ML23331A901
| ML23331A901 | |
| Person / Time | |
|---|---|
| Site: | 07103103 |
| Issue date: | 08/15/1997 |
| From: | Office of Nuclear Material Safety and Safeguards, Secured Transportation Services |
| To: | Boyle R US Dept of Transportation (DOT), Office of Hazardous Materials Safety |
| Shared Package | |
| ML23331A891 | List: |
| References | |
| EPID L-2023-DOT-0004, CAC 001794 | |
| Download: ML23331A901 (20) | |
Text
REGULATION 214/1997 Sb.
of the State Office for Nuclear Safety of August 15, 1997 on Quality Assurance in Activities Related to the Utilization of Nuclear Energy and in Radiation Practices, and Laying Down Criteria for the Assignment and Categorization of Classified Equipment into Safety Classes
The State Office for Nuclear Safety stipulates according to § 47, par. 7 to implement § 2, ad i), § 4, par. 7, § 13, par. 3, ad d) and par. 5 of the Law No.
18/1997 Sb. on peaceful utilisation of nuclear energy and ionising radiation (Atomic Law) including amendments and supplements of related acts (further on the Law):
PART ONE INTRODUCTORY PROVISIONS
§ 1 Subject and extent of regulation The Regulation codifies:
a) the implementation of the quality assurance system, b) the requirements for the quality system, c) the requirements for the quality assurance of selected equipment with regard to their ranking into safety classes, d) the requirements for the contents programmes of the quality assurance, e) the criteria for ranking and distribution of selected equipment into the safety
- classes, f) the extent and the way of performance the list of selected equipment.
§ 2 Implementation of quality assurance system (1) The quality assurance system for the activities connected with the using of nuclear energy and for the activities leading to the radiation exposure, except the activities according to § 2, ad a), par.6 of the Law shall be implemented with minimum extent of requirements according to § 3 and § 5 of this Regulation.
(2) The quality assurance system for the siting, construction of workplace with very significant source of ionising radiation, operation of workplace with very significant or significant source of ionising radiation1), and during the handling with the radioactive waste from the nuclear installations shall be implemented in the
1 extent of requirements of § 3 - 20 of this Regulation. This provision is not used for temporary workplace with source of ionising radiation.
(3) The quality assurance system for activities during the siting, construction, commissioning, operation and the decommissioning the nuclear installations shall be implemented in the extent of requirements according to § 3 - 24 of this Regulation.
This provision is also in corresponding measure related to the important activities connected, which are the designing and the performance the reconstruction of nuclear installations and their parts, designing, fabricating, erecting, maintenance, repairing and the verification of selected equipment including the materials used for the manufacturing, handling with the spare parts of selected equipment.
(4) The quality assurance system for activities according to paragraph 1 is necessary to implement and to document before the performance relevant activity.
(5) The quality assurance system for licensed activities according § 9 of the Law, shall be documented by the programmes of the quality assurance, the contents of which is stipulated in § 32 of this Regulation, and subsequent documentation on the quality assurance for all activities important of viewpoint of nuclear safety and radiation protection, and implemented by the licensee before the relevant licence issue.
(6) The quality assurance system for activities during the siting, construction, commissioning and the operation, including the decommissioning the nuclear installation, includes not only activities directly performed by the licensee, but also activities important of viewpoint of nuclear safety and radiation protection, performed by the supplying or subsupplying way, and so that as the whole shall be implemented and documented.
- 1) The Regulation of the State Office for Nuclear Safety No 184/ 1997 Sb., about requirements of the radiation protection.
PART TWO REQUIREMENTS TO THE QUALITY ASSURANCE SYSTEM
§ 3 Before the performance of activities connected with the using of nuclear energy and activities leading to the radiation exposure according to § 2 par. 1 of this Regulation, shall be:
a) identified the products, relations, systems and the persons (further on the items) important from the viewpoint of nuclear safety and radiation protection, b) stipulated and documented responsibilities, competencies and mutual links of persons who manage, perform, evaluate and verify the activities influencing the quality of items important from the viewpoint of nuclear safety and radiation protection,
2 c) stipulated and documented the procedure for the partial activities or their comprehensive sets important from the viewpoint of nuclear safety and radiation protection (further on processes).
d) ensured the sufficient financial, personal, technical and other sources, preconditions necessary for the performance of activities influencing the quality of items important from the viewpoint of nuclear safety and radiation protection.
§ 4 Before the performance of activities according to § 2, par 1 of this Regulation, shall be stipulated way and frequency of evaluation the quality system from the viewpoint of its compatibility and effectiveness with regard to the stipulated requirements.
§ 5 During the performance of activities connected with the using nuclear energy and activities leading to the exposure according § 2, par. 1 of this Regulation, there shall be:
a) performed and verified processes so that it may be ensured that their outputs (further on products) will be in the accordance with the stipulated requirements (technical guidelines, agreed specifications, standards, technical conditions, agreed administrative rules and procedures etc.).
b) kept records about the results of quality system evaluation and processes verification.
c) ensured the real persons, who control, verify, evaluate and perform the processes, may fulfil stipulated qualification and may be trained.
§ 6 The processes directly affecting quality of item and being important from the viewpoint of nuclear safety and radiation protection are planned and performed under the controlled conditions. These controlled conditions shall include:
a) the documented procedures, b) the appropriate equipment and appropriate environmental conditions, so that the requirements on the quality item may be fulfilled, c) the conformance with the established (stipulated) documentation, d) the monitoring the parameters and characters of item, e) the approval of documentation by the authorised (competent) persons, f) the explicit and understandable criteria on the quality item, g) ensured permanent qualification of item by the appropriate maintenance of equipment, h) the performance of activities by the qualified personnel.
§ 7
3 (1) Design of contracts, the subject of which is related to the items influencing the nuclear safety and radiation protection, shall be subjected at process of the timely (early) review the contract, before is the contract concluded, and about this review shall be performed the written record.
(2) The process of contract creation shall be ensured:
a) the clear and sufficient contractual formulation of requirements dealing with the quality items, quality assurance and records on the quality, b) the contractual party qualification to fulfil the contractual requirements according to letter a),
c) the manner stipulation of performance of contract amendments.
(3) The check (inspection) performed by the customer or the verification of supplied item, that influences the nuclear safety and the radiation protection, from the viewpoint of fulfilment of demands stipulated in par. 2, letter a), shall be agreed contractually.
§ 8 (1) The process of procurement of items important from the viewpoint of nuclear safety and radiation protection shall be performed the measures for the assurance of coincidence of supplied item with the contractual requirements, and further its measures which ensured:
a) the assessment and the approval of suppliers, including the supervision over the suppliers, and the stipulation of criteria for this approval and assessment, b) the sufficient frequency and the extent of supervision over the suppliers, in dependence on the importance of supplied item of viewpoint of nuclear safety and radiation protection, c) that in the documentation for the procurement there may be included the correct and complete requirements on the procured item, and on the processes related with the items, including the requirements of the processes verification and at the extent of the quality demonstration of procurement item, (2) The records supporting that items are in accordance with the requirements for the procurement, shall be at disposal before the use of pertinent item and they shall sufficiently prove that individual requirements were fulfilled in the procurement item.
§ 9 For the process of creation, development, and construction and of items design (further on design process) shall be stipulated content the measures which ensured:
a) the fulfilment of requirements from the viewpoint of nuclear safety and radiation protection, made on the designed item, b) the planning of sufficient sources ensuring the stages of application, creation, review and verification of design of item,
4 c) the definition of organisational and technical boundary among the organisational formations of persons and individual persons, who enter into the design process, d) the pursuing, recording, verification and the reviewing correctness and completeness of the important information from the viewpoint of nuclear safety and radiation protection, transferring in the frame of boundary, e) in the design process and in the documented outputs the consideration of requirements of legal rules related to the item, and of agreed specifications, standards, technical conditions, rules and procedures with a special respect to the nuclear safety and radiation protection, so that the deviations from these requirements shall be identified and recorded, f) the review of correctness of application and its subsequent record, on the review, g) such elaboration of documentation of resulting output of design process, so that its verification and review may be possible to perform, h) the planning and performance of review of output documentation of design process before its release in suitable stages, by both, who participated on its creation and who are impartial, sufficiently qualified persons, according to the need and importance of reviewed facts, and the keeping the records on this review, i) so that all amendments of output documentation of design process may be documented, reviewed and approved by the analogous manner as the original documentation by the competent persons with regard to the relevance of amendment.
§ 10 The processes of manipulation with the documentation and with the data important from the viewpoint of nuclear safety and radiation protection shall ensure:
a) the review and the approval of correctness, completeness and fitness of documentation and data important from the viewpoint of nuclear safety and radiation protection, including their amendments by the competent persons before their
- release, b) the identification of present state and the subsequent stipulation and implementation of such measures so that the use of void documentation and data may be prevented, c) the explicit identification of documentation and data, d) the stipulation of space of archiving time and keeping the documentation and data with the fact that they shall be at disposal at those working places, where they are necessary for performance of activities, e) so that all documentation and data necessary for performance of activities may be at disposal to all persons performing the activities important from the viewpoint of nuclear safety and radiation protection in the language that enables them the perfect understanding the documented subject.
§ 11
5 (1) For the identification of products important from the viewpoint of nuclear safety and radiation protection in the course of stages connected with these products shall be elaborated the procedures that assured:
a) the explicit identification and its performance by the acceptable means either directly on the product or in the form of records related to the product, b) so that in advance the incorrect use of product or its parts may be prevented, c) so that the identification mark on the product need not reduce the level of features of products quality important from the viewpoint of nuclear safety and radiation protection, (2) If is ensured the pursuing the product shall be connected for the stages with the pertinent product there shall be stipulated the procedures, which ensure so that the state of product and the manipulation with the product may be pursued at any time.
(3) The pursuing according to par. 2 is required for the selected equipment and their parts in the course of fabricating, mounting, inspections, transport, storage, commissioning and operation.
(4) The pursuing is also required during the manipulation with the ionising radiation sources, radioactive waste and nuclear materials.
§ 12 (1) For inspection and test processes for verification of quality product important from the viewpoint of nuclear safety and radiation protection shall be elaborated plans and procedures for their performance taking into account that:
a) if the inspection has the points that require witnessing without which the work is not possible to proceed, these specific hold points shall be indicated in the relevant documentation, b) the inspections and tests shall be performed and evaluated in the sequence that is included in the appropriate programmes and plans, c) initiation the performance of the follow-up (subsequent) activities at the control and test shall be conditional either by the successful evaluation of a given inspection or test, or by the review of product, if the product is not conform to the specified requirements, d) the inspection and test procedures shall be include the stipulation that ensures the requisite conditions for the given inspection or test, and the criteria for the results evaluation.
(2) There shall be created and maintained records providing the proof of evidence that the product was inspected or tested, and that it complied with the established (stipulated) criteria.
§ 13 For the inspection, calibrating, control and the maintenance of control, measuring and testing equipment there shall be established the procedures, that shall
6 ensure that the uncertainty of measurements is known and is conform to the required measurement qualification.
§ 14 For the state designation of product important from the viewpoint of nuclear safety and radiation protection, by the acceptable means after its inspection and tests, there shall be elaborated the procedures that ensure that there will be only used such product, that successfully passed by the required inspections and tests, or that was released after the proceeding on the discordant product.
§ 15 The process of proceeding dealing with the product important from the viewpoint of nuclear safety and radiation protection, that does not satisfy the quality requirements (further on discordant product), ensures so that a) the discordant product may be examined and, either repaired or reprocessed, or used without the reparation or the reprocessing, however, its quality shall not subsequently be more degraded, so that the level of nuclear safety and radiation protection shall be not negatively influenced.
b) this discordant product shall be not used without the examination of discordant product and without the subsequent record of decision on the appropriate repair, reprocessing and its use according to letter a),
c) the reviewed or repaired product may be submitted to the repeated inspections and tests for those quality indicators that can be affected, under the same or comparable conditions as the original product.
§ 16 (1) The ensured identification of conditions and disagreements negatively influencing the level of nuclear safety and radiation protection without delay, there shall be elaborated the procedures that ensure the finding the causes of these conditions and disagreements and the performance of corrective actions for the solution of disagreements and prevention of their repetition.
(2) For the processes determined for the exclusion of causes of possible disagreements (further on preventive measures) the procedures shall be elaborated.
(3) There is necessary to ensure so that the procedures according to (1) and (2) may include the means for the documentation of changes following from the corrective and preventive measures.
§ 17 The processes of handling, storing, packing, protection and delivering the product important from the viewpoint of nuclear safety and radiation protection shall
7 be created in such a manner so that during them the damage or degradation of required level of the quality of product may be excluded.
§ 18 For the identification, collection, registering, storing, archiving, conservation and the disposal of the records important from the viewpoint of nuclear safety and radiation protection (further on the records) it is necessary:
a) to maintain the records that evidence the conformance of item with the established (stipulated) requirements, b) to ensure in order that these records may be legible, and in order that their loss, deterioration, unauthorised handling or other misuse may be prevented, c) to establish (stipulate) the retention and archiving times of records, d) to ensure that the records may be unambiguously identifiable, retrievable for the use, and they may be minimally archived for the period of life-time of the pertinent item, to that the records are related in such a way so that it may be at any time possible to pursue the state of items important from the viewpoint of nuclear safety and radiation protection, for which the pursuit is required.
§ 19 The process of planning and performance of the quality assurance to verify the agreement of the implemented quality assurance system with this Regulation shall be created and shall ensure so that a) the audits may hold the adequate extent and regularity, so that on the basis of results of these audits the whole quality assurance system may be verified for the compliance with the requirements of this Regulation, at least once in two years, b) the results of audits may be documented and submitted to the persons responsible for the area audited, c) impartial persons who are sufficiently qualified and experienced shall perform the audits, independent on those who are responsible for the activity audited, d) the remedy and corrective measures may be implemented in time and may be subsequently verified.
§ 20 For the finding the needs of training and for ensured proper personnel training influencing the items quality important from the viewpoint of nuclear safety and radiation protection, there are stipulated (established) the procedures that include:
a) the stipulation of qualification criteria for this personnel, b) the manner of manipulation and conservation of records on the training and on the qualification achieved,
8 c) the way of assurance of demonstrable training the pertinently qualified personnel, so that the personnel may be capable to perform the assigned work and so that the personnel may understand the significance of its activities from the viewpoint of nuclear safety and radiation protection.
§ 21 (1) The design process of nuclear installation shall be stipulated and documented the procedures for the selection and the assessment of suitability of use of individual items requisite for the performance of functions important from the viewpoint of nuclear safety, including the individual selected equipment and their materials and shall be realised requirements on the design of nuclear installation.
(2) In the documentation of design of nuclear installation there shall be comprised the documents evidencing that the types of equipment, systems, software and constructions ranked as the selected equipment are suitable and their parameters and the adjustments fulfil the requirements on the design of nuclear installation.
(3) The impartial sufficiently qualified persons, who were not participated in the original elaboration of documented design, shall carry on, the verification of process of design of nuclear installation including the review of output documentation.
(4) The documentation of design of nuclear installation shall be reviewed from the viewpoint of nuclear safety and approved by the sufficiently qualified persons determined by the licensee, namely in the suitable agreed stages.
(5) The viewpoints for the assessment, the support computations, the analyses in the course of process of design of nuclear installation shall be recorded so that they may be reviewed and verified.
(6) The procedures for the verification of design of nuclear installation shall be created so that it may be ensured the verification of correctness of design by the suitable methods as there is the performance of analyses using the variant computational methods, the application of suitable test programme, the comparison with the analogue tested design, and the review of documentation of design before its release.
(7) The design of nuclear installation at normal, abnormal and accident conditions, accidents, including the over design actions is verified from the viewpoint of nuclear safety of ionising radiation, especially from the viewpoint:
a) the reactor physics, b) the thermal hydraulic, c), loading, reliability the functional capability, service life on the selected equipment.
(8) In the frame of design of nuclear installation there are further verified:
a) the adequacy of the materials used at selected equipment, b) the accessibility for the in-service inspections, the maintenance, the repairs and the appropriate replacement of the selected equipment,
9 c) the proposal of methods and the acceptance criteria for the inspections and tests at the selected equipment, d) the ranking the selected equipment into the safety classes.
10
§ 22 (1) The processes for the activities during the operation of nuclear installation, there shall be the evidenced, in case construction, where nuclear reactor is part of this construction, especially:
a) the operation control, including the abnormal emergency operation and liquidation of the breakdowns and accidents, b) the shut down control, c) the notification and the evaluation of incidents and accidents, d) the control of experiments and tests, e) the control of crew (work shift personnel, staff),
f) qualification and preparation the personnel, g) the maintenance and the repair of selected equipment, including their indication and assurance, h) the tests and inspections of selected equipment and their software during the operation, including evaluation their results, i) the evaluation of conditions (state) of selected equipment and their service life
- using, j) the performance and the proposals of changes and reconstruction, including the creation of the safety related documentation of such changes, k) the preservation, storing and protection of the selected equipment and spare parts for selected equipment, l) the calibration of measuring instruments (gauge),
m) the handling with nuclear fuel, n) the handling with nuclear waste, o) the control of outlet (discharge),
p) the water chemistry, q) the radiation protection and radioactive waste, r) the monitoring of environment, s) the fire protection, t) the physical protection, u) the emergency preparedness and planning.
(2) For other nuclear installations is hold par.1, at extent applicable for given equipment types.
§ 23
11 (1) The processes of welding, non-destructive examinations, heat treatment, coatings, software development and other processes the results of which can not be fully verified by the follow-up (subsequent) inspection and test (further on specific processes), shall have established the qualification criteria and they shall fit to these qualification criteria. The specific processes are performed by the adequately qualified personnel whose competence and capability to perform the given activity is regularly verified.
(2) The equipment for the performance of specific processes shall be qualified and this qualification is verified.
(3) On the fulfilment of qualification criteria and on the verification of the qualification competence according to par. 1 and 2 the records are kept.
§ 24 (1) The verification of realisation requirement taxed on the processes or items shall be performed by the persons participating on these processes or items, as by the independent or external persons, which are delegated to execute independent verification by the relevant level of management.
(2) The evaluation of the quality system shall be performed by the representatives of all control levels of processes and items, on which is the quality system related, as by the independent or external persons, who are delegated to execute independent evaluation by the relevant level of management.
(3) The persons, who perform the verification and evaluation, shall record the way and results of verification according to par.1 and evaluation according to par.2.
(4) Persons who perform independent verification in accordance with par.1, or independent evaluation in accordance with par.2, shall not directly participated at the processes or items, which are object of verification, also shall not have authority to control these processes or items, and shall have sufficient authority to give the results and reports about their own verification or evaluation to representatives of high level of management, where is verification or evaluation performed.
(5) The results of the independent verification and evaluation shall be to taken into account, and if is necessary corrective measures shall be performed.
(6) The evaluation of quality system and control verification of the quality assurance and quality of supplied items important from the viewpoint of nuclear safety, which are performed by the user (customer) and suppliers licensee shall be contractually agreed.
(7) Till the time of determination of possible consequences of evaluation of revealed disagreements of items important from the viewpoint of nuclear safety, there is necessary to judge the disagreement as the defect in accordance with its extreme unfavourable influence on the nuclear safety and to perform the measures corresponding to this state.
12 PART THREE REQUIREMENTS FOR QUALITY ASSURANCE OF SELECTED EQUIPMENT
§ 25 The selected equipment shall be explicitly established (stipulated) before the order for the nuclear installation, and their inventory shall be documented in the form of list of selected equipment.
§ 26 The documentation about the quality assurance (quality handbooks, manual of the quality assurance, the quality plan, etc.) on the selected equipment of the suppliers shall be review and approval by the respective licensee and about the approval shall be performed record.
§ 27 (1) To the design process of individual selected equipment of the safety class 1, and the equipment and systems ranked into the safety class 2, in the relevant extent the requirement of § 21 of this Regulation.
(2) The resulting documented design of selected equipment of the safety class 1 and the equipment and systems ranked into the safety class 2 shall include the quality criteria that are necessary for the assurance of functions important from the viewpoint of nuclear safety.
(3) The resulted documented design of selected equipment shall include the stipulation and justification of the prerequisite life time of selected equipment or its parts, and the conditions for the manipulation with the selected equipment and for the operation with it.
(4) The selected equipment with the specification of the safety classes shall be designated in the break-down of design, or in the drawing documentation of design and in the drawing documentation of actual state of nuclear installation.
(5) In the cases, in which for the verification of correctness of specific design characteristics of selected equipment there is applied the programme of tests instead of other verified processes, this programme shall include the acceptable tests of qualification of the prototype during the worse possible designed conditions. The results of verification are recorded.
§ 28 (1) The records dealing with the specific processes according to § 23 par. 3 of this Regulation, the records on quality and the records on the verification of design of selected equipment ranked into the safety classes 1 and 2, that include the evidence that there were fulfilled all quality criteria important from the viewpoint of nuclear
13 safety required for the selected equipment, for their parts and for the material used, shall be archived, kept (maintain) and completed during all stages of life time of selected equipment, starting with the design of selected equipment and its parts, till its putting out of operation.
(2) To the records on the quality according to par. 1 there shall be also includes the records on the quality of selected equipment of the safety class 1 and the equipment stressed by the internal overpressure of the safety class 2, that documented the location, size, frequency and the type of suppressed defects revealed by the inspection, way of performance of their repair and the abandon admissible defects (the size, frequency, type, location, etc.). The way of determination of defects, shall be included in the design of selected equipment.
(3) The licensee for the operation of nuclear installation shall ensure that the records on the quality of selected equipment of the safety classes 1 and 2 may be kept, archived, retrieved and completed in such extent and quality so that it may be possible to judge on their basis the state of selected equipment at any time.
§ 29 For the confirmation of approval with the requirements on the quality of supplied selected equipment, there shall be together with the selected equipment minimally delivered the certificate on the quality and the completeness of the supply, that includes the inventory of these requirement and the evaluation of results, that were found and recorded during the test and inspection activities.
§ 30 (1) In the course of operation of nuclear installation there can be only used the spare parts of selected equipment, that are qualified from the viewpoint of requirement on the quality of selected equipment, and of requirement on the records on the quality. To the spare parts of selected equipment are related the same requirements on the quality assurance as on the proper selected equipment.
(2) For the operation of nuclear installations there shall be stipulated the documented the plans and the procedures of preventive maintenance and repair of selected equipment so that the required level of quality of these equipment may be preserved. On the performed activities of maintenance and of repair the records shall be kept.
§ 31 (1) During the performance of repeated inspections and tests of selected equipment during the operation, including the shut down, there is necessary from the reason of comparability of results to use the comparable methods and instruments with those that were used during the performance of the first inspection or test, or such methods and instruments, that the comparability of results explicitly enables.
14 (2) The used methods of inspections and tests have such level of sensitivity in order that it may be possible with the acceptable uncertainty to evaluate the admissibility of found facts from the viewpoint of nuclear safety.
PART FOUR REQUIREMENTS ON CONTENTS OF QUALITY ASSURANCE PROGRAMMES
§ 32 The quality assurance programmes shall include:
a) the trade name, the location and the status of legal or real person of licensee and his/her direct suppliers of items important from the viewpoint of nuclear safety, b) the subject, the location and the extent of activities of licensee, c) the inventory of items important from the viewpoint of nuclear safety and radiation protection, including the processes to which the programme of the quality assurance is related, with the designation of activities important from the viewpoint of nuclear safety that are performed by the supplying way, d) the description of licensees quality system, including authorities, responsibilities and way of control and the organisational assurance, authorities and responsibilities individual elements of this system, e) the particular requirement of this Regulation on the quality system and on the suppliers and subsuppliers quality assurance of the items important from the viewpoint of the nuclear safety, including the evaluation way of the quality system and verification of the quality assurance of these suppliers and subsuppliers, f) the schedule of implementation of parts of quality system for the activities that are not immediately linked to the relevant license, g) the list of the follow-up (subsequent) documentation of the quality assurance with its explicit identification, h) the way and the frequency of audits on the approval with this Regulation, ensured by the licensee, and the way and the form of the recording these results of audits, i) the procedure of performance of reviews (revisions) and amendments of programme of the quality assurance and the follow-up (subsequent) documentation on the condition, that the procedure of verification and approval of revisions and amendments shall be performed according to the same principles as the original programme was.
15 PART FIVE CRITERIA FOR RANKING AND DISTRIBUTION OF SELECTED EQUIPMENT INTO SAFETY CLASSES
§ 33 (1) The selected equipment is ranked into three safety classes.
(2) The selected equipment can be also the component or its part that is important from the viewpoint of fulfilment of safety function of other selected equipment.
(3) The criteria for ranking and separating the selected equipment into the safety classes for the nuclear installations, part of which is a nuclear reactor, which is uses the chain fissions on thermal neutrons and is light water moderated and cooled, as for the nuclear installations for the radioactive waste storage, for the spent fuel storage, for the disposals of radioactive waste and spent nuclear fuel, and for equipment, fabricating, preparation, storing and depositing the nuclear materials are given in the Annex of this Regulation.
PART SIX SCOPE AND METHOD OF PERFORMANCE OF LIST OF SELECTED EQUIPMENT
§ 34 (1) The list of selected equipment is a separate document that:
a) shall be elaborated by both, text and drawings, b) precisely identifies the individual selected equipment, including the systems ranked into the selected equipment with the specification of their safety classes, the list is clearly arranged from the viewpoint of fulfilment of individual functions.
(2) On the drawings there shall be schematically included the technological systems, that include the selected equipment well arranged, so that there may be differentiated the safety classes and the boundaries between the selected equipment and the other equipment. Further, there shall be included the basic technological and quality parameters, design designation of equipment and of systems, and the other data from which the function of equipment in the given technological system follows.
(3) On the drawings there shall be the simplified sketches of construction, include the designation of construction part that is ranked into the selected equipment, so that there may be marked the safety classes, boundaries between the selected equipment, and the other parts of construction. Further, there shall be included the data from which there is explicitly evident where the selected equipment in the frame of construction are located, and where are the boundaries.
16 (4) The part of list of selected equipment there shall be the boundary (limit) and more accurate conditions that explicitly define the rules for the establishment (stipulation) of boundary among the systems ensuring the different safety functions, and the boundary between the individual classes of selected equipment.
(5) As the boundary between safety classes pass through the selected equipment there shall be on the drawings included the simplified sketch of selected equipment in which there are included the data, of which there is explicitly evident, where are these boundaries located.
(6) The list of selected equipment, including its amendments, shall correspond to the actual state of approved design documentation, and in the stage of operation to the actual state of nuclear installation.
(7) During every design amendment there is performed the analysis, if the amendment in the list of selected equipment does not come into existence. If such amendment is provoked there shall be decided, if it deals with the amendment influencing the nuclear safety.
PART SEVEN TEMPORARY AND CONCLUDING PROVISIONS
§ 35 The persons, stipulated in § 47, par. 3 of the Law and their suppliers and subsupplier performing their activities according to the approved programmes of quality assurance on the basis of decision - making according to § 7, par. 1, ad b) or d) of the Law No. 28/1984 Sb, on the state supervision on the nuclear safety of nuclear installations till the time of adaptation of their legal approaches to this Regulation, perform their activities at the non-difference, according to these approved programmes of quality assurance so that the amendments of programmes of quality assurance are approved as the amendments of documentation, according to § 17, par. 2, ad g) of the Law, and up to the time of approval of programme of quality assurance of licensee for the construction, individual stages of the commissioning and for the operation, according to § 13, par. 5 of the Law, there are considered as this programme the set of individual, partial and reference programmes of quality assurance approved on the basis of the Law No. 28/1984 Sb., on state supervision on the nuclear safety of nuclear installations.
§ 36 This Regulation comes into force by the day of proclamation.
The Chairman Ing. -tuller
17 ANNEX CRITERIA FOR RANKING AND DISTRIBUTION OF SELECTED EQUIPMENT INTO SAFETY CLASSES
A. The safety classes for nuclear installations the part of which is a nuclear reactor which uses the chain fissions on thermal neutrons and is light water moderated and cooled.
(1) The selected equipment ranked as the safety class 1 is the equipment of the reactor coolant pressure boundary, except those equipment the damage of which may be compensated for by the normal coolant make-up system.
(2) The selected equipment ranked as the safety class 2 is the fuel cladding and the following equipment:
a) the components creating the reactor coolant pressure boundary, that are not ranked as the class 1, b) the components for the reactor shutdown during the abnormal operation during the states which could lead to the accident conditions, and for the reactor shutdown with the aim to mitigate the consequences of accident conditions, c) the components necessary to retain the coolant inventory sufficient for the core cooling during the accident conditions when no damage of the reactor coolant pressure system has occurred, and after these conditions, d) the components necessary to remove the core heat 2, when the reactor coolant pressure system is damaged, with the aim to limit the fuel damage, e) the components of the residual heat removal system 2 during the normal and abnormal operation and under the accident conditions, without the loss of the reactor coolant pressure systems integrity, f) the components necessary for the prevention of radioactive leakage from the containment during the accident and post-accident conditions, g) the components necessary to limit the ionising radiation penetration outside the containment, during and after the accident conditions, h) the components necessary to accomplish the safety functions for the power supply or for the control of other components ranked as the safety class 2, (3) The selected equipment ranked as the safety class 3 is the equipment:
a) necessary to prevent the unallowable transient processes connected with the reactivity changes, b) necessary to maintain the nuclear reactor in the safe shutdown conditions, after its each shutdown, c) necessary to maintain the sufficient reactor coolant inventory for the core cooling during the normal and abnormal operation,
18 d) necessary to remove the heat from the safety systems to the first accumulating volume 3 which is sufficient from the viewpoint of performance of safety functions, e) necessary to maintain the radiation exposure of population and of nuclear installation personnel below the established limits, during the accident conditions connected with the leakage of radioactive substances and ionising radiation from the sources located outside the containment, and after such conditions, f) requisite to maintain such environmental conditions inside the nuclear installation that are necessary for the operation of safety systems and for the access of the personnel to perform the important activities related to safety, g) necessary to prevent the radioactive leakage from the irradiated fuel that is transported or stored within the nuclear installation, out of the core cooling system during all states of normal and abnormal operation, h) necessary to remove the fission heat from the irradiated fuel stored within the nuclear installation, out of the core cooling system, i) requisite to maintain the sufficient subcriticality of fuel stored within the nuclear installation, out of the core cooling system, j) requisite to limit the effluents or the leakage of solid, liquid or gaseous radioactive substances and ionising radiation below the established limiting values during all states of normal and abnormal operation, k) requisite to perform the safety functions related to the power supply or to the control of other components ranked as the safety class 3, l) requisite to perform the safety functions for the assurance of functional capability of other components ranked as the safety classes 1, 2 and 3, that are not related to the control or to the power supply, m) necessary for the prevention or the mitigation of consequences of failures of the other components or constructions of safety systems ranked as the safety classes 1, 2 and 3.
B. The safety classes for the nuclear installations for the radioactive waste storage.
(1) The selected equipment of the safety class 2 is the packing ensemble for the storage of radioactive waste of reprocessed nuclear fuel.
(2) The selected equipment of the safety class 3 are the equipment creating the engineering artificial barriers, and requisite to prevent the leakage of radioactive substances and ionising radiation into the environment and into the working surroundings under the established limiting values, during all design operational conditions.
19 C. The safety classes for the storage of spent nuclear fuel.
(1) The selected equipment of the safety class 2 is:
a) the packing ensembles (containers) for the storage of spent fuel.
b) requisite to maintain the sufficient subcriticality of nuclear fuel.
(2) Selected equipment of the safety class 3 is the equipment:
a) creating the engineering artificial barriers, requisite to prevent the leakage of radioactive substances into the environment and into the working surroundings under the established limiting values 2, during all designing operational states.
D. The safety classes for the nuclear installations for the disposal of radioactive waste and spent nuclear fuel and for the installation, fabrication, preparation, storing and depositing the nuclear (1) The selected equipment of the safety class 2 are:
a) the packing ensembles (containers) for the deposit of spent fuel and of radioactive waste of reprocessing the nuclear fuel.
b) the requisite to maintain the sufficient subcriticality of nuclear fuel.
(2) The selected equipment of the safety class 3, there are the equipment creating the engineering barriers to prevent the leakage of radioactive substances into the environment under the established limiting values 1),
1 It relates to the first stage of heat removal system.
2 It does not connected to the first stages of heat removal systems
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