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).
