Decree No. 10 / 2026 Coll.
Decree amending Decree No. 358 / 2016 Coll., on requirements for quality assurance and technical safety and assessment and verification of conformity of selected equipment
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23.01.2026
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10
DECLARATION
of 8 January 2026
amending Decree No 358 / 2016 Coll., on quality assurance and technical safety requirements and assessment and verification of conformity of selected equipment
The State Office for Nuclear Safety sets out, pursuant to § 236 of Act No. 263 / 2016 Coll., the Atomic Act, for the implementation of § 24 (7), § 56 (2), § 57 (3), § 58 (9) and § 59 (4):
Decree No 358 / 2016 Coll., on quality assurance and technical safety requirements and assessment and verification of conformity of selected equipment, is amended as follows:
1. In the introductory sentence, "7 'is replaced by" 9'.
2. In Article 1 (j), "requirements and 'is replaced by" requirements';
3. In Paragraph 1 (k), at the end of the dot, the word "a 'is replaced by" a'.
4. in Article 1, the following point (l) is added:
"(l) the conditions for the assessment of technical safety which must be fulfilled for the issue of a binding opinion by the Office under Paragraph 58 (3) of the Atomic Act.";
5. In Paragraph 2 (b) (4), the end of the dot is replaced by a comma.
6. in Section 2, the following points (c) and (d) are added:
"(c) by repairing the selected device by intervening in the operated selected device to remove its non-compliant state or the impact of ageing, in which the selected device may be retrofitted to meet the requirements set out in the technical specification of the selected device; and
(d) by maintaining the selected equipment, the activity carried out on the operated selected installation or part thereof in order to maintain the safe and operable condition of that installation or the activity associated with the replacement of the part of the selected device in a detachable manner, unless it is a repair. ';
7. In Paragraph 4 (4) of the Introductory Part of the provision, the word "fixed 'is replaced by" fixed by the following:'.
8. in Paragraph 4 (4) (b), the words "for monitoring and evaluation of durability" are replaced by the words "the parameters observed in the controlled ageing process."
9. in Article 4 (4) (e):
"(e) a list of the parts of the device selected; and ';
10. in Article 5 (1), the words "the device and parts selected" shall be inserted after the word "assembly."
11. in Article 5 (2) (d), the words "and parts of the selected equipment" and the words "its" shall be inserted after the words "equipment";
12. in Article 5 (2) (g), the words "unless it is a selected installation pursuant to Article 12 (3) (e)" shall be inserted after the words "it."
13. in Article 5 (3) (b), "production and" shall be replaced by "production or";
14. The heading of Section 6 reads:
"The scope and manner of quality assurance in the process of procuring the selected equipment and part of the selected equipment '.
15. in Article 6 (1) of the introductory part of the provision, the words "the selected equipment and parts" shall be inserted after the words "the provision."
16. in Article 6 (1) (a), the words "part of the selected installation" shall be added at the end.
17. in Article 6 (2) of the Introductory Part of the Provisions, the words "selected equipment and parts" shall be inserted after the words "procuring."
18. in Articles 6 (2) (b) and 6 (2) (d), the words "selected equipment and parts" shall be inserted after the words "quality."
19. in Article 7 (f), the word "overoperational" is replaced by "pre-operational."
20. in § 7 (g), "a" is replaced by a comma;
21. in § 7 (h), at the end of the period, "a" is replaced by "a."
22. in Article 7, the following point (i) is added:
"(i) an assessment of the conformity of the change of the selected device, which changes the design of the selected device.";
23. In Article 7, the current text becomes paragraph 1 and the following paragraph 2 is added:
"(2) The requirements of paragraph 1 shall not apply to the selected equipment referred to in Article 12 (3) (e). ';
24. in Paragraph 8 (1) (c), the words "if it is a pressure device in Class 1 or Class 2," shall be deleted;
25. in Article 8 (1) (d), the words "when it comes to pressure equipment classified in Security Class 1 or 2" shall be deleted;
26. In Paragraph 11 (1), the words "and assembly 'are replaced by the words" assembly and modification'.
27. in Article 12 (3) (c), "a" is replaced by a comma;
28. in Paragraph 12 (3) (d), the end of the period shall be replaced by "and."
29. in Article 12 (3), the following point (e) is added:
"(e) a selected device to cover the fuel element and the design of the fuel file."
30. Paragraph 12 (4) reads:
"(4) The conformity assessment of the selected installation referred to in paragraph 2 (c) may be carried out by an accredited person if the conformity assessment is carried out in accordance with the procedure referred to in Article 15 (1) (e) (1). ';
31. in Article 12 (6), the words "proposed," shall be deleted; the words "referred to in paragraph" shall be replaced by the words "classified in Security Class 2 or," the word "proposed," shall be deleted and the words "Conformity assessment of part of the selected installation referred to in paragraph 2 (b) may be carried out by the operator of the selected installation if it is" shall be added.
32. in Article 12 (6), the following points (a) and (b) are added:
"(a) conformity assessment carried out in accordance with the procedure laid down in Article 15 (2) (b) (1); and
(b) the operator of the selected installation shall assess compliance only with the part of the selected installation intended solely for its use. ';
33. In Article 12 (8), the word "authorised 'is deleted and the words" accredited person, manufacturer or importer of the selected installation' are replaced by the words "carrying out conformity assessment '.
34. In Article 12, paragraphs 9 to 12 are added:
"(9) The conformity assessment of pressure equipment safety equipment shall be carried out at least at the same level as the conformity assessment of the equipment selected to protect it.
(10) The conformity assessment procedure of the authorised person, accredited person and operator of the selected installation shall meet the requirements of:
(a) technical standards relating to the competence, consistent activity and impartiality of the bodies carrying out certification of products, processes and services as regards the conformity assessment procedures referred to in Parts 3 to 11 of Annex 7 to this Regulation;
(b) technical standards containing general criteria for the competence of the inspection bodies and for the impartiality and consistency of their inspection activities, as regards:
1. reconciliation of procedures according to section 6.5 And Annex 2 to this Order,
2. the activities listed in points 8.3, 13.6, 13.9.1 and 13.11 of Part A of Annex 2 to this Decree;
3. the conformity assessment procedure set out in Part 2 of Annex No 7 to this Regulation,
4. the procedure for assessing the conformity of part of the selected equipment by the operator as set out in Part 12 of Annex 7 to this Regulation.
(11) Compliance with the requirements of the conformity assessment procedure referred to in paragraph 10 shall be demonstrated by accreditation in accordance with the Act on Technical Requirements for Products.
(12) The technical safety assessment by the authorisation applicant, which must be carried out for the issue of a binding opinion by the Authority under Paragraph 58 (3) of the Atomic Act, shall be subject to compliance with the requirements of paragraphs 10 and 11. ';
35. in Article 13 (1), the words "the selected establishment or part of the selected establishment" shall be inserted after the word "the designation" and the words "the selected establishment or parts" shall be inserted after the word "the selected establishment or parts."
36. In Paragraph 13 (2), the words "the selected device or component 'shall be inserted after the word" conformity'.
37. in Paragraph 13 (3):
"(3) The conformity mark shall be affixed to the device or part of the device selected in an indelible and legible manner and shall not be less than 5 mm in size. The mark of conformity may be indicated in the accompanying technical documentation of the selected device or part of the selected device if it does not allow its connection to the selected device or part of the selected device of their design or dimensions, or if it is not accessible after installation of the selected device or part of the selected device. '
38. in Paragraph 14 (2) (b), the word "authorised" shall be deleted and the words "accredited person, manufacturer or importer of the selected equipment" shall be replaced by "carrying out conformity assessment."
39. in Paragraph 15 (2) (a) of the introductory part of the provisions, the words "and (b)" shall be deleted;
40. in Paragraph 15 (2) (a) (3), "G" is replaced by "F1."
41. in Article 15 (2) (b) of the introductory part of the provision, the text "(c)" is replaced by "(b)."
(42) In Article 15 (2) (b) (1), "A1" is replaced by "part of the selected operator's equipment."
43. In Paragraph 15 (2) (b) (2), the word "procedure" shall be replaced by the word "procedures" and the words "D1," or "shall be replaced by the words" (a) and. "
44. in Article 15 (2) (b), point 3 is deleted;
45. in Article 15 (2) (c), the words "2 (c) or 12 (c)" shall be inserted after the words "paragraph."
46. In Article 16 (2), the words "checks and 'are replaced by the words" checks and in the preventive maintenance programme'.
47. in Article 16 (6), the words "verified" are replaced by the words "secured."
48. In Paragraph 16 (6), the words "comply with technical requirements. The verification of part of the selected equipment must be carried out" replaced by "assessed '.
49. in Article 16 (6), "F1" is deleted;
50. In Article 16 (6), the words "Annex No 8 k 'are replaced by the words" Section 15 (2), if not for the part of the selected equipment in Class 2 or 3 for which no conformity assessment is required to the extent appropriate'.
51. in Article 16 (6), the word "Order" is replaced by the words "part of the selected device in the design of the selected device."
52.
Příloha č. 1
"Annex No 1 to Decree No 358 / 2016 Coll.
Technical requirements for selected equipment and parts of selected equipment
A. Technical requirements for pressure equipment and some other selected equipment and packaging for the transport, storage and storage of spent nuclear fuel
1. General requirements
1.1. The technical requirements set out in this Annex shall apply to all pressure equipment and assemblies of pressure equipment and parts thereof.
1.2. Technical requirements listed in
1.2.1. points 1.3 to 1.8, 1.13, 1.14, 2 to 5 and 11 to 14 apply to packages for the transport, storage and storage of spent nuclear fuel; and
1.2.2. points 1.3 to 1.10, 1.12 to 1.14, 2 to 5, 7, 8 and 11 to 15 shall apply to the selected installations referred to in § 12 (3) (a) and (d).
1.3. Pressure equipment shall be designed in accordance with the requirements laid down
1.3.1. in its technical specification under the Decree on requirements for a nuclear installation project; and
1.3.2. this decree.
1.4. The pressure equipment shall be so designed that:
1.4.1. there can be no sudden failure in all test and operating conditions, including unacceptable leakage of the medium;
1.4.2. it has been possible to carry out all necessary planned and unplanned checks or diagnoses of this equipment safely during its operation; and
1.4.3. it was possible to safely repair and maintain it.
1.5. The pressure equipment shall be designed to withstand the hazards arising from the properties of the territory for the location of nuclear installations, external influences and internal influences.
1.6. The pressure equipment shall be able to perform the required function in all operational states of the nuclear installation and in the emergency conditions for which it is intended to control.
1.7. The materials used for the manufacture of pressure equipment and parts thereof ensuring the hermetics of the protective envelope shall be subject to the requirements for materials for pressure equipment referred to in paragraphs 12 and 13 of Part A of Annex 2 to this Decree.
1.8. The pressure equipment shall be designed in such a way that it can be decontaminated and, where possible, followed by passive internal surfaces.
1.9. The design of the pressure equipment shall be based on the specified
1.9.1. the calculation, operation and test loads and their limits;
1.9.2. operating conditions for the pressure equipment;
1.9.3. the limit parameters of the operation of the pressure equipment, the function of which results in mechanical movement;
1.9.4. operating modes with regard to the classification of pressure equipment in the safety class;
1.9.5. chemical and physical parameters of the media used in pressure equipment,
1.9.6. the corrosive effects of the media used on the material of the pressure equipment during the required lifetime of the device; and
1.9.7. Requirements for the resistance of pressure equipment to seismic effects or to cyclic loads.
1.10. The pressure equipment shall be designed in such a way as to avoid or minimise the risk of significant loss of resistance to pressure due to a failure resulting in a breach of the integrity of the pressure equipment and the leakage of radioactive substances. In cases where this risk cannot be excluded, during the operation of the pressure equipment and after weaning, appropriate means of protection to maintain operational parameters shall be ensured to maintain a sufficient level of the medium in the pressure equipment and to remove residual heat by downstream supply and heat removal systems.
1.11. The pressure equipment constituting the protective envelope system, including those affecting the hermetic integrity of the protective envelope, shall be designed in such a way that the leak can be determined during the design calculation pressure after installation of all hermetic passages, hermetic doors and inputs.
1.12. The pressure equipment pipe shall be designed such that the risk of overload due to unacceptable wills or excessive forces arising, in particular, from flanges, joints and bellows is minimised, in particular by means of support, reinforcements, anchorages, levelling and prestressing of hinges.
1.13. The pressure equipment shall be designed for loading in all operational states of the nuclear installation and in emergency conditions to be controlled. It is necessary to take into account the various loads which may be combined, taking into account the likelihood of their present occurrence.
1.14. The design of the pressure equipment providing adequate strength shall be based on the calculation method referred to in point 2, if necessary supplemented by the experimental method. Only verified calculation programmes may be used in the calculation process.
2. Calculation method
2.1. The calculation method used shall be based on a conservative approach and limit the risks to individuals and property to the lowest reasonably achievable level in accordance with the requirements laid down in the technical regulations and technical conditions to:
2.1.1. implementation of strength calculations;
2.1.2. The mechanical characteristics of the base materials used,
2.1.3. unbreakable connections,
2.1.4. carrying out checks on pressure equipment; and
2.1.5. monitoring and evaluation of the ageing of pressure equipment.
Resistance to internal pressure and other load aspects
2.2. The authorised stress on pressure equipment shall be limited to the types of failure the occurrence of which can be predicted under operating conditions and operating modes. Safety factors shall be used to ensure that any uncertainty arising from production, actual operating conditions, stress, calculation models and properties and behaviour of the material are completely eliminated.
Strength
2.3. Appropriate strength calculations including appropriate calculation, operational and test loads shall be used to ensure the strength of the pressure equipment.
2.4. When calculating the strength of the pressure equipment, account shall be taken in particular of the following loads:
2.4.1. internal and external pressure,
2.4.2. the effect of the device's own load and load;
2.4.3. additional loads, including the effect of the load of connected equipment, insulation and pipes;
2.4.4. Strength induced by supports and pipes,
2.4.5. temperature effects, including temperature shocks;
2.4.6. vibration load,
2.4.7. seismic effects and environmental conditions in extreme atmospheric phenomena,
2.4.8. processes causing material degradation, including the influence of radioactivity;
2.4.9. hydraulic resistors and pressure shocks,
2.4.10.
2.4.11. other loads resulting from the risk analysis referred to in point 3.1 of Part And Annex 2 to this decree.
Calculation loads
2.5. The calculation pressure shall be greater than the maximum permitted pressure and shall take into account:
2.5.1. pressure shocks,
2.5.2. errors of the control system and measurement uncertainty; and
2.5.3. system configuration influences.
2.6. For parts of the pressure equipment loaded at the same time by internal and external pressure, the calculation pressure shall be determined as the difference between these pressures at which the greatest wall thickness is achieved.
2.7. The calculation temperature shall not be less than the expected maximum mean temperature after the thickness of the part under consideration to which the limits for normal and abnormal operating conditions apply. Where equipment or pipes are heated by heat transmission from sources such as induction spirals, sheaths or internal heat sources, their influence shall be taken into account when determining the calculation temperature.
2.8. Additional calculation loads shall be selected in such a way that, in combination with the effects of the calculation pressure to which the limits for normal operating conditions apply, the greatest thickness of the device wall is determined.
2.9. The pressure equipment shall be so designed that the maximum stress and voltage concentrations corresponding to the calculation load are kept within safe limits.
Operating load
2.10. When calculating the strength of the pressure equipment, all loads which may occur in all operational states of the nuclear installation and in emergency conditions for which it is intended to be managed shall be taken into account. In particular, stress and deformation loads shall be considered in the material from which the device is produced, resulting from the manufacture, transport, assembly and pressure tests, including residual stresses, the effect of which on the limits of strength must be assessed individually according to their significance.
Test load
2.11. When calculating the strength for the pressure equipment, the expected test load to which the pressure equipment is subjected during the final assessment shall be taken into account.
2.12. The test pressure shall be determined in proportion to the calculated and, where applicable, the highest permissible pressure, taking into account the assessment of geometric and material characteristics and test conditions in production and operation in accordance with the requirements laid down in the technical regulations or technical conditions for the production of pressure equipment.
Calculation of strength, design of basic dimensions and control calculation
2.13. The calculation of strength for pressure equipment shall be made for the following limits:
2.13.1. a sudden breach of integrity by tenacious or fragile refraction;
2.13.2. plastic deformations throughout the section of the pressure equipment,
2.13.3. the single-directional growth of the plastic component by proportional deformation at cyclic loads resulting in an unacceptable change in dimensions or in a breach of integrity;
2.13.4. the formation of cracks at cyclic load; and
2.13.5. loss of stability.
2.14. In the calculation of the strength for the limit states referred to in paragraph 2.13, values corresponding to the material, strength, plastic and brittle-column characteristics and resistance to deformation as set out in the technical regulations for the materials concerned shall be used or experimentally determined by an accredited testing laboratory. For the purpose of this calculation of strength, the values set out in the technical standards may be used.
2.15. In the case of unbreakable connections, the appropriate coefficient of unbreakable connections dependent on the type of materials connected, the type of non-destructive controls used and the function of the selected equipment in all operational states of the nuclear installation and in the emergency conditions for which it is intended to manage shall be selected for material characteristics.
2.16. In the design of the pressure equipment, foreseeable degradation mechanisms, in particular the effect of radioactivity, corrosion and fatigue of the material, shall be taken into account in an appropriate manner to the intended use of the pressure equipment and its intended lifetime.
2.17. When calculating the strength of the pressure equipment, it shall be carried out
2.17.1. the calculation for the design of the basic dimensions of the equipment (hereinafter referred to as "the design of the basic dimensions"); and
2.17.2. control calculation of pressure equipment ("control calculation").
2.18. When designing basic dimensions, the permissible stress shall be calculated from the tensile strength and from the contractual slip limit permitted for the production of pressure equipment. The relevant safety factors shall be considered when calculating the permitted stresses.
2.19. When designing basic dimensions it is necessary to consider limit states
2.19.1. Infringement of the integrity of a tough quarry,
2.19.2. plastic deformations throughout the section of the pressure equipment; and
2.19.3. loss of stability.
2.20. After the design of the essential dimensions of the pressure equipment, a control calculation shall be carried out to demonstrate:
2.20.1. strength at static load,
2.20.2. strength at cyclic load,
2.20.3. resistance to sudden breach,
2.20.4. vibration strength,
2.20.5. stability loss resistance; and
2.20.6. resistance to seismic effects.
2.21. The control calculation shall take into account all loads, including temperature effects, and all operating conditions specified in the technical specification. In particular, the degradation of material properties during operation, surface quality, influence of the voltage gradient and influence of the corrosion environment shall be taken into account.
3. Experimental method of design of pressure equipment
3.1. The accuracy of the design of the pressure equipment or parts thereof shall be verified by appropriate checks carried out on a representative sample of pressure equipment in accordance with the control programme established for the purposes of the experimental design method. This inspection programme shall be approved by an authorised person carrying out the design conformity assessment.
3.2. The test conditions and acceptance criteria shall be defined in the control programme. The actual values of the essential dimensions and properties of the materials constituting the pressure equipment shall be measured before each check is carried out.
4. Design of safe handling and operation of pressure equipment
4.1. The prescribed method of handling and operation of pressure equipment shall exclude risks arising from the risk analysis referred to in point 3.1 of Part A of Annex 2 to this Regulation. Particular attention must be paid to:
4.1.1. closures and openings,
4.1.2. hazardous fumes from fuses; and
4.1.3. elements which prevent the physical entry into the device if there is a pressure or vacuum in the device.
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Regulation Information
| Citation | Decree No. 10 / 2026 Coll., amending Decree No. 358 / 2016 Coll., on quality assurance and technical safety requirements and assessment and verification of conformity of selected equipment |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 23.01.2026 |
|---|---|
| Effective from | 01.02.2026 |
| Effective until | - |
| Status | Valid |
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