1 1. ------IND- 2016 0299 CZ - EN- ------ 20160719 --- --- PROJET 
 
DRAFT  
 
DECREE  
of ... 2016,  
 
on requirements for assurance of quality and technical safety and assessment and 
verification of conformity of selected equipment  
Pursuant to  § 236 of Act No .../.. ., the Atomic Act (hereinafter the 'Act'), the State Office for 
Nuclear Safety lays down the following to implement  § 24(7), §  56(2)(a) and (b), §  57(3)(a) 
to (c), §  137(6), §  58(7)(a) to (c), and §  59(4)(a) and (b) of the Act:  
§ 1 
Subj ect matter  
This Decree regulates:  
a) the content of the selected equipment list ; 
b) the quality assurance scope and method for the design, manufacturing, assembly, 
procurement, commissioning, and operation of selected equipment;  
c) the types of quality assurance re cords for selected equipment, and how they are kept;  
d) technical requirements for selected equipment and parts of selected equipment;  
e) requirements for ensuring compliance of selected equipment and parts of selected 
equipment with technical requirements;  
f) requirements for documentation on ensuring compliance of selected equipment and 
parts of selected equipment with technical requirements;  
g) the scope of and procedures for assessing conformity of selected equipment with 
technical requirements;  
h) requirements for d ocumenting the assessment of conformity of selected equipment 
with technical requirements;  
i) specific procedures that may be applied to assess the conformity of selected equipment 
with technical requirements;  
j) the scope of and method for verifying conformity of selected equipment in use with 
technical requirements; and  
k) the method for documenting verification of conformity of selected equipment in use 
with technical requirements and the content of this documentation.  
§ 2 
Definitions  
The following definitions apply  for the purposes of this Decree : 
l) pressure equipment is defined as selected equipment under stress from  pressure 
exerted by a process medium with maximum operating pressure in excess of 0.05 
MPa, including elements connected to parts  exposed to pressure, safety and pressure 
equipment and other equipment that ensures its functionality;  
m) a pressure equipment system is a set of several parts, at least one of which is pressure 
equipment that  2 1. are connected and constructed to be mutually com patible;  
2. only perform their stipulated safety function if all of the parts in the set are 
present;  
3. are installed by one contractor; and  
4. serve for joint use as a whole.  
§ 3 
Content of the selected equipment list  
(1) The text portion of the selected equipment list  must clearly specify individual pieces 
of selected equipment and state the safety class in which they are classified.  
(2) The drawing portion of the selected equipment list  must:  
a) schematically depict process systems and structural parts of the nuclear installation 
that contain selected equipment;  
b) mark the safety classes of individual pieces of selected equipment different ways, and 
highlight the boundary between selected equipment and other equipment or other parts 
of the nuclear installa tion building; and  
c) provide identification of selected equipment and other information from which its 
function and location within the scope of the nuclear installation is unmistakably clear.  
(3) The selected equipment list  must contain rules for  
a) specifying the  borders between systems, equipment, or parts of the nuclear installation 
building ensuring safety and other systems, equipment or parts of the nuclear 
installation building; and  
b) specifying the borders between individual safety classes of selected equipmen t. 
(4) The selected equipment list  must indicate selected equipment for which pursuant to 
§ 12(2) its conformity  with technical requirements (hereinafter ' conformity  assessment') is 
performed by an authorised or accredited person.  
§ 4 
Scope  and manner of quality assurance during the design process for selected equipment  
(1) During the design of selected equipment, which includes its development, 
engineering, and planning (hereinafter the 'design process'), final documentation for the 
design proc ess must be created (hereinafter the 'selected equipment design').  
(2) The design process and the selected equipment design must comply with technical 
requirements for the selected equipment and part of the selected equipment specified in §  9. 
(3) The design proce ss must be verified by  
a) the persons who implemented the design process; and  
b) independent persons.  
(4) The selected equipment design must stipulate the following:  
a) acceptability criteria for monitoring and assessing reliability;  
b) acceptability criteria for monitor ing and assessing service life;  
c) use and operating conditions;  
d) acceptability criteria related to performance of safety functions;  
e) acceptability criteria for quality assurance; and  3 f) technical regulations, technical standards, or technical specifications that are to be 
used.  
§ 5 
Scope and manner of quality assurance during the manufacture and installation process 
for selected equipment  
(1) Prior to commencing the manufacture and installation process for selected 
equipment, all documentation need ed to implement this process must be available.  
(2) During the manufacture and installation of selected equipment,  
a) the selected equipment design must be followed;  
b) technical specifications for the selected equipment and any changes thereto must be 
available;  
c) checks, tests, and inspections (hereinafter 'checks') must be performed to verify the 
compliance of the selected equipment with technical requirements;  
d) the manufacturing and installation method and process for the specified equipment 
must be documented, inc luding checks thereof, in accordance with requirements 
stipulated in the selected equipment design;  
e) the manner and extent to which the selected equipment will be reviewed, verified, and 
validated;  
f) the selected equipment must be identified in a unique manne r and this identification 
must be maintained;  
g) information on the current or past condition of the selected equipment, its location and 
use, or the manner in which it is being or has been treated must be available; and  
h) any part of the selected equipment tha t is delivered separately must be in a condition 
that permits verification of the manufacturing and installation process for this part.  
(3) Once the manufacture and installation of selected equipment has been completed,  
a) the selected equipment must be checked t o verify its conformity with technical 
requirements; and  
b) a final assessment must be performed to verify the conformity of the selected 
equipment with requirements in the selected equipment design and in its 
manufacturing and installation documentation; a f inal assessment of pressure 
equipment in accordance with the first sentence must take place after the pressure 
equipment system has been installed as a whole.  
(4) Requirements for checks pursuant to (3), including final assessment requirements, 
are specified i n Annex 6 to this Regulation.  
§ 6 
Scope and manner of quality assurance during the selected equipment procurement 
process  
(1) The selected equipment design must stipulate the following:  
a) the procurement documentation must specify the require ments for the selected 
equipment; and  
b) the selection method and evaluation criteria for the vendor of the product or service 
(hereinafter the 'vendor') must be specified.  
(2) During selected equipment procurement,  4 a) the vendor must be evaluated and selected in ac cordance with the stipulated method 
and evaluation criteria;  
b) the vendor's quality assurance documentation for the selected equipment must be 
reviewed to determine whether it is correct and complete;  
c) requirements for the method and extent to  which the vendo r will be notified of 
discrepancies and how they will be addressed must be specified; and  
d) the vendor must be supervised.  
§ 7 
Scope and manner of quality assurance during the commissioning and operation of 
selected equipment  
During the c ommissioning and operation of selected equipment,  
a) identification of the selected equipment and the use of spare parts of the selected 
equipment must be documented;  
b) information on the current and past condition of the selected equipment, its location 
and us e, or the manner in which it is being and has been treated must be available;  
c) plans and programmes for commission and operation of the selected equipment must 
be drawn up, implemented, and maintained;  
d) identification of the selected equipment assigned durin g manufacturing and 
installation must be maintained;  
e) activities must be performed in accordance with commissioning programmes for the 
selected equipment;  
f) activities must be planned and performed in accordance with internal rules and other 
operating documen tation, including plans and programmes for operating checks of 
selected equipment, the pre -operational and operational managed ageing programme, 
and plans and programmes for checks during maintenance, repairs, or changes to 
selected equipment, and with tec hnical requirements specified by this Decree;  
g) repairs, maintenance, or changes to selected equipment must be performed in 
accordance with requirements specified in repair, maintenance, or change 
documentation for the selected equipment; and  
h) it must be ensu red that selected equipment is handled and stored in a manner that 
prevents damage, incorrect use, or destruction of the selected equipment or part 
thereof.  
§ 8 
Types of quality assurance records for selected equipment, and how they are  kept  
(1) Quality assurance for selected equipment must be documented by the following  in 
particular : 
a) special process records;  
b) discrepancy assessment and evaluation records, in the case of selected equipment 
classified in safety class 1 to 3;  
c) records documenti ng fulfilment of quality requirements for the selected equipment, 
including qualification requirements for personnel performing checks and verification 
of the selected equipment design, the quality of its parts and materials used in its 
manufacture, in the  case of pressure equipment classified in safety class 1 or 2; and  
d) records documenting the elimination of found faults in selected equipment and the 
manner in which they were repaired, and records regarding faults that have not been 5 eliminated and the meth od for their managed monitoring and evaluation, in the case of 
pressure equipment classified in safety class 1 or 2.  
(2) Quality assurance records for selected equipment are permanent or temporary.  
(3) The following are permanent quality assurance records for sele cted equipment:  
a) the selected equipment design;  
b) a record that a selected equipment vendor's quality assurance documentation has been 
reviewed for correctness and completeness;  
c) a record of the current technical condition of selected equipment upon completion  of 
its manufacture;  
d) a record of the current technical condition of selected equipment after its installation 
and checks;  
e) a record that selected equipment is operated, maintained, or subjected to checks in 
accordance with technical requirements, technical  specifications, an operating check 
programme , a managed ageing operating programme, a maintenance programme, 
maintenance procedures, or legislative requirements;  
f) a record that documents that a person who plans, manages, or evaluates processes 
applicable t o the design, manufacture, installation, procurement, commissioning, or 
operation of selected equipment or part thereof meets qualification requirements;  
g) a record that documents planning and performance of maintenance, repairs, or changes 
to the selected e quipment, including quality certificates of spare parts used;  
h) a record that documents that he quality of originally in -built selected equipment, 
repaired or replaced selected equipment, or selected equipment that has been changed, 
complies with technical r equirements and technical specifications of the selected 
equipment; and  
i) a record that documents that a discrepancy has been corrected and preventive 
measures have been implemented to prevent these discrepancies.  
(4) A temporary quality assurance record for sel ected equipment is any quality assurance 
record for selected equipment that is not a permanent quality assurance records for selected 
equipment.  
(5) A permanent quality assurance records for selected equipment must be archived from 
the time of selected equipme nt design for its entire service life.  
(6) Quality assurance records for selected equipment must be kept to an extent and in a 
manner to ensure that it is possible to assess whether the condition of the selected equipment 
or parts thereof comply with relevant technical requirements  at any time . 
(7) Records from the manufacture, installation, and procurement of selected equipment 
must be created prior to the commencement of the selected equipment's commissioning phase.  
(8) Records from selected equipment's commissioning  phase must be created prior to the 
selected equipment being placed into operation.  
(9) Operating records must also contain how repairs, maintenance, or changes to selected 
equipment were performed.  6 § 9 
Technical requirements for selected e quipment and parts of selected equipment  
The technical requirements for selected equipment and parts of selected equipment that 
are applied during its design, manufacture, installation, commissioning, and operation are 
stipulated by Annex 1 to this Decree.  
§ 10 
Requirements for ensuring compliance of selected equipment and parts of selected 
equipment with technical requirements  
(1) Ensuring compliance of selected equipment and parts of selected equipment with 
technical requirements (hereinaf ter "compliance assurance") must be performed and 
documented in a manner that ensures that documentation and proof required to ensure 
technical safety are secured.  
(2) Anyone who designs, manufactures, installs, commissions, or repairs selected 
equipment or pa rts of selected equipment or maintains it, and a permit holder pursuant to 
§ 9f(1)(b) to (h) of the Act must provide the vendor information regarding the selected 
equipment or parts thereof, including requirements as to type, amount, terms and dates of 
delivery, the quality of the selected equipment or parts thereof according to its safety 
classification.  
(3) During compliance assurance, a permit holder must ensure the following within the 
scope of the contractual relationship with a vendor:  
a) there is a vendor s ystem with the required sources and external and internal 
communication, including a system of mutual independent checks;  
b) that quality assurance and managed ageing programme records are be kept for selected 
equipment, and are available for review;  
c) control mechanisms and mutual communication methods in the supply chain for the 
given selected equipment or part thereof;  
d) implementation of a system of checks and tests of the selected equipment or part 
thereof corresponding to the life cycle phase of the selected  equipment that is used to 
verify compliance with prescribed procedures and inspection records;  
e) checks of progress of activities on selected equipment corresponding to the life cycle 
of the selected equipment or parts thereof within the scope of a system o f independent 
checks by the permit holder and a system of independent checks by the vendor;  
f) performance of a final assessment of the selected equipment with technical 
requirements stipulated in manufacturing, installation, or repair procedures for the 
selected equipment;  
g) documentation of the final assessment of selected equipment pursuant to f);  
h) verification of fulfilment of technical requirements stipulated in procedures for 
maintenance of selected equipment by a vendor who maintains selected equipment;  
i) documentation of fulfilment of technical requirements pursuant to f);  
j) availability of documentation applicable to selected equipment or part thereof 
corresponding to its as -built condition to a predetermined extent.  
(4) Verification of the quality of materials u sed and the correctness and completeness of 
technical documentation, repair and maintenance documentation, and attendant technical 
documentation for selected equipment, including verification of final assessment procedures, 7 must be performed for selected e quipment stipulated in §  12(2) or part thereof by individuals 
who 
a) have achieved a university or higher technical education with successful completion of 
an accredited educational programme in the are a of mechanical engineering, electrical 
engineering, civi l engineering or a related field that has provided them with theoretical 
technical skills necessary for performance of these activities, or a high school 
education with a leaving exam in the field of mechanical engineering, electrical 
engineering, civil en gineering or a related field that has provided them with theoretical 
technical skills necessary  to perform these tasks ; and  
b) have at least five years' experience in the relevant field, in the case of individuals with 
a high school education with a leaving e xam, at least three years' experience in the 
relevant field, in the case of individuals with a higher technical education, or at least 
two years' experience in the relevant field in the case of individuals with a university 
education.  
(5) Requirements for comp liance assurance  
a) during the manufacture and installation of selected equipment and parts of selected 
equipment;  
b) during the commissioning of selected equipment and parts of selected equipment; and  
c) during operation of selected equipment and parts of selected  equipment are specified 
in Annex 2 to this Decree.  
§ 11 
Requirements for documentation on ensuring compliance of selected equipment and 
parts of selected equipment with technical requirements  
(1) The manner in which selected equipment and parts of selected equipment are 
designed, manufactured, and installed must be documented in a way that permits conformity 
assessment.  
(2) Conformity assessment must be documented in conformity assessment 
documentation pursuant to requirements stipulated  
a) in Ann ex 3 to this Decree, in the case of technical documentation for selected 
equipment; and  
b) in Annex 4 to this Decree, in the case of accompanying technical documentation for 
selected equipment.  
(3) Conformity assessment documentation must be archived for the enti re service life of 
the selected equipment.  
§ 12 
Scope of and procedures for assessing conformity of selected equipment with technical 
requirements  
(1) Conformity assessment must take place prior to the use of selected equipment in a 
nuclear  installation.  
(2) An authorised person performs conformity assessment for  
a) selected equipment in safety class 1, which is on the nuclear reactor coolant pressure 
circuit boundary, specifically  8 1. pressure vessels, tanks, and chillers, including the nuclear reacto r pressure vessel 
and steam generators, working with radioactive substances with a greatest 
operating pressure in excess of 0.05 MPa and volume in excess of 10 l; and  
2. pumps, piping, and armatures, working with radioactive substances with a 
greatest operati ng pressure in excess of 0.05 MPa and nominal diameter greater 
than DN 70;  
b) selected equipment in safety class 2, specifically  
1. pressure vessels, tanks, and chillers providing nuclear reactor cooling, volume 
compensation, hermetic area cooling, emergency fil ling, primary circuit after -
cooling, and cleaning of the pressure circuit process media, working with 
radioactive substances with a greatest operating pressure in excess of 0.05 MPa 
and volume in excess of 10 l;  
2. pumps, piping, and armatures providing nucle ar reactor cooling, volume 
compensation, hermetic area cooling, emergency filling, primary circuit after -
cooling, and cleaning of the pressure circuit process media, working with 
radioactive substances with a greatest operating pressure in excess of 0.05 M Pa 
and nominal diameter greater than DN 70;  
3. pressure equipment making up a protective envelope system, including 
equipment ensuring that the protective envelope is hermetically sealed during a 
basic design accident;  
4. secondary circuit pressure equipment whe re the greatest operating pressure of 
the process media at an operating pressure greater than 100  °C exceeds 4 MPa, 
and with a nominal diameter greater than DN 200;  
5. packaging for carriage, storage, and disposal of spent nuclear fuel; and  
6. reinforced concret e structures of the nuclear reactor building, including the 
profile of the nuclear reactor building's installation cover, and steel liners 
defining the hermetic area; and  
c) selected equipment in safety class 3, specifically  
1. pressure vessels, tanks, and chill ers ensuring normal filling, boron regulation, 
and cooling of spent nuclear fuel facilities working with radioactive substances 
with a greatest operating pressure in excess of 0.05 MPa and volume in excess of 
10 l; 
2. pumps, piping, and armatures ensuring nor mal filling, boron regulation, and 
cooling of spent nuclear fuel facilities working with radioactive substances with 
a greatest operating pressure in excess of 0.05 MPa and nominal diameter 
greater than DN 70; and  
3. secondary circuit pressure equipment where  the greatest operating pressure of 
the process media at an operating pressure greater than 100  °C exceeds 4 MPa, 
and with a nominal diameter greater than DN 200.  
(3) A manufacturer or importer performs conformity assessment for  
a) selected equipment with paramet ers lower than or equal to those stipulated in (2);  
b) electrical selected equipment and selected equipment belonging to automated process 
control systems, including software (hereinafter ' selected control equipment '); 
c) selected equipment that is part of the s tructural part of a nuclear installation 
(hereinafter 'selected structural equipment') in safety class 3; and  
d) other selected equipment in safety class 2 or 3 other than selected equipment specified 
in (2).  9 (4) An accredited person performs a conformity assessm ent on selected equipment 
specified in (2)(c) if the conformity assessment is performed as specified pursuant to 
§ 15(1)(e) Point  1.  
(5) In the case of a conformity assessment of a pressure equipment assembly, this 
assembly must be assessed as a whole. For co nformity assessment of a pressure equipment 
assembly, the results of conformity assessments of individual pieces of selected equipment 
that are part of the assembly are used. The conformity assessment of a pressure equipment 
assembly must be performed with  regards to the highest safety class pieces of selected 
equipment that are part of the assembly.  
(6) For individual parts of selected equipment that are independently designed, 
manufactured, or installed after manufacture, conformity assessment must take place  to the 
extent corresponding to this part of the selected equipment; this does not apply to parts of 
selected equipment specified in (3), for which conformity assessment to the extent 
corresponding to this part of selected equipment is not prescribed in th e selected equipment 
design. The results of conformity assessments of individual pieces of selected equipment that 
are independently designed, manufactured, or installed after manufacture are used  for the 
conformity assessment of selected equipment . 
(7) Confor mity assessment is performed inclusive of conformity assessment of raw 
materials and intermediate products with technical requirements for these materials and 
intermediate products.  
(8) In any case, an individual conformity assessment procedure may be performe d only 
by an authorised person, an accredited person, the manufacturer, or an importer of selected 
equipment. If a combination of conformity assessment procedures is prescribed, individual 
conformity assessment procedures may be performed by various person s. 
§ 13 
Conformity mark  
(1) A person pursuant to §  58(2) of the Act performing conformity assessment must 
mark the selected equipment with a conformity mark along with his identification; if the 
conformity assessment procedure stipulates pa rticipation of an authorised or accredited 
person, this person must also be identified.  
(2) Marking with a conformity mark confirms the conformity of selected equipment with 
technical requirements and adherence to the chosen conformity assessment procedure 
stipulated by this Decree.  
(3) The conformity mark must be placed on the selected equipment in an indelible and 
legible manner, and must not be smaller than 5 mm. The conformity mark may be placed in 
the accompanying technical documentation of selected equipment if it is impossible to place 
on the selected equipment due to its design or size, or if this selected equipment will not be 
accessible after installation.  
(4) The graphic appearance of the conformity mark is specified in Annex  9 to this 
Decree.  10 § 14 
Requirements for documenting the assessment of conformity of selected equipment with 
technical requirements  
(1) Documentation used for conformity assessment is as follows:  
a) technical documentation for selected equipment specified in Annex 3 to this De cree; 
and 
b) documentation concerning the management system of the manufacturer or person 
performing installation, and quality assurance documentation for selected equipment 
of the manufacturer or person performing installation, if the conformity assessment 
procedure includes an assessment of the management system of the manufacturer or 
person performing installation.  
(2) Conformity assessment must be documented via  
a) documents regarding the conformity assessment procedure used; and  
b) documents issued during conformit y assessment by an authorised person, an 
accredited person, a manufacturer, or an importer of selected equipment to the extent 
specified in individual conformity assessment procedures.  
(3) For each piece of selected equipment for which a conformity assessment has been 
performed, a written declaration of conformity must be issued by who mever performs design, 
manufacture, or post -manufacture installation of this equipment. The essentials of a 
declaration of conformity are stipulated in Annex 5 to this Decree.  
(4) A declaration of conformity is part of the accompanying technical documentation for 
selected equipment.  
(5) If an authorised or accredited person refuses to issue a conformity assessment 
certificate, the grounds for this decision are part of the conformity assess ment documentation.  
(6) The d ocumentation pursuant to (2) must be archived for the entire service life of the 
selected equipment.  
§ 15 
Specific procedures that may be applied to assess the conformity of selected equipment 
with technical req uirements  
(1) Individual conformity assessment procedures are as follows:  
a) for selected equipment specified in §  12(2)(a):  
1. conformity assessment procedures B and D;  
2. conformity assessment procedures B and F; or  
3. conformity assessment procedure G;  
b) for selected equ ipment specified in §  12(2)(b) Points  1 to 4:  
1. conformity assessment procedures B1 and D;  
2. conformity assessment procedures B1 and F;  
3. conformity assessment procedures B and E; or  
4. conformity assessment procedure G;  
c) for selected equipment specified in §  12(2) (b) Point  5, conformity assessment 
procedure F;  
d) for selected equipment specified in §  12(2)(b) Point  6: 
1. conformity assessment procedures B and E;  11 2. conformity assessment procedures B and D; or  
3. conformity assessment procedure G;  
e) for selected equipment specif ied in §  12(2)(c):  
1. conformity assessment procedure A1;  
2. conformity assessment procedure D1;  
3. conformity assessment procedure E1; or  
4. the conformity assessment procedure or a combination of conformity assessment 
procedure, if prescribed, specified in a) or b) ; and  
f) for selected equipment specified in §  12(2)(b) Point 3, conformity assessment 
procedure A.  
(2) Individual conformity assessment procedures within the scope of parts of selected 
equipment pursuant to §  12(6) are as follows:  
a) for selected equipment specifie d in §  12(2)(a) and (b):  
1. conformity assessment procedure D1;  
2. conformity assessment procedure E1; or  
3. conformity assessment procedure G;  
b) for selected equipment specified in §  12(2)(c):  
1. conformity assessment procedure A1;  
2. conformity assessment procedure D1; or 
3. conformity assessment procedure E1; and  
c) for selected equipment specified in §  12(3), conformity assessment procedure A.  
(3) Individual conformity assessment procedures are specified in Annex  7 to this Decree.  
§ 16 
Scope of and method fo r verifying conformity of selected equipment with technical 
requirements  
(1) Verification of conformity of selected equipment in operation with technical 
requirements (hereinafter 'verification of conformity') must be performed in a manner and 
within the scope  stipulated in Annex 8 to this Decree and in compliance with verification of 
conformity documentation pursuant to § 17(2).  
(2) Regular verification of conformity must be planned and performed at intervals and in 
the manner stipulated in a programme of operatin g checks and in compliance with the 
technical specifications of individual pieces of selected equipment.  
(3) Within the scope of regular verification of conformity, checks of selected equipment 
stipulated in a programme of operating checks must be performed. R equirements for these 
checks are stipulated in Annex 6 to this Decree.  
(4) The results of checks must be assessed in terms of the technical safety of selected 
equipment  within the scope of regular verification of conformity . 
(5) The results of checks stipulated in  repair or maintenance documentation must be 
assessed in terms of the technical safety of this equipment  within the scope of verification of 
conformity following repairs, maintenance, or re -installation following repairs or maintenance 
of selected equipmen t. 
(6) Within the scope of verification of conformity following repairs, maintenance, or re -
installation following repairs or maintenance of selected equipment, it is necessary to verify 
that the part of the selected equipment specified in § 12(2) used during repair or maintenance 12 of selected equipment complies with technical requirements. Verification of parts of selected 
equipment is performed via procedure F1 pursuant to Annex 8 to this Decree.  
(7) A final assessment pursuant to Annex 6 to this Decree must be pe rformed  within the 
scope of verification of conformity following repairs or post -repair re -installation and 
following changes to selected equipment.  
§ 17 
Method for documenting verification of conformity of selected equipment in use wit h 
technical requirements and the content of this documentation.  
(1) Requirements for verification of conformity documentation are stipulated by Annex 
8 to this Decree.  
(2) Verification of conformity documentation contains:  
a) work orders and guidelines for verificat ion of conformity;  
b) internal rules, if they contain information regarding checks of selected equipment;  
c) plans for operating checks;  
d) an operating check programme ; 
e) a managed ageing operating programme;  
f) accompanying technical documentation for selected equipm ent pursuant to Annex 4 to 
this Decree;  
g) documentation applicable to the preparation and performance of repairs and 
maintenance of selected equipment; and  
h) records of operating checks and checks performed during repairs, maintenance, or 
changes to selected e quipment.  
(3) An operating check programme  contains:  
a) lists of individual pieces of selected equipment broken down by selected equipment 
type;  
b) operating check programme s of individual pieces of selected equipment containing:  
1. checkpoints on selected equipment;  
2. check methods applied on checkpoints on selected equipment;  
3. acceptability criteria for assessing check methods;  
4. how often checks are performed during operation; and  
c) an overview of changes made to the operating check programme  during the 
commissioning and o peration of selected equipment.  
§ 18 
This Decree was notified in accordance with Directive (EU)  2015/1535 of the European 
Parliament and of the Council of 9  September  2015 laying down a procedure for the provision 
of information in the field of technical regulations and of rules on Information Society 
services.  
§ 19 
Transitional provisions  
(4) Conformity assessment of selected equipment that is specially designed for nuclear 
installation with technical requirements for en suring technical safety pursuant to Decree No 
309/2005, on provision of technical safety for selected equipment, as amended effective prior 13 to the effective date of this Decree, is considered to be conformity assessment of selected 
equipment or part thereo f pursuant to this Decree, and verification pursuant to §  16(6) of this 
Decree, and it is assumed that this selected equipment meets the requirements of this Decree.  
(5) Selected equipment which is not specially designed equipment for nuclear 
installations pur suant to Decree No 309/2005, on provision of technical safety for selected 
equipment, as amended , which was in effect before  this Decree  enters into legal effect , and 
which meets the requirements of Decree No 132/2008, on a quality assurance system in 
carrying out activities connected with use of nuclear energy and radiation protection and on 
quality assurance of selected equipment with regard to its safety classification, as amended 
effective prior to the effective date of this Decree, is considered select ed equipment or part 
thereof that has undergone a conformity assessment pursuant to this Decree, and it is assumed 
that it meets the requirements of this Decree.  
Chair:  14 Annex  1 to Decree  No …………  
Technical requirements for selected equipment and parts of s elected equipment  
A. Technical requirements for pressure equipment and some other selected equipment 
and packaging for the transport, storage, and disposal of spent nuclear fuel  
1. General requirements  
1.1. The technical requirements specified in this annex apply to  all pressure equipment and 
pressure equipment assemblies and parts thereof.  
1.2. Technical requirements specified in  
1.2.1.  Point s 1.3 to 1.8, 1.13, 1.14, 2 to 5, and 11 to 14 apply to packaging for the 
transport, storage, and disposal of spent nuclear fuel; and  
1.2.2.  Points 1.3 to 1.10, 1.12 to 1.14, 2 to 5, 7, 8 and 11 to 15 apply to selected 
equipment specified in §  12(3)(a) and (d).  
1.3. Pressure equipment must be designed in compliance with requirements stipulated  
1.3.1.  in its technical specifications pursuant to the decree on nu clear installation 
design requirements; and  
1.3.2.  this decree.  
1.4. Pressure equipment must be designed so that  
1.4.1.  a sudden breach cannot occur during all test and operating states, including 
impermissible media leaks;  
1.4.2.  all necessary planned and unplanned checks or diag nostics of this equipment 
can be safely performed during its operation; and  
1.4.3.  it can be safely repaired and maintained.  
1.5. Pressure equipment must be designed to resist hazards that follow from the properties 
of the area where the nuclear installation is locate d, external effects, and internal 
effects.  
1.6. Pressure equipment must be capable of performing its required function in all nuclear 
installation operating states and accident conditions for which it is intended.  
1.7. Materials used in the manufacture of pressure e quipment and parts thereof which 
ensure that the protective envelope is hermetically sealed are subject to requirements 
for materials for pressure equipment pursuant to Point  12 and 13 of part A of Annex 2 
to this Decree.  
1.8. Pressure equipment must be designe d so that it can be decontaminated, and if 
possible, so that its internal surfaces can then be passivated.  
1.9. Selected equipment design must be based on stipulated  
1.9.1.  calculated, operating, and test loads and their limits;  
1.9.2.  operating conditions for the given pres sure equipment;  
1.9.3.  limit parameters for operability of pressure equipment whose function involves 
mechanical motion;  
1.9.4.  operating modes with respect to classification of pressure equipment in the 
appropriate safety class;  
1.9.5.  chemical and physical parameters of medi a used in pressure equipment;  
1.9.6.  corrosion effects of media on pressure equipment material for the duration of 
this equipment's required service life; and  15 1.9.7.  requirements for the resistance of pressure equipment to seismic effects or to 
cyclic loading.  
1.10. Pressure equipment must be designed to rule out or minimise the risk of a substantial 
loss of resistance to pressure due to defects leading to a breach of the pressure 
equipment's integrity and leakage of radioactive substances. In cases where this risk 
cannot be r uled out, suitable means of maintaining operating parameters must be 
used during operation of pressure equipment and its shut -down to maintain sufficient 
medial levels in the pressure equipment and to eliminate excess heat, by connected 
feed systems and he at elimination systems.  
1.11. Pressure equipment making up the protective envelope system, including equipment 
affecting the hermetic seal of the protective envelope, must be designed so that it is 
possible to stipulate impermeability at calculated design pressu re after the installation 
of all hermetic bushings, hermetic doors, and inputs . 
1.12. Pipes that are pressure equipment must be designed so that the risk of overloading 
due to impermissible tolerances or excessive forces occurring especially at flanges, 
connecti ons, and bellows are minimised, in particular  through the use of supports, 
reinforcements, anchors, position levelling, and pre -stressing of hangers.  
1.13. Pressure equipment must be designed for loading during nuclear installation 
operating states and accident conditions for which it is intended. It is necessary to 
take into account various loads that can act in concert, taking into account the 
likelihood of their simultaneous occurrence.  
1.14. The design of pressure equipment ensuring suitable strength must be based on the 
calculation method pursuant to Point  2, supplemented by an experimental method if 
necessary. Only tested calculation programs may be used for calculations.  
2. Calculation method  
2.1. The calculation method used must apply a conservative approach and limit r isks to 
persons and property to the lowest reasonably achievable degree in accordance with 
requirements stipulated in technical requirements and technical specifications  
2.1.1.  for strength calculations;  
2.1.2.  for mechanical properties of basic and auxiliary materials used;  
2.1.3.  for permanent joints; 
2.1.4.  for performance of checks and tests of selected equipment; and  
2.1.5.  for monitoring and assessing ageing of selected equipment.  
Resistance to internal pressure and other stress perspectives  
2.2. Permitted loads on pressure equipment must b e limited with regards to the types of 
defects whose occurrence under operating conditions and operating modes can be 
predicted. Safety factors must be used that make it possible to entirely rule out any 
uncertainties that follow from manufacturing, real -life operating conditions, loads , 
calculation models, and material properties and behaviour.  
Strength  
2.3. To ensure the strength of pressure equipment, suitable strength calculations that 
include relevant calculated, operating, and test loads must be used.  
2.4. During the calculation of strength of pressure equipment, the following loads must be 
taken into account  in particular : 
2.4.1.  internal and external pressure;  16 2.4.2.  the effect of the equipment's own weight and its contents;  
2.4.3.  additional loads , including the effects of the we ight of connected equipment, 
insulation, and piping;  
2.4.4.  forces elicited by supports and piping;  
2.4.5.  thermal effects, including thermal shocks;  
2.4.6.  vibration loads ; 
2.4.7.  seismic effects and environmental conditions during extreme weather 
conditions;  
2.4.8.  processes leading to ma terial degradation, including the effects of radioactivity;  
2.4.9.  hydraulic resistance and pressure shocks;  
2.4.10.  plane crashes; and  
2.4.11.  other loads that follow from a risk analysis pursuant to Point  3.1 of Part  A of 
Annex  2 to this Decree.  
Calculated loads  
2.5. Calculated pre ssure must be higher than the highest permitted pressure, and must take 
into account  
2.5.1.  pressure shocks  
2.5.2.  control system errors and measurement uncertainties; and  
2.5.3.  system configuration effects.  
2.6. For parts of pressure equipment simultaneously subjected to internal  and external 
pressure, the calculation pressure is stipulated as the difference between these 
pressures for which the greatest wall thickness is achieved.  
2.7. The calculated temperature may not be less than the expected maximum mean 
temperature along the thic kness of the part in question  to which limits for normal and 
abnormal operating conditions apply. If equipment or pipes are heated by transfer of 
heat from sources such as induction spirals, sheathing, or internal heat sources, their 
effects must be taken into account when determining the calculated temperature.  
2.8. Other calculated loads  must be selected so that in combination with the effects of 
calculated pressure to which limits for normal operating conditions apply, they specify 
the maximum wall thickness for equipment.  
2.9. Pressure equipment must be designed so that the greatest stress and tension 
concentration values corresponding to calculated loads  are kept within safe limits.  
Operating loads  
2.10. When calculating the strength of pressure equipment, all loads  that can occur during 
normal operation and during accident conditions under which this equipment needs 
to perform its function must be taken into account. It is especially important to take 
into account loads causing strain and deformation in materials from which the 
equipment is made that occur during manufacture, transport, installation, and 
pressure tests, including residual strains, the effect of which on strength limit 
conditions must be assessed individually according to their significance.  
Test loads  
2.11. During strength calculations for pressure equipment, it is necessary to take into 
account test loads to which the pressure equipment will be subjected during the 
pressure test in the course of the final assessment.  
2.12. The test pressure must be stipulated in re lation to the calculated or highest permitted 
pressure, taking into account evaluation of geometric and material properties and test 17 conditions during manufacturing and operation in accordance with requirements 
specified in technical regulations or technic al specifications for the manufacture of 
pressure equipment.  
Strength calculation, design of basic dimensions, and check calculation  
2.13. A strength calculation for pressure equipment must be performed for the following 
limit conditions:  
2.13.1.  a sudden breach of inte grity due to a ductile or brittle fracture;  
2.13.2.  plastic deformation across the entire cross -section of the pressure equipment;  
2.13.3.  unidirectional growth of the plastic component of relative deformation during 
cyclic loading leading to impermissible changes in dime nsions or breach of 
integrity;  
2.13.4.  creation of fractures during cyclic loading; and  
2.13.5.  loss of stability.  
2.14. Strength calculations for limit states listed in Point  2.13 must use values that 
correspond to material, strength, plastic, and brittle fracture characterist ics and 
resistance to deformation stipulated for the given materials in technical regulations or 
experimentally stipulated by an accredited test facility. For purposes of this strength 
calculation, values stipulated in technical standards may be used.  
2.15. In the case of permanent join ts, suitable permanent join t coefficients must be chosen 
for material properties depending on the type of materials being joined, the type of 
non-destructive tests used, and expected operating conditions.  
2.16. Pressure equipment design must, in a suitable manner corresponding to its intended 
use and its planned service life, take into account foreseeable degradation 
mechanisms, in particular  the effect of radioactivity, corrosion, and material fatigue.  
2.17. During the calculation of strength of pressure equipment, the following must be 
performed:  
2.17.1.  a calculation for the design of basic equipment dimensions (hereinafter the 
'basic dimensions design'); and  
2.17.2.  a check calculation for the equipment (hereinafter the 'check calculation').  
2.18. During the desi gn of basic dimensions, permitted strains are calculated from tensile 
strength and from the proof stresses permissible for manufacture of pressure 
equipment. During the calculation of permitted strains, appropriate safety factors 
must be taken into account . 
2.19. During the design of basic dimensions, limit states must be considered for  
2.19.1.  breach of integrity due to a ductile fracture;  
2.19.2.  plastic deformation across the entire cross -section of the pressure equipment; 
and 
2.19.3.  loss of stability.  
2.20. Following the design of basic equipment dimensions, a check calculation must be 
performed that must demonstrate:  
2.20.1.  strength during static loading;  
2.20.2.  strength during cyclic loading;  
2.20.3.  resistance to a sudden breach;  
2.20.4.  strength during vibration;  
2.20.5.  resistance to loss of stability; and  
2.20.6.  resistance to seismic effects.  18 2.21. The pressure equipment check calculation must take into account all loading, 
including thermal effects, and all operating states specified in technical 
specifications. Degradation of material properties during operation, surface quality, 
the effect of strain gradient, and the effect of a corrosive environment must be taken 
into account  in particular . 
3. Experimental design method for pressure equipment design  
3.1. Correct design of pressure equipment or part thereof must be verified through suitabl e 
checks made on representative samples of pressure equipment in accordance with a 
check programme established for purposes of the experimental design method. This 
checks programme must be approved by an authorised person responsible for the 
design conform ity assessment procedure.  
3.2. The checks and testing programme must define test conditions and acceptability 
criteria. Prior to the performance of individual checks and tests, true values of basic 
dimensions and the properties of which the pressure equipment i s made must be 
measured.  
4. Design of safe handling and operation of pressure equipment  
4.1. The prescribed manner of handling and operation of pressure equipment must rule out 
risks that follow from a risk analysis pursuant to Point  3.1 of Part  A of Annex  2 to th is 
Decree. Special attention must be given to  
4.1.1.  closures and openings;  
4.1.2.  hazardous blow -off from relief fittings; and  
4.1.3.  elements that prevent physical entry to the system, if the equipment is 
pressurised or contains a vacuum.  
5. Test equipment  
5.1. Pressure equipment mu st be designed so that all checks necessary to ensure technical 
safety can be performed.  
5.2. If pressure equipment cannot be designed so that it can be checked to the required 
extent during operation,  
5.2.1.  other checks ensuring the same degree of technical safety, including indirect 
checks, must be stipulated; or  
5.2.2.  approved calculation methods must be used;  
and safety margins must be stipulated in a conservative manner and reasonable safety 
measures must be taken to rule out possible unexpected pressure equipment fail ure. 
6. Means for purging water and air  
6.1. The pressure equipment design must, for its entire service life and during its testing, 
through the use of suitable means for purging water and air from the pressure 
equipment  
6.1.1.  prevent water shocks, destruction of the pr essure equipment due to vacuum or 
corrosion and uncontrolled chemical reactions and other negative effects; and  
6.1.2.  permit the safe decontamination, cleaning, checking, and maintenance of 
pressure equipment.  
7. Corrosion and other chemical effects  
7.1. If the risk ana lysis pursuant to Point  3.1 of part A of Annex 2 to this Decree identified 
a risk of corrosion or other chemical effects,  these effects must be minimised , taking 19 into account the intended use of the pressure equipment in the pressure equipment 
design, by  
7.1.1.  using other corrosion -resistant material;  
7.1.2.  increasing wall thickness by an additional corrosion factor; or  
7.1.3.  protecting against corrosion or other chemical effects.  
8. Wear and tear  
8.1. If the risk analysis pursuant to Point  3.1 of part A of Annex 2 to this Decree id entified 
a risk of erosion or wear, these effects must be minimised , taking into account the 
intended use of the pressure equipment in the pressure equipment design, by  
8.1.1.  using other material resistant to erosion or wear;  
8.1.2.  increasing wall thickness by an addi tional wear factor; or  
8.1.3.  using liners or plating that allow the replacement of parts that are most affected; 
or 
8.1.4.  other measures minimising the effects of wear and tear.  
9. Selected equipment assembly  
9.1. A pressure equipment assembly must be designed so that  
9.1.1.  the par ts being assembled are suitable and reliable for the given purpose;  
9.1.2.  all parts of the pressure equipment assembly are properly incorporated and 
assembled; and  
9.1.3.  parts are included in the pressure equipment assembly  
9.1.3.1.  based on foreseeable risks identified in the  risk analysis pursuant to 
Point  3.1 of Part  A of Annex  2 to this Decree;  
9.1.3.2.  with regard to the suitability and reliability of assembly;  
9.1.3.3.  based on correct layout of jointly assembled parts of the pressure 
equipment assembly; and  
9.1.3.4.  with regards to the safety clas s into which the pressure equipment 
assembly is placed.  
9.2. The manner in which the pressure equipment assembly is protected from exceeding 
operating limits and safety equipment checks must be designed with respect to the 
safety class into which the pressure e quipment assembly is placed.  
9.3. A pressure equipment assembly must be placed in the safety class that matches the 
highest safety class of at least one of its parts.  
10. Filling and emptying  
10.1. The pressure equipment design must use suitable construction, pressure eq uipment 
accessories, or the use of measure s for its installation to ensure safe filling and 
emptying of the pressure equipment and sampling of process media, in particular 
keeping in mind risks  
10.1.1.  during its filling, which are  
10.1.1.1.  overfilling or exceeding pressur e, in particular  with respect to the filling 
ratio and to vapour pressures at the relevant temperature; and  
10.1.1.2.  pressure equipment instability;  
10.1.2.  during emptying that involves uncontrolled release of media under pressure; 
and 
10.1.3.  during filling or emptying that invo lves dangerous connections and interruption 
of connections.  20 11. Protection from exceeding permitted limits  
11.1. If during the operation of pressure equipment permitted limits could be exceeded, the 
pressure equipment design must  
11.1.1.  include protective equipment to prev ent these limits from being exceeded, or a 
combination of several pieces of such protective equipment; or  
11.1.2.  have suitable measures in place for its installation.  
11.2. Protective equipment or a combination of several pieces of such protective 
equipment must be des igned with regards to the specific properties of the pressure 
equipment or pressure equipment assembly that it is to protect.  
11.3. Protective equipment or a combination of several pieces of such protective 
equipment is defined as  
11.3.1.  safety equipment; or  
11.3.2.  monitoring  equipment such as indicators or warning devices that allow suitable 
automatic or manual intervention in order to maintain pressure equipment 
operation within permitted limits.  
12. Safety equipment  
12.1. Safety equipment  
12.1.1.  must be designed to ensure suitable and relia ble protection of the given 
pressure equipment;  
12.1.2.  must be designed with regards to maintenance and supervision of this 
equipment;  
12.1.3.  must be designed to primarily ensure  
12.1.3.1.  protection from faults;  
12.1.3.2.  safety equipment redundancy;  
12.1.3.3.  various designs; and  
12.1.3.4.  automatic self -diagnostics;  
12.1.4.  must also protect, if required for its correct functionality, aside from the 
mechanical parts of the pressure equipment, power, control, measurement, and 
regulation systems and related nuclear installation control systems; and  
12.1.5.  must be assessed w ithin the scope of conformity assessment of the pressure 
equipment or pressure equipment assembly.  
12.2. Safety equipment must not be assigned any other functions unrelated to protection of 
pressure equipment , except for cases where these other functions cannot affect its 
protective functionality.  
12.3. Equipment limiting media pressure, level, or flow must be designed so that the 
greatest permitted media pressure, level, or flow is not exceeded; a short -term 
pressure increase caused by safety equipment is permitted if  it does not exceed 10 % 
of the greatest permitted pressure value.  
12.4. Temperature measurement devices must have a suitable delay period in accordance 
with their measurement functions.  
13. Electrical equipment  
13.1. Electrical equipment must be designed  
13.1.1.  together with pr essure equipment; and  
13.1.2.  in a manner that permits the reliable performance of the safety function of 
pressure equipment.  21 14. External fire protection  
14.1. Taking into account its intended use, pressure equipment must be equipped with 
suitable accessories or measures m ust be put into place for its installation to meet 
requirements for damage control in the case of external fire.  
15. Hydraulic and pneumatic equipment ensuring control, regulation, signalling, and 
measurement  
15.1. The general requirements in Point s 1.1 to 1.8, 1.13 , and 1.1.4 and technical 
requirements for pressure equipment specified in Point s 2, 3, 5 to 8, and 13 apply  to 
hydraulic and pneumatic equipment providing control, regulation, signalling, and 
measurement . 
15.2. Every quick -acting armature in a nuclear installat ion's safety system must be 
controlled by its own air line.  
15.3. Pneumatic drives and air distribution lines must permit repeated application of 
pressure using air or another gas.  
15.4. Pneumatic drives must be designed  
15.4.1.  to minimise creation of deposits, corrosion pro ducts , dust, and other impurities; 
and 
15.4.2.  so that its inner and outer surfaces make it as easy as possible to remove 
deposits, corrosion products , dust, and other impurities.  
B. Technical requirements for selected control equipment  
1. Selected control equipment  must be designed in compliance with requirements stipulated  
1.1. in its technical specifications pursuant to the decree on nuclear installation design 
requirements; and  
1.2. in this Decree.  
2. Selected control equipment  must bear the name of its manufacturer, or if the m anufacturer 
cannot be marked directly on the equipment, this identification must be marked on the 
package. The manufacturer must always be identified in accompanying technical 
documentation for this equipment.  
3. Basic technical characteristics of selected co ntrol equipment  that need to be adhered to 
during the operation of this equipment in order for its safe use in conditions for which it 
was made must be marked on the selected equipment and stated in its accompanying 
technical documentation, or if this info rmation cannot be marked directly on this selected 
equipment, it must be stated in its accompanying technical documentation.  
4. Pressure equipment must be designed to ensure that  
4.1. individuals are protected to a reasonable degree from injury or other hazards th at 
could result from electrical current upon contact with live or non -live parts;  
4.2. individuals and property are protected from non -electrical hazards that the selected 
control equipment  could cause;  
4.3. dangerous temperature increases, electrical arcs, or radia tion do not occur;  
4.4. selected control equipment  insulation design corresponds to all nuclear installation 
operating states and accident conditions for which this equipment is intended;  
4.5. it will resist hazards that follow from the properties of the area where  the nuclear 
installation is located, external effects, and internal effects;  
4.6. it is capable of performing its required function in all nuclear installation operating 
states and accident conditions for which it is intended;  22 4.7. during operation or planned shutd own, it can be worked on safely, in particular  
regarding  its separability ability to be disassembled; and  
4.8. diagnostic equipment can be used effectively.  
5. Cables that are selected control equipment  or that are part of selected control equipment  
must be  
5.1. desig ned so that they can be installed in a manner that prevents their damage in an 
environment for which their characteristics were intended; and  
5.2. placed on racks in a pre -specified arrangement in layers and gaps prescribed in the 
laying plan in order to ensur e uninterruptible power system cables are separate from 
other cable sets.  
C. Technical requirements for selected structural equipment  
1. Selected structural equipment must be designed in compliance with requirements 
stipulated  
1.1. in its technical specifications pur suant to the decree on nuclear installation design 
requirements; and  
1.2. with requirements stipulated by this Decree.  
2. Selected structural equipment must be designed so that it meets requirements pursuant to 
(1) during nuclear installation operating states and  accident conditions for which it is 
intended.  
3. Selected structural equipment must be designed to resist hazards that follow from the 
properties of the area where the nuclear installation is located, external effects, and internal 
effects.  
4. Selected structur al equipment must be capable of performing its required function in all 
nuclear installation operating states and accident conditions for which it is intended.  
5. The design of selected structural equipment must be supported by calculations, models, or 
supple mented with experimental verification if required. Only tested calculation programs 
may be used for calculations.  
6. Selected structural equipment must be designed so that the effects of loading and 
properties of the area where the nuclear installation is loc ated, external effects, and internal 
effects stipulated by the nuclear installation's design cannot cause  
6.1. structural collapse;  
6.2. impermissible structural deformation;  
6.3. interference with structural stability;  
6.4. reduction of the structure's mechanical resistance ; 
6.5. impermissible structural vibration;  
6.6. a threat to the functionality of selected equipment located inside the structure or in its 
vicinity; or  
6.7. structural damage incommensurate to the root cause.  
7. Selected structural equipment must be designed so that in case  of fire  
7.1. the integrity and load -bearing capability of the structure is preserved for a specified 
period;  
7.2. spatial design and hermetic elements limit its propagation within the structure;  
7.3. its propagation to adjacent structures is limited; and  
7.4. individuals can  exit the structure via escape routes.  23 Annex  2 to Decree  No …………  
Requirements for ensuring compliance of selected equipment and parts of selected 
equipment  
A. Requirements for ensuring compliance during the design, manufacture, and 
installation of pressure e quipment and some other selected equipment and parts 
thereof, and packaging for the transport, storage, and disposal of spent nuclear fuel  
1. Selected equipment and parts thereof must be  
1.1. designed, manufactured, and installed in a manner that their technical s afety is ensured 
during their commissioning; and  
1.2. manufactured in accordance with the technical documentation for the given type of 
packaging approved pursuant to the decree on type approval of certain products in the 
area of the peaceful use of nuclear ene rgy and ionising radiation that transport of 
radioactive or fissile material, in the case of packaging for the transport, storage, and 
disposal of spent nuclear fuel.  
2. Requirements for ensuring compliance during the design, manufacture, and installation of 
selected equipment specified in  
2.1. Point s 1 and 3 to 17 apply to packaging for the transport, storage, and disposal of 
spent nuclear fuel; and  
2.2. Point s 1, 3 to 5, 6.1 to 6.4, 6.5 sentence one, 6.6, 6.8, 7.1, 8.1, 8.2, 9, 10, 11, 12, 13.1 
to 13.5, 13.7, 13.8, 13 .9.3 and 14 to 17 apply to selected equipment specified in 
§ 12(3)(a) and (d).  
Pressure equipment design  
3. During pressure equipment design,  
3.1. a risk analysis must be performed from the perspective of safety in order to identify 
and assess its possible risks; in order to assess these safety influences through a risk 
analysis, required states must be stipulated under which the pressure equipment must 
perform its function;  
3.2. the technical design of the pressure equipment must be performed taking into account 
the re sults of the risk analysis pursuant to Point  3.1; 
3.3. during the selection of the most suitable technical design of pressure equipment  
3.3.1.  every foreseeable risk must be ruled out to an achievable degree; or  
3.3.2.  suitable protective measures must be implemented to limi t the effects of risks 
that cannot be ruled out; and  
3.4. the selected equipment design must be reviewed in terms of suitability and adequacy 
of stipulation of technical requirements, verified in terms of compliance with technical 
requirements, and validated in  terms of technical requirements and its intended use.  
Pressure equipment manufacture  
4. Manufacturing procedures  
4.1. Pressure equipment must be manufactured in compliance with its technical 
documentation. Manufacturing methods and procedures must be designed so that all 
prescribed checks can be performed. During manufacturing, technical requirements 
that were adopted during the design process are applied.  24 5. Parts manufacturing  
5.1. During the manufacture of pressure equipment, defects and cracks or changes in 
mechanical  properties that could threaten its technical safety must not occur.  
6. Permanent joint s 
6.1. Requirements for permanent joints apply primarily to the following joint types:  
6.1.1.  welded metal joints; 
6.1.2.  soldering; and  
6.1.3.  sprayed -on and welded -on materials.  
6.2. Permanent joints and their adjacent areas must be performed so that they are free of 
any surface or internal defects that could threaten the technical safety of pressure 
equipment.  
6.3. The basic mechanical properties of permanent joints must at least correspond to the 
propertie s of the basic materials that are being joined, unless values corresponding to 
other mechanical properties of the material were intentionally taken into account 
during strength calculations.  
6.4. Technical, checking, and technological activities applicable to p ermanent joints on 
selected equipment may only be performed by welding supervisors certified by a 
national authorised body for the area of the creation and testing of permanent joints. 
6.5. Permanent joints of parts of selected equipment specified in §  12(2) th at contribute to 
the ability to equipment to resist internal pressure, and directly connected elements, 
must be made by appropriately qualified personnel using suitable work procedures. 
These work procedures and qualified personnel making permanent joints and welding 
supervisors must be approved by an authorised person, except for permanent joints on 
selected equipment specified in §  12(3).  
6.6. Within the scope of conformity assessment of selected equipment,  
6.6.1.  checks must be performed to verify that the proposed technical procedure for 
creating a permanent joint is in compliance with technical requirements for 
permanent joints, including requirements of technical standards for checking 
permanent joints; or 
6.6.2.  a test weld joint must be made for selected equipment spec ified in §  12(2)(a) or 
(b). 
6.7. An authorised person supervises performance of checks pursuant to 6.6.1 and of the 
test weld joint, including supervision of performance of relevant checks to assess this 
joint and transfer of markings.  
6.8. Technical documentation f or selected equipment dealing with welding must certify 
fulfilment of requirements for  
6.8.1.  the creation, assessment, and approval of work procedures for creation of 
permanent joints; 
6.8.2.  the required qualifications of personnel making permanent joints; 
6.8.3.  the require d qualifications of personnel designing, verifying, and evaluating the 
welding process; and  
6.8.4.  the fitness of the welding and checking equipment.  
7. Non-destructive checks  
7.1. Non-destructive checks of permanent joints must be performed by personnel certified 
by a s ubject accredited by an accreditation authority pursuant to relevant technical 25 standards regarding qualification and certification of personnel performing non -
destructive checks of welded joints. 
7.2. Personnel performing non -destructive checks of permanent joints must be approved 
by an authorised person, except for permanent joints on selected equipment specified 
in § 12(3).  
8. Heat treatment  
8.1. If there is a risk that a manufacturing procedure will change material properties to an 
extent that could threaten the tech nical safety of pressure equipment, adequate heat 
treatment must be applied at a suitable stage of the manufacturing process.  
8.2. Heat treatment of parts of pressure equipment must be performed by qualified 
personnel.  
8.3. The heat treatment of parts of selected eq uipment specified in §  12(2)(a) must be 
performed under the supervision of an authorised person.  
8.4. Personnel performing heat treatment of parts of pressure equipment specified in 
§ 12(2)(a) must be approved by an authorised person.  
9. Identifiability  
9.1. Procedures  must be implemented and follow to ensure the identifiability of  
9.1.1.  materials;  
9.1.2.  parts of pressure equipment; and  
9.1.3.  checks of materials and parts of pressure equipment.  
9.2. Identifiability must be ensured from initial checks of delivered material or parts of 
pressure  equipment until final assessment of pressure equipment.  
10. Marking and affixing labels  
10.1. Pressure equipment must be marked with a label, or in another manner. The label or 
other manner of marking must include  
10.1.1.  the name of the manufacturer or person performing i nstallation; for example 
name, surname, and place of business in the case of a natural person, or the 
company name and registered offices, in the case of a legal entity ; 
10.1.2.  the year of manufacture;  
10.1.3.  identification of pressure equipment according to its nature,  for example type, 
series, or identification of production batch and serial number;  
10.1.4.  basic highest and lowest operating limits; and  
10.1.5.  designation of the person who performed a conformity  assessment of pressure 
equipment, in the case of equipment specified in § 12(2).  
10.2. The required information must be provided on the pressure equipment or on a label 
permanently affixed to it, except for cases when  
10.2.1.  suitable documentation us used, if possible, to prevent the repeated marking of 
individual parts intended for the sa me assembly, for example pipe sections; or  
10.2.2.  the pressure equipment is too small and information is provided on a separate 
label affixed to the pressure equipment.  
11. Instruction manuals  
11.1. If pressure equipment is being commissioned, if possible it must be accomp anied by 
an instruction manual or other appropriate operating documentation containing all 
required information concerning  technical safety concerning its  26 11.1.1.  installation, or installation of a part thereof;  
11.1.2.  commissioning;  
11.1.3.  operation, including identification o f its parts, operating conditions, and manner 
of its use; and  
11.1.4.  maintenance, including in -service checks.  
11.2. The manual must contain information specified in Point  1.1, and if necessary for 
complete comprehension of the manual, must contain technical documentat ion, 
drawings, and schematics.  
12. Pressure equipment materials  
12.1. Only approved basic and auxiliary materials on the list of materials permitted for this 
use may be used to manufacture, repair, or modify pressure equipment. The list of 
materials must be drawn u p with respect to classification of pressure equipment in 
the appropriate safety class.  
12.2. Basic and auxiliary materials used must be suitable for the given use for the entire 
expected service life of the pressure equipment.  
12.3. Auxiliary welding materials must m eet requirements specified in Point s 12 and 13, 
both alone and when incorporated within a structure.  
13. Materials of parts of pressure equipment exposed to pressure  
13.1. The basic materials affecting the technical safety of pressure equipment must meet 
the require ments of technical specifications for pressure equipment, both alone and 
in a structure together with suitable auxiliary material, especially requirements for 
suitable properties under all operating conditions under which the pressure 
equipment is to perfo rm its function.  
13.2. Parts of selected equipment exposed to pressure are always considered to be those 
parts that make up a pressure interface or that are joined to these parts in a permanent 
manner.  
13.3. In choosing material for manufacture, installation, repair, or modification of pressure 
equipment, it is necessary to take into account its chemical composition, physical and 
mechanical properties, weldability and ability to operate under operating conditions 
in which the pressure equipment is to perform its functi on. 
13.4. The material used in the manufacture, installation, repair, or modification of pressure 
equipment must be  
13.4.1.  the same as the material of the original part listed in the technical specifications 
of the pressure equipment;  
13.4.2.  on the list of materials permitted  for the given use; or  
13.4.3.  another material, if material pursuant to Point  13.4.1 or 13.4.2 cannot be used.  
13.5. If material pursuant to Point  13.4.2 is used that has properties different from the 
original material, it is necessary to prove that its properties are suitable for the given 
use with respect to operating conditions and the safety class of the given pressure 
equipment.  
13.6. If the proposed material is not on the list of materials permitted for the given use, a 
specific assessment of the proposed material must take place; for pressure equipment 
specified in §  12(2), an authorised person must arrange the specific assessment of the 
proposed material.  27 13.7. Suitable measures must be implemented during manufacture, installation, repair, or 
modification to ensure that the material used complies with the requirements of the 
technical specifications for the pressure equipment. In particular, there must be 
documentation for all basic and auxiliary materials used available confirming the 
compliance of the materials used with th e material's technical specifications.  
13.8. Only material that has undergone an assessment of its conformity with technical 
requirements for material may be used to manufacture, repair, or modify pressure 
equipment.  
13.9. The material assessment must be certified in terms of its compliance with technical 
material specifications,  
13.9.1.  by a material certificate issued by the manufacturer, confirmed by an authorised 
person, in the case of material for pressure equipment specified in §  12(2)(a) or 
(b);  
13.9.2.  by a material certifica te issued by the manufacturer, in the case of material for 
pressure equipment specified in §  12(2)(c); and  
13.9.3.  by a material certificate issued by the manufacturer, in the case of material for 
pressure equipment specified in §  12(3).  
13.10.  For pressure equipment spe cified in §  12(2)(a) or (b), material for which a material 
certificate was issued pursuant to Point  13.9.2 and 13.9.3 may be used only if 
additional checks were performed with the participation of an authorised person in 
order to prove that this material i s suitable for use in this pressure equipment. If the 
results of checks agree with the values specified in the original material certificate, 
the authorised person shall issue an inspection report or certificate proving 
compliance with conditions for use o f the material in pressure equipment specified 
in § 12(2)(a) or (b).  
14. Material quality control  
14.1. Material quality control  must be performed to the extent and using methods specified 
in technical regulations, technical standards, or technical specifications fo r materials.  
14.2. Intermediate products for the manufacture of pressure equipment, in particular  sheet 
metal, forged pieces, pressed pieces, cast pieces, rolled steel for joint parts, and 
intermediate products for the manufacture of seals, must be manufactured in 
compliance with requirements stipulated by the pressure equipment design, technical 
standards, or other technical specifications that determine the extent and methods of 
checks used to verify their quality.  
14.3. Limit values for the steel's cobalt content mu st be stipulated  for intermediate parts 
made of austenitic steels for the manufacture of pressure equipment that come into 
contact with primary circuit media . 
Pressure equipment installation  
15. Pressure equipment must be installed in compliance with a technic al installation procedure 
that includes installation methods and procedures that make it possible to perform all 
prescribed checks. Technical requirements that were adopted during the design process are 
applied  during installation . 
16. Special processes used d uring installation of selected equipment or selected equipment 
assemblies must be performed in accordance with requirements for permanent joints, non -
destructive checks, and thermal treatment specified in Point s 6 to 8.  28 17. Installation quality must be verifie d based on a plan or programme of checks according to 
which the installation is performed.  
B. Requirements for ensuring compliance during the design, manufacture, and 
installation of selected control equipment  and parts thereof  
1. Selected equipment and parts of  selected equipment must be designed, manufactured, and 
installed in a manner that during their commissioning their technical safety is ensured.  
Selected control equipment design  
2. During the design of selected control equipment , 
2.1. a risk analysis must be perf ormed from the perspective of safety in order to identify 
and assess its possible risks; in order to assess these safety influences through a risk 
analysis, required states must be stipulated under which the selected control 
equipment  must perform its func tion; 
2.2. the technical design of the selected control equipment  must be performed taking into 
account the results of the risk analysis pursuant to Point  2.1; 
2.3. during the selection of the most suitable technical design of selected control 
equipment  
2.3.1.  every forese eable risk must be ruled out to an achievable degree; or  
2.3.2.  suitable protective measures must be implemented to limit the effects of risks 
that cannot be ruled out; and  
2.4. the selected equipment design must be reviewed in terms of suitability and adequacy 
of sti pulation of technical requirements, verified in terms of compliance with technical 
requirements, and validated in terms of technical requirements and its intended use.  
Selected control equipment  manufacture  
3. Selected control equipment  must be manufactured i n compliance with a technical 
documentation for this equipment that includes suitable methods and appropriate 
manufacturing procedures that make it possible to perform all prescribed checks. During 
manufacturing, technical requirements that were adopted du ring the design process are 
applied.  
4. For the manufacture of selected control equipment , it is necessary to implement and adhere 
to procedures ensuring the identification of this equipment during its manufacture.  
5. During the manufacture of selected control equipment , checks must be performed in 
accordance with requirements stipulated in its technical documentation.  
Selected control equipment  installation  
6. Selected control equipment  must be installed in compliance with a technical installation 
procedure that i ncludes installation methods and procedures that make it possible to 
perform all prescribed checks. During installation, technical requirements that were 
adopted during the design process are applied.  
7. Special processes used during installation of selected control equipment  must be 
performed in accordance with requirements for permanent joints, non -destructive checks, 
and thermal treatment specified in Part A Point s 6 to 8 and software development 
requirements.  
8. Installation quality must be verified based on a programme of checks according to which 
the installation is performed.  29 C. Requirements for ensuring compliance during the design, manufacture, and 
installation of selected structural equipment and parts thereof  
1. Selected equipment and parts of selected equipm ent must be designed, manufactured, and 
installed in a manner that during their commissioning their technical safety is ensured.  
Selected structural equipment design  
2. Selected equipment design must be reviewed in terms of suitability and adequacy of 
stipula tion of technical requirements, verified in terms of compliance with technical 
requirements, and validated in terms of technical requirements and its intended use.  
Selected structural equipment manufacture and installation  
3. Selected structural equipment mus t be designed, manufactured, and installed in accordance 
with technical documentation so that all prescribed checks necessary to ensure technical 
safety can be performed. During construction, technical requirements that were adopted 
during the design proce ss are applied.  
4. Concrete must be produced in compliance with prescribed production procedures that 
during hardening guarantee prescribed strength values and other properties stipulated in 
the selected equipment design. Prescribed strength values and other properties stipulated in 
the selected equipment design must be stipulated within the scope of production 
procedures.  
5. Special processes used during installation of  selected structural equipment  must be 
performed in accordance with requirements for permanent  joints, non -destructive checks, 
and thermal treatment specified in Part A Point s 6 to 8.  
6. Only metal and construction materials stipulated in this selected equipment design may be 
used for its manufacture and installation.  
D. Requirements for ensuring complia nce when commissioning selected equipment and 
parts thereof  
1. Selected equipment or part thereof must be manufactured and supplied to ensure their safe 
and correct installation and connection.  
2. Once installation of technologies and construction of the nuclear  installation they are part 
of have completed, it must be verified whether technical specifications and unique 
identification of the placement of selected equipment is in compliance with the as -built 
status of the nuclear installation and whether they have  appropriate accompanying 
technical documentation supplied by the manufacturer of the selected equipment or parts 
thereof and the installation and construction contractor to the extent of Annex 4 to this 
Decree, and it has been marked with the actual deliv eries and work performed, specifically  
2.1. prior to the first insertion of nuclear fuel into a nuclear reactor or a nuclear installation 
without a nuclear reactor in the period immediately after deliveries or work have been 
completed;  
2.2. prior to the acceptance of the equipment by the operator of the nuclear installation and 
its use for the purpose for which it was made.  
3. When commissioning a nuclear installation, individual selected equipment must be 
gradually tested in compliance with a predetermined  
3.1. operating check programme ;  
3.2. pre-operational managed ageing programme for first physical startup; and  30 3.3. an operational managed ageing programme for first power startup and test operation in 
order to verify their compliance with technical requirements pursuant to Annex  1 to 
this Decree that are applied during operation, in order to facilitate the functional 
verification of the entire nuclear installation prior to the commencement of test 
operation.  
4. Before commencing each phase of commissioning of selected equipment, the  following 
must be certified:  
4.1. the training of operators and managers, with a list of names and job positions;  
4.2. the ability of personnel to manage and perform checks of selected equipment;  
4.3. the readiness of selected equipment in the relevant phase; and  
4.4. fulfilment of other requirements stipulated by the Office based on an assessment of 
the previous phase of commissioning.  
E. Requirements for ensuring compliance when operating selected equipment and parts 
thereof  
1. Selected equipment must be operated so that its te chnical safety is maintained during 
operation.  
2. During operation, accompanying technical documentation of the selected equipment must 
be supplemented with additional documents regarding the performance of repairs, 
maintenance, or modifications to this equip ment. A system of maintaining accompanying 
technical documentation must be implemented to make it possible to verify the fulfilment 
of technical requirements for selected equipment.  
3. Selected equipment can be installed and de -installed only under predeterm ined safe 
conditions and in compliance with rules for installation, de -installation, and re -
commissioning.  
4. Selected equipment must be operated in compliance with the requirements of internal rules 
and other documentation for the operation of a nuclear fac ility. Rules for the maintenance 
and operation of selected equipment must include technical requirements and 
recommendations of the manufacturer of the selected equipment.  
5. The selected equipment may be operated and used only for purposes and under conditio ns 
for which it is intended, and in compliance with the nuclear installation's design. Technical 
and organisational measures must be put in place that shall ensure that selected equipment 
is operated under conditions for which it has been designed, and doe s not threaten human 
health or present an inadmissible risk of damage to property.  
6. During the operation of selected equipment, a system of tracking and documenting 
discrepancies from normal operation that could lead to defects and a reduction of the 
safety  level of the selected equipment must be implemented.  
7. During the operation of selected equipment, within the scope of an implemented managed 
ageing process for selected equipment, its condition must be tracked systematically, the 
impact of ageing and the e ffect of degradation mechanisms that could lead to defects and a 
reduction of the safety level of the selected equipment must be determined.  
8. During the operation of selected equipment, a maintenance system and a system of checks 
performed during the operat ion of selected equipment must be put into place, which must  
8.1. be implemented with respect to operating conditions affecting the technical safety of 
this equipment; and  
8.2. stipulate technical and organisational measures for conformity assurance.  31 9. Maintenance, re pairs, or modifications of selected equipment that is in operation must be 
performed in compliance with compliance assurance requirements for design, 
manufacturing, installation, and commissioning of selected equipment specified in Part A 
to D; if special processes are performed during maintenance, repairs, or modifications of 
selected equipment that is in operation, they must be performed in compliance with 
requirements for permanent joints, non -destructive checks, and thermal treatment specified 
in Part A  Point s 6 to 8.  
10. During maintenance, repairs, or modifications of selected equipment, contractor 
supervision must take place involving verification that activities occurring during 
maintenance, repairs, or modifications of selected equipment are performed i n compliance 
with documentation applicable to the preparation and performance of maintenance, repairs, 
or modifications of selected equipment.  
11. Activities taking place on selected control equipment  may be performed only by personnel 
qualified pursuant to De cree No 50/1978, on professional electrical engineering 
qualifications, as amended.  32 Annex  3 to Decree  No 
Requirements for technical documentation for selected equipment  
Technical documentation for selected equipment must be drawn up in a well -organised 
manner to make it possible to assess conformity to the extent prescribed by this Decree.  
A. Technical documentation for design, manufacture, and installation of pressure 
equipment and some other selected equipment and packaging for the transport, 
storage, and d isposal of spent nuclear fuel  
Technical documentation for design, manufacture, and installation of pressure equipment, 
selected equipment specified in §  12(3)(a) and (d), and packaging for the transport, storage, 
and disposal of spent nuclear fuel contains  
1. the name of the selected equipment, its identification, and description;  
2. identification of the manufacturer;  
3. the selected equipment design;  
4. connection schematics;  
5. manufacturing drawings and schematics of assemblies and sub -assemblies containing  
5.1. a descript ion of the prescribed quality and condition of forged intermediate products 
or other selected equipment parts;  
5.2. a description of the prescribed quality of auxiliary materials;  
5.3. the dimensions and thickness of walls and information needed for their dimensioni ng; 
5.4. the placement, type, dimensions, values of coefficients of welded joints, and their 
class;  
5.5. types of checks, test media and their parameters, and acceptability criteria;  
5.6. descriptions and legends needed to understand drawings, schematics, and functions o f 
selected equipment; and  
5.7. the greatest permitted pressure, calculated temperature, and test pressure, in the case 
of pressure equipment;  
6. technical information regarding pressure gear, including its technical documentation if it is 
stand -alone selected equ ipment;  
7. technical information regarding safety equipment and equipment ensuring the functionality 
of pressure equipment;  
8. a list of technical regulations, technical standards, and technical specifications that were or 
should be used;  
9. certificates of suitab ility for solutions used in designing selected equipment;  
10. results of strength calculations, service life calculations, including conditions for their 
applicability, seismic resistance calculations, and other important technical information 
drawn up accord ing to technical standards and technical specifications used, or new 
scientific and technical developments;  
11. degradation mechanisms or impacts of ageing used in service life calculations;  
12. results of risk analyses in terms of technical safety performed durin g selected equipment 
design;  
13. certificates confirming compliance of material with technical specifications for basic and 
auxiliary materials used in the manufacture of selected equipment or parts thereof;  
14. technical specifications for the manufacture and ins tallation of selected equipment or 
similar documents that contain  
14.1. technical specifications for basic and auxiliary materials or intermediate products;  
14.2. specific requirements for materials processing technology, in particular  requirements 
for the thermal tre atment process and internal crystalline structure and homogeneity;  
14.3. a description of expected service conditions;  33 14.4. information important to reliability, service life, and other information important to 
technical safety;  
14.5. a description of initial, intra -operat ional, and final checks, acceptability criteria, 
media used during these checks, and their parameters;  
14.6. the method and scope for verifying the technical condition of selected equipment 
during its operation; and  
14.7. a description of the scope of accompanying tec hnical documentation for selected 
equipment;  
15. check plans and programmes for the design, manufacture, and installation of selected 
equipment;  
16. a preliminary managed ageing programme;  
17. a list of parts of selected equipment and technical requirements for these  parts of selected 
equipment;  
18. a description of technological procedures for manufacturing or installation, including a 
description of technical and organisational measures;  
19. regulations for the commissioning or operation of selected equipment;  
20. a list of wel ding supervisors and personnel checking and assessing permanent joints, 
including their authorisation and their name, surname, and date of birth, if a permanent 
joint is created during manufacturing or installation;  
21. a list of personnel performing special p rocesses, including the type and validity of their 
authorisation and their name, surname, and date of birth, if a special process is performed 
during manufacturing or installation; and  
22. sample record forms, including test attestation and certificates, used during manufacturing 
or installation of selected equipment.  
B. Technical documentation for the design, manufacture, and installation of selected 
control equipment  
Technical documentation for the design, manufacture, and installation of selected control 
equipm ent contains  
1. the name of the selected equipment, its identification, and description;  
2. the selected equipment design;  
3. identification of the manufacturer;  
4. drawings and schematics of parts and circuits containing  
4.1. a description of the prescribed quality of par ts of selected equipment; and  
4.2. descriptions and legends needed to understand drawings, schematics, and functions of 
selected equipment;  
5. a list of technical regulations, technical standards, and technical specifications that were or 
should be used;  
6. results o f risk analyses from the perspective of technical safety performed during selected 
equipment design;  
7. instruction manuals;  
8. the results of design calculations;  
9. results of service life calculations, including conditions for their applicability, seismic 
resist ance calculations, and other important technical information drawn up according to 
technical standards and technical specifications used, or new scientific and technical 
developments;  
10. degradation mechanisms or impacts of ageing used in service life calcula tions;  
11. check plans and programmes for the design, manufacture, and installation of selected 
equipment;  
12. a preliminary managed ageing programme;  34 13. test certificates from type examinations and results of assessments by independent test 
facilities;  
14. a list of par ts of selected equipment and technical requirements for these parts of selected 
equipment;  
15. requirements for checking selected equipment and parts thereof;  
16. a list of welding supervisors and personnel checking and assessing permanent joints, 
including their authorisation and their name, surname, and date of birth, if a permanent 
joint is created during manufacturing or installation;  
17. a list of personnel performing special processes, including the type and validity of their 
authorisation and their name, surname , and date of birth, if a special process is performed 
during manufacturing or installation;  
18. a description of the scope of accompanying technical documentation for selected 
equipment; and  
19. regulations for the installation, commissioning, and operation of se lected equipment.  
C. Technical documentation for the design, manufacture, and installation of selected 
structural equipment  
Technical documentation for the design, manufacture, and installation of selected structural 
equipment contains  
1. the name of the selecte d equipment, its identification, and description;  
2. the selected equipment design;  
3. a description of the structural part into which it will be incorporated;  
4. identification of how it will be incorporated into or used in the structural part;  
5. identification of  the manufacturer;  
6. a list of technical regulations, technical standards, and technical specifications that were or 
should be used;  
7. complete static calculations and dynamic calculations, if performed;  
8. manufacturing drawings and drawings of the structural pa rt into which the selected 
equipment will be incorporated, containing  
8.1. a description of the prescribed quality of parts of selected equipment;  
8.2. a description of the prescribed quality of materials used; and  
8.3. descriptions and legends needed to understand draw ings and functions of selected 
equipment;  
9. manufacturing, installation, and usage procedures for selected equipment, including 
requirements for  
9.1. pouring concrete and installing rebar;  
9.2. implementation of bushings, hermetic doors, hatches, and closures;  
9.3. impleme ntation of surface treatments of structures;  
9.4. implementation of individual terminals used for individual leak checks of individual 
parts of pressure equipment that is part of the protective envelope system; and  
9.5. implementation of structural electrical wiring ; 
10. information regarding the properties of structural or metal materials;  
11. results of service life calculations, including conditions for their applicability, seismic 
resistance calculations, and other important technical information drawn up according to 
technical standards and technical specifications used, or new scientific and technical 
developments;  
12. degradation mechanisms or impacts of ageing used in service life calculations;  
13. check plans and programmes for the design, manufacture, and installation of se lected 
equipment;  
14. a preliminary managed ageing programme;  35 15. a list of welding supervisors and personnel checking and assessing permanent joints, 
including their authorisation and their name, surname, and date of birth, if a permanent 
joint is created during  manufacturing or installation;  
16. a list of personnel performing special processes, including the type and validity of their 
authorisation and their name, surname, and date of birth, if a special process is performed 
during manufacturing or installation;  
17. records with the results of design and engineering calculations and tests, as well as 
certificates , if these were issued prior to conformity assessment; and  
18. a description of the scope of accompanying technical documentation for selected 
equipment.  36 Annex  4 to Decree  No 
Requirements for accompanying technical documentation for selected equipment  
Accompanying technical documentation for selected equipment must be drawn up in a well -
organised manner in order to document the results of conformity assurance and ver ification to 
the necessary degree for the entire duration of this equipment's operation.  
A. Accompanying technical documentation for pressure equipment and some other 
selected equipment and packaging for the transport, storage, and disposal of spent 
nuclear f uel 
Accompanying technical documentation for pressure equipment specified in §  12(3)(a) and 
(d), and packaging for the transport, storage, and disposal of spent nuclear fuel contains  
1. a technical passport made out by the manufacturer containing  
1.1. the name of the selected equipment, its identification, and description;  
1.2. a declaration of conformity;  
1.3. a check plan and programme for the design, manufacture, and installation of selected 
equipment in terms of fulfilment of the requirements they contain;  
1.4. material certi ficates;  
1.5. records of checks performed and their evaluation;  
1.6. thermal treatment records; and  
1.7. final assessment records;  
2. results of strength calculations, service life calculations, including conditions for their 
applicability, seismic resistance calculations, and other important technical information 
drawn up according to technical standards and technical specifications used, and new 
scientific and technical developments;  
3. a preliminary managed ageing programme;  
4. drawings for selected equipment containing  
4.1. an asse mbly drawing with the main connection dimensions;  
4.2. a drawing of individual parts of selected equipment;  
4.3. a drawing for the expected scope of repairs specified in the manual;  
4.4. axonometric schematics indicating individual welds, suspension points, fixed points,  
and supports, in the case of pipes, or  
4.5. drawings indicating individual welds, bushings, access holes, hatches, hermetic doors, 
or other equipment ensuring the protective envelope is hermetically sealed, in the 
case of pressure equipment making up the prote ctive envelope system;  
5. attestation certificates for welding technologies used;  
6. a list of personnel performing special processes, including the type and validity of their 
authorisation and their name, surname, and date of birth;  
7. a list of welding supervisor s and personnel checking and assessing permanent joints, 
including their authorisation and their name, surname, and date of birth;  
8. technical information regarding pressure gear, including its technical documentation if it 
is stand -alone selected equipment;  
9. technical information regarding safety equipment and equipment ensuring the 
functionality of pressure equipment;  
10. information regarding repairs performed during manufacturing or installation;  
11. documentation containing information concerning  technical safe ty during operation of 
selected equipment, in particular  an instruction manual and installation, commissioning, 
and operating instructions, including repair and maintenance instructions;  
12. documentation containing information concerning  managed ageing of sel ected equipment 
during its commissioning and operation, in particular  monitored parameters and their limit 37 values for monitoring and evaluation of the ageing of selected equipment and measures to 
be taken when the limit values of monitored parameters are r eached;  
13. records of repairs and maintenance performed on selected equipment, including records of 
the results of checks performed after repair, maintenance, or re -installation following 
repair or maintenance of selected equipment, or information as to where  these records are 
kept and archived; and  
14. records of modifications to selected equipment, including records of the results of checks 
performed after this equipment  has been re -installed , or information as to where these 
records are kept and archived.  
B. Accom panying technical documentation for selected control equipment  
Accompanying technical documentation for selected control equipment  contains  
1. the name of the selected equipment, its identification, and description;  
2. a declaration of conformity;  
3. a check plan and programme for the design, manufacture, and installation of selected 
equipment assessed in terms of fulfilment of the requirements they contain;  
4. a preliminary managed ageing programme;  
5. records of checks performed and inspection reports and their evalua tion; 
6. documentation containing information concerning  technical safety during operation of 
selected equipment, in particular an instruction manual and installation, commissioning, 
and operating instructions, including repair and maintenance instructions;  
7. a list of personnel performing special processes, including the type and validity of their 
authorisation and their name, surname, and date of birth;  
8. a list of welding supervisors and personnel checking and assessing permanent joints, 
including their authori sation and their name, surname, and date of birth;  
9. cable laying plans, including documentation regarding fire prevention measures in cable 
channels and areas where cables are located;  
10. selected equipment design, including internal schematics for switchgear;   
11. attestation certificates for welding technologies used;  
12. records of repairs and maintenance performed on selected equipment, including records of 
the results of checks performed after repair, maintenance, or re -installation following 
repair or maintenance  of selected equipment, or information as to where these records are 
kept and archived;  
13. documentation containing information concerning  managed ageing of selected equipment 
during its commissioning and operation, in particular  monitored parameters and thei r limit 
values for monitoring and evaluation of the ageing of selected equipment and measures to 
be taken when the limit values of monitored parameters are reached; and  
14. records of modifications to selected equipment, including records of the results of che cks 
performed after re -installation of this equipment, or information as to where these records 
are kept and archived.  
C. Accompanying technical documentation for selected structural equipment  
Accompanying technical documentation for selected structural equip ment contains  
1. the name of the selected equipment, its identification, and description;  
2. a declaration of conformity;  
3. a check plan and programme for the design, manufacture, and installation of selected 
equipment assessed in terms of fulfilment of the requi rements they contain;  
4. a preliminary managed ageing programme;  
5. results of strength calculations, service life calculations, including conditions for their 
applicability, seismic resistance calculations, and other important technical information 38 drawn up ac cording to technical standards and technical specifications used, and new 
scientific and technical developments;  
6. records of checks performed and their evaluation, including records from concrete 
property checks;  
7. selected equipment drawings and drawings of the structural part into which the selected 
equipment will be incorporated;  
8. documentation containing information regarding properties of selected equipment;  
9. a list of personnel performing special processes, including the type and validity of their 
authoris ation and their name, surname, and date of birth;  
10. a list of welding supervisors and personnel checking and assessing permanent joints, 
including their authorisation and their name, surname, and date of birth;  
11. identification of how it will be incorporated i nto or used in the structural part;  
12. documentation containing information concerning  technical safety during operation of 
selected equipment, in particular  commissioning and operating instructions, including 
repair and maintenance instructions; and  
13. documen tation containing information concerning  managed ageing of selected equipment 
during its commissioning and operation, in particular  monitored parameters and their limit 
values for monitoring and evaluation of the ageing of selected equipment and measures t o 
be taken when the limit values of monitored parameters are reached.  39 Annex  5 to Decree  No 
Essentials of a declaration of conformity  
A declaration of conformity for selected equipment contains  
1. identification of the declaration of conformity;  
2. identificatio n information of the person issuing the declaration of conformity;  
3. the name of the selected equipment, its identification, and basic description;  
4. identification of the structural part into which the selected equipment is to be 
incorporated, in the case of selected structural equipment;  
5. identification information of the manufacturer;  
6. identification information of the person performing the conformity assessment of selected 
equipment;  
7. references to technical requirements and technical specifications of selecte d equipment;  
8. information regarding the conformity assessment procedure or combination of conformity 
assessment procedures used;  
9. references to documents issued during conformity assessment by the person performing 
the conformity assessment to the extent sp ecified in individual conformity assessment 
procedures;  
10. references to legislation, technical regulations, technical standards, or technical 
specifications used;  
11. a declaration that the selected equipment meets the requirements of this Decree  from the 
manufa cturer, importer, or installer of the selected equipment ; 
12. the date the declaration of conformity was issued; and  
13. the name and function of the person authorised to sign the declaration of conformity for 
the person issuing the declaration of conformity.  
Identification information is the name(s), surname, residential or business address and ID 
number, if assigned, in the case of a natural person, or the company name, registered offices, 
and ID number in the case of a legal entity . 40 Annex  6 to Decree  No  
Requir ements for performance of selected equipment checks  
A. General checking requirements  
1. Basic requirements for the scope, type, and manner in which checks are performed during 
the design, manufacture, installation, commissioning, and operation of selected equipm ent 
and acceptability criteria used during these checks must be stipulated in  
1.1. technical documentation for selected equipment;  
1.2. documentation regarding repairs, maintenance, or modifications to selected 
equipment; or  
1.3. operating check programme s for selected e quipment:  
2. The scope, type, and manner in which checks are performed on selected equipment and 
acceptability criteria used during these checks must be chosen in a manner that proves that 
the selected equipment meets technical requirements.  
3. Selected equipmen t must be checked in accordance with procedures stipulated in the 
checks programme. Technical, organisational, and safety measures must be implemented 
to meet requirements for the scope, type, and manner in which checks are performed.  
4. Selected equipment ma y only be checked by personnel qualified to check selected 
equipment and authorised to perform this activity by a person is obliged to perform 
conformity assurance  that pursuant to §  57 of the Act ; only personnel authorised by a 
nuclear installation operat ing permit holder may check selected equipment that is in 
operation.  
5. All measuring instruments used during checks must at the time of the checks are 
performed have valid metrological calibration or verification in accordance with 
requirements for ensuring metrological uniformity and correctness of measuring 
instruments and measurements pursuant to the Metrology Act. Metrological continuity of 
measuring instruments used must be documented.  
6. The results of checks must be documented by a check performance recor d. A check 
performance records contains  
6.1. information regarding the subject of the check;  
6.2. a description of the scope of the check;  
6.3. a description of the procedure used during the check or the checking activity 
methodology;  
6.4. a list of measuring instruments and other devices used during the check; and  
6.5. an evaluation of the results of the check in terms of acceptability criteria used during 
the check.  
7. The list of checks performed must be confirmed by the signature and assigned mark of 
those performing them.  
B. Require ments for checks of selected equipment upon completion of manufacturing 
and installation, and checks of selected equipment performed within the scope of 
conformity assessment after repair, maintenance, or re -installation after repair or 
maintenance of sele cted equipment  
1. Final assessment  
1.1. Prior to commencing final assessment of selected equipment, authorised personnel 
performing supervision during the manufacture, installation, or repair of selected 
equipment must have at their disposal all documentation and information needed to 
perform the final assessment, including  in particular : 41 1.1.1.  final assessment procedures, including final test, pressure test, tightness test, or 
other equivalent test procedures; and  
1.1.2.  accompanying technical documentation for selected equipm ent. 
1.2. The conformity assessment is issued contingent on a positive final assessment.  
Final assessment of pressure equipment  
1.3. Final assessment of pressure equipment includes  
1.3.1.  a final test;  
1.3.2.  a pressure test, a tightness test, or other equivalent test; and  
1.3.3.  a chec k of safety equipment and equipment ensuring the functionality of 
pressure equipment;  
1.4. A pressure test, a tightness test, or other equivalent test  
1.4.1.  During a pressure test or tightness test, it must be verified that during test 
pressure the pressure equipment  does not exhibit significant deformation or 
leakage exceeding stipulated acceptability criteria.  
1.4.2.  If a pressure test or tightness test is unsuitable for or impossible to perform on 
the given pressure equipment, other equivalent tests must be performed that  
can be used to verify the strength and tightness of the pressure equipment.  
1.4.3.  A pressure test and tightness test is performed using hydraulic pressure 
prescribed in technical specifications for the given pressure equipment. The 
test hydraulic pressure must be stipulated pursuant to Point  2.12 of Part  A of 
Annex  1 to this Decree;  
1.5. Final test  
1.5.1.  During the final test, a visual inspection of the pressure equipment and a check 
of the accompanying technical documentation for the selected equipment must 
be performed t o assess whether the selected equipment and related quality 
assurance records are in mutual accord and comply with all requirements 
stipulated in technical documentation or compliance verification 
documentation.  
1.5.2.  Tests performed during the manufacturing of the pressure equipment can also 
be taken into account  in performing the final test . 
1.5.3.  During the final test, every part of the pressure equipment must be visually 
inspected internally as well as externally in terms of technical safety , if 
necessary . If this inspection cannot be arranged during the final test, especially 
in cases where the nature of the pressure equipment makes inspection of its 
individual parts impossible without the need for disassembly, this inspection 
can be performed during checking opera tions preceding the final test, and the 
final test will simply involve a check of the accompanying technical 
documentation.  
1.5.4.  The final test must primarily verify the following:  
1.5.4.1.  identification markings on the pressure equipment, including information 
on equi pment labels and information embossed on pressure parts and 
markings on materials, castings, and intermediate products;  
1.5.4.2.  the main dimensions of the equipment, the location of orifices, access 
holes, gear, feet, supports, and the assembly of individual parts  according 
to drawings;  
1.5.4.3.  the results of checks of welded joints via an external or internal 
inspection, including the results of prescribed checks during the 42 performance of special processes, welders' marks, welding supervision 
records, thermal treatment re cords, and materials certification of 
materials and intermediate products used; and  
1.5.4.4.  compliance with welders' marks placed on selected equipment with lists 
of welders, identifying their qualifications.  
1.6. Check of safety equipment and equipment ensuring the fu nctionality of pressure 
equipment;  
1.6.1.  A check of safety equipment and equipment ensuring the functionality of 
pressure equipment must be made to verify fulfilment of requirements 
stipulated  
1.6.1.1.  for safety equipment in Point  12 of Part A of Annex  1 to this Decree;  
1.6.1.2.  for electrical equipment in Point  13 of Part A of Annex  1 to this Decree; 
and 
1.6.1.3.  for hydraulic and pneumatic equipment providing control, regulation, 
signalling, and measurement during operation in Point  15 of Part  A of 
Annex  1 to this Decree.  
1.7. Final assessme nt after repair or modifications to selected equipment specified in 
§ 12(2)(a) or (b) must always be performed under the supervision of an authorised 
representative of a permit holder.  
1.8. A final assessment for pressure equipment that makes up the protective envelope 
system, equipment ensuring the protective envelope is hermetically sealed during a 
maximum design accident, including selected structural equipment, consists only of a 
final test that includes:  
1.8.1.  a check that the structure and relevant equipment ar e complete once 
construction and installation work has been completed;  
1.8.2.  a check that quality records for individual selected equipment are complete, 
including quality records for equipment ensuring they are hermetically sealed;  
1.8.3.  individual tightness checks of individual parts of pressure equipment that is 
part of the protective envelope system, dimensioned for internal overpressure; 
and 
1.8.4.  A pressure test and tightness test is performed using hydraulic pressure 
prescribed in technical specifications for the giv en pressure equipment.  
1.9. Successful performance of the final test is required for commencement of pressure 
tests, tightness tests, and other equivalent tests.  
1.10. A final test and a pressure test, tightness test, or other equivalent test performed 
within the sco pe of conformity verification following repair or re -installation 
following repair must be performed by a technical inspector pursuant to Decree No 
18/1979, which specifies certain pressure equipment subject to specific obligations 
and provides for certain  conditions to ensure the safety thereof, as amended.  
Final assessment of selected control equipment  
1.11. A final assessment of selected control equipment  only includes a final test, during 
which a visual inspection and a check of the accompanying technical 
documentation for the selected equipment must be performed to assess whether the 
selected equipment and related quality assurance records are in mutual accord and 
comply with all requirements stipulated in technical documentation or compliance 
verification do cumentation.  43 1.12. In performing the final test, tests performed during the manufacture of the selected 
control equipment  can also be taken into account.  
1.13. The final test of selected control equipment  must primarily verify the following:  
1.13.1.  identification of the sele cted equipment;  
1.13.2.  that checks stipulated in technical documentation or repair documentation for 
selected equipment were performed completely.  
2. Other checks after the completion of manufacture and installation of selected 
equipment  
2.1. Once the installation of pre ssure equipment has been completed, an individual test of 
the pressure equipment must be performed, if one has been stipulated in the design 
for this selected equipment, to verify that the equipment is complete and functional, 
and that it has been properly  installed.  
2.2. Once the installation of selected control equipment  that ensures the activity of 
emergency systems and primary circuit after -cooling systems has been completed, in 
particular  of their power, control, regulation, protection, signalling, and meas urement, 
their correct functionality must be verified.  
C. Requirements for checking selected equipment within the scope of regular 
conformity verification  
1. Checks performed as part of regular conformity verification must verify whether the 
technical condition of selected equipment has not deteriorated and whether it is suitable 
for continued operation.  
2. During conformity verification, it must be ensured that the following are performed:  
2.1. periodical operating checks;  
2.2. checks pursuant to the managed ageing operating  programme;  
2.3. a final assessment following repair or modification;  
2.4. periodic strength and tightness checks of the primary and secondary circuit of the 
nuclear installation;  
2.5. periodic strength and tightness checks of hermetic areas of the protective envelop 
system; and  
2.6. other checks prescribed by internal rules for the operation of the nuclear installation.  
3. Within the scope of conformity verification of selected equipment, it must be ensured that 
the following are performed:  
3.1. periodical operating checks;  
3.2. checks p ursuant to the managed ageing operating programme;  
3.3. a final assessment following repair or modification; and  
3.4. other checks prescribed by internal rules for the operation of the nuclear installation.  44 Annex  7 to Decree  No 
Conformity assessment procedures  
1. CONF ORMITY ASSESSMENT PROCEDURE A (INTERNAL 
MANUFACTURING CONTROL)  
1. A manufacturer, importer, or person installing selected equipment  after manufacture 
performing conformity assessment through this procedure must, in compliance with this 
procedure, ensure that the selected equipment meets the requirements of this Decree, and 
issue a declaration of conformity.  
2. A manufacturer, importer, or person installing selected equipment  after manufacture must 
ensure the performance of an initial selected equipment type exami nation on a sample and 
assess whether the selected equipment type meets technical requirements, technical 
standards, or technical specifications, in the case of selected structural equipment pursuant 
to § 12(3)(c).  
3. A manufacturer, importer, or person insta lling selected equipment  after manufacture must 
take all necessary measures to ensure the manufacturing process and its supervision 
ensures compliance of the selected equipment with the requirements of this Decree.  
4. A manufacturer, importer, or person insta lling selected equipment  after manufacture must 
ensure  that a final assessment is performed on every piece of selected equipment.  
5. If the selected equipment meets the requirements of this Decree, the manufacturer, 
importer, or person installing the selected  equipment after manufacture shall mark it with 
a conformity mark along with his identification, and issue a declaration of conformity; in 
the case of selected structural equipment pursuant to § 12(3)(c), a declaration of 
conformity can only be issued if t he selected equipment is the same as the type assessed 
pursuant to Point  2. 
2. CONFORMITY ASSESSMENT PROCEDURE A1 (INTERNAL 
MANUFACTURING CONTROL WITH SUPVERVISION OF FINAL 
ASSESSMENT)  
1. A manufacturer, importer, or person installing selected equipment  after ma nufacture 
performing conformity assessment through this procedure must, in compliance with this 
procedure and conformity assessment procedure A and under the supervision of an 
accredited or authorised person of the final assessment, ensure that the selecte d equipment 
meets the requirements of this Decree, and issue a declaration of conformity.  
2. An accredited or authorised person performs supervision of the final assessment by 
performing unannounced checks, within the scope of which  
2.1. he checks that the final a ssessment of the selected equipment is performed in 
compliance with final assessment requirements in Annex 6 to this Decree; and  
2.2. takes samples of selected equipment from manufacturing or storage areas for 
checking.  
3. The accredited or authorised person deter mines the number of pieces of selected 
equipment in the sample for which he shall include in conducting in the final assessment.  
4. In cases in which one or more pieces of selected equipment is not satisfactory, the 
accredited or authorised person shall speci fy suitable measures to eliminate the 
discrepancy.  45 5. Based on the results of supervision of the final assessment, the accredited or authorised 
person must issue a report on the check.  
6. If the performance of the final assessment complies with the requirements of this Decree, 
the accredited or authorised person shall mark the selected equipment for which he 
performed the supervision of final assessment with his identification; selected equipment 
may be marked with the identification of the accredited or authoris ed person by the 
manufacturer or importer based on authorisation by the accredited or authorised person.  
3. CONFORMITY ASSESSMENT PROCEDURE B (TYPE EXAMINATION)  
1. The manufacturer or importer must ensure, in compliance with this procedure, that the 
sample of se lected equipment that is to be manufactured (hereinafter the 'type') meets the 
requirements of this Decree.  
2. The type may include multiple modifications to selected equipment, assuming that 
differences between individual modifications do not affect its degr ee of technical safety.  
3. The manufacturer or importer must submit a request for a conformity assessment to the 
chosen authorised person. The request contains  
3.1. identification information of the manufacturer or importer, as follows:  
3.1.1.  the name(s), surname, resid ential or business address and ID number, if 
assigned, in the case of a natural person; or  
3.1.2.  the company name, registered offices, and ID number in the case of a legal 
entity ; 
3.2. a written declaration that a conformity assessment contract has not been concluded  
with a different authorised person;  
3.3. technical documentation for the selected equipment;  
3.4. its type; and  
3.5. other information on the selected equipment necessary for the conformity assessment, 
in particular  its safety class.  
4. The authorised person will ask for a dditional types if this is necessary for the performance 
of the test programme.  
5. An authorised person  
5.1. reviews technical documentation for the selected equipment, including an assessment 
of whether it meets requirements stipulated in Annex 3 to this Decree;  
5.2. assesses materials used, including assessment of material certificates pursuant to 
Point  13.9 of Part  A of Annex  2 to this Decree, if they were not already assessed by a 
different authorised person;  
5.3. checks technological procedures for the creation of perma nent joints pursuant to 
Point  6.6 of Part  A of Annex  2 to this Decree and approves these procedures, if they 
were not already approved by a different authorised person;  
5.4. checks that personnel performing special processes and welding supervisors have 
valid q ualification certificates, and approves these personnel pursuant to Point  6.6, 
7.2, and 8.3 of part A of Annex 2 to this Decree;  
5.5. performs checks or has them performed in order to determine whether technical 
standards or technical specifications have been used properly;  
5.6. reaches  an agreement with the manufacturer, importer, or person installing selected 
equipment  after manufacture regarding the location where verification of whether the 
type was manufactured in compliance with reviewed technical documentatio n will 
take place;  46 5.7. verifies whether the type is in compliance with the requirements of this Decree, 
including performing necessary related checks; and  
5.8. creates an inspection report on the assessment of activities specified in Points 5.1 to 
5.7 and their res ults. 
6. If the type complies with the requirements of this Decree, the authorised person shall issue 
the manufacturer, importer, or person installing selected equipment  after manufacture a 
type examination certificate. The certificate contains  
6.1. the name of th e selected equipment, its identification, and basic description;  
6.2. identification information of the manufacturer or importer, as follows:  
6.2.1.  the name(s), surname, residential or business address and ID number, if 
assigned, in the case of a natural person; or  
6.2.2.  the company name, registered offices, and ID number in the case of a legal 
entity ; 
6.3. the conclusions of the type examination;  
6.4. the expiry date of the certificate; and  
6.5. other documents needed to prove the type's compliance with the requirements of the 
Decree.  
7. The manufacturer or importer must inform the authorised person that issued the type 
examination certificate regarding all changes to the type described in the type examination 
certificate. If the type change could affect the selected equipment ’s compliance  with 
technical requirements, the authorised person verifies this change by proceeding in 
accordance with  Point 5, and if this change corresponds to the requirements of this 
Decree, issued an addendum to the original type examination certificate.  
8. The authori sed person keeps a copy of the type examination certificate and the inspection 
report on file.  
9. The authorised person informs the Office of type examination certificates or their addenda 
that have been issued, rescinded, suspended, or otherwise restricted, and makes them 
available to the Office upon request.  
10. The authorised person informs other authorised persons performing conformity 
assessment of type examination certificates or their addenda that have been issued, 
rescinded, suspended, or otherwise restric ted. 
4. CONFORMITY ASSESSMENT PROCEDURE B1 (DESIGN EXAMINATION)  
1. The manufacturer or importer must ensure, in compliance with this procedure, that the 
selected equipment design meets the requirements of this Decree.  
2. This conformity assessment procedure cannot be used for the experimental design 
method.  
3. The manufacturer or importer must submit a request for a conformity assessment to the 
chosen authorised person. The request contains  
3.1. identification information of the manufacturer or importer, as follows:  
3.1.1.  the nam e(s), surname, residential or business address and ID number, if 
assigned, in the case of a natural person; or  
3.1.2.  the company name, registered offices, and ID number in the case of a legal 
entity ; 
3.2. a written declaration that a conformity assessment contract ha s not been concluded 
with a different authorised person;  
3.3. technical documentation for the selected equipment;  47 3.4. the selected equipment design; and  
3.5. other information on the selected equipment necessary for the conformity assessment, 
in particular  its safety cl ass. 
4. The design may include multiple modifications to selected equipment being designed, 
assuming that differences between individual modifications do not affect its degree of 
technical safety.  
5. An authorised person  
5.1. reviews technical documentation for the s elected equipment, including an assessment 
of whether it meets requirements stipulated in Annex 3 to this Decree;  
5.2. assesses materials used, including assessment of material certificates pursuant to 
Point  13.9 of Part  A of Annex  2 to this Decree, if they wer e not already assessed by a 
different authorised person;  
5.3. checks technological procedures for the creation of permanent joints pursuant to 
Point  6.6 of Part  A of Annex  2 to this Decree and approves these procedures, if they 
were not already approved by a di fferent authorised person;  
5.4. checks that personnel performing special processes and welding supervisors have 
valid qualification certificates, and approves these personnel pursuant to Point  6.6, 
7.2, and 8.3 of part A of Annex 2 to this Decree;  
5.5. performs chec ks or has them performed in order to determine whether technical 
standards or technical specifications have been used properly;  
5.6. checks that the selected equipment design is in compliance with the requirements of 
this Decree; and  
5.7. creates an inspection repor t on the assessment of activities specified in Points 5.1 to 
5.6 and their results.  
6. If the selected equipment design complies with the requirements of this Decree, the 
authorised person shall issue the manufacturer, or importer a design examination 
certifi cate. The certificate contains  
6.1. the name of the selected equipment, its identification, and basic description;  
6.2. identification information of the manufacturer or importer, as follows:  
6.2.1.  the name(s), surname, residential or business address and ID number, if 
assigned, in the case of a natural person; or  
6.2.2.  the company name, registered offices, and ID number in the case of a legal 
entity ; 
6.3. the conclusions of the selected equipment design examination;  
6.4. the expiry date of the certificate; and  
6.5. other documents needed to p rove the compliance of the selected equipment design 
with the requirements of the Decree.  
7. The manufacturer or importer must inform the authorised person that issued the design 
examination certificate regarding all changes to the design described in the de sign 
examination certificate. If the design change could affect the selected equipment ’s 
compliance  with technical requirements, the authorised person verifies this change by 
proceeding pursuant to Point 5, and if this change corresponds to the requirement s of this 
Decree, issued an addendum to the original selected equipment design examination 
certificate.  
8. The authorised person keeps a copy of the design examination certificate and the 
inspection report on file.  48 9. The authorised person informs the Office of selected equipment design examination 
certificates or their addenda that have been issued, rescinded, suspended, or otherwise 
restricted, and makes them available to the Office upon request.  
10. The authorised person informs other authorised persons performing  conformity 
assessment of selected equipment design examination certificates or their addenda that 
have been issued, rescinded, suspended, or otherwise restricted.  
5. CONFORMITY ASSESSMENT PROCEDURE D (TYPE CONFORMITY BASED 
ON MANUFACTURING QUALITY ASSURANCE)  
1. A manufacturer, importer, or person installing selected equipment  after manufacture must, 
in compliance with this procedure and under the supervision of an authorised person, 
ensure that the selected equipment conforms to  
1.1. the type described in the type ex amination certificate pursuant to conformity 
assessment procedure B; or  
1.2. the selected equipment design described in the design examination certificate 
pursuant to conformity assessment procedure B1  
and meets the requirements of this Decree, and issue a decl aration of conformity . 
2. A manufacturer or person installing selected equipment  after manufacture must have 
implemented a management system, including a manufacturing quality assurance method, 
in accordance with the requirements of the decree on management s ystem requirements. 
An importer must have implemented a system of selected equipment checks.  
3. A manufacturer, importer, or person installing selected equipment  after manufacture must 
ensure that a  final assessment is performed on every piece of selected equ ipment.  
4. A manufacturer, importer, or person installing selected equipment  after manufacture must 
submit a request for a conformity assessment to the chosen authorised person. The request 
contains  
4.1. the identification information of the manufacturer, importer , or person installing 
selected equipment  after manufacture, as follows:  
4.1.1.  the name(s), surname, residential or business address and ID number, if 
assigned, in the case of a natural person; or  
4.1.2.  the company name, registered offices, and ID number in the case o f a legal 
entity ; 
4.2. a written declaration that a conformity assessment contract has not been concluded 
with a different authorised person;  
4.3. management system documentation applicable to the quality assurance method used 
for manufacturing or installation, or d ocumentation regarding a system of checks in 
the case of a request submitted by an importer;  
4.4. a copy of the type examination certificate or of the design examination certificate;  
4.5. technical documentation for the selected equipment; and  
4.6. other information on t he selected equipment necessary for the conformity assessment, 
in particular  its safety class.  
5. The authorised person assesses the management system of the manufacturer or person 
installing selected equipment  after manufacture, including the manufacturing q uality 
assessment method; and verifies that  
5.1. the management system ensures conformity of the selected equipment with the type 
described in the type examination certificate or the design of the selected equipment 
with the design examination certificate, incl uding conformity with technical 49 documentation for the selected equipment, and with the requirements of this Decree; 
and 
5.2. management system documentation contains:  
5.2.1.  a description of the objectives of the quality and organisational structure, 
including the rig hts and obligations of persons who plan and manage 
manufacturing or installation of selected equipment;  
5.2.2.  a description of manufacturing procedures, process quality management and 
assurance methods, and other systematic measures that will be used, in 
particu lar procedures ensuring the fulfilment of basic requirements for 
ensuring technical safety;  
5.2.3.  a description of checks that will be performed prior to commencement , during, 
and upon completion of manufacturing or installation, stating their frequency 
and acce ptability criteria applied during these checks;  
5.2.4.  quality assurance records for selected equipment; and  
5.2.5.  a description of means permitting supervision of achievement of the prescribed 
quality level for selected equipment and assessing the efficacy of the 
mana gement system in the area of assuring its quality.  
6. The management system must be assessed by an authorised person on the premises of the 
manufacturer or of the person installing selected equipment  after manufacturing. At least 
one employee of the authorise d person with experience in assessing the manufacturing 
process for the selected equipment and who is familiar with the requirements of this 
Decree shall participate in the assessment. The authorised person must inform the 
manufacturer, importer, or person  installing selected equipment  after manufacture of the 
results of the management system assessment, including requirements for elimination of 
any discrepancies.  
7. The importer must ensure that foreign manufacturers ’ management system s are assessed 
in accord ance with  Point 5 and 6. The authorised person assesses an importer's system of 
checks and ensures that the checks he performs on selected equipment ensure conformity 
of the selected equipment with the type described in the type examination certificate or the 
design of the selected equipment with the design examination certificate, including 
conformity with technical documentation for the selected equipment, and with the 
requirements of this Decree.  
8. If the management system complies with the requirements sp ecified in Point 5, the 
authorised person shall issue the manufacturer, importer, or person installing selected 
equipment  after manufacture a management system approval certificate.  
9. A manufacturer, importer, or person installing selected equipment  after ma nufacture must 
comply with requirements stipulated in the management system as approved by the 
authorised person, and ensure that it continues to be factually correct  and effective.  
10. A manufacturer, importer, or person installing selected equipment  after ma nufacture must 
provide the authorised person who approved  the management system information 
regarding planned changes to the management system described in the management 
system approval certificate. The authorised person shall assess the proposed change a nd 
decide whether the modified system complies with requirements pursuant to Point 5. The 
authorised person conveys the conclusions of the assessment, including justification, to 
the manufacturer, importer, or person installing selected equipment  after man ufacture, and 
if the change to the management system complies with requirements pursuant to Point 5, 
issues an addendum to the original management system approval certificate.  50 11.  Supervision by an authorised person  
11.1. Supervision must ensure that a manufacturer , importer, or person installing selected 
equipment  duly complies with requirements that follow from the examined 
management system, including manufacturing quality assurance requirements.  
11.2. A manufacturer, importer, or person installing selected equipment  after 
manufacture must grant the authorised person access to manufacturing, inspection, 
test, and storage areas in order to perform supervision, and provide him with all 
needed information.  
11.3. For purposes of supervision, an authorised person has implemented a  system of 
checks that specifies the type and frequency of checks performed on the premises 
of the manufacturer, importer, or person installing selected equipment  after 
manufacture.  
11.4. Within the scope of supervision, an authorised person performs regular che cks to 
make sure that the manufacturer, importer, or person installing selected equipment  
after manufacture maintains and applies the management system as it was 
approved. He chooses the frequency of regular checks so that a new complete audit 
takes place at least once every 12 months.  
11.5. Within the scope of supervision, an authorised person performs unannounced 
checks on the premises of a manufacturer, importer, or person installing selected 
equipment  after manufacture. The authorised person stipulates the ty pe and 
frequency of unannounced checks primarily taking into account  
11.5.1.  the safety class of the selected equipment;  
11.5.2.  the results of previous checks performed as part of supervision;  
11.5.3.  the need to monitor adherence to corrective measures; and  
11.5.4.  significant changes in the organisation of manufacturing or manufacturing 
concept or technology.  
11.6. During these checks, the authorised person may perform checks (or have them 
performed) to verify whether the management system is working correctly.  
11.7. Based on performed checks, an authorised person creates reports on the results of 
supervision and gives them to the manufacturer, importer, or person installing 
selected equipment  after manufacture.  
12. If the selected equipment complies with the requirements of this Decree and if it compl ies 
with the type described in the type examination certificate or the design described in the 
design examination certificate, the manufacturer, importer, or person installing selected 
equipment  after manufacture affixes a conformity mark along with his id entification, and 
under the responsibility of the authorised person, as well as his identification , and issues a 
declaration of conformity.  
13. The authorised person keeps a copy of the management system approval certificate and of 
the supervision results repo rt on file.  
14. The authorised person informs the Office of management system approval certificates or 
their addenda that have been issued, rescinded, suspended, or otherwise restricted, and 
makes them available to the Office upon request.  
15. The authorised perso n informs other authorised persons performing conformity 
assessment of management system approval certificates or their addenda that have been 
issued, rescinded, suspended, or otherwise restricted.  51 6. CONFORMITY ASSESSMENT PROCEDURE D1 (MANUFACTURING 
QUALITY ASSURANCE)  
1. A manufacturer, importer, or person installing selected equipment  after manufacture must  
ensure that the selected equipment conforms to the requirements of this Decree, and issue 
a declaration of conformity  in compliance with this procedure and under the supervision 
of an authorised person . 
2. A manufacturer or person installing selected equipment  after manufacture must have 
implemented a management system, including a manufacturing quality assurance method , 
in accordance with the requirements of th e decree on management system requirements. 
An importer must have implemented a system of selected equipment checks.  
3. A manufacturer, importer, or person installing selected equipment  after manufacture must 
ensure that a  final assessment is performed on eve ry piece of selected equipment.  
4. A manufacturer, importer, or person installing selected equipment  after manufacture must 
submit a request for a conformity assessment to the chosen authorised person. The request 
contains  
4.1. the identification information of th e manufacturer, importer, or person installing 
selected equipment  after manufacture, as follows:  
4.1.1.  the name(s), surname, residential or business address and ID number, if 
assigned, in the case of a natural person; or  
4.1.2.  the company name, registered offices, and  ID number in the case of a legal 
entity ; 
4.2. a written declaration that a conformity assessment contract has not been concluded 
with a different authorised person;  
4.3. management system documentation applicable to the manufacturing quality assurance 
method, or do cumentation regarding a system of checks in the case of a request 
submitted by an importer;  
4.4. technical documentation for the selected equipment; and  
4.5. other information on the selected equipment necessary for the conformity assessment, 
in particular  its safet y class.  
5. The authorised person assesses the management system of the manufacturer or person 
installing selected equipment  after manufacture, including the manufacturing quality 
assessment method; and verifies that  
5.1. the management system ensures compliance o f selected equipment with technical 
documentation for selected equipment and the requirements of this Decree; and  
5.2. management system documentation contains:  
5.2.1.  a description of the objectives of the quality and organisational structure, 
including the rights an d obligations of persons who plan and manage 
manufacturing or installation of selected equipment;  
5.2.2.  a description of manufacturing procedures, process quality management and 
assurance methods, and other systematic measures that will be used, in 
particular  procedures ensuring the fulfilment of basic requirements for 
ensuring technical safety;  
5.2.3.  a description of checks that will be performed prior to commencing, during, 
and upon completion of manufacturing or installation, stating their frequency 
and acceptabilit y criteria applied during these checks;  
5.2.4.  quality assurance records for selected equipment; and  52 5.2.5.  a description of means permitting supervision of achievement of the prescribed 
quality level for selected equipment and assessing the efficacy of the 
management s ystem in the area of assuring its quality.  
6. The management system must be assessed by an authorised person on the premises of the 
manufacturer or of the person installing selected equipment  after manufacturing. At least 
one employee of the authorised person  with experience in assessing the manufacturing 
process for the selected equipment and who is familiar with the requirements of this 
Decree shall participate in the assessment. The authorised person must inform the 
manufacturer, importer, or person install ing selected equipment after manufacture of the 
results of the management system assessment, including requirements for elimination of 
any discrepancies.  
7. The importer must ensure assessment of a foreign manufacturer's management system 
pursuant to Point 5 and 6. The authorised person assesses an importer's system of checks 
and ensures that the checks he performs on selected equipment ensure conformity of the 
selected equipment with the requirements of this Decree.  
8. If the management system complies with the requirements specified in Point 5, the 
authorised person shall issue the manufacturer, importer, or person installing selected 
equipment  after manufacture a management system approval certificate.  
9. A manufacturer, importer, or person installing selected equ ipment  after manufacture must 
comply with requirements stipulated in the management system as approved by the 
authorised person, and ensure that it continues to be factually correct  and effective.  
10. A manufacturer, importer, or person installing selected equ ipment  after manufacture must 
provide the authorised person who approved  the management system information 
regarding planned changes to the management system described in the management 
system approval certificate. The authorised person shall assess the pr oposed change and 
decide whether the modified system complies with requirements pursuant to Point 5. The 
authorised person conveys the conclusions of the assessment, including justification, to 
the manufacturer, importer, or person installing selected equi pment  after manufacture, and 
if the change to the management system complies with requirements pursuant to Point 5, 
issues an addendum to the original management system approval certificate.  
11. Supervision by an authorised person  
11.1. Supervision must ensure that a manufacturer , importer, or person installing selected 
equipment  duly complies with requirements that follow from the examined 
management system, including manufacturing or installation quality assurance 
requirements.  
11.2. A manufacturer, importer, or person i nstalling selected equipment  after 
manufacture must grant the authorised person access  to manufacturing, inspection, 
test, and storage areas in order to perform supervision, and provide him with all 
needed information.  
11.3. For purposes of supervision, an autho rised person has implemented a system of 
checks that specifies the type and frequency of checks performed on the premises 
of the manufacturer, importer, or person installing selected equipment  after 
manufacture.  
11.4. Within the scope of supervision, an authoris ed person performs regular checks to 
make sure that the manufacturer, importer, or person installing selected equipment  
after manufacture maintains and applies the management system as it was 
approved. He chooses the frequency of regular checks so that a n ew complete audit 
takes place at least once every 12 months.  53 11.5. Within the scope of supervision, an authorised person performs unannounced 
checks on the premises of a manufacturer, importer, or person installing selected 
equipment  after manufacture. The autho rised person stipulates the type and 
frequency of unannounced checks primarily taking into account  
11.5.1.  the safety class of the selected equipment;  
11.5.2.  the results of previous checks performed as part of supervision;  
11.5.3.  the need to monitor adherence to corrective meas ures; and  
11.5.4.  significant changes in the organisation of manufacturing or manufacturing 
concept or technology.  
11.6. During these checks, the authorised person may perform checks (or have them 
performed) to verify whether the management system is working correctly.  
11.7. Based on performed checks, an authorised person creates reports on the results of 
supervision and gives them to the manufacturer, importer, or person installing 
selected equipment  after manufacture.  
12. If the selected equipment complies with the requirements of this Decree, the 
manufacturer, importer, or person installing selected equipment  after manufacture affixes 
a conformity mark along with his identification, and under the responsibility of the 
authorised person, as well as his identification, and issues a declaration of conformity.  
13. The authorised person keeps a copy of the management system approval certificate and of 
the supervision results report on file.  
14. The authorised person informs the Office of management system approval certificates or 
their addend a that have been issued, rescinded, suspended, or otherwise restricted, and 
makes them available to the Office upon request.  
15. The authorised person informs other authorised persons performing conformity 
assessment of management system approval certificates or their addenda that have been 
issued, rescinded, suspended, or otherwise restricted.  
7. CONFORMITY ASSESSMENT PROCEDURE E (QUALITY ASSURANCE FOR 
SELECTED EQUIPMENT)  
1. A manufacturer, importer, or person installing selected equipment  after manufacture must, 
in compliance with this procedure and under the supervision of an authorised person, 
ensure that the selected equipment conforms to  
1.1. the type described in the type examination certificate pursuant to conformity 
assessment procedure B; or  
1.2. the selected equipmen t design described in the design examination certificate 
pursuant to conformity assessment procedure B1  
and meets the requirements of this Decree, and issue a declaration of conformity . 
2. A manufacturer or person installing selected equipment  after manufactu re must have 
implemented a management system, including a manufacturing quality assurance method, 
in accordance with the requirements of the decree on management system requirements. 
An importer must have implemented a system of selected equipment checks.  
3. A manufacturer, importer, or person installing selected equipment  after manufacture must 
ensure that a  final assessment is performed on every piece of selected equipment.  
4. A manufacturer, importer, or person installing selected equipment  after manufacture m ust 
submit a request for a conformity assessment to the chosen authorised person. The request 
contains  54 4.1. the identification information of the manufacturer, importer, or person installing 
selected equipment  after manufacture, as follows:  
4.1.1.  the name(s), surname , residential or business address and ID number, if 
assigned, in the case of a natural person; or  
4.1.2.  the company name, registered offices, and ID number in the case of a legal 
entity ; 
4.2. a written declaration that a conformity assessment contract has not been co ncluded 
with a different authorised person;  
4.3. management system documentation applicable to the manufacturing quality assurance 
method, or documentation regarding a system of checks in the case of a request 
submitted by an importer;  
4.4. a copy of the type exami nation certificate or of the design examination certificate;  
4.5. technical documentation for the selected equipment; and  
4.6. other information on the selected equipment necessary for the conformity assessment, 
in particular  its safety class.  
5. The authorised person assesses the management system of the manufacturer or person 
installing selected equipment  after manufacture, including the manufacturing quality 
assessment method; and verifies that  
5.1. the management system ensures conformity of the selected equipment with t he type 
described in the type examination certificate or the design of the selected equipment 
with the design examination certificate, including conformity with technical 
documentation for the selected equipment, and with the requirements of this Decree; 
and 
5.2. management system documentation for manufacturing contains:  
5.2.1.  a description of the objectives of the quality and organisational structure, 
including the rights and obligations of persons who plan and manage 
manufacturing or installation of selected equipm ent; 
5.2.2.  a description of manufacturing procedures, process quality management and 
assurance methods, and other systematic measures that will be used, in 
particular  procedures ensuring the fulfilment of basic requirements for 
ensuring technical safety;  
5.2.3.  a descr iption of checks that will be performed upon completion of 
manufacturing or installation, stating their frequency and acceptability criteria 
applied during these checks;  
5.2.4.  quality assurance records for selected equipment; and  
5.2.5.  a description of means permittin g supervision of achievement of the prescribed 
quality level for selected equipment and assessing the efficacy of the 
management system in the area of assuring its quality.  
6. The management system must be assessed by an authorised person on the premises of t he 
manufacturer or of the person installing selected equipment  after manufacturing. At least 
one employee of the authorised person with experience in assessing the manufacturing 
process for the selected equipment and who is familiar with the requirements o f this 
Decree shall participate in the assessment. The authorised person must inform the 
manufacturer, importer, or person installing selected equipment  after manufacture of the 
results of the management system assessment, including requirements for elimin ation of 
any discrepancies.  
7. The importer must ensure assessment of a foreign manufacturer's management system 
pursuant to Point 5 and 6. The authorised person assesses an importer's system of checks 
and ensures that the checks he performs on selected equi pment ensure conformity of the 55 selected equipment with the type described in the type examination certificate or the 
design of the selected equipment with the design examination certificate, including 
conformity with technical documentation for the selecte d equipment, and with the 
requirements of this Decree.  
8. A manufacturer or person installing selected equipment  after manufacture must examine 
each piece of selected equipment upon completion of manufacture or installation. An 
importer must examine each piec e of selected equipment within the scope of import. 
Within the scope of examination, checks specified in technical documentation for selected 
equipment must be performed in order to ensure conformity of the selected equipment 
with the type described in the  type examination certificate or the design of the selected 
equipment with the design examination certificate, and with the requirements of this 
Decree.  
9. If the management system complies with the requirements specified in Point 5, the 
authorised person sha ll issue the manufacturer, importer, or person installing selected 
equipment  after manufacture a management system approval certificate.  
10. A manufacturer, importer, or person installing selected equipment  after manufacture must 
comply with requirements stipu lated in the management system as approved by the 
authorised person, and ensure that it continues to be factually correct  and effective.  
11. A manufacturer, importer, or person installing selected equipment  after manufacture must 
provide the authorised person who approved  the management system information 
regarding planned changes to the management system described in the management 
system approval certificate. The authorised person shall assess the proposed change and 
decide whether the modified system complie s with requirements pursuant to Point 5. The 
authorised person conveys the conclusions of the assessment, including justification, to 
the manufacturer, importer, or person installing selected equipment  after manufacture, and 
if the change to the management  system complies with requirements pursuant to Point 5, 
issues an addendum to the original management system approval certificate.  
12. Supervision by an authorised person  
12.1. Supervision must ensure that a manufacturer, importer, or person installing selected 
equipment  duly complies with requirements that follow from the examined 
management system, including quality assurance requirements for the selected 
equipment.  
12.2. A manufacturer, importer, or person installing selected equipment  after 
manufacture must grant the a uthorised person access  to manufacturing, inspection, 
test, and storage areas in order to perform supervision, and provide him with all 
needed information.  
12.3. For purposes of supervision, an authorised person has implemented a system of 
checks that specifies the type and frequency of checks performed on the premises 
of the manufacturer, importer, or person installing selected equipment  after 
manufacture.  
12.4. Within the scope of supervision, an authorised person performs regular checks to 
make sure that the manufac turer, importer, or person installing selected equipment  
after manufacture maintains and applies the management system as it was 
approved. He chooses the frequency of regular checks so that a new complete audit 
takes place at least once every 12 months.  
12.5. Within the scope of supervision, an authorised person performs unannounced 
checks on the premises of a manufacturer, importer, or person installing selected 56 equipment  after manufacture. The authorised person stipulates the type and 
frequency of unannounced c hecks primarily taking into account  
12.5.1.  the safety class of the selected equipment;  
12.5.2.  the results of previous checks performed as part of supervision;  
12.5.3.  the need to monitor adherence to corrective measures; and  
12.5.4.  significant changes in the organisation of manufactur ing or manufacturing 
concept or technology.  
12.6. During these checks, the authorised person may perform checks (or have them 
performed) to verify whether the management system is working correctly.  
12.7. Based on performed checks, an authorised person creates reports  on the results of 
supervision and gives them to the manufacturer, importer, or person installing 
selected equipment  after manufacture.  
13. If the selected equipment complies with the requirements of this Decree and if it complies 
with the type described in th e type examination certificate or the design described in the 
design examination certificate, the manufacturer, importer, or person installing selected 
equipment  after manufacture affixes a conformity mark along with his identification, and 
under the respo nsibility of the authorised person, as well as his identification , and issues a 
declaration of conformity.  
14. The authorised person keeps a copy of the management system approval certificate and of 
the supervision results report on file.  
15. The authorised person  informs the Office of management system approval certificates or 
their addenda that have been issued, rescinded, suspended, or otherwise restricted, and 
makes them available to the Office upon request.  
16. The authorised person informs other authorised person s performing conformity 
assessment of management system approval certificates or their addenda that have been 
issued, rescinded, suspended, or otherwise restricted.  
8. CONFORMITY ASSESSMENT PROCEDURE E1 (QUALITY ASSURANCE FOR 
SELECTED EQUIPMENT CHECKS AND TES TS) 
1. A manufacturer, importer, or person installing selected equipment  after manufacture must, 
in compliance with this procedure and under the supervision of an authorised person, 
ensure that the selected equipment conforms to the requirements of this Decre e, and issue 
a declaration of conformity.  
2. A manufacturer or person installing selected equipment  after manufacture must have 
implemented a management system, including a manufacturing quality assurance method, 
in accordance with the requirements of the dec ree on management system requirements. 
An importer must have implemented a system of selected equipment checks.  
3. A manufacturer, importer, or person installing selected equipment  after manufacture must 
ensure that a  final assessment is performed on every pi ece of selected equipment.  
4. A manufacturer, importer, or person installing selected equipment  after manufacture must 
submit a request for a conformity assessment to the chosen authorised person. The request 
contains  
4.1. the identification information of the man ufacturer, importer, or person installing 
selected equipment  after manufacture, as follows:  
4.1.1.  the name(s), surname, residential or business address and ID number, if 
assigned, in the case of a natural person; or  57 4.1.2.  the company name, registered offices, and ID n umber in the case of a legal 
entity ; 
4.2. a written declaration that a conformity assessment contract has not been concluded 
with a different authorised person;  
4.3. management system documentation applicable to the manufacturing quality assurance 
method, or docume ntation regarding a system of checks in the case of a request 
submitted by an importer;  
4.4. technical documentation for the selected equipment; and  
4.5. other information on the selected equipment necessary for the conformity assessment, 
in particular  its safety cl ass. 
5. The authorised person assesses the management system of the manufacturer or person 
installing selected equipment  after manufacture, including the manufacturing quality 
assessment method; and verifies that  
5.1. the management system ensures compliance of se lected equipment with technical 
documentation for selected equipment and the requirements of this Decree; and  
5.2. management system documentation for manufacturing contains:  
5.2.1.  a description of the objectives of the quality and organisational structure, 
including  the rights and obligations of persons who plan and manage 
manufacturing or installation of selected equipment;  
5.2.2.  a description of manufacturing procedures, process quality management and 
assurance methods, and other systematic measures that will be used, in 
particular  procedures ensuring the fulfilment of basic requirements for 
ensuring technical safety;  
5.2.3.  a description of checks that will be performed upon completion of 
manufacturing or installation, stating their frequency and acceptability criteria 
applied during these checks;  
5.2.4.  quality assurance records for selected equipment; and  
5.2.5.  a description of means permitting supervision of achievement of the prescribed 
quality level for selected equipment and assessing the efficacy of the 
management system in the area o f assuring its quality.  
6. The management system must be assessed by an authorised person on the premises of the 
manufacturer or of the person installing selected equipment  after manufacturing. At least 
one employee of the authorised person with experience in  assessing the manufacturing 
process for the selected equipment and who is familiar with the requirements of this 
Decree shall participate in the assessment. The authorised person must inform the 
manufacturer, importer, or person installing selected equipm ent after manufacture of the 
results of the management system assessment, including requirements for elimination of 
any discrepancies.  
7. The importer must ensure assessment of a foreign manufacturer's management system 
pursuant to Point 5 and 6. The authoris ed person assesses an importer's system of checks 
and ensures that the checks he performs on selected equipment ensure conformity of the 
selected equipment with the requirements of this Decree.  
8. A manufacturer or person installing selected equipment  after m anufacture must examine 
each piece of selected equipment upon completion of manufacture or installation. An 
importer must examine each piece of selected equipment within the scope of import. 
Within the scope of examination, checks specified in technical do cumentation for selected 
equipment must be performed in order to ensure conformity of the selected equipment 
with the requirements of this Decree.  58 9. If the management system complies with the requirements specified in Point 5, the 
authorised person shall iss ue the manufacturer, importer, or person installing selected 
equipment  after manufacture a management system approval certificate.  
10. A manufacturer, importer, or person installing selected equipment  after manufacture must 
comply with requirements stipulated in the management system as approved by the 
authorised person, and ensure that it continues to be factually correct  and effective.  
11. A manufacturer, importer, or person installing selected equipment  after manufacture must 
provide the authorised person who ap proved  the management system  with information 
regarding planned changes to the management system described in the management 
system approval certificate. The authorised person shall assess the proposed change and 
decide whether the modified system complies  with requirements pursuant to Point 5. The 
authorised person conveys the conclusions of the assessment, including justification, to 
the manufacturer, importer, or person installing selected equipment  after manufacture, and 
if the change to the management system complies with requirements pursuant to Point 5, 
issues an addendum to the original management system approval certificate.  
12. Supervision by an authorised person  
12.1. Supervision must ensure that a manufacturer , importer, or person installing selected 
equip ment  duly complies with requirements that follow from the examined 
management system, including quality assurance requirements for the selected 
equipment.  
12.2. A manufacturer, importer, or person installing selected equipment  after 
manufacture must grant the au thorised person access  to manufacturing, inspection, 
test, and storage areas in order to perform supervision, and provide him with all 
needed information.  
12.3. For purposes of supervision, an authorised person has implemented a system of 
checks that specifies t he type and frequency of checks performed on the premises 
of the manufacturer, importer, or person installing selected equipment  after 
manufacture.  
12.4. Within the scope of supervision, an authorised person performs regular checks to 
make sure that the manufact urer, importer, or person installing selected equipment  
after manufacture maintains and applies the management system as it was 
approved. He chooses the frequency of regular checks so that a new complete audit 
takes place at least once every 12 months.  
12.5. Within the scope of supervision, an authorised person performs unannounced 
checks on the premises of a manufacturer, importer, or person installing selected 
equipment  after manufacture. The authorised person stipulates the type and 
frequency of unannounced ch ecks primarily taking into account  
12.5.1.  the safety class of the selected equipment;  
12.5.2.  the results of previous checks performed as part of supervision;  
12.5.3.  the need to monitor adherence to corrective measures; and  
12.5.4.  significant changes in the organisation of manufacturi ng or manufacturing 
concept or technology.  
12.6. During these checks, the authorised person may perform checks (or have them 
performed) to verify whether the management system is working correctly.  
12.7. Based on performed checks, an authorised person creates reports on the results of 
supervision and gives them to the manufacturer, importer, or person installing 
selected equipment  after manufacture.  
13. If the selected equipment complies with the requirements of this Decree, the 
manufacturer, importer, or person installing  selected equipment  after manufacture affixes 59 a conformity mark along with his identification, and under the responsibility of the 
authorised person, as well as his identification, and issues a declaration of conformity.  
14. The authorised person keeps a copy of the management system approval certificate and of 
the supervision results report on file.  
15. The authorised person informs the Office of management system approval certificates or 
their addenda that have been issued, rescinded, suspended, or otherwise rest ricted, and 
makes them available to the Office upon request.  
16. The authorised person informs other authorised persons performing conformity 
assessment of management system approval certificates or their addenda that have been 
issued, rescinded, suspended, or  otherwise restricted.  
9. CONFORMITY ASSESSMENT PROCEDURE F (VERIFICATON OF 
SELECTED EQUIPMENT)  
1. A manufacturer, importer, or person installing selected equipment  after manufacture must, 
in compliance with this procedure, ensure that the selected equipment con forms to  
1.1. the type described in the type examination certificate pursuant to conformity 
assessment procedure B;  
1.2. the selected equipment design described in the design examination certificate 
pursuant to conformity assessment procedure B1; or  
1.3. a type approved pursuant to §  138 of the Act, in the case of selected equipment 
specified in §  12(2)(b) Point  5; 
and meets the requirements of this Decree, and issue a declaration of conformity.  
2. A manufacturer, importer, or person installing selected equipment  after manuf acture must 
implement all necessary measures so that the manufacturing or installation process and its 
checking ensures conformity of the selected equipment with the type described in the type 
examination certificate, the design of the selected equipment w ith the design examination 
certificate, or with the type approved pursuant to §  138 of the Act and with the 
requirements of this Decree.  
3. A manufacturer, importer, or person installing selected equipment  after manufacture must 
ensure that a final assessment  is performed on every piece of selected equipment.  
4. A manufacturer or person installing selected equipment  after manufacture must examine 
each piece of selected equipment upon completion of manufacture or installation. An 
importer must examine each piece o f selected equipment within the scope of import. 
Within the scope of examination, checks specified in technical documentation for selected 
equipment must be performed in order to ensure conformity of the selected equipment 
with the type described in the ty pe examination certificate, the design of the selected 
equipment with the design examination certificate, or with the type approved pursuant to 
§ 138 of the Act and with the requirements of this Decree.  
5. A manufacturer, importer, or person installing select ed equipment  after manufacture must 
submit a request for a conformity assessment to the chosen authorised person. The request 
contains  
5.1. the identification information of the manufacturer, importer, or person installing 
selected equipment  after manufacture, as follows:  
5.1.1.  the name(s), surname, residential or business address and ID number, if 
assigned, in the case of a natural person; or  
5.1.2.  the company name, registered offices, and ID number in the case of a legal 
entity ; 60 5.2. a written declaration that a conformity ass essment contract has not been concluded 
with a different authorised person;  
5.3. technical documentation for the selected equipment;  
5.4. a copy of the type examination certificate, of the design examination certificate, or of 
the type approval decision pursuant to § 138 of the Act; and  
5.5. other information on the selected equipment necessary for the conformity assessment, 
in particular  its safety class.  
6. An authorised person  
6.1. assesses materials used, including assessment of material certificates pursuant to 
Point  13.9 of  Part A of Annex  2 to this Decree, if they were not already assessed by a 
different authorised person;  
6.2. checks technological procedures for the creation of permanent joints pursuant to 
Point  6.6 of Part  A of Annex  2 to this Decree and approves these procedu res, if they 
were not already approved by a different authorised person;  
6.3. checks that personnel performing special processes and welding supervisors have 
valid qualification certificates, and approves these personnel pursuant to Point  6.6, 
7.2, and 8.3 of p art A of Annex 2 to this Decree;  
6.4. supervises final assessment;  
6.5. verifies that each piece of selected equipment conforms to the type described in the 
type examination certificate, the design of the selected equipment with the design 
examination certificate, o r with the type approved pursuant to §  138 of the Act, and 
meets the requirements of this Decree, including the performance of necessary related 
checks; and  
6.6. creates an inspection report on the assessment of activities specified in Points 6.1 to 
6.5 and the ir results.  
7. If the selected equipment complies with the requirements of this Decree and if it conforms 
to the type described in the type examination certificate, the design described in the design 
examination certificate, or with the type approved pursuant  to § 138 of the Act, the 
authorised person issues the manufacturer, importer, or person installing selected 
equipment  after manufacture a selected equipment verification certificate for each piece of 
selected equipment. The certificate contains  
7.1. the name o f the selected equipment, its identification, and basic description;  
7.2. the identification information of the manufacturer, importer, or person installing 
selected equipment  after manufacture, specifically  
7.2.1.  the name(s), surname, residential or business address  and ID number, if 
assigned, in the case of a natural person; or  
7.2.2.  the company name, registered offices, and ID number in the case of a legal 
entity ; 
7.3. the conclusions of the verification of the selected equipment; and  
7.4. other documentation required to prove con formity of the selected equipment with the 
type described in the type examination certificate, the design of the selected 
equipment with the design examination certificate, or the type approval decision 
pursuant to §  138 of the Act, and with the requiremen ts of this Decree.  
8. If the selected equipment complies with the requirements of this Decree and if it complies 
with the type described in the type examination certificate, the design of the selected 
equipment with the design examination certificate, or the type approval decision pursuant 
to § 138 of the Act, the manufacturer, importer, or person installing selected equipment  
after manufacture affixes a conformity mark along with his identification, and under the 61 responsibility of the authorised person, as we ll as his identification , and issues a 
declaration of conformity.  
9. The authorised person keeps a copy of the selected equipment verification certificate and 
the inspection report on file.  
10. The authorised person informs the Office of selected equipment verifi cation certificates 
that have been issued, rescinded, suspended, or otherwise restricted, and makes them 
available to the Office upon request.  
11. The authorised person informs other authorised persons performing conformity 
assessment of selected equipment ver ification certificates or their addenda that have been 
issued, rescinded, suspended, or otherwise restricted.  
10. CONFORMITY ASSESSMENT PROCEDURE G (VERIFICATION OF A 
COMPLEX)  
1. A manufacturer, importer, or person installing selected equipment  after manufacture must, 
in compliance with this procedure, ensure that the selected equipment conforms to the 
requirements of this Decree, and issue a declaration of conformity.  
2. A manufacturer, importer, or person installing selected equipment  after manufacture must 
submit a request for a conformity assessment to the chosen authorised person. The request 
contains  
2.1. the identification information of the manufacturer, importer, or person installing 
selected equipment  after manufacture, as follows:  
2.1.1.  the name(s), surname, residenti al or business address and ID number, if 
assigned, in the case of a natural person; or  
2.1.2.  the company name, registered offices, and ID number in the case of a legal 
entity ; 
2.2. a written declaration that a conformity assessment contract has not been concluded 
with a different authorised person;  
2.3. technical documentation for the selected equipment;  
2.4. the selected equipment design; and  
2.5. other information on the selected equipment necessary for the conformity assessment, 
in particular  its safety class.  
3. A manufacturer, imp orter, or person installing selected equipment  after manufacture must 
ensure that a  final assessment is performed on every piece of selected equipment.  
4. A manufacturer or person installing selected equipment  after manufacture must examine 
each piece of sele cted equipment upon completion of manufacture or installation. An 
importer must examine each piece of selected equipment within the scope of import. 
Within the scope of examination, checks specified in technical documentation for selected 
equipment must be  performed in order to ensure conformity of the selected equipment 
with the requirements of this Decree.  
5. An authorised person  
5.1. reviews technical documentation for the selected equipment, including an assessment 
of whether it meets requirements stipulated i n Annex 3 to this Decree;  
5.2. assesses materials used, including assessment of material certificates pursuant to 
Point  13.9 of Part  A of Annex  2 to this Decree, if they were not already assessed by a 
different authorised person;  62 5.3. checks technological procedures  for the creation of permanent joints pursuant to 
Point  6.6 of Part  A of Annex  2 to this Decree and approves these procedures, if they 
were not already approved by a different authorised person;  
5.4. checks that personnel performing special processes and weldin g supervisors have 
valid qualification certificates, and approves these personnel pursuant to Point  6.6, 
7.2, and 8.3 of part A of Annex 2 to this Decree;  
5.5. performs verification and needed checks or has them performed in order to determine 
whether technical  standards or technical specifications have been used properly;  
5.6. checks that the selected equipment design is in compliance with the requirements of 
this Decree;  
5.7. supervises final assessment;  
5.8. verifies whether each piece of selected equipment is in compliance  with the 
requirements of this Decree, including performing necessary related checks; and  
5.9. creates an inspection report on the assessment of activities specified in Points 5.1 to 
5.8 and their results.  
6. If the selected equipment complies with the requirement s of this Decree, the authorised 
person shall issue the manufacturer, importer, or person installing selected equipment  after 
manufacture a verification certificate for the complex. The certificate contains  
6.1. the name of the selected equipment, its identific ation, and basic description;  
6.2. the identification information of the manufacturer, importer, or person installing 
selected equipment  after manufacture, specifically  
6.2.1.  the name(s), surname, residential or business address and ID number, if 
assigned, in the cas e of a natural person; or  
6.2.2.  the company name, registered offices, and ID number in the case of a legal 
entity ; 
6.3. the conclusions of the verification of the complex; and  
6.4. other documents needed to prove the compliance of the selected equipment design 
and the sel ected equipment with the requirements of the Decree.  
7. If the selected equipment complies with the requirements of this Decree, the 
manufacturer, importer, or person installing selected equipment  after manufacture affixes 
a conformity mark along with his ide ntification, and under the responsibility of the 
authorised person, as well as his identification , and issues a declaration of conformity.  
8. The authorised person keeps a copy of the complex verification certificate and the 
inspection report on file.  
9. The aut horised person informs the Office of complex verification certificates that have 
been issued, rescinded, suspended, or otherwise restricted, and makes them available to 
the Office upon request.  
10. The authorised person informs other authorised persons perform ing conformity 
assessment of complex verification certificates that have been issued, rescinded, 
suspended, or otherwise restricted.  63 Annex  8 to Decree  No 
Requirements for compliance verification  
VERIFICATION OF PART OF SELECTED EQUIPMENT (PROCEDURE F1)  
1. A manufacturer, importer, or person installing selected equipment  after manufacture must, 
in compliance with this procedure, ensure that the part of selected equipment conforms to 
the requirements of this Decree, and issue a declaration of conformity.  
2. A manu facturer, importer, or person installing selected equipment  after manufacture must 
take all necessary measures to ensure the manufacturing process and its supervision 
ensure compliance of the part of selected equipment with the requirements of this Decree.  
3. A manufacturer, importer, or person installing selected equipment  after manufacture must 
ensure that a  final assessment is performed on every part of selected equipment.  
4. A manufacturer or person installing selected equipment  after manufacture must examine  
each part of selected equipment upon completion of manufacture or installation. An 
importer must examine each part of selected equipment within the scope of import. Within 
the scope of examination, checks specified in technical documentation for selected 
equipment applicable to the assessed part of the selected equipment must be performed in 
order to ensure conformity of the part of selected equipment with the requirements of this 
Decree.  
5. A manufacturer, importer, or person performing installation of a par t selected equipment 
after manufacture must submit a request for a conformity assessment to the chosen 
authorised person. The request contains  
5.1. the identification information of the manufacturer, importer, or person performing 
installation of part of select ed equipment after manufacture, as follows:  
5.1.1.  the name(s), surname, residential or business address and ID number, if 
assigned, in the case of a natural person; or  
5.1.2.  the company name, registered offices, and ID number in the case of a legal 
entity ; 
5.2. a written d eclaration that a conformity assessment contract has not been concluded 
with a different authorised person;  
5.3. the part of technical documentation for selected equipment applicable to the assessed 
part of the selected equipment; and  
5.4. other information on the s elected equipment and part of the selected equipment 
necessary for the conformity assessment, in particular  its safety class.  
6. An authorised person  
6.1. assesses materials used, including assessment of material certificates pursuant to 
Point  13.9 of Part  A of An nex 2 to this Decree, if they were not already assessed by a 
different authorised person;  
6.2. checks technological procedures for the creation of permanent joints pursuant to 
Point  6.6 of Part  A of Annex  2 to this Decree and approves these procedures, if they 
were not already approved by a different authorised person;  
6.3. checks that personnel performing special processes and welding supervisors have 
valid qualification certificates, and approves these personnel pursuant to Point  6.6, 
7.2, and 8.3 of part A of Anne x 2 to this Decree;  
6.4. supervises final assessment; and  
6.5. verifies whether each part of selected equipment is in compliance with the 
requirements of this Decree, including performing necessary related checks.  64 7. If the part of selected equipment complies with the requirements of this Decree, the 
authorised person shall issue the manufacturer, importer, or person installing selected 
equipment  after manufacture a verification certificate for the part of selected equipment. 
The certificate contains  
7.1. the name of the par t of selected equipment, its identification, and basic description;  
7.2. the identification information of the manufacturer, importer, or person performing 
installation of the part of selected equipment after manufacture, specifically  
7.2.1.  the name(s), surname, resi dential or business address and ID number, if 
assigned, in the case of a natural person; or  
7.2.2.  the company name, registered offices, and ID number in the case of a legal 
entity ; and  
7.3. the conclusions of the selected equipment verification.  
8. If the part of select ed equipment complies with the requirements of this Decree, the 
manufacturer, importer, or person installing selected equipment  after manufacture affixes 
a conformity mark along with his identification, and under the responsibility of the 
authorised person , as well as his identification , and issues a declaration of conformity.  
9. The authorised person keeps a copy of the part of selected equipment verification 
certificate and the inspection report on file.  
Requirements for the scope of and method for verifying  conformity of selected 
equipment in operation with technical requirements  
1. Checks performed within the scope of conformity assessment of selected equipment with 
technical requirements are subject to general requirements for checks pursuant to Part A 
of Ann ex 6 to this Decree.  
2. Every piece of selected equipment in operation must be checked in compliance with  
2.1. internal rules;  
2.2. an operating check programme ; and  
2.3. documentation regarding repairs, maintenance, or modifications to selected 
equipment.  
3. When stipulating requirements for the scope, type, manner, and periodicity with which 
checks of selected equipment in operation are performed and acceptability criteria used 
during these checks, in particular  the following must be taken into account:  
3.1. the properties of the selected equipment;  
3.2. stipulated conditions for safe operation;  
3.3. requirements of internal rules for the operation of the nuclear installation; and  
3.4. existing skills and experience with the operation of selected equipment and nuclear 
installations.  
4. Personnel per forming checks must be informed of plans for operating checks prior to their 
commencement.  65 Annex  9 to Decree  No 
Conformity mark  
1. The conformity mark is the capital Greek letter delta in this shape:  
 
2. If the conformity mark is reduced or enlarged, its propo rtions given by the grid in the 
figure shown in Point  1 must be preserved.  
3. The conformity mark must be at least 5 mm wide.  
4. The sample conformity mark is displayed on an auxiliary grid that is not part of the mark 
and is used for its proportional enlargemen t or reduction in size.