Key Benefits:
| Chapter 1 | Scope and definitions |
| Chapter 2 | Requirements for supporting documents |
| Chapter 3 | Application for commissioning permission |
| Chapter 4 | Modification of existing railway infrastructure |
| Chapter 5 | Approval and use of the auditors |
| Chapter 6 | Commissioning of railway infrastructure |
| Chapter 7 | Pensation |
| Chapter 8 | Punishment and redress |
| Chapter 9 | Entry into force and transitional provisions |
| Appendix 1 | DEFINITIONS AND CONCEPTS |
| Appendix 2 | RISK ASSESSMENT |
| Appendix 3 | CRITERIA FOR WHICH THE VARIETIES ARE TO BE MET |
Completion of the commissioning authorisation for subsystems in the railway infrastructure
In accordance with section 21 h (1) (i), ONE, ONE. pkt., section 21 k, paragraph 1. 5 and 6, section 22, paragraph 1. 6, section 24 c (3). Article 26 (2) and section 26 (2). ONE, ONE. pkt;, in the law of rail, cf. Law Order no. 1249 of 11. In November 2010, according to section 24 h, paragraph, shall be adopted. 1 :
Chapter 1
Scope and definitions
Scope of application
§ 1. The notice shall lay down procedures applicable to the application for commissioning authorisations for the railway infrastructure. Use of usage permissions may be issued with terms and conditions, including Fixed Term Terms.
Paragraph 2. The announcement shall apply to both the railway infrastructure covered by the interoperability directive, cf. § 4, no. 9, and the risk assessment regulation (CSM-RA), cf. § 4, no. 3, and for railway infrastructure not covered by the Directive and CSM-RA.
§ 2. Railway infrastructure not covered by the risk assessment regulation (CSM-RA) shall comply with the risk assessment requirements set out in Annex 1-3 for this notice.
§ 3. The announcement shall not apply to :
1) Veteranlanes and
2) Private railway infrastructure used exclusively for the owner's own freight transport.
Definitions
§ 4. For the purposes of this notice :
1) Applies : an adjudicating entity as defined in Article 2 (s) of the interoperability Directive.
2) Assessor : an independent and competent person, organisation or entity carrying out investigations to reach a documented decision on the suitability of a system to meet the safety requirements of this.
3) CSM-RA : Commission Regulation (EC) No 352/2009 of 24. April 2009 on the adoption of a common security method for risk assessment and assessment as referred to in Article 6 (2). (3) (a) of Directive 2004 /49/EC of the European Parliament and of the Council.
4) Subsystems : the result of the fragmentation of the rail system into structural or functional subsystems, cf. Article 2 (s) and Annex II of the Interoperability Directive.
5) Parts of the subsystem : bounded parts of a subsystem.
6) EEA country : a country which has fully joined EU legislation in this area.
7) Renewal : a greater work that is about to replace a subsystem or part of a subsystem without changing the overall performance of the subsystem.
8) The operating permit for a subsystem in the railway infrastructure means the approval of the subsystem's security characteristics and that the subsystem complies with the applicable legislation.
9) The Interoperability Directive : Directive 2008 /57/EC of the European Parliament and of the Council of 17. June 2008 on the interoperability of the railway system in the Community, carried out by executive order no. 459 of 28. In April 2010, with subsequent changes.
10) Railway infrastructure, as defined in Article 3 of Council Directive 91 /440/EEC on the development of the Community's railways.
11) Upgrade : a larger job that is to replace a subsystem or part of a subsystem that improves the overall performance of the subsystem.
12) Risk assessment : the overall process, which includes a risk analysis and a risk assessment, cf. Article 3 (2), 4 in CSM-RA and Annex 1, Section 2 of this Order.
13) Significant change : a change that affects the security, as specified in Article 4 of the CSM-RA and Annex 1 (3) to this notice.
14) Security Assessment Report : a document containing the conclusions of an assessment carried out by an assessor, of the assessed system.
15) System Definition : the description of a subsystem or part of a subsystem and its use, interfaces and interaction with all surroundings, cause of the renewal or upgrade, and all identified requirements of the subsystem or part of a part of one ; subsystem as described in Annex I, Section 2.1.2 of CSM-RA and Annex 2, point. 3.1.2 to this notice.
16) Technical Specifications for the Interoperability (TSI) : a specification adopted in accordance with the interoperability directive and applicable to each subsystem or part of a subsystem aimed at meeting the essential requirements and ensuring interoperability of the trans-European rail system.
17) Veteranbane : infrastructure in the VA territory as defined in section 2 (2). 3, in the notice. 1354 of 2. In December 2010, non-commercial railway operations.
Chapter 2
Requirements for supporting documents
§ 5. Where applicants submit documentation written in languages other than Danish or English, the Management Board may require an applicant to translate the documentation into one of the two languages referred to.
Paragraph 2. Application for commissioning authorization shall be carried out at the application form of the traffic management application.
Chapter 3
Application for commissioning permission
§ 6. Railway infrastructure may not be used until the Traffic Management Board has issued commissioning authorisations to the structural subsystems used in the railway infrastructure, as well as that section 11 is met.
Paragraph 2. In order to obtain a suitable entry permit for a structural subsystem in the railway infrastructure, the application shall be accompanied by the following :
1) system definition
2) the safety assessment report in accordance with the CSM-RA, or Annexes 1 and 2 of this notice, drawn up by a examiner approved by the Traffic Management Board, cf. § 10, and
3) a " EC " declaration of verification, cf. Article 18 of the interoperability Directive, the subsystem is covered by a TSI.
Chapter 4
Modification of existing railway infrastructure
Assessment of the change
§ 7. Before a change in an existing railway infrastructure is implemented, the undertaking to consider the amendment shall assess the significance in accordance with the principles set out in Article 4 (2). 1 and 2 of the CSM-RA or Annex 1 of this notice.
Paragraph 2. Evaluate it that the change, cf. paragraph 1 is significant, the company must submit the traffic management to the Traffic Control as set out in Section 8.
Paragraph 3. Assess that the change is to consider a renewal or upgrade, you will have to submit the traffic management amendment to the Traffic Control as set out in section 8.
Paragraph 4. Where the change is not covered by paragraph 1 2 or 3, the documentation for the assessment and associated preliminary system definition shall be submitted to the Traffic Management Board until 31. December, 2013.
Paragraph 5. If the Traffic Management Board disagrees with the undertaking ' s assessment, cf. paragraph 4 weeks shall inform the establishment within 4 weeks of the Management Board.
Immolation of changes in the railway infrastructure
§ 8. In the case of an alteration of an existing subsystem, cf. Section 7 (2). 2 or 3, a project description of the Traffic Management Board shall be submitted before the change is initiated, after which the Traffic Management Board shall decide whether or not the change requires a new commissioning authorisation under section 6.
Paragraph 2. The project description shall include the following information :
1) the documentation for the impact of the undertaking on the significance of the change, cf. § 7
2) a preliminary system definition of the modification of the subsystem, including information on :
a) the undertaking wants to use documentation from a corresponding change which has previously obtained an approval in Denmark, an EU or EEA country after identical requirements under similar operating conditions ; and
b) whether the amendment to the company ' s assessment is subject to the TSI requirements.
Changes that do not require a new commissioning permission
§ 9. Amendment of a subsystem that is not covered by the evaluation in section 7 (4). 2 or 3 does not require a commissioned authorisation from the Traffic Management Board. Such changes shall be carried out in accordance with the railway infrastructure manager ' s security management system.
Chapter 5
Approval and use of the auditors
§ 10. Apples must use an assessor for the assessment of the risk assessment of the applicant in connection with the application for the authorisation for use of the application.
Paragraph 2. Assessor must complete a security assessment report that will be included in the application.
Paragraph 3. The traffic management system must be approved by the Traffic Control Agency.
Paragraph 4. In order to obtain approval by an inspector, the applicant shall submit the following to the Traffic Management Board :
1) the interim system definition ; and
2) evidence that the processor for the relevant task meets the criteria for the auditors listed in Annex II of the CSM-RA or Annex 3 of this notice.
Chapter 6
Commissioning of railway infrastructure
§ 11. A structural subsystem in the railway infrastructure to which the Traffic Management Board has issued in service authorisation can only be used in the use of railway infrastructure managers.
Paragraph 2. Before using a structural infrastructure subsystem in the railway infrastructure, the railway infrastructure manager shall implement the necessary risk measures in accordance with the rules for the approval of railway infrastructure managers.
Chapter 7
Pensation
§ 12. The Management Board may dispense with the provisions of this notice, where it is, moreover, compatible with EU rules in this field.
Chapter 8
Punishment and redress
Punishment
§ 13. The withdrawal of section 6 (2). ONE, ONE. Prectangle, punished by fine, unless a higher penalty is inflicted on the line under section 22 of the law of rail.
Paragraph 2. The person who makes a change without carrying out an assessment as specified in section 7 shall be punished by penalty unless higher penalties are imposed on the rail road.
Paragraph 3. The conditions laid down in section 1 (1) of this Article shall be subject to the conditions laid down in Article 1. One, punishable by fine.
Paragraph 4. Companies can be imposed on companies, etc. (legal persons) punishable by the rules of the penal code 5. Chapter.
Appeal access
§ 14. Any person who has received a decision on discharges or only partial partial response to an application may, within four weeks, request the Traffic Management Board to re-evaluate the case.
Paragraph 2. where the case referred to in paragraph 1 is renewed, Paragraph 1 does not, in the case of the complainant, be able to reach the Board of Railway, within four weeks of the time being brought before the rail.
Chapter 9
Entry into force and transitional provisions
§ 15. The announcement shall enter into force on 1. January 2013.
Paragraph 2. Publication no. 1031 of 7. November 2011 on the commissioning authorisation for the infrastructure subsystem in the railway infrastructure.
Paragraph 3. In the case of applications received before the date of entry into force of the notice, the applicable rules shall apply.
Traffic Management, the 12th. December 2012
Carsten Falk Hansen
-Lise Aena Kobberholm
Appendix 1
DEFINITIONS AND CONCEPTS
1. Objective and scope
This Annex lays down the conditions for risk assessment for the railway systems which are not covered by the CSM RA, cf. Section 2 of the notice.
The risk assessment method shall apply by :
-WHAT? metros, trailers, and letdown systems ; and
-WHAT? nets that are functionally separated from the rest of the rail system, which are designed only for passenger transport in local, urban and suburban areas.
2. Definitions
In the case of risk assessment, the definitions set out in Article 3 of Directive 2004 /49/EC shall apply.
The following definitions shall also apply :
1) Risk : The relative frequency with which accidents and incidents cause harm (caused by danger) and the severity of this damaged
2) Risk analysis : the systematic use of all available information to identify hazards and estimasts of risk
3) Risk evaluation : the procedure which, in the risk analysis, determines whether an acceptable risk has been obtained ;
4) Risk assessment : the overall process, which includes a risk analysis and a risk assessment ;
5) Safety : absence of unacceptable harm risks
6) Risk management : the systematic application of management policies, procedures and practices with a view to analyzing and evaluating risks and keeping hazards under control ;
7) Interfaces : all of the interactions in the life cycle of a system or a subsystem, including operation and maintenance, in which various operators in the railway sector cooperate in managing the risks ;
8) Stakeholders : all parties directly or through contractual conditions participating in the use of this risk assessment method ;
9) Safety requirements : the necessary safety characteristics (qualitative or quantitative) of a system and operation of such a system (including operating regulations) in order to comply with the security objectives of the applicable law or undertakings ;
10) Security measures : a number of actions that either reduce the relative frequency of a danger or the consequences of fines for the purpose of reaching or maintaining an acceptable risk level ;
11) Danger : a situation that could lead to an accident
12) Assessor : an independent and competent person, organisation or entity carrying out investigations to reach a documented decision on the suitability of a system to meet the safety requirements for this ;
13) Risk acceptance criteria : the reference basis for the assessment of whether a specific risk is acceptable. These criteria are used to establish that the level of risk is so low that it is unnecessary to take immediate measures to reduce it further ;
14) Fareregists : the document in which it is registered and referenced by known hazards, measures relating to this and their reasons, and in which reference is made to the organisation which takes account of them ;
15) Field identification : the process that consists of uncovering, registering and characterizing hazards ;
16) Risk acceptance principle : the rules used to determine whether the risk of one or more specific hazards is acceptable ;
17) Recanted practices : a written rule which, when followed, can be used to keep one or more specific hazards under control ;
18) Reference system : a system which has been established in practice to have an acceptable level of security and which may be used in comparison to the extent to which the risk is acceptable in a system that has been assessed ;
(19) Risk estimation : a process that is used to quantify the level of the hazards that are analyzed and which consist of the following steps : estimation of frequency, impact assessment and their integration
20) Technical system : a product or whole of products, including the design, implementation and documentation. The development of a technical system shall begin with requirement specifications to this end and be completed with an approval of the system. Although the design of interfaces, where human behavior is taken into account, is taken into consideration, operators and their actions are not taken into account in a technical system. The maintenance process is described in the maintenance manuals, but is not in itself a part of the technical system ;
21) Disaster follows : death and / or multiple serious injuries and / or significant environmental damage caused by an accident ;
(22) Acceptance of security : the status given by the applicant on the assessment by the investigator ' s safety assessment report ;
23) System : any part of the railway system in which changes are made ;
24) Member States shall be provided in national terms : all national rules notified to the Commission by the Member States pursuant to Council Directive 2004 /49/EC.
3. Significent changes
The undertaking shall adopt a position on the potential impact of the change in the safety of the rail system. If the proposed change has no effect on security, there is no need to use the risk management process described in Section 4.
Has the proposed change of influence on safety shall take the establishment on the basis of an expert opinion on the significance of the change from the following criteria :
1) consequence of failure : a probable worst-case scenario in the event of failure of the system that is under consideration in the field of security barriers outside the system ;
2) innovations used to make the change : this applies to both what is innovative to the railway sector and what is only new to the organisation that implements the change.
3) the complexity of the change
4) monitoring : failure to control the completed change in the overall life cycle of the system and make appropriate action ;
5) reversibility : inability to go back to the system as it was before the change
6) accumulation : assessment of the significance of the change in respect of all recent safety-related changes which were not considered significant by the system that has been taken up for assessment.
The company must retain sufficient evidence to justify its decision.
4. Risk Management Process
The risk management process described in Annex 2 shall apply to a significant change as specified in Section 3.
The risk management process described in Annex 2 shall be used by the applicant. The applicant shall ensure that the risks to be taken into account by suppliers, service providers and their subcontractors are taken into account. For this purpose, the applicant may request that suppliers, service providers and their sub-contractors participate in the risk management process described in Appendix 2.
5. Independent assessment
An independent assessment of the correct application of the risk management process described in Annex 2 and the results of this application shall be carried out by a body to comply with the criteria set out in Annex 3.
The conformity assessment of the safety management system required by Directive 2004 /49/EC and the conformity assessment carried out by the examiner in accordance with this Directive must be avoided as regards the conformity assessment required by Directive 2004 /49/EC and the conformity assessment carried out by the " Constable " ; risk assessment.
6. Security Assessment Reports
Assessor shall submit to the applicant a safety assessment report.
If a system or a subsystem has already been accepted as a conclusion to the risk management process specified in this Annex to the notice, the resulting security assessment report shall not be called into question by any other examiner, responsibility for a new assessment of the same system. Recognition shall be granted only if it is documented that the system will be applied to the same functional, operational and environmental conditions as is the case for the already accepted system and that the corresponding risk acceptance criteria are applied ; used.
7. Management of Risk Management / Internal and External Revisions
Rail infrastructure managers shall allow audits of the use of the risk assessment safety method to be included in their ongoing audit plans for the security management system, cf. Article 9 of Directive 2004 /49/EC.
8. Feedback and technical progress
Each railway infrastructure manager shall report in its annual safety report, cf. Article 9 (1). 4, in Directive 2004 /49/EC, in summary of its experience with the application of this security method for risk assessment. The report shall also contain a summary of the decisions concerning the significance of the change.
Appendix 2
RISK ASSESSMENT
1. Objective and scope
This Annex lays down the conditions for risk assessment for the railway systems which are not covered by the CSM RA, cf. Section 2 of the notice.
The risk assessment method shall apply by :
-WHAT? metros, trackwagons and letdown systems ; and
-WHAT? nets that are functionally separated from the rest of the rail system, which are designed only for passenger transport in local, urban and suburban areas.
2. GENERAL PRINCIPLES OF THE RISK MANAGEMENT PROCESS
2.1 General principles and obligations
2.1.1 The Risk Management process is based on a definition of the system assessed and includes the following activities :
a) the risk assessment process in which an identification of the risks is made, the risks, the associated security measures, and the following safety requirements which the assessed system must comply with ;
b) the detection of the system meeting the safety requirements laid down ; and
c) management of all identified hazards and associated security measures.
This risk management process is an iterative process, and it is depient in the chart at the end of annex 3. The process will be completed when it is shown that the system meets all security requirements that are necessary to accept the risks associated with the identified hazards.
2.1.2 This iterative risk management process :
a) it must include appropriate quality assurance activities and carried out by competent staff ; and
b) shall be the subject of an independent evaluation of one or more of the auditors.
2.1.3 The applicant with responsibility for the risk management process shall draw up an ongoing Pharastery according to section 5.
2.1.4 The operators who have already established risk assessment methods or tools may continue to apply these under the following conditions :
a) the risk assessment methods or tools shall be described in a security management system accepted by a national security authority in accordance with Article 10 (1). Paragraph 2 (a) or Article 11 (1). 1 (a) of Directive 2004 /49/EC, or
b) the risk assessment methods or tools meet the publicly available standards specified in the national provisions of the notified national legislation.
2.1.5 Unless otherwise stated in the legal provisions of the Member States relating to civil liability, the applicant shall be responsible for the risk assessment process. With the consent of the actors concerned, the applicant shall, inter alia, decide on who is responsible for meeting the safety requirements arising from the risk assessment. This decision shall depend on the type of security measures chosen to maintain the risks of an acceptable level. The performance of the safety requirements shall be shown in accordance with Section 4.
2.1.6 In the first stage of the risk management process, the applicant documents the tasks and risk-management activities of the various actors in writing. The applicant shall coordinate close cooperation between the various actors concerned in accordance with their respective tasks in order to deal with the dangers and the associated security measures.
2.1.7 It is the responsibility of the independent examiner to evaluate the correct application of the risk management process.
2.2 Interfaces Management
2.2.1 For each interface of relevance to the assessed system, the relevant railway sector operators concerned shall collaborate on the identification and handling of hazards and related safety measures that must be addressed in these interfaces. The applicant shall coordinate the management of common hazards in the interfaces.
2.2.2 When a stakeholder in fulfils of a safety requirement determines a need for a security measure that the operator may not carry out, the actor shall, by way of agreement with another operator, arrange the handling of the danger to the latter, by means of a different actor ; the process described in section 5.
2.2.3 For the estimated system, any actor who ascertains that a safety measure is not in conformity or that it is inadequate shall be responsible for notifying it to the applicant who subsequently informs the operator, implementing the safety measure.
2.2.4 The stakeholder who implements the security measure shall then inform all stakeholders concerned within the terms of the system or-provided that the operator is aware of this-within other existing systems ; where the same security measure is used.
2.2.5 Dissender differences between two or more actors shall be the applicant ' s responsibility for finding an appropriate solution.
2.2.6 A player does not meet a requirement in the notification of national provisions, the applicant shall seek advice from the relevant competent authority.
2.7 Undependent on the definition of the assessed system shall bear the responsibility of the applicant to ensure that risk management encomps the system itself and its integration into the overall rail system.
3. DESCRIPTION OF THE RISK ASSESSMENT PROCESS
3.1 General description
3.1.1 The Risk Assessment Process is the parent iterative process that includes :
a) the system definition
b) risk analysis, including hazard identification,
c) the risk assessment.
The risk-assessment process must be included in a interaction with the handling of hazards in accordance with Section 5.1.
3.1.2 The system definition should at least address the following areas :
a) a system objective, for example, the intended purpose ;
b) system functions and elements where appropriate (including, for example, human, technical and operational elements)
c) system-limit, including interactions with other systems ;
d) physical (i.e. interaction-acting systems) and functional (i.e. functional input and output) interfaces
(e) the environment (e.g. energy and heat currents, shock waves, vibrations, electromagnetic interference, operational use),
(f) existing security measures and, after an iterative process, define the safety requirements identified in the risk assessment process ;
g) assumptions in order to limit the risk assessment.
3.1.3 A danger identification of the defined system is carried out in accordance with section 3.2.
3.1.4 One or more of the following risk acceptprinciples shall be used in the evaluation of whether the risk of the estimated system is acceptable :
a) the application of recognised practices (section 3.3) ;
b) comparison with similar systems (Section 3.4),
c) explicit risk estimation (Section 3.5).
In accordance with the general principle as referred to in 2.1.5, the examiner shall be responsible for imposing a specific risk acceptance principle from the applicant.
3.1.5 The applicant is documented in the risk assessment that the principle of risk acceptance has been applied appropriately. Furthermore, the applicant shall verify that the selected risk acceptance principles are applied consistently.
3.1.6 On the application of these risk acceptance principles, possible safety measures that make the risk or the risks of the estimated system be deemed acceptable. Among these safeguards, those selected in order to limit the risk or risks are made to safety requirements that must be met by the system. The documentation for compliance of these safety requirements shall be carried out in accordance with Section 4.
3.1.7 The iterative risk assessment process may be deemed to have been completed when it has been documented that all safety requirements are fulfilled and no further dangers which may reasonably be foreseen are taken into account.
3.2 Fareat
3.2.1 The applicant shall be systematically identified and with the assistance of a broad-based team of competent experts all hazards that may reasonably be foreseeable for the overall estimated system, its functions, when relevant, and its interfaces :
All identified hazards shall be recorded in the pharastery according to Section 5.
3.2.2 In order to target the risk assessment against the essential risks, the risks must be classified according to the estimated risk they entail. On the basis of an expert opinion, dangers which involve almost acceptable risks should not be analysed further, but recorded in the pharmacoetal. The classification of these must be justified in such a way as to allow an independent assessor to carry out an independent assessment.
3.2.3 risks may be classified as broadly acceptable according to the criterion that the risk must be so small that it is not reasonable to implement additional safety measures. The expert opinion must take into account the fact that the contribution of all the largely acceptable risks must not exceed a fixed share of the overall risk.
3.2.4 Security measures may be designated in connection with the hazard identification. They shall be recorded in the subject of the pharastery according to section 5.
3.2.5 The area identification shall be carried out only at the level of detail necessary to establish that security measures may be expected to keep the risks under control in accordance with one of the risk acceptance principles referred to in section 3.1.4. Thus, a iterative process may be required between risk analysis and risk evaluation phase until a sufficient level of detail has been achieved in relation to the hazard identification.
3.2.6 When a recognized practice or a reference system is used to keep the risk under control, the hazard identification may be delimited to :
a) a verification of the relevance of the recognised practice or of the reference system,
b) an identification of the deviations from recognised practice or the reference system.
3.3 Application of recognised practices and risk evaluation
3.3.1 The applicant shall analyse the support of other participating actors and, on the basis of the requirements of section 3.3.2, whether one or more hazards are sufficiently covered in the application of appropriate recognised practices.
3.3.2 These practices must, as a minimum, comply with the following requirements :
a) are generally recognised in the railway sector. If this is not the case, then the recognised practice must be justified, and the examiner must be able to accept them.
b) have relevance to the hazards in the assessed system being kept under control.
c) be publicly available to all actors who wish to use them.
3.3.3 TSIs may be considered as a recognised practice in order to keep hazards under the supervision provided that the requirement set out in (c) in section 3.3.2 is fulfilled.
3.3.4 National provisions notified in accordance with Article 8 of Directive 2004 /49/EC may be regarded as recognised practices provided that the requirements of section 3.3.2 have been met.
3.3.5 If one or more hazards are kept under the control of recognized practices that meet the requirements of 3.3.2, the risks of these hazards are considered acceptable. This implies the following :
a) there is no need to further analyse these risks,
b) the use of recognised practices shall be registered in the pharmaco, as safety requirements for the pertinent hazards.
3.3.6 In the event that an alternative approach is not fully in conformity with recognised practices, the applicant shall demonstrate that the alternative method leads to at least the same level of security.
3.3.7 Can the risk of a particular risk not be brought to an acceptable level by means of recognised practices, additional security measures shall be identified by applying one of the two other risk acceptprinciples.
3.3.8 When all hazards are kept under the control of recognised practices, the risk management process may be limited to :
a) The danger identification, cf. section 3.2.6
b) the registration of the application of a recognised practice in the pharmacostracy, cf. section 3.3.5
c) documentation of the use of the risk management process, cf. Section 6
d) an independent assessment, cf. Annex 1, Section 5.
3.4 Use of a reference system and risk evaluation
3.4.1 The applicant shall analyse, with assistance from other participating operators, whether one or more hazards are covered by an equivalent system which could be used as a reference system.
3.4.2 A reference system shall meet at least the following requirements :
a) Whereas it is already in practice to have an acceptable level of safety, and it must continue to be acceptable in the Member State in which the amendment is to be introduced,
b) its functions and interfaces correspond to the estimated system ;
c) it is used under operating conditions corresponding to the estimated system,
d) it is used in environmental conditions corresponding to the estimated system.
3.4.3 If a reference system is referred to in 3.4.2, the system shall apply to the estimated system that :
a) the risks of hazards covered by the reference system shall be deemed acceptable to be acceptable ;
b) safety requirements relating to the dangers covered by the reference system may be derived from security analyses or by an evaluation of the security statements for the reference system ;
c) these safety requirements shall be registered in the pharmaco, as safety requirements for the pertinent hazards.
3.4.4. If the system from the reference system resets the system, it shall be documented in the risk evaluation that the estimated system atleast the same level of security as the reference system. The risks of hazards covered by the reference system shall be regarded as acceptable in such cases.
3.4.5 it is not documented that a level of safety is reached, corresponding to the reference system, further safeguards for the discrepancies, one of the two other risk acceptance principles.
3.5. Explicit Risk Estimation and Evaluation
3.5.1 When the dangers are not covered by one of the two risk acceptance principles described in sections 3.3 and 3.4, it is shown that the estimated risk of the estimated system is acceptable, with an explicit risk estimation and evaluation. The risks arising from these dangers shall be estimated either quantitatively or qualitatively, taking into account existing safety measures.
3.5.2 Evaluation of whether the estimated risks are acceptable is carried out on the basis of risk acceptance criteria either derived from or based on rules of law in either Community legislation or in the notification of national provisions. Depending on the risk acceptance criteria, the evaluation of whether or not the estimated risks are acceptable is carried out either separately for each associated hazard or collectively for all hazards under one taken into consideration in the explicit risk estimation.
If the estimated risk is not accepted, additional security measures must be identified and implemented to limit the risk to an acceptable level.
3.5.3 When the danger of a hazard or a combination of several hazards is considered acceptable, the identified safety measures shall be recorded in the subject of the pharmacoetal.
3.5.4 Acting hazards due to failure of technical systems which are not covered by the recognised practice or the use of a reference system shall be subject to the following risk acceptance in the form of the design of the technical system :
For technical systems in which a function failure has a credible direct potential for catastrophic effects, the associated risk must not be further limited if the relative error rate is less than or equal to 10 -9 per operating hours.
3.5.5 Unless otherwise specified in the procedure referred to in Article 8 of Directive 2004 /49/EC, on the basis of a national regulation, a stricter criterion is being used to maintain a national security level.
3.5.6, a technical system is substituted for the use of 10 -9 -the criterion, cf. in 3.5.4, the principle of mutual recognition shall apply in accordance with Annex 1, Section 6.
However, the applicant can document that the national security level in Denmark may be maintained with a relative error rate higher than 10 ; -9 per operating patheses, the applicant may use this criterion.
3.5.7. The explicit risk estimation and evaluation shall meet at least the following requirements :
a) the methods used for explicit risk estimation must correctly reflect the estimated system and its parameters (including all operating modes) ;
b) the results must be sufficiently precise to provide a solid basis for decision-making, in other words. that minor changes in the data warehouse or assumptions may not result in significant changes to the requirements.
4. THE DOCUMENTATION OF COMPLIANCE WITH SAFETY REQUIREMENTS ;
4.1 In addition to acceptance of the security of the change, the performance of the safety requirements arising from the risk assessment phase shall be documented during the application of the applicant.
4.2 This documentation shall be carried out by each of the operators responsible for meeting the safety requirements as determined in accordance with paragraph 2.1.5.
4.3 The procedure chosen to document compliance with safety requirements, and the documentation itself must be subjected to an independent assessment of the judgment.
4.4 Any security measures expected to meet the safety requirements or any hazards detected in the documentation of compliance with the safety requirements shall lead to the possibility of : the applicant is reconsidered and evaluates the associated risks in accordance with Section 3. The new hazards shall be recorded in the pharastery according to section 5.
5. DANGER HANDLING
5.1 Farehandling process
5.1.1 One or more pharmacotuses shall be drawn up or updated (if they already exist) by the applicant during the design and implementation phase, and until the change is accepted, or until the security assessment report is submitted. The Pharereal must accompany progress in monitoring the monitoring of risks at the risk of identified dangers. In accordance with point 2 (g) of Annex III to Directive 2004 /49/EC, the pharmacist shall, where the system is accepted and put into operation, shall be updated subsequently by the railway infrastructure manager or the railway undertaking responsible for the operation of : the system that has been addressed as an integral part of the system's security management system.
5.1.2 The Registry shall include all hazards, together with all related security measures and assumptions concerning the system identified in connection with the risk assessment process. In particular, it shall contain a clear reference to the origin and the selected risk acceptance principles, as well as a clear designation of it or those responsible for keeping each of the risks under control.
5.2 Exchange of information
All the hazards and associated safety requirements that cannot be kept under the control of a single actor must be communicated to other relevant actors in order to find a suitable solution together. The hazards recorded in the pharmacery of the operator who trandrail them shall be kept under control only when the other actor has carried out the evaluation of the risks associated with these hazards, and all parties concerned agree on the solution.
6. DOCUMENTATION FROM THE APPLICATION OF THE RISK MANAGEMENT PROCESS ;
6.1. The applicant documents the risk management process that is used to assess security levels and compliance with security requirements so that a manager has access to the total necessary supporting evidence that the risk management process has been used ; Correct. The detector sets his conclusions in a safety assessment report.
6.2. The document the applicant shall draw up after paragraph 6.1 shall contain at least :
a) a description of the organisation and the experts designated to carry out the risk assessment process ;
b) the results of the various stages of risk assessment and a list of all the necessary safety requirements, which must be fulfilled in order to keep an acceptable level of risk.
Appendix 3
CRITERIA FOR WHICH THE VARIETIES ARE TO BE MET
1. Objective and scope
This Annex lays down the requirements for the auditors to assess the railway systems which are not covered by the CSM RA, cf. § 2.
The risk assessment method shall apply by :
-WHAT? metros, trailers, and letdown systems ; and
-WHAT? nets that are functionally separated from the rest of the rail system, which are designed only for passenger transport in local, urban and suburban areas.
2. Criteria for which the varieties are to be met
The 2.1 Assessor shall not directly or as authorised representatives be involved in the design, manufacture, construction, marketing, operation or maintenance of the system that has been assessed. This does not preclude the possibility of exchanges of technical information between this body and all the participating actors.
The 2.2 Assessor shall carry out the assessment of the highest technical integrity and technical competence and be independent of any pressure or incentive, in particular of an economic nature, which could exert influence on their assessment or on the results of : their assessment, in particular by persons or groups of persons who are interested in the assessments.
the 2.3 of the examiner must have the necessary resources to perform adequately the technical and administrative tasks related to the performance of assessments ; it must also have access to the equipment necessary for the implementation ; Special evaluations.
The 2.4 Assessor staff shall be in possession of :
1) a sound technical and vocational training ;
2) adequate knowledge of the requirements of the assessment it carries out and sufficient experience of such assessment ;
3) the skill in drawing up the safety assessment reports which render the conclusions of the assessment carried out.
The 2.5 staff responsible for the independent assessment must be guaranteed full independence. The remuneration of each employee shall not depend on the number of assessments carried out by the person concerned or of the results of the assessment.
2.6 If the processor is not part of the applicant ' s organisation, the body shall have an assurance that covers the liability of civil liability unless that responsibility is covered by the State, or the Member State itself is directly responsible for : the evaluation.
2.7 If the holder is not part of the applicant ' s organisation, the obligation of the body shall be bound by professional secrecy (except in the case of the competent administrative authorities in Denmark) on all knowledge of the exercise of its business under the exercise of its activities ; this risk assessment.
