Guide for JvSFS 2006:1

Guide to the approval procedure

CONTENTS 1 General information.................................................................................................... 1 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8 1.9 1.10 1.11 2 2.1 2.2 2.3 3 3.1 3.2 4 Field of application........................................................................................... 1 How to read the guide...................................................................................... 1 Who should apply for approval? .................................................................... 2 What must be approved?................................................................................. 2 How to apply..................................................................................................... 3 Which approval process is applied? ............................................................... 4 Approval of upgrading and renewal............................................................... 5 Simplified approval procedure for vehicles .................................................. 8 Time-limited and permanent approval .......................................................... 8 Re-appraisal of permits .................................................................................... 9 Definitions ....................................................................................................... 10 Metros and tramways ..................................................................................... 11 Exemptions for certain rail vehicles............................................................. 12 Exemptions for certain rail infrastructure................................................... 13 Applications..................................................................................................... 14 Different procedures depending on TEN/non-TEN .............................. 15

Exemptions from the requirement for approval .................................................. 11

Applications for derogation from TSI ................................................................... 14

Approval of subsystems specified in TSIs............................................................. 17 4.1 Appraisal against standardised rules general............................................ 17 4.2 Applications..................................................................................................... 19 4.3 Time of handing-in of application documents........................................... 20 4.4 Market surveillance......................................................................................... 20 4.5 Checking that the subsystem is compatible with the system into which it is integrated................................................................................................................. 21 4.6 Checking of any open points and specific cases in TSIs .......................... 21 4.7 Checking any derogation from conforming to the requirements of a TSI 22

Approval of subsystems not specified in TSIs...................................................... 23 5.1 5.2 5.3 5.4 5.5 5.6 5.7 5.8 5.9 Appraisal against national rules general ................................................... 23 Checking against the safety requirements of the Railway Act.................. 23 Checking against the essential requirements............................................... 24 Application....................................................................................................... 24 Assessor............................................................................................................ 24 Rail vehicles ..................................................................................................... 25 Rail vehicles with valid foreign approval..................................................... 30 Foreign rail vehicles in temporary use in Sweden...................................... 31 Railway infrastructure..................................................................................... 33

Exemptions ................................................................................................................ 38

Vgledning

REFERENCES
The requirements for the approval of track installations, vehicles and railway infrastructure are based on the following acts, directives and specifications: The Railway Act The Railway Ordinance: The metro and tramway safety act: The metro and tramway safety ordinance: The regulations of the Swedish Rail Agency on the approval of subsystems in railways, etc. The specification and demonstration of reliability, availability, maintainability and safety (RAMS) : Communication, signalling and processing systems. Safety related electronic systems for signalling: Council Directive on the interoperability of the trans-European high-speed rail system: Council Directive on the interoperability of the trans-European conventional rail system: Technical specifications for interoperability of high-speed trains (TSIs): 2004:519 2004:526 1990:1157 1990:1165 JvSFS 2006:1 SS-EN 50126:1999

SS-EN 50129:2003 96/48/EC 2001/16/EC Infrastructure Energy Control command and signalling Rolling stock

The above documents (except the Swedish SS-EN standards) can be found on the Swedish Rail Agency website www.jvs.se . The SS-EN standards can be ordered from the Swedish Standards Institute, SIS.

1 General information
1.1 Field of application

Chapter 1 Section 1 These regulations contain rules on the approval procedure for new, renewed and upgraded subsystems. The regulations also contain rules which state how to apply for derogation from technical specifications for interoperability (TSIs).

This guide is intended to assist applicants when reading the regulation JvSFS 2006:1 Jrnvgsstyrelsens freskrift om godknnande av delsystem m.m. (The regulations of the Swedish Rail Agency on the approval of subsystems in railways, etc.). The term subsystem refers to distinct parts of the railway system, such as vehicles and railway infrastructure. JvSFS 2006:1 governs what information forms the basis for approval by the Swedish Rail Agency and when this information must be submitted to the Technical Unit of the Swedish Rail Agency. This guide provides the applicant with further information about the processes used for approval and about how the Swedish Rail Agency conducts the appraisal (appraisal against standardised rules and appraisal against national rules). The purpose of approval by the Swedish Rail Agency is both to ensure that different subsystems can be used together in practice without the risk of damage or accidents occurring, and that relevant safety requirements in Sections 1-5 of the Railway Act have been met. A decision to grant approval means that the subsystem in question may be used for railway operations in Sweden.
Chapter 1 Section 2 The regulations in Chapters 2 and 5 also apply to new or significantly renewed metro and tramway track installations and vehicles.

This is an important section if the application relates to vehicles or infrastructure for metros and tramways. The regulation on approval has its origin both in the Railway Act and the legislation concerning metro and tramway safety. To avoid the necessity of repeating all fields of application in every section of Chapters 2 and 5, this has been set out once and for all in Chapter 1, Section 2. The purpose is to make the regulation easier to read.

1.2

How to read the guide

The guide is set out in the form of comments on the regulation. First, the wording of the section is presented in a box with a coloured background. This is followed by clarifications and explanations. The guide also contains examples and templates (appendices) to make the application process easier for applicants. Every applicant needs to read Chapters 1 and 2. These chapters contain general information that applies throughout.

2 Applicants affected by TSIs (railway systems standardised within the EU) also need to read Chapters 3 and 4. Applicants subject only to national requirements (i.e. not affected by TSIs) need to read Chapter 5. Consequently, this chapter applies to the following objects for approval: tramway tracks and metros 1 , tramcars, metro cars. national safety constituents. maintenance machines (although these must satisfy TSI noise requirements during transport). Anything not yet specified in a TSI, e.g. multiple units, locomotives and passenger carriages, parts of the railway infrastructure. (This subsection is only valid for a transitional period. In step with the gradual introduction of TSIs, the approval process described in Chapter 4 must be applied.)

Infrastructure and vehicles intended to be used for local purposes, historical purposes or purposes of tourism, or infrastructure whose operation is independent of the rest of the railway system. It may sometimes be necessary for an applicant to read both Chapter 4 and Chapter 5, specifically when the object for approval comprises subsystems covered by a TSI and parts that are not covered by a TSI. The Swedish Rail Agency takes the view that will be very common for a long transitional period. Staff at the Swedish Rail Agency will then determine whether the combination of European and national requirements is met and if so that the combination of systems works safely together in an interoperable manner.

1.3

Who should apply for approval?

Applicants may be the inventor or purchasers of a vehicle, infrastructure or technical system, for instance a railway undertaking, a manufacturer or an infrastructure manager.

1.4

What must be approved?

A vehicle for rail traffic must be approved by the Swedish Rail Agency before it can be used in Sweden. This applies to new, imported and significantly renewed vehicles. Likewise, a new or significantly renewed track installation or technical system must be approved before it can be taken into service. This is laid down in the Railway Act 2004:519. National safety constituents are approved by the Swedish Rail Agency since they form parts of the railway infrastructure subsystem (a change in the subsystem), whilst constituents that are affected by TSIs (interoperability constituents) are generally 2 not to be approved by the Swedish Rail Agency. (However, interoperability constituents must have a certificate of conformity with TSI when they form part of a subsystem that must be approved by the Swedish Rail Agency.)
1 2

personal rail transport, PRT, (sprtaxi) is classed as a metro There are certain exceptions to this principle. For example, brake block and STMs (Specific Transmission Modules) are to be approved by national safety authorities.

3 Approvals issued in the days of the Railway Inspectorate are valid and need not be repeated as long as a subsystem has not been modified. All equipment that was in use when the new Railway Act came into force can also be regarded as approved. Figure 1 below shows how the various parts of the railway system are designated according to the nomenclature of the EC directives. For instance the term interoperability constituent often corresponds to units of great complexity. (RU = railway undertaking , IM = infrastructure manager). Railway system - the entire railway

Subsystems that require approval - Infrastructure - Energy - Control, command and signalling - Rolling stock

Subsystems that do not require approval (aimed at RUs and IMs) - Telematics applications for freight services - Traffic operation and management

Interoperability constituents Standardised constituents that must have an EC declaration from the manufacturer, for example: rails, sleepers, switches, overhead contact wire, pantographs, collector heads, onboard ETCS, external STM, Eurobalises, wheels, buffers and draw gear, front windscreens, etc.

National safety constituents Non-standardised constituents that are approved nationally, for example: ATP system, automatic block, track circuits, switch drives, switch blade detection contacts, level crossing systems, etc.

Figure 1 The various parts of the railway system.

1.5 How to apply

The applicant may submit an application with the aid of this guide and using the forms in the appendices. The submitted documentation may be more or less detailed, depending on the complexity of the system. In certain cases, the content of the document required by the Swedish Rail Agency can be considerably simplified. It is

4 always a good idea to consult the Swedish Rail Agency when submitting an application. 1.5.1 When to contact the Swedish Rail Agency It is important for applicants to get in touch with the Swedish Rail Agency at an early stage to discuss how the process will be conducted from then on. For approval issues where a TSI is to be applied, it is important that the notified body is involved from the project planning stage. Contacting the Swedish Rail Agency at an early stage enables the Agency to provide information about current legislation, regulations and official requirements, even in adjacent areas such as the environment, health and safety and electrical safety. If the application relates to the approval of a vehicle, the applicant should also contact the infrastructure manager. The Swedish Rail Agency and the applicant should conduct a running dialogue during the course of the project. This will create good continuity in the approval process. This makes the work of the applicant and the Swedish Rail Agency easier and shortens the processing time. Initial contact may be made in the simplest manner, for instance in the form of a telephone call, an e-mail or a letter, in which the applicant announces his intention to develop a new system or modify an existing one. The issue will be assigned to an operative at the Swedish Rail Agency.

1.6 Which approval process is applied?

The Swedish Rail Agencys regulation on approval describes two processes. One is harmonised within Europe and is used for standardised railway systems (of the kind specified in TSIs). The harmonised approval process is described in Chapter 4 of the regulation. The other process is national and is used for subsystems that are based on national rules (e.g. metro and tramway systems and national safety constituents). The national approval process is described in Chapter 5 of the regulation.
Chapter 1 Section 3 Applications for the approval of subsystems governed by a TSI which has came into force, and when the subsystem has been planned, designed, renewed or upgraded after the end of June 2004 must be made in accordance with Chapter 4. Applications for the approval of subsystems governed by a TSI which has came into force, and which have been planned, designed, renewed or upgraded before the end of June 2004, or before a TSI has come into force, must be made in accordance with Chapter 5. The second paragraph also applies to subsystems not regulated by a TSI, regardless of when planning, building, renewal or modernisation began.

This section clarifies a major dividing line as regards the application of regulation JvSFS 2006:1, namely the date from which the new Railway Act applies (1 July 2004).

5 The purpose of the section is to guide the applicant to the relevant part of the regulation, depending on the nature of the object of the application. Examples: According to the last sub-section of the section, if the application relates to infrastructure that is not covered by a TSI, an application for approval must be made in accordance with Chapter 5. If you refer to Chapter 5 you will receive further guidance (in Section 2) that the application is subject either to Sections 14-17, or to Sections 18-20. If the application relates to a vehicle for a metro, only national rules apply. According to the last sub-section of the section, an application for approval must be made in accordance with Chapter 5. If you refer to Chapter 5 you will receive further guidance (in Sections 1-2) that the application is subject to one of Sections 4-13. According to the first sub-section of the section, if the application relates to a standardised control command system specified in a TSI that was planned after the end of June 2004, an application for approval must be made in accordance with Chapter 4. If you refer to Chapter 4 you will find further guidance.

Partial stretches of line commissioned successively The construction of a new stretch of track is usually a project that takes several years to complete, and construction takes place by stages. It is difficult to decide the best way to view such projects. Should they be viewed as one project, even though it may run for 15 years, or should each stage be viewed as a (sub-)project? In the opinion of the Swedish Rail Agency, it is easiest to handle each stage individually, that is, to view each stage as one project. Consequently, a planned stretch of track may initially be approved in accordance with Chapter 5 of the regulation, if planning began before 1 July 2004, and later be approved in accordance with Chapter 4 (when planning and application design took place entirely after the end of June 2004). If a planned stretch of track is made up of a number of partial stretches which are commissioned separately, each partial stretch must be approved separately, with a valid certificate of conformity and EC declaration of verification.

1.7

Approval of upgrading and renewal

Form G1

Chapter 1 Section 4 When the intention is to undertake modernisation or renewal of an already approved subsystem, this must be described and a risk analysis must be submitted to the Swedish Rail Agency. The Swedish Rail Agency then requests the supplementary information required for approval. The stipulations of the first paragraph about upgraded and renewed subsystems is correspondingly applicable to significantly renewed metro and tramway track installations and vehicles.

An approval decision applies until a railway infrastructure, a track installation or a vehicle is renewed or upgraded.

6 In the case of upgrading and renewal, an application must be submitted in the same way as for new constructions if the nature of the activity is such that approval is required (i.e. if the change affects safety). As far as possible, the information on which the Swedish Rail Agency bases its approval must be limited to the actual change, but the change must be described in relation to the whole, so that the context can be understood. This section states the minimum information that the applicant must send to the Swedish Rail Agency. The supplementary information that the Swedish Rail Agency requests depends on the nature of the renewal, but consists of information in accordance with chosen sections in Chapters 4 and 5. More information about risk analyses is given in Appendix 2. A safety-relevant renewal or upgrading that affects interoperability with neighbouring systems or constituents must be assessed against a TSI. Following a TSI is optional for the replacement of a system or constituent if the replacement does not alter the operation or performance of the subsystem. 1.7.1 Vehicles If may be difficult to determine what changes or modifications need to be approved. Examples of vehicle renewal that does not require approval by the Swedish Rail Agency are set out below. If in doubt, contact the Swedish Rail Agency: Replacement of a part that affects neither safety nor interoperability, for example a transformer. Replacement of the interior fittings in the passenger and personnel areas. A risk analysis must be conducted and documented, showing that the new interior fittings are at least as safe as the replaced ones. For example, the fire classification of new seats must be at least as good as that of the replaced seats. Replacement of a safety-relevant part (valve, relay, sensor, wheel box, spring, shock absorber, transformer, etc.) that meets the same specification as the part it replaces. A risk analysis must be conducted and documented, showing that the new part is at least as safe as the replaced part and that it is suitable for the vehicle in question. maintenance actions, both preventive and corrective.

The following vehicle renewal operations are examples of changes that require approval: A renewed or reprogrammed ATP system. Such a system must per se be approved for installation in vehicles. A new type of service and emergency brake system or wheel slide protection system. New brake control software. A new type of drivers panel, driver monitoring or controls for the control of traction and braking. New electronics or software for safety-relevant functions. The updating of software in high-risk functions such as ATP, emergency brake, brake antilocking system. A new type of bogie, axles or wheels. A new type of coupling, frame or body.

A new type of door, door locking, emergency system, fire alarm. A new use of a vehicle, for example increased speed or greater axle load. A change in the type designation of the vehicle (the Swedish Rail Agency has a register of the type designations of all approved vehicles in Sweden). Installation of ETCS in a vehicle.

An example of a special vehicle to be approved is a radio-controlled locomotive. This is an ordinary locomotive fitted with radio control (for marshalling). The actual locomotive must have been approved as a basis. After this, approval of the installation of the radio control equipment is required a separate approval for each type of loco. 1.7.2 Infrastructure Examples of renewal of railway infrastructure that DOES NOT require the approval of the Swedish Rail Agency: a replacement of a part without any change in function or performance, for instance: replacement of sleepers, replacement of rails, replacement of cables, replacement of point blades, replacement of a relay. maintenance actions, both preventive and corrective maintenance (for example grinding, ballast cleaning, track alignment). noise protection. elimination of a level crossing. marginal change of track length (in consultation with the Swedish Rail Agency, typically less than 100 metres). line changes such as curve straightening. introduction of a level crossing installation of an approved type (however, there must be a decision by Banverket 3 ). replacement of part of an approved type, provided that they meet the same specification as the part replaced. Work on equipment that does not affect safety, e.g. certain parts of interlocking system.

The following major renewal operations are examples of changes that require approval: new meeting track or passing track. new switches between running tracks. capacity enhancement such as increased axle load, larger loading gauge, increased speed.

If you plan to construct a new level crossing installation or remodel an existing one, you must contact Banverket. After consultation with The Swedish Road Administration (Vgverket), Banverket will decide which type installation (full barrier, half-barrier, etc.) there should be at a level crossing, as stated in Section 79 of the Traffic Sign ordinance (Vgmrkesfrordningen) (1978:1001). This applies regardless of the identity of the infrastructure manager.

changed functionality or technical solution at a level crossing, a interlocking system, ATP system, GSM-R, base stations, telephone exchanges. change of technology (a technical solution that differs from the solution previously approved). Significant increase in track length (in consultation with the Swedish Rail Agency, typically more than 100 metres). Significant increase in complexity, e.g. the introduction of more switches, level crossings, etc. A railway infrastructure or track installation that is to be equipped with a new type of signal safety installation that has not previously been approved.

1.8

Simplified approval procedure for vehicles

Form G7

Chapter 1 Section 5 An application for approval will be processed with a simpler approval procedure if, on an earlier occasion, the Swedish Rail Agency has approved other series-manufactured rail vehicles of the same technical design. Applications must include details of the earlier approval decision, as well as the details and documents requested by the Swedish Rail Agency. The first paragraph is correspondingly applicable to metro and tramway vehicles.

The purely formal approach for vehicles is to use individual approval, even if the work procedure of the Swedish Rail Agencys operatives largely takes the form of a simplified approval procedure. If an application relates to series-manufactured vehicles, approval must be sought for all vehicles in the series. The Swedish Rail Agency appraises the first vehicle in the series before it goes into service and decides on approval for all vehicles. After this, simplified approval is applied, in conjunction with the putting into service of each individual vehicle in the series. The reason for this is that each individual vehicle must be included in a vehicle register which is being created within the EU, so data is needed for each individual vehicle. Exactly what data will be asked for is not clear at present. Note that, in addition to approval of the vehicle by the Swedish Rail Agency, a track access agreement with the infrastructure manager is required.

1.9

Time-limited and permanent approval

The Swedish Rail Agency often grants approval in two stages, first a time-limited approval in order to conduct trial operation or to gain experience with operation of the vehicle, and then permanent approval. Time-limited approval may also include restrictions and conditions on use. Both trial operation and operation to gain experience may be needed to gather practical experience of the subsystem. Another reason for time-limited approval is to allow the applicant to carry out connection and commissioning and then to prepare documentation of these activities. The difference between trial operation and operation to gain experience is that trial operation takes place in a protected environment; in other words the trials take place in an actual operating environment, (in the field) but without involving passengers or other vehicles

9 (possibly as well as other restrictions). Operation to gain experience, on the other hand, involves commercial use of the subsystem.

1.10

Re-appraisal of permits

In connection with approval issues, the companys operating rules (swedish TRI) may be affected in such a way that the TRI needs to be changed. One result of a changed TRI is that the licence of the company (primarily railway undertakings and infrastructure managers) needs to be re-appraised. In such cases, applicants should contact the Swedish Rail Agencys infrastructure unit or railway undertaking unit. The following requirements apply to TRIs and training plans, as well as safety organisations within a company: New and changed TRIs, training plans and organisations must be at least as safe as the existing ones The traffic rules must be based on the presence of barriers against faults/errors so that a single fault/error cannot cause a dangerous situation.

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1.11 Definitions
Chapter 1 Section 6 In these regulations, the following terms have the meanings given below: user manual: a document that describes how to operate a system, RAM programme and safety plan: documents that describe how the applicant plans to control reliability, availability, maintainability and safety during all phases of development in accordance with SS-EN 50126:1999, specification of requirements: document that specifies the functionality and performance of the system and its interfaces to and interaction with other parts of vehicles, track installation, rail infrastructure and users. The document also specifies requirements to be met by design, manufacture and validation, installation and commisioning, operation and maintenance, documentation, modification and phasing out, risk analysis: a document that identifies and assesses sources of risk that arise when a system is used (for normal operation, incorrect use, technical faults in the system, emergency operation and other conceivable situations). The document contains an estimate of how often the risk sources arise and their consequences, safety inspection: a check of the safety status of a vehicle, track installation or railway infrastructure, safety case: a document that contains a description of the system, the manufacturers quality control, the manufacturers safety control, the technical safety of the system, related safety cases and a conclusion as to the safety of the system according to SS-EN 50129:2003 Chapter 5, TSI: the technical specifications for interoperability with which every subsystem and every constituent of a subsystem must comply. The purpose of the specifications is to ensure interoperability over the trans-European rail system, type designation: combination of numbers and/or letters used to identify seriesmanufactured vehicle of the same technical design, maintenance manual: a document that describes corrective and preventive maintenance of a system, maintenance plan: a document that describes the maintenance operations to be carried out and at what intervals, validation: an activity such as testing, analysis and checking with the purpose of demonstrating that the finished system meets specified requirements, validation plan: a document that describes how conformity of the system with the specification of requirements will be demonstrated. The document contains detailed plans for what must be done, when and how, validation report: a document that describes all tests, analyses and checks carried out to ensure that the system meets the requirements laid down (the procedure, who did what, what the result showed), version designation: a combination of numbers and/or letters to identify a specific edition of a document, software or hardware that changes.

In addition to these definitions, the following terms are defined: ATP: Automatic Train Protection, the Swedish ATP-system is called ATC. NB: Notified Body.

11 Infrastructure manager: The body that manages railway infrastructure and operates installations that belong to the infrastructure. The term railway infrastructure means: track, signalling and safety installations intended for rail services, traffic control centers, arrangements for supplying the traffic with electric power, as well as other fixed arrangements for the stock, operation or use of the installations. National safety constituents: Non-standardised constituents of Swedish railway infrastructure, vehicles or track installations that affect safety, for instance the national ATP system (e.g. balises), interlocking systems including object controllers, automatic block, national radio block centre, level crossing system including obstacle detector and barrier drive gear, track circuit, switch drives and blade switch detection contacts, hot box detector. Risk source: a state or a series of circumstances in a system, which, together with other circumstances in its surroundings, may lead to an accident that may cause injury to people or damage to property. Sidings (industrial sidings): railway infrastructure normally intended only for marshalling movements, max 30 km/h. TEN: Trans-European Network, i.e. the Trans-European rail system for conventional train and high-speed trains. The definition of the TEN is set out in the Railway Ordinance (2004:526) as well as in Annex I to Directives 96/48/E.G. and 2001/16/EG. Running track: railway infrastructure in the form of a track installation that is normally controlled by signals and is intended for train movements (also applies to railway infrastructure in tunnels and on bridges).

2 Exemptions from the requirement for approval

2.1 Metros and tramways
Chapter 2 Section 1 The stipulations of this chapter about railway infrastructure and rail vehicles is correspondingly applicable to metro and tramway track installations and vehicles.

Note: Chapter 2 also applies to vehicles and infrastructure for metros and tramways.

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2.2 Exemptions for certain rail vehicles

Chapter 2 Section 2 Approval is not needed for rail vehicles that travel at not more than 20 kilometres per hour and which are not used to carry passengers, and which 1) are used in an area where other traffic has been shut off, or 2) are used in an area where other traffic only operates with on-sight driving, 3) only has track-running wheels which have no significance for propulsion and braking, or 4) are being towed. Rail vehicles approved in another country may be used without approval within the framework of international agreements on mutual recognition.

This section must be taken to mean that the conditions relating to 20 km/h and the non-use of the vehicle to transport passengers must always be met, and in addition that at least one of the conditions in subsections 1-4 must be met at the same time. The speed of 20 km/h was chosen because the consequence of an accident or derailment is considered to be small. The expression on-sight driving means that the speed is set so that the movement can be stopped: before a vehicle or obstacle on the track is reached. before point blades that do not close. before a wrongly set trailing switch or derailer in the active position.

before a signal or sign showing stop. Approval is not needed for rail vehicles that are covered by mutual recognition rules in TSIs for freight wagons or appendices to COTIF.

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2.3 Exemptions for certain rail infrastructure

Chapter 2 Section 3 Approval is not needed for railway infrastructure which 1) carries traffic at a top speed of not more than 20 kilometres per hour, 2) is not used to carry passengers, 1 3) is not used to transport dangerous goods covered by the regulations in RID-S , 4) is not used by more than one rail vehicle or one locomotive connected to other vehicles, 5) has no bridges and tunnels or level crossings where the track is crossed by a street or road open to public traffic, 6) forms the outermost part of the network in which it is included, and 7) is equipped with technical protection which prevents rail vehicles from rolling out on to the tracks of another infrastructure manager.
1

See Section 1.1.3 on exemptions from the regulations of the Swedish Rescue Service Agency (SRVFS 2004:15) on the carriage of dangerous goods by rail (RID-S)

Subsections 1-7 must be complied with at the same time. The section is aimed primarily at managers of sidings, such as tracks in industrial areas. The speed of 20 km/h was chosen because the consequence of an accident or derailment is considered to be small. The statement that something forms the outermost part of the network in which it is included means that there is no track beyond this track (i.e. no other infrastructure managers track). 2.3.1 Other railway infrastructure that does not require approval Certain minor track installations do not require approval by the Swedish Rail Agency. According to JvSFS 2005:2, track installations that are not considered to be railway infrastructure and which do not form a metro or tramway are the following: fairground installations mountain railways mine railways intended for ore extraction and which are not connected to railway infrastructure, track installations on which only pedal dollies are permitted track installations intended only for the movement of cranes, overhead cranes and the like, and other short track installations open only to freight services and which are not connected to railway infrastructure.

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3 Applications for derogation from TSI

Chapter 3 need only be read by those concerned with TSI.

3.1 Applications
Chapter 3 Section 1 An application for derogation from TSI must contain the following information: Form G2 1) Name, address and company registration number of applicant. 2) A description of the work to be done, including a plan, geographical location, functional and technical scope. 3) Details of the TSI(s) from which derogation is requested and whether the application applies to parts or all of the TSI. 4) Statement of the reasons (technical, administrative and/or financial) for the application for derogation. 5) Statement of the corresponding specifications that the applicant wishes to apply. 6) Action plan setting out the measures the applicant is taking and will take to achieve, in due course, compliance with the part or parts of the TSI to which the application for derogation relates.

Derogations are temporary deviations from TSI, unlike national specific cases, which are permanent. This means that an application must always include an action plan for how and when to achieve agreement between the TSI and the directive. Applications and appendices should be written in Swedish. According to Chapter 2, Section 11 of the Railway Ordinance (2004:526), an applicant is entitled to apply for an derogation from compliance with the requirements of a TSI, in the following cases and under the following circumstances (Note: derogations can also be sought for a vehicle TSI, even if the wording below appears only to cover infrastructure): a) For a project involving a new line or renewal of an existing line, if the project is already well advanced or if a contract for such a project is being carried out when the TSI is published. b) For a project that involves upgrading or renewal of an existing line, if the loading gauge, track gauge, track spacing or voltage according to a TSI is incompatible with the existing line. c) For a project involving a new line or renewal of an existing line, if the application of a TSI threatens the profitability of the project or the interoperability of the Swedish railway system. d) If the conditions for rapidly restoring rail connections after an accident or a natural disaster do not permit the application of a TSI, technically or financially. The European Commission has produced a guide for applications for derogations from TSIs. It can be found on the Swedish Rail Agency website: www.jvs.se.

15 Projects that receive financial support to incorporate the requirements in the TSIs should not apply for derogations from conforming to TSIs (such derogations are only granted in very special circumstances).

3.2 Different procedures depending on TEN/non-TEN

Chapter 3 Section 2 Applications for derogations that relate to subsystems that are not included in the trans-European rail system must reach the Swedish Rail Agency as early as possible, but not later than with the application for approval. Chapter 3 Section 3 Applications for derogations that relate to Chapter 3 Section 11 subsections 1-3 and Section 12 of the Railway Ordinance (2004:526) must reach the Swedish Rail Agency as soon as possible after publication of the TSD in the Official Journal of the European Union. If an application for derogation relates to Chapter 2 Section 11 subsection 4 of the Railway Ordinance, the application must reach the Swedish Rail Agency as soon as possible after the incident.

The sections state when derogation application documents must be submitted. This is different depending on whether the application relates to TEN or non-TEN. What distinguishes Section 2 from Section 3 (apart from the times when the application must be submitted) is that, under Section 2, the Swedish Rail Agency alone decides on derogations. On the other hand, if the derogation application relates to railway infrastructure included in TEN, the Swedish Rail Agency may only decide on derogation after the European Commission has been notified. TEN is divided into lines for high-speed trains and lines for conventional trains. In Sweden, about half of the entire infrastructure consists of TEN. Appendix 1 shows which lines are classed as TEN lines in Sweden. Figure 2 below shows schematically how TEN, national lines and sidings are related to each other (not to scale and far from comprehensive).

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Stockholm

Gteborg
TEN high speed TEN conventional

Malm

Other national lines Sidings

Figure 2

The outermost part of a rail network

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4 Approval of subsystems specified in TSIs

4.1 Appraisal against standardised rules general
Chapter 4 need only be read by those concerned with TSIs. When an application relates to a subsystem covered by a TSI, the applicant must engage a notified body (NB). The notified body should follow the entire development of the subsystem from the start of the project to commissioning and check agreement with the requirements of the TSI with a focus on interoperability. For an infrastructure project, project start means the system handling phase, whilst for a vehicle it means the specification phase. Before the project starts, the applicant should inform the Swedish Rail Agency which notified body has been engaged. The notified body may be accredited in any EU country, Norway or Switzerland. Accredited NBs are listed at http://europa.eu.int/comm/enterprise/nando-is/home/index.cfm. The Swedish Rail Agency appraises the necessary documents primarily the EC declaration of verification and the EC declaration of conformity and suitability for use which the applicant must submit (in accordance with Section 1). The appraisal consists of: checking that the notified body has been duly accredited. checking of any open points and specific cases in TSIs (specific cases are permanent derogations for Sweden). checking any granted (time-limited) derogation from conforming to the requirements of a TSI. checking that the subsystem is compatible with the system into which it is integrated.

In addition to this, the Swedish Rail Agency can carry out market surveillance, i.e. spot checks for complies with the requirements of the TSI. The subsystem must meet the prescribed requirements regarding safety, reliability, availability, health, environmental protection and technical compatibility. In addition, each subsystem must conform to the prescribed TSIs. There are certain TSIs that do not require approval before commissioning, for example TSI Telematics Applications for Freight services (TAF) and TSI Traffic Operation and Management (OPE). These TSIs are aimed directly at railway undertakings and infrastructure managers. The individual parts of these TSIs are closely linked with the operating procedures and processes that are required for the undertakings to obtain a safety licence/certificate in accordance with Directive 2004/49/EG. Compliance is checked by appraisal of licences.

18

4.1.1 Which TSI applies? The table below shows which TSIs are to be applied for different types of approval issue. Note, however, that since the TSIs are subject to constant development, the information in this table may be out of date. Up-to-date information about which TSIs exist and apply, as well as their content, can be found on the Swedish Rail Agency website (www.jvs.se).

CR COA

CR ENE

HS ENE

Infrastructure, highspeed. Infrastructure, conventional. Sidings High-speed trains Locos, multiple units, passenger carriages Maintenance vehicles Freight wagons HS RST HS INF HS ENE CCS SRT PRM WAG NOI CR INF CR ENE CR COA CR LOC x

x x x x

x x x x x

x4 x x

TSI Rolling stock for high-speed trains, 2002 TSI Infrastructure for high-speed lines, 2002 TSI Energy supply for high-speed lines, 2002 TSI Control command and signalling (high-speed 2002, conventional dir. 2006) TSI Safety in railway tunnels (2007) TSI Persons of reduced mobility (2007) TSI Freight wagons (2006) TSI Noise (June 2006) TSI Infrastructure for conventional lines (2009) TSI Energy supply for conventional lines (2009) TSI Passenger carriages (2009) TSI Locomotives and multiple units (2009)

CR LOC

HS RST

CR INF

HS INF

WAG

PRM

NOI

CCS

SRT

19 In Sweden, the following lines are classed as high-speed lines: Copenhagen Stockholm Sundsvall Copenhagen Gteborg (Oslo) Gteborg Stockholm including Karlstad Lax

4.1.2 TSIs are constantly being updated The content of TSIs is constantly being revised. Each TSI is expected to be updated approximately every third year. In between, the need arises to introduce urgent changes, for instance due to errors and shortcomings that have a negative effect on interoperability. Such quick changes are managed by means of a special process at the EU Commission. For this reason there may be confirmed changed requirements in a TSI that do not appear in the official Swedish version of that TSI. Information about such confirmed changes can be found on the Swedish Rail Agencys website.

4.2 Applications
Chapter 4 Section 1 An application for approval must consist of the following information: Form G3 1) Name, address and company registration number of applicant. 2) Description of the subsystem The description must contain details of: - the nature of the subsystem, - how the subsystem is to be used, - which TSIs apply, - when the subsystem is to be inaugurated, and - proposed type/version designation, if any. 3) The EC declaration of verification for the subsystem. 4) The notified bodys certificate of compliance or suitability of the subsystem. 5) EC declarations of conformity and suitability for use of the interoperability constituents included in the subsystem. 6) Reference to any decisions on derogations from TSIs made by the Swedish Rail Agency. 7) Documents confirming that the subsystem has been tested in its operating environment.

Applications and appendices should be written in Swedish. The contracting entity (generally the applicant) must issue an EC declaration of verification for the subsystem. The EC declarations of verification must be based on the certificate of conformity that the notified body must issue for the subsystem in question (a certificate from an independent party stating that the subsystem conforms to the requirements of the TSI). Correspondingly, the manufacturer of an interoperability constituent must issue an EC declaration of conformity and suitability for use for the constituent. In certain cases, the EC declaration of conformity and suitability for use must be based on a certificate from a notified body. There must be an EC declaration for every interoperability constituent that is included in a subsystem to be approved. The
4

However, TSIs need not be complied with while work is in piogress.

20 relevant TSI gives more information about the EC declaration of conformity and suitability for use and the EC declaration of verification. The description of the subsystem must include a general description of the subsystem, its overall design, construction and performance. Where infrastructure is concerned, geographical details must be included (e.g. location and delimitation points). An example of a document that confirms that a subsystem has been tested in its operating environment is a report from a function test of a vehicle in a winter environment.

4.3 Time of handing-in of application documents

Chapter 4 Section 2 The documents in Section 1 should be submitted to the Swedish Rail Agency at the following times: - subsections 1-2 and 6: as soon as possible, but not later than four months before the subsystem is to be commissioned, - subsections 3-5: not later than two months before the subsystem is to be commissioned, - subsection 7: after tests have been carried out in the operating environment.

To reduce the time taken to process applications, documents should be handed in not later than the stated dates/times. The stated processing times are the maximum times needed by the Swedish Rail Agency in the various situations.

4.4 Market surveillance

When the requested information according to Chapter 4 Section 1 of JvSFS 2006:1 has been received by the Swedish Rail Agency, the Agencys operatives may carry out market surveillance. The EUs aim with market surveillance in the railway field is to prevent the occurrence of non-interoperable products and to stop frivolous importers, manufacturers and notified bodies. Market surveillance is important for the integration of the markets in the communities and for the confidence of consumers and companies in the approval process. Market surveillance is only carried out on subsystems and constituents covered by TSIs and which are therefore necessary for interoperability. Market surveillance is carried out by the safety authorities in the respective member state, in Sweden by the Swedish Rail Agency. The purpose of market surveillance is to ensure that subsystems and interoperability constituents that come on to the market satisfy the essential requirements set out in TSIs, for instance with regard to health, safety, reliability, availability, compatibility and protection of the environment. Market surveillance takes place either when an interoperability constituent is introduced on the market or alternatively when a subsystem is commissioned (for freight wagons, at the time of registration in Sweden). Market surveillance can also take the form of inspection activity, after the constituent or subsystem has been in use for a time.

21 Market surveillance is conducted as a spot check of the work done by a notified body or, in other words: to check that subsystems and constituents satisfy the interoperability requirements as defined in TSIs. Market surveillance may reveal a non-conformity, but may also show up shortcomings in TSIs or standards, for instance. In the latter case, the European Commission must be informed so that it can have the TSI or standard in question corrected. If a non-conformity is found for an interoperability constituent, the Swedish Rail Agency has the right to restrict the field of application of the constituent by banning its use or withdrawing it from the market. If a nonconformity is found for a subsystem, the Swedish Rail Agency may decide on supplementary checks and must immediately inform the Commission (for further action).

4.5 Checking that the subsystem is compatible with the system into which it is integrated
When the information requested according to Chapter 4 Section 1 has been received by the Swedish Rail Agency, it is reviewed to ensure that the notified body has checked the interfaces of the concerned subsystem in relation to the system into which it will be integrated. The TSI that governs the concerned subsystem states how the notified body is to carry out this check. In certain cases, the check is done by testing the subsystem in its operating environment, and the application must then contain a document certifying that the test has been carried out.

4.6 Checking of any open points and specific cases in TSIs

Chapter 4 Section 3 If a subsystem is only partly regulated by a TSI or if a TSI contains specific cases with expressed reference to national rules, applications for approval must be accompanied by the documents in Chapter 5 that the Swedish Rail Agency requests.

This section relates to matters not yet standardised on the European level, where the only available regulations are national ones. In such cases, approval must take place in accordance with national rules, that is, in accordance with Chapter 5 of the regulation. Most TSIs contains open points, identified areas that remain to be specified. Such open points refer to national rules while standardised requirements are awaited. Specific cases included in TSIs are permanent derogations for the respective member state. These are deviations from EU standards that will continue to apply until further notice. Sweden has a number of such specific cases which must be fulfilled where applicable. By reading the relevant TSI, an applicant can check what permanent derogations apply in Sweden. When the information requested in accordance with Section 3 has been received by the Swedish Rail Agency, the Agencys operatives will appraise the material to determine whether the object of the approval application complies with national rules.

22

4.7 Checking any derogation from conforming to the requirements of a TSI

If the applicant has been granted a time-limited derogation from conforming to the requirements in a TSI, the Swedish Rail Agency checks that the object of the application fulfils the commitments stated in the application for the time-limited derogation (concerning which standards are complied with instead, for instance). Since the chosen solution is time-limited, the decision on approval is also timelimited (not beyond the date when the applicant has undertaken to conform to the TSI requirements).

23

5 Approval of subsystems not specified in TSIs

Chapter 5 of JvSFS 2006:1 need only be read by those covered by national rules (see 1.2).

5.1 Appraisal against national rules general

Projects not covered by TSIs are based entirely on national rules. No notified body is involved in the approval process; instead, the Swedish Rail Agencys operatives have the equivalent role of monitoring safety control from the start of the project until commissioning. The Swedish Rail Agency checks that the safety requirements laid down in Sections 1-5 of the Railway Act (2004:519) are met. For approval objects developed after 1 July 2004, the Swedish Rail Agency checks that the object complies with the essential requirements set out in Annexes III of directives 96/48 and 2001/16 (not applicable to metros and tramways). The fundamental safety requirements according to the Railway Act state that it is the railway undertaking who is responsible for ensuring that the standard of traffic safety of every subsystem is sufficiently high.

5.2 Checking against the safety requirements of the Railway Act

The safety requirements referred to are those set out in Sections 1-5 of the Railway Act (2004:519). The life-cycle perspective is important, that is to say, the appraisal covers the chosen technical solution and design, installation, operation, maintenance and modification. The operatives of the Swedish Rail Agency check that the methodology that leads to a specification of requirements and subsequently to a finished product is structured and well documented. A development process in accordance with SS-EN 50126 is a good reference in terms of safety control (Chapter 5 of the regulation is based on that standard). The Swedish Rail Agencys fundamental requirements for safety are: A new subsystem must be at least as safe as the subsystem currently used in the same operation. One fault in an individual constituent must not result in serious harm to passengers, personnel, rolling stock or the environment. Vehicles, traffic management systems and infrastructure must be at least as safe after modification as they were before.

The Swedish Rail Agency has different grounds for assessment depending on the technical and safety-related scope of the system. This has an indirect effect on the requirements imposed by the Swedish Rail Agency as regards documentation of the safety of the system. For this reason, the Swedish Rail Agency has divided the required information into two sections: information that is always required and information that is required where the system has a major affect on safety.

24

5.3 Checking against the essential requirements

In the case of railway infrastructure and rail vehicles developed after the Railway Act came into force (i.e. after 1 July 2004), the Swedish Rail Agency checks that the essential requirements set out in Annexes III to EC directives 96/48 and 2001/16 (concerning safety, reliability, availability, health, environment and technical compatibility) are met. The regulations about interoperability in Railway Act 2004:519 cover not only TEN but also other parts of the Swedish rail system. Track installations for metros and tramways are not covered, however. The purpose of the essential requirements is technical harmonisation of the European rail system, making safe, unhindered rail travel and transport possible.

5.4 Application
5.4.1 Metros and tramways
Chapter 5 Section 1 The stipulations of this chapter about railway infrastructure and rail vehicles is correspondingly applicable to metro and tramway track installations and vehicles.

Note: Chapter 5 also applies to vehicles and infrastructure for metros and tramways. 5.4.2 Subsystems
Chapter 5 Section 2 An application for approval of a subsystem must be made in accordance with: 1) Sections 4-7 if the subsystem is a rail vehicle, 2) Sections 8-10 if the subsystem is a rail vehicle that has been approved in another country, 3) Sections 11-13 if the subsystem is a foreign rail vehicle that is to have a time-limited approval, 4) Sections 14-17 if the subsystem is railway infrastructure, or 5) Sections 18-20 if the subsystem is railway infrastructure that is based on technology that has already been tested.

The purpose of this section is to help applicants find the correct sections in the chapter.

5.5 Assessor
Chapter 5 Section 3 The Swedish Rail Agency can require the applicant to have an independent party carry out checks of functions that affect traffic safety. The independent party must be accepted by the Swedish Rail Agency.

The Swedish Rail Agency accepts assessors individually for each application object and each instance. For projects with a major safety impact, the Swedish Rail Agency requires applicants to engage an assessor. The assessor must be a third party, independent of the group developing and reviewing the system. It is assumed that the assessor has far-reaching

25 expertise in the field of safety-critical designs. The role of the assessor is, among other things, to review the development of the system and the work that is done by different key individuals (who have had responsibility for safety-related tasks). One of the most important tools for the assessor is the safety case according to SS-EN 50129:2003. The documentation of a project and a system (the safety case) must be complete. It must not be necessary to have been involved in a project to know why something is the way it is. The assessor should preferably be engaged early in the process. The assessor and the applicant may work together interactively, so that the assessor can give feedback on the prepared documentation. In this way, the assessor can point out any shortcomings at an early stage, without actually suggesting solutions.

5.6 Rail vehicles

In principle there are no differences in the approval of different types of vehicle, e.g. locomotives, multiple units and freight wagons. The information requested is needed so that the applicants safety control can be assessed. However, there are major differences, both technical and financial, between, for instance, a maintenance machine and an entire train set carrying many passengers. As a rule, the more complex the vehicle and the higher the speed at which the vehicle will be driven, the more detailed the information needed will be. 5.6.1 Applications
Chapter 5 Section 4 An application for approval must consist of the following information: 1) Name, address and company registration number of applicant. 2) Description of the rail vehicle, containing details of Form G4 - the nature of the rail vehicle, - how the subsystem is to be used, - when the rail vehicle is to be commissioned, - suggested type designation for the rail vehicle, and - version designation of the rail vehicle. 3) Risk analysis for the rail vehicle. 4) Specification of requirements for the rail vehicle. 5) Preliminary time schedule showing the dates of design and validation. 6) Validation plan. 7) User manual. 8) Maintenance manual. 9) Validation report. 10) Safety case for the rail vehicle. 11) Maintenance plan. 12) Documents confirming that the rail vehicle has been tested in its operating environment.

Applications and appendices should be written in Swedish. Applications according to this section must be submitted for new vehicles or for a renewed or upgraded vehicle, if the renewal or upgrading affects safety. At the same

26 time a track access agreement 5 must be signed with the relevant infrastructure manager. The applicant may be a railway undertaking, the manufacturer, the importer or some other interested party. The essential point is that whoever formally submits the application also assumes responsibility for ensuring that the Swedish Rail Agency receives all the necessary details. If several parties are involved, the applicant assumes a coordinating role with respect to the Swedish Rail Agency. Before applying for approval, the applying parties should agree who will stand as the applicant. In addition to the definition given below of each term according to the regulation, further guidance is provided for applicants as to the meanings of the terms in Section 4. The description must include a general description of the vehicle, its overall design, construction and performance. Basic functions must be stated, for instance maximum permitted speed, maximum axle load, profile, brake, coupling-up into trains, any software to control functions that affect safety, and so on. The Swedish Rail Agency issues a type designation for the vehicle, but the applicant may make suggestions. International standards must be followed. The risk analysis is described in a separate appendix (Appendix 2), which also provides further information about it. The result of the risk analysis should form the basis for which requirements for the object to be approved are specified, as well as for design decisions later in the development process. In its assessment, the Swedish Rail Agency decides whether the risk analysis presented is sufficiently comprehensive and deep. If necessary it may ask for clarifications and additional information. In principle, a specification of requirements is a detailed order for the object that is to be developed (or alternatively modified). The specification of requirements is usually drawn up by the contracting entity (or by the manufacturer himself). The specification of requirements should be drawn up after a risk analysis has been conducted, but before design begins. As a recommendation, it should express functional requirements and not specify technical solutions. In addition, it should contain requirements regarding performance, environmental compatibility, interfaces, standards to be followed, requirements on design, validation (including testing) as well as associated documentation and manuals. A specification of requirements may be written as normal running text, as mathematical/logical expressions or in the form of a drawing (e.g. plan and profile drawings for infrastructure). The validation plan describes how conformity of the system to the specification of requirements will be demonstrated. Which method should be used: a test, a mathematical analysis or a review? Often the validation plan comprises more than one stage, for example, tests at the factory first, then tests in the field. When testing the functionality it is especially important to bear in mind unusual situations and to try out several sequences of commands: drive in reverse, change direction, change command during execution and so on. The validation plan must be matched to Swedish conditions and must show that trial running can be done in such a way that traffic safety during trial running is not dependent on the functions to be tested. It is a good idea to write the validation plan in parallel with the specification of requirements (since this enhances the quality of the requirements).
5

Under the track access agreement, the infrastructure manager appraises, among other things, the running dynamics, profile, bogie, track circuit capacity and electromagnetic compatibility (EMC).

27

The validation report must describe the conducted validation and shows which requirements are met and which requirements, for one reason or another, are not met. Who did the tests, what was the result, how many re-tests? Documentation of tests must describe the test environment and always state which version of the object for approval is being tested (since tests are often done in several stages and more than once). Correct execution of the installation must be documented in a report from the commissioning inspection (stating the version). Any deviations from the stated requirements must be specified, including a description of the consequences. If the contracting entity considers that the deviations mentioned are acceptable, the justification for this must be stated. The Swedish Rail Agency can accept deviations if there is a good justification and if there is no negative impact on safety. In the safety case, the manufacturer (or the applicant) must certify that the object for approval satisfies the safety requirements purely technically and that it was developed in a structured and controlled manner. For example, what safety control was applied after shortcomings were found during testing? Were subsequent changes made in a controlled and structured way? Read more in Chapter 5 of SS-EN 50129:2003, which provides very sound guidance for the design of the safety case, which is a documented proof of safety. There must be six parts to the safety case: description of the system, description of the companys quality management, description of the companys safety management, description the technical safety of the system, description of related safety cases, conclusion. Manuals for installation, operation and maintenance must be available in the language of the users. Manuals must have been reviewed by the end users and there must be confirmation that they are usable and safe. The maintenance plan must show how safety is maintained during the entire life of the system. It may, for instance, state how often safety inspections and function checks are to be carried out during the period of operation. Documents confirming that the vehicle has been tested in its operating environment may, for instance, take the form of a report on a function test with the aim of checking that communication between a vehicle and the traffic control centre works as intended and therefore that GSM-R is correctly installed on a particular type of vehicle. Another example is testing in a winter environment.

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5.6.2 More application documents that may be requested if needed

Chapter 5 Section 5 An application for approval must, when the Swedish Rail Agency demands it, be supplemented by the applicant with the following: 1) A description of how to produce and test an individual series-manufactured rail vehicle. 2) Information about who will be engaged as assessor. 3) RAM programme and safety plan. 4) Hazard Log. 5) Assessors report. 6) Documentation certifying the safety-related interaction of the rail vehicle with Swedish railway infrastructure or track installation. The documentation must contain information about - retardation ability, - detectability from the point of view of signal safety, - technical monitoring of the speed, - detection of defective rail vehicles by the railway infrastructure or the track installation, - communication between the rail vehicle and the traffic control centre, - the dynamic and static interaction with the track, - the dynamic and static profile, and - the electromagnetic compatibility.

This section is applied when the object for approval has a major safety impact, e.g. for brake systems and bogies on vehicles. For such projects, the Swedish Rail Agency may require the applicant to engage an independent assessor. The Swedish Rail Agency determines what information must be submitted, depending on the complexity of the subsystem and the degree of its impact on safety. The Swedish Rail Agency requests a description of how to produce and test an individual series-manufactured vehicle. As far as possible, these activities should be common to all vehicles in the series. A RAM programme and safety plan (RAMS plan) must describe how the applicant controls functional reliability, availability, maintainability and safety during all phases of development. For example, how will a need for change be handled in the operating stage (e.g. updating of safety documents or of the approval object itself)? What process must be applied when future modifications are needed? If an accident occurs, how will information about it be disseminated to other owners? The RAMS plan need not be one document. There may be advantages in dividing it up into a safety plan and a RAM programme. Compare the requirements of SS-EN 50126:1999. The structure of the hazard log must conform to SS-EN 50129:2003. The document contains all identified sources of risk from the risk analysis. Any sources of risk that occur during the life cycle or that are learnt about from closely-related projects are added. The document must show what decisions about action have been made and any risk-reducing action taken.

29 The assessors report must describe in detail what has been checked (all stages), what criteria the assessor has used for each stage checked, and the result of each stage. Conclusions must be stated. 5.6.3 Time of handing-in of application documents
Chapter 5 Section 6 The documents in Section 4 should be submitted to the Swedish Rail Agency at the following times: - subsections 1-3: when development of the rail vehicle starts, - subsections 4-5: before design and manufacture of the rail vehicle begin, - subsection 6: before validation begins, - subsections 7-11: before the rail vehicle is to be taken into service for trial operation, - subsection 12: after tests have been carried out in the operating environment, before permanent approval.

To reduce the time taken to process applications, documents should be handed in not later than the stated dates/times. The Swedish Rail Agency is in favour of requested documents being handed in as they are completed during the development phase. The applicant sends in the completed document to the Swedish Rail Agency, which can then work in parallel with the applicant. In this way, the processing time before commissioning can be shortened. Any updates of information sent in must be re-sent to the Swedish Rail Agency, so that the information on which the decision is based is up to date. 5.6.4 Time-limited approval for trial operation
Chapter 5 Section 7 Before permanent approval, the Swedish Rail Agency may decide on time-limited approval. The purpose of time-limited approval is to enable applicants to carry out tests in the operating environment and gain the experience needed for permanent approval.

Normally, the functions to be tested are brakes, track forces, couplings, load securing and profile. For passenger carriages, doors, fire safety and alarm and evacuation equipment must also be tested. Certain tests must be done in both winter and summer conditions. After trial running, a report must be written. The Swedish Rail Agency accepts tests done by accepted companies in and outside Sweden, as well as test reports from independent testing organisations. When trial operation or operation to gain experience has been conducted and the result is approved and documented, the Swedish Rail Agency can give permanent approval.

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5.7 Rail vehicles with valid foreign approval

These sections of the regulation relate to rail vehicles that come from countries outside the EES and Switzerland (e.g. Russia, Romania, Ukraine, Turkey) as well as rail vehicles from EES countries and Switzerland if there is no TSI. 5.7.1 Applications
Chapter 5 Section 8 An application for the approval of a rail vehicle that has been approved in another country must consist of: 1) Name, address and company registration number of applicant. Form G5 2) Description of the rail vehicle, containing details of - the nature of the rail vehicle, - how the rail vehicle is to be used, - when the rail vehicle is to be taken into service, - suggested type designation for the rail vehicle, and - version designation of the rail vehicle. 3) A copy of the other countrys valid approval decision. 4) A list of the documents on which the other countrys approval was based. 5) Manuals and instructions in the language used for the operation and maintenance of the rail vehicle. 6) Documentation certifying the safety-related interaction of the rail vehicle with Swedish railway infrastructure. The documentation must contain information about - retardation ability, - detectability from the point of view of signal safety, - technical monitoring of the speed, - detection of defective rail vehicles by the railway infrastructure, - communication between the rail vehicle and the traffic control centre, - the dynamic and static interaction with the track, - the dynamic and static profile, and - the electromagnetic compatibility. 7) Documentation confirming reliability in Swedish climatic conditions.

Applications and appendices should be written in Swedish. Appraisal of foreign vehicles by the Swedish Rail Agency is the same as for national vehicles. The difference is that for foreign vehicle there is a foreign approval, and the Swedish Rail Agency re-uses the work that was done in the foreign country as far as possible. The requested information from the applicant must show how testing was conducted in the foreign country. On the basis of the list in sub-section 4 of Section 8, the Swedish Rail Agency may ask for any further information required for appraisal of the approval. 5.7.2 Time-limited approval Chapter 5 Section 10 Before permanent approval, the Swedish Rail Agency may decide on time-limited approval. The purpose of time-limited approval is to enable applicants to carry out tests in the operating environment and gain the experience needed for permanent approval.

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The same comment as for Chapter 5 Section 7.

5.8 Foreign rail vehicles in temporary use in Sweden

5.8.1 General Chapter 5 Section 11 Time-limited approval may be granted for foreign rail vehicles that are to be used in Sweden for no more than ten months. The vehicles must not be used in regular traffic for the carriage of passengers or goods. If the rail vehicles are driven with their own tractive effort (actively), the speed must not exceed 80 kilometres per hour and they must not travel more than 50 kilometres on each occasion when used for transport. This section relates to rail vehicles not covered by international mutual recognition agreements. It is assumed that the vehicles do not have Swedish ATP, in which case the speed on ATP-equipped lines with other traffic is limited to 80 km/h. The distance travelled is also limited, to 50 km (in other words, the traffic is only intended for transport to and from a work site). These restrictions are applied in an attempt to compensate for the increased risk associated with the absence of ATP. These restrictions do not apply on closed lines, nor if the vehicle is not travelling under its own power. Examples of temporary use are track maintenance with rented vehicles, demonstration of vehicles at trade fairs and exhibitions, and vehicles passing through Sweden on their way to another country.

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5.8.2 Applications
Chapter 5 Section 12 An application for time-limited approval must consist of the following information: Form G6 1) Name, address and company registration number of applicant. 2 Description of the rail vehicle, containing details of - the nature of the rail vehicle, - how the subsystem is to be used, - when the rail vehicle is to be commissioned, - suggested type designation for the rail vehicle, and - version designation of the rail vehicle. 3) A copy of the other countrys valid approval decision. 4) Documentation certifying the safety-related interaction of the rail vehicle with railway infrastructure. The documentation must contain information about - retardation ability, - detectability from the point of view of signal safety, - technical monitoring of the speed, - detection of defective rail vehicles by the railway infrastructure or the track installation, - communication between the rail vehicle and the traffic control centre, - the dynamic and static interaction with the track, - the dynamic and static profile, and - the electromagnetic compatibility. 5) Report on completed safety inspection. 6) Documents certifying that the rail vehicle is maintained in the country where the approval was issued.

Applications and appendices should be written in Swedish. If the application does not include a report from a completed safety inspection (subsection 5 of Section 12) a requirement for a safety inspection will be imposed in the Swedish Rail Agencys decision on approval. The Swedish Rail Agency should be informed that the applicant does not intend to send in the report before the decision. The requirement that a safety inspection must be carried out before the vehicles may be used is laid down in Section 8 of Railway Inspectorate regulations BV-FS 2000:1. An example of a document that confirms maintenance abroad (subsection 6 of Section 12) is a report from a completed inspection or action and a date for the next maintenance action. 5.8.3 Time of handing-in of application documents
Chapter 5 Section 13 An application for approval should be submitted to the Swedish Rail Agency not later than 15 working days before the rail vehicle is to be used.

The appraisal of foreign vehicles that will be temporarily stopping in Sweden has been simplified since the Swedish Rail Agency considers that the risk of accident is smaller because of restrictions on use, and because the vehicle is maintained and inspected abroad. The fifteen-day period assumes that the application is complete.

33 Safety inspection is often done as the last activity. A report of the inspection can be sent later than 15 days before approval, after consultation with the Swedish Rail Agency.

5.9 Railway infrastructure

For railway infrastructure, individual approvals are generally applied; in other words, each object for approval is approved separately. However, the Swedish Rail Agency can foresee that a simplified approval according to Section 5.9.4 will very commonly occur. The reason for individual approvals is that, by their nature, these issues have a unique geographical adaptation. If this is not the case, for example for certain seriesmanufactured national safety constituents, the Swedish Rail Agency will appraise the first safety constituent in the series, after which all subsequent identical safety constituents may be put into service without separate approval.
Chapter 5 Section 14 An application for approval must consist of the following information: Form G8 1) Name, address and company registration number of applicant. 2) Description of the rail infrastructure, containing details of - the geographical location, with limiting points specified, - area of use, - date of commissioning, and - version designation, if any. 3) Risk analysis. 4) Specification of requirements. 5) Details stating who does planning, design review and commissioning. 6) Details of the standards on which the technical design is based. 7) Preliminary time schedule showing the dates of design, construction and validation. 8) Validation plan. 9) Validation report. 10) Safety case. 11) Report on commissioning inspection. 12) Documents confirming tests in the operating environment.

Applications and appendices should be written in Swedish. Note that railway infrastructure comprises much more than the actual track installation, for instance technical systems such as interlocking systems and automatic block systems. National safety constituents A national safety constituent is approved when the subsystem in which it is included is put into service. For example, the introduction of a new type of switch drive is a safety-affecting modification of the railway infrastructure subsystem, so that approval by the Swedish Rail Agency is required before it goes into service. A renewed national safety constituent also requires a new approval, if the renewal involves safety-relevant mechanisms in the railway infrastructure subsystem. Certain national safety constituents are individual, that is, they are characterised by a unique geographical adaptation (e.g. an interlocking system). Such safety constituents

34 require appraisal in each individual case. However, a simplified approval procedure can be used for these interlocking systems; for further information see Section 5.9.4. Other national safety constituents, such as switch drives or switch blade contacts are mass-produced and have no geographical adaptation. For such safety constituents, the Swedish Rail Agency carries out an appraisal when the first safety constituent is put into service. All subsequent safety constituents may then be put into service without separate approval. However, the applicant must inform the Swedish Rail Agency about the action taken (this applies to railways but not to tramways and metros), since this information about the railway infrastructure is needed for the infrastructure register. Note, however, that the Swedish Rail Agency does not carry out retrospective approvals, so subsystems that contain national safety constituents that have been in used for a long time are regarded as approved. These include existing track switches, switch drives, switch blade contacts, track circuits, rail fastenings, insulated rail joints, mechanical interlocking systems, electrical interlocking systems, relay interlocking systems, computerised interlocking systems, ATC2, automatic block systems, level crossing systems, obstacle detectors, barrier drives, hot box detectors and slope failure warning systems. Note, however, that if these national safety constituents are modified and the modification affects safety, the modified subsystem requires approval. Further information about requested information The description of the railway infrastructure should contain general drawings and technical descriptions, such as plan and profile drawings, track geometry, dimensioning factors (speed, axle load, track radii, maximum gradient particular gradient against other infrastructure), signalling systems, etc. The description must also state the approved systems that are included in the installation, such as interlocking systems and ATP systems. The term report on commissioning inspection refers to a technical inspection that is carried out before a railway infrastructure is commissioned and which makes sure that it has been constructed in accordance with the required standards and construction documents. The report of the commissioning of a railway infrastructure must show any comments relating to traffic safety made during the inspection. The report must also show, with date and initials, that the issues commented on have been dealt with. Apart from the above, the same comments as for Chapter 5 Section 4.

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5.9.1 Further application documents about major impact on safety

Chapter 5 Section 15 An application for approval must, when the Swedish Rail Agency demands it, be supplemented by the applicant with the following information: 1) A description of the method for producing and testing an individual installation on the basis of the basic design. 2) Information about who will be engaged as assessor. 3) RAM programme and safety plan. 4) User manual. 5) Maintenance and installation manual. 6) Documents describing the change control management. 7) Hazard Log. 8) Assessors report.

This section need only be read if the object of the approval has a major impact on safety, for example interlocking systems and automatic block systems, as well as automatic train control systems. For such projects, the Swedish Rail Agency requires the applicant to engage an independent party for safety assessment. The description of how to produce and test an installation deals, for instance, with the process that has been decided on for planning an interlocking system. This information must show that the applicant has taken steps to minimise the risks associated with planning and testing individual installations. Manuals for installation, operation and maintenance must be available in the language of the users. Manuals must have been reviewed by the end users and there must be confirmation that they are usable and safe. Documents that describe the change control management deal with version management. Normally, version management covers safety documentation, hardware and software. It is important that the applicant demonstrates that there is control over changes made during every phase of the life cycle. Apart from the above, the same comments as for Chapter 5 Section 5.

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5.9.2 Time of handing-in of application documents

Chapter 5 Section 16 The documents in Section 14 should be submitted to the Swedish Rail Agency at the following times: - subsections 1-3: when the construction document or specification is produced, - subsections 4-7: before design and manufacture begin, - subsection 8: before validation begins, - subsections 9-10: at least one month before commissioning, - subsection 11: after the commissioning inspection. - subsection 12: after tests have been carried out in the operating environment.

The same comments as for Chapter 5 Section 6. 5.9.3 Time-limited approval for trial operation Chapter 5 Section 17 Before permanent approval, the Swedish Rail Agency may decide on time-limited approval. The purpose of time-limited approval is to enable applicants to carry out tests in the operating environment and gain the experience needed for permanent approval. This may be appropriate in cases where wholly unappraised solutions are produced, both when general technical systems and individual components are being developed. 5.9.4 Simplified approval
Chapter 5 Section 18 An application for approval will be processed with a simpler approval procedure if, on an earlier occasion, the Swedish Rail Agency has approved similar railway infrastructure.

The complete process is applied the first time a subsystem (such as a new or changed railway infrastructure or track installation) is to be commissioned. Large parts of this appraisal are packaged, specifically parts that are common to similar approval matters. The terms simplified processing means that, for all subsequent approval matters (relating to a similar approval object), the earlier approval is referred to for common parts. This means that the simplified appraisal can concentrate on parts that are unique to the approval object in question. For example, the applicant may have built a railway infrastructure that was approved by the Swedish Rail Agency before commissioning. If the applicant now builds further new railway infrastructure, with the same technology and methods as before, it is sufficient to submit information that is specific to the new infrastructure (such as extent, geographical and topological conditions, any risk analysis, and so on). The Swedish Rail Agency will re-use relevant parts of the earlier approval (for instance with regard to the process used to guarantee safety). Another example is where the applicant applies for approval of a new type of interlocking system. The Swedish Rail Agency approves the interlocking system when it is commissioned for the first time. Every subsequent commissioning of this type of interlocking system requires separate approval, but the applicant need only

37 submit information that is relevant for the specific installation (provided that there is an approval of common characteristics to refer to). The individual appraisals (for all interlocking systems except the first in a series) can therefore be carried out as a simplified approval and be limited to what is (geographically) unique to the interlocking system in question. Application, simplified approval
Chapter 5 Section 19 An application for approval must consist of the following information: 1) Name, address and company registration number of applicant. Form G9 2) Description of the rail infrastructure, containing details of - the geographical location, with limiting points specified, - area of use, - date of commissioning, and - version designation: 3) Reference to a previously announced approval that the applicant wishes to invoke. 4) Risk analysis which describes in particular any technical differences compared with solutions previously approved. 5) Documents in Sections 14-15 that the Swedish Rail Agency may request if needed.

The risk analysis can be limited to what is related to construction, project planning, installation and operation of the specific installation. The information referred to in subsection 5 of Section 19 can be limited to that which is specific to the object for approval. Some examples: For the railway infrastructure example, the specification of requirements consists of drawings etc. for the stretch of line in question. For the interlocking system example, it is project planning information and functional requirements that are relevant for the specific installation. A validation plan is limited to the testing, analysis and review activities that are planned for the specific object for approval. The validation report must provide a picture of the work that has actually been done in terms of testing, analysis and review of the specific object for approval. For the interlocking system, the safety case must be a specific application safety case. For the railway infrastructure example, this is the final installation documentation. Manuals adapted for the specific installation.

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Time of handing-in of application documents

Chapter 5 Section 20 The documents in Sections 19 subsections 1-3 should be submitted to the Swedish Rail Agency as early as possible but not later than two months before the railway infrastructure is to be commissioned. The documents in Section 19 subsection 4 should be submitted to the Swedish Rail Agency at the times stated in Section 16.

The same comment as for Chapter 5 Section 6.

6 Exemptions
Chapter 6 Section 1 Exemptions from these regulations will be examined by the Swedish Rail Agency.

JvSFS 2006:1 is primarily an implementation regulation which lays down which documents must be submitted so that the Swedish Rail Agency can apply certain stipulations of the Railway Act. In rare cases, the Swedish Rail Agency can, on the basis of Chapter 6 Section 1, decide on exemptions from some of the stipulations of the regulations. For example, the Swedish Rail Agency may decide that an application for approval of a subsystem need not contain a particular document which is mandatory according to a stipulation in the regulation. However, Chapter 6 Section 1 cannot be used to decide on exemptions from the Railway Act. If the application relates to derogations from compliance with the requirements of a TSI, see Chapter 3.

APPENDIX 1: Map of TEN in Sweden (according to a decision of the European Parliament of 21 April 2004)

High-speed lines Conventional lines Upgraded high-speed lines

Planned high-speed lines Planned conventional lines Connection to a third country

APPENDIX 2: Risk analyses

Risk analysis is a systematic method for identifying and evaluating risks when using a system. Risk analysis methods and their depth vary depending on what is to be analysed. The greater the risk associated with a system, the stricter the demands that the risk analysis must meet. For a new interlocking system, therefore, a deeper analysis is needed than for a minor modification to a freight wagon, for instance. A risk analysis must be carried out in the following cases (which are examples): development of new vehicles, signalling systems or infrastructure in connection with safety-relevant modifications of existing vehicles, signalling systems and infrastructure minor modifications of vehicles, signallingsystems and infrastructure new or modified operating rules (TRIs) and training plans safety-relevant changes to the existing organisation other safety-relevant untried solutions.

Vehicles The subsystems of a vehicle for which the Swedish Rail Agency requires risk analyses are brakes, bogies, couplings and mechanical stability. For freight wagons, the Swedish Rail Agency also wishes to see analyses of load securing. For passenger carriages, door functions, fire risks, emergency and alarm system must be analysed, as well as evacuation. In principle, the analysis must show that there are barriers to dangerous brake faults, derailings, uncouplings, lost load or serious injury to passengers. Railway infrastructure Examples of railway infrastructure subsystems for which the Swedish Rail Agency requires risk analyses (in the event of a change of technology for instance): switch drives, switch blade contacts, track circuits, interlocking systems and automatic block systems, ATP systems, level crossing systems, obstacle detectors, hot box detectors, slope failure warning systems. System interaction When using and maintaining systems, there may be risks and dangerous situations may arise. In the risk analysis, possible interactions between the systems should also be evaluated, where people must be seen as one of the systems (man-machine interface, MMI). In a system that is not safety-classified, there may, for example, be functions that have a major impact on safety through their interaction with an operator. An example would be a situation when a control system gives information that an operator uses to take a decision to bypass a technical safety barrier.

Vgledning

The diagram shows schematically a few examples of possible interactions between systems (both operational and functional): Rules Dispatcher Control system Technical system Maintenance

Rules

Driver

Interface

Vehicle

Maintenance

The four stages of a risk analysis There are four main stages in a risk analysis: 1. identify sources of risk that arise when using the object of the approval: normal operation, incorrect use, technical faults in the system, emergency operation and other conceivable situations. 2. to estimate for each risk source how often it occurs 3. to estimate for each risk source the consequence of it happening 4. on the basis of a risk matrix, to show what risk sources action has been taken against. A risk analysis may need to be done in several stages and by different organisations (for instance a risk analysis by the manufacturer and a risk analysis by the organisation that will operate and maintain the system). For a minor modification, stage 1 may be sufficient as a basis for an approval, whilst work on equipment that will have a major safety impact requires a complete risk analysis including all four stages. 1. Identify sources of risk Stage 1 involves a number of people (5-10) meeting and identifying risk sources together (brainstorming). Examples of the people who should be involved in this identification are developers, designers, operation and maintenance personnel. It is important to identify risks in all phases of the life cycle (specification, design, documentation, training, use, maintenance, modification and retrofit, decommissioning and disposal. It is also important not to set limits too early, but to begin with a very wide angle of attack. The identified risks must be documented. For risk analyses that concern equipment that has a major safety impact, a hazard log must be established. This document must contain all identified risk sources and must then be updated with any risk sources that occur later in the life cycle.

2. Estimate the frequency When the risk sources have been identified, the people who identified them must estimate how probable each risk source is. The table below (extract from EN 50126:1999) expresses in qualitative terms a grouping of the probability and gives a description of each group. This may be a good guide when the frequency has to be estimated (but the levels may need to be adapted to the relevant application). Probablility Frequent Probable Occasional Remote Improbable Incredible Probability of hazardous event Occurs often. Occurs several times/unit. May occur on every unit. May occur on the occasional unit. Unlikely to occur at all. Does not occur. Events/design life 100 10 - 50 1-5 0.1 0.5 0.001 0.05 0.0005

3. Assessment of the consequence The consequence of each risk source must then be assessed. The table below describes typical levels for the seriousness of a risk source and the consequence associated with each level. How serious Catastrophic Critical Marginal Insignificant Consequence to individuals or property Fatality and/or several serious injuries and/or major damage to property A single fatality and/or serious injury and/or significant damage to property Minor injury and/or significant damage to property Possible minor damage Loss of critical parts of the system Serious damage to the system Minor damage to the system Consequence for operation

4. Risk evaluation and reducing measures The final stage of the risk analysis is a risk evaluation. This is done by setting up a risk matrix, i.e. by combining the frequency of a risk source with the consequence of that risk source; see the example below:
Co n s e qu e n c e Fr eq u en cy Fr eq u en t P r ob a b l e O cca si on a l R em ot e Im p r ob a b l e Im cr ed i b l e In si g n i fi ca n t UD! T T N N N Ma r g i n a l IT! UD! UD! T N N Cr i t i ca l IT! IT! UD! UD! T N D i sa st er IT! IT! IT! UD! UD! N

The risk matrix classifies the risk levels. These levels must be interpreted as follows as regards action to be taken: IT! = intolerable risk, must be eliminated UD! = undesirable, shall only be accepted when risk reduction is impracticable. The consent of the Swedish Rail Agency is required. T = tolerable risk, acceptable with adequate control and the agreement of the Swedish Rail Agency N = negligible risk, accepted by the Swedish Rail Agency. Risk sources in the top right corner of the risk matrix must be eliminated, and action must be suggested. The risk matrix is a guide for any decisions on action that must be taken. These decisions must be documented in the hazard log beside each risk source. The hazard log must be updated with details of date and name after the action has been taken. Actions can be decisions about how the requirements are to be specified, how the technical design must be carried out or, for example, restrictions in manuals/routines about the use of the approval object (a vehicle, railway infrastructure or technical system). The important thing with the risk analysis is not to produce lots of paperwork, but for the applicant to show that they have taken the safety risks seriously. Risk analysis methods When the technical solution and design of an approval object is known, e.g. by manufacturers, there are numerous accepted and structured methods for risk analyses such as FTA (fault tree analysis) for evaluating the effect of multiple faults, and FMECA (failure modes and effects critical analysis). For further information see Annex B of SS-EN 50128:2001 (Software for railway control and protection systems, which is a railway standard for the development of safety-critical software) or in SS-EN 50129:2003 Table E6 (which is a railway standard for safety cases and approvals). DMI (driver-machine interface) analysis is a method that is appropriate for the analysis of new and modified drivers cabs and control centres.

Guide for

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