Advanced Search

Notice Of Approval Of Vehicles Into Railway Premises

Original Language Title: Bekendtgørelse om godkendelse af køretøjer på jernbaneområdet

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now for only USD$40 per month.
Table of Contents
Chapter 1 Scope and definitions
Chapter 2 Requirements for submission of application
Chapter 3 Application for component type-approval
Chapter 4 Application for authorisation for deployment and experience management
Chapter 5 Changes to existing vehicles or an approved type
Chapter 6 Applications for authorisation to test or transport
Chapter 7 Use of the examiner
Chapter 8 Exemption from application for authorisation
Chapter 9 Drift of vehicles
Chapter 10 Pensation
Chapter 11 Punishment and redress
Chapter 12 Entry into force and transitional provisions
Appendix 1 DEFINITIONS AND CONCEPTS
Appendix 2 RISK ASSESSMENT
Appendix 3 ASSESSOR'S SAFETY ASSESSMENT REPORT
Appendix 4 Verification declaration for subsystems that are not covered by the interoperability directive

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). 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 Bekendom Decision lays down procedures for the application for approval of vehicles in the railway sector, including the issue of commissioning permits, type-approvals, transport permits, test permits, and the authorisations for the experience of experience, cf. however, section 3.

Paragraph 2. The Traffic Management Board may issue permits and approvals with terms and conditions, including Fixed Term Terms.

Paragraph 3. The Traffic Management Board may withdraw the provisions referred to in paragraph 1. 1 specified permits and approvals for failure to comply with conditions.

§ 2. A proposal for a vehicle or a series of vehicles to be approved and which are not covered by the risk assessment regulation (CSM-RA) must comply with the risk assessment requirements, cf. Annex 1-3 of this notice.

Paragraph 2. Annex 4 shall be used in the drawing up of verification declarations for subsystems that are not covered by the interoperability directive.

§ 3. The announcement shall not apply to :

1) Veterantrailers, who are running on their own infrastructure.

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

Definitions

§ 4. For the purposes of this notice :

1) Decorated track : trace sections temporarily sealed off for normal traffic.

2) Assessor : An independent and competent, external or internal person, organisation or entity conducting investigations in order to reach a documented decision based on an objective basis of the suitability of a system to meet the required conditions ; safety requirements to be used.

3) Authorised bodies : 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.

4) Bugring : a vehicle being dragged or pushed, without the use of its own brakes or traction, coupled with another approved vehicle.

5) CSM-RA : Commission implementing Regulation 402 /2013/EU of 30. April 2013 on the common safety method for risk assessment and-assessment and repealing of Regulation (EC) No 2. 352/2009.

6) Subsystems : The result of the fragmentation of the rail system in structurally or functional defined subsystems, cf. Article 2 (e) and Annex II of the Interoperability Directive.

7) Experience-Experience : A period in which a subsystem is operational and where experience is collected with technology, operation, operation and maintenance.

8) For the EEA country, a country which fully joined EU law in this area.

9) Proposents : Proposor as defined in CSM-RA Article 3 (s) 11, or Annex 1, paragraph 11, of this notice.

10) Proposal statement : Written statement as specified in the CSM-RA Article 16 or Annex 1 (7) of this Order.

11) Vehicle vehicle : a vehicle taken out of operation f. ex with a view to a later revision.

12) Vehicle authorisation for vehicles : Permission to bring a vehicle, or a series of vehicles in an operation of a state of operation.

13) holder : The person who is permanently responsible for the economic operation of a railway vehicle, whether this is the owner of the vehicle or has been uprooted by it and registered as such for vehicle registration in a national vehicle register (NVR).

14) The ISV declaration (Intermediate Statements of Verification (ISV)) : A declaration made by an applicant on the basis of an ISV certificate that certifies certain parts of a subsystem or certain phases of the verification procedure.

15) 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.

16) Compatibility certificate : the certificate drawn up by the notified body or expert as evidence to ensure that the vehicle is compatible with the network on which the vehicle is to be used.

17) vehicles : a railway vehicle 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.

18) Risk assessment : The overall process, which includes a risk analysis and a risk assessment, cf. Article 3 (2), 4, in the CSM-RA, or Annex 2, Section 3, of this notice.

(19) Experts : An independent and competent person, organisation or entity, approved by the Traffic Management Board, carrying out investigations to issue certificates in accordance with this notice.

20) Significant change : a change as specified in Article 4 of the CSM-RA or annex 1 (3) of this notice.

21) Security Assessment Report : A document containing the conclusions of an assessment carried by an examiner by the system in question, cf. CSM-RA Article 3, nr. 12, or Annex 1, Section 6, of this notice.

(22) System Definition : 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 the CSM-RA, section 2.1.2 or Annex 2, point. 3.1.2, in this notice.

23) TSI : Technical Specification for Interoperability adopted in accordance with the interoperability directive, applicable to each subsystem or part of a subsystem, aimed at meeting the essential requirements and interoperability of it ; trans-European railway system.

24) Test : Run for the purpose of testing certain technical characteristics or controls which are not subject to a commissioning authorisation.

25) Transport : Drone on a specified line to relocate a vehicle that does not have a valid Danish commissioning permission.

26) Type : A vehicle type defining the basic design characteristics of a vehicle.

27) Type-examination certificate or design-examination certificate : the certificate confirming that the design meets the requirements applicable to the subsystem in question.

28) Component type-approval : The approval of the traffic management approval of a type's design, including safety features, and if the type is covered by TSIs that it is interoperable.

29) The declaration of conformity of type means the declaration which documents that the vehicle is in conformity with a type that has already been approved.

(30) Designated bodies : the bodies responsible for assessing whether the vehicle is in conformity with the notified national technical rules.

31) Verification certificate : The certificate which certifies that a subsystem in the vehicle complies with the requirements applicable to the subsystem concerned.

32) " Verification declaration " means the EC declaration of verification made out in accordance with Article 18 of and Annex V to Directive 2008 /57/EC and which contains a declaration that the subsystem fulfils the requirements of relevant European legislation, including : any national rules applicable to the implementation of the essential requirements of the interoperability directive or as the verification declaration being made out for subsystems that are not covered by the interoperability directive, cf. Annex 4 of this notice.

Chapter 2

Requirements for submission of application

§ 5. Application for type-approvals, authorisations or presentation of changes shall be made to the Traffic Management Board. Application can be done using the application form of the Traffic Management application. Information may be transmitted electronically in a format determined by the Traffic Management Board.

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.

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

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

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

c) a qualified expert if the subsystem is not covered by the TSIs or national rules.

3) A safety assessment report and certificate shall be issued if :

a) this is required, jf., CSM-RA, or

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

4) Compatibility certificate.

5) The service and maintenance manuals.

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

Paragraph 3. The report, cf. paragraph 1, no. 3, shall be drawn up in accordance with the CSM-RA or Annex 1-3 of this notice. The report shall be prepared by a examiner, cf. § 16.

Chapter 4

Application for authorisation for deployment and experience management

New vehicles

§ 7. For the application for a vehicle or a series of vehicles based on a type of 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. § 8 (3) 1, no. 2.

§ 8. In the case of applications for commissioning of a vehicle or a series of vehicles not having a type-approval issued in Denmark, the application shall be accompanied by the following :

1) documentation as specified in section 6,

2) a declaration of verification for each subsystem, cf. Article 17 (1) of the interoperability Directive, 3, and Article 18 or Annex 4 of this Order, and

3) verification certificates.

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

Paragraph 3. Verification certificates, cf. paragraph 1 and 2 shall be drawn up by :

1) notified bodies if the subsystem is covered by TSIs,

2) designated bodies where the subsystem is subject to any notified national technical rules ; or

3) an expert, if the subsystem is not covered by the TSIs or notified national technical rules.

Paragraph 4. Type-approval is granted at the same time as the issuing of the commissioning authorisation.

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 verification declarations as referred to in paragraph 1 may be verified. 1, no. 2, replace with ISV declarations.

Vehicles approved abroad

§ 9. For an application for the entry into service to a vehicle or a series of vehicles already approved in another EU country or the territory of the EEA country, the application shall be accompanied by the following :

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

2) compatibility certificate,

3) the documentary evidence of the vehicle registration in the national vehicle register of the country concerned, provided that the vehicle is subject to registration ; and

4) control and maintenance manuals.

Paragraph 2. If the vehicle does not have a foreign commissioning permit, cf. paragraph 1, no. Paragraph 10 shall apply.

Existing Danish vehicles without use of commissioned authorization

§ 10. For an application for commissioning of an existing vehicle, which has been operating in Denmark before 1. In August 1996, the following documents shall be accompanied :

1) a system definition or description of the vehicle ;

2) a compatibility certificate,

3) a steering manual,

4) a maintenance manual,

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 placed for more than one year and

7) documentation of the vehicle ' s industrial properties and communication equipment, provided that the vehicle is to be used in tunnels that are longer than 1 kilometres, except with the exception of the line between the Central Bank of the Central Station and the Eastern Port Station.

Paragraph 2. The one in paragraph 1. 1, no. 2, the compatibility certificate referred to above may be omitted provided that the vehicle is registered in the national vehicle register (NVR).

Paragraph 3. The Traffic Management Board may require it to be provided for in paragraph 1. 1, no. The analysis referred to above shall be supplemented by a statement of assurance and certificate, drawn up in accordance with the CSM-RA or Annex 1-3 of this notice. The safety assessment report shall be drawn up by a examiner, cf. § 16.

Chapter 5

Changes to existing vehicles or an approved type

Assessment of the change

§ 11. Before a change is carried out in an existing vehicle or in an approved vehicle type, it shall be required to make proposals for each subsystem in accordance with the principles referred to in Article 4 (2). 1 and 2 of the CSM-RA, or Annex 2, assess whether the change affects the 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 to the Traffic Management as specified in section 12.

Alteration of changes

§ 12. In the case of a modification of a vehicle, or a modification of an approved vehicle type, cf. Section 11 is submitted a project description to the Traffic Management Board prior to the change operation. The Traffic Management Board shall then decide whether a new commissioning authorisation is required, or a new type-approval and to which section 8 shall be applied.

Paragraph 2. The project description shall include the following :

1) Documentation for authors ' estimates of the significance of the change, cf. Section 11 (1). 1.

2) Provisional system definition of the change, including information about :

a) whether 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 corresponding operating conditions,

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

c) the notified national technical rules affected by the change and of the notified national technical rules expected to be used, and

d) the verification procedures which the undertaking wishes to use.

3) Tentative risk analysis.

Changes that do not require a new commissioning permission or a new type-approval

§ 13. A non-use permit or component type-approval should not be required where :

1) the change is not significant, cf. Section 11 (1). 1, or

2) The Traffic Management Board shall assess the non-application of a new commissioning permit or a new type-approval, cf. § 12, paragraph 1. 1.

Paragraph 2. Provided that non-use permit or a new type-approval is not required, cf. paragraph 1, the change shall be carried out in accordance with the laws in force and the quality and risk management procedures of the undertaking applying the change.

Paragraph 3. The holder of the vehicle shall keep documentary evidence of the assessments, cf. Section 11 (1). 1, as well as all the other documentation produced in connection with the change in question. The documentation must be stored throughout the life of the vehicle.

Chapter 6

Applications for authorisation to test or transport

Testing

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

1) a system definition,

2) a significant assessment, cf. CSM-RA Article 4 (4), 2, or Annex 1 of this notice, and

3) a compatibility certificate.

Paragraph 2. If the Proposal of the Proposal considers that the run is significant, a safety assessment report and certificate shall also be submitted in accordance with the opinion of the proposal. CSM-RA or Annex 1-3 of this notice. The safety assessment report shall be drawn up by a examiner, cf. § 16.

Paragraph 3. The one in paragraph 1. 1, no. The compatibility rate referred to in paragraph 3 may be omitted if the vehicle is registered in the national vehicle register (NVR) or, where the technical compatibility may be documented in another way.

Transport

§ 15. Permit to transport of a vehicle not to be used for passengers or freight transport may be requested.

Paragraph 2. The procedure laid down in section 14 shall be accompanied by an application for authorisation to transport which is subject to paragraph 1. 1.

Chapter 7

Use of the examiner

§ 16. The risk management of the successful tenderers pursuant to the CSM-RA or in accordance with Annex 1-3 of this notice shall be assessed by a examiner in connection with the application for authorisation and type-approval.

Paragraph 2. Assessor must complete a security assessment report, cf. CSM-RA or Annex 3 of this notice to be included in the application.

Paragraph 3. If the vehicle is to operate within the scope of the interoperability directive, the Accountant shall be accredited after the Traffic Management notification of the accreditation of the accreditation of the railway undertakings in the railway sector.

Paragraph 4. If the vehicle is to run outside the interoperability of the interoperability Directive, the inspector must be approved by the Traffic Management Board of Traffic Management by means of the approval of the processors and experts on the approval of railway infrastructure ; and vehicles or accredited, cf. paragraph 3.

Chapter 8

Exemption from application for authorisation

§ 17. Vehicles there 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 a commissioning authorisation unless changes are made, cf. § 11 or § 12.

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.

§ 18. Vehicles registered in a national vehicle register may ferry the traits the Danish-German border and to the station limit in the north of the Padborg station and the Danish-German border and to the station limit in the north of the Tønder ; station without a Danish commissioning permit. This derogation shall not apply to electric vehicles which use the driving power of 25 kV meat release.

Paragraph 2. The responsible railway undertaking shall ensure, at all times, the compatibility of the vehicle and the compatibility of the vehicle in paragraph 1. 1 specified lines, and registration in a national vehicle register.

§ 19. 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.

20. The exemption from the application for commissioned authorisation shall be that vehicles which are carried out at a speed of less than 20 kilometres per hour and not used for passenger transport and which :

1) are used in corded-off,

2) toxed, or

3) ranged directly from the scene of a sealed trail.

Chapter 9

Drift of vehicles

§ 21. Vehicles may not be used in operation until the Traffic Management Board has issued an commissioning authorisation to the vehicle and the requirements of paragraph 1. 2 is met, cf.. however, paragraph 1 4-7.

Paragraph 2. Vehicle for which the Traffic Management Board has issued an commissioning authorisation may be used only by railway undertakings, railway infrastructure managers, safety-certified contractors. Railway clubs, associations, etc., which have obtained a permit to exercise non-commercial railway operations, must use vehicles to which the Traffic Management Board has issued an commissioning authorisation.

Paragraph 3. Vehicle which already has an entry permit for the use of the routes covered by the interoperability Directive must be applied to all conventional lines covered by the interoperability Directive without a renewed review ; commissioning permission. The establishments, a vintage car club or safety certified contractor using the vehicle shall assess and store the documentation for the vehicle being compatible with the lines concerned.

Paragraph 4. Vehicle without entry into service, which has been in operation in Denmark from before 1. In August 1996, they may continue to be used without authorisation to apply, provided that they are in accordance with paragraph 1. The conditions laid down shall be met and the conditions laid down in paragraph 1. 6 mentioned documentation may be viewed, cf. however, section 25 (3). 4.

Paragraph 5. The following conditions must be met for vehicles to be used without the use of commissioned, cf. paragraph FOUR :

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, except with the exception of the line between the Central Bank of the Central Bank and the Eastern Port Station.

2) Vehicle has not been modified after 1. August 1996.

3) Vehicles have not been referred to in more than one year.

Paragraph 6. The following vehicle documentation must be available in a satisfactory manner so that vehicles can be used without the use of the use of the use of the vehicle in accordance with. paragraph FOUR :

1) Documentation for the use of trained personnel for the vehicle in question.

2) Documentation for maintenance work management.

3) The service manual.

4) Maintenance manual.

5) Documentation of registration in the national vehicle register.

Paragraph 7. Vehicles for which the Traffic Management Board has issued a test and transport permit shall be carried out only by the responsible railway undertaking, security certified contractors or railway club. However, infrastructure managers can make their own vehicles.

Chapter 10

Pensation

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

Chapter 11

Punishment and redress

Punishment

-23. The withdrawal of section 21 (2). Paragraph 1 shall be punished by fine unless a higher penalty is imposed on the railways by section 22.

Paragraph 2. A non-Danish non-user service certificate in addition to the in section 18 (3). The lines of paragraph 1 shall be punished by penalty unless higher penalties are imposed on the rail road by section 22.

Paragraph 3. The one that makes a change without carrying out an assessment as set out in section 11 (1). Paragraph 1 shall be punished by penalty unless higher penalties are imposed on the rail road by section 22.

Paragraph 4. Clause of conditions or conditions laid down in section 1 (1). Two, 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

§ 24. Any person who has received a decision on discharges or only partial partial response to an application may, within four weeks, call for a new assessment of the case by the Traffic Management Agency.

Paragraph 2. where the case referred to in paragraph 1 is renewed, Paragraph 1 does not lead to the complainant in full to the complainant, within 4 weeks of its time being brought to the rail of the Railway Board.

Chapter 12

Entry into force and transitional provisions

§ 25. The announcement shall enter into force on the 21. May 2015.

Paragraph 2. Publication no. 56 of 24. January 2013 for the approval of vehicles in the railway sector shall be deleted, cf. however, paragraph 1 3.

Paragraph 3. For applications for authorisations and approvals received in the Traffic Management Board before 21. In May 2015, the applicable rules have been applied in the past.

Paragraph 4. Permissions and approvals issued before the entry into force of the notice shall remain in force in accordance with their content.

Paragraph 5. Vehicles at the time of entry into force of the notice shall not be subject to entry into service and which are covered by Section 21 (1). 5, before 1. August 2016 issued an commissioning permission. After this date, the vehicles must not be used in the operation without using a non-use permit.

Paragraph 6. Statements of conformity, issued by Banedanmark before 1. In July 2013, it may be used instead of a compatibility certificate.

Traffic Management, the 8th. May 2015

Carsten Falk Hansen

/ Leif Funch


Appendix 1

DEFINITIONS AND CONCEPTS

1. Scope 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.

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 frequency with which accidents and incidents cause harm (caused by danger) and the severity of this hurt.
2)
Risk analysis : the systematic use of all available information to identify hazards and estible risk.
3)
Risk evaluation : a procedure which, in the risk analysis, determines whether an acceptable level of risk has been achieved.
4)
Risk assessment : the overall process, which includes a risk analysis and a risk assessment.
5)
Security : absence of unacceptable damage to the injury.
6)
Risk management : the systematic application of management policies, procedures and practices with a view to analysing and evaluating risks and keeping risks 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 are involved in the application 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) and maintenance in order to comply with the security objectives of the applicable law or business.
10)
Safety measures shall mean a number of actions which reduce the frequency of tenor, or the consequences of fines for the purpose of reaching or maintaining an acceptable risk level.
11)
Proposents :
a)
A railway undertaking or railway infrastructure manager that implement risk management measures in accordance with Article 4 of Directive 2004 /49/EC.
b)
Certified unit responsible for maintenance implementing measures in accordance with Article 14a (3). 3, in Directive 2004 /49/EC.
c)
Contracting entities or manufacturers which call for a notified body to use the EC verification procedure in accordance with Article 18 (1). 1, in Directive 2008 /57/EC, or a body designated in accordance with Article 17 (1). 3, in the same Directive.
d)
An applicant for authorisation to take structural defined subsystems.
(e)
A veteran's operator who assesses the significance of a change.
12)
Safety Assessment Report : The document containing the conclusions of an assessment carried out by a examiner by the relevant system.
13)
Danger : a situation that could lead to an accident.
14)
Assessor : the independent and competent, external or internal person, organisation or entity carrying out investigations to reach a decision based on an objective basis of the suitability of a system to meet the required conditions ; safety requirements to be used.
15)
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 sufficiently low, that it is unnecessary to initiate immediate measures to reduce it further.
16)
Fareregists : the document in which it is registered and refers to identified hazards, measures relating to this and their reasons, and in which reference is made to the organisation handling them.
17)
Field identification : the process that consists of uncovering, registering and characterizing hazards.
18)
Risk acceptance principle : the rules used to determine whether the risk of one or more specific hazards is acceptable.
(19)
Appliable practices means a written set of rules which, when used correctly, may be used to keep one or more specific hazards under control.
20)
Reference system : a system that has been established in practice to have an acceptable level of safety and which can be used to compare the extent to which the risk is acceptable in a system that is considered to be an assessment.
21)
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 product.
(22)
Technical system : a product or whole of products, including 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 development of relevant interfaces, where human behaviour is of relevance, is taken into consideration, human 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 ;
23)
Disaster follows : death and / or multiple serious injuries and / or significant environmental damage caused by an accident.
24)
Acceptance of security : the status provided by the author of the Proposal for the Assessment of the Assessment and Security Assessment Report of the Assessment.
25)
System : whole consisting of interconnected or interconnected parts.
26)
Conformity assessment body : the conformity assessment body as defined in Article 2 of Regulation 2008 /765/EC of the European Parliament and of the Council of 9. July 2008, on the requirements for accreditation and market surveillance in relation to the marketing of products and repealing Council Regulation No 2, 339 /93/EEC. 2.

3. Significante changes

The successful tenderer 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 of this Annex.

In the case of the proposed change of security, the author of the proposer on the basis of an expert opinion on the significance of the change shall be based on the following criteria :

1) Dare of failure : a plausible, worst-conceivable scenario in the event of failure of the system under evaluation, in the case of security barriers outside the system ;

2) innovations used to make the change : this applies to both for 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 revert to the system as it was before the change

6) accumulation : assessment of the significance of the change, taking into account all recent safety-related changes which were not considered significant by the system that has been considered to be assessed.

The tenderer shall keep sufficient evidence to justify its decision.

4. Risk Management Process

The successful tenderer shall be responsible for the use of the risk management process described in Appendix 2 to a significant change as specified in section 3 of this Annex and by design, construction and integration of new subsystems.

The tenderer shall ensure that the risks which are anchors by their suppliers, service providers and their subcontractors are governed by the requirements of the Annex. The successful tenderer may, for this purpose, agree with its suppliers, service providers and their sub-contractors that they have a duty to participate in the risk management process described in Appendix 2.

5. Independent Rating

An independent assessment of the suitability of the suitability of the risk management process in Annex 2 shall be carried out by an independent examiner, and shall be used by an independent examiner. This examiner shall be approved by the Traffic Management Board, in accordance with the notice of approval of the processors and experts in the context of the approval of railway infrastructure and vehicles or accredited, cf. section 16 of this notice.

In order to carry out the independent assessment, the examiner must :

(a) ensure that the examiner himself has a detailed understanding of the significant change on the basis of the documentation provided by the author of the proposal ;

(b) perform an assessment of the processes used to control the safety and quality of the design and implementation of the significant change, and by design, construction and integration of new subsystems, if these processes do not : have already been certified by a relevant conformity-assessment body ;

c) carry out an assessment of the use of these security and quality processes during the design and implementation of the significant change and design, construction and integration of new subsystems.

When the assessment has been carried out in accordance with subparagraphs (a), (b) and (c), the examiner shall prepare a safety assessment report as provided for in section 6 of this Annex and in the notice Annex 4 of this Annex.

Doppings must be avoided in the case of the following assessments :

(a) the conformity assessment of the security management system and the maintenance system of the maintenance units responsible for maintenance required by Directive 2004 /49/EC;

(b) any other independent assessment carried out by the examiner in accordance with Annex 1 (3).

6. Security Assessment Reports

Assessor will submit a safety assessment report in accordance with the requirements of Appendix 3 of this Order Decision. The successful tenderer shall be responsible for determining whether and how the conclusions of the safety assessment report shall be taken into account in the acceptance of the assessment of the estimated change. In the end, the author of the proposal is in a position to disagree with part of the safety assessment report, justify and document its position.

If a system or a subsystem has already been accepted as a conclusion of the risk management process specified in Annex 1-3 to this notice, the resulting safety assessment report shall not be called into question by any other director of responsibility ; to carry out a new assessment of the same system. Mutual recognition requires documentation that the system will be applied to the same functional, operational and environmental conditions, as is the case already for the already accepted system and that similar risk acceptance criteria are used.

7. Proposal statement declaration

On the basis of the results of the application of Annex 1-3 of this notice and the assessment report of the report, the author shall issue a written declaration that all identified hazards and risks in these hazards have been kept acceptable ; level.


Appendix 2

RISK ASSESSMENT

1. Scope 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.

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 meet ;

(b) the demonstration that the system meets 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 depived in the diagram in the Annex 2 of the notice, where it is shown that the system meets all the safety requirements necessary to accept the risks associated with it ; with the identified hazards.

2.1.2. The risk-management process must include suitable quality assurance activities and carried out by competent employees. It must be the subject of an independent assessment carried out by one or more of the auditors.

2.1.3. The broadcaster with responsibility for the risk management process leads to an ongoing pharastership according to paragraph 5.

2.1.4. The operators who have already established risk assessment methods or tools may continue to apply these where they are compatible with Annex 1-3 of this notice under the following conditions :

(a) the risk assessment methods or tools are 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 are required in accordance with a TSI or meet publicly available recognised standards specified in the national provisions of the notification.

2.1.5. Without prejudice to the laws of the Member States concerning civil liability, the author ' s liability shall be responsible for the risk assessment process. With the consent of the stakeholders concerned, the author of the motion for a motion, in particular, shall decide who is responsible for complying with the safety requirements arising from the risk assessment. The safety requirements to be provided by the author of the proposer shall not be provided outside the scope of their responsibility and control. 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 point 4.

2.1.6. In the first phase of the risk management process, the author of the Proposal document will document the tasks and the risk management activities of the various actors. The successful tenderer shall be responsible for coordinating close cooperation between the various actors concerned under 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 for the estimated system and with reservation for interface specifications defined in relevant TSIs, the relevant railway sector operators shall cooperate in order to identify and manage the dangers and take them together ; necessary safety precautions for these interfaces. The successful tenderer coordinates the management of common hazards in the interfaces.

2.2.2. If a stakeholder in fulfils of a safety requirement determines a need for a security measure that the operator may not carry out, the holder shall, by agreement with another operator, arrange the handling of the danger to the latter in question ; according to the process described in paragraph 5.

2.2.3. As far as the estimated system is concerned, any actor who ascertains that a safety measure does not meet the requirements or is inadequate shall be responsible for notifying this to the author who subsequently informs the actor who : implement the safety measure.

2.2.4. The stakeholder who implements the safety 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 it is carried out ; the same safety measure is used.

2.2.5. If there is a difference of opinion between two or more actors, it is up to the author of the motion to find a solution.

2.2.6. If a stakeholder does not meet a requirement in notified national regulations, the author ' s advices shall seek advice from the relevant competent authority.

2.2.7. Independently for the definition of the assessed system, the author is responsible for ensuring that the 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 overall iterative process, which includes :

a) the system definition

b) risk analysis, including hazard identification,

c) risk evaluation.

The risk-assessment process must be included in a interaction with the management of hazards in accordance with paragraph 5.1.

3.1.2. The system definition must, at the very least, address the following areas :

a) a system objective (for the intended purpose),

(b) system functions and elements where appropriate (including human, technical and operational elements)

c) system-limit, including interaction with other systems ;

(d) physical (interacting systems) and functional (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, in accordance with the appropriate iterations, the definition of the safety requirements identified in the risk assessment process ;

and (g) assumptions with a view to the mitigating 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) application of recognised practices (3.3) ;

(b) comparison with similar systems (3.4),

c) explicit risk estimation ( Point 3.5).

In accordance with the principle set out in 2.1.5, the author of the author of the motion of the motion is to make use of a specific risk acceptance principle.

3.1.5. The successful tenderer is documenting the risk assessment that the selected risk acceptance principle has been applied satisfactorily. The tenderer also checks that the selected risk acceptprinciples are applied consistently.

3.1.6. For the purposes 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 paragraph 4.

3.1.7. The iterative risk assessment process shall 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. Hazard identification

3.2.1. The successful tenderer shall be systematically identified and with assistance from a parallel range of competent experts all hazards that may reasonably be foreseen for the overall estimated system, its functions, when relevant, and its interfaces.

All identified hazards are recorded in the pharastery according to point 5.

3.2.2. In order to target the risk assessment measures against the essential risks, the risks must be classified according to the estimated risk they entail. On the basis of an expert opinion, hazards involving generally accepted 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 from hazards may be classified as general accepted by 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 that the contribution of all the general accepted risks must not exceed a fixed share of the overall risk.

3.2.4. The identification of the security measures may be identified in connection with the hazard identification. They shall be recorded in the subject of the pharastery according to point 5.

3.2.5. It is only necessary to carry out the hazard identification at the level of detail necessary to establish where the security measures can be expected to keep the risks under control in accordance with one of the risk acceptance principles that are ; referred to in section 3.1.4. There may be a need for an iterative process between risk analysis and risk evaluation phase until a sufficient level of detail has been obtained with regard to the hazard identification.

3.2.6. Where a recognised practice or a reference system is used to keep the risk under control, the hazard identification may be limited to :

a) a verification of the relevance of the recognised practice or of the reference system,

b) the identification of the deviations from the recognised practice or the reference system.

3.3. Application of recognised practices and risk evaluation

3.3.1. The successful tenderer shall analyse, with the support of other participating stakeholders, of one, several, or all hazards adequately covered by the application of relevant recognised practices.

3.3.2. Anerwell-known practices must at least comply with the following requirements :

(a) They must be generally recognised in the railway sector. If this is not the case, the recognised practices must be justified, and the examiner must be able to accept them.

b) They must be relevant in order to keep the relevant hazards in the assessed system under control. The successful use of recognised practices used in similar cases to manage changes and to effectively control identified hazards in a system in accordance with Annex 1-3 of this notice shall be sufficient to ensure that it is deemed to have been deemed necessary for the purpose of the relevant.

c) On request, they must be made available to the auditors in order to assess or, where appropriate, mutually recognise the suitability for use of both the risk management process in accordance with Annex 1 (6). And the results of it.

3.3.3. Where the requirements of Directive 2008 /57/EC require compliance with TSIs and the relevant TSI does not require the application of the risk management process laid down in Annex 1-3 of this notice, the TSI may be regarded as recognised practice for the purpose of : maintain hazards under the supervision provided that the requirement referred to in (b) in section 3.3.2 is fulfilled.

3.3.4. National regulations notified in accordance with Article 8 of Directive 2004 /49/EC, and Article 17 (1). The third Directive, in Directive 2008 /57/EC, may be considered as recognised practices, provided that the requirements of section 3.3.2 have been met.

3.3.5. If one or more dangers are kept under the control of recognised practices which meet the requirements of 3.3.2, the risks of these hazards shall be considered acceptable. This means :

a) that there is no need to further analyse these risks further ;

b) that the use of a recognised practice must be registered in the pharmaco, as security requirements for the pertinent hazards.

3.3.6. In the event that an alternative approach is not fully in conformity with recognised practices, the author of the proposer must demonstrate that the alternative approach leads to at least the same level of security.

3.3.7. If the risk of a particular risk is not reduced to an acceptable level by applying a recognised practice, additional security measures should be identified by applying one of the two other risk acceptance principles.

3.3.8. When all hazards are kept under the control of recognised practices, the risk management process may be limited to :

(a) Risk identification, cf. item 3.2.6

(b) the registration of the use of a recognised practice in the pharmacostracy, cf. section 3.3.5

c) the documentation of the use of the risk management process, cf. point 6

d) an independent assessment, cf. Annex 1, Section 5.

3.4. Use of a reference system and risk evaluation

3.4.1. The tenderer shall analyse with the assistance of other participating agents, whether one, more or all of the hazards are adequately 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) It is already in practice to have an acceptable level of safety, and that must therefore be allowed to continue to be approved 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 to be acceptable ;

(b) the 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 must be documented in the risk evaluation that the estimated system atleast the same level of security as the reference system, by another reference system or one of the other two ; the risk acceptance principles shall be applied. The risks of hazards covered by the reference system shall be regarded as acceptable in such cases.

3.4.5. If a level of safety at least equivalent to the reference system is obtained, further safety measures shall be identified for the derogations, as one of the other two other risk acceptance principles is applied.

3.5. Explicit Risk Estimation and Evaluation

3.5.1. If the risks are not covered by one of the two risk acceptance principles laid down in points 3.3 and 3.4, the 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 in either EU law or in the notification of national regulations. Depending on the risk acceptance criteria, the evaluation of whether the estimated risks are acceptable is carried out either for each associated hazard or overall hazard for all the hazards that are 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. If the danger or combination of several hazards is considered acceptable, the security measures identified in the Pharastery shall be recorded.

3.5.4. In the event of danger arising from failure of technical systems which are not covered by the recognised practice or the use of a reference system, the following shall be the following risk acceptance in relation to the design of the technical system :

For technical systems where a malfunction has a plausible direct potential for catastrophic effects, the associated risk is not required to be further limited if the error frequency is less than or equal to 10 -WHAT? 9 per operating hours.

3.5.5. Except as otherwise stated in the procedure laid down in Article 8 of Directive 2004 /49/EC, the application of a stricter criterion for the application of a stricter criterion other than that referred to in section 3.5.4 shall be applied to maintain a national law ; level of security.

3.5.6. develop a technical system during the application of 10 -9 -the criterion, cf. in 3.5.4, the principle of mutual recognition applies.

However, the author of the Proposal may document that the national security level of the Member State of application may be maintained with an error rate higher than 10 ; -9 per in the case of operation, the author of the motion may use this criterion in this Member State.

3.5.7. The explicit risk estimation and evaluation shall meet at least the following requirements :

(a) The methods used for the explicit risk estimation must correctly reflect the estimated system and the parameters (including all operating modes).

b) the results must be sufficiently precise to provide a solid basis for decision-making. Minor changes in the original assumptions or preconditions must not result in significant changes to the requirements.

4. DOCUMENTATION OF COMPLIANCE WITH SAFETY REQUIREMENTS

4.1. In addition to the acceptance of security in connection with the change, the performance of the safety requirements arising from the risk assessment phase shall be documented under the supervision of the proposal.

4.2. This documentation shall be carried out by each of the operators responsible for complying with the safety requirements as determined in accordance with 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 deficiencies in the security measures expected to meet the safety requirements or any dangers detected in the documentation of compliance with the safety requirements shall lead to the possibility of : the author of the motion for a new consideration and evaluates the associated risks in accordance with paragraph 3. The new hazards shall be recorded in the pharastery according to point 5.

5. HAZARD HANDLING

5.1. Merger handling process

5.1.1. One or more of the pharmacist shall be prepared or updated (if they already exist) by the author of the project during the design and implementation phase and until the amendment is accepted, or until the security assessment report is available. The vessel must accompany progress in monitoring the monitoring of risks linked to the identified hazards. Once the system is accepted and operated, the pharmacist shall subsequently be updated by the railway infrastructure manager or the railway undertaking or the veterans operator who is responsible for the operation of the system that has been taken up for assessment ; 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 the risk assessment process. It shall contain a clear reference to the origin of the dangers and the selected risk acceptance principles and a clear designation of the person 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 entranred them shall be regarded as ' under control ` when the other operator 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 successful tenderer will document the risk management process that is used to assess security levels and compliance with security requirements so that a manager has access to the overall evidence base of the suitability for use the risk management process and the results of it.

6.2. The documentation provided for in paragraph 6.1 of the Proposal shall contain at least :

a) a description of the organization 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 that must be met to keep the risk at acceptable level ;

c) documentation of the fulfils of all necessary safety requirements ;

(d) all assumptions that are relevant to the integration, operation or maintenance of the system, which has been made in connection with the system definition, project planning and risk assessment.

6.3. The examiner shall draw up its conclusions in a safety assessment report in accordance with Annex 4.

The Risk Management Process and the independent assessment

bj


Appendix 3

ASSESSOR'S SAFETY ASSESSMENT REPORT

1. Assessor's safety assessment report shall contain at least the following :

a) identification of the examiner,

(b) the plan for the independent assessment ;

c) the definition of the object and the extent of the independent assessment, as well as the definition of the assessment ;

(d) the results of the independent assessment in particular :

(i) detailed information on the activities carried out in the context of the independent assessment to verify compliance with the provisions of Annex 1-2 of this notice ;

(ii) any identified cases of failure to comply with the provisions of Annex 1-2 of this notice and of the recommendations made by the recommendations ;

(e) the conclusions of the independent evaluation.


Appendix 4

Verification declaration for subsystems that are not covered by the interoperability directive

The declaration of verification and the documents accompanying it must be dated and signed.

It must be written in the same language as the technical file accompanying the declaration, and must include at least the following elements :

a) a reference to the safety assessment report and the statement of the motion for a motion.

b) name and address of the declarent, in other words. the adjudicating entity or the manufacturer or the contracting entity or

c) the manufacturer ' s representative (company name and full address is reported ;

d) the name of the contracting entity or the manufacturer ' s business name shall also be specified,

(e) a brief description of the subsystem and the reference to the system definition ;

(f) the name and address of the expert, which has issued certificates,

g) references to the documents contained in the technical file,

(h) references to all relevant provisions and safety requirements, whether they are provisional ;

i) or final to which the subsystem must comply, including any restrictions in or conditions for operation ;

j) the declaration has been set for the time being, if any ;

c) identity of the signatory.

It must be stated in the statement that all relevant legislation has been complied with.