Approved by

Order of the Federal

Environmental, Industrial

and Nuclear Supervision Service

dated 6 February 2018 No. 52

 

FEDERAL RULES AND REGULATIONS

IN THE FIELD OF ATOMIC ENERGY USE "RULES

FOR ASSESSMENT OF COMPLIANCE OF PRODUCTS, FOR WHICH

REQUIREMENTS RELATED TO SAFETY IN THE FIELD OF

ATOMIC ENERGY USE AS WELL AS REQUIREMENTS FOR PROCESSES OF ITS DESIGNING

(INCLUDING SURVEYS), PRODUCTION,

CONSTRUCTION, INSTALLATION, ADJUSTMENT, OPERATION, STORAGE,

SHIPMENT, SALE, UTILIZATION AND FINAL DISPOSAL ARE ESTABLISHED"

(NP-071-18)

 

 

I. Purpose and scope

 

1. These federal rules and regulations in the field of atomic energy use "Rules for assessment of compliance of products, for which requirements related to safety in the field of atomic energy use as well as requirements for processes of its designing (including surveys), production, construction, installation, adjustment, operation, storage, shipment, sale, utilization and final disposal" (NP-071--18) (hereinafter referred to as the Rules) are developed in accordance with Articles 6 and 37 of Federal Law No.170-FZ "On atomic energy use" dated 21 November 1995, Provisions for development and approval of federal rules and regulations in the field of atomic energy use approved by Decree of the Government of the Russian Federation No. 1511 dated 1 December 1997 (Collected Acts of the Russian Federation, 1997, N 49, art. 5600; 2012, N 51, art. 7203), Decree of the Government of the Russian Federation No. 544 dated 15 June 2016 N 544 "On specifics of assessment of conformity of products, for which requirements are established related to assurance of security in the field of atomic energy use, and processes of its designing (including survey), production, construction, installation, adjustment, operation, storage, shipment, sale, utilization and final disposal" (Collected legislation of the Russian Federation, 2016, N 26, Art. 4052).

2. These Rules establish requirements to assessment of conformity and forms of assessment of conformity of products at the stages of its life cycle, used at nuclear power plants, facilities and complexes with research nuclear reactors, critical and subcritical nuclear stands (hereinafter, for the purposes of these Rules, referred to as nuclear facilities), as well as non-destructive testing systems, complexes of engineering and technical means of physical protection of nuclear materials, nuclear installations, nuclear material storage facilities.

3. These Rules apply to the assessment of conformity of the following products:

a) products that are applied at a nuclear facility as elements of the nuclear facility, classified in accordance with the federal rules and regulations in the field of atomic energy use to safety classes 1, 2, and 3 safety classes, with the exception of nuclear materials and spent nuclear fuel;

b) fuel elements and assemblies, including working cassettes, regulators of control and protection systems used in reactor cores of nuclear power plants and research nuclear installations;

c) load-lifting cranes referred according to federal rules and regulations in the field of atomic energy use to groups A, B and C, and used at nuclear facilities;

d) products classified in accordance with federal rules and regulations in the field of atomic energy use to safety class 4, as well as components of such products, the failure of which leads to a decrease in generation or unscheduled shutdown of a power unit of the nuclear power plant;

e) designed specifically to be used in nuclear power industry:

steam and hot water boilers with a working steam overpressure above 0.07 MPa and water temperature over 115 °C;

(as amended by the Order of Rostechnadzor of No. 163 dated April 5, 2018)

steam and hot water pipelines with a working steam overpressure above 0.07 MPa and water temperature over 115 °C;

(as amended by the Order of Rostechnadzor of No. 163 dated April 5, 2018)

vessels operating at a water steam overpressure above 0.07 MPa and water temperature over 115 °C;

(as amended by the Order of Rostechnadzor of No. 163 dated April 5, 2018)

f) general industrial equipment subject to the requirements of the technical regulations of the Customs Union "On safety of equipment operating under excessive pressure" (TR CU 032/2013), adopted by the decision of the Council of the Eurasian Economic Commission of July 2, 2013. N 41 (official website of the Eurasian Economic Commission www.eurasiancommission.org, July 3, 2013), operated in the same room with the products specified in subparagraph "a" of this paragraph;

g) components, welding and surfacing materials, semi-finished products used in the products (product components) specified in subparagraphs "a", "b" and "c" of this paragraph;

h) straight-line parts of pipelines made by assembly organizations at the construction of a nuclear facility referred according to federal rules and regulations in the field of atomic energy use to group B;

i) pipelines referred according to federal rules and regulations in the field of atomic energy use to groups A and B;

j) products included in the list of products that are subject to mandatory certification and for which the requirements related to safety in the field of atomic energy use are established, approved by the order of the Federal Service for Environmental, Technological and Nuclear Supervision of July 21, 2017. N 277 (registered by the Ministry of Justice of Russia on September 26, 2017, registration N 48327) (hereinafter - the List of Products);

(p. "j" as revised by Rostechnadzor Order N 163 dated 05.04.2018)

k) complexes of engineering and technical means of physical protection of nuclear materials, nuclear installations, nuclear material storage facilities.

 

II. General

 

4. Methodological and organizational and technical support for assurance of the functioning of the conformity assessment system in the field of atomic energy use includes, inter alia:

a) establishing the structure, principles and rules for the formation and operation of the conformity assessment system in the field of atomic energy use;

b) ensuring compliance with the rules of operation of the conformity assessment system in the field of atomic energy use;

c) keeping a register of issued product conformity certificates;

d) keeping a register of issued expert opinions on compliance of technical documentation with mandatory requirements;

e) keeping registers of issued certificates of attestation of non-destructive testing systems, new materials, new technologies of smelting and casting of steels, welding, heat treatment, pressure treatment;

e) presentation of a conformity assessment system for the use of nuclear energy in international organizations within the framework of international cooperation in the field of the use of nuclear energy.

5. Products must be evaluated for compliance with the mandatory requirements established thereto.

6. These Rules establish requirements for conformity assessment of products in the forms of:

expert examination of technical documentation;

testing;

control;

acceptance;

decision on the application of imported products for nuclear facilities;

mandatory product certification;

registration.

7. The participants of activities on conformity assessment are: Rostechnadzor; operating organizations; specialized organizations; certification bodies and testing laboratories (centers) performing works on conformity assessment; expert organizations; developers, manufacturers (suppliers) of products, as well as other organizations performing works and providing services in the field of atomic energy use.

8. Participants of works on conformity assessment are obliged to provide information on the results of conformity assessment of products and evidentiary materials on requests sent within the respective competence to:

a) the operating organization;

b) a specialized organization on conformity assessment in the form of acceptance;

c) State Atomic Energy Corporation Rosatom (hereinafter, the Corporation);

d) Rostechnadzor;

e) federal executive authorities within the powers determined by acts of the President of the Russian Federation and the Government of the Russian Federation unless otherwise established by federal laws, judicial authorities, bodies of prosecutor's office and law enforcement agencies considering cases related to placement and execution of orders for performance of works and rendering services in the field of atomic energy use.

9. When selecting suppliers of products for which the requirements related to safety in the field of atomic energy use are established, the availability of the documents provided for in these rules confirming compliance of products with mandatory requirements shall be taken into account.

 

III. Product compliance assessment in the form of expert examination

of technical documentation

 

10. Conformity assessment of products in the form of expert examination of technical documentation should be carried out in relation to the detailed design documentation of the following products:

a) specified in subparagraph "a" of paragraph 3 hereof, developed after entry into force of these Rules and subject to conformity assessment in the form of tests (acceptance, standard, preliminary comprehensive and (or) autonomous), and for products manufactured outside the Russian Federation and imported to the Russian Federation, specified in subparagraphs "a", "c", "g" of paragraph 3 hereof;

b) referred in accordance with federal rules and regulations in the field of atomic energy use to safety classes 1, 2 and 3 as specified in subparagraph "k" of paragraph 3 hereof, the technical documentation for which was developed, including before the entry into force of these Regulations.

Technical documentation for fire-fighting devices and systems, steam turbines, buildings and structures, complexes of engineering and technical means of physical protection of nuclear materials, nuclear installations, storage facilities of nuclear materials and technical means of physical protection is not subject to conformity assessment in the form of expert examination of technical documentation (hereinafter - expert examination of technical documentation).

11. Expert examination of technical documentation shall be carried out prior to the assessment of conformity of products in other forms provided hereby.

12. Expert examination must be performed by expert organizations. Information about expert organizations is posted on the official website of the Corporation in the Internet information and telecommunication network.

13. Experts on examination of technical documentation must meet the requirements set out in GOST R 50.03.02-2017 "Conformity assessment system in the field of atomic energy use. Experts on conformity assessment in the form of examination of technical documentation. Requirements and order of competence confirmation" approved by Order of the Federal Agency on Technical Regulation and Metrology dated December 22, 2017 No. 2062-st (Standartinform, 2017).

14. Expert examination of technical documentation by an expert organization and experts who participated in its development, including rendering consulting services at its development, is not allowed.

15. Customers of expert examination of technical documentation for products are developers of technical documentation or suppliers of products.

16. Expert examination of technical documentation is carried out in accordance with GOST R 50.03.01-2017 "Conformity assessment system in the field of atomic energy use. Conformity assessment in the form of expert examination of technical documentation. The procedure" approved by Order of the Federal Agency on Technical Regulation and Metrology dated December 22, 2017 No. 2061-st (Standartinform, 2017).

17. Expert examination of technical documentation shall be carried out, among other things, on compliance with the technical requirements (initial requirements) approved by the operating organization. During the expert examination of technical documentation, the expert organization is required to check the compliance of the technical requirements with conditions of application of products at the nuclear facility (the parameters of working media and the environment) under normal operation conditions and operational occurrences, if the product needs to maintain its operability and function at such occurrences.

18. According to the results of the expert examination of technical documentation, an expert opinion on the compliance of the submitted technical documentation with the mandatory requirements is issued.

19. The customer of the expert examination of technical documentation that has passed the expert examination is obliged to notify the expert organization of amendments introduced to the technical documentation. These changes can be applied after their consideration and approval by the expert organization. The procedure for consideration of changes made to the technical documentation is established in GOST R 50.03.01-2017 "Conformity assessment system in the field of atomic energy use. Conformity assessment in the form of expert examination of technical documentation. Procedure" approved by Order of the Federal Agency on Technical Regulation and Metrology dated December 22, 2017 No. 2061-st (Standartinform, 2017).

20. The expert organization shall carry out, throughout service life of products established in technical documentation, storage of copies of the technical documentation provided for carrying out expert examination of technical documentation, one copy of the original of the expert opinion on compliance of technical documentation with obligatory requirements, correspondence and materials related to consideration and approval of the changes made to technical documentation, and provide data on results of expert examination of technical documentation and consideration of the changes made to technical documentation, on requests from bodies and organizations referred to in paragraph 8 hereof.

21. Upon the termination of the activities of the expert organization, consideration and approval of changes introduced to technical documentation shall be carried out by another expert organization engaged by the customer of these activities.

22. According to the results of the positive expert examination of technical documentation, the developer of technical documentation is obliged to indicate the number of the expert opinion on compliance of technical documentation with mandatory requirements and the name of the expert organization subject to a procedure defined by GOST R 50.03.01-2017 "Conformity assessment system in the field of atomic energy use. Conformity assessment in the form of expert examination of technical documentation. The procedure" approved by Order of the Federal Agency on Technical Regulation and Metrology dated December 22, 2017 No. 2061-st (Standartinform, 2017).

 

IV. Product conformity assessment in the form of tests

 

23. Conformity assessment of products in the form of tests shall be carried out in respect of products specified in subparagraphs "a", "b", "c", "d", "g" and "l" of paragraph 3 hereof.

24. Conformity assessment of products in the form of tests shall be carried out by the operating organizations; specialized organizations; developers, manufacturers (suppliers) of products, and other organizations performing works and providing services in the field of atomic energy use with their own testing facilities or with involvement of testing laboratories (centers) accredited in accordance with the legislation of the Russian Federation in the field of atomic energy use.

25. Product conformity assessment shall be carried out in the form of the following tests:

a) acceptance tests (except for equipment for automated process control systems) carried out according to GOST R 15.301-2016 "System of product development and launching into manufacture. Products of industrial and technical designation. Procedure of product development and launching into manufacture" approved by Order of the Federal Agency on Technical Regulation and Metrology dated October 31, 2016 No. 1541-st (Standartinform, 2016), as well as GOST 15.005-86 "System of product development and launching into manufacture. Development of single and small-scale production units assembled at the place of use", approved by resolution of the USSR Gosstandart dated October 15, 1986. No. 3095 (M.: Publishing and Printing Complex Standards Publisher, 1999);

b) qualification tests held in accordance with GOST R 15.301-2016 "System of product development and launching into manufacture. Products of industrial and technical designation. Procedure of product development and launching into manufacture" approved by Order of the Federal Agency on Technical Regulation and Metrology dated October 31, 2016 No. 1541-st (Standartinform, 2016);

c) period tests held in accordance with GOST R 15.309-1998 "System of product development and launching into manufacture. Testing and acceptance of the output product. Basic provisions (approved by the Resolution of the State Committee of the Russian Federation on Standardization and Metrology dated June 11, 1999) No. 189 (M., Publishing and Printing Complex Standards Publisher, 1999);

b) type tests held in accordance with GOST R 15.309-1998 "System of product development and launching into manufacture. Testing and acceptance of the output product. Basic provisions (approved by the Resolution of the State Committee of the Russian Federation on Standardization and Metrology dated June 11, 1999) No. 189 (M., Publishing and Printing Complex Standards Publisher, 1999);

e) preliminary comprehensive and (or) autonomous (for equipment of automated process control systems) which are carried out according to GOST 34.603-92 "Information technology. Types of tests of automated systems" approved by the resolution of Gosstandart of the USSR dated February 17, 1992. No. 161 (M.: Publishing and Printing Complex Standards Publisher, 1992);

f) attestation tests held in accordance with:

GOST R 50.04.01-2018 "Conformity assessment system for the use of nuclear energy. Conformance assessment in the form of tests. Qualification testing. General provisions" approved by Order of the Federal Agency on Technical Regulation and Metrology dated February, 13, 2018 No. 75-st (Standartinform, 2018);

GOST R 50.04.06-2018 "Conformity assessment system for the use of nuclear energy. Conformance assessment in the form of tests. Qualification testing for new material (base or welding)" approved by Order of the Federal Agency on Technical Regulation and Metrology dated February 27, 2018 No. 98-st (Standartinform, 2018);

GOST R 50.04.03-2018 "Conformity assessment system for the use of nuclear energy. Conformance assessment in the form of tests. Qualification testing of welding (cladding) technologies" approved by Order of the Federal Agency on Technical Regulation and Metrology dated February 2, 2018 No. 42-st (Standartinform, 2018);

GOST R 50.04.04-2018 "Conformity assessment system for the use of nuclear energy. Conformance assessment in the form of tests. Qualification testing for technologies of workpiece processing by pressure" approved by Order of the Federal Agency on Technical Regulation and Metrology dated February 13, 2018 No. 77-st (Standartinform, 2018);

GOST R 50.04.05-2018 "Conformity assessment system for the use of nuclear energy. Conformance assessment in the form of tests. Qualification testing for the steels and alloys melting and casting procedures" approved by Order of the Federal Agency on Technical Regulation and Metrology dated February 13, 2018 No. 78-st (Standartinform, 2018);

GOST R 50.04.02-2018 "Conformity assessment system for the use of nuclear energy. Conformance assessment in the form of tests. Qualification testing of heat treatment processes" approved by Order of the Federal Agency on Technical Regulation and Metrology dated February 13, 2018 No. 76-st (Standartinform, 2018);

GOST R 50.04.07-2018 "Conformity assessment system for the use of nuclear energy. Conformance assessment in the form of tests. Qualification tests of non-destructive inspection systems" approved by Order of the Federal Agency on Technical Regulation and Metrology dated March 6, 2018 No. 123-st (Standartinform, 2018);

(s/p "f" as revised by Rostechnadzor Order No. 163 dated April 5, 2018)

26. Other types of tests of products for control of characteristics of its properties in the course of production, installation and operation are carried out at assessment of conformity of products in the forms of obligatory certification of products, control, acceptance, registration, decision on application of imported products at the nuclear facility, and are not forms of assessment of conformity assessment.

27. In the case that separate delivery of large-size and (or) multi-component equipment to the nuclear facility is provided, that may only be subjected to final assembly at the nuclear facility, acceptance tests are held on the site of its operation.

28. The product test results shall be entered in the test report containing information about the products, the test methods applied, testing facilities, testing conditions.

29. According to the results of product conformity assessment in the form of tests specified in subparagraphs "a" - "e" of paragraph 25 hereof, a test certificate shall be issued  containing a conclusion on compliance (non-compliance) of products with the mandatory requirements.

30. According to the results of product conformity assessment in the form of tests specified in paragraph 25 (f) hereof, an attestation report shall be executed and a certificate of attestation shall be issued.

31. The products specified in subparagraph "l" of paragraph 3 hereof shall be subject to conformity assessment in the form of tests specified in subparagraph "a" of paragraph 25 hereof, with an issue of an acceptance certificate based on results of such assessment.

 

V. Product conformity assessment in the form of control

 

32. Product conformity assessment in the form of control shall be carried out in respect of the products specified in paragraph 3 hereof, in the course of its manufacture, assembly and operation.

33. Product conformity assessment in the form of control shall be carried out:

at production and assembly of products - by organizations performing works and providing services in the field of atomic energy use for production and assembly of products, respectively;

at operation of products - by operating organizations.

Organizations accredited in accordance with the legislation of the Russian Federation in the field of atomic energy use as testing laboratories (centers) can be involved in the assessment of conformity of products in the form of control.

34. Conformity assessment in the form of control in the course of manufacture and assembly of products must be carried out in accordance with:

a) federal codes and regulations in the field of atomic energy use "Regulations for Control of Metal of Equipment and Pipelines of Nuclear Power Installations at Manufacture and Assembly";

b) documents on standardization establishing mandatory requirements to products, providing, in particular, the control of products and components as these are received, periodically during long-term storage, upon completion of transportation, prior to issuance to production, before release to assembly with identification of products and their components and assessment of the condition (absence of mechanical damage, integrity of packages and seals, absence of traces of corrosion damage and traces of other damaging factors);

c) federal codes and regulations in the field of use of atomic energy "Welding and Buildup of Equipment and Pipelines of Nuclear Power Installations".

34. Conformity assessment in the form of control in the course of operation of products must be carried out in accordance with:

a) federal rules and regulations in the field of atomic energy use "Rules for control of base metal, welded joints and welded surfaces at operation of equipment, pipelines and other elements of nuclear power plants" (NP-084-15), approved by the order of Rostechnadzor of December 7, 2015 No. 502 (registered by the Ministry of Justice on March 10, 2016, registration No. 41366);

b) federal rules and regulations in the field of atomic energy use "Welding and Buildup of Equipment and Pipelines of Nuclear Power Installations";

с) program on management of service life characteristics of equipment and pipelines, standard and working programs of pre-operational and operational control;

d) programs of testing in the course of commissioning works and programs of testing in the course of operation;

e) manuals and instructions on operation, regulations of maintenance and repair of products, process regulations of operation of the nuclear facility;

f) organizational and technical arrangements prepared based on periodic safety assessment of the nuclear installation;

g) conditions of validity of Rostechnadzor license;

h) documents on standardization establishing mandatory requirements for operation of products and the procedure of control in the course of operation.

36. The personnel engaged in non-destructive and destructive testing of products must comply with the requirements of GOST R 50.05.11-2018 "Conformity assessment system for the use of nuclear energy. Personnel in the non-destructive and destructive testing of metal. Requirements and qualification procedure" approved by Order of the Federal Agency on Technical Regulation and Metrology dated March 6, 2018 No. 122-st (Standartinform, 2018).

(p. 36 as revised by Rostechnadzor Order N 163 dated 05.04.2018)

37. Throughout the service life of products documented results shall be kept (conclusions on results of non-destructive and destructive testing, test reports and certificates, technical inspection certificates and reports) of conformity assessment in the form of control carried out:

a) at manufacture - by manufacturers of products;

b) at assembly - by assembly organizations;

c) at operation - by operating organizations.

 

VI. Product compliance assessment in the form of acceptance

 

38. Conformity assessment of products in the form of acceptance shall be carried out in respect of products specified in subparagraphs "a", "b", "c", "d", "g" and "i" of paragraph 3 hereof, except for:

a) shipping packaging sets supplied to the Russian Federation with the aim of using them to carry out import or export of nuclear materials (returnable containers);

b) radioactive substances, products thereof, equipment using radioactive substances and isotopes, which are included in the List of products and industrial waste, the free sale of which is prohibited, approved by the decree of the President of the Russian Federation of February 22, 1992. No. 179 (Collected Acts of the President and the Government of the Russian Federation, 1992, N 23);

c) welding and surfacing materials.

Conformity assessment of products in the form of acceptance is carried out by means of participation at the manufacturing enterprise and its subcontractors of representatives of the operating and (or) specialized organization engaged by it in control operations (tests) of products; supervision of the course of process and control operations (tests); examination of accounting documentation based on results of the corresponding operations.

39. Conformity assessment in the form of acceptance shall be carried out in respect of the products specified in subparagraphs "h" and "i" of paragraph 3 hereof, through the participation of representatives of the operating organization and (or) those of a specialized organization involved thereby in monitoring the progress of technological and control operations during assembly, in control operations (tests) of products based on the results of assembly, in checking the reporting documentation on the results of the relevant operations. Conformity assessment of products specified in subparagraphs "h" and "i" of paragraph 3 hereof is carried out for nuclear facilities of incomplete construction, where on assembly of products began after entry into force of these Rules.

(as amended by the Order of Rostechnadzor of No. 163 dated April 5, 2018)

40. Prior to the assessment of conformity of products in the form of acceptance, the operating organization is obliged to develop and put into operation:

a) a procedure for implementing by the operating organization of the requirements of these Rules, regulatory legal acts of the Corporation and standardization documents establishing mandatory requirements for conformity assessment of products and components in the form of acceptance;

b) a procedure for monitoring the activities of specialized organizations involved in the assessment of conformity of products and their components in the form of acceptance;

c) a procedure for timely detection of non-conformities of products and its components with established requirements and control of elimination of such non-conformities by the manufacturer of products and the assembling organization;

d) a register of records of inspections of contractors and conformity assessments of products and their components, including records of all subsequent repairs and repeated tests;

e) a procedure for communicating to Rostechnadzor of information about the facts of non-conformity of products with established requirements and the measures taken in respect of such products in the case that the identified non-conformities affected or could affect the safety of the nuclear facility.

41. The components of a particular product, the conformity assessment of which will be carried out in the form of acceptance at their manufacture, as well as the stage of manufacture of each component of the product, from which the conformity assessment will be carried out in the form of acceptance, shall be established by the operating organization taking into account the requirements hereof.

42. The operating organization shall form data on products containing its identification features (the name and (or) the designation, the safety class) which are subject to assessment of conformity in the form of acceptance in relation to specific nuclear facility in interaction with the developer of the project of the nuclear facility and submits the same to the Corporation for posting on its official site in the Internet information and telecommunication network.

43. By a decision of the operating organization, it is allowed not to carry out conformity assessment in the form of acceptance in respect of products classified as safety class 3, if these products are subject to mandatory certification in the field of atomic energy use. In respect of certified products, such a decision is made if, during the period of validity of the certificate for these products, no violations of the terms of the certificate of conformity or non-compliance of products with mandatory requirements were found, including during inspection.

44. Results of conformity assessment of products in the form of acceptance are executed with a quality plan and (or) a conclusion about acceptance in the order established in GOST R 50.06.01-2017 "Conformity assessment system for the use of nuclear energy. Conformity assessment of products in the form of acceptance. The procedure" approved by Order of the Federal Agency on Technical Regulation and Metrology dated December 29, 2017 No. 2131-st (Standartinform, 2017).

 

VII. Assessment of conformity of imported products

in the form of decision on use

 

45. Conformity assessment of imported products in the form of decision on use of imported products at the nuclear facility (hereinafter - conformity assessment in the form of decision on use of imported products) should be carried out in relation to products manufactured outside the Russian Federation and imported to the Russian Federation,  referred to in subparagraphs "a", "b", "g" of paragraph 3 of hereof (hereinafter - imported products), except:

a) shipping packaging sets supplied to the Russian Federation with the aim of using them to carry out import or export of nuclear materials (returnable containers);

b) radioactive substances, products thereof, equipment using radioactive substances and isotopes, which are included in the List of products and industrial waste, the free sale of which is prohibited, approved by the decree of the President of the Russian Federation of February 22, 1992. No. 179;

c) imported insulation materials of shells, protective hoses, screens, fillers (including polymer and rubber compositions, sealing compounds, dye concentrates, polyvinyl chloride plastics, cross-linked polyethylene, polypropylene film, water-blocking materials, tapes for thermal barrier, fastening, separating and water-blocking tapes, threads), materials of cores and conductors used in the Russian Federation in the manufacture of cables, optical fibers, intended for use at the nuclear facility as elements and (or) as parts of elements referred in accordance with federal rules and regulations in the field of atomic energy use to safety classes 1, 2 and 3;

d) imported paints and varnishes delivered to the manufacturer in the territory of the Russian Federation for their use at production of the equipment intended for use at the nuclear facility as elements and (or) as parts of elements referred in accordance with federal rules and regulations in the field of atomic energy use to safety classes 1, 2 and 3;

e) imported semi-finished products delivered to the manufacturer on the territory of the Russian Federation for their use in the manufacture of labels of equipment intended for use at the nuclear facility as elements and (or) as parts of elements referred in accordance with federal rules and regulations in the field of atomic energy use to safety classes 1, 2 and 3;

f) imported blooms and slabs used for manufacture of semi-finished products.

46. The conducted conformity assessment in the form of a decision on the use of imported products should provide for the minimization of risks for the safe use of nuclear energy in the Russian Federation related to differences in national legislation, safety requirements in the field of atomic energy use, product requirements, differences in rules, methods and standards for quality assessment based on the results of control and testing, differences in methods of calculated substantiations, differences in metrological support, as well as possible inaccuracies and errors in the translation of technical documentation.

Application of imported production at nuclear facilities of the Russian Federation is performed taking into account:

a) compliance with the legislation of the Russian Federation in the field of atomic energy use, including the requirements of federal rules and regulations in the field of atomic energy use;

b) availability of experience in the use of products at nuclear facilities of foreign countries and (or) the Russian Federation;

c) excluding deterioration of characteristics (parameters) of elements and systems provided by the project of the nuclear facility, where imported products are supposed to be used;

d) providing representatives of the customer of imported products and Rostechnadzor with access to information relevant to the quality and reliability of imported products, as well as enabling the representatives to hold inspections and assessments of the quality of imported products in the process of their manufacture;

e) implementation by the customer of imported products of interaction with the foreign manufacturer of the products, the developer of the project of the nuclear facility and Rostechnadzor;

f) providing the customer of  imported products with identical translation into the Russian language of technical documentation for the imported products.

47. A decision on use of imported products at the nuclear facility is made in accordance with GOST R 50.07.01-2017 "Conformity assessment system for the use of nuclear energy. Decision on the application of imported products for nuclear power plants. The decision-making procedure" approved by Order of the Federal Agency on Technical Regulation and Metrology dated December 21, 2017 No. 2039-st (Standartinform, 2017).

48. Depending on the technical complexity of imported products, conformity assessment in the form of decision on the use of imported products should include a combination of conformity assessment forms:

a) assessment of conformity in the form of expert examination of technical documentation for imported products (technical requirements, technical conditions and (or) technical specifications, programs of acceptance, acceptance-handover tests, strength and other calculated substantiations) and changes made to the specified documentation for conformity with the requirements of regulatory legal acts of the Russian Federation related to safety in the field of atomic energy use, for compliance with the documents on standardization establishing mandatory requirements for products, as well as the conditions of use of products at a specific nuclear facility;

b) assessment of conformity of imported products in the form of acceptance in the process of its manufacture (production) to a scope established on the basis of technical complexity of the product, the ability and availability for control of its main components upon completion of its manufacture;

c) conformity assessment in the form of tests for the initial delivery of imported products to the Russian Federation;

d) conformity assessment in the form of mandatory certification in respect of products included in the List of products.

Conformity assessment in the form of a decision on the use of imported products should include analysis of the results of conformity assessments carried out in accordance with subparagraphs "a" - "d" of this paragraph of the Rules, the substantiation for the admissibility of identified non-conformities (if any) and making a decision on the use of imported products.

49. Decisions on the use of imported products at nuclear facilities should be made for products or components for the manufacture (production) of products manufactured outside the Russian Federation and imported into the Russian Federation. No separate decisions are issued on application by a foreign manufacturer of components of products as a part of products imported to the Russian Federation.

50. Decisions on the use of imported products at nuclear facilities are made and approved by the operating organization based on the results of the analysis of conformity assessments, substantiation of admissibility of identified non-conformities (if any) and submitted to Rostechnadzor for approval.

51. At subsequent deliveries of imported products for its application as elements and (or) as a part of elements of safety classes 2 and 3 of nuclear facilities, a decision may be made on use of imported products referred to the specified safety classes for a period of no more than 5 years without registration of decisions on application of imported products for each particular delivery. Adoption of the above decision on use of imported products is allowed provided the following conditions are concurrently met:

a) passing of conformity assessment of initially delivered imported products  in the form of a decision on use, as well as the absence of non-conformities of such products and the results of incoming inspection, assembly, startup & adjustment and pre-operational control at the nuclear facility;

b) assessment of conformity of products pursuant to subparagraphs "b" and "d" of paragraph 48 hereof during the validity period of the decision on use of imported products;

c) creation of a procedure of accounting of imported products in use allowing to identify nuclear facilities and elements of a nuclear facility, as which or as a part of which imported products are used.

52. Decisions made in accordance with paragraph 51 of these Rules on the use of imported products must contain the mandatory conditions under which these products can be used:

a) availability of positive results of conformity assessment of imported products in the form of acceptance to a scope corresponding to the standard quality plan attached to the decision on use of imported products;

b) the validity of the certificate of conformity for imported products subject to mandatory certification in the field of atomic energy use is not suspended, nor is the certificate of conformity canceled;

с) availability of positive results of periodic tests of imported products and (or) equipment manufactured in Russia (except for custom-production equipment, for which engineering documentation for manufacture and testing bears the letter "I" in accordance with GOST 2.103-2013 "Unified system for design documentation. Stages of designing" entered into force by Order of Federal Agency on Technical Regulating and Metrology dated November 26, 2014 No. 1794-st, Standartinform, 2015), within which imported products are used, that are held at least once in every three years according to the program and methodology of periodic tests agreed upon with the operating organization;

d) approval by the operating organization of changes made to technical requirements (specifications), the program and methods of tests, to the scope of control of imported products and availablity of positive results of consideration of the above changes by Rostechnadzor;

e) submission to the operating organization by the supplier of reporting documents on each delivery about the nomenclature and quantity of imported products delivered to nuclear facilities and (or) the equipment manufactured in Russia, within which such products are used, with indication of the name and designation of the nuclear facility and its system, within which the imported products are used, as an element, or the name and designation of an element of the nuclear facility, within which the imported products are used, as well as numbers of quality plans.

53. In case of detection of non-conformities of imported products and (or) violations of obligatory conditions of its use, the decision on use may be suspended at the initiative of the operating organization, or at the request of Rostechnadzor, for a period necessary for elimination of non-conformities and (or) violations, or canceled, should such non-conformities and (or) violations fail to be eliminated within the specified period of time.

54. The decision to use imported products at a nuclear facility shall be included in the register of decisions on use of imported products, the procedure for the formation and maintenance of which is determined in accordance with paragraph 4 of resolution of the Government of the Russian Federation of June 15, 2016. No. 544 "On specifics of assessment of conformance of products, for which requirements related to safety in the field of use of atomic energy as well as requirements for design processes (including surveys), production, construction, installation, adjustment, operation, storage, shipment, sale, utilization and final disposal" are established by the Corporation.

 

VIII. Assessment of product conformity

in the form of mandatory certification

 

55. Conformity assessment of products in the form of mandatory certification shall be carried out in respect of products specified in subparagraph "j" of paragraph 3 hereof, subject to a procedure established in GOST R 50.08.01-2017 "Conformity assessment system for the use of nuclear energy. Conformity assessment in the form of mandatory certification of products. Procedure" approved by Order of the Federal Agency on Technical Regulation and Metrology dated 14 December 2017 No. 1961-st (Standartinform, 2017).

56. Development and maintenance of the List of Products shall be carried out subject to a procedure established by GOST R 50.08.06-2017 "Conformity assessment system for the use of nuclear energy. The list of products subjected to conformity assessment in the form of mandatory certification. Procedure for the development and maintenance" approved by Order of the Federal Agency on Technical Regulation and Metrology dated December 14, 2017 No. 1966-st (Standartinform, 2017).

57. Conformity assessment of products in the form of mandatory certification is carried out by certification bodies accredited in accordance with the legislation of the Russian Federation in the field of atomic energy use.

58. Схемы сертификации продукции приведены in GOST R 50.08.01-2017 "Conformity assessment system for the use of nuclear energy. Conformity assessment in the form of mandatory certification of products. Procedure" approved by Order of the Federal Agency on Technical Regulation and Metrology dated December 14, 2017 No. 1961-st (Standartinform, 2017).

59. Applicants for certification of products shall be the manufacturer and (or) supplier of products.

60. Based on the results of conformity assessment of products in the form of mandatory certification, a conformity certificate shall be issued, which is a confirmation that the certified products meet the mandatory requirements established thereto.

61. Results of studies (tests) and measurements shall be recognized in accordance with GOST R 50.08.04-2017 "Conformity assessment system for the use of nuclear energy. The results (protocols) of product testing. Procedure of recognition" approved by Order of the Federal Agency on Technical Regulation and Metrology dated 14 December 2017 No. 1964-st (Standartinform, 2017). The certification body shall verify the results of studies (tests) and measurements.

62. Experts performing work on conformity assessment of products in the form of mandatory certification must meet the requirements of GOST R 50.08.05-2017 "Conformity assessment system in the field of atomic energy use. Experts in certification of products. Requirements and order of competence confirmation" approved by Order of the Federal Agency on Technical Regulation and Metrology dated 14 December 2017 No. 1965-st (Standartinform, 2017).

63. Certification tests shall be carried out by the testing laboratories (centers) accredited according to the legislation of the Russian Federation in the field of atomic energy use subject to a procedure established by GOST R 50.08.03-2017 "Conformity assessment system in the field of atomic energy use. Certification testing of products. Procedure" approved by Order of the Federal Agency on Technical Regulation and Metrology dated 14 December 2017 No. 1963-st (Standartinform, 2017).

64. The testing laboratory (center) shall prepare the results of studies (tests) and measurements with the relevant reports, which make the basis for the decision to issue a certificate of conformity by the certification body.

65. The applicant for certification of products may:

a) propose a scheme for certification of products;

b) apply for implementation of mandatory certification to any certification body, whose area of accreditation applies to the products, which the applicant intends to certify.

66. The manufacturer of the product, which has received a certificate of conformity for commercially available products, shall:

a) ship products subject to mandatory certification to nuclear facilities only if there is a certificate of conformity;

b) indicate information about the certificate of conformity in the accompanying documentation for the products;

c) ensure inspection of certified products;

d) report to the certification body, and to the expert organization which carried out expert examination of technical documentation, about changes in the design and production of commercially manufactured certified products.

 

IX. Product conformity assessment in the form of registration

 

23. Conformity assessment of products in the form of registration (hereinafter referred to as registration) shall be carried out in respect of products specified in subparagraphs "a", "c", "e", "f", "g" paragraph 3 hereof.

68. Registration must be conducted by a Commission consisting of not less than 3 persons appointed by the administration of the nuclear facility under the chairmanship of an officer having the permission to carry out activities in the field of atomic energy use.

During registration of equipment and pipelines referred to safety classes 1 and 2, and cranes referred to groups A and B, a representative of the department of inspections of interregional territorial administration for supervision of nuclear and radiation safety of Rostechnadzor (hereinafter referred to as interregional territorial administration of Rostechnadzor) exercising continuous supervision at the nuclear facility shall be invited to a meeting of the Commission.

69. The nomenclature of equipment and pipelines subject to registration specified in subparagraphs "a", "e" and "f" of paragraph 3 hereof, and the boundaries of registration are defined by the lists approved by the administration of nuclear facility jointly with the developer of the project of the nuclear facility prior to primary technical inspection of the equipment and pipelines.

70. When determining the boundaries of registration, the following requirements must be met:

a) the boundaries of equipment registration are the inlet (or outlet) branch pipes and nozzles (where a welded connection of the pipeline to a branch pipe or nozzle of the equipment belongs to the pipeline); it is allowed to register the pipeline sections that are not disconnected from the equipment by shut-off valves together with the equipment;

b) if the working medium of at least one cavity of equipment corresponds to the parameters given in subparagraph "e" of paragraph 3 hereof, the equipment shall be subject to registration in its entirety;

c) it is allowed to register separately reactor units, deaerator columns and tanks subject to availability of separate certificates and other equipment, the components of which have separate certificates.

d) valves, indicating and safety devices, safety instruments installed on equipment shall be subject to registration as a part of the equipment;

e) valves, indicating and safety devices, safety instruments installed on pipelines shall be registered as a part of the pipeline;

f) sections of low-pressure pipelines after reducing devices, together with safety devices and the first stop valves along the flow of the medium, shall be registered together with high-pressure pipelines;

g) discharge pipelines from the safety and pressure-reducing devices shall not be registered, if the medium is discharged into a tank under atmospheric pressure or vacuum;

h) the boundaries of a pump are the inlet and outlet branch pipes;

i) main steam lines are registered before they are welded to the branch pipe of the turbine shut-off valve body;

j) if there are no shut-off valves on the steam extraction pipeline from the turbine to the equipment, the check valve serves as the registration boundary, and in its absence - the welded connection of the pipeline with the branch pipe or nozzle of the equipment.

71. Registration of equipment and pipelines shall be carried out after their primary technical examination. The primary technical examination shall be carried out after non-destructive pre-operational control works, before the commissioning works, as well as after the replacement or modernization of the equipment.

(p. 71 as revised by Rostechnadzor Order N 163 dated 05.04.2018)

72. To register equipment, the operating organization - owner of the equipment must submit the following documents to the commission:

a) written application;

b) equipment certificate with all the appendices thereto;

c) as-built diagram of connection of the equipment with specification of the working medium, sources of pressure and their parameters (maximum achieved pressure and flow rate), valves, safety and control & instrumentation devices, places of installation (take-off) on control & instrumentation devices, relief, welded flow-measuring, purging and drainage devices;

d) report certifying that assembly and installation of the equipment are performed according to the project and requirements of federal rules and regulations in the field of atomic energy use, and the equipment is in good condition, approved by the chief engineer of nuclear facility and the head of the assembling organization, with attachment of a drawing specifying the actual data on installation of the equipment, supports, limit stops, and shock absorbers;

e) report on technical examination of equipment;

f) results of conformity assessment in the form of acceptance and (or) in the form of mandatory certification of equipment related to the products specified in subparagraphs "a", "g" of paragraph 3 hereof, and for imported equipment - in addition, the results of conformity assessment in the form of a decision on the use of imported products.

73. To register a pipeline, the operating organization - owner of the pipeline - must submit the following documents to the commission:

a) written application;

b) pipeline certificate with all the appendices thereto;

c) as-built spatial circuit of the pipeline indicating the working medium parameters, diameters and thicknesses of pipe walls, locations of expansion joints, headers, valves, instrumentation and safety devices, flow restrictors, supports, suspensions, limit stops, shock absorbers, movement benchmarks, all welded joints with indication of their numbers, and actual slopes of pipelines.

d) report certifying that assembly of the pipeline is executed according to the project, requirements of federal rules and regulations and the pipeline is in good condition, approved by the chief engineer of the nuclear facility and the head of the assembling organization;

e) certificate of assembly of the pipeline, results of the assessment of conformity in the form of acceptance of parts and assembly units of the pipeline related to provisions of subparagraphs "a", "g", "h", and "k" of paragraph 3 hereof, and for imported parts and assembly units of the pipeline - in addition, results of the assessment of conformance in the form of decision on the use of imported products.

74. At the commission's request, the operating organization - the owner of the equipment or pipeline - shall be required to submit, in addition to the documents mentioned in paragraphs 72 and 73 hereof, records of the incoming control, testing programs and reports, engineering documentation, certificates of welders, supervisors and heat treatment operators, opinions on the results of nondestructive and destructive testing, information about welding and deposited materials used at assembling.

75. When considering the documents, the commission must examine:

a) registration and filling of the certificate, including availability of filled columns on carrying out technical survey, including hydraulic (pneumatic) tests, data on the person responsible for operable condition and safe operation, presence of signatures, seals and dates;

b) preparation and filling of the certificate on installation of the pipeline, on assembling (elaboration) of the equipment;

c) preparation and filling of the welding form of the pipeline, including the availability of signatures of representatives of the assembling company, contractor and customer, compliance of the form with requirements of the project to trace the pipeline, the availability and location of valves, pressure relief, instrumentation & control and drainage devices, location of supports and suspensions, expansion joints, the number and type of welded joints, marking, type of welding, geometric shapes and dimensions of blocks of pipelines, grades of basic and welding materials used;

d) registration and filling of the welding form of the equipment, including availability of signatures of representatives of the assembling organization, the contractor and the customer, compliance of the form with the project requirements regarding availability and arrangement of valves, safety and control & instrumentation devices, relief, purging and drainage devices, type of welding, quantity and type of welded connections, grades basic and welding materials used;

e) compliance of the as-built spatial circuit of the pipeline and the as-built diagram of connection of equipment with requirements of the project and data of welding forms;

f) compliance of the pipeline registration boundaries on the as-built spatial diagram with the boundaries specified in the list of the registered equipment and pipelines and the registration boundaries specified in the pipeline certificate, as well as compliance of the equipment registration boundaries with the boundaries specified in the list of the registered equipment and pipelines;

g) compliance of the scope of control of welded joints specified in the project with the fulfilled scope of control provided in the certificate of assembly, and the requirements of the federal rules and regulations:

h) availability of a positive act of incoming control for the equipment, parts and assembly units of the pipeline submitted for registration and for valves, indicating and safety devices, safety instruments used as a part of the equipment and the pipeline, and positive results of previous assessments of conformity of the specified products and its main components in the forms provided hereby;

i) compliance of the information set out in the report on hydraulic (pneumatic) tests, the requirements of the comprehensive and working program of testing, as well as the requirements of the project in terms of parameters and circuit of hydraulic (pneumatic) tests;

j) compliance of initial data used in the calculation of strength of equipment and pipelines, operating parameters of equipment and pipelines, as well as compliance with the seismic resistance category, values of design and safe shutdown earthquake, and load combinations, the requirements of the federal rules and regulations, availability of a positive opinion on the results of the calculation.

76. For registration of a crane, the operating organization - the owner of the crane, must submit to the commission, along with an application:

a) crane certificate with all the appendices thereto;

b) certificate on availability of trained and certified personnel allowed to operate the crane;

c) report certifying that assembly of the crane is executed according to the crane installation manual and the project, the crane complies with requirements of federal rules and regulations and is in operable condition, approved by the chief engineer of the nuclear facility and the head of the assembling organization;

d) crane installation diagram, with indication of the arrangement of the main trolleys (or the feeding cable) and the landing platform for entrance on the crane (for a bridge crane), and the actual distances of the crane metalwork from columns, trusses and the landing platform;

e) project of crane track, report on acceptance of the crane track confirming that the crane track complies with the project, and certificate about compliance of the overground crane track to loads from the crane;

f) calculation of the crane track, confirming the possibility of simultaneous operation of several cranes (if several cranes work on one crane track);

g) reports on acceptance of counterweight and ballast (for tower and portal cranes) with specification of their weight.

77. Documents submitted for registration of the crane must be considered by the commission. In this regard, the following shall also be considered:

a) results of assessment of conformity of the crane in the form of acceptance (quality plans), in the form of tests (acts and certificates of acceptance tests), and in case of application, as a part of the crane, of imported materials, components, parts and assemblies, results of assessment of their conformity in the form of decision on use;

b) acts, certificates and reports on the results of commissioning works;

c) certificate of primary technical examination;

d) certificates on static and dynamic tests of the crane;

e) test certificates for motion limiters and the loading capacity of the crane;

f) certificates on measurement of impedance of electric circuits;

g) certificates on examination of parameter recorder.

78. The Commission has the right to request, and the operating organization - the owner of the crane - is obliged to provide documents, data and information related to the quality and reliability of the crane in addition to the documents specified in paragraphs 76 and 77 hereof, including: certificates of incoming control of deliverable assemblies of the crane, general view drawings of the crane, single-line basic electric and hydraulic diagrams, kinematic diagrams of mechanisms and rope reeving arrangements, certificates of welders, inspectors and flaw detectors, opinions based on results of nondestructive and destructive testing, information on components and fasteners, base and welding materials used during assembling.

79. During confirmation based on results of consideration of documents of conformity of equipment, a pipeline or a crane with the requirements established thereto, the commission must check the completeness of assembling and their actual condition at their respective locations:

a) compliance of the fulfilled assembly works with the as-built diagram of connection of the equipment, the as-built spatial circuit of the pipeline, the availability of welder stamps on welded joints, marking, designation and nameplates that enable to identify the equipment and the pipeline;

b) completeness of assembly of level gauges, supports, suspensions, platforms and ladders provided by the project for maintenance, limiters, reference points and motion compensators, dampers, valves complete with drives, position sensors and limit switches, safety and control & instrumentation devices, safety instruments, relief, purging and drainage devices;

c) completeness of installation of the crane and crane tracks, as well as designed sound and light alarm systems, interlocks and limiters, complete scope of ropes, traverses and load gripping fixtures;

d) availability of manuals (instructions) on operation, maintenance and repair, availability of personnel trained and admitted to perform works on operation, maintenance and repair of the equipment, the pipeline, or the crane;

e) appointment by the administration of the nuclear facility of persons for supervision and persons responsible for the operability and safe operation of the equipment, the pipeline or the crane.

80. Based on the results of consideration of documents submitted for registration and examination of completeness of assembling of equipment, a pipeline or a crane, the commission shall make a decision on registration of (refusal to register) the equipment, pipeline or crane, approved by the chief engineer of the nuclear facility.

81. Registration of equipment, a pipeline or a crane shall be carried out for the period of their designated service life.

82. If the assembled crane is provided to be used at the construction of a nuclear facility, and its compliance with the legislation of the Russian Federation and federal rules and regulations in the field of industrial safety is confirmed, such crane can be registered for the period of construction of the nuclear facility and subsequently brought in line with with requirements of federal rules and regulations in the field of atomic energy use, retrofitting and registration.

83. Equipment, pipelines and cranes shall be subject to re-registration when extending their service life, if the availability of their residual life is substantiated and confirmed, as well as after their overhaul and modernization.

84. The approved decision on registration of equipment, a pipeline or a crane shall be assigned with an identification (accounting) number corresponding to the serial number in the register, and data on registration shall be entered in the certificate of the equipment, the pipeline or the crane by an officer appointed by the administration of the nuclear facility. The form of the log and the procedure for keeping the same shall be established by the operating organization.

85. The administration of the nuclear facility shall keep a register (electronic database) of registered equipment, pipelines and cranes containing the following information: identification (accounting) number, name and designation of the equipment, pipe or crane of the nuclear facility and the facility system, which comprises the equipment, pipeline, or crane, safety class, safety group, date of manufacture, date of commissioning, assigned operation period, assigned service life, date of primary technical examination, periodicity of technical examinations, accessibility for external (internal) inspection, dates of static and dynamic tests and other information according to the decision of the administration of the nuclear facility.

86. The administration of the nuclear facility must provide access to the registry (with monitoring rights) to the department of inspections of interregional territorial administration of Rostechnadzor exercising continuous surveillance at the nuclear facility, as well as notify the same on amendments and additions to the registry.

87. Equipment, piping and cranes shall be removed off the register:

a) on exhaustion of their assigned service life, dismantling and decommissioning;

b) in case of detection, during implementation of control and supervisory activities by the department of inspections of the interregional territorial administration of Rostechnadzor, of violations of requirements of these Rules, as well as unreliable information, data, references or other documents, on the basis of which the decision on registration is made.

88. Operation of unregistered equipment, pipelines or cranes subject to registration shall not be allowed.

89. The procedures of registration, re-registration and de-registration of equipment, pipelines and cranes, register management and entry of information in the register shall be established by the administration of the nuclear facility.

90. Equipment, pipelines and cranes, containing safety systems and components that are registered before the entry into force of these Rules, shall be removed off the register in the departments of inspections of interregional territorial administrations of Rostechnadzor exercising continuous supervision at nuclear facilities, and registered at the nuclear facility within two years from the date of entry into force of these Rules, or removed off the register, if their registration is not stipulated by paragraph 67 hereof.