On The Technical Safety Of The Device

Original Language Title: o zajišťování technické bezpečnosti vybraných zařízení

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now

Read the untranslated law here: https://portal.gov.cz/app/zakony/download?idBiblio=60309&nr=309~2F2005~20Sb.&ft=txt

309/2005 Sb.



DECREE



of 22 March. July 2005



on the technical safety of the device



State Office for nuclear safety shall be determined according to § 47 para. 7 to the

implement section 2 (a). nn), section 4A(1). 1, § 4 b paragraph 1. 1 and § 17 para. 1

(a). m) Act No. 18/1997 Coll. on peaceful uses of nuclear energy and

ionizing radiation (the Atomic Act), and amending and supplementing certain

laws, as amended by Act No. 83/1998 Coll., Act No. 71/2000 Coll., Act

No. 132/2000 Coll., Act No. 13/2002 Coll., Act No. 310/2002 Coll., Act

No. 320/2002 Coll., Act No. 279/2003 Coll., Act No. 186/2004 Coll., Act

No. 1/2005 Coll. and Act No. 253/2005 Coll. (hereinafter the "Act"):



§ 1



The subject of the edit



(1) this Ordinance has been notified in accordance with the directive of the European

Parliament and Council Directive 98/34/EC of 22 December 2004. June 1998 on the procedure for the provision of

information in the field of technical standards and regulations and of rules on services,

the information society, as amended by Directive 98/48/EC.



(2) this Ordinance governs the



and how to specify the selected devices), which are specially designed

for nuclear facilities,



(b)) the technical requirements to ensure the technical safety of

devices in the production and operation,



(c)) the procedures for conformity assessment of selected devices that are

specially designed for nuclear facilities, with the technical requirements and



(d) to ensure technical safety) selected devices in operation.



§ 2



Basic concepts



For the purposes of this Ordinance, means the



and) selected device specifically proposed for nuclear installations (hereinafter

"specifically proposed the selected device") of the selected device

^ 1) safety class 1, 2, and 3, whose failure may cause

leakage of radioactive substances or ionising radiation and endanger human

health,



(b)) pressure equipment specifically proposed the selected device loaded

the pressure of the working fluid, including the elements attached to components

exposed to pressure,



(c) a pressure maximum pressure) is used for the design of the basic dimensions

pressure equipment, which permits the operation of normal

operating conditions,



(d) the highest permissible pressure) maximum pressure specified by the manufacturer for which the

the pressure equipment is designed,



(e)) the calculated temperature highest temperature used for the design of the basic

the dimensions of the pressure equipment, which permits the operation when

normal operating conditions,



f) parts of the selected part of the selected device, device whose failure or

malfunction may threaten the safety of this equipment, technical



g) a notified body is a legal person in charge according to § 4 b paragraph 1. 1

the law acts in the assessment of conformity with the technical requirements,



h) production process leading to the making of the selected device to the

commissioning, or its individual stages. Production includes in particular the

the design phase, making its parts and the Assembly or installation of the selected

device from the parts of the selected device



I) indicating the selected device to the moment when operation is selected

the device is taken and used by the ^ 2) for the purpose for which the

It was made,



j) technical documentation file of the documents provided for in this Decree,

which the manufacturer indication of the method of production specifically of the proposed

the selected device or parts of it and the way and the extent of its authentication

the technical condition of operating over the entire lifetime,



the accompanying technical documentation file) documents provided for in this

the Decree, which the manufacturer indication of status, specially of the proposed

the selected device or any part thereof after completion of their manufacture,



l) Declaration of conformity a document whereby the manufacturer Declaration for

evaluation of the conformity of the proposed selected device with specially

the technical requirements in the manufacture of this device.



§ 3



How to determine specifically the proposed selected devices



(§ 4a, paragraph 1, of the Act)



(1) specially selected devices are proposed



a) pressure equipment constituting the boundary pressure refrigerant circuit of a nuclear

reactor safety classified in class 1 involving pressure vessels and

steam generators working with radioactive substances, of which the maximum

permissible pressure exceeds 0.05 MPa and whose volume is greater than 10 litres,

or pumps, pipes and fittings, working with radioactive substances with

the highest permissible pressure exceeding 0.05 MPa luminance above DN 70,



(b)) pressure equipment classified in safety class 1, 2 and 3

securing the reactor cooling, cooling systems and volume compensation

airtight compartments, normal and emergency replenishment systems,

cooling systems primary circuit and device for cooling systems

storage of spent nuclear fuel with a maximum permissible working

pressure exceeding 0.05 MPa luminance above DN 70,



c) pressure equipment systems cleaning of working fluids of a nuclear installation

included in the safety class 2 and 3 (the working fluid cleaning system

the pressure circuit working with the highest permissible pressure exceeding

0.05 MPa luminance above DN 70),



(d)) pressure equipment constituting the building part of the hermetic envelope dimensioned

on the internal overpressure safety included in class 2, including

her assurance at the maximum leak project accident



e) secondary circuit pressure equipment classified in safety class 2

and 3, for which the calculated pressure working fluid at the calculation temperature

more than 100th. (C) is greater than 4 MPa and lightness of the pipes is greater than DN

200, or



f) packaging files for transport, warehousing and storage of spent

nuclear fuel included in the safety class 2.



(2) in the list of selected equipment for the nuclear device is specially

the proposed selected device separately.



§ 4



Technical requirements to ensure technical safety

used in the manufacture of specially the proposed selected devices



[To section 2 (a). nn) and section 4A(1). 1 of the law]



(1) the production of specially selected device are proposed to ensure

technical safety carried out so that the outputs of the individual stages of production

were in conformity with the technical requirements. Technical requirements for specially

the proposed selected establishments laid down in annex 1.



(2) the technical requirements on specially selected device proposed that

shall be applied in the manufacture of this device under annex 1, subject to

even on the part of the device.



(3) the method of manufacture specially proposed for the selected device or its

part a way to authenticate their technical condition for operation

documents in the technical documentation. Requirements for technical documentation

modifies the part I of the annex No. 2.



(4) in the course of manufacture specially proposed for the selected device or

its part of the checks are carried out, which verifies their compliance with

technical requirements. The requirements for these checks set out in annex 3.



(5) after completion of a specifically proposed the selected device or

its part of their status in terms of technical safety indication in

the accompanying technical documentation according to the requirements set out in part II of

Annex No. 2. The quality of the implementation evaluation of the conformity of production shall be demonstrated

specially proposed for the selected device or parts of it with the technical

requirements and demonstrates with a certificate of conformity issued by the manufacturer.

Declaration of conformity requirements provides for part III of the annex No. 2.

The Declaration of conformity is included in the accompanying technical documentation.



§ 5



Conformity assessment, specially the proposed selected devices with

technical requirements laid down on this device



[To section 2 (a). nn) and Section 4a and section 4b of paragraph 1. 1 of the law]



(1) the assessment of conformity with the technical requirements to ensure the technical

Safety (hereinafter referred to as "conformity assessment") shall be carried out in accordance with the

paragraph 2 and the conformity assessment procedures adapted in Appendix 4.

Assessment of conformity under a specially selected device are proposed

carried out before it is used in a nuclear device.



(2) the various conformity assessment procedures specifically proposed

the selected device are for



and specially the proposed selected devices) safety class 1



1. the type-examination and quality assurance in the manufacture of specially

proposed for the selected device (conformity assessment procedures B and D) according to the

parts 1 and 4 of the annex No 4,



2. type-examination and verification of the specially selected for the proposed

equipment (conformity assessment procedures (B) and (F)) in accordance with parts 1 and 5 of the annex No.

4,



3. verification of specially selected devices proposed as a whole

(conformity assessment procedure (G)) under Part 6 of the annex No 4,



(b)), the proposed safety devices specially selected class 2, with

the exception of the packaging for the transport, warehousing and storage

spent nuclear fuel and of pressure equipment making up the building

part of the hermetic envelope designed for internal overpressure



1. the type-examination and quality assurance in the manufacture of specially

proposed for the selected device (conformity assessment procedures B and D) according to the

parts 1 and 4 of the annex No 4,



2. type-examination and verification of the specially selected for the proposed


equipment (conformity assessment procedures (B) and (F)) in accordance with parts 1 and 5 of the annex No.

4,



3. verification of specially selected devices proposed as a whole

(conformity assessment procedure (G)) under Part 6 of the annex No 4,



4. comprehensive quality assurance (conformity assessment procedure H) according to the

Part 7 of annex 4,



(c) the packaging files for transport), warehousing and storage of spent

nuclear fuel included in the safety class 2 authentication, specially

proposed for the selected device (conformity assessment procedure (F)) under part

5 the annex No. 4,



(d)) pressure equipment constituting the building part of the hermetic envelope dimensioned

on the internal pressure classified in safety class 2 authentication as a whole

(conformity assessment procedure (G)) under Part 7 or type examination and

verification (conformity assessment procedures (B) and (F)) in accordance with parts 1 and 5 of the annex No.

4,



e) specially selected establishments proposed security class 3



1. the examination of the design and quality assurance in the manufacture of specially

proposed for the selected device (procedures for conformity assessment of B1 and D) according to the

parts 2 and 4 of annex 4;



2. the examination of the design and validation of specially selected for the proposed

equipment (conformity assessment procedures B1 and (F)) in accordance with parts 2 and 5 of the annex No.

4,



3. design examination and type conformity (conformity assessment procedures B and C1)

in accordance with parts 1 and 3 of annex 4;



4. verification of specially selected devices proposed as a whole

(conformity assessment procedure (G)) under Part 6 of the annex No 4,



5. comprehensive quality assurance (conformity assessment procedure H) according to the

Part 7 of annex 4.



(3) conformity assessment specifically proposed selected devices

in accordance with paragraph 2 (a). e) shall also apply to a different procedure referred to in paragraph 2

(a). and) or (b)), if it exists.



(4) for the assessment of conformity of the proposed section specially selected

a device shall apply the conformity assessment procedures laid down in

paragraph (2).



(5) the procedure used for assessing compliance with indication. Papers of the

the conformity assessment procedure shall include



and specially the proposed technical documentation) to the selected device

or a part thereof listed in annex No. 2 and



b) documents issued by a notified body in the conformity assessment to the extent

referred to in the various conformity assessment procedures according to annex 4.



§ 6



Way of ensuring the technical safety of the device and during operation

technical requirements for them



[To section 17, paragraph 1, point (a). m) of the Act]



(1) the selected device is put into operation only if the

the final examination, that after the end of production is ensured by the technical

the safety of the selected device in accordance with the technical requirements.



(2) the technical requirements on the selected device, which apply when

the operation provides for special legislation ^ 3) technical requirements for

specially the proposed selected device, which apply when operating,

set out in annex 1.



(3) the basic requirement to ensure technical safety in operation

the selected device is the implementation and evaluation of controls

compliance with the technical requirements of the selected device. For checks

shall be drawn up in accordance with the operating regulations of the programmes of checks,

control plans and procedures for their implementation and evaluation. The requirements of the

These controls provides for part III of annex 3.



(4) documentation supporting the technical safety of the selected device

including documentation preparation and implementation of reconstruction, repair and

maintenance, updated the accompanying technical documentation, including records,

the archives throughout the operation of the selected device in accordance with the

special legal regulation ^ 1).



(5) during the time of selected devices is based on the results

regularly evaluate the technical safety checks.



§ 7



Transitional provision



The authorisation holder, who runs the selected device at the time of the acquisition

the effectiveness of this Ordinance, no later than 2 years after the entry into force of this

the Decree shall ensure that the list of selected devices has been marked

specifically, the proposed selected establishments in accordance with § 3 (1). 2, and

shall submit the list of selected devices for approval by the State Office for

nuclear safety.



§ 8



The effectiveness of the



This Decree shall enter into force on 10 July 2004. August 2005.



Chair:



Ing. Drábová in r.



Č. 1



Technical requirements for specially selected establishments proposed

1. General requirements

1.1. Technical provisions set out in this annex shall apply to

specifically, the proposed selected establishments provided for in § 3

paragraph. 1.

1.2. The technical requirements for specially selected proposed

the devices are

1.2.1. the technical specifications contained in the file

technical regulations, technical standards, or

technical conditions, which sets out the required

the characteristics of the specially selected for the proposed

devices, such as quality level, utility

properties, safety, dimensions, condition and

requirements for control device and method of testing

equipment labelling requirements for establishments, procedures for

conformity assessment, production methods and processes with

influence on the characteristics of the specially proposed

selected device, or

1.2.2. requirements applying to after it has been specially

the proposed selected device is put into service, and

It's own conditions for operation, the conditions for

operational control and the methods and conditions for

repeated use after repairs or

specially the proposed reconstruction of the selected

If the device can influence the technical

safety of the equipment throughout its life cycle.

1.3. Specifically proposed the selected device is proposed in

compliance

1.3.1. with the requirements of a special legal regulation, ^ 4)

1.3.2. with the technical requirements laid down in this

the Decree,

1.3.3. the requirements laid down in its technical

specification.

1.4. Specifically proposed the selected device is proposed so that the

1.4.1. prevent its sudden violation of at all

testing and operating conditions, including

unacceptable media leaks,

1.4.2. it was possible to safely perform in the course of its operation

all necessary scheduled or unscheduled inspections,

tests or revision, or the diagnosis device

1.4.3. have been allowed to safely perform the cleaning and washing

dezaktivačními solutions, repairs and maintenance of equipment.

1.5. Specifically proposed the selected device is produced,

přezkušuje and can be mounted in such a way that, after its introduction

putting into service ensure its technical safety.

1.6. Specifically, the proposed selected device must be capable of

to perform the desired function in normal operation,

abnormal operation, emergency conditions, the design and

the maximum design limit the consequences of accidents and capable

malfunctions and accidents.

1.7. when processing specially the proposed design of the selected

the establishment or modification of its technical characteristics,

possibly as a result of changes in the status of the device caused by

operating the degradation of material processes analysis

the danger in terms of the technical security and the final draft

shall be carried out taking into account the outcome of this analysis.

1.8. in selecting the most appropriate solutions, the manufacturer must apply below

the principles set out in this order

1.8.1. reasonably practicable to exclude or restrict the

every foreseeable risk,

1.8.2. apply appropriate protection measures against hazards,

that cannot be ruled out.

1.9. The materials used for the production of specially the proposed

selected devices and parts thereof belonging to the

the hermetically sealed envelope are subject to similar

requirements as to the pressure equipment materials in accordance with clause

4.

2. the pressure equipment Design

2.1. General

2.1.1. The pressure equipment is proposed in accordance with its

technical specifications and having regard to the established

burden, particularly for normal operating conditions,

abnormal operating conditions, emergency conditions and

test pressure test, in order to ensure the

technical safety of pressure equipment throughout the

for its intended life.

2.1.2. In the design of pressure equipment it is necessary to apply the

appropriate factors of safety in the use of complex

methods, which is known to be in an appropriate manner

are calculated with a reasonable level of safety with respect to all

types of disorders that come into consideration.

2.1.3. in designing the pressure equipment must be

be based on the established

2.1.3.1. calculation, operating and testing

loads and their limits

2.1.3.2. operating conditions relevant for the

the pressure equipment,

2.1.3.3. the limit parameters for serviceability

the pressure equipment in which it is

required mechanical movement,

2.1.3.4. operating modes with regard to its

inclusion in relevant safety class

under special legislation, "^ 1")

2.1.3.5. the chemical and physical parameters


used media in the pressure equipment,

2.1.3.6. corrosive effects of media on the material

pressure equipment for the period required

the life of the construction of this device,

2.1.3.7. the requirements for demonstrating resistance to

seismic effects or against the cyclical

loads.

2.1.4. the pressure equipment designs and manufactures to

eliminate or at least reduce the risk of

a significant loss of pressure resistance as a result of

disorders leading to the violation of the integrity of the pressure

devices and the spread of radioactive substances. In these

cases, provide appropriate means of protection to

maintain operating parameters, and that successive

power systems and heat dissipation

ensuring the maintenance of the above levels of media in

pressure equipment and allowing safe removal

residual heat during the operation or after

weaning.

2.1.5. The pressure equipment constituting the building part of the hermetic

envelopes, including those affecting the tightness of the

sealed envelopes is proposed, builds and assembles

so, in order to establish the tightness when

the projected a calculated pressure after installing all

penetrations.

2.1.6. The pipeline, which is the pressure, is proposed and

produced, so that the risk of overload as a result of

of undue backlash or excessive forces

emerging on the flanges, joints, vlnovcích

etc. It has been regulated for example. with the aid of reinforcements,

docking, alignment, position, and preload.

2.2. Design for adequate strength

2.2.1. The pressure equipment is proposed for loads

appropriate to its intended use and reasonably

foreseeable operating conditions. It is necessary to take

into account the different loads, which may cause

together, taking into account the probability of their

the current occurrence.

2.2.2. Design for adequate strength is based

on the calculation method according to section 2.2.3, if

necessary supplemented by experimental method. When

processing of the calculation, use only certified

calculation programs.

2.2.3. Calculation method

2.2.3.1. Calculation methods provide a pleasant

the level of safety in accordance with the requirements of

set out the technical regulations or

technical standards

2.2.3.1.1. to calculate the strength,

2.2.3.1.2. on mechanical properties

the basic and additional

materials,

2.2.3.1.3. on non-separable (weld)

connections and

2.2.3.1.4. on carrying out the checks and tests

the pressure equipment.

2.2.3.2. Resistance to internal pressure and more

loading aspects

Allowable stresses for pressure equipment is

limited with regard to the types of disorders

the occurrence of which under operating conditions and

operating modes is impossible to predict.

Therefore, it is necessary to use such factors

security that allow you to completely

eliminate any uncertainty arising out of

manufacture, actual operating conditions,

stresses, calculation models, as well as

the properties and behaviour of the material.

2.2.3.3. The strength of

2.2.3.3.1. To ensure the strength of the pressure

the device will use the appropriate

strength calculations involving

the relevant calculation, operating and

the load test.

whereas. when calculating the strength of the pressure

the device shall take into account, in particular,

This load

2.2.3.3.2.1. internal and external pressure,

2.2.3.3.2.2. effect of its own weight

the device and its content,

2.2.3.3.2.3. additional load

(the effect of the weight of the attached

equipment, insulation, pipe

etc.),

2.2.3.3.2.4. forces from Struts and

the pipeline,

2.2.3.3.2.5. temperature effects including

thermal shocks,

2.2.3.3.2.6. the vibrating load

2.2.3.3.2.7. seismic effects

wind, flood,

2.2.3.3.2.8. the processes causing the

material degradation due to

of radioactivity,

2.2.3.3.2.9. hydraulic resistance and

pressure surges,

2.2.3.3.2.10. the plane crash

and other relevant load

resulting from the analysis of the risk according to

1.7.

2.2.3.3.3. Calculation of the load

2.2.3.3.3.1. The calculated pressure is equal to the

or is greater than the highest

permitted pressure and takes into account the

pressure surges, fault management

system and the effects of configuration

the system. Test pressure equal to

or greater than 1.25 times

the design pressure shall be applied

for the design of the basic dimensions

device. The parts of the structure,

loaded at the same time the internal and

external pressure, for calculation

pressure takes the difference of the two pressures,

When that is achieved, the largest

the thickness of the walls.

2.2.3.3.3.2. The calculated temperature

sets with the appropriate degree of

safety. Calculated temperature

must not be less than expected

the maximum mean temperature after

the thickness of the part under consideration, to

subject to the limits for

normal and abnormal operating

terms and conditions. If the device or

pipe heated transfer

heat sources, such as

the Induction coil, casing

or an internal heat source, notes

their influence into account when

determination of the calculated temperature.

2.2.3.3.3.3. A calculated load

selected so that, in combination with

influences of design pressure was

determined by the largest wall thickness

the devices, which are covered by

for normal operating limits

terms and conditions.

2.2.3.3.3.4. the maximum value of the

stress and stress concentration

must be kept in the safe

the limits.

2.2.3.3.4. Operating load

In the calculation of the strength of the pressure

the device in an appropriate fashion taking into

account of all the loads occurring

under normal operating conditions,

Furthermore, even the loads that are given by

technological operation, to which

the pressure equipment is made and the external

loads that are commonly found.

They also belong to the load

causing stress and strain in the

the material in the manufacture of the device,

transport, Assembly and pressure

tests, including residual

voltage, whose influence on the limit State

strength shall be assessed individually according to the

their significance.

2.2.3.3.5. the test load

2.2.3.3.5.1. the strength calculation

the pressure equipment,

taking into account the estimated

load test, which

verifies the integrity of the device

After the end of its production,

Assembly, the period of operation,

repair or reconstruction.

2.2.3.3.5.2. The test loads are

in particular, pressure tests,

the aim is to check

When the pressure laid down rate

security in relation to the

the calculation, or to

the highest legitimate pressure,

If the device does not show

significant deformation or

leaks that exceed the

a determined threshold.

2.2.3.3.5.3. the test pressure

determined taking into account the

reviews of geometric and

material properties and

the test conditions in the production

race or for a service in accordance

with the requirements referred to in

technical regulations,

technical standards or

technical conditions

for the manufacture of pressure equipment.

2.2.3.3.6. Strength calculation for pressure

the device shall be drawn up for

the following limit conditions

2.2.3.3.6.1. a sudden breach of

(tough or brittle),


plastic deformation in 2.2.3.3.6.2.

the entire cross section of the component

2.2.3.3.6.3. unidirectional growth

plastic folder relative

deformation in a circular

load leading to unacceptable

change the dimensions or to violate,

2.2.3.3.6.4. cracking when

cyclic loading,

2.2.3.3.6.5. the loss of stability.

2.2.3.3.7. In the calculation of strength for limit

the States referred to in paragraph 2.2.3.3.6,

use the values that correspond to the

material strength, plastic,

křehkolomovým characteristics and

resistance to deformation, laid down

in the technical regulations, or

the technical standards for the

materials, or experimentally

established by an accredited laboratory.

2.2.3.3.8. in the case of welded joints is

must choose for material

the properties of the appropriate values for the factors

connections depend on the type of the connected

materials on the kind of the used

non-destructive inspection and

the intended operating

conditions.

2.2.3.3.9. in the case of the design of the pressure equipment,

they take into account in an appropriate manner

foreseeable degradation mechanisms

(e.g. impact of radioactivity, corrosion,

metal fatigue) corresponding to the

the intended use of the device and

related to the life of the equipment.

strength calculation of pressure 2.2.3.3.10.

the device shall be drawn up in two stages

2.2.3.3.10.1. calculation for the design of

the basic dimensions of the device

(hereinafter the ' draft Basic

dimensions "),

2.2.3.3.10.2. check calculation

equipment (hereinafter referred to as "control

the calculation ").

2.2.3.3.11. In the design of the basic dimensions

holiday stress calculated from the

tensile strength and of contracting limits

yield strength, which are the basic

the characteristics of the materials,

permitted for the manufacture of the device. When

calculation of the permissible stresses are discounted

the appropriate safety factors.

2.2.3.3.12. In the design of the basic dimensions

It is necessary to consider the limit States

2.2.3.3.12.1. tough violation,

plastic deformation in 2.2.3.3.12.2.

the entire cross section of the component

2.2.3.3.12.3. the loss of stability.

2.2.3.3.13. After the basic design dimensions

device control shall be drawn up

the calculation whose aim is to

2.2.3.3.13.1. demonstration of strength when you

static (monotone)

load,

2.2.3.3.13.2. demonstration of strength when you

Circular (dynamic) load,

2.2.3.3.13.3. demonstration of resistance

against sudden (unstable)

violation of,

2.2.3.3.13.4. demonstration of strength when you

vibration,

2.2.3.3.13.5. demonstration of resistance

against the loss of stability and

2.2.3.3.13.6. demonstration of resistance

against seismic effects.

In the calculation of the pressure

the device shall take into account all

load, including temperature effects and

all operational procedures referred to in

the technical specifications and

operating conditions. In particular, the

take into account the degradation of properties

during the operation, the quality of the material

the surface, the effect of the voltage gradient effect

corrosion environment, etc.

2.2.4. experimental design method

2.2.4.1. The design of the pressure equipment such as

in whole or in part shall be verified by suitable

the program checks and tests carried out by the

on a representative sample of the device.

2.2.4.2. Before starting the tests is determined

the program checks and tests. Program

the examinations and tests is recognized

the notified body responsible for the procedure

the assessment of conformity of the draft, unless such

There are.

2.2.4.3. in the examinations and tests shall be defined

test conditions and acceptance criteria or

the rejection. Before testing will be measured

the actual value of the basic dimensions and

characteristics of the materials from which the test

the device consists of.

2.3. Provisions to ensure safe handling and operation

2.3.1. The method of operation of the pressure equipment

in the proposal, the analysis eliminates the predictable

risks in the operation of the equipment. Where I find

into account, with particular attention to the

2.3.1.1. closures and openings,

2.3.1.2. dangerous odfukům of valves,

2.3.1.3. the device, which prevents the physical input,

If the device the pressure or vacuum.

2.3.2. in particular, pressure equipment fitted with an input slot

shall be automatic or manually operated

device, by means of which the user easily finds

whether it is possible without the danger of open hole. In

Furthermore, the pressure equipment provides

the device, which prevents it from opening, if the pressure

or the temperature of the media represent a danger.

2.4. the means of examination

2.4.1. the pressure equipment designs and manufactures to

It was impossible to carry out all necessary examinations

to ensure technical safety.

2.4.2. Where it is necessary to ensure the continued

technical security devices are available

resources for determining the internal condition

the pressure equipment so that appropriate examinations and

checks can be carried out safely and

ergonomically.

2.4.3. where pressure equipment cannot be designed

so it can be checked during operation in

to the extent required, the other replacement

or indirect methods or using approved

calculation methods and apply conservative

safety margins or other reasonable

security measures to avoid possible

an unexpected failure.

2.5. the means of draining and venting

2.5.1. Where it is necessary to use appropriate

means of draining and venting

the pressure equipment,

2.5.1.1. in order to avoid the adverse effects,

such as water hammer, vacuum collapse,

corrosion and uncontrolled chemical reactions

at all stages of operation and testing,

in particular, for pressure tests, and

2.5.1.2. in order to secure manner

decontamination, cleaning, inspection

and maintenance.

2.6. corrosion

Where it is necessary to propose additions to the amplification

the thickness of the wall or corrosion protection, with due

taking into account the intended use.

2.7. Wear

If you can experience a substantial erosion or abrasion,

measures to reduce these effects to the lowest possible level

good solution design, for example. increasing the thickness of the

material or the use of, or the lining of the přeplátování, which

permit replacement of parts which are most affected.

2.8. pressure equipment Report

2.8.1. The report of the pressure equipment shall be designed so as to

2.8.1.1. the constituent parts assembled together

have been for the purpose of appropriate and reliable,

2.8.1.2. all components have been correctly

integrated and assembled in an appropriate manner.

2.9. Filling and discharge

2.9.1. Where applicable, pressure equipment

designs and equips the accessories, or shall

measures for its installation so that it

ensure safe filling and discharge

equipment, in particular with regard to the risks which

is

2.9.1.1. when carrying out

2.9.1.1.1. overfilling or exceeding the

pressure, in particular with regard to the filling

ratio and to vapour pressure at the appropriate

temperature,

2.9.1.1.2. the instability of the pressure

the device,

2.9.1.2. in the discharge of uncontrolled leakage of media

under pressure,

2.9.1.3. When filling or discharge dangerous

connection and disconnection.

2.10. Protection against exceeding the allowable limits of pressure

device

2.10.1. Where, under operating conditions, there may be a

exceeding the allowable limits, equips with a pressure

device or suitable protective devices

shall take appropriate measures for its installation, if

It is not protected by other protective

devices within an Assembly.


2.10.2. Appropriate protective device or a combination of such

device is proposed, taking account of the specific

the relevant characteristics of the pressure equipment or

the report.

2.10.3. the appropriate protective devices and their combination with

consider

2.10.3.1. safety accessories, or

2.10.3.2. appropriate control devices, such as

indicators and/or alarms which

allow you to automatically or manually

carried out adequate action which is

operation of the pressure equipment is maintained in

the allowable limits.

2.11. Safety accessories

2.11.1. Safety accessories

2.11.1.1., designs and manufactures to

reliable and suitable for their estimated

function, or with regard to the requirements

the maintenance and testing of these devices,

2.11.1.2. is independent of other functions, in addition to

in cases where such other functions cannot

be affected by the safety function,

2.11.1.3. complies with relevant design principles

in order to ensure reliable

the protection. These principles include, in particular,

security functions against disruption,

backup safety equipment, miscellaneous

design and automatic diagnosis of its own

functionality.

2.11.2. Pressure limiting devices

This device shall be designed so as to avoid

Permanent crossing of the highest permissible

pressure; possible short-term increase of pressure in the

safety equipment, however, is impressing

permissible, but must not exceed 10% of the value of

the highest permissible pressure.

2.11.3. temperature control devices

These devices are for safety reasons

the appropriate time delay, in accordance with the measurement function.

2.12. External fire

Where necessary, pressure equipment designs and

where appropriate, equips suitable accessories, or shall

measures for its installation so as to meet the requirements of

the limitations of damages in case of external fire, with due

taking account of the intended use of the pressure equipment.



3. the manufacture of pressure equipment

3.1. Manufacturing processes

The pressure equipment is made in accordance with the technical

documentation involving the appropriate methods and the corresponding

manufacturing processes so that it can carry out all

the requisite checks to ensure technical safety. When

production by technical requirements that have been

received in stage design.

3.1.1. Manufacture of parts

In the manufacture of parts must not be subject to defects and

cracks or changes in the mechanical properties,

that could compromise the safety of the technical

the pressure equipment.

3.1.2. Welded joints

3.1.2.1. Welded joints and adjacent area

be carried out free of any surface

or internal defects that could compromise the

the technical safety of the pressure equipment.

3.1.2.2. The properties of the weld joints match

at a minimum, the characteristics of the basic

the materials, which are associated, if

the strength calculation were not intentionally

taken into account other relevant values

the properties.

3.1.2.3. a technical and technological activities

relating to the welded joints on

pressure equipment shall be carried out only

qualified personnel (welding inspection)

in accordance with the technical standard. ' ^ 5)

3.1.2.4. Workers who process of welding

the designer, check and verify, approve

the authorized person.

3.1.2.5. Welded joints of structural parts of the pressure

the device, which contribute to the resilience of

the device against internal pressure and

components that are directly

connected, carried out respectively

qualified personnel with the use of

suitable working procedures. These working

the procedures and competent staff approved

the authorized person. For the purposes of approval

welding procedures and approvals

the notified body carries out the supervision of

implementation of the relevant checks and tests

welded joints, to evaluate these joints

in accordance with technical standards. ^ 6)

The authorized person in the framework of the examination

specially selected for the proposed compliance

equipment safety class 1 and 2 done

supervision over the implementation of the control

welded joints, including the supervision of

implementation of the relevant checks and tests to

the evaluation of these services and the supervision of

carrying signs.

3.1.2.6. In the technical documentation of the pressure

device, including the welding process,

demonstrates compliance with the requirements

3.1.2.6.1. processing, assessment and

the approval of the technological processes

welding,

3.1.2.6.2. on the necessary qualifications

workers welding process

be carried out,

3.1.2.6.3. on the necessary qualifications

workers welding process

design, validate, and evaluate

3.1.2.6.4. the fitness of the device to the

the implementation of the process of welding, inspection

and trials.

3.1.3. Non-destructive control

Non-destructive tests of welded joints of pressure

equipment safety class 1 to 3 shall be carried out

qualified personnel, according to the respective

technical standards, ^ 7) approval by an authorized

person.

3.1.4. Heat treatment

3.1.4.1. In the case of danger that the manufacturing process

changes the properties of the material, to the extent

that could jeopardize the technical

the safety of the pressure equipment,

appropriate stage of manufacture performed a reasonable

thermal processing.

3.1.4.2. The heat treatment of parts of the pressure

the device shall be carried out by qualified

workers. Custom thermal processing

parts specially the proposed selected

class 1 safety devices shall be carried out

under the supervision of an authorized person.

3.1.5. Identifikovatelnost

It is necessary to establish and adhere to appropriate procedures

ensuring the identification of materials, parts

pressure equipment, inspections and tests, which

contribute to its resistance to pressure,

applied by appropriate means of acceptance

materials and parts through production to final

test the manufactured pressure equipment.

3.2. final assessment

3.2.1. For pressure equipment shall be made of the final assessment

involving the

3.2.1.1. the final examination in accordance with the requirements referred to

in part II of annex 3 and

3.2.1.2. a pressure test, which is considered normal

circumstances, the form of hydrostatic

the pressure at the pressure specified in accordance with the

the point of 2.2.3.3.5.3, and is carried out in accordance

with the requirements referred to in point 2.2 of part II

Annex No. 3.

3.2.2. Security Check

For reports, the final assessment includes checks

safety equipment in accordance with the requirements of point

2.3 part II of Appendix No. 3.

3.3. Labelling and tagging

3.3.1. Depending on the nature of the pressure equipment with pressure

the device indicate the label containing these

information

3.3.1.1. for all pressure equipment

3.3.1.1.1. the name and address or other method of

identification of the manufacturer,

3.3.1.1.2.however. year of manufacture,

3.3.1.1.3. identification of the pressure equipment,

According to its nature, such as type,

series or batch identification

and the serial number,

3.3.1.1.4. basic top or bottom

Working limits

3.3.1.1.5. the authorized person

conformity assessment bodies.

3.3.1.2. depending on the type of pressure equipment

other information necessary for the safe

the installation, operation or use and, for the maintenance and

regular check-ups.

3.3.2. marking and the required information is indicated by the

the pressure equipment or on a label fixed to it

connected to the following exceptions

3.3.2.1. If appropriate, you can use the appropriate

documentation, in order to avoid duplication

the labelling of the individual components

intended for the same report, for example,

piping parts

3.3.2.2. where the pressure equipment is too small, they can

the information referred to in section 3.3.1.2 indicated

on a label attached to the pressure

device.

3.4. Instructions for use

3.4.1. When pressure equipment is placed in service,

connects to it, where applicable,


instruction or other appropriate operational documentation

containing all the necessary information related with the

to technical safety

3.4.1.1. the installation of the pressure equipment or its

parts,

3.4.1.2. putting into service,

3.4.1.3. the use, including the designation of parts of pressure

the device,

3.4.1.4. maintenance, including examinations and tests

carried out in the course of the operation.

3.4.2. Manual contains information affixed to the pressure

referred to in section 3.3, or is accompanied by a

additional technical documentation, drawings and

schemas necessary for a full understanding of this

the walkthrough.



4. materials of the pressure equipment

For the manufacture, repair or reconstruction of the pressure equipment,

use only approved basic material included in the list

materials permitted for use in connection with processed

on the classification of pressure equipment in safety class. ^ 1)

The basic materials used must be suitable for this use after the

estimated useful lives all the time.

Filler metals for welding and surfacing shall comply with the

only the relevant requirements specified in paragraphs 4.1.1 to 4.1.7,

both independently and in a joined structure.

4.1. Materials for pressurized parts

4.1.1. materials that affect the technical security of the

pressure equipment must meet the requirements

the relevant technical requirements for the design of

pressure equipment, particularly the requirements for appropriate

properties under all anticipated operating

conditions, both separately and in the construction of the

conjunction with the appropriate additional material.

4.1.2. When choosing the material for the manufacture, repair or

reconstruction of the pressure equipment shall be its

the chemical composition, physical and mechanical

properties, weldability and roadworthiness

in the terms of use of the equipment during its

expected life-span.

4.1.3. To produce, repair or reconstruction of part of the pressure

the device must be a priority to use materials

identical to the original parts of the materials referred to in

the technical specification for the device, and at the same time

included in the list of materials permitted for

the use of the. If the used material referred to in

list, but a different brand than the original material

the part you need to demonstrate that its properties are

suitable for use with regard to the operational conditions and the

safety class to which the equipment is

classified.

4.1.4. in the event that the proposed material is not listed in the

list of materials acceptable for use and cannot be

use of a substitute material for

the corresponding operational conditions, the

the specific assessment of the proposed material.

4.1.5. For pressure equipment safety class 1 and 2

provides a specific evaluation of the proposed

material in accordance with clause 4.1.4 of the authorized person

responsible for assessing the conformity of the pressure equipment.

4.1.6. the manufacturer of the pressure equipment shall take appropriate measures,

to ensure that the material used is in accordance with the

specified requirements. In particular, it must be for the

all the basic and additional materials to

available documentation prepared by their manufacturer and

certifying conformity with technical specifications

material.

4.1.7. For the manufacture of pressure equipment shall apply only

material which has been carried out the assessment of conformity

with the technical specifications of the material documented by the

the equipment included

4.1.7.1. the safety class 1 and 2 material

a certificate issued by the manufacturer to do this together

the purpose of the notified body;

4.1.7.2. the security class 3 material

a certificate issued by the manufacturer.

4.2. Quality control materials

4.2.1. Quality control materials permitted for use

in accordance with point 4.1.2 is carried out to the extent

and methods set out in the relevant technical

legislation, technical standards or technical

conditions on the materials, if such exist.

4.2.2. Preparations for the manufacture of pressure equipment (plates,

forgings, extrusions, castings, rolled steel for

fittings) correspond to the requirements of the relevant

technical standards or technical conditions, which

determine the extent and method of testing for the purpose of verifying

their quality and other requirements (e.g., marking).

4.2.3. Preparations for the production of austenitic steel

pressure equipment, which are in contact with the medium

the primary circuit, the set limit values for

cobalt in the steel.



5. packaging files for transport, warehousing and storage of spent

nuclear fuel

5.1. For packaging files for the transport and storage of spent

fuel apply in addition to the General requirements of section

1 similar technical requirements for pressure equipment

set out in points 2.2 to 2.4, 2.10, 2.11, 3.1 to

3.4, 4, and 5.

5.2. packaging files for transport, warehousing and storage

spent nuclear fuel is produced in accordance with the

the technical documentation of the approved packaging

According to the relevant requirements of the specific prescription. ^ 8)



Č. 2



The proposed documentation requirements specifically selected devices

I. technical documentation



Technical documentation specifically proposed for the selected device are

transparently handles to allow conformity assessment specifically

proposed for the selected device to the extent necessary for such

the assessment. The technical dossier contains

1. General description of the proposed equipment, specially selected

2. conceptual design and manufacturing drawings, assembly drawings and subassemblies,

wiring diagrams; drawings containing

2.1. indication of the required quality and State of the metallurgical products,

or other parts, parts and auxiliary materials

the quality of the concrete with the fixing of technical delivery

the conditions of the materials used,

2.2. the dimensions, wall thicknesses and the information required for their

sizing,

2.3. the location, type, dimensions, values of factors of welded

connections and their classification,

2.4. test type, test media and their parameters,

the criteria of success of the tests

2.5. the descriptions and explanations necessary for the understanding of said

drawings, diagrams and features specially the proposed

the selected device taking into account the reasonably foreseeable

operating conditions (risk analysis);

drawings of pressure equipment includes:

2.6. the maximum permitted pressure, maximum temperature and

completely assembled pressure test equipment,

2.7. important technical data for the proposed security

Accessories;

3. the list of the technical standards and technical conditions or other

technical regulations, which are to be used,

4. the results of strength calculations and carried out the examination,

the results of calculations, seismic resistance, life and more

important technical specifications drawn up by the competent

of technical standards, technical conditions, or new

knowledge of science and technology,

5. documents certifying the conformity with the technical specifications of the material

for basic and supplementary materials used for the production of specially

the proposed selected device or its parts,

6. technical conditions for the production of specially selected for the proposed

the device, or to the level of other documentary evidence that built

in particular, they contain the appropriate technical specifications, in particular for

6.1. basic material and auxiliary materials or semi-finished products for

parts specially proposed for the selected device,

6.2. specific requirements for material processing technology

(the process of heat treatment, internal Crystal

structure, homogeneity, etc.),

6.3. the expected working conditions,

6.4. the data relevant for reliability, life

and safety during installation and operation,

6.5. precise identification of the manufacturer and the manufactured equipment,

6.6. the entry, transit and exit checks and tests,

including the determination of the allowable limits, the progressions

the tests, test media and their parameters as well as

the method and scope of the verification of the technical condition of a specially

proposed for the selected device in operation all the time

his life, including the criteria for success of the tests

6.7. the qualification of the production, construction and Assembly

workers, as well as the welding personnel

supervision, control and evaluation of welded joints,

4.2. the scope, the nature and implementation of accompanying technical documentation

specially proposed for the selected device;

7. the programmes and plans of the examinations and tests and technological procedures

production necessary for assessing the technical aspects of security,

including the technical, organisational and security measures to

their implementation,

8. regulations for installation, commissioning and operation,

9. the list of qualified persons, indicating the type and duration of

permissions and specifying their name, surname and date of birth


involved in the specific processes (welding, inspection

non-destructive methods and heat treatment),

10. patterns of records (i.e., in particular, the certificates and test reports)

used in the production.



II. The accompanying technical documentation



1. The accompanying technical documentation specifically proposed for the selected

the device contains

1.1. passport drawn up by the manufacturer with the following documents

1.1.1. Declaration of conformity with the corresponding particulars

According to section III (a)

1.1.2. evaluated the plans of checks and tests, including

material certificates, attestations and

the inspection reports,

1.2. Drawing documentation specifically proposed for the selected

device (drawing a report with the main connection dimensions,

Alternatively, the drawing for the estimated range of the corrections referred to in

the instructions, Alternatively, axonometric drawings showing the

deviations corresponding to the actual implementation of routes with

identifiable marking welds, hinges, supports, including

their evaluation in terms of safety),

1.3. in the case of the use of welding certificates of this

technology,

1.4. list of welders carrying out welding work, designating the

type and duration of their permissions, list of workers

welding supervision, together with their qualifications, list of

non-destructive testing personnel on

heat treatment of welded joints; to identify the

Welders and workers in lists, you can use the name,

last name and date of birth,

1.5. data on safety and pressure equipment devices

(valves, shut-off valve, insurance and equipment

for measuring, signalling, control and automatic protection,

If you are part of the supply of equipment),

1.6. list of documents issued by a notified body in

conformity assessment,

1.7. instructions for use and maintenance instructions or other

equivalent to the operational documentation for the operator

containing all the necessary information relating to the

technical safety during operation, all the time

the life of the device.

2. specially selected For the proposed device referred to in § 3 (1). 1

(a). d) accompanying technical documentation contains

2.1. the manufacturer for each passport drawn up the room with

the following documents

2.1.1. the Declaration of conformity with the corresponding particulars

pursuant to part III,

2.1.2. evaluated the plans of checks and tests, including

material certificates, attestations and

the inspection reports,

2.2. drawings showing the deviations corresponding to the actual

design with an identifiable marking welds,

penetrations, trapdoors and hermetic door

2.3. list of welders carrying out welding work, designating the

type and duration of their permissions, list of workers

welding supervision, together with their qualifications, list of

workers carrying out non-destructive tests; to

identification of welders and workers in lists can be used

name, surname and date of birth,

2.4. a list of documents issued by a notified body in

conformity assessment,

2.5. instructions for use and maintenance instructions or other

equivalent to the operational documentation for the holder

containing all the necessary information relating to the

technical safety during operation, all the time

the life of the device,

2.6. in the case of the use of welding certificates of this

technology.



III. the formalities for the Declaration of conformity



The Declaration of conformity shall contain in particular the following elements:

1. the identity of the manufacturer (for natural persons name, surname

and a permanent residence or place of business in the legal entity name

or trade name and the registered office),

2. Description of the specially selected device proposed, including data

listed in the technical specifications with which it is declared

match.

For pressure equipment making up the building part of the hermetic envelope

designed for internal overpressure, where appropriate, a description of the concerned

specially the proposed selected devices and parts thereof

securing the leak at the maximum design

the accident,

3. the procedure used for conformity assessment

4. the identification of the notified body which performs the

conformity assessment specifically proposed for the selected device,

5. references to the issued documents for conformity assessment,

6. references to the legislation, technical regulations,

technical standards or technical specifications

7. details of the person empowered to sign the Declaration for the manufacturer (name,

surname and position of the person).



Č. 3



Inspection requirements of the selected device

I. General inspection requirements



1. The basic requirements for the scope, type, way of carrying out the checks and

their acceptance criteria during and after their production,

set out in the technical documentation of the production of the selected device.

2. the scope, the nature and way of performing the checks of the selected device

chosen so as to demonstrate that the selected equipment meets the

technical safety requirements and is provozovatelné with

minimal risk of damage to human health and property or with

a complete exclusion of this risk.

3. results of checks his proving a worker inspecting

in written form. Written proof of the outcome of the checks (record,

message) contains the identification of the subject, scope, procedure

or methodology of control activities by the State at the time of

control and evaluation of the fulfilment of the technical requirements

safety.

4. The basic requirements for the scope, type, method of implementation and

the periodicity of checks of the selected device in the course of the operation

sets out the operating rules and other documentation for the safe

the operation of a nuclear installation licence holder a specified special

legislation. ^ 1) ^ 2) in the determination of these requirements is

in particular, shall take into account the properties of the selected device, laid down

conditions for safe operation, the requirements of technical regulations

for the operation of a nuclear facility set out in the project

the documentation and to the knowledge and experience of the holder with the

the current operation of the nuclear facility.

5. Checks for the device shall be carried out in accordance with the procedures

set out in the programmes or plans of checks processed for

the production area and the area of operation. For their implementation,

ensure appropriate technical, organisational and security

measures.

6. Control of the selected devices are planned and the time

the plans of these checks, approve the holder of the authorisation prior to their

your own implementation.

7. Checks for the device may perform only the workers with

applicable documents illustrating their qualifications, credentials,

by the manufacturer or the holder of the authorization. An inspection report on the

the examinations must be confirmed by signature and allocated

the brand name of their processors.



II. Inspection requirements after completion of a specially

the proposed selected devices



1. after completion of a specially selected for the proposed

the device or its parts are subject to when you use the procedures

conformity assessment, C1, (D), (F), (G) and (H) according to the annex No. 4 supervisors

authorized persons.

2. After completion of a specially selected devices are proposed

performs their final assessment comprising

2.1. the final test, which is based on Visual

inspections and controls accompanying technical documentation

assess compliance with the requirements of this Ordinance. While you can

consider the tests carried out during production. If

This is necessary for security reasons, it must be

the final test is performed from the inside and the outside of each part of the

the device, if necessary, especially if it is no longer possible

tour during the final exam in the course of manufacture;

When the final test checks whether it agrees with the

presented by the accompanying technical documentation,

2.1.1. the identification marks of the device (the information on the labels

and the data stamped on the pressure parts, tags

materials, taveb, semi-finished)

2.1.2. the main dimensions of the device, the location of nozzles, hatches,

equipment, patek, pedestals and assembling

individual parts according to drawings,

2.1.3. the results of the quality checks of welded connections (external and

the inner tour), including the results of the prescribed

checks in the course of the implementation of specific processes,

brand welders, welding results records

supervision, records of heat treatment, testimonials

the materials and the products,

2.1.4. the identification marks of the welders are listed at selected

Lists devices with their welders '

professional competence;

2.2. the pressure test, leakage test, where appropriate, by the

pressure equipment hydraulic pressure prescribed in

technical specification for this device. Where there is a

hydrostatic pressure, inappropriate or impractical,

other equivalent tests, shall be carried out and evaluate their

adequacy to a pressure test,

2.3. the final report assessment of pressure equipment

It also includes security checks to verify the

their full compliance with the requirements of section 2.11 of Appendix No. 1.

3. for devices according to § 3 (2). 1 (b). (d)) shall be carried out after their


construction and Assembly work the final test that includes

3.1. the completeness of the documents on the quality control of the selected device

and its affiliates,

3.2. the elaboration of a Protocol on the completion and completeness

construction and Assembly works,

3.3. individual leakage checks of individual elements

pressure equipment making up the building part of the hermetic

envelope designed for internal overpressure,

3.4. an integral part of the hermetic sealing of building control

the envelope pressure prescribed in the technical specification.

4. Before the start of the final test according to item 2 and 3 has authorized

a person in possession of all the necessary documents and information

including in particular

4.1. the procedures for the implementation of the final assessment (IE. final

the test or hydraulic pressure and leakage

pressure),

4.2. the accompanying technical documentation, specifically the proposed

the selected device, whose accuracy and completeness is committed

inspecting officer of the manufacturer.



III. requirements for checking selected device when the



1. To fulfill the obligations according to § 17 para. 1 (b). m) of the Act

the authorisation holder shall ensure that the processed by programs and plans

checks for selected devices operated by design

1.1. periodic operational controls,

1.2. repeated pressure or těsnostních test

carried out repairs or renovations

1.3. periodic checks the strength and tightness of the primary and

secondary circuit of a nuclear device,

1.4. periodic checks the strength and tightness of the hermetic

space pressure envelope.

2. The checks or revisions of selected devices and their

evaluation of the indication of the control messages that demonstrate

compliance with the relevant plans, programmes of checks and procedures.



Č. 4



The conformity assessment procedures

1. Type examination (CONFORMITY ASSESSMENT PROCEDURE (B))



1. Type-examination is the procedure by which a notified body has tested and

certifies that a pattern specifically proposed for the selected device,

that has to be manufactured, meets the provisions of this order, which

apply to it.

2. The manufacturer grants a notified body for type-examination

2.1. identification data of the manufacturer (at the physical person, the name and

last name and domicile or place of business, for legal

the person's name or trade name and the registered office),

2.2. technical documentation described in point 3 and

2.3. the sample specifically proposed for the selected device

representing intended production (hereinafter referred to as "type").

The notified body will require more samples of this type,

If it is necessary to perform the test program. The type of the

may include more specifically to the proposed modification

the selected equipment provided that the differences between the

each of the modifications do not affect the level of technical

safety.

3. the technical documentation enables conformity assessment specifically

proposed for the selected device with the technical requirements

laid down in annex 1 which apply to it. Technical

documentation shall include, to the extent necessary for such assessment,

design, manufacture and operation of specially selected for the proposed

equipment in accordance with the requirements of part I of Annex No. 2.

4. The notified body

4.1. examine the technical documentation with regard to the completeness of requirements

laid down in part I of Annex No. 2 and verify that the type has been

manufactured in conformity with the technical documentation,

4.2. examine the materials used, and if they are not listed in the

list of materials acceptable for use, the

performs a specific evaluation of the proposed material,

4.3. Approves the technological methods for welded joints specifically

the proposed selected device or checks that have been

has been previously approved in accordance with the technical regulations,

technical standards or technical specifications

the notified body;

4.4. verifies whether workers who perform welded joints and

non-destructive tests, or workers who process

welding design, check and verify they are qualified

accompanied by a valid papers issued for this purpose

by a notified body or recognised

organizations. To identify staff for validation purposes

or approval of their qualifications, you can use the name,

last name and date of birth,

4.5. perform or have performed the validation and the necessary checks to

determine whether, where the technical standards have been used, have been

These standards applied correctly and if the technical standards

have not been applied, the solutions adopted by the manufacturer meet within

technical specifications of the technical requirements laid down in

Annex No 1.

5. If the type conforms to the requirements of this Ordinance, shall issue to the authorized

person type examination voucher manufacturers. The document, which is

a recoverable file contains identifying information about the manufacturer (name and

the last name of a natural person, the place of residence and place of business at

legal entity business name and seat), the conclusions of the

of the examination, conditions for its validity and the necessary data for

identification of the inspected type. The notified body marks

the final documentation of your identification. To proof of

type-examination shall be accompanied by a list of the relevant parts of the technical

documentation, one copy of the list must keep the notified body.

6. The manufacturer shall inform the authorized person who has issued the document of

type-examination of all modifications to the approved specially

proposed for the selected device. If these changes can

affect the conformity of the proposed selected device with specially

technical requirements according to annex No 1, or the conditions for the

the use or operation of a specially selected device, proposed

the notified body shall issue, after a review of these changes, the

the original document type-examination.

7. the manufacturer must keep with the technical documentation referred to in point 3

copies of the documents of the type-examination and their additions for a period of time

the life of a specially selected device of the proposed

type.



2. the examination of the proposal (CONFORMITY ASSESSMENT PROCEDURE B1)



1. This procedure involves part of the conformity assessment, when authorized

person checks that were applied the methods and procedures of the draft

specifically proposed for the selected device according to the provisions of this

the Ordinance, which apply to it. In connection with this

the procedure cannot be used in the experimental design method.

2. The manufacturer grants a notified body for examination of the design

2.1. identification data of the manufacturer (at the physical person, the name and

last name and domicile or place of business, for legal

the person's name or trade name and the registered office),

2.2. technical documentation described in point 3.

The proposal may include several modifications specifically proposed

the selected device, provided that the individual differences

modifications do not affect the level of its technical safety.

3. the technical documentation enables conformity assessment specifically

proposed for the selected device with the technical requirements

laid down in annex 1 which apply to it. Technical

documentation shall include, to the extent necessary for such assessment,

design, manufacture and operation of specially selected for the proposed

equipment in accordance with the requirements of Annex No. 2.

4. The notified body

4.1. examine the technical documentation with regard to the completeness of requirements

laid down in part I of Annex No. 2,

4.2. examine the materials used, and if they are not listed in the

list of materials acceptable for use, the

performs a specific evaluation of the proposed material,

4.3. Approves the technological methods for welded joints specifically

the proposed selected device or checks that have been

has been previously approved in accordance with the technical regulations,

technical standards or technical specifications

4.4. verifies whether workers who perform welded joints and

non-destructive tests, or workers who process

welding design, check and verify they are qualified

accompanied by a valid papers issued for this purpose

by a notified body or recognised

organizations. To identify staff for validation purposes

or approval of their qualifications, you can use the name,

last name and date of birth,

4.5. perform or have performed the validation and the necessary checks to

determine whether, where the technical standards have been used, have been

These standards applied correctly and if the technical standards

have not been applied, the solutions adopted by the manufacturer meet within

technical specifications of the technical requirements laid down in

Annex No 1.

5. If the proposal conforms to the requirements of this Ordinance, the authorized person

shall issue to the manufacturer for examination of the design document. The document contains

manufacturer identification data (name and surname of the natural person

her place of residence and place of business of the legal entity, business

the company, its registered office), conclusions of the examination, conditions for its

the validity and the necessary data for identification of the approved design.

The authorized person marks the final documentation of its

identification. The document of tested design shall be accompanied by

a list of the relevant parts of the technical documentation, and a copy

must keep the notified body.

6. The manufacturer shall inform the authorized person who has issued the document of

examination of the design of all modifications to the approved specially

proposed for the selected device. If these changes can


affect the conformity of the proposed selected device with specially

technical requirements or the conditions for the application of this

the device, the notified body shall issue, after a review of these changes,

addition to the original document for examination of the design.

7. the manufacturer together with the technical documentation referred to in point 3 shall keep

copies of the documents for examination of the design, and their additions throughout the

for the life of the proposed selected device of this type.



3. Type conformity (CONFORMITY ASSESSMENT PROCEDURE C1)



1. conformity to type is the procedure by which the manufacturer ensures and issues

the Declaration, specifically proposed that the selected device is in

conformity with the type as described in the type-examination and the document complies with the

the provisions of this Ordinance which apply to it. The manufacturer of the

each specifically proposed the selected device marks and issues

the Declaration of conformity.

2. The manufacturer shall take all the necessary measures to ensure that production

How to ensure compliance of the manufactured specially for the proposed

Select equipment with the type as described in the document of the examination

the type and the requirements of this Decree which apply to them.

3. The manufacturer shall keep a copy of the Declaration of conformity for a period of time

the life of a specially selected device of the proposed

type.

4. the manufacturer carries out the final assessment and its implementation is under

the supervision of an authorized person.

5. A notified body under the supervision carried out by the

5.1. ensure that the manufacturer actually performs final

assessment in accordance with part II of annex 3,

5.2. take samples of selected devices from the specially-proposed

the manufacturing or storage premises for inspection.

6. The notified body shall assess the number of specially the proposed

the selected device in the sample to determine whether it is necessary to make

or have carried out the final assessment of all or some of the

specially selected devices in the proposed sample

6.1. in cases where one or more specially the proposed

the selected device does not conform, the notified body shall take

the appropriate measures; and

6.2. shall ensure that its identification of the manufacturer, has tagged each

specifically proposed the selected device.

7. The notified body on the basis of the results of the evaluation of the conformity to type

publishes the document on the eligibility of the manufacturer to carry out the final

assessment.



4. PRODUCTION QUALITY ASSURANCE (CONFORMITY ASSESSMENT PROCEDURE (D))



1. Conformity assessment by this procedure the manufacturer complying with the

the provisions of point 2 ensures and declares that the specially

the proposed selected device is in conformity with the type as described in the

document type-examination or design-examination in the document

and complies with the provisions of this order, that it

apply. The manufacturer of each specially selected device proposed

marks and draw up a written declaration of conformity. Indicate the following

the identification of the notified body responsible for surveillance as specified in point

4.

2. the manufacturer applies the approved quality system, taking into account

requirements laid down by special legislation "^ 1") for the manufacture,

for the final examination referred to in point 3. The manufacturer is subject to the supervision

According to paragraph 4.

3. Quality System

3.1. the manufacturer provides for assessment of his quality system with a

authorized person

3.1.1. all necessary information about the appropriate specially

the proposed device you selected,

3.1.2. the quality system documentation,

3.1.3. the technical documentation of the approved type and a copy of the

document type-examination or evidence of

examination of the design.

3.2. The quality system guarantees the compliance of specially the proposed

Select equipment with the type as described in the document of

type-examination or design-examination in the document, and with

the requirements of this Ordinance that apply to it.

All the elements, requirements and provisions adopted by the manufacturer shall be

systematically and properly documented in the form of written

procedures and instructions. This quality system documentation must

allow uniform interpretation of the quality programmes, plans,

quality manuals and quality records. The structure of the

documentation of the quality system is described in the quality manual

and quality plans.

The quality system documentation shall describe

3.2.1. the quality objectives and the organizational structure, responsibilities

and powers of the management with regard to the quality of a specially

proposed for the selected device,

3.2.2. the manufacture and the procedures for the quality control and assurance

quality processes and other systematic actions

that will be used, particularly the procedures

securing the fulfillment of basic requirements to

ensure technical safety,

3.2.3. the checks to be carried out before the start of

production, during and after its completion, with

indication of the frequency of their implementation and criteria

acceptability,

3.2.4. quality records, such as. control

messages that contain the results of the test data

calibration, qualifications of staff

for the field of activities related to the production,

in particular workers who are pursuing specific

processes (welding, non-destructive control and

heat treatment), indicating their name,

last name and date of birth,

3.2.5. the means of monitoring the achievement of the

of the required quality, specially the proposed selected

equipment and efficient operation of the quality system.

3.3. The notified body shall assess the quality system to determine whether it

satisfies the requirements referred to in 3.2. Assessment system

the notified body carries out the quality in the service of the manufacturer.

The assessment will attend at least one worker is authorized

a person who has experience of assessments of the technology

the specially proposed for the selected device.

The authorized person is required to notify the producers of the conclusions of the

assessment of the quality system, including requirements for the removal of

any disagreements. Based on the positive outcome of the assessment of the

the notified body shall issue the document of approval system manufacturers

quality related to a specially

proposed to the selected device, or to a part thereof.

3.4. the manufacturer shall carry out the requirements of the quality system,

as approved by an authorized person, and takes care to

no longer was factually correct and effective. The manufacturer shall

a notified body, which approved the quality system,

information about the intended adjustment to the quality system.

The notified body shall evaluate the proposed changes and decide whether the

modified quality system will meet the requirements of point

3.2, or whether to carry out a new assessment system

the quality. The notified body shall communicate its decision to the manufacturer.

The notification shall contain the conclusions of the assessment, including the preamble.

4. supervision of the notified body

4.1. monitoring is to ensure that the manufacturer duly fulfils the requirements

arising out of the approved quality system.

4.2. the manufacturer shall allow the notified body entrance for the supervision

to the production, control, testing space and storage

and provide it with all necessary information, in particular

4.2.1. documentation of the quality system and

4.2.2. quality records containing the results of the tests

calibration data, reports on the qualifications of

workers, indicating their name, last name and date

of birth, etc.

4.3. The notified body carries out periodic monitoring, to

ensure that the manufacturer maintains and applies a system of

quality, and shall provide reports on the results of supervision.

The frequency of the periodic tests such that the new, full

screening has been done every third year.

4.4. The notified body shall be authorised to carry out unannounced

check with the manufacturer. The need for such additional checks

and their frequency shall be determined on the basis of the system of checks

used by an authorized person. To carry out unannounced

the checks shall take into account, in particular, the following factors

4.4.1. safety class specially the proposed selected

the device,

4.4.2. the results of previous checks on the exercise of supervision,

4.4.3. the need to monitor the implementation of corrective measures,

4.4.4. any special conditions linked to the approval

of the quality system,

4.4.5. significant changes in the organisation of production, concept or

production technology.

During these inspections, the notified body may carry out, or

have carried out tests to verify that the quality system

is working correctly. The notified body must provide a message

on the results of supervision.

5. the manufacturer shall keep at the disposal of the notified body and the

the holder of an authorisation for a period of 10 years after the manufacture of the last

specially the proposed selected device of that type

the quality system documentation, including its revisions. Proof of

assessment of the quality system of the manufacturer and the inspection of

results of final tests, specifically the proposed selected

the device or its parts, and the results of surveillance carried out by the manufacturer

maintains and archives throughout the life of a specially

the proposed device of the type you selected.



5. verification of the SELECTED DEVICE (ESPECIALLY the PROPOSED PROCEDURE

CONFORMITY ASSESSMENT (F))



1. during the conformity assessment procedure of the manufacturer, this meeting

the provisions of point 2, ensures and declares that the specially


the proposed selected equipment meets the provisions of this order,

which apply to it, and corresponds to the type described

1.1. in the type-examination, or

1.2. in the examination of the design.

2. the manufacturer is taking all the necessary measures in the manufacture

ensures compliance of the specially selected device with the proposed

the requirements of this Ordinance that apply to it, and with the type of

as described

2.1. in the type-examination or

2.2. in the examination of the design.

3. the manufacturer, each specially selected device marks and proposed

issue a written declaration of conformity.

4. The notified body shall verify in accordance with point 5 of each examination

specially the proposed match specially selected device

proposed for the selected device with the requirements of this Ordinance.

The manufacturer shall keep a copy of the Declaration of conformity for a period of time

the life of a specially selected device of the proposed

type.

5. Verification by examination and testing of every specially the proposed

the selected device

5.1. Each specifically proposed the selected device individually

checks and carry out the appropriate examinations and tests

referred to in the technical documentation or the equivalent

verification and inspection, in order to verify the conformity of a specially

proposed for the selected device with the type and the requirements of this

the Ordinance, which apply to it.

5.2. The notified body

5.2.1. checks whether the workers who are pursuing the weld

joints and non-destructive tests, or personnel,

welding process design, control and

validate, qualified and approved for this purpose,

by a notified body or recognised

organizations. To identify the workers for the purposes of

validation of their skills or their approval

You can use the name, surname and date of birth,

5.2.2. verifies the material certificates issued in accordance with

point 4.1.7 of Appendix No. 1,

5.2.3. ensure the completion of the final exam or pressure

tests according to paragraph 2 of part II of annex 3. In the case of

pressure equipment shall ensure that an examination of his

safety equipment.

5.3. The notified body affix or have your

identification of specially selected for each proposed

the device and issue a document of compliance relating to the performed

checks. This document shall be kept by all the time

life specially proposed for the selected device.



6. Unit verification (CONFORMITY ASSESSMENT PROCEDURE (G))



1. Conformity assessment by this procedure the manufacturer ensures and

declares that specifically proposed the selected device, for which

the document has been issued in accordance with section 4.2, complies with the provisions of this

the Ordinance, which apply to it. Manufacturer of all specially

the proposed selected device marks and draw up a written to them

the Declaration of conformity.

2. The manufacturer grants a person authorized

2.1. identification data of the manufacturer (at the physical person, the name and

last name and domicile or place of business, for legal

the person's name or trade name and the registered office),

2.2. technical documentation described in point 3.

3. the technical documentation enables conformity assessment specifically

proposed for the selected device with the technical requirements

laid down in annex 1 which apply to them. Technical

documentation shall include, to the extent necessary for such assessment,

design, manufacture and operation of specially selected for the proposed

equipment in accordance with the requirements of Annex No. 2.

4. The notified body shall examine the design and construction of each specially

the proposed selected equipment and during manufacture perform

the appropriate checks and tests referred to in the technical standards and

technical conditions, or an equivalent examination and

tests in order to ensure the conformity of specially the proposed

the selected device with the technical requirements laid down in

Annex 1 which apply to it.

4.1. The notified body, in particular,

4.1.1. examine the technical documentation with regard to the completeness of the

the requirements set out in part I of Annex No. 2,

4.1.2. will examine the materials used, if they are not listed in the

list of materials acceptable to the competent

the use of specific assessment, carry out the proposed

material,

4.1.3. shall approve the technological methods for welded joints

specially proposed for the selected device or

checks to see whether they have been previously approved in accordance

with technical regulations, technical standards, or

the appropriate technical conditions authorized

person,

4.1.4. verifies whether workers who are pursuing the weld

joints and non-destructive tests, or personnel,

welding process design, control and

they have the qualifications, accompanied by the applicable

papers issued by the authorized person for that purpose,

or by a recognized third-party organization. To

the identification of workers for the purposes of verification or

approval of their qualifications, you can use the name,

last name and date of birth,

4.1.5. the completion of the final exam or pressure

the test according to annex No 3. In the case of the pressure

the device shall ensure its safety-examination

equipment.

4.2. If the design and performance of a specially the proposed

the selected device to the requirements of this order, the authorized

person affix or have to specifically proposed

the selected device, its identification and proof of

conformity relating to the tests carried out. This document is

together with the technical documentation referred to in point 3 must keep after

for the life of a specially selected for the proposed

device.



7. COMPREHENSIVE quality assurance (CONFORMITY ASSESSMENT PROCEDURE (H))



1. during the conformity assessment procedure of the manufacturer, this meeting

the provisions of point 2, ensures and declares that the specially

the proposed selected equipment meets the provisions of this order,

which apply to it. The manufacturer of every specially marked

the proposed selected device and shall issue to him a written declaration of

conformity. The designations make up the identification of authorized person

responsible for the surveillance as specified in point 4.

2. the manufacturer applies the approved quality system, taking into account

requirements laid down by special legislation "^ 1") for the design,

for production, for the final examination referred to in point 3. The manufacturer is subject to the

surveillance as specified in point 4.

3. Quality System

3.1. the manufacturer shall provide the notified body for assessment of the

the quality of the

3.1.1. all information on the specially

the proposed device you selected,

3.1.2. the documentation concerning the quality system.

3.2. The quality system guarantees compliance specifically proposed

the selected device with the requirements of this Decree, which shall be at

it. All the basic principles, requirements and

the measures adopted by the manufacturer are systematically and properly

documented in the form of written procedures and instructions. This

documentation of the quality system allows a consistent interpretation

the quality programmes, plans, manuals and quality

quality records. The quality system documentation includes

in particular, a description of the

3.2.1. the quality objectives and the organizational structure, responsibilities

and powers of the management with regard to the quality of a specially

proposed for the selected device,

3.2.2. the technical design specifications, including the list of

used technical standards which are used

whole or in part, and descriptions of the solutions adopted in the framework of the

technical conditions to meet the essential

requirements, if technical standards are not applied,

3.2.3. management methods of work on the design and design verification,

processes and systematic actions that will be

used in the design of the specially selected for the proposed

equipment, in particular in relation to the materials used,

3.2.4. production technology, quality control and

quality assurance, systematic measures,

in particular, the procedures used for welded joints,

3.2.5. the examinations and tests that will be carried out before the

the production, during and after its completion, with

indication of the frequency with which they will be carried out,

3.2.6. quality records that contain the results of the tests

details of the calibration procedure, qualifications or

the approval of the workers, especially those who are

special processes (welding, non-destructive

control and heat treatment) with an indication of their

name, surname and date of birth,

3.2.7. the means to monitor the achievement of the

the desired quality of design, specially of the proposed

the selected device, as well as the effective functioning of the

the quality system.

3.3. The notified body shall assess and examine the introduction of a

the quality system to determine whether it satisfies the requirements referred to in

3.2. The assessment will attend at least one worker

an authorized person who has experience in assessing

technology, specifically the proposed selected

device. The notified body shall notify the manufacturer, the conclusions

assessment of the quality system, including requirements for the removal of

any disagreements. Based on the positive outcome of the assessment of the

issued by the notified body the manufacturer proof of approval


of the quality system relating to a specific specially

proposed to the selected device, or to a part thereof.

3.4. the manufacturer shall fulfil the requirements laid down in the quality system,

How was approved by a notified body, and takes care to

still, he was factually correct and effective. The manufacturer shall

a notified body, which approved the quality system,

information about the intended adjustment to the quality system.

3.5. The notified body shall evaluate the proposed changes and decide whether the

modified quality system will meet the requirements of point

3.2, or whether to carry out a new assessment system

the quality. The notified body shall communicate its decision to the manufacturer.

The notification shall contain the conclusions of the assessment, including the preamble.

4. supervision of the notified body

4.1. monitoring is to ensure that the manufacturer duly fulfils the obligations

arising out of the approved quality system.

4.2. the manufacturer shall allow the notified body entrance for the supervision

to the production, control, testing space and storage

and provide it with all necessary information, in particular

4.2.1. the quality system documentation,

4.2.2. quality records specified in the quality system for

the area of development, such as results of analyses, calculations,

the tests and the like,

4.2.3. quality records containing the results of the tests

data, calibration data, qualification reports of the inspection

workers, indicating their name, surname and

the date of birth, etc.

4.3. The notified body carries out periodic monitoring, to

make sure that the manufacturer maintains and applies the quality system and

must provide reports on the results of supervision. The frequency of the

supervision is chosen so as to complete the new background check

held every third year.

4.4. The notified body shall be entitled to perform with the manufacturer

the unannounced check. The need for these further checks and

their frequency shall be determined on the basis of the system of checks

used by an authorized person. Under this system,

shall take into account, in particular,

4.4.1. safety class specially the proposed selected

the device,

4.4.2. the results of previous checks on the exercise of supervision,

4.4.3. the need to monitor the implementation of corrective measures,

4.4.4. any special conditions linked to the approval

of the quality system,

4.4.5. significant changes in the organisation of production, concept or

production technology.

4.5. During these inspections, the notified body may carry out, or

have carried out tests to verify that the quality system

is working correctly. The notified body must provide a message

on the results of supervision.

5. the manufacturer shall keep for a period of 10 years after the date of manufacture

the last selected device of specially the proposed

the type of documentation referred to in section 3.1.2 and update in accordance with section

4.5. the document on the assessment of manufacturer's quality system and control

reports on the results of surveillance carried out by the manufacturer maintains and

archives for the lifetime of a specially the proposed

the selected device of this type.



1) Decree No. 214/1997 Coll. on quality assurance activities

associated with the use of nuclear energy and the activities leading to the

exposure and about the establishment of criteria for the classification and distribution of selected

the device in the security classes.



2) Act 18/1997 Coll., on the peaceful use of nuclear energy and

ionizing radiation (the Atomic Act), and amending and supplementing certain

laws, as amended.



3) Decree No. 195/1999 Coll., about the requirements for nuclear facilities to

to ensure nuclear safety, radiation protection and emergency

preparedness.



Decree 106/1998 Coll., on ensuring nuclear safety and radiation

protection of nuclear facilities during commissioning and when their

operation.



4) Decree No. 195/1999 Coll.



5) to EN 719.



6) for example, ČSN EN 287, EN 288.



7) for example, ČSN EN 473, ČSN EN 45013.



8) Decree No. 317/2002 Coll. on the type approval of containers

for the transport, warehousing and storage of nuclear materials and

radioactive material, type approval of ionizing radiation sources

and on the transport of nuclear materials and radioactive substances (designated on the

type-approval and transport).