Decree No. 317 / 2002 Coll.
Decree of the State Office of Nuclear Safety on the type approval of packaging packages for the transport, storage and storage of nuclear materials and radioactive substances, on the type approval of sources of ionising radiation and on the transport of nuclear materials and designated radioactive substances (type approval and transport)
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Order
Effective from 18.07.2002
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317
DECLARATION
State Office for Nuclear Security
of 13 June 2002
on the type-approval of packages for the transport, storage and storage of nuclear materials and radioactive substances, the type-approval of sources of ionising radiation and the transport of nuclear materials and of designated radioactive substances (type-approval and transport)
According to § 47 (7) of the Act, the State Nuclear Safety Authority provides for the implementation of § 9 (1) (m) and (p), § 13 (3) (d), § 20 (1) (b) and (d) and § 23 of Act No. 18 / 1997 Coll., on the Peaceful Use of Nuclear Energy and Ionising Radiation (Atomic Act), and amending and supplementing certain laws, as amended by Act No. 13 / 2002 Coll., ("the Act '):
Subject matter
This Order
(a) provide for the details and procedure for the type-approval of packaging files for the transport or storage of nuclear materials and radioactive substances and sources of ionising radiation, the verification and documentation of their conformity with the approved type;
(b) specify the nuclear materials and radioactive substances for which authorisation, method of transport security, content, scope and manner of implementation of the approved dossier which is part of the application for authorisation is required;
(c) regulates, in accordance with European Community law, the scope and modalities of international shipments of radioactive waste and the closed September (1)
TYPE APPROVAL
Type-approved products
(Paragraph 23 (1) of the Law)
(1) Type-approval shall be subject to:
(a) such types of packaging for the transport, storage and storage of nuclear materials and radioactive substances
1. packaging files of type IP - 1, IP - 2 and IP - 3 for transporting nuclear materials,
2. packaging packages for the transport of 0,1 kg or more of uranium hexafluoride;
3. Type of packaging files And for the transport of nuclear materials,
4. type B (U), B (M) and C packaging packages for the transport of nuclear materials and radioactive substances;
5. type D packaging files for storage of spent or irradiated nuclear fuel or radioactive waste resulting from its reprocessing;
6. S-type packaging sets intended for storage of nuclear materials and radioactive substances, for radioactive substances of specific forms whose activity exceeds A1 values, or for radioactive substances other than specific forms whose activity exceeds A2 values. The values A1 and A2 are given in Table 1 (I.) of Annex 3,
(b) radioactive substances of specific forms, which are solid non-dispersive radioactive substances or radioactive substances in a tightly closed housing and radioactive substances with a low dispersiveness, which are radioactive substances in solid form having a limited capacity to disperse, or radioactive substances in a closed housing;
(c) sources of ionising radiation
1. radiation generators, except non-significant sources of ionising radiation,
2. closed radionuclide radionuclide lamps and devices containing closed radionuclide lamps;
3. open radionuclide radionuclide lamps intended for use in medical and industrial applications, except for radiopharmaceuticals registered under special legislation2) with the approval of the State Office for Nuclear Safety ("the Authority"),
4. ionisation fire detectors;
5. light sources with radionuclide radionuclides;
6. consumer products, provided for by specific legislation, (3) containing radioactive substances and products to which radioactive substances have been intentionally added in their manufacture.
(2) Type-approval is also subject to the products referred to in paragraph 1 (b) and (c) if they are placed on the market as used or after total repair and the products referred to in paragraph 1 (a) in the cases provided for in the decision on type-approval.
(3) Products referred to in paragraph 1 which are intended for demonstration or testing and are not intended for marketing are not subject to type-approval.
Forms of application for type approval
(Paragraph 23 (2) of the Law)
(1) The application for type approval shall contain:
(a) in the case of a natural person, the business firm, the date of birth, the address of the place of permanent residence, the identification number, if any, if any, the name and surname, date of birth, the address of the place of permanent residence of the agent, (4) if any; in the case of a legal person, the business firm, the registered office, the identification number, where it has been assigned, the name and surname, the address of the place of permanent residence of the person or persons who are its statutory authority or designated representative;
(b) the identification of the manufacturer, if different from the applicant; for a natural person, the business name, registered office or place of business, the identification number, if assigned; in the case of a legal person, a business firm, registered office, identification number, if assigned;
(c) identification of the approved product, name, description, designation of the design type, its parts, classification, 3) use and, for the packaging set, the limit values for its use;
(d) a description of the use and the way in which the product is placed on the market and, for sources of ionising radiation, a justification for its use under Article 4 (2) of the Act;
(e) an indication of the list of legislation and technical standards applied in the type approval documents;
(f) determination of the time for the regular repetition of operational controls and their manner and scope, for sources of ionising radiation, also data on the extent and manner of taking-over tests, long-term stability and stability tests according to specific legislation, 3)
(g) instructions for use in the Czech language, including rules on the safe handling of the product,
(h) the required period of validity of the type approval;
(i) a description of the method of quality assurance laid down in the specific legislation, 5)
(j) documentation of the tests referred to in Section 4.
(2) The application for type approval is supported by:
(a) for all packaging files
1. the material specification of the radioactive substances or nuclear materials for which the packaging is designed, in particular by describing their physical and chemical status,
2. a detailed description of the packaging file type, including design documentation, complete technical drawings, a list of materials and technological methods used for its manufacture,
3. a description of the method of quality assurance provided for in the specific legislation, 5)
4. a technological and manufacturing documentation with a detailed description of the materials and technological methods used in the manufacture of the restraint system, a description of the sampling and types of tests to be carried out when the packaging is designed for a maximum normal operating pressure exceeding 100 kPa;
5. evidence of radiation protection or evidence of nuclear safety if the packaging is designed for special fissile materials or 241Pu;
6. the calculation and justification of the assumptions concerning the characteristics of irradiated nuclear fuel used in the safety analyses in the sub-criticism calculations when the packaging is designed for irradiated nuclear fuel,
7. a list of the specific requirements necessary to remove heat for packages containing nuclear materials or radioactive substances producing heat, in relation to a particular type of transport and means of transport,
8. reproducible image of the packaging on A4 format with a maximum size of 21 cm per 30 cm,
(b) the packaging files type B (M) are further documented
1. a list of supplementary technical, operational and administrative measures to ensure nuclear safety and radiation protection, provided that the packaging does not comply with the requirements set out in paragraphs 43, 59, 60 and 63 of Part I of Annex 1;
2. details of any restrictions in relation to the mode of transport and any special procedures for loading, transport, unloading or handling;
3. the highest and lowest values of ambient effects (temperature, sunlight) which can be expected during transport and which were based on design design,
(c) for sources of ionising radiation,
1. a detailed description of the basic technical details of the particular type, design drawings, descriptions and explanatory notes used in the manufacture,
2. a list of the laws, regulations and technical standards applied in manufacturing, in the absence of the standards of the technical solution descriptions and evidence of compliance with radiation protection requirements;
3. a test report by the device manufacturer, including data on actual operating parameters,
(d) for sources of ionising radiation which are radioactive substances, further evidence shall be provided:
1. data on the type of radionuclide, its type, manufacturer, activity, chemical and physical form, descriptions of the solution of the requirements of radiation protection, evidence of the authorisation of production in the country of the manufacturer, of open radionuclide radionuclide radionuclide lamp accompanying sheet issued by the manufacturer, for closed radionuclide radionuclide radionuclide radionuclide lamp, data on the classification of resistance, method of closure, description of construction, recommended closure checks, period of validity of radionuclide radionuclide radionuclide radion issued by the manufacturer, where applicable;
2. the concept of decommissioning them, including a description of the safe management of radioactive waste.
Test documentation
(Paragraph 23 (3) of the Law)
The test documentation shall be:
(a) for packaging sets, the results of the tests carried out in accordance with Annex 1, Part II, paragraphs 13 to 37 and evaluated in accordance with Annex 1, Part II, paragraphs 1 and 2, showing compliance with the relevant requirements set out in points 1 to 9 below:
1. the requirements of paragraphs 9 to 21 of Part I of Annex No 1 for all packages;
2. the requirements of paragraphs 26 to 34 of Part I of Annex No 1 for packaging files of type IP - 1, IP - 2 and IP - 3,
3. the requirements of paragraphs 35 to 38 of Part I of Annex No 1 for packages for the transport of 0,1 kg or more of uranium hexafluoride;
4. the requirements of paragraphs 39 to 55 of Part I of Annex No 1 for type A packaging files;
5. the requirements of paragraphs 56 to 70 of Part I of Annex No 1 for type B (U) packaging files;
6. the requirements of paragraphs 71. and 72. of Part I of Annex No 1 for type B (M) packaging files;
7. the requirements of paragraphs 73. to 76. of Part I of Annex No 1 for type C packaging files;
8. the requirements of paragraphs 77. to 88. of Part I of Annex No 1 for packages containing fissile materials;
9. the requirements of paragraphs 56. to 70. of Part I of Annex No 1 and the requirements of Annex No 2 for type D packaging and type S packaging files;
(b) for radioactive substances, the results of tests carried out in accordance with paragraphs 4 to 11 of Part II of Annex 1;
(c) in the case of low dispersive radioactive substances, the results of the tests carried out in accordance with paragraph 12 of Part II of Annex 1;
(d) for radiation generators, test results demonstrating compliance with the relevant technical standards, 6)
(e) for closed radionuclide radionuclide radionuclide radionuclide, the results of tests demonstrating their tightness and degree of resistance in accordance with the relevant technical standards, 7)
(f) for equipment containing radionuclide radionuclide radionuclide radionuclide, the results of tests demonstrating the conformity of the device and its classification in accordance with technical standards, 8)
(g) for open radionuclide radionuclide radionuclide radionuclide radionuclide radionuclide, or for products containing open radionuclide radionuclide radionuclide radion, test results within the scope of the accompanying sheet of an open radionuclide as provided for in the specific legislation, 3)
(h) for ionising fire detectors with closed radionuclide radionuclide radiator, test results demonstrating the degree of resistance to fire, very high temperatures and tightness in accordance with the relevant technical standards, 7)
(i) for sources of ionising radiation in which radionuclides are produced, reports of test results demonstrating that the declared properties meet the radiation protection requirements for the purpose and use of the source;
(j) for consumer products containing radioactive substances to which radioactive substances have been intentionally added during their manufacture, a document demonstrating the essential requirements of radiation protection throughout their use.
(2) Tests shall be carried out on products, prototypes or samples thereof. Tests may also be carried out on models or models designed to mimic, to the maximum extent, the characteristics relevant to the assessment of nuclear safety, radiation protection and the proposed content of radionuclides.
(3) The documentation of product tests may be replaced by reference to previous satisfactory results of tests of products of the same or similar use and characteristics, documentation of replacement tests or documentation of calculations which have been carried out by authorised persons or persons designated by the Office and where the reliability or conservativity of the calculation methods and the parameters used are acceptable for evaluation by the Office.
Method of approval
(Paragraph 23 (2) of the Law)
In the decision on type approval, the Office shall specify:
(a) identification of the applicant, to the extent provided for in Article 3 (1) (a);
(b) the identification of the manufacturer to the extent specified in Article 3 (1) (b);
(c) identification of the product to the extent provided for in Article 3 (1) (c);
(d) the scope and manner of conformity assessment referred to in Article 6;
(e) the conditions under which product approval is granted; in the case of a package, a specific form of radioactive material and a low dispersion in their identification marking;
(f) for sources of ionising radiation, its classification, frequency and minimum range of acceptance tests, long-term stability and operational stability tests;
(g) the period of validity of the decision on type approval.
Verification and verification of conformity, scope and method
(Paragraph 23 (4) and (5) of the Act)
(1) The manufacturer, importer or person placing the product on the market shall ensure that the conformity of the product with the approved type is verified
(a) for each package subject to type-approval in accordance with Article 2 (1), for radioactive substances of a specific form and for radioactive substances of a low variance to the extent specified in the decision on type-approval;
(b) for each closed radionuclide radionuclide radionuclide radionuclide, a leak test and other tests within the scope of the certificate of the closed radionuclide provided for in the specific legislation, (3), where applicable, to the extent specified in the decision on type approval;
(c) for each open radionuclide radionuclide radionuclide lamp, by tests within the scope of the accompanying sheet of an open lamp laid down by a specific legislation, (3), where appropriate, to the extent specified in the type approval decision;
(d) for sources of ionising radiation other than radioactive substances:
1. procedures under special legislation, 9)
2. for other sources of ionising radiation on each product or on a statistically selected sample, provided that it is determined by the Authority in its decision on its type-approval.
(2) The conformity of products is demonstrated by the manufacturer, importer or person placing the product on the market:
(a) in the case of closed radionuclide radionuclide radionuclide lamps by certification;
(b) in the case of open radionuclide radionuclide radionuclide radionuclide, by means of a accompanying sheet;
(c) in the case of packages, radioactive substances, special forms, radioactive substances with low dispersiveness, sources of ionising radiation other than radionuclide radiators and other products, by written declaration of conformity of the products in the Czech language containing the following particulars:
1. identification of the manufacturer or importer issuing the certificate of conformity to the extent provided for in Article 3 (1) (a);
2. product identification data, at least to the extent of § 3 (1) (c);
3. a declaration that the product is safe and suitable for the purpose;
4. the method of verification of conformity used and the list of laws and technical standards used in the verification of conformity, 9)
5. the name, address and identification number of the person involved in the conformity assessment;
6. the date of issue of the certificate of conformity, the name and function of the responsible person.
(3) The manufacturer, importer or person placing the product on the market shall issue a new declaration of conformity of the product if there is a change in the facts which may affect the characteristics of the product in terms of nuclear safety or radiation protection and the product is to continue to be placed on the market after that change.
(4) Products for which a written declaration of conformity has been issued shall bear the mark of conformity in accordance with a specific legislation, 9) in addition to closed radionuclide radionuclide radionuclides, special forms and radioactive substances with low dispersiveness, which shall replace the certificate of closed radionuclide radionuclide radionuclide radionuclide radionuclide radionuclide radionulates with a low dispersiveness of their type approval for closed radionuclide radionuclide radionuclide radionuclide radion and for radioactive substances.
(5) For sources of ionising radiation for which conformity has been verified under a specific legislation, 9) the manufacturer, importer or person placing the product on the market shall determine the classification of the product and the minimum range of acceptance tests, long-term stability tests and operational standard.3)
TRANSPORT OF NUCLEAR MATERIALS AND CERTAIN RADIOACTIVE SUBSTANCES
Transport authorisation
[K § 9 (1) (m) of the Act]
Authorisations of the Office shall be:
(a) for the transport of nuclear materials, with the exception of uranium depleted by isotope 235U, if it constitutes shielding of packaging sets;
(b) for the transport of radioactive substances of specific forms of activity exceeding 3.103 A1 and radioactive substances other than specific forms of activity exceeding 3.103 A2 or radioactive substances of activity exceeding 1000 TBq, whichever is the lower;
(c) for the transport of nuclear materials or radioactive substances in type B (M) packages which are not designed for temperature ranges from minus 40 ° C to plus 70 ° C or are designed to allow occasional controlled ventilation;
(d) transport under specific conditions where all the requirements of Paragraph 9 cannot be met and those requirements are replaced by specific conditions which ensure that the level of nuclear safety, radiation protection and physical protection during transport is equal or higher;
(e) transport by a special purpose vessel with a specified radiation protection programme;
(f) for the transport of nuclear materials or radioactive substances whose values A1 and A2 have been calculated.
Scope and manner of implementation of the approved documentation for the authorisation to transport
[Paragraph 13 (3) (d) of the Law]
(1) The timetable for transporting and transporting nuclear materials and radioactive substances is drawn up by the transporter in accordance with a specific legislation; (10) This shall be without prejudice to the obligation for the carrier to have at his disposal transport documents under specific legislation. 11)
(2) The inclusion of the nuclear material transported in the relevant category in terms of physical protection is carried out in accordance with specific legislation. 12) The method of ensuring physical protection is laid down in specific legislation. 12), 13)
(3) Where a part of the transport takes place in international transport through the territory of the Czech Republic, the scope and implementation of the documentation referred to in paragraphs 1 and 2 shall be required only for that part of the transport.
Transport and transport security by the transporter
[K § 20 (1) (b) and (d) of the Act]
(1) When transporting nuclear materials and radioactive substances pursuant to § 7 of the transporter
(a) notify the start of the shipment to the Office 7 days in advance, unless otherwise specified under special legislature14;
(b) demonstrate in the documentation that all cooperation with third parties in dealing with emergency situations is ensured. If the emergency plan envisages cooperation with the fire brigade of several regions, it will be provided through the Ministry of the Interior - Directorate General of the Fire Department of the Czech Republic,
(c) provide evidence in the documentation that all pre-identified transport participants have been shown to have been familiar with the emergency rules;
(d) in the event of a radiation accident or suspected occurrence, the Office, the competent operational centre of the Police of the Czech Republic, the competent operational and information centre of the fire brigades and the competent administrative office; in both cases, the transporter shall send to the Office within 30 days of the occurrence of the event its evaluation in cooperation with the carrier;
(e) ensure physical protection of transport under special legislation, 12), 13)
(f) meet the relevant requirements set out in Annex 4 and the requirements of specific legislation. 12)
INTERNATIONAL TRANSPORT OF RADIOACTIVE WASTE
Scope and modalities of international shipments of radioactive waste, documentation for authorisation and supervision of such shipments
[For Paragraph 9 (1) (p) and point P of the Annex to the Act]
(1) The authorisation provided for in Article 9 (1) (p) of the Act, whose validity may be limited by time, is required for international shipments of radioactive waste, the activity and mass activity of which exceeds the levels laid down in the specific legislation, (2) and for the following types of transport:
(a) from the Czech Republic to a Member State of the European Union,
(b) from a Member State of the European Union to the Czech Republic,
(c) from the Czech Republic to a State not a member of the European Union, including transit by Member States of the European Union;
(d) from a State not a member of the European Union to the Czech Republic, including transit by Member States of the European Union;
(e) between non-Member States of the European Union and transit through Member States of the European Union, the Czech Republic being the first Member State of the European Union in whose territory waste enters.
(2) The completed forms, the models of which are set out in Sections 1, 3 and 4 of Annex 6, must be accompanied by documents which are transported together with radioactive waste.
(3) An authorisation to carry out more than one shipment may be requested by one application if:
(a) the radioactive waste covered by the application has essentially the same physical, chemical and radioactive characteristics;
(b) the transport is carried out only between the same holder and the same consignee and always involves the same competent authorities. The holder of radioactive waste shall be a natural or legal person who is legally responsible for the waste before the shipment takes place and intends to transport it to the consignee,
(c) carriage in respect of the Czech Republic and a country which is not a member of the European Union shall be carried out through the same border crossing points, unless consent is given to another route of transport.
(4) For international shipments of radioactive waste referred to in paragraph 1 (a)
(a) the holder of the radioactive waste shall submit to the Office an application using the form set out in Section 1 of Annex 6 and complete and confirm the form set out in Section 4 of Annex 6;
(b) The Office
1. request an opinion from the competent authorities in the country of destination and the country or countries of transit, using the form set out in Section 2 of Annex 6;
2. use the form set out in Section 3 of Annex 6 to decide on the application for international shipment of radioactive waste;
3. inform the competent authorities of the country of destination and of the countries of transit of the authorisation and use a form the model of which is given in Section 3 of Annex 6,
4. send a copy of the form, a specimen of which is given in Section 5 of Annex 6, which it receives from the competent authority of the country of destination to the holder of the radioactive waste.
(5) For international shipments of radioactive waste referred to in paragraph 1 (b)
(a) the consignee of radioactive waste shall, within 15 days of receipt of the waste, send to the Office a completed and validated form, a specimen of which is given in Section 5 of Annex 6;
(b) The Office shall, upon receipt of the form, the specimen of which appears in Section 5 of Annex 6, send a copy thereof to the competent authorities of the Member States of the European Union concerned by the shipment.
(6) For international shipments of radioactive waste referred to in paragraph 1 (c)
(a) holder of radioactive waste
1. submit to the Office an application using a form the model of which is set out in Section 1 of Annex 6;
2. ensure that, as soon as the radioactive waste has been received, the consignee sends to him a completed and validated form, a model of which appears in Section 5 of Annex 6, or a self-declaration of the same content, indicating the customs office through which the shipment was carried out,
3. complete and confirm the form the model of which is set out in Section 4 of Annex 6,
4. It shall send to the Office, within 14 days of the transmission of radioactive waste, forms the models of which are set out in Sections 4 and 5 of Annex 6. In the event that the consignee fails to complete the form, the model of which is given in Section 5 of Annex 6, it shall be completed by the holder of the radioactive waste and supported by a declaration by the consignee in accordance with paragraph 6 (a) (2),
(b) The Office
1. Requires an opinion from the competent authorities of the Member States of the European Union concerned by the shipment, using the form set out in Section 2 of Annex 6 and cooperating with the authorities of the other countries concerned by the shipment,
2. use the form set out in Section 3 of Annex 6 to decide on the application for international shipment of radioactive waste;
3. inform the competent authorities of the countries concerned by the shipment of the authorisation and use a form in accordance with Section 3 of Annex 6,
4. Upon receipt of the forms, the specimen of which appears in Sections 4 and 5 of Annex No 6, shall send copies thereof to the competent authorities of the Member States of the European Union concerned by the shipment.
(7) For international shipments of radioactive waste referred to in paragraph 1 (d)
(a) recipient of radioactive waste
1. submit to the Office an application using a form the model of which is set out in Section 1 of Annex 6;
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Regulation Information
| Citation | Decree of the State Office for Nuclear Safety No. 317 / 2002 Coll., on the type approval of packaging packages for the transport, storage and storage of nuclear materials and radioactive substances, on the type approval of sources of ionising radiation and on the transport of nuclear materials and designated radioactive substances (on type approval and transport) |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 18.07.2002 |
|---|---|
| Effective from | 18.07.2002 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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