358/2016 Sb.
DECREE
of 17 May. October 2016
about the requirements for quality assurance and technical safety and
assessment and verification of the conformity of the selected device
State Office for nuclear safety, establishes, pursuant to section 236 of the Act No.
263/2016 Coll., the Atomic Act, to implement section 24 para. 7, § 56 para. 2, §
paragraph 57. 3, § 58 para. 7 and section 59 paragraph 1. 4:
§ 1
The subject of the edit
This Ordinance regulates:
and the contents of the selected devices list),
(b)), the scope and quality of the selected device in the process
its design, manufacturing, installation, procurement, commissioning and
operation,
(c) quality assurance records) the types of the selected device and the way they
leadership,
d) technical requirements on the selected device and part of the selected device
e) requirements for the method of ensuring compliance of the selected equipment and parts
the selected device with the technical requirements,
f) documentation requirements compliance for the selected device, and
part of the selected device with the technical requirements,
(g)) the conformity assessment procedures and the scope of the selected device with the technical
requirements,
h) requirements for documentation of the assessment of conformity of the selected device
the technical requirements,
I) individual procedures that can be applied to the assessment of the conformity of the selected
equipment with the technical requirements,
(j)), the scope and verification of conformity of the operated devices selected
technical requirements and
to the documentation and the contents of) the method of verification of conformity documentation
operated by the selected device with the technical requirements.
§ 2
The concepts of
For the purposes of this Ordinance, means the
a) pressure equipment selected device pressure working fluid
with the highest working pressure exceeding 0.05 MPa, including the elements
connected to components exposed to pressure, safety and pressure
equipment and other equipment, which ensures its functionality,
(b)) the report of the pressure equipment file several parts, of which at least
one is the pressure equipment,
1. are associated and executed so that they are compatible with one another,
2. carries out the specified safety function only if they are present in all
parts of this file,
3. are mounted one vendor and
4. use the common use as a single unit.
§ 3
The contents of the list of selected devices
(1) in the list of selected devices must be clear from the text section
determined by each selected device and put the safety class, to
that are included.
(2) in the drafting of the list of selected devices must be
a) schematically shown technology systems and building parts
nuclear devices that contain the selected device,
b) safety class marked differently each of the selected device
and highlighted the boundaries between the selected device and the other devices or
other parts of the construction of a nuclear installation and
c) listed the identification information of selected devices and other information from the
which is clearly evident in their function and location within the
the nuclear device.
(3) included in the list of selected devices must be rules for the
and determine the boundaries between systems), devices or parts of the construction of the nuclear
device designed to ensure that the performance of the safety features and other systems,
devices or parts of the construction of a nuclear installation and
(b) the boundary between the) determination of the safety of selected classes
device.
(4) in the list of selected devices must be marked with the selected device
which, according to § 12 para. 2 the conformity of the selected device with the
technical requirements (hereinafter referred to as "conformity assessment") carry out authorized
or accredited person.
§ 4
The scope and quality assurance in the design process of the selected
device
(1) in the design of the selected device, which includes its development,
construction and design, (hereinafter referred to as the "design process") must be
handled by the output of the design process documentation (hereinafter the ' draft
the selected device ").
(2) the design process and the design of the selected device must be in accordance with the
technical requirements on the selected device and part of the selected device
referred to in section 9.
(3) the verification of the design process must be carried out
and) persons who carry out, and the design process
(b)) by persons not involved in the design process.
(4) in the design of the selected device must be determined
and) acceptance criteria for the monitoring and evaluation of reliability,
b) acceptance criteria for monitoring and evaluation of service life,
(c)) the conditions for treatment and operation,
d) acceptance criteria relating to the performance of the safety features
e) acceptance criteria for quality assurance and
f) technical regulations, technical standards, technical conditions, which
are to be used.
§ 5
The scope and quality assurance in production and installation process
the selected device
(1) before the start of the process of production and Assembly of the equipment must be selected
obtain all the technical documentation for the selected device according to the
Annex No. 3 to this Decree is required to perform this process.
(2) for the production and Assembly of the equipment must be selected
and) followed in accordance with the proposal of the selected device
b) technical specifications for the selected device available and its changes
(c) verifying compliance checks) to the selected device or its
part with the technical requirements,
(d) the documented way and progress), production and installation of the selected device
including its inspections, in accordance with the requirements laid down in the draft
the selected device,
(e)) was established as a way and the scope of the review, verification and validation of the selected
the device,
(f)) of the selected device identified by the distinctive and this
identification is maintained,
g) available information on the current status, location, or the past and
the use of the selected device or the present or the past how
handling and
h) part of the selected device, which is separately supplied, in a State of
enabling the validation of the process of production and Assembly of this part.
(3) After termination of the manufacture or Assembly of the selected device must be
and the selected device checks) to verify compliance with the
the technical requirements, and
(b)), the final assessment carried out to verify the conformity of the selected device
the requirements specified in the design of the selected device and the documentation
for its manufacture and Assembly; report of the final assessment of the pressure equipment
must be done after mounting reports of pressure equipment as a whole.
(4) the inspection requirements and final assessment referred to in paragraph 3 lays down the
Appendix 6 to this Ordinance.
§ 6
The scope and quality assurance in the procurement process for the selected
device
(1) prior to procuring equipment must be selected
and the documentation for the procurement) set out the requirements for the selected
equipment and
(b)) was established as the method of selection and criteria for the evaluation of the vendor of the product
or services (hereinafter referred to as "supplier").
(2) the procurement of the equipment must be selected
and evaluated and selected) the supplier in accordance with the established way to choose
and criteria for the evaluation,
(b) carried out a review of the documentation of the supplier) on quality assurance
the selected device in terms of its accuracy and completeness,
(c) set out the requirements on the way) and notification of disagreement range supplier
and ways of their solution, and
(d) adopted measures to implement) the supervision of supplier of
ongoing monitoring and control processes in terms of compliance with the
ensuring the quality of the selected device from the supplier.
§ 7
The scope and quality assurance in the process of commissioning and
operation of the selected device
Commissioning and operation of the equipment must be selected
and the identification of the selected device are documented) and the use of surrogate
the part of the selected device
(b) information on the current available) and the last condition, location and use of
the selected device or on the current and previous treatment
the selected device,
c) processed, implemented and maintained marketing plans and programs of the selected
the device into operation and its operation
(d) the identification of the selected device is maintained) allocated in the production or
installation,
(e)) the implementation of activities carried out in accordance with marketing programs
the selected device into operation,
(f) the implementation of the activities planned and) carried out in accordance with the internal
regulations and other documentation for the operation, including the plans and programmes
operational controls the selected device, přeprovozního and operational
program controlled aging and plans and programmes in the implementation of controls
maintenance, repairs or changes to the selected device, and with the technical requirements
laid down by this Decree,
g) repair, maintenance or change the selected device in accordance with
the requirements set out in the documentation of repair, maintenance or changes to the selected
equipment and
h) ensures that the selected device handling and storage are
carried out in a manner which prevents damage, misuse or
the destruction of the selected device or its parts.
§ 8
Types of quality assurance records the selected device and the way they
leadership
(1) ensuring the quality of the selected device must be documented
in particular, the
and records concerning specific) processes,
(b)) a record of the assessment and evaluation of non-conformity,
(c)) dokladujícími records meet the requirements on the quality of the selected
device, including the requirements for the qualification of the workers administering
control and verification of the design of the selected device, its parts, and quality
the materials used for its production, in the case of pressure equipment classified
to safety class 1 or 2, and
(d) dokladujícími delete) records defects of the selected device and
How to perform the repairs and undeleted records defects and how to
their controlled monitoring and evaluation, in the case of pressure equipment
included in the safety class 1 or 2.
(2) quality assurance Record the selected device is permanent or
temporary.
(3) the Permanent record of the quality assurance of the selected device is
and the design of the selected device),
(b) the record of the examination) the accuracy and completeness of documentation provision
the quality of the selected device vendor
(c)) the current record for the technical condition of the selected device after their
its production,
(d) the record of the current technical) status of the selected device
installation and inspection
(e)) record that the selected device is operated, maintained or
subjected to inspections in accordance with the technical requirements, the technical
specifications, program, operational controls, operational program-controlled
Aging, program maintenance, maintenance procedures or legal requirements
regulations,
f) record that documents that a person who plans, directs or
evaluate the processes related to the design, manufacture and installation, procurement,
commissioning or operation of the selected device or its parts,
meets the requirements for qualifications,
g) record that documents the planning and implementation of maintenance, repair or
changes to the selected device, including quality used replacement card
parts,
h) record that documents the quality originally built for the selected
the device repaired or replaced for the selected device or
the selected device, in which the change was made, in accordance with the
technical requirements and technical specifications for the selected device, and
I) record that documents that ensure redress mismatches and
preventive measures are taken against this mismatch.
(4) a temporary quality assurance record is a record of the selected device
ensuring the quality of the selected device, which is not a permanent record
ensuring the quality of the selected device.
(5) a permanent record of ensuring the quality of the selected device must be
kept from the selected device design throughout its service life.
(6) quality assurance Records the selected equipment must be kept in
the extent and manner, in order to assess whether the status at any time
the selected device or its part corresponds to the relevant technical
requirements.
(7) records of production and Assembly and of procurement of selected device must
be made in the course of production and Assembly and procurement of selected
devices and assembled before the beginning stages of placing selected
the device into operation.
(8) records from the stage of placing the selected device into operation must be
drawn up in the course of placing the selected operation
assembled before the start of operation of the selected device.
(9) records of traffic must also include the method and extent of the implementation of
repair, maintenance or changes to the selected device.
§ 9
Technical requirements on the selected device and part of the selected device
Technical requirements on the selected device and part of the selected device
that apply to the design, manufacture, Assembly, putting into
operation and service, set out in annex 1 to this notice.
§ 10
The requirements of the method of ensuring compliance of the selected equipment and parts
the selected device with the technical requirements
(1) ensuring the conformity of the selected equipment and parts for the selected device with the
technical requirements (hereinafter referred to as "ensuring compliance") must be carried out
and documented so as to ensure that the documents and evidence necessary for the
provision of technical safety.
(2) any person who designs, manufactures, assembles, or put into operation
corrects the selected device or part of a selected device, or performing
its maintenance, and the holder of the authorization referred to in § 9 para. 1 (b). (b) to (h)))
the Atomic Act is obliged to provide the supplier of the information about the selected
the device or its parts, including the requirements for the type, amount, terms and
delivery dates and the quality level of the selected device or its parts,
by its inclusion in the security class.
(3) compliance is holder of the authorization must provide
and supply system with the necessary) resources and with the external and internal
communications, including a system of mutual inspections, independent
(b)) on quality assurance documentation for the selected device, and
programmes controlled aging and allow their review
c) control mechanisms and ways of communication within the
supply-chain for selected device or its
part,
(d) establishment of a system of checks) the selected device or its parts
the corresponding stage of the life cycle of the selected device
compliance with the prescribed procedures and records of the checks,
(e) control over the activities on) the device corresponding to the stage
the life cycle of the selected device or parts of it within the system
independent supervision of the holder of the authorization and independent control system
the vendor,
(f) implementation of the final assessment) of the selected device with the technical
the requirements set out in the procedures for the manufacture, installation or repair
the selected device,
g) documenting the final assessment of the selected device referred to in point (a)
(f)),
h) verifying compliance with the technical requirements laid down in the procedures for
maintenance of the selected device supplier who performs maintenance for the selected
the device,
I) documenting the fulfilment of the technical requirements referred to in subparagraph (h))
and
j) availability of documentation relating to the selected device or its
section corresponding to its actual execution at a predetermined
the range.
(4) the verification of the quality of the materials used and the accuracy and completeness of the
technical documentation, documentation of repairs and maintenance, and the accompanying technical
documentation for the selected device, including authentication procedures final
the assessment must be for the selected device referred to in § 12 para. 2 or
his part is carried out by natural persons, that
and higher education) or higher vocational degree
education of an accredited educational program successful in
the field of education, electronics, construction, or scope
a related, whose passing had gained theoretical expertise
necessary for the implementation of these activities, or the degree of secondary education
with a GCSE in the machinery, electronics, building,
or a related field, whose passing received theoretical training
knowledge necessary for performing these activities, and
(b)) have at least five years experience in a relevant field, if it is a physical
the person with the degree of education secondary education with the GCSE,
at least three years experience in a relevant field, in the case of natural persons,
levels of education higher vocational education, or at least two years experience in the
the field, in the case of a natural person with a university degree.
(5) Appendix 2 to this Decree shall lay down the requirements for the way
ensuring compliance
and when designing, production) and the installation of the selected equipment and parts
the selected device,
(b)) when placing the selected equipment and parts for the selected device into operation
and
(c)) in the operation of the selected equipment and parts for the selected device with the
technical requirements.
§ 11
Documentation requirements for the compliance of the selected equipment and parts
the selected device with the technical requirements
(1) how to design, manufacture and installation of the selected equipment and parts
the selected device must be documented to allow the implementation of
assessment of conformity.
(2) compliance shall be documented in the documentation for provisioning
conformity in accordance with the requirements laid down
and) in annex No. 3 to this Decree, in the case of technical documentation
the selected device, and
(b)) in Appendix 4 to this Decree, in the case of the accompanying technical
documentation for the selected device.
(3) documentation of compliance must be retained at all times
the life of the selected device.
§ 12
The conformity assessment procedures and the scope of the selected device with the technical
the requirements of the
(1) the conformity assessment must be carried out before using the selected device
in a nuclear device.
(2) the notified body performs conformity assessments for
and) of selected equipment safety class 1, which are
the border of the primary circuit cooling nuclear reactor (hereinafter referred to as
"the primary circuit), and for
1. pressure vessels, tanks and coolers, including nuclear pressure vessel
the reactor and parogenerátorů, working with radioactive substances with
maximum allowable pressure exceeding 0.05 MPa, which is
greater than 10 litres, and
2. pumps, pipes and valves working with radioactive substances with
maximum allowable pressure exceeding 0.05 MPa, whose nominal
the luminosity is greater than DN 70,
(b)) of selected equipment safety class 2 and for
1. pressure vessels, reservoirs and radiator cooling systems to ensure
nuclear reactor, compensation volume, the cooling of the hermetic space
emergency replenishment, the primary circuit of the cooling and cleaning
the working fluid pressure circuit working with radioactive substances
with the highest working pressure exceeding 0.05 MPa, which is
more than 10 l;
2. pumps, pipes and fittings systems providing the cooling of nuclear
the reactor, compensation volume, the cooling of the hermetic space, emergency
the completion of the primary circuit cooling and cleaning of the working fluid
the pressure circuit working with radioactive substances with the highest
working pressure exceeding 0.05 MPa, whose diameter is
greater than DN 70,
3. the pressure equipment constituting the system of protective envelope, including
ensuring the hermetically protective envelope when the base project
the accident,
4. pressure equipment in secondary circuit of a nuclear reactor cooling
(hereinafter referred to as "secondary circuit"), for which the maximum working pressure
the working fluid at operating temperatures higher than 100 ° c is greater than 4 MPa
and whose diameter is greater than DN 200,
5. transport, packaging and storage of spent storage
nuclear fuel and
6. construction of the reinforced concrete structure of the building of a nuclear reactor, including
the outline of the mounting of the lid of a nuclear reactor building, and the steel lining of the
defining the hermetic space and
(c)) of the selected equipment safety class 3, in
1. pressure vessels, tanks and coolers systems to ensure normal
topping, bórovou regulation and cooling equipment for storage
spent nuclear fuel work with radioactive substances with
maximum allowable pressure exceeding 0.05 MPa, which is
more than 10 l;
2. pumps, pipes and fittings systems to ensure normal
topping, bórovou regulation and cooling equipment for storage
spent nuclear fuel work with radioactive substances with
maximum allowable pressure exceeding 0.05 MPa, whose nominal
the luminosity is greater than DN 70, and
3. pressure equipment secondary circuit, for which the maximum allowable
the pressure of the working fluid at operating temperatures higher than 100 ° c is greater than 4
MPA and whose diameter is greater than DN 200.
(3) the producer or importer shall conduct an assessment of the conformity of the
and the selected device parameters) less or equal to the values of the
laid down in paragraph 2,
(b) electrical equipment and selected) for the selected device
automated control systems of technological processes, including their
software (hereinafter referred to as "control the selected device"),
(c)) for the selected device, which is part of the building part of a nuclear
equipment (hereinafter referred to as "building the selected device") included in the
safety class 3 and
(d)) of another of the selected device to the safety class 2 or 3,
unless the selected device referred to in paragraph 2.
(4) an accredited person carries out the assessment of conformity for the selected device
referred to in paragraph 2 (a). (c)), if it is a conformity assessment carried out
procedure laid down in article 15, paragraph 2. 1 (b). (e)), point 1.
(5) in the case of conformity assessment of pressure equipment must be report this
the report assessed as a whole. When the conformity of the pressure report
the device will make use of the results of conformity assessment of each of the selected
devices that are parts of the report of the pressure equipment. Assessment of conformity
the report, the pressure equipment must be carried out having regard to the
the most important safety class to which the is one of the
selected devices, which are parts of the report of the pressure equipment.
(6) for each part of the selected device separately proposed,
manufactured or assembled after the production conformity assessment must be carried out in
extent that this part of the selected device; This does not apply for
part of the selected device referred to in paragraph 3, for which there is
the conformity of this section to the extent appropriate for the selected device
prescribed in the design of the selected device. In the assessment of the conformity of the selected
the device will make use of the results of conformity assessment of the individual parts
the selected device separately proposed, manufactured or prefabricated
After production.
(7) the conformity assessment must be carried out, including the default
materials and semi-finished products with the technical requirements for these materials and
semi-finished products.
(8) the Individual conformity assessment procedure can be carried out only
once by a notified body, the manufacturer or a qualified person,
the importer of the selected device. If the prescribed combination of procedures
conformity assessment can be individual conformity assessment procedures carried out
different people.
section 13 of the
Mark of conformity
(1) the manufacturer or the importer must, in the framework of the implementation of the conformity assessment
mark the selected device mark of conformity together with the identification of
the manufacturer; If it is within the framework of the conformity assessment procedure provided for the participation of
authorized or accredited person must be connected also
the identification of this person.
(2) the designation mark of conformity certifying conformity of the selected device
technical requirements and compliance with the conformity assessment procedure chosen
provided for by this regulation.
(3) the mark of conformity shall be appended to the selected device, indelible and
legible manner, and its size must not be less than 5 mm. Brand
conformity may be affixed in the accompanying technical documentation for the selected device,
If it does not connect to the selected device, its design or
dimensions, or if after the installation of the selected device to be accessible.
(4) graphic design of mark of conformity provided for in annex 9 to this Decree.
§ 14
The requirements for documentation of the assessment of conformity of the selected device
technical requirements
(1) the Documentation used in the assessment of the conformity of the
and technical documentation for the selected device) listed in annex 3 to the
This Decree and
b) documentation concerning the management system of the manufacturer or the person
carrying out Assembly and quality assurance documentation for the selected device
by the manufacturer or by a person carrying out the installation, if it is in the context of the procedure
assessment of conformity assessment on the control system of the manufacturer or the person
performing the installation.
(2) conformity assessment must be documented
and the documents of the procedure) the conformity assessment and
(b) documents issued in) conformity assessment by a notified body,
an accredited person, the manufacturer or importer of the selected device in the
the scope specified in the various conformity assessment procedures.
(3) to each selected device, for which the assessment has been conducted
conformity must be issued a declaration of conformity issued by who
performs design, manufacture or production of this device.
Formalities for the Declaration of conformity set out in annex 5 to this Decree.
(4) a declaration of conformity is included in the accompanying technical documentation
the selected device.
(5) if the authorized or accredited person to issue a document about the
conformity assessment, conformity assessment is included in the preamble to the
This decision.
(6) the dossier referred to in paragraph 2 must be kept at all times
the life of the selected device.
§ 15
Each of the procedures that can be applied to the assessment of the conformity of the selected
equipment with the technical requirements
(1) the various conformity assessment procedures are to
and) the selected device referred to in § 12 para. 2 (a). and)
1. the conformity assessment procedures (B) and (D),
2. the conformity assessment procedures, (B) and (F), or
3. conformity assessment procedure (G),
(b)) the selected device referred to in § 12 para. 2 (a). (b) paragraphs 1 to 4)
1. the conformity assessment procedures of B1 and D,
2. the conformity assessment procedures of B1 and (F),
3. conformity assessment procedures (B) and (E), or
4. conformity assessment procedure (G),
(c)) the selected device referred to in § 12 para. 2 (a). (b) point 5 of the procedure)
conformity assessment (F),
(d)) the selected device referred to in § 12 para. 2 (a). (b) section 6)
1. the conformity assessment procedures, (B) and (E),
2. the conformity assessment procedures, (B) and (D), or
3. conformity assessment procedure (G),
(e)) the selected device referred to in § 12 para. 2 (a). (c))
1. the conformity assessment procedure A1,
2. the conformity assessment procedure,
3. conformity assessment procedure E1, or
4. conformity assessment procedure or combination of procedures the conformity assessment, if the
prescribed, referred to in point (a)), or (b)), and
f) selected establishments referred to in § 12 para. 3 conformity assessment procedure and.
(2) the various conformity assessment procedures in the scope section of the selected
device pursuant to § 12 para. 6 are for
and) the selected device referred to in § 12 para. 2 (a). a) and b)
1. the conformity assessment procedure,
2. procedure for assessment of conformity of E1, or
3. conformity assessment procedure (G),
(b)) the selected device referred to in § 12 para. 2 (a). (c))
1. the conformity assessment procedure A1,
2. the conformity assessment procedure, or
3. conformity assessment procedure E1 and
(c)) the selected device referred to in § 12 para. 3 conformity assessment procedure and.
(3) the conformity assessment procedures laid down in annex 7 to this no.
the Decree.
section 16 of the
The scope and verification of conformity of selected devices operated with
technical requirements
(1) Verification of compliance with the technical device operated by the selected
requirements (hereinafter referred to as "verification of conformity") must be carried out in the manner and
to the extent set out in annex 8 to this Decree and in accordance with the
examination of the conformity of the documentation referred to in § 17 paragraph 2. 2.
(2) periodic verification of conformity must be planned and carried out in the
intervals and in the manner set out in the programme, operational controls and in
accordance with the technical specifications of each of the selected device.
(3) in the context of the periodic verification of conformity checks shall be carried out
the selected equipment set out in programme operational controls. The requirements of the
on these checks set out in annex 6 to this Ordinance.
(4) in the context of the periodical verification of conformity must be the results of the checks
evaluated in terms of the technical safety of the device you have selected.
(5) in the framework of the examination of the conformity after the repair, maintenance or reassembling after
repair or maintenance of the equipment must be selected results of the checks
set out in the documentation of repairs or maintenance are evaluated in terms of
the technical safety of the device.
(6) in the context of the examination of the conformity after the repair, maintenance or reassembling after
repair or maintenance of the selected device must be carried out to verify that
part of the selected device referred to in § 12 para. 2, applied during the repair
or maintenance of the selected device is in accordance with the technical requirements.
Part of the validation of the selected device must be carried out according to the procedure F1
Annex 8 to this Ordinance.
(7) in the framework of the examination of the conformity of the after repair or reassemble after the repair and
After you make changes to the selected equipment must be done by the final
assessment referred to in annex 6 to this Ordinance.
§ 17
The method of documenting and examining the conformity documentation contents
operated by the selected device with the technical requirements
(1) the requirements for documenting the screening of conformity set out in annex 8 to
This Decree.
(2) documentation of the examination of conformity shall contain the
and) work orders, and the methodology for checking conformity,
(b)) the internal rules, if they contain information on the checks selected
the device,
c) plans the operational controls,
(d)) the program operational controls,
e) operating program controlled aging
f) accompanying technical documentation of the selected devices according to annex No.
4 to this Decree,
g) documentation relating to the preparation and implementation of repairs and maintenance
the selected device and
h) records from operational controls and carried out checks on the implementation of the
repairs, maintenance, or changes to the selected device.
(3) the Program shall contain the operational controls
and each of the selected device) lists broken down by species,
the selected device
(b) the operational controls each) programs of the selected device
containing the
1. control points on select devices,
2. the control methods applied to control points selected
the device,
3. acceptance criteria for the evaluation of the methods of inspection and
4. the period of in-process operation and
(c) an overview of the changes to the operating program) checks carried out in the course of the
commissioning and operation of the selected device.
section 18
Notification
This Decree was notified in accordance with the directive of the European Parliament
and of the Council (EU) 1535 of 9 June. September 2015, the procedure for the provision
information in the field of technical regulations and of rules on services,
the information society.
§ 19
Transitional provisions
(1) an assessment of the conformity of the selected device, which is specifically proposed
for a nuclear device, with the technical requirements to ensure the technical
safety in accordance with Decree No. 309/2005 Coll. on the provision of technical
safety of the device, in the version in force prior to the date of acquisition
the effectiveness of this Ordinance, shall be considered to assess the conformity of the selected
device or part of a selected device pursuant to this Decree, and validation
According to § 16 para. 6 of this Ordinance and it shall be deemed that the selected
the device complies with the requirements of this order.
(2) the selected device that is not specifically proposed by the selected
equipment for a nuclear device, according to Decree No. 309/2005 Coll. on
ensuring the technical safety of the device, in the version in force
before the date of entry into force of this order, and which meets the requirements
Decree No. 132/2008 Coll., on the system of the quality in implementation and provisioning
activities related to the use of nuclear energy and radiation
activities, and the quality assurance of selected devices with regard to the
their inclusion in the safety classes, in the version in force before the date of
entry into force of this order, shall be deemed to have selected the device or
part of the selected device, for which the conformity assessment procedure has been carried out
According to this Decree, and it is considered that it complies with the requirements of this order.
section 20
The effectiveness of the
This Decree shall enter into force on 1 January 2000. January 2017.
Chair:
Ing. Drábová, Ph.d., v. r.
Č. 1
Technical requirements on the selected device and the parts of the selected device
A. technical requirements for pressure equipment and some other selected
the device and the packaging files for transport, warehousing and storage
spent nuclear fuel
1. General requirements
1.1. Technical provisions set out in this annex shall apply to all
pressure equipment and assemblies of pressure equipment, and parts thereof.
1.2. The technical requirements referred to in
1.2.1. points 1.3 to 1.8, 1.13, 1.14, 2 to 5 and 11 to 14 shall apply to the
packaging files for transport, warehousing 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
apply to selected establishments referred to in § 12 para. 3 (b). a) and (d)).
1.3. Pressure equipment must be designed in accordance with the requirements of
laid down
1.3.1. in its technical specifications referred to in the Decree on requirements for
the project of a nuclear device, and
1.3.2. the provisions of this Decree.
1.4. Pressure equipment must be designed to
1.4.1. the cause of his sudden failure when all test and
States of operation, including a non-compliant media leaks,
1.4.2. it was possible to safely perform in the course of the operation of all
necessary scheduled or unscheduled inspections or diagnosis of this
equipment and
1.4.3. it was possible to safely perform its repair and maintenance.
1.5. The pressure equipment must be designed to withstand the danger
resulting from the properties of the territory to the location of the nuclear device, external
influences and internal influences.
1.6. The pressure equipment must be able to perform the desired function in the
all States of operation of nuclear installations and in emergency conditions,
the coping is specified.
1.7. The materials used for the manufacture of pressure equipment and parts thereof
securing the hermetically mailers are subject to the requirements of the
pressure equipment materials in accordance with section 12 and 13 of section A of Annex No. 2
to this Decree.
1.1. Pressure equipment must be so designed that it can be
its decontamination, and if possible the subsequent preparation of the internal
surfaces.
1.9. When designing the pressure equipment must be based on the
laid down
1.9.1. the calculation, operating and test loads and their limits
1.9.2. the operating conditions for the pressure equipment,
1.9.3. the limit parameters of serviceability of the pressure equipment,
the function of the mechanical movement occurs,
1.9.4. operating modes with regard to the classification of pressure equipment to
safety class
1.9.5. chemical and physical parameters of the media used in the pressure
the device,
1.9.6. corrosive the effects used on the material pressure equipment
for the desired service life of the device, and
1.9.7. durability requirements of the pressure equipment to seismic effects
or cyclic loads.
1.10. The pressure equipment must be so designed as to preclude or
minimize the risk of substantial losses as a result of pressure resistance
disorders leading to the violation of the integrity of the pressure equipment and the leak
radioactive substances. In cases where this risk cannot be avoided, it must
be in the operation of the pressure equipment, and after weaning, by appropriate
means of protection to maintain operating parameters ensures maintaining
sufficient level of media in the pressure equipment and the removal of residual
the heat, connecting power systems and heat dissipation.
1.11. The pressure equipment constituting the system of protective envelope, including
influencing Hermeticism protective envelope, must be designed so that
It was possible to determine the tightness at the projected a calculated pressure after
install all airtight penetrations, airtight doors and entrances.
1.12. The pipeline, which is the pressure equipment must be designed so that
the risk of overload as a result of undue or excessive forces
emerging, in particular on the flanges, joints and vlnovcích was
in particular, the use of aid, minimize reinforcement, anchors, application
position and preload.
1.13. Pressure equipment must be designed for loadings in all
States of operation of nuclear installations and in emergency conditions, to
whose management is addressed. It is necessary to take into account the various loads
may act jointly, taking into account the probability of their
the current occurrence.
1.14. pressure equipment Design for adequate strength must be
based on the calculation method described in point 2, if necessary, supplemented by
the experimental method. When you process a calculation can only be used
the verified calculation programs.
2. Calculation method
2.1. the calculation method must apply a conservative approach and
to limit the risk to individuals and property to the lowest reasonably
achievable peace in accordance with the requirements laid down in the technical
regulations and technical conditions to
2.1.1. the implementation of the calculations of the fortress
2.1.2. the mechanical properties of the basic and auxiliary
materials,
2.1.3. permanent joining,
2.1.4. carrying out checks on pressure equipment and
2.1.5. monitoring and evaluation of the ageing of the pressure equipment.
Pressure containment and other loading aspects
2.2. Allowable stresses for pressure equipment must be limited with a view
on the occurrence of the failure modes under operating conditions and operational
modes is impossible to predict. Safety factors must be used,
that allow you to completely rule out any uncertainty arising out of the manufacture,
actual operating conditions, stresses, calculation models and
the properties and behaviour of the material.
The strength of
2.3. To ensure the strength of the pressure equipment must be used by the appropriate
strength calculations involving the relevant calculation, operating and testing
load.
2.4. when calculating the strength of pressure equipment must be taken into account
in particular, this load:
2.4.1. internal and external pressure,
2.4.2. the effect of the weight of the equipment and its own cartridges,
2.4.3. additional load, including the effect of the weight of the connected devices,
insulation and piping,
2.4.4. the forces induced by the braces and pipes,
2.4.5. temperature effects, including thermal shocks,
2.4.6. the vibrating load
2.4.7. seismic effects and ambient conditions for extreme
atmospheric phenomena
2.4.8. the processes causing degradation of the material, including the impact
of radioactivity,
2.4.9. hydraulic resistance and pressure surges,
2.4.10. the plane crash and
2.4.11. other loads resulting from the risk analysis referred to in point 3.1 of part
And annex 2 to this Decree.
Calculated load
2.5. The calculated pressure must be greater than the maximum allowable pressure and must
take into account the
2.5.1. pressure surges,
2.5.2. the control system error and uncertainty of measurement and
2.5.3. the effects of the system configuration.
2.6. For parts of pressure equipment loaded at the same time the inner and outer
the pressure is determined as a pressure difference calculation for these pressures, in which
the largest wall thickness is achieved.
2.7. the Calculated temperature must not be less than the expected maximum medium
the temperature of the part under consideration, thickness, subject to the limits for
normal and abnormal operating conditions. If the device or pipe
heated by heat transfer from sources such as the Induction coil,
casing or internal heat sources must be taken into account when their influence
determination of the calculated temperature.
2.8. Additional computational load must be chosen so that, in combination with
influences of design pressure, subject to the limits on normal
operating conditions, the maximum thickness of the walls was specified for the device.
2.9. The pressure equipment must be designed to the highest values of
stress and stress concentration corresponding to the calculated loads were
kept within safe limits.
Operating load
2.10. when calculating the strength of pressure equipment must be taken into account
all loads that can occur in all States of operation
nuclear facilities and in emergency conditions, to whose management is
specified. The load must be considered, in particular, causing tension and
deformation in the material from which the device is manufactured, from the
production, transport, Assembly and pressure tests, including residual
voltage, the effect on the strength limit State must be assessed
individually according to their significance.
Load test
2.11. when calculating the strength for pressure equipment must be taken into account
estimated load test, which is when pressure equipment pressure
during the test of the final assessment.
2.12. the test pressure must be determined in relation to the calculation, or
the maximum permitted pressure with regard to the evaluation of the geometric
and material properties and test conditions in the production of and traffic in
accordance with the requirements of the technical regulations or technical
conditions for the manufacture of pressure equipment.
Strength calculation, design of the basic dimensions and check calculation
2.13. Strength calculation for pressure equipment must be drawn up for
the following limit conditions:
2.13.1. the sudden violation of the integrity of the high-impact or brittle fracture,
2.13.2. plastic deformation in the cross section of the pressure equipment,
2.13.3. unidirectional growth of plastic strains in the folder
cyclic loading resulting in unacceptable change of dimensions or to violate the
integrity,
2.13.4. cracking with fatigue loading and
2.13.5. loss of stability.
2.14. In the calculation of strength for limit State referred to in paragraph 2.13 shall be
used values that correspond to the material strength, plastic
and křehkolomovým characteristics, and resistance to deformation, which are
for the materials provided in the technical regulations, or
experimentally determined by an accredited laboratory. For the purposes of this
calculation, you can use the values specified in the technical standards.
2.15. in the case of permanent joints must be selected for
material properties of the appropriate coefficient of permanent joints
dependent on the type of the connected materials, the type of used
non-destructive inspection and on the function of the selected device in all
States of operation of nuclear installations and in emergency conditions, to
whose management is addressed.
2.16. In the design of pressure equipment must be appropriately
the corresponding intended use of pressure equipment and its planned
lifespan into account foreseeable degradation mechanisms, in particular the impact of
radioactivity, corrosion and fatigue.
2.17. when calculating the strength of the pressure equipment must be carried out
2.17.1. the calculation for the design of the basic dimensions of the device (hereinafter the ' draft
basic dimensions "), and
2.17.2. check calculation of pressure equipment (hereinafter referred to as "control
the calculation ").
2.18. When designing the basic dimensions voltage calculated from the holidays
tensile strength and yield point of contracting, permitted for the production
the pressure equipment. When calculating permissible stresses shall be considered
the appropriate safety factors.
2.19. When designing the basic dimensions should be considered the limit States
2.19.1. breach of integrity with tough fracture,
2.19.2. plastic deformation in the cross section of the pressure equipment and
2.19.3. loss of stability.
2.20. After the draft basic dimensions of pressure equipment must be carried out
check calculation, which must be demonstrated
2.20.1. strength at static loading,
2.20.2. strength with cyclic loading,
2.20.3. resistance to sudden violation of,
2.20.4. strength, vibration
2.20.5. resistance to loss of stability and
2.20.6. resistance to seismic effects.
2.21. In the calculation of the load must be taken into account, including all
temperature effects, and all the conditions specified in the technical
specification. In particular must be taken into account the degradation of material properties
during the operation, quality, effect of stress gradient and the influence of corrosion
environment.
3. experimental design method of pressure equipment
3.1. The design of the pressure equipment or its parts must be
verified by appropriate checks carried out on a representative sample of
pressure equipment in accordance with the programme of checks laid down for the purposes of
the experimental design method. This program checks must be
approved by a notified body that performs conformity assessment of the proposal.
3.2. in the inspection programme must be defined test conditions and
the criteria for admissibility. Before you perform the various checks must be
measured the actual values of the basic dimensions and properties of the materials
where the pressure equipment is made up.
4. design of the safe handling and operation of the pressure equipment
4.1. The method of handling and operation of the pressure equipment must
eliminate the risks arising from the risk analysis referred to in point 3.1 of part A
Annex No. 2 to this Decree. Special attention must be paid to the
4.1.1. closures and openings,
4.1.2. dangerous fittings and odfukům of insurance
4.1.3. the elements that impede the physical entry into this machine, if
in this device the pressure or vacuum.
5. the means of examination
5.1. The pressure equipment must be so designed that it is possible to carry out
all the necessary checks to ensure the technical safety.
5.2. If the pressure equipment cannot be so designed that it is possible in
during the operation carried out checks on the device in the desired
the range must be
5.2.1. different monitoring for ensuring the same level of technical
security, including indirect controls, or
5.2.2. used approved calculation methods
and must be applied to the safety provisions set out conservative
access and reasonable security measures to avoid possible
an unexpected failure of the pressure equipment.
6. the means of draining and venting
6.1. Proposal for the pressure equipment must, throughout the service life of the pressure
device and in the implementation of controls by the use of appropriate means of
draining and venting of pressure equipment
6.1.1. to prevent water shock, collapse of the vacuum pressure equipment
or corrosion and uncontrolled chemical reactions and other adverse
effects and
6.1.2. to permit the safe decontamination, cleaning, inspection and maintenance
the pressure equipment.
7. Corrosion and other chemical reactions
7.1. If the risk analysis referred to in point 3.1 of annex 2 to this
the notice identified the risk of corrosion or other chemical reactions,
must be having regard to the intended use of the pressure equipment in the design
pressure equipment to minimize these effects using
7.1.1. other corrosion-resistant material,
7.1.2. the wall thickness of reinforcement corrosion allowance, or
7.1.3. protection against corrosion or other chemical reactions.
8. Wear
8.1. If the risk analysis referred to in point 3.1 of annex 2 to this
the notice identified the risk of erosion or abrasion, it must be with regard to the
the intended use of the pressure equipment in the design of pressure equipment
These effects are minimized by using
8.1.1. other material erosion or abrasion resistant,
8.1.2. addition of wall thickness on the gain of wear,
8.1.3. the use of lining or přeplátování, which will allow the replacement of parts,
which are the most affected, or
8.1.4. other measures that minimize the effects of wear and tear.
9. Report of the pressure equipment
9.1. Report of pressure equipment must be designed to
9.1.1. jointly compiled the report parts of pressure equipment have been for
the use of appropriate and reliable,
9.1.2. all parts of the set pressure equipment have been properly incorporated and
assembled in an appropriate manner and
9.1.3. the classification of the parts in the report of the pressure equipment has been carried out
9.1.3.1.use. on the basis of the foreseeable risks identified in advance in
the risk analysis referred to in point 3.1 of Annex No. 2 to this Decree,
9.1.3.2. with regard to the suitability and reliability of the installation and
9.1.3.3. on the basis of the correct breakdown of parts assembled together
report of the pressure equipment.
9.2. Protection against exceeding the pressure equipment report
operating limits and safety equipment check report must be
designed with regard to the most significant safety class to which it is
included some of the selected devices that are parts of a report
the pressure equipment.
10. Filling and discharge
10.1. In the design of the pressure equipment must be of suitable design,
Accessories for pressure equipment or taking measures for its
installation to ensure safe filling and discharge devices and
sampling of the working fluid, in particular with regard to the risks
10.1.1. in its implementation, which are
10.1.1.1. overfilling or exceeding the pressure, in particular with regard to the filling
ratio and to vapour pressure at the appropriate temperature, and
10.1.1.2. instability of the pressure equipment,
10.1.2. in a discharge, which is the uncontrolled escape of media under pressure
and
10.1.3. When filling or discharge, which are unsafe connection and
disconnection.
11. protection against exceeding the allowable limits
11.1. If, in the course of the operation of the pressure equipment may be
exceeding the allowable limits, must be in the design of pressure equipment
11.1.1. accompanied by the protective device to prevent exceeding these limits
or a combination of such protective devices, or
11.1.2. taken appropriate measures for its installation.
11.2. The protective device or a combination of the protective devices must be
designed with regard to the specific characteristics of the pressure equipment or
report of the pressure equipment, which they are intended to be protected.
11.3. Protective device or a combination of the protective device is
11.3.1. safety accessories, or
11.3.2. control devices such as indicators or warning
devices that allow you to automatically or manually executed
adequate action by which the operation of the pressure equipment is maintained in
the allowable limits.
12. Safety accessories
12.1. the safety accessories must
12.1.1. be designed so as to ensure for pressure equipment
suitable and reliable protection,
12.1.2. be designed with regard to the maintenance and inspection requirements of this
the device,
12.1.3. be designed, in particular, provided
12.1.3.1. protection against faults,
12.1.3.2. backup safety equipment,
12.1.3.3. diversity of safety equipment and
12.1.3.4. automatic diagnosis of custom functionality,
12.1.4. ensure, where necessary for its correct operation, in addition to
protection of the machine parts of pressure equipment and protection systems power supply,
control, measuring and regulation and control system of nuclear-related
equipment and
12.1.5. be assessed in the framework of the assessment of the conformity of the pressure equipment or
report of the pressure equipment.
12.2. the safety accessories must not be intended for the performance of other functions
unrelated to the protection of the pressure equipment, except where the
other features cannot be affected by the performance of its protective function.
12.3. Pressure limiting devices, level, or flow rate of the media must be
designed to avoid crossing the highest permissible
pressure, level, or flow of the media; short-term increase of pressure in the
impressing the safety equipment is permitted provided it does not exceed 10% of the
the highest value of the permitted pressure.
12.4. temperature control devices must have the appropriate time delays in
consistent with the measurement function.
13. electrical equipment
13.1. electrical equipment must be designed
13.1.1. together with pressure equipment and
13.1.2. to allow reliable implementation of security features
the pressure equipment.
14. Protection against external fire
14.1. The pressure equipment must be for the purpose of its use, equipped with
suitable accessories, or such measures must be adopted for its
installation to meet damage-limitation requirements in the case of
external fire.
15. Hydraulic and pneumatic devices that provide control,
regulating, signalling and measurement
15.1. For hydraulic and pneumatic devices that provide
controlling, regulating, signalling and measurement shall apply the General
the requirements referred to in points 1.1 to 1.8, 1.13 and 1.14 and technical
requirements for pressure equipment referred to in items 2, 3, 5 to 8, and 13.
15.2. Each rychločinná valve safety system of nuclear
the device must be controlled by a private air carrier.
15.3. Pneumatic actuators and the air Distributor must allow repeated
pressurization with air or any other gas.
15.4. the Pneumatic actuator must be designed to
15.4.1. minimize the formation of incrustations, corrosion products, dust
and other impurities and
15.4.2. external and internal adjustment of its surface allow the highest
extent possible, the removal of deposits, corrosion products, dust and other
impurities.
B. technical requirements for managing the selected device
1. the management of the selected equipment must be designed in accordance with the requirements of
laid down
1.1. in its technical specifications referred to in the Decree on requirements for
the project of a nuclear device, and
1.2. this Decree.
2. On the control device must be provided for the identification of the manufacturer
This device, or, if you cannot identify the manufacturer put on the
This device, this must be indicated on the packaging identification.
Identification of the manufacturer must be indicated in the accompanying technical
the documentation for the device.
3. The basic technical characteristics of the management of the selected device
the operation of this device is necessary for it to
This device has been used safely and in conditions for which it was
made, shall be marked on the device and specified in its
the accompanying technical documentation, or, where this cannot be included directly
on this device, you must be listed in the accompanying technical
the documentation.
4. Control the selected device must be designed to ensure
that
4.1. natural persons are adequately protected against the danger of personal injury
or other hazards that may be caused by electric shock
When you touch the living or non-living parts,
4.2. the natural person and property will be protected from the dangers
enjoy nature, which may selected device control
cause,
4.3. There will be a dangerous rise in temperature, the emergence of the electric
the arc or radiation,
4.4. the proposed isolation control for the selected device matches the conditions
all operating States of the nuclear device and emergency conditions, to
whose management is addressed,
4.5. the danger arising from the will to resist the territory's property to the location of the
the nuclear device, external influences and internal influences
4.6. will be able to perform the desired function in all States of operation
nuclear facilities and in emergency conditions, to whose management is
determined,
4.7. can be on it or when the scheduled shutdown to perform
the activity safely, in particular it must be ensured, and Severability
will the device, and
4.8. can effectively take advantage of the diagnostic equipment.
5. The cables that are managing the selected device or that are
part of the control device must be selected
5.1. designed to be a way to prevent their damage
mounted in an environment for which they are intended and the characteristics
5.2. placed on catwalks in predetermined arrangement in layers and
the interstices of the prescribed in the kladečském the plan so as to ensure
the cable systems Division seized power from other files
cables.
C. the technical requirements for building the selected device
1. building the selected device must be designed in accordance with the requirements of
laid down
1.1. in its technical specifications referred to in the Decree on requirements for
the project of a nuclear device, and
1.2. this Decree.
2. building the selected device must be so designed that the requirements referred to in
point 1 shall meet in all States of operation of nuclear installations and in
emergency conditions, for which the management is determined.
3. building the selected device must be designed to withstand
the danger resulting from the properties of the territory to the location of the nuclear facility,
external influences and internal influences.
4. Building the selected device must be able to perform the desired function
in all States of operation of nuclear installations and in emergency
conditions for which the management is determined.
5. the proposal for the building of the selected device must be supported by calculations,
models or, if necessary, supplemented by experimental verification. When
You can use the calculation only verified calculation programs.
6. Construction of the selected equipment must be designed so that the effects of
the load characteristics of the territory to the location of the nuclear device, external
influences and internal effects set by the project of a nuclear facility cannot
cause
6.1. the collapse of the building,
6.2. inadmissible deformation of buildings,
6.3. the unstable building,
6.4. the reduction of mechanical resistance of buildings,
6.5. unacceptable vibration design,
6.6. hazard functions for the selected device in space
of the building or its surroundings, or
6.7. the damage to the buildings to an extent disproportionate to the original cause.
7. building the selected device must be so designed that, in the case of
fire
7.1. has been maintained for a specified period of time and the integrity of the load-bearing capacity building
construction,
7.2. the solution was & hermetickými surround elements limited its spread
within the building,
7.3. was limited its spread to neighboring buildings, and
7.4. the natural person could leave the building escape routes.
Č. 2
The requirements of the method of ensuring compliance of the selected equipment and parts
the selected device
A. requirements for a way of ensuring compliance in the design, manufacture and
installation of pressure equipment and some other selected facilities and
their parts and containers for transport, warehousing and storage
spent nuclear fuel
1. The selected equipment and parts for the selected device must be
1.1. designed, manufactured and assembled in such a way that their
putting into operation ensure their technical safety and
1.2. prepared in accordance with the technical documentation of the type of packaging
approved by the Decree on the file type-approval of certain products in the
the peaceful use of nuclear energy and ionising radiation and
carriage of radioactive or fissile substance, if it is a packaging file for
transport, warehousing and storage of spent nuclear fuel.
2. the requirements on the way to ensuring compliance in the design, manufacture and
installation of the selected equipment referred to in
2.1. points 1 and 3 to 17 shall apply to the packaging files for transmission,
storage and storage of spent nuclear fuel and
2.2. points 1, 3 and 5, 6.1 to 6.4, 6.5, first sentence, 6.6, 6.8, 7.1, 8.1,
8.2, 9, 10, 11, 12, 13.1 to 13.5, 13.7, 13.8, 13.9.3 and 14 to 17,
apply to selected establishments referred to in § 12 para. 3 (b). a) and (d)).
Designing the pressure equipment
3. In designing the pressure equipment must be
3.1. risk analysis in terms of technical safety in order to
identification and evaluation of risks that are under consideration; for
the assessment of the safety effects of risk analysis must be
set the desired conditions, in which the pressure equipment to
function,
3.2. the technical solution of the pressure equipment made with regard to the
the result of the risk analysis referred to in point 3.1,
3.3. in the selection of the most suitable technical solution of the pressure equipment
3.3.1. in so far as is reasonably ruled out any foreseeable risk
or
3.3.2. apply appropriate safeguards to limit the impact of the risk,
that cannot be excluded, and
3.4. the draft reviewed by selected device in terms of fitness and
the proportionality of the establishment of technical requirements, verified for compliance
with the technical requirements and validated for compliance in the technical
requirements and its intended use.
Manufacture of pressure equipment
4.
Production procedures
4.1. The pressure equipment must be manufactured in accordance with the technical
the documentation for the device. Methods and manufacturing processes must be designed
so, to be able to carry out all the requisite checks. In the manufacture of
apply the technical requirements, which were adopted in the design process.
5.
Production of parts
5.1. In the manufacture of pressure equipment must be no parts for defects, and
cracks or changes in the mechanical properties, which could endanger the
the technical safety of the pressure equipment.
6.
The permanent joining
6.1. permanent joining, requirements relate in particular to the coupling
type
6.1.1. fusion welding and surfacing metal
6.1.2. soldering and
6.1.3. spraying and deposit build-up.
6.2. Permanent joining and their adjacent areas must be made
so that they are free from any surface or internal defects that
could compromise the technical safety of the pressure equipment.
6.3. the basic mechanical properties of permanent joints must
correspond to at least the characteristics of the basic materials that are
associated, if not in the strength calculation of the deliberately taken into account
the values corresponding to different mechanical properties of the material.
6.4. technical, inspection and technological activities related to
couplings conform to the selected devices may be carried out only
welding supervision by qualified national personnel authorized
authority for the area of creation and testing permanent joints.
6.5. The permanent joining of parts of the selected device referred to in section 12 of the
paragraph. 2 contributing to the device's resistance to the internal pressure, and
elements that are directly connected to it, must be carried out respectively
qualified personnel using appropriate workflows. These
working procedures and personnel performing non-separable
Joint and welding supervision staff must be designated
by a notified body, unless the non-separable coupling on the selected
the device referred to in § 12 para. 3.
6.6. In the framework of the conformity of the selected device
6.6.1. checks must be performed to verify that the proposed technology
How to perform a nerozebíratelného connection is in accordance with the technical
permanent joining requirements, including the requirements of technical standards
to carry out checks of permanent joints, or
6.6.2. the inspection must be performed the weld joint, in the case of the selected
the device referred to in § 12 para. 2 (a). a) or (b)).
4.2. Supervision over the implementation of the checks referred to in section 6.6.1 and control
the welded connection, including the supervision of the implementation of the relevant checks to
evaluation of joints and carrying signs, must be carried out
by a notified body.
6.8. In the technical documentation of the selected device relating to welding
must be satisfied that the requirements of the
6.8.1. processing, assessment and workflow for reconciliation
making permanent joints,
6.8.2. the qualifications of permanent joining personnel
be carried out,
6.8.3. the qualifications of the staff the welding process
design, validate, and evaluate, and
6.8.4. the eligibility of facilities to be used in the implementation of the process of welding and
checks.
7.
Non-destructive control
7.1. Non-destructive control of permanent joints must be carried out
workers certified by the person accredited by the accreditation body
According to the relevant technical standards relating to the qualifications and
certification of workers carrying out non-destructive control of weld
joints.
7.2. non-destructive control of permanent personnel
joints must be agreed on by a notified body, unless the
non-separable coupling on the selected device referred to in § 12 para. 3.
8.
Heat treatment
8.1. If there is a risk that the manufacturing process changes the properties of the material in the
the range, which could endanger the technical safety of the pressure
the device must be in the appropriate stage of manufacture carried out adequate heat
processing.
8.2. the heat treatment of parts of pressure equipment must perform
qualified personnel.
8.3. the Custom heat process parts pressure selected devices
referred to in § 12 para. 2 (a). and) must be carried out under the supervision of
authorized persons.
5.2. Personnel carrying out heat treatment of parts of pressure equipment
referred to in § 12 para. 2 (a). and) must be agreed on by an authorized
person.
9.
Identifikovatelnost
9.1. Must be implemented and complied with procedures for secure identification
9.1.1. the materials
9.1.2. pieces of pressure equipment, and
9.1.3. the checks of the materials and parts of pressure equipment.
9.2. Identifikovatelnost must be protected from input controls
flashing material or parts of pressure equipment in the final
assessment of pressure equipment.
10.
Labelling and tagging
10.1. The pressure equipment must be marked with a label, or in any other way.
On the label or another method of marking must be listed
10.1.1. the identification of the manufacturer or the person performing the installation; for example, the
name, surname and address of place of business, in the case of a natural person, or
business name and registered office, in the case of a legal person,
10.1.2. year of manufacture,
10.1.3. identification of the pressure equipment according to its nature, such as
type, series or batch identification and serial number,
10.1.4. the base top and bottom working limits and
10.1.5. designation of the person who carried out the assessment of conformity of the pressure
the device, in the case of devices referred to in § 12 para. 2.
10.2. the required information must be given on the pressure equipment or
on the label firmly attached to it, with the exception of cases, when
10.2.1. appropriate documentation is used, where appropriate, to
avoid repetitive marking of individual parts intended for the same
report of the pressure equipment, such as piping sections, or
10.2.2. the pressure equipment is too small, and information are listed on the
a separate label affixed to the pressure equipment.
11.
Instructions for use
11.1. When pressure equipment is placed into service, it shall be, if it
applicable, connected to it or other corresponding operating instructions
documentation containing all the necessary information relating to the
technical safety and concerning its
11.1.1. the installation or Assembly of its components,
11.1.2. putting into service,
11.1.3. operation, including the designation of its parts, working conditions and
the method of its use, and
11.1.4. maintenance, including the inspections carried out during operation.
11.2. the Instructions shall contain the information referred to in section 11.1 and, if it is
necessary for the full understanding of the manual must be provided with a supplementary
technical documents, drawings and diagrams.
12.
Materials for pressure equipment
12.1. In the manufacture, repair or modification of the pressure equipment can only be used
approved Basic and additional materials included in the list of materials
permitted for this use. The list of materials must be processed in
following the classification of pressure equipment in safety class.
12.2. the basic and supplementary materials must be suitable for the
the use, throughout the expected life of the pressure
device.
12.3. Welding consumables must meet the requirements
in paragraphs 12 and 13, both independently and in conjunction with the design.
13.
Materials parts of pressure equipment exposed to pressure
13.1. basic materials affecting the technical safety of the pressure
the device must, both individually and in construction in conjunction with the
appropriate additional material, meet the requirements of the technical specifications
pressure equipment, in particular the requirements for appropriate properties for all
operating conditions, in which the pressure equipment perform their function.
13.2. For the part of the selected equipment exposed to pressure, are always
considered to be parts that make up the pressure interface or are these parts
associated conform way.
13.3. In the choice of material for production, installation, repair, or modification of the
pressure equipment must take account of its chemical composition,
physical and mechanical properties, weldability and eligibility
traffic in the operating conditions in which pressure equipment with
their function.
13.4. the manufacture, Assembly, maintenance, repair or modification under pressure
the device must be used material
13.4.1. the same as the original part of the material referred to in the technical
the specification of the pressure equipment,
13.4.2. included in the list of materials acceptable for a given application,
or
13.4.3. other material, if you can not use the material in accordance with section 13.4.1 or
13.4.2.
13.5. If the material is used in accordance with section 13.4.2, which has other
properties than the original material, it is necessary to demonstrate that its properties
they are suitable for the use with regard to the operational conditions and the
safety class to which the pressure equipment is classified.
8.5. in the event that the proposed material is not listed in the list of materials
acceptable for the application, must be carried out specific evaluation
the proposed material; for pressure equipment referred to in § 12 para. 2
must be specific valuation of the proposed material ensures
by a notified body.
8.5. the manufacture, Assembly, repair, or modification must be made appropriate
measures to ensure that the material used is in accordance
technical specifications of the requirements of the pressure equipment. In particular, must be
for all the basic and additional materials available
documentation confirming the compliance of the materials used with the technical
the specifications of the material.
13.8. The manufacture, Assembly, correction or amendment of the pressure equipment may be
use only material which has been carried out the assessment of conformity with the
the technical requirements for the material.
13.9. The assessment of the material from the point of view of its conformity with the technical
the specifications of the material must be accompanied by an
13.9.1. certificate issued by the material manufacturer, which was confirmed by the
by a notified body, in the case of materials for pressure equipment referred to in
§ 12 para. 2 (a). and) or (b)),
13.9.2. certificate issued by the materials manufacturer, in the case of material for
pressure equipment referred to in § 12 para. 2 (a). (c)), and
13.9.3. certificate issued by the materials manufacturer, in the case of material for
pressure equipment referred to in § 12 para. 3.
13.10. the pressure equipment referred to in § 12 para. 2 (a). a) or b) can be
use the material for which the material was issued the certificate referred to in point
13.9.2 and 13.9.3 only if they were in the presence of the authorized person
carried out additional checks so that it was shown that this
the material is suitable to use for this item of pressure equipment. Match if the
the results of checks to the values given in the original material
certificate, the notified body shall issue an inspection report or certificate
demonstrating compliance with the terms and conditions for use of materials for pressure equipment
referred to in § 12 para. 2 (a). a) or (b)).
14.
Quality control of materials
14.1. quality control materials must be made within the scope and
those specified in the technical regulations, technical standards, or
technical conditions for materials.
14.2. the Preparations for the manufacture of pressure equipment, in particular plates,
forgings, extrusions, castings, rolled steel for fasteners and
preparations for production of seals must be manufactured in accordance with the requirements of
set out the design of the pressure equipment, technical standards or
technical conditions, which determine the scope and method of testing for the purpose of
a review of their quality.
14.3. the preparations of austenitic steels for the manufacture of pressure
a device which are in contact with the medium in the primary circuit must be
set limit values for the content of cobalt in the steel.
Installation of pressure equipment
15. Assembly of pressure equipment must be carried out in accordance
technological procedure of installation involving methods and Assembly procedures
so, to be able to carry out all the requisite checks. When mounting the
apply the technical requirements, which were adopted in the design process.
16. the specific processes involved in the installation of the selected device or
reports of pressure equipment must be carried out in accordance with the requirements of the
non-destructive control, permanent joining and heat treatment
referred to in paragraphs 6 to 8.
17. the quality of the installation must be verified on the basis of the plan or programme
checks, according to which the Assembly is carried out.
B. requirements for a way of ensuring compliance in the design, manufacture and
installation of the management of the selected device and its parts
1. The selected equipment and parts for the selected device must be designed,
manufactured and assembled in such a way that, when putting them into
operation ensure technical safety.
Design of the management of the selected device
2. When designing the control device must be selected
2.1. risk analysis in terms of technical safety in order to
identification and evaluation of risks that are under consideration; for
the assessment of the safety effects of risk analysis must be
set the required States that has a control selected equipment with
their function,
2.2. the technical solution of the management of the selected device made with respect
the result of the risk analysis referred to in point 2.1,
2.3. in the selection of the most suitable technical solution of the management of the selected
device
2.3.1. in so far as is reasonably ruled out any foreseeable risk
or
2.3.2. apply appropriate safeguards to limit the impact of the risk,
that cannot be excluded, and
2.4. the application of the selected device examined in terms of the suitability and
the proportionality of the establishment of technical requirements, verified for compliance
with the technical requirements and validated for compliance in the technical
requirements and its intended use.
Production control of the selected device
3. The control selected equipment must be made in accordance with the technical
documentation of this device including the appropriate methods and the corresponding
manufacturing processes so that it is possible to make all the prescribed
checks. In the manufacture shall apply the technical requirements that have been
adopted in the design process.
4. For the production of the management of the selected device is necessary to implement and comply with the
procedures to ensure the identification of the equipment during its production.
5. During the manufacture of the control selected equipment checks must be carried out
in accordance with the requirements laid down in the technical documentation.
Installation of the management of the selected device
6. installation of the management of the selected device must be carried out in accordance with the
technological procedure of installation involving methods and Assembly procedures
so, to be able to carry out all the requisite checks. When mounting the
apply the technical requirements, which were adopted in the design process.
7. special processes used during installation of the management of the selected device
must be carried out in accordance with the requirements of the permanent joining,
non-destructive control and the heat treatment referred to in part A, sections
6 to 8 and the requirements for the creation of the software.
8. the quality of the installation must be verified on the basis of the programme of checks,
According to which the Assembly is carried out.
C. requirements for a way of ensuring compliance in the design, manufacture and
Assembly for the building of the selected device and its parts
1. The selected equipment and parts for the selected device must be designed,
manufactured and assembled in such a way that, when putting them into
operation ensure technical safety.
The design for the building of the selected device
2. When designing the construction of the selected device must be his design
examined in terms of the appropriateness and proportionality of the establishment of technical
requirements, verified for compliance with the technical requirements and
validated for compliance of the technical requirements and the intended
the use of the.
Production and Assembly of the construction of the selected device
3. building the selected device must be made, manufactured and assembled in the
accordance with the technical documentation, so that it can carry out all
the requisite checks to ensure technical safety. During the construction of the
apply the technical requirements, which were adopted in the design process.
4. concrete Production must take place in accordance with the prescribed production
procedures that guarantee during the solidification of the prescribed strength and
other characteristics laid down in the proposal for the selected device. In the framework of the
production processes must be established to control the prescribed values
strength and other characteristics laid down in the proposal for the selected device.
5. the specific processes used in the installation for the building of the selected device
must be carried out in accordance with the requirements of the permanent joining,
non-destructive control and the heat treatment referred to in part A, sections
6 to 8.
6. for the production and Assembly of the construction of the selected device can only be used
metal and building materials specified in the design of this device.
D. requirements for a way of ensuring compliance of the marketing of the selected device
and its parts into operation
1. The selected device or its part shall be constructed and delivered so as to
ensure their safe and correct installation and connection.
2. After mounting the technology and the construction of a nuclear device, which
part of the selected device, must be verified whether the technical
specifications and the unique identification of the location of the selected device is in
accordance with the actual making of a nuclear device, and whether they are
the selected device equipped with the corresponding accompanying technical documentation
supplied by the manufacturer of the selected device or its parts and supplier
Assembly and construction within the scope of annex 4 to this Decree and is in her
indicate the actual execution of the supplies and works, and
2.1. before the first zavezením of nuclear fuel in a nuclear reactor or
for a nuclear installation without a nuclear reactor in the period immediately after the
their supplies or works and
2.2. before taking the selected device by the operator of a nuclear
the device and its use for the purpose for which it was made.
3. when placing a nuclear device into operation it must be the individual
the selected device has gradually tested in accordance with a previously processed
3.1. program operational controls,
3.2. the pre-operational program controlled aging for the first physical
starting and
3.3. operational program-controlled aging for the first energy
run and test the operation of the
so, in order to verify their conformity with the technical requirements according to annex
No 1 to this Decree, which shall be applied during operation, and was so
to allow for functional checking of the nuclear devices before you start
trial operation.
4. Before the beginning of each stage of the placing into service of the selected device
must be documented
4.1. training of serving and management personnel and list namespace
an indication of their functions,
4.2. eligibility workers to manage and carry out the checks selected
the device,
4.3. readiness of the selected device in the appropriate stage and
4.4. compliance with the other requirements laid down by the Office on the basis of
the evaluation of the previous stage of commissioning.
E. method of ensuring compliance requirements in the operation of the selected device
and its parts
1. the devices must be operated so that during operation
was maintained its technical safety.
2. in the course of the operation the accompanying technical documentation must be selected
supplemented by other evidence of equipment repair, maintenance, or
make a change to this device. There must be a system maintenance
the accompanying technical documentation, in order to check compliance with the
technical requirements on the selected device.
3. The selected device can be mounted and removed only for predetermined
safe conditions, and in accordance with the regulations for Assembly, disassembly and
Re-commissioning.
4. the device must be operated in accordance with the requirements of
internal rules and other documentation for the operation of a nuclear installation.
The regulations for the maintenance and operation of the selected device must be included
technical requirements and recommendations of the manufacturer of the selected device.
5. the device may only be operated and used only for the purposes and under the
conditions for which it is intended and in accordance with the project of a nuclear
device. Must be taken technical and organisational measures, that
ensure that the selected device is operated in conditions for which
It was designed and does not endanger the health of individuals and does not constitute
unacceptable risk of property damage.
6. During operation of the selected device must be put in place a system to monitor and
documenting deviations from normal operation, which could lead to
breakdowns and reduce the levels of technical security for the selected device.
7. During operation of the equipment must be selected within an established process
controlled ageing of the selected device carried out systematic monitoring of its
the State and determining the impact of aging and development effect of degradation
mechanisms that could lead to a reduction in the level of technical security
the selected device.
8. During operation of the selected device maintenance system must be in place and
the system of checks carried out during the operation of the selected device, which must
8.1. be introduced with regard to operating conditions affecting the technical
the safety of this device and
8.2. provide for the technical and organisational measures to ensure compliance.
9. Maintenance, repair or modification of the operated equipment must be selected
carried out in accordance with the requirements of the method of zajišťováni conformity
design, manufacture, installation and commissioning of the selected device
set out in parts A to D; If they are in the maintenance, repair or modification
operated by the selected device specific processes must be carried out
carried out in accordance with the requirements of the permanent joining,
non-destructive control and the heat treatment referred to in part A, sections
6 to 8.
10. In the course of maintenance, repairs and changes to selected device must be carried out
supervision of the contractor, within which it must be verified that the carried out
activities in the maintenance, repair, or modify the selected device are
carried out in accordance with the documentation relating to the preparation and implementation of
repairs, maintenance, or changes to the selected device.
11. activities on control of selected devices may only be carried out
personnel qualified in accordance with Decree No. 50/1978 Coll., on professional
competence in standardization, as amended.
Č. 3
Requirements for technical documentation of the selected device
The technical documentation of the selected device must be processed at a glance
in order to allow assessment of the conformity to the extent provided by this Decree.
A. the technical documentation for the design, manufacture and installation of pressure
equipment and some other selected devices and packaging for
transport, warehousing and storage of spent nuclear fuel
The technical documentation for the design, manufacture and installation of pressure
equipment and other selected equipment referred to in § 12 para. 3 (b). (d))
and packaging for the transport, warehousing and storage of spent
nuclear fuel must contain
1. the name of the selected device, its identification and description
2. identification of the manufacturer,
3. the proposal for the selected device,
4. wiring diagrams,
5. manufacturing drawings and diagrams and drawings of the report and subreport that contains
5.1. the prescribed quality and State of the metallurgical products, where appropriate,
other parts of the selected device
5.2. the prescribed quality consumables,
5.3. dimensions and the thickness of the walls and the data needed for their dimensioning,
5.4. the location, type, dimensions and values of factors of welded joints and
their classification,
5.5. kind of checks, test media and their parameters and criteria
acceptance of checks,
5.6. the descriptions and explanations necessary for the understanding of the drawings and diagrams and the
the function of the selected device and
5.7. the maximum allowable pressure, the temperature and the calculated test pressure, if it is
of the pressure equipment,
6. technical data of the pressure equipment, including its technical
the documentation is to separate the selected device,
7. technical data on the safety gear and equipment, which ensures
the functionality of the pressure equipment,
8. a list of the technical rules, technical standards and technical
the conditions which have been or are to be used,
9. the suitability of the solution cards are used in the design of the selected device
10. the results of strength calculations, calculations, including conditions of life
their validity, calculations, seismic resistance, and other important
specifications drawn up according to the technical standards,
technical conditions, or new knowledge in science and technology,
11. the degradation mechanisms or the effects of aging entering calculations
the life,
12. the results of the risk analysis in terms of technical safety of processed
When designing for the selected device,
13. documents certifying the conformity of the material with the technical specifications for
the basic and supplementary materials used for the production of the selected device or
its parts,
14. technical conditions for the production and installation of the selected device or
similar documents containing the
14.1. the technical specifications for the basic and additional material or
semi-finished product,
14.2. the specific requirements for material processing technology, particularly
the requirements on the process of heat treatment and the internal Crystal
structure and homogeneity,
14.3. a description of the intended working conditions;
14.4. data important in terms of reliability and durability and more
information of importance for the technical safety,
14.5. the description of the course of input and output elements, controls,
the criteria for admissibility checks, media used during these inspections and
their parameters,
14.6. the method and scope of the verification of the technical state of the selected device
During its operation and
9.1. a description of the scope of the accompanying technical documentation for the selected device,
15. plans and programmes of checks for design, manufacture and installation of the selected
the device,
16. the provisional programme of controlled aging
17. the parts of the selected device and the technical requirements for these
parts,
18. Description of technological processes for the production or Assembly, including a description of
technical and organisational measures,
19. regulations for installation, putting into service or the operation of the selected
the device,
20. the list of workers welding supervision and personnel
inspection and evaluation of permanent joints, including their
permissions and putting their name, surname and date of birth, if you
production or Assembly carried out a non-separable connection,
21. the list of persons performing special processes, including the nature and
the validity of their authorisations and putting their name, last name and date
of birth, if it is implemented in the production or Assembly of the special process, and
22. pattern of records, including certificates and inspection reports, the
in the context of the manufacture or Assembly of the selected device.
(B). the technical documentation for the design, manufacture and installation of the control
the selected device
The technical documentation for the design, manufacture and installation of the control
the selected device must contain
1. the name of the selected device, its identification and description
2. the application for the selected device,
3. identification of the manufacturer,
4. drawings and diagrams of components and circuits containing
4.1 designation of prescribed quality parts for the selected device, and
4.2 the descriptions and explanations necessary for the understanding of the drawings and diagrams, and
the function of the selected device
5. the list of the technical rules, technical standards and technical
the conditions which have been or are to be used,
6. the results of the risk analysis in terms of technical safety of processed
When designing for the selected device,
7. instructions for use
8. the results of design calculations,
9. the results of the calculations of life, including the conditions of their validity,
calculations, seismic resistance, and other important technical data
drawn up according to the technical standards and technical conditions
or new knowledge in science and technology,
10. degradation mechanisms or the effects of aging entering calculations
the life,
11. the plans and programmes of checks for design, manufacture and installation of the selected
the device,
12. Provisional agenda for the controlled aging
13. the reports of the type tests carried out with the results of the assessment
independent testing laboratories,
14. the parts of the selected device and the technical requirements for these
parts,
15. the inspection requirements of the selected device and its parts,
16. the list of workers welding supervision and personnel
inspection and evaluation of permanent joints, including their
permissions and putting their name, surname and date of birth, if you
production or Assembly carried out a non-separable connection,
17. the list of persons performing special processes, including the nature and
the validity of their authorisations and putting their name, last name and date
of birth, if it is implemented in the production or Assembly of a specific process,
18. Description of the scope of the accompanying technical documentation for the selected device, and
19. regulations for installation, commissioning and operation of the selected
device.
C. the technical documentation for the design, manufacture and Assembly of building
the selected device
The technical documentation for the design, manufacture and Assembly of building
the selected device must contain
1. the name of the selected device, its identification and description
2. the application for the selected device,
3. a description of the construction section, into which it will be installed,
4. definition of the manner of its incorporation, or its use in construction
parts,
5. identification of the manufacturer,
6. the list of the technical rules, technical standards and technical
the conditions which have been or are to be used,
7. the complete static and dynamic calculations, calculations have been made, the
8. manufacturing drawings and drawings of the construction section, into which will be selected
devices installed, containing,
8.1 designation of prescribed quality parts for the selected device,
8.2 designation of the quality of the materials used and prescribed
8.3 the descriptions and explanations necessary for the understanding of the drawings and features
the selected device,
9. the procedures for manufacture, installation and use of the selected device, including
the requirements for the
9.1 storage concrete and functional design,
9.2 execute penetrations, airtight doors, hatches and closures,
9.3 implementation of surface finishing of building structures,
9.4 perform the individual outlets to individual sealing
the control of different pieces of pressure equipment, which is part of the
the system of protective envelope, and
9.5 the carrying out electrical installations,
10. the characteristics of the construction or metal materials,
11. the results of the calculations of life, including the conditions of their validity,
calculations, seismic resistance, and other important technical data
drawn up according to the technical standards and technical conditions
or new knowledge in science and technology,
12. the degradation mechanisms or the effects of aging entering calculations
the life,
13. plans and the program checks for the design, manufacture and installation of the selected
the device,
14. the provisional programme of controlled aging
15. the list of workers welding supervision and personnel
inspection and evaluation of permanent joints, including their
permissions and putting their name, surname and date of birth, if you
production or Assembly carried out a non-separable connection,
16. the list of persons performing special processes, including the nature and
the validity of their authorisations and putting their name, last name and date
of birth, if it is implemented in the production or Assembly of a specific process,
17. the records of the design and results of the design calculations and made
tests or certificates issued prior to the assessment
conformity, and
18. Description of the scope of the accompanying technical documentation for the selected device.
Č. 4
The accompanying technical documentation requirements of the selected device
The accompanying technical documentation of the selected device must be clearly
treated to the extent necessary, documenting the results of the provision of
and verification of compliance, and during the whole period of operation of this device.
And the accompanying technical documentation of the pressure equipment and some
other selected devices and packaging for the carriage, storage
and storage of spent nuclear fuel
The accompanying technical documentation of pressure equipment and other selected
equipment referred to in § 12 para. 3 (b). (d)) and for packaging
transport, warehousing and storage of spent nuclear fuel must
contain
1. passport drawn up by the manufacturer containing the
1.1. the name of the selected device, its identification and description
1.2. a declaration of conformity,
1.3. the plan and the program checks in the design, production and Assembly of the selected
devices evaluated in terms of the fulfillment of the requirements contained therein,
1.4. material certificate,
1.5. the records of the inspections carried out and their evaluation,
1.6. records of heat treatment and
1.7. the records of the final assessment,
2. the results of strength calculations, calculations, including conditions of life
their validity, calculations, seismic resistance, and other technical data
drawn up according to the technical standards, technical conditions and
new knowledge of science and technology,
3. the provisional agenda for the aging, řízeního
4. drawings of the selected device containing
4.1. Drawing of the Assembly with the main connection dimensions,
4.2. drawings of the individual parts of the selected device
4.3. Drawing for the estimated range of repair, if it is part of the instructions,
4.4. axonometrická schemes with the designation of the individual welds, curtains,
fixed points and supports, if the pipeline route, and
4.5. the drawings with the designation of each weld seams, penetrations, hatches,
any trapdoors, airtight doors or other devices
the hermetically protective envelope, in the case of the pressure equipment constituting the system
protective envelopes
5. the documents concerning the certificate used welding technology,
6. list of staff performing special processes, including the nature and
the validity of their authorisations and putting their name, last name and date
birth,
7. the list of workers welding supervision and personnel
inspection and evaluation of permanent joints, including their
permissions and putting their name, surname and date of birth,
8. technical data of the pressure equipment, including its technical
the documentation is to separate the selected device,
9. technical data on the safety gear and equipment, which ensures
the functionality of the pressure equipment,
10. details of the corrections made in the course of manufacture or Assembly,
11. the documentation containing the information relating to the technical
safety in the operation of the selected device, in particular, the user manual and
instructions for Assembly, commissioning and operation, including guidelines for
repair and maintenance,
12. documentation containing information relating to the controlled aging
the selected equipment when its marketing operation, and operation, in particular
the monitored parameters and limit values for the monitoring and evaluation
aging of the selected device and the measure when it reaches the limit values
monitored parameters,
13. records of repair and maintenance carried out on the selected device, including
records of the results of the checks carried out after the repair, maintenance or reverse
After you repair the installation or maintenance of the selected device, or links where
These records are kept and stored and
14. a record of the changes to the selected device, including
the results of the controls carried out after reassembling the device, or
links where these records are kept and stored.
B. the accompanying technical documentation of the management of the selected device
The accompanying technical documentation of the control selected equipment must
contain
1. the name of the selected device, its identification and description
2. the Declaration of conformity,
3. the plan and the program checks in the design, production and Assembly of the selected
devices evaluated in terms of the fulfillment of the requirements contained therein,
4. Provisional agenda for the controlled aging
5. the records of the inspections carried out and the audit reports and their evaluation,
6. documentation that contains information related to the technical
safety in the operation of the selected device, in particular, the user manual and
instructions for Assembly, commissioning and operation, including guidelines for
repair and maintenance,
7. list of staff performing special processes, including the nature and
the validity of their authorisations and putting their name, last name and date
birth,
8. the list of workers welding supervision and personnel
inspection and evaluation of permanent joints, including their
permissions and putting their name, surname and date of birth,
9. plans include installation, including documents on fire
measures of cable channels and areas where cables are
placed,
10. the design of the selected device, including the internal control schemes
11. the documents concerning the certificate used welding technology,
12. records of repair and maintenance carried out on the selected device, including
records of the results of the checks carried out after the repair, maintenance or reverse
After you repair the installation or maintenance of the selected device, or links where
These records are maintained and stored,
13. a dossier containing information relating to the controlled aging
the selected equipment when its commissioning and operation, in particular
the monitored parameters and limit values for the monitoring and evaluation
aging of the selected device and the measure when it reaches the limit values
monitored parameters, and
14. a record of the changes to the selected device, including
the results of the controls carried out after reassembling the device, or
links where these records are kept and stored.
C. accompanying technical documentation for the building of the selected device
The accompanying technical documentation for the building of the selected device must
contain
1. the name of the selected device, its identification and description
2. the Declaration of conformity,
3. the plan and the program checks in the design, production and Assembly of the selected
devices evaluated in terms of the fulfillment of the requirements contained therein,
4. Provisional agenda for the controlled aging
5. the results of strength calculations, calculations, including conditions of life
their validity, calculations, seismic resistance, and other technical data
drawn up according to the technical standards, technical conditions and
new knowledge of science and technology,
6. records of the inspections carried out and the evaluation thereof, including the records of the
checks the properties of concrete,
7. drawings of the selected device and the drawings of the construction section, into which will be
the selected device installed,
8. a dossier containing information about the properties of the selected device
9. list of staff performing special processes, including the nature and
the validity of their authorisations and putting their name, last name and date
birth,
10. the list of workers welding supervision and personnel
inspection and evaluation of permanent joints, including their
permissions and putting their name, surname and date of birth,
11. the definition of the manner of its incorporation, or its use in construction
parts,
12. documentation containing information relating to the technical
safety in the operation of the selected device, in particular guidelines for placing
and operation, including instructions for repair and maintenance, and
13. a dossier containing information relating to the controlled aging
the selected equipment when its commissioning and operation, in particular
the monitored parameters and limit values for the monitoring and evaluation
aging of the selected device and the measure when it reaches the limit values
monitored parameters.
Č. 5
Formalities for the Declaration of conformity
The Declaration of conformity must contain the selected device.
1. identification of the Declaration of conformity,
2. identification data of the person issuing the Declaration of conformity,
3. the name of the selected device, its identification and basic description,
4. identification of the construction section, into which the device is to be selected
incorporated, in the case of building selected device,
5. identification details of the manufacturer,
6. the identification data of the person who carries out the assessment of conformity of the selected
the device,
7. links to technical requirements and the technical specification selected
the device,
8. an indication of the conformity assessment procedure or combination of procedures
conformity assessment,
9. links to documents issued on the conformity of a person performing
conformity assessment in the scope specified in the individual assessment procedures
conformity,
10. references to the legal regulations, technical rules, technical
standards or technical specifications
11. Declaration by the manufacturer, the importer or the person carrying out the installation of the selected
the device after manufacture that the selected device meets the requirements of this
the Decree,
12. date and place of issue of the certificate of conformity and
13. name and title of the person authorized to sign the Declaration of conformity,-per person
issuing a declaration of conformity.
Identifying information are the name or names, last name, address
the place of residence or place of business and the identification number of the person if
granted, in the case of a natural person, or the business name, registered office and
the identification number of the person, in the case of a legal person.
Č. 6
The requirements for carrying out the checks of the selected equipment and final assessment
A. General inspection requirements
1. The basic requirements for the scope, type and method of carrying out the checks in
design, manufacture, Assembly, commissioning and operation of the selected
device and acceptance criteria used during these inspections shall
be laid down in
1.1. technical documentation for the selected device,
1.2. documentation of repairs, maintenance, or changes to the selected device, or
1.3. the programme, operational controls of the selected device.
2. the scope, the nature and method of carrying out the checks for the selected device, and
the acceptance criteria used during these inspections must be chosen
so, to demonstrate that the selected device meets the technical
requirements.
3. Check the selected device must be carried out in accordance with the procedures
set out in the programme of checks. The technical control must be established,
organizational and security measures so that they are filled with requests for
the scope, nature and how to perform the check.
4. Check the selected device may perform only the workers with
qualifications to perform checks on the selected device performance credentials
This activity by a person pursuant to section 57 of the Atomic Act required to
to ensure compliance; control operated by the selected device can
carried out by personnel authorised by the holder of a permit to operate a nuclear
device.
5. All gauges used for checking must have at the time of the inspection
metrological calibration or verification of valid in accordance with the requirements of the
metrological assurance of consistency and accuracy of measuring instruments and measurements
the law on metrology. Metrological traceability of the measuring instruments must be used
documented.
6. The results of the inspections must be documented track record of execution
checks. Record of inspections must contain a
6.1. data on the subject,
6.2. the description of the scope of the inspection,
6.3. Description of the procedure used in controlling or monitoring methodology
activities,
6.4. the list of measuring instruments and other instruments used in the control and
6.5. evaluation of the results of the checks in terms of acceptance criteria
used during the inspection.
7. A record of the inspection must be confirmed by signature and allocated
the brand name of their processors.
B. requirements for final assessment and control of the selected device after
their production and installation and checks carried out in the selected device.
the verification of conformity for repair, maintenance or reassembling after repair
or maintenance of the selected device
1. final assessment
1.1. Before the start of the final assessment of the selected device must be
authorized personnel carrying out supervision of manufacture, Assembly or
repair the selected device available to all documents and information
required to perform a definitive assessment, including in particular
1.1.1. the procedures for the implementation of the final assessment, including the implementation of the
the final tests, pressure tests, leak tests or other equivalent
checks, and
1.1.2. the accompanying technical documentation for the selected device.
1.2. For issuance of the Declaration of conformity is a positive result
the final assessment.
The final assessment of the pressure equipment
1.3. The final assessment of the pressure equipment must include
1.3.1. the final exam
1.3.2. a pressure test, leakage test, or equivalent
review and
1.3.3. control of safety equipment and equipment to ensure the functionality of the
the pressure equipment.
1.4. The pressure test, leakage or an equivalent exam review
1.4.1. when pressure test or test leakage must be verified that the
at the test pressure of the pressure equipment does not exhibit significant distortion or
leaks that exceed the criterion for admissibility.
1.4.2. in the event that the pressure test or test leakage for the
pressure system unsuitable or impracticable shall be made to the other
equivalent controls, you can verify the strength and tightness
the pressure equipment.
1.4.3. The pressure test and leakage test must be carried out by the pressure
prescribed in the technical specification of the pressure equipment. Test
the pressure must be determined in accordance with section 2.12 of section A of annex 1 to the
This Decree.
1.5. Final Exam
1.5.1. the final test shall be based on a Visual inspection
pressure equipment and control the movement of the technical documentation of the selected
the device examined whether the selected device and related records
quality assurance are mutually consistent and correspond to all
the requirements that have been laid down in the technical documentation or in the
examination of the conformity of the documentation.
1.5.2. in implementing the final exam can be taken into account as well as the inspections, the
carried out during the manufacture of pressure equipment.
1.5.3. Visual inspection of the pressure equipment within the framework of final exams
must be done from the inside and the outside of each part of the pressure equipment,
If it is necessary from the point of view of technical safety. If it is not possible to
ensure the implementation of this inspection in the framework of the final tests, in particular in the
where the nature of the pressure equipment does not allow inspection of its
individual parts without disassembly, can this tour
do it during control operations prior to the final test and
When the final test will only be checking the accompanying technical
documentation.
1.5.4. In the framework of the final exam must be verified, in particular
1.5.4.1. the identification marks of the pressure equipment, including data on
device and data labels minted on pressurised parts and brands
materials and semi-finished products, taveb
1.5.4.2. the main dimensions of the device, the location of nozzles, hatches, gear,
Patek, pedestals and assembling the individual parts according to drawings,
1.5.4.3. the results of the inspection of welded joints, the inner or outer
the tour, including the results of the prescribed checks during the implementation of
special processes, brand welders, welding results records
supervision, records of the heat treatment and material certificates of the materials
and the preparations and
1.5.4.4. the compliance of the identifying marks of welders are listed at selected
Lists devices with their qualification of welders.
1.6. checking the safety equipment and other equipment to ensure
the functionality of the pressure equipment,
1.6.1. The control of safety equipment and other equipment to ensure
the functionality of the pressure equipment must be verified by compliance with the requirements
laid down
1.6.1.1. the safety accessories in point 12 of part A of annex 1 to this
the Decree,
1.6.1.2. the electrical equipment in point 13 of annex 1 to this
the decree and the
1.6.1.3. the hydraulic and pneumatic devices that provide
controlling, regulating, signalling and traffic measurement in point 15 of part A of
Annex No. 1 to the present Decree.
1.7. The final assessment after repair or modification of the selected device
referred to in § 12 para. 2 (a). and) or (b)), must always be carried out under the
the participation of the responsible representative of the holder of the authorization.
1.8. The final assessment of the pressure equipment, which make up the system
protective covers, and equipment ensuring the hermetically protective envelopes
at the maximum design accident, including construction of the selected device
the consists only of the final examination, which must include
1.8.1. the control of completeness of the construction and the equipment after completion of the
construction and Assembly works,
1.8.2. checking the completeness of the records on the quality of each of the selected
equipment, including quality records belonging to their device
Hermeticism,
1.8.3. individual sealing control of different pieces of pressure
the device, which is part of the protective envelope of container, the
internal pressure and
1.8.4. integral leakage control system of protective envelope pressure
prescribed in the technical specification of the pressure equipment.
1.9. The successful completion of the final examination is a condition for opening pressure
tests, tests, leakage or other equivalent examinations.
1.10. the final test, pressure test, leakage test, or other
equivalent examination conducted under control of the conformity of after repair or
reassembling after the repair work must be carried out according to the technician review
Decree No. 18/1979 Sb, which determine the reserved pressure equipment, and
stipulates certain conditions to ensure their safety, as amended by
amended.
The final assessment of the management of the selected device
1.11. The final assessment of the management of the selected device includes a final
the exam, which must be based on a Visual inspection and control
the accompanying technical documentation examined whether the selected device and
quality assurance related records are consistent and
comply with all the requirements laid down in the technical
documentation or verification of conformity documentation.
1.12. in carrying out the final tests you can take into account the checks
carried out during the manufacture of the control for the selected device.
1.13. In the framework of the final tests of the control device must be selected
verified in particular
1.13.1. identification of the selected device, and
1.13.2. completeness of the carried out the checks provided for in the technical documentation
or documentation patches the selected device.
2. Additional checks after their manufacture or Assembly of the selected device
2.1. After mounting the pressure equipment must be carried out
individual test of pressure equipment if it is fixed in the design
This selected device, which must be checked for completeness and functionality
equipment and the proper execution of the installation.
2.2. After mounting the control for the selected device, which secures the
the activities of the emergency systems and cooling systems primary circuit,
in particular, their power, control, regulation, protection, alarm and
measurements must be verified with its proper function.
C. inspection requirements for the selected device in the context of regular
examination of the conformity of the
1. The checks carried out in the context of the periodical verification of conformity must
be verified that there is no deterioration of the technical status of the selected
devices and that this device is eligible for further operation.
2. in the framework of the examination of conformity must be ensured by the implementation of
2.1. periodic operational controls,
2.2. the checks provided for in the operational program-controlled aging
2.3. the final assessment after correction or amendment,
2.4. periodic checks the strength and tightness of the primary and secondary
the circuit of a nuclear installation,
2.5. periodic checks the strength and tightness of the hermetic space
the system of protective envelopes and
2.6. additional checks prescribed by the internal rules for the operation of
the nuclear device.
3. In the context of examining the conformity of the control device must be selected
to ensure the implementation of
3.1. periodic operational controls,
3.2. checks pursuant to the operational program-controlled aging
3.3. final assessment after correction or amendment and
3.4. additional checks prescribed by the internal rules for the operation of
the nuclear device.
Č. 7
Conformity assessment procedures
1. The CONFORMITY ASSESSMENT PROCEDURE and (internal production control)
1. the manufacturer, the importer or the person performing the installation of the selected device after
carrying out the assessment of conformity of production by this procedure must, in accordance with the
Use this procedure to ensure that the selected device meets the requirements of this
decrees, and issue a declaration of conformity.
2. the manufacturer, the importer or the person performing the installation of the selected device after
the production must ensure the implementation of the initial tests of the sample selected
the device that is to be produced, (hereinafter referred to as "type"), and to assess
whether the production type is equivalent to the technical rules, laid down by the technical
standards or technical conditions, in the case of building the selected device
According to § 12 para. 3 (b). (c)).
3. the manufacturer, the importer or the person performing the installation of the selected device after
production must take all necessary measures to ensure that the manufacturing process and
its monitoring ensure conformity of the selected device with the requirements of this
the Decree.
4. the manufacturer, the importer or the person performing the installation of the selected device after
the production must ensure the implementation of the final assessment of the selected device.
5. If the selected device is equivalent to the requirements of this Decree, the manufacturer,
the importer or the person performing the installation of the selected device after manufacture to
must mark the mark of conformity along with his identification and must issue a
Declaration of conformity; in the case of building selected device pursuant to § 12 para.
3 (b). (c)), the Declaration of conformity can be issued only if the selected device
in conformity with the type of production posouzeným according to point 2.
2. CONFORMITY ASSESSMENT PROCEDURE A1 (internal PRODUCTION CONTROL with supervision over
THE FINAL ASSESSMENT)
1. the manufacturer, the importer or the person performing the installation of the selected device after
carrying out the assessment of conformity of production by this procedure must, in accordance with the
This procedure and the procedure of conformity assessment and and under the supervision of an accredited
or an authorized person of the final assessment to ensure that the selected
equipment or part meets the requirements of this order, and to issue
the Declaration of conformity.
2. Accredited or authorized person in the form of unannounced checks
carried out surveillance of the final assessment, in which the
2.1. verifies that the final assessment of the selected device is carried out in
accordance with the requirements of the final assessment in Appendix 6 to this Ordinance
and
2.2. removing samples of selected equipment from the manufacturing or storage
space for review.
3. Accredited or authorized person shall determine the number of selected device
in the sample, which will participate in the implementation of the final assessment.
4. In cases where one or more of the selected equipment does not,
accredited or authorized person shall determine the appropriate measures to eliminate
disagreements.
5. on the basis of the results of the surveillance of the final assessment must
accredited or authorized person to issue a report on the controls carried out.
6. If the implementation of the final assessment of the requirements of this Ordinance,
accredited or authorized person must indicate the selected device
which carries out surveillance of the final assessment, their identification;
indicate the selected device identification accredited or authorized
people can be done by the manufacturer or importer on the basis of a mandate
accredited or authorized person.
3. CONFORMITY ASSESSMENT PROCEDURE B (type-examination of the type)
1. the manufacturer or importer must, in accordance with the following procedure to ensure that
production type meets the requirements of this order.
2. the factory type can include multiple modifications to the selected device
provided that the differences between the modifications do not affect the
level of technical security.
3. the manufacturer or importer must submit an application to an authorized person chosen
for conformity assessment. The application must include
3.1. identification of the manufacturers, or importers,
3.1.1. name or name, last name, address, place of residence, or
the place of business and the identification number of the person, if any, with respect to
a natural person, or
3.1.2. business name, registered office and identification number of the person, if it is a
the legal entity,
3.2. a written declaration that the Treaty was negotiated for the assessment of conformity with the
any other notified body,
3.3. technical documentation for the selected device,
3.4. production type and
3.5. for more information about the selected device necessary for conformity assessment,
in particular, the safety class to which it is classified.
4. A notified body will require more samples, if necessary to the
implementation of pilot program.
5. The notified body must
5.1. perform an examination of the technical documentation of the selected device
including an assessment of whether it meets the requirements set out in annex 3 to this
the Decree,
5.2. assessment of the materials used, including the assessment of
material certificates in accordance with section 8.6 of the annex 2 to this
the Decree, where not previously assessed by another notified body,
5.3. carry out checks on the implementation of technological processes
permanent joints in accordance with section 6.5 of annex 2 to this
Ordinance and these procedures requires that, unless previously agreed by
any other notified body,
5.4. to verify that the personnel undertaking the specific processes and personnel
welding supervision have valid qualifications, and these workers
reconcile according to section 6.5, 7.2 and 5.2 of annex 2 to this
the Decree,
5.5. perform or have performed the necessary checks to establish whether
have been properly applied technical standards or technical specifications
5.6. to agree with the manufacturer, the importer or the person performing the installation
the selected device after manufacture, the place where it will be done to verify whether the
type of production made in conformity with the technical documentation,
5.7. to verify whether the production type is in accordance with the requirements of this order,
including the necessary inspections related to it, and
5.8. draw up an inspection report on the evaluation activities referred to in
points 5.1 to 5.7 and their outputs.
6. If the production type is equivalent to the requirements of this Ordinance, the authorized person
must be issued by manufacturers, importers or to the person carrying out the installation of the selected
the device after manufacture of the type examination certificate. The certificate must
contain
6.1. the name of the selected device, its identification and basic description,
6.2. the manufacturer or importer identification data,
6.2.1. the name or name, last name, address, place of residence, or
the place of business and the identification number of the person, if any, with respect to
a natural person, or
6.2.2. business name, registered office and identification number of the person, if it is a
the legal entity,
6.3. the conclusions of the examination of the type,
6.4. the period of validity of the certificate and
6.5. additional documents necessary to demonstrate the conformity of the type with the
the requirements of this Ordinance.
7. the manufacturer or importer must inform an authorized person
has released the type examination certificate of all modifications to the production of
as described in the type-examination certificate. If the change of the type of
may affect the conformity with the technical requirements of the selected device,
the notified body must examine the change procedure provided for in section 5, and,
If this change corresponds to the requirements of this Ordinance, shall issue a supplement to the
the original type-examination certificate.
8. The notified body shall retain a copy of the certificate of
type-examination and inspection reports.
9. The notified body must inform the Authority of the certificates issued, revoked,
suspended or otherwise restricted the type-examination certificate, or
additions thereto and, on request, make available to the authority.
10. The notified body must inform the other notified body
carrying out the conformity assessment relating to certificates issued, revoked, suspended or
restricted type-examination certificates and/or any additions thereto.
4. CONFORMITY ASSESSMENT PROCEDURE (EXAMINATION of the DESIGN of the SELECTED DEVICE)
1. the manufacturer or importer must, in accordance with the following procedure to ensure that
the design of the selected device meets the requirements of this order.
2. The conformity assessment procedure cannot be used for the experimental method
the proposal.
3. the manufacturer or importer must submit an application to an authorized person chosen
for conformity assessment. The application must include
3.1. identification of manufacturers or importers,
3.1.1. name or name, last name, address, place of residence, or
the place of business and the identification number of the person, if any, with respect to
a natural person, or
3.1.2. business name, registered office and identification number of the person, if it is a
the legal entity,
3.2. a written declaration that the Treaty was negotiated for the assessment of conformity with the
any other notified body,
3.3. technical documentation for the selected device,
3.4. the draft of the selected device and
3.5. for more information about the selected device necessary for conformity assessment,
in particular, the safety class to which it is classified.
4. the application of the selected device may include several modifications
the proposed selected equipment provided that the differences of each
modifications do not affect the level of its technical safety.
5. The notified body must
5.1. perform an examination of the technical documentation of the selected device
including an assessment of whether it meets the requirements set out in annex 3 to this
the Decree,
5.2. assessment of the materials used, including the assessment of
material certificates in accordance with section 8.6 of the annex 2 to this
the Decree, where not previously assessed by another notified body,
5.3. carry out checks on the implementation of technological processes
permanent joints in accordance with section 6.5 of annex 2 to this
Ordinance and these procedures requires that, unless previously agreed by
any other notified body,
5.4. to verify that the personnel undertaking the specific processes and personnel
welding supervision have valid qualifications, and these workers
reconcile according to section 6.5, 7.2 and 5.2 of annex 2 to this
the Decree,
5.5. perform or have performed the necessary checks to establish whether
have been properly applied technical standards or technical specifications
5.6. to verify that the design of the selected device in accordance with the requirements of this
decrees, and
5.7. to draw up an inspection report on the evaluation activities referred to in
points 5.1 to 5.6, and their outputs.
6. If the proposal corresponds to the selected device to the requirements of this order,
the notified body shall issue a certificate of the producers or importers
examination of the design. The certificate shall contain
6.1. the name of the selected device, its identification and basic description,
6.2. identification data of the manufacturer or importer, and it
6.2.1. the name or name, last name, address, place of residence, or
the place of business and the identification number of the person, if any, with respect to
a natural person, or
6.2.2. business name, registered office and identification number of the person, if it is a
the legal entity,
6.3. the conclusions of the examination of the design of the selected device
6.4. the period of validity of the certificate and
6.5. additional documents necessary to demonstrate the conformity of the selected design
equipment with the requirements of this order.
7. the manufacturer or importer must inform an authorized person
has released the design-examination certificate of all modifications to the proposal
the selected device as described in the type-examination certificate. If
change the design of the selected device may affect the conformity of the selected device
with the technical requirements, the authorized person must examine this change
procedure referred to in paragraph 5 and, if this change corresponds to the requirements of this
the decree must issue a supplement to the original examination certificate
the proposal.
8. The notified body shall retain a copy of the certificate of
design examination and inspection reports.
9. The notified body must inform the Authority of the certificates issued, revoked,
suspended or otherwise restricted design examination certificates
or additions thereto and, on request, make available to the authority.
10. The notified body must inform the other notified body
carrying out the conformity assessment relating to certificates issued, revoked, suspended or
otherwise, limited design examination certificates and/or any additions to
them.
5. CONFORMITY ASSESSMENT PROCEDURE D (CONFORMITY BASED on QUALITY ASSURANCE
Production)
1. the manufacturer, the importer or the person performing the installation of the selected device after
the production of must, in accordance with the following procedure, and under the supervision of an authorized
persons to ensure that the selected device is in compliance with
1.1. the production type described in the type-examination certificate referred to in
conformity assessment procedure, (B), or
1.2. selected device as described in the design-examination certificate
the proposal by the conformity assessment procedure, B1
and meets the requirements of this order, and to issue a declaration of conformity.
2. the manufacturer or the person performing the installation of the selected device after manufacture
must have in place a management system, including the method of quality assurance
production in accordance with the Decree about the requirements for the management system. The importer
must have in place a system of checks of the selected device.
3. the manufacturer, the importer or the person performing the installation of the selected device after
the production must ensure the implementation of the final assessment of the selected device.
4. the manufacturer, the importer or the person performing the installation of the selected device after
production for the selected notified body an application for examination
of conformity. The application must include
4.1. identification of manufacturer, importer or the person performing the
installation of the selected device after manufacture,
4.1.1. the name or name, last name, address, place of residence, or
the place of business and the identification number of the person, if any, with respect to
a natural person, or
4.1.2. the trade name, registered office and identification number of the person, if it is a
the legal entity,
4.2. a written declaration that the Treaty was negotiated for the assessment of conformity with the
any other notified body,
4.3. management system documentation relating to the method of providing
the quality of manufacture or Assembly, or documentation of the system of checks, if the
a request made by the importer,
4.4. a copy of the type-examination certificate or certificate of
examination of the design,
4.5. technical documentation for the selected device, and
4.6. for more information about the selected device necessary for conformity assessment,
in particular, the safety class to which it is classified.
5. The notified body must evaluate the management system of the manufacturer or of the person
installation of the selected device after manufacture, including how
quality assurance of the production, and verify that the
5.1. control system ensures conformity of the selected device to the type of
as described in the type-examination certificate or the design of the selected
equipment as described in the type-examination certificate, including compliance with
the technical documentation for the selected device, and with the requirements of this order
and
5.2. management system documentation includes
5.2.1. a description of the quality objectives and the organizational structure, including the rights and
obligations of persons who plan and control the manufacture or Assembly of the selected
the device,
5.2.2. a description of the manufacturing processes, management and quality assurance
processes and other systematic measures that will be used,
in particular those belonging to the fulfilment of the essential requirements to
ensure technical safety,
5.2.3. Description of the checks to be carried out before, during and
after their manufacture or Assembly, with an indication of the frequency of their
the making and acceptance criteria applied in these
checks,
5.2.4. quality assurance records for the selected device, and
5.2.5. Description of the means of monitoring the achievement of the prescribed
the level of quality of the selected device and the assessment of the effectiveness of the management system
in the area of ensuring the quality of the service.
6. assessment of the management system, the notified body must carry out the operational
the manufacturer or the person carrying out the installation of the selected device after manufacture.
The assessment must take part in at least one employee of a notified body,
who has experience of assessments of the technology for the production of the selected device
and knowledge of the requirements of this Ordinance. A notified body is required to
notify the manufacturers, importers or to the person carrying out the installation of the selected
the device after manufacture, the results of the assessment of the management system, including the requirements
to remove nonconformities.
7. the importer must ensure that the assessment of the management system of the foreign producer
as specified in point 5 and 6. The notified body must assess the system of checks
the importer and to verify that the checks carried out on the selected device
ensure compliance of the selected device to the type as described in the
type-examination certificate or the design of the selected device as described
in the design-examination certificate, including compliance with the technical
documentation for the selected device, and with the requirements of this Ordinance.
8. If the management system requirements specified in point 5, the authorized
the person must be issued by manufacturers, importers, or the person performing the installation
the selected device after manufacture, evidence of the approval of the management system.
9. the manufacturer, the importer or the person performing the installation of the selected device after
the production must fulfil the requirements set out in the management system as
approved by a notified body, and to ensure that he was still materially
the correct and efficient manner.
10. the manufacturer, the importer or the person performing the installation of the selected device
After the production of the authorized person must submit, which was approved by the system
management, information on planned changes to the management system described in
document management system approvals. The notified body must assess
a proposed amendment and decide whether the modified control system meets the
requirements referred to in point 5. The authorized person must communicate their conclusions
assessment, including the preamble, manufacturers, importers, or the person performing the
installation of the selected device after manufacture and corresponds with the change of management system
the requirements referred to in section 5, it shall issue a supplement to the original of the document of
approval of the management system.
11. supervision of the notified body
11.1. the supervision must ensure that the manufacturer, the importer or the person performing the
installation of the selected device after manufacture, duly fulfils the requirements
arising from the approved management system, including requirements for
ensure the quality of the production.
11.2. the manufacturer, the importer or the person performing the installation of the selected device
After production must allow the notified body for the supervision, access to
production, control and test space and storage and provide it with
all the necessary information.
11.3. The notified body must have a system in place for supervision purposes
the checks, which are set out the type and frequency of checks
carried out by the manufacturer, the importer or the person carrying out the installation of the selected
the device after manufacture.
7.1. The notified body must carry out periodic surveillance
checks to ensure that the manufacturer, importer, or a person
installation of the selected device after manufacture, maintain and operate
management system as has been approved. The frequency of the periodic inspection must
to vote, so that new, full verification has been done at least once a
12 months.
7.1. The notified body must be carried out under the supervision of the undeclared
check with the manufacturer, the importer or the person carrying out the installation of the selected
the device after manufacture. The type and frequency of unannounced checks must
the authorized person to lay down, in particular, with regard to the
11.5.1. safety class to which the equipment is classified is selected,
11.5.2. the results of the previous checks carried out in the framework of supervision,
11.5.3. the need to monitor compliance with the measures to rectify the disagreement and
11.5.4. significant changes in the organisation of production, concept or technology
the production.
7.2. During these inspections, the notified body may carry out, or give
carry out checks to verify that the control system is working properly.
7.3. The notified body must, on the basis of checks carried out
to prepare reports on the results of supervision and to transmit them to manufacturers, importers,
or to the person carrying out the installation of the selected device after manufacture.
12. If the selected device is equivalent to the requirements of this Ordinance and, if the
conformity with the type described in the type-examination certificate, or
the design of the selected device as described in the type-examination certificate,
manufacturer, the importer or the person performing the installation of the selected device after
the production of it must mark the mark of conformity along with his identification and with the
identification of authorized persons and must issue a declaration of conformity.
13. The notified body shall retain a copy of the document of approval
management system and reports on the results of supervision.
14. The notified body must inform the Authority of the certificates issued, revoked,
suspended or otherwise restricted documents management system approvals
or additions thereto and, on request, make available to the authority.
15. The notified body must inform the other notified body
carrying out the conformity assessment relating to certificates issued, revoked, suspended or
restricted documents management system approvals or additions to
them.
6. CONFORMITY ASSESSMENT PROCEDURE D1 (PRODUCTION QUALITY ASSURANCE)
1. the manufacturer, the importer or the person performing the installation of the selected device after
the production of must, in accordance with the following procedure, and under the supervision of an authorized
persons to ensure that the selected device meets the requirements of this order, and
make a declaration of conformity.
2. the manufacturer or the person performing the installation of the selected device after manufacture
must have in place a management system, including the method of quality assurance
production in accordance with the Decree about the requirements for the management system. The importer
must have in place a system of checks of the selected device.
3. the manufacturer, the importer or the person performing the installation of the selected device after
the production must ensure the implementation of the final assessment of the selected device.
4. the manufacturer, the importer or the person performing the installation of the selected device after
production for the selected notified body an application for examination
of conformity. The application must include
4.1. identification of manufacturer, importer or the person performing the
installation of the selected device after manufacture,
4.1.1. the name or name, last name, address, place of residence, or
the place of business and the identification number of the person, if any, with respect to
a natural person, or
4.1.2. the trade name, registered office and identification number of the person, if it is a
the legal entity,
4.2. a written declaration that the Treaty was negotiated for the assessment of conformity with the
any other notified body,
4.3. management system documentation relating to the method of providing
the quality of production, or documentation of the system of checks, if the request
to be filed by the importer,
4.4. the technical documentation of the selected device and
4.5. for more information about the selected device necessary for conformity assessment,
in particular, the safety class to which it is classified.
5. The notified body must evaluate the management system of the manufacturer or of the person
installation of the selected device after manufacture, including how
quality assurance of the production, and verify that the
5.1. control system ensures conformity of the selected device with the technical
documentation of the selected device and with the requirements of this order and
5.2. management system documentation includes
5.2.1. a description of the quality objectives and the organizational structure, including the rights and
obligations of persons who plan and control the manufacture or Assembly of the selected
the device,
5.2.2. a description of the manufacturing processes, management and quality assurance
processes and other systematic measures that will be used,
in particular those belonging to the fulfilment of the essential requirements to
ensure technical safety,
5.2.3. Description of the checks to be carried out before, during and
after their manufacture or Assembly, with an indication of the frequency of their
the making and acceptance criteria applied in these
checks,
5.2.4. quality assurance records for the selected device, and
5.2.5. Description of the means of monitoring the achievement of the prescribed
the level of quality of the selected device and the assessment of the effectiveness of the management system
in the area of ensuring the quality of the service.
6. assessment of the management system, the notified body must carry out the operational
the manufacturer or the person carrying out the installation of the selected device after manufacture.
The assessment must take part in at least one employee of a notified body,
who has experience of assessments of the technology for the production of the selected device
and knowledge of the requirements of this Ordinance. A notified body is required to
notify the manufacturers, importers or to the person carrying out the installation of the selected
the device after manufacture, the results of the assessment of the management system, including the requirements
to remove nonconformities.
7. the importer must ensure that the assessment of the management system of the foreign producer
as specified in point 5 and 6. The notified body must assess the system of checks
the importer and to verify that the checks carried out on the selected device
ensure compliance of the selected device with the requirements of this order.
8. If the management system requirements specified in point 5, the authorized
the person must be issued by manufacturers, importers, or the person performing the installation
the selected device after manufacture, evidence of the approval of the management system.
9. the manufacturer, the importer or the person performing the installation of the selected device after
the production must fulfil the requirements set out in the management system as
approved by a notified body, and to ensure that he was still materially
the correct and efficient manner.
10. the manufacturer, the importer or the person performing the installation of the selected device
After the production of the authorized person must submit, which was approved by the system
management, information on planned changes to the management system described in
document management system approvals. The notified body must assess
a proposed amendment and decide whether the modified control system meets the
requirements referred to in point 5. The authorized person must communicate their conclusions
assessment, including the preamble, manufacturers, importers, or the person performing the
installation of the selected device after manufacture and corresponds with the change of management system
the requirements referred to in section 5, it shall issue a supplement to the original of the document of
approval of the management system.
11. supervision of the notified body
11.1. the supervision must ensure that the manufacturer, the importer or the person performing the
installation of the selected device after manufacture, duly fulfils the requirements
arising from the approved management system, including requirements for
ensure the quality of manufacture or Assembly.
11.2. the manufacturer, the importer or the person performing the installation of the selected device
After production must allow the notified body for the supervision, access to
production, control and test space and storage and provide it with
all the necessary information.
11.3. The notified body must have a system in place for supervision purposes
the checks, which are set out the type and frequency of checks
carried out by the manufacturer, the importer or the person carrying out the installation of the selected
the device after manufacture.
7.1. The notified body must carry out periodic surveillance
checks to ensure that the manufacturer, importer, or a person
installation of the selected device after manufacture, maintain and operate
management system as has been approved. The frequency of the periodic inspection must
You can choose to complete the screening has been done at least once every 12
months.
7.1. The notified body must be carried out under the supervision of the undeclared
check with the manufacturer, the importer or the person carrying out the installation of the selected
the device after manufacture. The type and frequency of unannounced checks must
the authorized person to lay down, in particular, with regard to the
11.5.1. safety class to which the equipment is classified is selected,
11.5.2. the results of the previous checks carried out in the framework of supervision,
11.5.3. the need to monitor compliance with the measures to rectify the disagreement and
11.5.4. significant changes in the organisation of production, concept or technology
the production.
7.2. During these inspections, the notified body may carry out, or give
carry out checks to verify that the control system is working properly.
7.3. The notified body must, on the basis of checks carried out
to prepare reports on the results of supervision and to transmit them to manufacturers, importers,
or to the person carrying out the installation of the selected device after manufacture.
12. If the selected device to the requirements of this order, the manufacturer,
the importer or the person performing the installation of the selected device after manufacture to
must mark the mark of conformity along with his identification and identification
authorized persons and must issue a declaration of conformity.
13. The notified body shall retain a copy of the document of approval
management system and reports on the results of supervision.
14. The notified body must inform the Authority of the certificates issued, revoked,
suspended or otherwise restricted documents management system approvals
or additions thereto and, on request, make available to the authority.
15. The notified body must inform the other notified body
carrying out the conformity assessment relating to certificates issued, revoked, suspended or
restricted documents management system approvals or additions to
them.
7. CONFORMITY ASSESSMENT PROCEDURE E (QUALITY ASSURANCE of the SELECTED DEVICE)
1. the manufacturer, the importer or the person performing the installation of the selected device after
the production of must, in accordance with the following procedure, and under the supervision of an authorized
persons to ensure that the selected device is in compliance with
1.1. the production type described in the type-examination certificate referred to in
conformity assessment procedure, (B), or
1.2. selected device as described in the design-examination certificate
the proposal by the conformity assessment procedure, B1
and meets the requirements of this order, and to issue a declaration of conformity.
2. the manufacturer or the person performing the installation of the selected device after manufacture
must have in place a management system, including the method of quality assurance
production in accordance with the Decree about the requirements for the management system. The importer
must have in place a system of checks of the selected device.
3. the manufacturer, the importer or the person performing the installation of the selected device after
the production must ensure the implementation of the final assessment of the selected device.
4. the manufacturer, the importer or the person performing the installation of the selected device after
production for the selected notified body an application for examination
of conformity. The application must include
4.1. identification of manufacturer, importer or the person performing the
installation of the selected device after manufacture,
4.1.1. the name or name, last name, address, place of residence, or
the place of business and the identification number of the person, if any, with respect to
a natural person, or
4.1.2. the trade name, registered office and identification number of the person, if it is a
the legal entity,
4.2. a written declaration that the Treaty was negotiated for the assessment of conformity with the
any other notified body,
4.3. management system documentation relating to the method of providing
the quality of production, or documentation of the system of checks, if the request
to be filed by the importer,
4.4. a copy of the type-examination certificate or certificate of
examination of the design,
4.5. technical documentation for the selected device, and
4.6. for more information about the selected device necessary for conformity assessment,
in particular, the safety class to which it is classified.
5. The notified body must evaluate the management system of the manufacturer or of the person
installation of the selected device after manufacture, including how
quality assurance of the production, and verify that the
5.1. control system ensures conformity of the selected device to the type of
as described in the type-examination certificate or the design of the selected
equipment as described in the type-examination certificate, including compliance with
the technical documentation for the selected device, and with the requirements of this order
and
5.2. for the production management system documentation includes
5.2.1. a description of the quality objectives and the organizational structure, including the rights and
obligations of persons who plan and control the manufacture or Assembly of the selected
the device,
5.2.2. a description of the manufacturing processes, management and quality assurance
processes and other systematic measures that will be used,
in particular those belonging to the fulfilment of the essential requirements to
ensure technical safety,
5.2.3. Description of the controls which will be carried out after completion of production or
installation, with an indication of the frequency of their implementation and criteria
the acceptability of applied during these inspections,
5.2.4. quality assurance records for the selected device, and
5.2.5. Description of the means of monitoring the achievement of the prescribed
the level of quality of the selected device and the assessment of the effectiveness of the management system
in the area of ensuring the quality of the service.
6. assessment of the management system, the notified body must carry out the operational
the manufacturer or the person carrying out the installation of the selected device after manufacture.
The assessment must take part in at least one employee of a notified body,
who has experience of assessments of the technology for the production of the selected device
and knowledge of the requirements of this Ordinance. A notified body is required to
notify the manufacturers, importers or to the person carrying out the installation of the selected
the device after manufacture, the results of the assessment of the management system, including the requirements
to remove nonconformities.
7. the importer must ensure that the assessment of the management system of the foreign producer
as specified in point 5 and 6. The notified body must assess the system of checks
the importer and to verify that the checks carried out on the selected device
ensure compliance of the selected device to the type as described in the
type-examination certificate or the design of the selected device as described
in the design-examination certificate, including compliance with the technical
documentation for the selected device, and with the requirements of this Ordinance.
8. the manufacturer or the person performing the installation of the selected device after manufacture
should the selected device after manufacture or Assembly.
The importer must be checked in the context of the selected device. In the framework of the
the examination must be carried out the checks referred to in the technical documentation
the selected device so as to ensure the conformity of the selected device
the production type described in the type-examination certificate or design
the selected device as described in the type-examination certificate and with the
the requirements of this Ordinance.
9. If the management system requirements specified in point 5, the authorized
the person must be issued by manufacturers, importers, or the person performing the installation
the selected device after manufacture, evidence of the approval of the management system.
10. the manufacturer, the importer or the person performing the installation of the selected device
after manufacture shall comply with the requirements set out in the management system as
approved by a notified body, and to ensure that he was still materially
the correct and efficient manner.
11. the manufacturer, the importer or the person performing the installation of the selected device
After the production of the authorized person must submit, which was approved by the system
management, information on planned changes to the management system described in
document management system approvals. The notified body must assess
a proposed amendment and decide whether the modified control system meets the
requirements referred to in point 5. The authorized person must communicate their conclusions
assessment, including the preamble, manufacturers, importers, or the person performing the
installation of the selected device after manufacture and corresponds with the change of management system
the requirements referred to in section 5, it shall issue a supplement to the original of the document of
approval of the management system.
12. monitoring of the authorized person
12.1. the supervision must ensure that the manufacturer, the importer or the person performing the
installation of the selected device after manufacture, duly fulfils the requirements
arising from the approved management system, including requirements for
ensure the quality of the selected device.
12.2. the manufacturer, the importer or the person performing the installation of the selected device
After production must allow the notified body for the supervision, access to
production, control and test space and storage and provide it with
all the necessary information.
12.3. The notified body must have a system in place for supervision purposes
the checks, which are set out the type and frequency of checks
carried out by the manufacturer, the importer or the person carrying out the installation of the selected
the device after manufacture.
12.4. The notified body must carry out periodic surveillance
checks to ensure that the manufacturer, importer, or a person
installation of the selected device after manufacture, maintain and operate
management system as has been approved. The frequency of the periodic inspection must
You can choose to complete the screening has been done at least once every 12
months.
12.5. A notified body must be carried out under the supervision of the undeclared
check with the manufacturer, the importer or the person carrying out the installation of the selected
the device after manufacture. The type and frequency of unannounced checks must
the authorized person to lay down, in particular, with regard to the
12.5.1 metric. safety class to which the equipment is classified is selected,
12.7.2. results of previous checks carried out in the framework of supervision,
12.5.3. the need to monitor compliance with the measures to rectify the disagreement and
12.5.4 imperial. significant changes in the organisation of production, concept or technology
the production.
12.6. During these inspections, the notified body may carry out, or give
carry out checks to verify that the control system is working properly.
12.7. The notified body must, on the basis of checks carried out
to prepare reports on the results of supervision and to transmit them to manufacturers, importers,
or to the person carrying out the installation of the selected device after manufacture.
13. If the selected device is equivalent to the requirements of this Ordinance and, if the
conformity with the type described in the type-examination certificate, or
the design of the selected device as described in the type-examination certificate,
manufacturer, the importer or the person performing the installation of the selected device after
the production of it must mark the mark of conformity along with his identification and
identification of authorized persons and must issue a declaration of conformity.
14. The notified body shall retain a copy of the document of approval
management system and reports on the results of supervision.
15. The notified body must inform the Authority of the certificates issued, revoked,
suspended or otherwise restricted documents management system approvals
or additions thereto and, on request, make available to the authority.
16. The notified body must inform the other notified body
carrying out the conformity assessment relating to certificates issued, revoked, suspended or
restricted documents management system approvals or additions to
them.
8. CONFORMITY ASSESSMENT PROCEDURE E1 (QUALITY ASSURANCE CHECKS SELECTED
Device)
1. the manufacturer, the importer or the person performing the installation of the selected device after
the production of must, in accordance with the following procedure, and under the supervision of an authorized
persons to ensure that the selected device meets the requirements of this order, and
make a declaration of conformity.
2. the manufacturer or the person performing the installation of the selected device after manufacture
must have in place a management system, including the method of quality assurance
production in accordance with the Decree about the requirements for the management system. The importer
must have in place a system of checks of the selected device.
3. the manufacturer, the importer or the person performing the installation of the selected device after
the production must ensure the implementation of the final assessment of each of the selected
device.
4. the manufacturer, the importer or the person performing the installation of the selected device after
production for the selected notified body an application for examination
of conformity. The application must include
4.1. identification of manufacturer, importer or the person performing the
installation of the selected device after manufacture,
4.1.1. the name or name, last name, address, place of residence, or
the place of business and the identification number of the person, if any, with respect to
a natural person, or
4.1.2. the trade name, registered office and identification number of the person, if it is a
the legal entity,
4.2. a written declaration that the Treaty was negotiated for the assessment of conformity with the
any other notified body,
4.3. management system documentation relating to the method of providing
the quality of production, or documentation of the system of checks, if the request
to be filed by the importer,
4.4. the technical documentation of the selected device and
4.5. for more information about the selected device necessary for conformity assessment,
in particular, the safety class to which it is classified.
5. The notified body must evaluate the management system of the manufacturer or of the person
installation of the selected device after manufacture, including how
quality assurance of the production, and verify that the
5.1. control system ensures conformity of the selected device with the technical
documentation of the selected device and with the requirements of this order and
5.2. for the production management system documentation includes
5.2.1. a description of the quality objectives and the organizational structure, including the rights and
obligations of persons who plan and control the manufacture or Assembly of the selected
the device,
5.2.2. a description of the manufacturing processes, management and quality assurance
processes and other systematic measures that will be used,
in particular those belonging to the fulfilment of the essential requirements to
ensure technical safety,
5.2.3. Description of the controls which will be carried out after completion of production or
installation, with an indication of the frequency of their implementation and criteria
the acceptability of applied during these inspections,
5.2.4. quality assurance records for the selected device, and
5.2.5. Description of the means of monitoring the achievement of the prescribed
the level of quality of the selected device and the assessment of the effectiveness of the management system
in the area of ensuring the quality of the service.
6. assessment of the management system, the notified body must carry out the operational
the manufacturer or the person carrying out the installation of the selected device after manufacture.
The assessment must take part in at least one employee of a notified body,
who has experience of assessments of the technology for the production of the selected device
and knowledge of the requirements of this Ordinance. A notified body is required to
notify the manufacturers, importers or to the person carrying out the installation of the selected
the device after manufacture, the results of the assessment of the management system, including the requirements
to remove nonconformities.
7. the importer must ensure that the assessment of the management system of the foreign producer
as specified in point 5 and 6. The notified body must assess the system of checks
the importer and to verify that the checks carried out on the selected device
ensure compliance of the selected device with the requirements of this order.
8. the manufacturer or the person performing the installation of the selected device after manufacture
should the selected device after manufacture or Assembly.
The importer must be checked in the context of the selected device. In the framework of the
the examination must be carried out the checks referred to in the technical documentation
the selected device so as to ensure the conformity of the selected device
the requirements of this Ordinance.
9. If the management system requirements specified in point 5, the authorized
the person must be issued by manufacturers, importers, or the person performing the installation
the selected device after manufacture, evidence of the approval of the management system.
10. the manufacturer, the importer or the person performing the installation of the selected device
after manufacture shall comply with the requirements set out in the management system as
approved by a notified body, and to ensure that he was still materially
the correct and efficient manner.
11. the manufacturer, the importer or the person performing the installation of the selected device
After the production of the authorized person must submit, which was approved by the system
management, information on planned changes to the management system described in
document management system approvals. The notified body must assess
a proposed amendment and decide whether the modified control system meets the
requirements referred to in point 5. The authorized person must communicate their conclusions
assessment, including the preamble, manufacturers, importers, or the person performing the
installation of the selected device after manufacture and corresponds with the change of management system
the requirements referred to in section 5, it shall issue a supplement to the original of the document of
approval of the management system.
12. monitoring of the authorized person
12.1. the supervision must ensure that the manufacturer, the importer or the person performing the
installation of the selected device after manufacture, duly fulfils the requirements
arising from the approved management system, including requirements for
ensure the quality of the selected device.
12.2. the manufacturer, the importer or the person performing the installation of the selected device
After production must allow the notified body for the supervision, access to
production, control and test space and storage and provide it with
all the necessary information.
12.3. The notified body must have a system in place for supervision purposes
the checks, which are set out the type and frequency of checks
carried out by the manufacturer, the importer or the person carrying out the installation of the selected
the device after manufacture.
12.4. The notified body must carry out periodic surveillance
checks to ensure that the manufacturer, importer, or a person
installation of the selected device after manufacture, maintain and operate
management system as has been approved. The frequency of the periodic inspection must
You can choose to complete the screening has been done at least once every 12
months.
12.5. A notified body must be carried out under the supervision of the undeclared
check with the manufacturer, the importer or the person carrying out the installation of the selected
the device after manufacture. The type and frequency of unannounced checks must
the authorized person to lay down, in particular, with regard to the
12.5.1 metric. safety class to which the equipment is classified is selected,
12.7.2. results of previous checks carried out in the framework of supervision,
12.5.3. the need to monitor compliance with the measures to rectify the disagreement and
12.5.4 imperial. significant changes in the organisation of production, concept or technology
the production.
12.6. During these inspections, the notified body may carry out, or give
carry out checks to verify that the control system is working properly.
12.7. The notified body must, on the basis of checks carried out
to prepare reports on the results of supervision and to transmit them to manufacturers, importers,
or to the person carrying out the installation of the selected device after manufacture.
13. If the selected device to the requirements of this order, the manufacturer,
the importer or the person performing the installation of the selected device after manufacture to
must mark the mark of conformity along with his identification and identification
authorized persons and must issue a declaration of conformity.
14. The notified body shall retain a copy of the document of approval
management system and reports on the results of supervision.
15. The notified body must inform the Authority of the certificates issued, revoked,
suspended or otherwise restricted documents management system approvals
or additions thereto and, on request, must be made available to the Office.
16. The notified body must inform the other notified body
carrying out the conformity assessment relating to certificates issued, revoked, suspended or
restricted documents management system approvals or additions to
them.
9. CONFORMITY ASSESSMENT PROCEDURE (F) (verification of the SELECTED DEVICE)
1. the manufacturer, the importer or the person performing the installation of the selected device after
the production of must, in accordance with the following procedure, ensure that the selected device is
in conformity with the
1.1. The production type described in the type-examination certificate referred to in
conformity assessment procedure, (B),
1.2. selected device as described in the design-examination certificate
the proposal by the conformity assessment procedure, B1, or
1.3. product type approved pursuant to § 137 para. 1 (b). a) nuclear
the Act, in the case of the selected device referred to in § 12 para. 2 (a). (b)) point
5, and meets the requirements of this order, and to issue a declaration of conformity.
2. the manufacturer, the importer or the person performing the installation of the selected device after
production must take the necessary measures to ensure that production or installation
process and its monitoring ensure conformity of the selected device with the production
type described in the type-examination certificate, the design of the selected
equipment as described in the type-examination certificate, or with the type
product approved under section 137 para. 1 (b). and the Atomic Act and with)
the requirements of this Ordinance.
3. the manufacturer, the importer or the person performing the installation of the selected device after
the production must ensure the implementation of the final assessment of the selected device.
4. the manufacturer or the person performing the installation of the selected device after manufacture
should the selected device after manufacture or Assembly.
The importer must be checked in the context of the selected device. In the framework of the
the examination must be carried out the checks referred to in the technical documentation
the selected device so as to ensure the conformity of the selected device
the production type described in the type-examination certificate,
the selected device as described in the type-examination certificate, or
product type approved pursuant to § 137 para. 1 (b). the Atomic Act)
and with the requirements of this Ordinance.
5. the manufacturer, the importer or the person performing the installation of the selected device after
production for the selected notified body an application for examination
of conformity. The application must include
5.1. identification of the manufacturer, the importer or the person performing the
installation of the selected device after manufacture,
5.1.1. the name or name, last name, address, place of residence, or
the place of business and the identification number of the person, if any, with respect to
a natural person, or
5.1.2. business name, registered office and identification number of the person, if it is a
the legal entity,
5.2. a written declaration that the Treaty was negotiated for the assessment of conformity with the
any other notified body,
5.3. technical documentation for the selected device,
5.4. a copy of the type-examination certificate, the certificate examination
draft decision or approval of the product pursuant to § 137 para. 1
(a). the Atomic Act) and
5.5. for more information about the selected device necessary for conformity assessment,
in particular, the safety class to which it is classified.
6. The notified body must
6.1. assessment of the materials used, including the assessment of
material certificates in accordance with section 8.6 of the annex 2 to this
the Decree, where not previously assessed by another notified body,
6.2. carry out checks on the implementation of technological processes
permanent joints in accordance with section 6.5 of annex 2 to this
Ordinance and these procedures requires that, unless previously agreed by
any other notified body,
6.3. to verify that the personnel undertaking the specific processes and personnel
welding supervision have valid qualifications, and these workers
reconcile according to section 6.5, 7.2 and 5.2 of annex 2 to this
the Decree,
6.4. to carry out surveillance of the final assessment,
6.5. to verify that the selected device is in conformity with the type described
in the type-examination certificate, the design of the selected device as described in the
the design-examination certificate or with the product type approved in accordance with
§ 137 para. 1 (b). the Atomic Act) and meets the requirements of this
the Decree, including the necessary inspections related to it, and
6.6. to draw up an inspection report on the evaluation activities referred to in
6.1 to 6.5, and their outputs.
7. If the selected device corresponds to the requirements of this order, and if the
conformity with the type described in the type-examination certificate,
the design of the selected device as described in the type-examination certificate
or with the product type approved pursuant to § 137 para. 1 (b). a) nuclear
the law, the authorized person must issue a manufacturer, importer, or a person
installation of the selected device after manufacture certificate of verification
the selected device. The certificate shall contain
7.1. the name of the selected device, device identification and basic description,
7.2. the identification details of the manufacturer, the importer or the person performing the installation
the selected device after manufacture,
7.2.1. name or name, last name, address, place of residence, or
the place of business and the identification number of the person, if any, with respect to
a natural person, or
7.2.2. business name, registered office and identification number of the person, if it is a
the legal entity,
7.3. the conclusions of the validation of the selected device and
7.4. other documents necessary to demonstrate the conformity of the selected device
the production type described in the type-examination certificate,
the selected device as described in the type-examination certificate or with
product type approved pursuant to § 137 para. 1 (b). the Atomic Act)
and with the requirements of this Ordinance.
8. If the selected device corresponds to the requirements of this order, and if the
conformity with the type described in the type-examination certificate,
the design of the selected device as described in the type-examination certificate
or with the product type approved pursuant to § 137 para. 1 (b). a) nuclear
the law, the manufacturer, the importer or the person performing the installation of the selected
the device after manufacture you must mark the mark of conformity together with his
the identification and the identification of authorized persons and must make a declaration
of conformity.
9. The notified body shall retain a copy of the certificate of verification
the selected device and inspection reports.
10. The notified body must inform the Authority of the certificates issued, revoked,
suspended or otherwise restricted certificates of verification of the selected
device and, on request, make available to the authority.
11. The notified body must inform the other notified body
carrying out the conformity assessment relating to certificates issued, revoked, suspended or
restricted certificates of authentication for the selected device.
10. CONFORMITY ASSESSMENT PROCEDURE G (UNIT VERIFICATION)
1. the manufacturer, the importer or the person performing the installation of the selected device after
the production of must, in accordance with the following procedure, ensure that the selected device
meets the requirements of this order, and to issue a declaration of conformity.
2. the manufacturer, the importer or the person performing the installation of the selected device after
production for the selected notified body an application for examination
of conformity. The application must include
2.1. identification data of the manufacturer, the importer or the person performing the
installation of the selected device after manufacture,
2.1.1. name or name, last name, address, place of residence, or
the place of business and the identification number of the person, if any, with respect to
a natural person, or
2.1.2. business name, registered office and identification number of the person, if it is a
the legal entity,
2.2. a written declaration that the Treaty was negotiated for the assessment of conformity with the
any other notified body,
2.3. technical documentation for the selected device,
2.4. the application of the selected device and
2.5. for more information about the selected device necessary for conformity assessment,
in particular, the safety class to which it is classified.
3. the manufacturer, the importer or the person performing the installation of the selected device after
the production must ensure the implementation of the final assessment of each of the selected
device.
4. the manufacturer or the person performing the installation of the selected device after manufacture
should the selected device after manufacture or Assembly.
The importer must be checked in the context of the selected device. In the framework of the
the examination must be carried out the checks referred to in the technical documentation
the selected device so as to ensure the conformity of the selected device
the requirements of this Ordinance.
5. The notified body must
5.1. perform an examination of the technical documentation of the selected device
including an assessment of whether it meets the requirements set out in annex 3 to this
the Decree,
5.2. assessment of the materials used, including the assessment of
material certificates in accordance with section 8.6 of the annex 2 to this
the Decree, where not previously assessed by another notified body,
5.3. carry out checks on the implementation of technological processes
permanent joints in accordance with section 6.5 of annex 2 to this
Ordinance and these procedures requires that, unless previously agreed by
any other notified body,
5.4. to verify that the personnel undertaking the specific processes and personnel
welding supervision have valid qualifications, and these workers
reconcile according to section 6.5, 7.2 and 5.2 of annex 2 to this
the Decree,
5.5. carry out or have carried out the necessary checks to verify and to
determine whether they were properly used technical standards or technical
conditions,
5.6. to verify that the design of the selected device in accordance with the requirements of this
the Decree,
5.7. to conduct surveillance of the final assessment,
5.8. to verify that the selected device is in conformity with the design of the selected
equipment and meets the requirements of this order, including the necessary
checks related to, and
5.9. to draw up an inspection report on the evaluation activities referred to in
points 5.1 to 5.8 and their outputs.
6. If the selected device corresponds to the requirements of this Ordinance, the authorized
the person must be issued by manufacturers, importers, or the person performing the installation
the selected device after manufacture certificate of verification of the whole. Certificate
must contain the
6.1. the name of the selected device, its identification and basic description,
6.2. identification details of the manufacturer, the importer or the person performing the installation
the selected device after manufacture,
6.2.1. the name or name, last name, address, place of residence, or
the place of business and the identification number of the person, if any, with respect to
a natural person, or
6.2.2. business name, registered office and identification number of the person, if it is a
the legal entity,
6.3. the conclusions of the validation of the whole and
6.4. additional documents necessary to demonstrate the conformity of the selected design
device and the selected device with the requirements of this Ordinance.
7. If the selected device corresponds to the requirements of this Decree, the manufacturer,
the importer or the person performing the installation of the selected device after manufacture to
must mark the mark of conformity along with his identification and identification
authorized persons and must issue a declaration of conformity.
8. The notified body shall retain a copy of the certificate of verification
a whole and inspection reports.
9. The notified body must inform the Authority of the certificates issued, revoked,
suspended or otherwise restricted certificates of verification and
the application is required to disclose to the Office.
10. The notified body must inform the other notified body
carrying out the conformity assessment relating to certificates issued, revoked, suspended or
restricted certificates of verification of the whole.
Č. 8
Requirements for verification of conformity
PART Of The VALIDATION Of The SELECTED DEVICE (F1)
1. the manufacturer, the importer or the person performing the installation part of the selected
the device after manufacture in accordance with the following procedure, ensure that the part of the
the selected device meets the requirements of this order, and make a declaration
of conformity.
2. the manufacturer, the importer or the person performing the installation part of the selected
the device after manufacture you must take the necessary measures to ensure that production or
the mounting process and its monitoring ensure conformity of the parts of the selected
equipment with the requirements of this order.
3. the manufacturer, the importer or the person performing the installation part of the selected
the device after manufacture you must ensure the implementation of the final assessment of each
part of the selected device.
4. the manufacturer or the person performing the installation of the selected device after manufacture
must every part of the selected device after manufacture or Assembly
to be checked. The importer must each part of the selected device to be checked in
the imports. In the context of the examination must be carried out the checks referred to in
parts of the technical documentation relating to the selected device.
considered part of the selected device so as to ensure the conformity of the parts
the selected device with the requirements of this Ordinance.
5. the manufacturer, the importer or the person performing the installation part of the selected
the device after manufacture you must for the selected authorized persons to submit a request for
assessment of conformity. The application must include
5.1. identification of the manufacturer, the importer or the person performing the
mounting parts for the selected device after manufacture,
5.1.1. the name or name, last name, address, place of residence, or
the place of business and the identification number of the person, if any, with respect to
a natural person, or
5.1.2. business name, registered office and identification number of the person, if it is a
the legal entity,
5.2. a written declaration that the Treaty was negotiated for the assessment of conformity with the
any other notified body,
5.3. the part of the technical documentation relating to the selected device.
considered part of the selected device and
5.4. for more information about the selected device and the parts of the selected device
necessary for conformity assessment, in particular the safety class to which it is
classified.
6. The notified body must
6.1. assessment of the materials used, including the assessment of
material certificates in accordance with section 8.6 of the annex 2 to this
the Decree, where not previously assessed by another notified body,
6.2. carry out checks on the implementation of technological processes
permanent joints in accordance with section 6.5 of annex 2 to this
Ordinance and these procedures requires that, unless previously agreed by
any other notified body,
6.3. to verify that the personnel undertaking the specific processes and personnel
welding supervision have valid qualifications, and these workers
reconcile according to section 6.5, 7.2 and 5.2 of annex 2 to this
the Decree,
6.4. to carry out surveillance of the final assessment and
6.5. to verify that a part of the selected device meets the requirements of this
the Decree, including the necessary inspections related to it.
7. If the part of the selected device to the requirements of this order,
the notified body must issue a manufacturers, importers, or the person performing the
mounting parts for the selected device after manufacture certificate of verification section
the selected device. The certificate shall contain
7.1. the name of the selected device, its identification and basic
Description
7.2. the identification details of the manufacturer, the importer or the person performing the installation
part of the selected device after manufacture,
7.2.1. name or name, last name, address, place of residence, or
the place of business and the identification number of the person, if any, with respect to
a natural person, or
7.2.2. business name, registered office and identification number of the person, if it is a
legal person, and
7.3. the conclusions of the validation part of the selected device.
8. If the part of the selected device to the requirements of this order,
manufacturer, the importer or the person performing the installation of the selected device after
the manufacture, it must mark the mark of conformity along with his identification and
identification of authorized persons and must issue a declaration of conformity.
9. The notified body shall retain a copy of the certificate of verification
part of the selected device.
The requirements for the scope and verification of conformity of the operated selected
equipment with the technical requirements
1. The checks carried out in the framework of the examination of the conformity of the operated
the selected device with the technical requirements shall be applied to the General
inspection requirements under part A of the annex No 6 to this Ordinance.
2. Each operated by the selected device shall be checked in accordance with the
2.1. internal regulations,
2.2. Programme of operational controls of the selected device and
2.3. documentation of repairs, maintenance, or changes the selected device.
3. In determining the requirements for the scope, type, method of implementation and
the periodicity of checks operated by the selected device and the criteria
the acceptability of the used during these inspections must be taken into account
in particular, the
3.1. the properties of the selected device
3.2. conditions for safe operation,
3.3. the requirements of the internal rules for the operation of a nuclear installation and
3.4. knowledge and experience with the operation of the selected device and
the nuclear device.
4. Plans of operational controls shall be workers carrying out checks
announced before the start of the operational controls.
Č. 9
Mark of conformity
1. the mark of conformity is the Greek letter delta in this form:
2. If the conformity mark is reduced or enlarged, must be preserved
the proportions of the grid in the picture referred to in point 1.
3. the mark must be at least 5 mm wide.
4. the specimen mark of conformity is shown on the auxiliary grid that is not
part of this is used for the purposes of his proportional
Zoom in or out.