The Requirements For Quality Assurance And Safety Equipment

Original Language Title: požadavky na zajišťování kvality a bezpečnosti zařízení

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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

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