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Decree On The Approval Of Vehicles Used For Railway Purposes

Original Language Title: Bekendtgørelse om godkendelse af køretøjer på jernbaneområdet

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Table of Contents
Chapter 1 Scope and definitions
Chapter 2 Requirements for supporting documents
Chapter 3 Application for component type-approval
Chapter 4 Application for commissioning permission
Chapter 5 Existing Danish vehicles
Chapter 6 Changes to existing vehicles
Chapter 7 Applications for authorisation to test or transport
Chapter 8 Authorisation and use of the examiner and expert
Chapter 9 Exemption from application for authorisation
Chapter 10 Drift of vehicles
Chapter 11 Pensation
Chapter 12 Punishment and redress
Chapter 13 Entry into force and transitional provisions
Appendix 1 Conditions for the continued use of vehicles which have been operating from 1. In August 1996 without an entry into service :
Appendix 2 DEFINITIONS AND CONCEPTS
Appendix 3 RISK ASSESSMENT
Appendix 4 CRITERIA FOR WHICH THE VARIETIES ARE TO BE MET

Completion of the approval of vehicles in the railway sector

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). Paragraph 2 and section 26 (4). ONE, ONE. Act. 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 for the application for approval of vehicles, including the issue of commissioning permits, type-approvals, transport permits, test permits, and the authorisations for experience of the operation. Permissions and approvals may be issued with terms and conditions, including Fixed Term.

Paragraph 2. The announcement shall apply to both vehicles covered by the interoperability directive, cf. Section 4 (4). 12, and the risk assessment regulation (CSM-RA), cf. Section 4 (4). 5, and for vehicles not covered by the Directive and CSM-RA.

§ 2. Vehicles covered by the risk assessment regulation (CSM-RA) shall comply with the requirements of the Regulation for risk assessment.

Paragraph 2. Vehicles not covered by the risk assessment regulation (CSM-RA) shall comply with the risk assessment requirements referred to in Annex 2 to 4 for this notice.

§ 3. The announcement shall not apply to :

1) Veterantrailers are only running on their own infrastructure.

2) Vehicles are used exclusively on private-owned infrastructure for the owner's own freight transport.

Definitions

§ 4. The corded-off track is understood to be a temporary corded-off for normal traffic.

Paragraph 2. Applicability shall mean the contracting entity as defined in Article 2 (s) of the interoperability Directive (s) or manufacturer or a representative of one of these.

Paragraph 3. The operator shall mean an independent and competent person, organisation or entity conducting investigations in order to reach a documented decision on the suitability of a system to meet the safety requirements of this.

Paragraph 4. The notified bodies shall mean the bodies responsible for assessing the conformity or suitability for use of interoperability constituents and to carry out the EC verification procedure for the subsystems.

Paragraph 5. Bugring means a vehicle being dragged or pushed, without the use of its own brakes or traction, coupled with another approved vehicle.

Paragraph 6. For the purposes of CSM RA, the Commission Regulation No 352/2009 of 24 is defined by Commission Regulation. April 2009 on the adoption of a common security method for risk assessment and assessment as referred to in Article 6 (2). (3) (a) in the European Parliament and Council Directive 2004 /49/EC.

Paragraph 7. " subsystems " means the result of the fragmentation of the railway system in structurally or functional defined subsystems in accordance with Article 2 (s) and Annex II to the interoperability directive.

Paragraph 8. Experience operations means a period in which a subsystem is operational and where experience is collected with technical, operation, operation and maintenance.

Niner. 9. For the purposes of the ISV declaration (Intermediate Statements of Verification (ISV), a declaration drawn up by the applicant on the basis of an ISV certificate issued by a notified body or appointed body or expert certifying certain parts of one subsystem or specific phases of the verification procedure.

Paragraph 10. A country of EEA is understood to be a country which has fully endorsed EU legislation in this field.

Paragraph 11. For vehicles, approval of the individual vehicle and its subsystem's security properties and that the subsystems are in compliance with the applicable laws, including TSIs.

Nock. 12. Directive 2008 /57/EC of the European Parliament and of the Council is understood by the European Parliament and Council Directive 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.

Paragraph 13. The compatibility certificate shall mean the certificate drawn up by the notified body or expert as evidence that the vehicle is compatible with the network.

Paragraph 14. Vehicle means a railway practice with or without traction force, which on its own wheels is running on a railway line. A vehicle consists of one or more structural or functionally defined subsystems or parts of such subsystem.

Paragraph 15. Risk assessment is the overall process, which includes a risk analysis and a risk assessment, cf. Article 3 (2), 4 in CSM RA and Annex 2, section 3.

Paragraph 16. A expert means an independent and competent person, organisation or entity conducting investigations to issue certificates in accordance with the notice.

Paragraph 17. In the case of significant change, a change is understood as specified in Article 4 of CSM-RA and Annex 2, Section 3.

Paragraph 18. The safety assessment report shall mean a document containing the conclusions of the assessment carried out by a examiner, of the assessed system.

Paragraph 19. The system definition means the description of the vehicle and its use, interfaces and interaction with all surroundings, cause of the change, and all identified requirements for the vehicle as described in section 2.1.2 of CSM RA and Annex 3, point to point 2.1.2 of the CSM and Annex 3. 3.1.2.

Nock. 20. Technical Specification for Interoperability (TSI) is understood to mean a specification adopted under the interoperability directive, which applies to each subsystem or part of a subsystem with the aim of meeting the essential requirements and ensuring Interoperability of the trans-European rail system.

Nock. 21. For purposes of testing, the purpose of testing certain technical characteristics or operating conditions as part of the approval procedure of the vehicle is intended.

Paragraph 22. Transport means driving a line with the specified objectives in section 19 (3). 1 pkt (a)-d).

Paragraph 23. Type of vehicle means a vehicle type defining the basic design characteristics of a vehicle.

Paragraph 24. Type-examination certificate or design-examination certificate shall mean the certificate drawn up by the notified body or body or expert confirming that the design meets the requirements applicable to the subsystem concerned.

Paragraph 25. For the purposes of type-approval, the approval of the traffic management of a type ' s design, including safety features, and if the type is covered by the TSI, shall mean that it is an interoperable TSI.

Nock. 26. The declaration of conformity shall mean the declaration drawn up by the applicant and which documents that the vehicle is in conformity with a type that has already been approved.

Nock. 27. The designated bodies shall mean the bodies responsible for assessing whether the vehicle complies with the national rules.

Nock. 28. The verification certificates shall be taken to mean the certificate drawn up by a notified body or body or expert and certify that the subsystems of the vehicle are built in accordance with the conditions of the type-examination certificate.

Paragraph 29. The declaration of verification shall mean the declaration drawn up by the applicant and document that vehicles and its subsystems are in accordance with relevant TSIer, national rules and safety requirements.

Chapter 2

Requirements for supporting documents

§ 5. The Management Board may obtain additional evidence for the application of the application, if necessary.

Paragraph 2. 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 3. The application for type-approvals or authorisations shall be applied to the application form of the Traffic Management Board. Information should be transmitted electronically in a format determined by the Traffic Management Board.

Chapter 3

Application for component type-approval

New Vehicle Type

§ 6. In application for type-approval, the following shall be attached :

1) system definition

2) a safety evaluation report provided that :

a) it is required, cf. CSM RA, or

b) the vehicle is not covered by the TSIs or national rules.

The report shall be prepared in accordance with the CSM-RA or Annex 2-4 of this notice of an inspector approved by the Traffic Management Board, cf. § 20,

3) type-examination certificates or design-examination certificates for all of the subsystems prepared by :

a) notified bodies if the subsystem is covered by TSIer,

b) designated bodies where the subsystem is governed by national rules ;

c) a experts if the subsystem is not covered by TSIer or national rules ; and

4) a compatibility certificate.

Paragraph 2. For the subsystems not covered by TSIas, the notified body or expert shall use Module SB, cf. Commission Decision No 2. 2010 /713/EU of 9. November 2010 on the modules for procedures for the assessment of conformity and suitability for use and for EC verification to be used in technical specification for interoperability adopted under the interoperability directive.

Vehicle types approved abroad

§ 7. For the application for component type-approval to a vehicle that is either covered by the interoperability directive or is not covered by the Directive and approved in another EU or EEA country, the application shall be accompanied by the following information :

1) copies of the authority of the other country, including the reference to the technical basis for the approval, and

2) compatibility certificate.

Chapter 4

Application for commissioning permission

§ 8. Vehicles may not be used until the Traffic Management Board has issued an entry into service to the vehicle and the requirement in section 24 is fulfilled.

New vehicles

§ 9. In order to obtain an entry permit for a vehicle that does not have a type-approval issued in Denmark, the application shall be accompanied by the following :

1) the documentation provided in section 6, and

2) declarations of verification for each subsystem, cf. Article 17 (1) of the interoperability Directive, 3 and Article 18.

Paragraph 2. For the subsystems that are not covered by TSIs, a verification certificate must be drawn up by using the module SD or SF, cf. Commission Decision No 2. 2010 /713/EU of 9. November 2010 on the modules for procedures for the assessment of conformity and suitability for use and for EC verification to be used in the technical specification for interoperability, cf. the interoperability directive.

Paragraph 3. Verification certificates, cf. 2 shall be prepared by :

1) designated bodies where the subsystem is governed by national rules ; or

2) a experts if the subsystem is not covered by the TSIs or national rules.

Paragraph 4. The vehicle type is approved at the same time as the issuing of the commissioning authorisation in cases where no type-approval is already available.

Paragraph 5. The Management Board may issue authorizations for the marketing of experience in accordance with the conditions set out in paragraph 1. 1-3. However, the confirmatory declarations shall be set out in paragraph 1. One, that's it. 2 shall be replaced by ISV declarations.

§ 10. For applications for commissioning of a vehicle based on a type of Danish type-approval, the application shall be accompanied by the following :

1) a type-approval issued in Denmark, and

2) a declaration of conformity to the declaration of verification, cf. section 9 (4). One, that's it. 2).

Vehicles approved abroad

§ 11. For applications for the entry into service of a vehicle that is fully covered by the TSIs, cf. in accordance with Article 23 of the Interoperability Directive, the interoperability Directive is not fully covered by TSIas, cf. Whereas Article 25 of the Directive and already authorized in another EU country or the country of the EEA country must be accompanied by the following :

1) copies of the authority of the other country, including the reference to the technical basis for the approval, and

2) compatibility certificate.

§ 12. For applications for commissioning of a vehicle approved in another EU country or of the EEA country, which are not approved in accordance with section 11, the application shall be accompanied by the documents referred to in Section 7.

Paragraph 2. If the vehicle, cf. paragraph 1, do not have a valid entry permit for the documentation referred to in paragraph 1. 1 shall be supplemented by :

1) the documentary evidence of the vehicle registration in the national vehicle register of the country concerned ;

2) a belief and promise declaration of the condition of the vehicle ; and

3) a security assessment report, cf. CSM RA or Annex 2-4 of this notice drawn up by an inspector approved by the Traffic Management Board, cf. 20.

Chapter 5

Existing Danish vehicles

Vehicles with commissioned permission

§ 13. Vehicles which already have an entry permit and a declaration of conformity from Banedanmark shall be applied to other networks without applying for a re-entry authorisation. However, it is provided that the railway undertaking or the infrastructure manager that uses the vehicle is to assess and store the documentation for the vehicle being compatible with the network in question.

Paragraph 2. Vehicles already have a non-use permit, but which do not have a declaration of conformity from Banedanmark, apply for a re-entry authorisation, provided that it is to be applied to other networks. The application for a new commissioning authorization shall be attached :

1) copy of the commissioning authorization, and

2) compatibility certificate.

Vehicles without use of commissioned authorization

§ 14. Vehicles that have been uninterrupted in Denmark from before 1. In August 1996, the conditions set out in Appendix 1 shall continue to be used without authorisation to be used.

Paragraph 2. Provided that the provisions of paragraph 1 that is not applicable to the conditions listed in Annex 1 may be requested in the use of the authorization. The following documentation shall be accompanied :

1) a description of the vehicle,

2) compatibility certificate,

3) maintenance instructions or maintenance in writing ;

4) operating instructions or operational instructions ;

5) a faith and promise declaration on the condition of the vehicle ;

6) an analysis of the risks which may exist if the vehicle, in one or more periods after 1. August 1996 has been unused, and

7) documentation of the vehicle characteristics and communication equipment where the vehicle is to be used in tunnels, cf. Annex 1, point. 1.

Chapter 6

Changes to existing vehicles

Assessment of the change

§ 15. Before a change in an existing vehicle is implemented, the undertaking to assess the change in accordance with the principles referred to in Article 4 (2) shall be taken into force. 1 and 2 of the CSM-RA or Annex 2 of this notice, whether the change affects safety and whether it is significant.

Paragraph 2. Evaluate the fact that the change affects security and that it is significant, cf. paragraph 1, the applicant shall present the traffic management amendment to the Traffic Management as set out in section 16.

Paragraph 3. Where the change is not covered by paragraph 1 2, the evaluation documentation and associated preliminary system definitions shall be submitted to the Traffic Management Board. However, certified railway undertakings may fail to submit to the railway undertakings and approved infrastructure managers.

Paragraph 4. If the Traffic Management Board disagrees with the undertaking ' s assessment, cf. paragraph 3, the Management Board shall inform the establishment within a four-week time.

Preventing of alterations to the vehicle

§ 16. In the event of a modification of a vehicle, cf. Section 15 (3). 2 is submitted a project description to the Traffic Management prior to the change to be implemented, after which the Traffic Management Board shall decide on the application of a new commissioning authorisation and to which section 9 shall be used.

Paragraph 2. The project description shall include the following information :

1) the evidence of the applicant ' s significant assessment of the significance of the change, cf. § 15, and

2) a provisional system definition of the modification of the vehicle, including information on :

a) the undertaking wishes to use documentation from a corresponding change which has previously obtained an approval in Denmark, an EU or the EEA country after identical requirements under similar operating conditions,

b) the TSIs likely to be used if the change in the company ' s assessment is covered by a TSI,

c) the TSIs which are proposed to be omitted if the change in the undertaking ' s assessment is covered by a TSI,

d) the technical specifications and verification procedures which were used instead of under the pkt. c mentioned TSI requirements, and

(e) the nature of the national technical rules and verification procedures that the company wishes to use.

Changes that do not require a new commissioning permission

§ 17. A non-service authorisation shall not be required where :

1) the modification of a vehicle is not significant, cf. Section 15 (3). 2, or

2) The Traffic Management Board, cf. section 16, paragraph 1. 1 assesses that a new commissioning authorisation should not be issued.

Paragraph 2. Provided that the commissioning authorisation is not required, cf. paragraph Paragraph 1 shall be implemented in accordance with the safety management system of the railway undertaking or railway infrastructure manager.

Paragraph 3. The railway undertaking or the railway infrastructure manager shall keep documentation of the firm ' s significant assessment, cf. Section 15 (3). 2, as well as documentation produced in connection with the change.

Chapter 7

Applications for authorisation to test or transport

Testing

§ 18. For the application for a permit, the application shall include the following :

1) a system definition,

2) a safety assessment report, in accordance with CSM-RA or Annex 2-4 of this notice, drawn up by an inspector approved by the Traffic Management Board, see section 20, and

3) compatibility certificate.

Transport

§ 19. The procedure in section 18 shall be followed by application for authorization for transport to and from :

1) a test line for the purpose of testing a vehicle ;

2) a workshop in order to bring the vehicle into an approved operating mode,

3) a staging area for the purpose of storage of the vehicle ; or

4) repositioning of vintage vehicles.

Paragraph 2. Transport, cf. paragraph 1 may be done by its own force or withdrawn by another vehicle.

Paragraph 3. For applications for carriage not covered by paragraph 1, 1, the procedure laid down in Chapter 4 shall be followed.

Chapter 8

Authorisation and use of the examiner and expert

20. Apples shall use the examiner to assess the risk assessment of the application in connection with the application for authorisation and type-approval.

Paragraph 2. Assessor must complete a security assessment report that will be included in the application.

Paragraph 3. Assessors and experts must be approved by the Traffic Management Board.

Paragraph 4. In order to obtain approval by an inspector or a qualified expert, the applicant shall submit the following information to the Traffic Management Board :

1) the preliminary system definition ; and

2) evidence that the processor or expert on the task in question satisfies the criteria for the auditors listed in Annex II of the CSM-RA and Annex 2-4 of this notice.

Chapter 9

Exemption from application for authorisation

§ 21. Vehicles that are RIV-labelled in accordance with the RIV Agreement on the date of termination of the RIV Agreement, i.e. 1. July 2006, cf. the Convention on International Railway Pasces from 1999 shall not have issued an commissioning authorisation unless changes are made, cf. section 15 or § 16.

Paragraph 2. Vehicles that are the RIC mark before 19. In July 2008, in accordance with the RIC Agreement, it may be used without a supplementary authorisation for use, provided that they are not used in tunnels in a length of a kilometre or more.

§ 22. Vehicles which comply with Article 23 (1). 1 in the interoperability Directive may be used without additional use of the use of the use of the interoperability Directive.

-23. Vehicles that are carried out at a speed of less than 20 kilometres per hour are not used for passenger transport and which :

1) are used in caged tracks or,

2) toxed, or

3) ranged directly from the scene of a sealed track

has been exempted from the application for authorisation to be applied.

Chapter 10

Drift of vehicles

§ 24. Vehicles for which the Traffic Management Board has issued an commissioning authorisation may only be used by a railway undertaking or a railway infrastructure manager.

Paragraph 2. Before the vehicle is used, the railway undertaking or the railway infrastructure manager shall implement the necessary risk-management measures in accordance with the rules on the certification of railway undertakings and the approval of : railway infrastructure managers.

Chapter 11

Pensation

§ 25. The Management Board may dispense with the provisions of this notice, where it is, moreover, compatible with EU rules in this field.

Chapter 12

Punishment and redress

Punishment

SECTION 26. Inherit of § 8 and § 14 (3). Paragraph 1 shall be punished by fine unless a higher penalty is imposed on the railways by section 22.

Paragraph 2. The person who makes a change without carrying out an assessment as set out in section 15 shall be punished by penalty unless a higher penalty is owed in accordance with section 22 in the law of rail.

Paragraph 3. Clause of conditions or conditions laid down in section 1 (1). One, section 18-19 punishable by fine.

Paragraph 4. Existing vehicles that have been uninterrupted in Denmark since 1. August 1996 and which is used in operation after the expiry of the deadline, cf. Section 28 (1). Five punishable by fine.

Paragraph 5. Companies can be imposed on companies, etc. (legal persons) punishable by the rules of the penal code 5. Chapter.

Appeal access

§ 27. Decisions taken by the Traffic Authority may within 4 weeks of the date of the decision to be made, to the Railway Board, cf. however, paragraph 1 2.

Paragraph 2. Any person who has received a decision on discharges or only partial dissent of an application may request the Traffic Management Board to review the case.

Paragraph 3. where the case referred to in paragraph 1 is renewed, 2 does not lead to the complainant fully satisfied, the decision may be brought to the Railway Board, cf. paragraph 1.

Chapter 13

Entry into force and transitional provisions

§ 28. The announcement shall enter into force on 1. January 2012.

Paragraph 2. Publication no. 686 of two. July 2009 on the approval of rolling stock (vehicles) in the railway sector is hereby repealed.

Paragraph 3. Component type-approvals and commissioning authorisations issued before the entry into force of the notice shall remain in force in accordance with their content.

Paragraph 4. In the case of applications received before the date of entry into force of the notice, the applicable rules shall apply.

Paragraph 5. Vehicles relating to the date of entry into force of the notice shall not be subject to entry into service and which are covered by section 14 (4). 1, before 1. August 2016 has issued an commissioning permission, cf. Section 14, paragraph 14. 2. After this date, the vehicles must not be used in the operation without using a non-use entry permit.

Traffic Control, the 7th. November, 2011

Carsten Falk Hansen

/ Leif Funch


Appendix 1

Conditions for the continued use of vehicles which have been operating from 1. In August 1996 without an entry into service :

1) Passenger vehicles and traction units which are used for cargo or passenger transport may not be used in tunnels that are either a kilometre of kilometres or more without an entry into service, except with the exception of the line between the Central Bank of Copenhagen ; and Oygate Station.

2) Vehicles that have been operating at Banedanmarks net since 1. In August 1996 may also be used on other networks, provided that the responsible railway undertaking or infrastructure manager assesses that the vehicle is compatible with the network in question. The assessment shall be documented in the railway undertaking or the infrastructure manager ' s security management system, and shall be presented at the request of the Traffic Management Board.

3) Vehicles that have been operating on a given net since 1. In August 1996, the network must continue to be used in the network concerned without issuing an entry into service.

4) Vehicles may not be used without an entry permit if significant changes have been made in accordance with 1. August 1996.

5) Vehicles may not be used without an entry into service if they have been unused for more than 12 months.

6) Vehicles may continue to be used if ownership changes are taken. In the case of registration of vehicles, the owner shall be registered in the national vehicle register in accordance with the rules on the registration of vehicles in the railway sector.

7) The use of the vehicle is conditional on the responsible railway undertaking or infrastructure manager of their security management system to ensure that the following documents are available and are complete :

a) Documentation that the company employing staff trained for the vehicle in question.

b) Documentation for maintenance work management.

c) An operational structure.

d) A maintenance writing.

(e) Documentation of registration in the national vehicle register.

(f) Documentation for network compatibility, cf. Act. 2).


Appendix 2

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 (2). 2 in 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.

-WHAT? VVs,

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 ` shall mean the relative frequency with which accidents and incidents cause harm (caused by danger) and the severity of this damage ;

2) ' risk analysis ` shall mean the systematic use of all available information to identify hazards and estimasts ;

3) ' risk assessment ` shall mean the procedure which determines whether the risk analysis has been established whether an acceptable risk has been obtained ;

4) ' risk assessment ` shall mean the overall process, which includes a risk analysis and a risk assessment ;

5) ' safety ` shall mean the absence of unacceptable damage ;

6) ' risk management ` means the systematic application of management policies, procedures and practices in order to analyse and evaluate risks and keep risks under control 7) "Interfaces" : all interactions in the running of a system or subsystem life-cycle, including operation and maintenance, in which various operators in the railway sector cooperate in managing the risks ;

7) ' actors ` shall mean all parties, directly or through contractual conditions, participate in the use of this risk assessment method ;

8) ' safety requirements ' shall mean 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 ;

9) ' security measures ' means 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 ;

10) ' hazard ` shall mean a situation which could lead to an accident ;

11) ' operator ` shall mean an independent and competent person, organisation or entity conducting investigations in order to reach a documented decision on the suitability of a system to meet the safety requirements of this ;

12) ' risk acceptance criteria ` shall mean the reference basis for the assessment of the acceptable nature of a specific risk. 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 ;

13) ' Fareregists ` means the document in which it is registered and referred to known hazards, measures relating to this and their reasons, and in which reference is made to the organisation taking account of them ;

14) "Risk identification" means the process that consists of uncovering, registering and characterizing hazards ;

15) ' risk-acceptance principle ` shall mean the rules used to determine whether the risk of one or more specific hazards is acceptable ;

16) ' recognized practice ` means a written rule which, when followed, can be used to keep one or more specific hazards under control ;

17) ' Reference system ` shall mean a system which has been established in practice to have an acceptable level of safety and which may be used in comparison to the extent to which the risk is acceptable in a system taken up for assessment ;

18) ' risk estimation ` shall mean a process used to quantify the level of the hazards analysed and consisting of the following stages : estimation of frequency, impact assessment and their integration ;

(19) ' technical system ` means any 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 ;

20) ' disastrous effects ` shall mean deaths and / or multiple serious injuries and / or significant environmental damage caused by an accident ;

21) ' acceptance of security ` shall mean the status given by the applicant on the assessment by the investigator ' s safety assessment report ;

(22) ' system ` shall mean any part of the railway system in which changes are made ;

23) ' notified national regulation ` shall mean all national provisions 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 :

a) 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 ;

b) 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.

c) the complexity of the change

d) monitoring : failure to control the completed change in the overall life cycle of the system and make appropriate action ;

(e) reversibility : inability to go back to the system as it was before the change

(f) 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 3 shall apply to a significant change as specified in Section 3.

The risk management process described in Annex 3 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 3.

5. Independent assessment

An independent assessment of the correct application of the risk management process described in Annex 3 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 shall be avoided as regards conformity assessment as required by Directive 2004 /49/EC, the conformity assessment carried out by the examiner in accordance with this Directive ; 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

Railway infrastructure managers and railway undertakings 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 and railway undertaking 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 3

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 (2). 2 in 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.

-WHAT? VVs,

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 4. 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 ;

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, the accepted 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 2, 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 relative error frequency 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 will be substituted for the 10-9 criteria, cf. in 3.5.4, the principle of mutual recognition shall apply in accordance with Annex 2, 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 or 9 per 1. 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 4

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. Section 2 (2). 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.

-WHAT? VVs,

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 :

-WHAT? a sound technical and vocational training ;

-WHAT? adequate knowledge of the requirements of the assessment it carries out and sufficient experience of such assessment ;

-WHAT? 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.

The Risk Management Process and the independent assessment

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