in the territory of Ukraine on condition of confirmation of their compliance to requirements of this Technical regulation.
The producer identifies the closed source by engraving or pro-stamping on it own number, markings is familiar to radiation hazard and in case it is impossible, applies sign of radiation hazard on container of the closed source (the external surface of packaging), specifies source type, radionuclide and its activity.
If the closed sources are imported or exported from Ukraine, the supplier provides drawing on the closed source of own number, sign of radiation hazard or information on container of the closed source on source type, radionuclide and its activity.
The owner shall be convinced that each closed source has the documents confirming its identification and marking, and also pictures or other schemes or drawings of source, its container, shipping package, the device, equipment and so forth.
The main technical requirements to the closed sources
5. The closed sources shall:
have design which under proper service conditions ensures radiation safety in places of operation and storage, and number which proshtampovyvatsya on source and its container. If the container of reusable use is used, on it information on source type is placed;
be produced according to standards and specifications on specific type of the closed source, other technological documentation approved in accordance with the established procedure;
be hermetically sealed (level of hermeticity is determined by application of one of radiometric or not radiometric methods in accordance with the established procedure);
answer the purpose and the main technical requirements.
Under the conforming service conditions the main technical requirements to the closed sources shall be fulfilled during fixed term of service.
Assessment procedure of compliance
6. Assessment of conformity of the closed source to requirements of this Technical regulation (further - assessment of conformity) is carried out by the producer or resident person of Ukraine authorized by it by declaring or the conformity assessment body appointed in the procedure established by the legislation - by use of modules according to the Technical regulation of modules of assessment of conformity approved by the resolution of the Cabinet of Ministers of Ukraine on October 7, 2003 No. 1585 (The Official Bulletin of Ukraine, 2003, No. 41, Art. 2175; 2011, No. 67, the Art. 2581), with the subsequent issue of the certificate of conformity of the closed source.
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