guide to the approval procedure

7/27/2019 Guide to the Approval Procedure

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Guide for JvSFS 2006:1

Guide to theapproval procedure


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CONTENTS

1 General information.................................................................................................... 1

1.1 Field of application........................................................................................... 1

1.2

How to read the guide...................................................................................... 1

1.3 Who should apply for approval? .................................................................... 21.4 What must be approved?................................................................................. 21.5 How to apply..................................................................................................... 31.6 Which approval process is applied? ............................................................... 41.7 Approval of upgrading and renewal............................................................... 51.8 Simplified approval procedure for vehicles .................................................. 81.9 Time-limited and permanent approval .......................................................... 81.10 Re-appraisal of permits .................................................................................... 91.11 Definitions....................................................................................................... 10

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

2.1 Metros and tramways ..................................................................................... 112.2 Exemptions for certain rail vehicles............................................................. 122.3 Exemptions for certain rail infrastructure................................................... 13

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

3.1 Applications..................................................................................................... 143.2 Different procedures depending on TEN/non-TEN .............................. 15

4 Approval of subsystems specified in TSIs............................................................. 17

4.1 Appraisal against standardised rules general............................................ 174.2 Applications..................................................................................................... 19

4.3 Time of handing-in of application documents........................................... 204.4 Market surveillance......................................................................................... 204.5 Checking that the subsystem is compatible with the system into which itis integrated................................................................................................................. 214.6 Checking of any open points and specific cases in TSIs .......................... 214.7 Checking any derogation from conforming to the requirements of a TSI

22

5 Approval of subsystems not specified in TSIs...................................................... 23

5.1 Appraisal against national rules general ................................................... 235.2 Checking against the safety requirements of the Railway Act.................. 23

5.3 Checking against the essential requirements............................................... 245.4 Application....................................................................................................... 245.5 Assessor............................................................................................................ 245.6 Rail vehicles ..................................................................................................... 255.7 Rail vehicles with valid foreign approval..................................................... 305.8 Foreign rail vehicles in temporary use in Sweden...................................... 315.9 Railway infrastructure..................................................................................... 33

6 Exemptions ................................................................................................................ 38

Vgledning


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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 2004:519

The Railway Ordinance: 2004:526

The metro and tramway safety act: 1990:1157

The metro and tramway safety ordinance: 1990:1165

The regulations of the Swedish Rail Agency on the approval ofsubsystems in railways, etc. JvSFS 2006:1

The specification and demonstration of reliability, availability,maintainability and safety (RAMS) :

SS-EN 50126:1999

Communication, signalling and processing systems. Safetyrelated electronic systems for signalling: SS-EN 50129:2003

Council Directive on the interoperability of the trans-Europeanhigh-speed rail system: 96/48/EC

Council Directive on the interoperability of the trans-Europeanconventional rail system: 2001/16/EC

Technical specifications for interoperability of high-speed trains(TSIs): Infrastructure

EnergyControl command andsignalling

Rolling stock

The above documents (except the Swedish SS-EN standards) can be found on theSwedish Rail Agency websitewww.jvs.se . The SS-EN standards can be ordered fromthe Swedish Standards Institute, SIS.
http://www.jvs.se/http://www.jvs.se/


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1 General information

1.1 Field of application

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

This guide is intended to assist applicants when reading the regulation JvSFS 2006:1Jrnvgsstyrelsens freskrift om godknnande av delsystem m.m. (The regulations ofthe Swedish Rail Agency on the approval of subsystems in railways, etc.). The term subsystemrefers to distinct parts of the railway system, such as vehicles and railwayinfrastructure.

JvSFS 2006:1 governs what information forms the basis for approval by the SwedishRail Agency and when this information must be submitted to the Technical Unit ofthe Swedish Rail Agency. This guide provides the applicant with further informationabout the processes used for approval and about how the Swedish Rail Agencyconducts the appraisal (appraisal against standardised rules and appraisal againstnational rules).

The purpose of approval by the Swedish Rail Agency is both to ensure that differentsubsystems can be used together in practice without the risk of damage or accidentsoccurring, and that relevant safety requirements in Sections 1-5 of the Railway Acthave been met. A decision to grant approval means that the subsystem in questionmay be used for railway operations in Sweden.

Chapter 1 Section 2 The regulations in Chapters 2 and 5 also apply to new orsignificantly renewed metro and tramway track installations and vehicles.

This is an important section if the application relates to vehicles or infrastructure formetros 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 necessityof repeating all fields of application in every section of Chapters 2 and 5, this hasbeen set out once and for all in Chapter 1, Section 2. The purpose is to make theregulation easier to read.

1.2 How to read the guideThe guide is set out in the form of comments on the regulation. First, the wording ofthe section is presented in a box with a coloured background. This is followed byclarifications 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 generalinformation that applies throughout.


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Applicants affected by TSIs (railway systems standardised within the EU) also needto read Chapters 3 and 4.

Applicants subject only to national requirements (i.e. not affected by TSIs) need toread Chapter 5. Consequently, this chapter applies to the following objects for

approval: tramway tracks and metros1, tramcars, metro cars.

national safety constituents.

maintenance machines (although these must satisfy TSI noise requirementsduring transport).

Anything not yet specified in a TSI, e.g. multiple units, locomotives andpassenger carriages, parts of the railway infrastructure. (This subsection is only

valid for a transitional period. In step with the gradual introduction of TSIs, theapproval process described in Chapter 4 must be applied.)

Infrastructure and vehicles intended to be used for local purposes, historicalpurposes or purposes of tourism, or infrastructure whose operation isindependent of the rest of the railway system.

It may sometimes be necessary for an applicant to read both Chapter 4 and Chapter5, specifically when the object for approval comprises subsystems covered by a TSIand 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 Agencywill then determine whether the combination of European and national requirementsis met and if so that the combination of systems works safely together in aninteroperable manner.

1.3 Who should apply for approval?Applicants may be the inventor or purchasers of a vehicle, infrastructure or technicalsystem, for instance a railway undertaking, a manufacturer or an infrastructuremanager.

1.4 What must be approved?A vehicle for rail traffic must be approved by the Swedish Rail Agency before it canbe used in Sweden. This applies to new, imported and significantly renewed vehicles.Likewise, a new or significantly renewed track installation or technical system mustbe approved before it can be taken into service. This is laid down in the Railway Act2004:519.

National safety constituents are approved by the Swedish Rail Agency since theyform parts of the railway infrastructure subsystem (a change in the subsystem), whilstconstituents that are affected by TSIs (interoperability constituents) are generally2 notto be approved by the Swedish Rail Agency. (However, interoperability constituentsmust have a certificate of conformity with TSI when they form part of a subsystemthat must be approved by the Swedish Rail Agency.)

1 personal rail transport, PRT, (sprtaxi) is classed as a metro2 There are certain exceptions to this principle. For example, brake block and STMs (Specific

Transmission Modules) are to be approved by national safety authorities.


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Approvals issued in the days of the Railway Inspectorate are valid and need not berepeated 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 terminteroperability 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 notrequire approval (aimed atRUs and IMs)

- Telematics applications forfreight services

- Traffic operation andmanagement

Interoperability constituents

Standardised constituents that musthave an EC declaration from themanufacturer, for example:

rails, sleepers, switches, overheadcontact wire, pantographs, collectorheads, onboard ETCS, external STM,Eurobalises, wheels, buffers and drawgear, front windscreens, etc.

National safety constituents

Non-standardised constituentsthat are approved nationally,for example:

ATP system, automatic block,track circuits, switch drives,switch blade detectioncontacts, level crossingsystems, 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 theforms 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


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always a good idea to consult the Swedish Rail Agency when submitting anapplication.

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 earlystage 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 fromthe project planning stage.

Contacting the Swedish Rail Agency at an early stage enables the Agency to provideinformation about current legislation, regulations and official requirements, even inadjacent areas such as the environment, health and safety and electrical safety. If theapplication relates to the approval of a vehicle, the applicant should also contact theinfrastructure 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 approvalprocess. This makes the work of the applicant and the Swedish Rail Agency easierand shortens the processing time.

Initial contact may be made in the simplest manner, for instance in the form of atelephone call, an e-mail or a letter, in which the applicant announces his intention todevelop a new system or modify an existing one. The issue will be assigned to anoperative at the Swedish Rail Agency.

1.6 Which approval process is applied?

The Swedish Rail Agencys regulation on approval describes two processes. One isharmonised within Europe and is used for standardised railway systems (of the kindspecified in TSIs). The harmonised approval process is described in Chapter 4 of theregulation. The other process is national and is used for subsystems that are based onnational rules (e.g. metro and tramway systems and national safety constituents). Thenational approval process is described in Chapter 5 of the regulation.

Chapter 1 Section 3 Applications for the approval of subsystems governed by a TSIwhich has came into force, and when the subsystem has been planned, designed, renewedor 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 intoforce, 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 Chapter5.

The second paragraph also applies to subsystems not regulated by a TSI, regardless ofwhen planning, building, renewal or modernisation began.

This section clarifies a major dividing line as regards the application of regulationJvSFS 2006:1, namely the date from which the new Railway Act applies (1 July2004).


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The purpose of the section is to guide the applicant to the relevant part of theregulation, depending on the nature of the object of the application. Examples:

According to the last sub-section of the section, if the application relates toinfrastructure 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 receivefurther guidance (in Section 2) that the application is subject either to Sections14-17, 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 approvalmust be made in accordance with Chapter 5. If you refer to Chapter 5 you willreceive further guidance (in Sections 1-2) that the application is subject to one ofSections 4-13.

According to the first sub-section of the section, if the application relates to astandardised control command system specified in a TSI that was planned after

the end of June 2004, an application for approval must be made in accordancewith 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 yearsto complete, and construction takes place by stages. It is difficult to decide the best

way to view such projects. Should they be viewed as oneproject, even though it mayrun for 15 years, or should each stage be viewed as a (sub-)project? In the opinion ofthe Swedish Rail Agency, it is easiest to handle each stage individually, that is, to vieweach 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 beapproved in accordance with Chapter 4 (when planning and application design tookplace entirely after the end of June 2004).

If a planned stretch of track is made up of a number of partial stretches which arecommissioned 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 renewalForm G1

The stipulations of the first paragraph about upgraded and renewed subsystems iscorrespondingly applicable to significantly renewed metro and tramway track installationsand vehicles.

Chapter 1 Section 4 When the intention is to undertake modernisation or renewal of analready approved subsystem, this must be described and a risk analysis must be submittedto the Swedish Rail Agency. The Swedish Rail Agency then requests the supplementaryinformation required for approval.

An approval decision applies until a railway infrastructure, a track installation or a

vehicle is renewed or upgraded.


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In the case of upgrading and renewal, an application must be submitted in the sameway as for new constructions if the nature of the activity is such that approval isrequired (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 actualchange, 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 theapplicant must send to the Swedish Rail Agency. The supplementary informationthat the Swedish Rail Agency requests depends on the nature of the renewal, butconsists 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 neighbouringsystems or constituents must be assessed against a TSI. Following a TSI is optionalfor the replacement of a system or constituent if the replacement does not alter theoperation 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 examplea transformer.

Replacement of the interior fittings in the passenger and personnel areas. A riskanalysis must be conducted and documented, showing that the new interiorfittings 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 itreplaces. A risk analysis must be conducted and documented, showing that thenew 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 requireapproval:

A renewed or reprogrammed ATP system. Such a system mustper sebeapproved for installation in vehicles.

A new type of service and emergency brake system or wheel slide protectionsystem. New brake control software.

A new type of drivers panel, driver monitoring or controls for the control oftraction and braking.

New electronics or software for safety-relevant functions. The updating ofsoftware in high-risk functions such as ATP, emergency brake, brake anti-locking system.

A new type of bogie, axles or wheels.

A new type of coupling, frame or body.


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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 aregister 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. Thisis an ordinary locomotive fitted with radio control (for marshalling). The actuallocomotive must have been approved as a basis. After this, approval of theinstallation of the radio control equipment is required a separate approval for eachtype of loco.

1.7.2 Infrastructure

Examples of renewal of railway infrastructure that DOES NOT require the approvalof the Swedish Rail Agency:

a replacement of a part without any change in function or performance, forinstance: 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 examplegrinding, 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, theremust be a decision by Banverket3).

replacement of part of an approved type, provided that they meet the samespecification as the part replaced.

Work on equipment that does not affect safety, e.g. certain parts of interlockingsystem.

The following major renewal operations are examples of changes that requireapproval:

new meeting track or passing track.

new switches between running tracks.

capacity enhancement such as increased axle load, larger loading gauge, increasedspeed.

3If you plan to construct a new level crossing installation or remodel an existing one, you mustcontact 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, asstated in Section 79 of the Traffic Sign ordinance (Vgmrkesfrordningen) (1978:1001). This appliesregardless of the identity of the infrastructure manager.


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changed functionality or technical solution at a level crossing, a interlockingsystem, ATP system, GSM-R, base stations, telephone exchanges.

change of technology (a technical solution that differs from the solutionpreviously approved).

Significant increase in track length (in consultation with the Swedish RailAgency, typically more than 100 metres).

Significant increase in complexity, e.g. the introduction of more switches, levelcrossings, etc.

A railway infrastructure or track installation that is to be equipped with a newtype of signal safety installation that has not previously been approved.

1.8 Simplified approval procedure for vehicles

Chapter 1 Section 5 An application for approval will be processed with a simplerapproval procedure if, on an earlier occasion, the Swedish Rail Agency has approved otherseries-manufactured rail vehicles of the same technical design. Applications must includedetails of the earlier approval decision, as well as the details and documents requested bythe Swedish Rail Agency.

Form G7

The first paragraph is correspondingly applicable to metro and tramway vehicles.

The purely formal approach for vehicles is to use individual approval, even if thework procedure of the Swedish Rail Agencys operatives largely takes the form of asimplified approval procedure. If an application relates to series-manufactured

vehicles, approval must be sought for all vehicles in the series. The Swedish RailAgency appraises the first vehicle in the series before it goes into service and decideson 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 vehicleregister 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 trackaccess agreement with the infrastructure manager is required.

1.9 Time-limited and permanent approvalThe Swedish Rail Agency often grants approval in two stages, first a time-limitedapproval in order to conduct trial operation or to gain experience with operation ofthe vehicle, and then permanent approval. Time-limited approval may also includerestrictions and conditions on use.

Both trial operation and operation to gain experience may be needed to gatherpractical experience of the subsystem. Another reason for time-limited approval is toallow the applicant to carry out connection and commissioning and then to preparedocumentation of these activities. The difference between trial operation andoperation to gain experience is that trial operation takes place in a protectedenvironment; in other words the trials take place in an actual operating

environment, (in the field) but without involving passengers or other vehicles


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(possibly as well as other restrictions). Operation to gain experience, on the otherhand, 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 achanged TRI is that the licence of the company (primarily railway undertakings andinfrastructure managers) needs to be re-appraised. In such cases, applicants shouldcontact the Swedish Rail Agencys infrastructure unit or railway undertaking unit.

The following requirements apply to TRIs and training plans, as well as safetyorganisations within a company:

New and changed TRIs, training plans and organisations must be at least as safeas the existing ones

The traffic rules must be based on the presence of barriers against faults/errorsso that a single fault/error cannot cause a dangerous situation.


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1.11Definitions

Chapter 1 Section 6 In these regulations, the following terms have the meanings givenbelow: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 ofdevelopment in accordance with SS-EN 50126:1999,

specification of requirements: document that specifies the functionality andperformance of the system and its interfaces to and interaction with other parts of

vehicles, track installation, rail infrastructure and users. The document also specifiesrequirements to be met by design, manufacture and validation, installation andcommisioning, operation and maintenance, documentation, modification and phasingout,

risk analysis: a document that identifies and assesses sources of risk that arise whena system is used (for normal operation, incorrect use, technical faults in the system,emergency operation and other conceivable situations). The document contains anestimate of how often the risk sources arise and their consequences,

safety inspection: a check of the safety status of a vehicle, track installation or railwayinfrastructure,

safety case: a document that contains a description of the system, the manufacturersquality 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-EN50129:2003 Chapter 5,

TSI: the technical specifications for interoperability with which every subsystem andevery 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 series-manufactured vehicle of the same technical design,

maintenance manual: a document that describes corrective and preventivemaintenance of a system,

maintenance plan: a document that describes the maintenance operations to becarried out and at what intervals,

validation: an activity such as testing, analysis and checking with the purpose ofdemonstrating that the finished system meets specified requirements,

validation plan: a document that describes how conformity of the system with thespecification of requirements will be demonstrated. The document contains detailedplans for what must be done, when and how,

validation report: a document that describes all tests, analyses and checks carried outto ensure that the system meets the requirements laid down (the procedure, who didwhat, what the result showed),

version designation: a combination of numbers and/or letters to identify a specificedition 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.


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Infrastructure manager:The body that manages railway infrastructure and operatesinstallations that belong to the infrastructure. The term railway infrastructuremeans: track, signalling and safety installations intended for rail services, trafficcontrol centers, arrangements for supplying the traffic with electric power, as well asother fixed arrangements for the stock, operation or use of the installations.

National safety constituents: Non-standardised constituents of Swedish railwayinfrastructure, vehicles or track installations that affect safety, for instance thenational ATP system (e.g. balises), interlocking systems including object controllers,automatic block, national radio block centre, level crossing system including obstacledetector and barrier drive gear, track circuit, switch drives and blade switch detectioncontacts, hot box detector.

Risk source: a state or a series of circumstances in a system, which, together withother circumstances in its surroundings, may lead to an accident that may causeinjury to people or damage to property.

Sidings (industrial sidings): railway infrastructure normally intended only formarshalling movements, max 30 km/h.

TEN: Trans-European Network, i.e. the Trans-European rail system forconventional train and high-speed trains. The definition of the TEN is set out in theRailway Ordinance (2004:526) as well as in Annex I to Directives 96/48/E.G. and2001/16/EG.

Running track: railway infrastructure in the form of a track installation that isnormally controlled by signals and is intended for train movements (also applies torailway 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 andrail 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

Rail vehicles approved in another country may be used without approval within theframework of international agreements on mutual recognition.

3) only has track-running wheels which have no significance for propulsion and braking,or

4) are being towed.

2) are used in an area where other traffic only operates with on-sight driving,

Chapter 2 Section 2 Approval is not needed for rail vehicles that travel at not morethan 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

This section must be taken to mean that the conditions relating to 20 km/h and thenon-use of the vehicle to transport passengers must always be met, and in additionthat 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 orderailment is considered to be small.

The expression on-sight driving means that the speed is set so that the movementcan 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 rulesin 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 which1) carries traffic at a top speed of not more than 20 kilometres per hour,2) is not used to carry passengers,

3) is not used to transport dangerous goods covered by the regulations in RID-S1,

4) is not used by more than one rail vehicle or one locomotive connected to othervehicles,5) has no bridges and tunnels or level crossings where the track is crossed by a street orroad open to public traffic,6) forms the outermost part of the network in which it is included, and7) is equipped with technical protection which prevents rail vehicles from rolling out onto the tracks of another infrastructure manager.

1

See Section 1.1.3 on exemptions from the regulations of the Swedish Rescue ServiceAgency (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 aimedprimarily at managers of sidings, such as tracks in industrial areas. The speed of 20km/h was chosen because the consequence of an accident or derailment isconsidered to be small.

The statement that something forms the outermost part of the network in which itis 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 railwayinfrastructure 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, overheadcranes and the like, and

other short track installations open only to freight services and which arenot connected to railway infrastructure.


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

3.2 Different procedures depending on TEN/non-TENChapter 3 Section 2 Applications for derogations that relate to subsystems that are notincluded in the trans-European rail system must reach the Swedish Rail Agency as earlyas possible, but not later than with the application for approval.

Chapter 3 Section 3 Applications for derogations that relate to Chapter 3 Section 11subsections 1-3 and Section 12 of the Railway Ordinance (2004:526) must reach theSwedish 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. Thisis different depending on whether the application relates to TEN or non-TEN. Whatdistinguishes Section 2 from Section 3 (apart from the times when the applicationmust be submitted) is that, under Section 2, the Swedish Rail Agency alone decideson derogations. On the other hand, if the derogation application relates to railwayinfrastructure included in TEN, the Swedish Rail Agency may only decide onderogation 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 showswhich lines are classed as TEN lines in Sweden. Figure 2 below shows schematicallyhow TEN, national lines and sidings are related to each other (not to scale and farfrom comprehensive).


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Malm

Gteborg

Stockholm

TENhigh speed

TEN

conventional

Other national

lines

Sidings

The outermost part

of a rail network

Figure 2


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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 mustengage a notified body (NB). The notified body should follow the entiredevelopment of the subsystem from the start of the project to commissioning andcheck agreement with the requirements of the TSI with a focus on interoperability.For an infrastructure project, project start means the system handling phase, whilstfor a vehicle it means the specification phase.

Before the project starts, the applicant should inform the Swedish Rail Agency whichnotified body has been engaged. The notified body may be accredited in any EUcountry, Norway or Switzerland. Accredited NBs are listed athttp://europa.eu.int/comm/enterprise/nando-is/home/index.cfm.

The Swedish Rail Agency appraises the necessary documents primarily the ECdeclaration of verification and the EC declaration of conformity and suitability foruse which the applicant must submit (in accordance with Section 1). The appraisalconsists of:

checking that the notified body has been duly accredited.

checking of any open points and specific cases in TSIs (specific cases arepermanent 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 isintegrated.

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, forexample TSI Telematics Applications for Freight services (TAF) and TSI TrafficOperation and Management (OPE). These TSIs are aimed directly at railwayundertakings and infrastructure managers. The individual parts of these TSIs areclosely linked with the operating procedures and processes that are required for theundertakings to obtain a safety licence/certificate in accordance with Directive2004/49/EG. Compliance is checked by appraisal of licences.
http://europa.eu.int/comm/enterprise/nando-is/home/index.cfmhttp://europa.eu.int/comm/enterprise/nando-is/home/index.cfm


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4.1.1 Which TSI applies?

The table below shows which TSIs are to be applied for different types of approvalissue. 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 whichTSIs exist and apply, as well as their content, can be found on the Swedish RailAgency website (www.jvs.se).

HSRST

HSINF

HSENE

CCS

SRT

PRM

WAG

NOI

CRINF

CRENE

CRCOA

CRLOC

Infrastructure, high-speed.

x x x

Infrastructure,conventional.

x x x

Sidings

High-speed trains x x

Locos, multipleunits, passengercarriages

x x x x

Maintenance vehicles x4

Freight wagons x x

HS RST TSI Rolling stock for high-speed trains, 2002

HS INF TSI Infrastructure for high-speed lines, 2002

HS ENE TSI Energy supply for high-speed lines, 2002

CCS TSI Control command and signalling (high-speed 2002, conventionaldir. 2006)

SRT TSI Safety in railway tunnels (2007)

PRM TSI Persons of reduced mobility (2007)

WAG TSI Freight wagons (2006)

NOI TSI Noise (June 2006)

CR INF TSI Infrastructure for conventional lines (2009)

CR ENE TSI Energy supply for conventional lines (2009)

CR COA TSI Passenger carriages (2009)

CR LOC TSI Locomotives and multiple units (2009)


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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 updatedapproximately every third year. In between, the need arises to introduce urgentchanges, for instance due to errors and shortcomings that have a negative effect oninteroperability. Such quick changes are managed by means of a special process atthe EU Commission. For this reason there may be confirmed changed requirementsin a TSI that do not appear in the official Swedish version of that TSI. Informationabout 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 followinginformation: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.

Form G3

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 interoperabilityconstituents 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 operatingenvironment.

Applications and appendices should be written in Swedish.

The contracting entity (generally the applicant) must issue an EC declaration ofverification for the subsystem. The EC declarations of verification must be based onthe certificate of conformity that the notified body must issue for the subsystem inquestion (a certificate from an independent party stating that the subsystemconforms to the requirements of the TSI).

Correspondingly, the manufacturer of an interoperability constituent must issue anEC declaration of conformity and suitability for use for the constituent. In certaincases, the EC declaration of conformity and suitability for use must be based on acertificate from a notified body. There must be an EC declaration for everyinteroperability constituent that is included in a subsystem to be approved. The

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


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relevant TSI gives more information about the EC declaration of conformity andsuitability for use and the EC declaration of verification.

The description of the subsystem must include a general description of thesubsystem, its overall design, construction and performance. Where infrastructure is

concerned, geographical details must be included (e.g. location and delimitationpoints).

An example of a document that confirms that a subsystem has been tested in itsoperating environment is a report from a function test of a vehicle in a winterenvironment.

4.3 Time of handing-in of application documents

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

To reduce the time taken to process applications, documents should be handed innot later than the stated dates/times. The stated processing times are the maximumtimes needed by the Swedish Rail Agency in the various situations.

4.4 Market surveillanceWhen the requested information according to Chapter 4 Section 1 of JvSFS 2006:1has been received by the Swedish Rail Agency, the Agencys operatives may carry outmarket surveillance.

The EUs aim with market surveillance in the railway field is to prevent theoccurrence of non-interoperable products and to stop frivolous importers,manufacturers and notified bodies. Market surveillance is important for theintegration of the markets in the communities and for the confidence of consumersand companies in the approval process. Market surveillance is only carried out onsubsystems and constituents covered by TSIs and which are therefore necessary for

interoperability. Market surveillance is carried out by the safety authorities in therespective member state, in Sweden by the Swedish Rail Agency.

The purpose of market surveillance is to ensure that subsystems and interoperabilityconstituents that come on to the market satisfy the essential requirements set out in

TSIs, for instance with regard to health, safety, reliability, availability, compatibilityand protection of the environment.

Market surveillance takes place either when an interoperability constituent isintroduced on the market or alternatively when a subsystem is commissioned (forfreight wagons, at the time of registration in Sweden). Market surveillance can alsotake the form of inspection activity, after the constituent or subsystem has been in

use for a time.


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Market surveillance is conducted as a spot check of the work done by anotified body or, in other words: to check that subsystems andconstituents 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 EuropeanCommission must be informed so that it can have the TSI or standard in questioncorrected. If a non-conformity is found for an interoperability constituent, theSwedish Rail Agency has the right to restrict the field of application of theconstituent by banning its use or withdrawing it from the market. If a non-conformity is found for a subsystem, the Swedish Rail Agency may decide onsupplementary checks and must immediately inform the Commission (for furtheraction).

4.5 Checking that the subsystem is compatible with the system

into which it is integratedWhen the information requested according to Chapter 4 Section 1 has been receivedby the Swedish Rail Agency, it is reviewed to ensure that the notified body haschecked 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 howthe notified body is to carry out this check. In certain cases, the check is done bytesting the subsystem in its operating environment, and the application must thencontain 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 containsspecific cases with expressed reference to national rules, applications for approval mustbe 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 theonly available regulations are national ones. In such cases, approval must take placein accordance with national rules, that is, in accordance with Chapter 5 of theregulation.

Most TSIs contains open points, identified areas that remain to be specified. Suchopen points refer to national rules while standardised requirements are awaited.

Specific cases included in TSIs are permanent derogations for the respective memberstate. These are deviations from EU standards that will continue to apply untilfurther notice. Sweden has a number of such specific cases which must be fulfilled

where applicable. By reading the relevant TSI, an applicant can check whatpermanent derogations apply in Sweden.

When the information requested in accordance with Section 3 has been received bythe Swedish Rail Agency, the Agencys operatives will appraise the material todetermine whether the object of the approval application complies with nationalrules.


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4.7 Checking any derogation from conforming to therequirements of a TSI

If the applicant has been granted a time-limited derogation from conforming to therequirements in a TSI, the Swedish Rail Agency checks that the object of the

application fulfils the commitments stated in the application for the time-limitedderogation (concerning which standards are complied with instead, for instance).Since the chosen solution is time-limited, the decision on approval is also time-limited (not beyond the date when the applicant has undertaken to conform to the

TSI requirements).


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5 Approval of subsystems not specified in TSIs

Chapter 5 of JvSFS 2006:1 need only be read by those covered by national rules (see1.2).

5.1 Appraisal against national rules general

Projects not covered by TSIs are based entirely on national rules. No notified body isinvolved in the approval process; instead, the Swedish Rail Agencys operatives havethe equivalent role of monitoring safety control from the start of the project untilcommissioning.

The Swedish Rail Agency checks that the safety requirements laid down in Sections1-5 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 essentialrequirements set out in Annexes III of directives 96/48 and 2001/16 (not applicableto metros and tramways). The fundamental safety requirements according to theRailway Act state that it is the railway undertaking who is responsible for ensuringthat 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 RailwayAct (2004:519).

The life-cycle perspective is important, that is to say, the appraisal covers the chosentechnical solution and design, installation, operation, maintenance and modification.

The operatives of the Swedish Rail Agency check that the methodology that leads toa specification of requirements and subsequently to a finished product is structuredand well documented. A development process in accordance with SS-EN 50126 is agood reference in terms of safety control (Chapter 5 of the regulation is based onthat 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 thesame operation.

One fault in an individual constituent must not result in serious harm topassengers, personnel, rolling stock or the environment.

Vehicles, traffic management systems and infrastructure must be at least as safeafter modification as they were before.

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


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5.3 Checking against the essential requirements

In the case of railway infrastructure and rail vehicles developed after the Railway Actcame into force (i.e. after 1 July 2004), the Swedish Rail Agency checks that theessential requirements set out in Annexes III to EC directives 96/48 and 2001/16

(concerning safety, reliability, availability, health, environment and technicalcompatibility) are met. The regulations about interoperability in Railway Act2004:519 cover not only TEN but also other parts of the Swedish rail system. Trackinstallations for metros and tramways are not covered, however.

The purpose of the essential requirements is technical harmonisation of theEuropean rail system, making safe, unhindered rail travel and transport possible.

5.4 Application

5.4.1 Metros and tramways

Note: Chapter 5 also applies to vehicles and infrastructure for metros and tramways.

5.4.2 Subsystems

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

chapter.

5.5 Assessor

Chapter 5 Section 1 The stipulations of this chapter about railway infrastructure and railvehicles is correspondingly applicable to metro and tramway track installations and vehicles.

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

Chapter 5 Section 2 An application for approval of a subsystem must be made inaccordance 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 anothercountry,3) Sections 11-13 if the subsystem is a foreign rail vehicle that is to have a time-limitedapproval,4) Sections 14-17 if the subsystem is railway infrastructure, or5) Sections 18-20 if the subsystem is railway infrastructure that is based on technology thathas already been tested.

The Swedish Rail Agency accepts assessors individually for each application objectand 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 groupdeveloping and reviewing the system. It is assumed that the assessor has far-reaching


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expertise in the field of safety-critical designs. The role of the assessor is, amongother things, to review the development of the system and the work that is done bydifferent 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 toknow why something is the way it is.

The assessor should preferably be engaged early in the process. The assessor and theapplicant may work together interactively, so that the assessor can give feedback onthe prepared documentation. In this way, the assessor can point out anyshortcomings 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 neededso that the applicants safety control can be assessed. However, there are majordifferences, both technical and financial, between, for instance, a maintenancemachine and an entire train set carrying many passengers. As a rule, the morecomplex the vehicle and the higher the speed at which the vehicle will be driven, themore detailed the information needed will be.

5.6.1 Applications

Form G4

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- 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 according to this section must be submitted for new vehicles or for arenewed or upgraded vehicle, if the renewal or upgrading affects safety. At the same


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time a track access agreement5 must be signed with the relevant infrastructuremanager. The applicant may be a railway undertaking, the manufacturer, the importeror some other interested party. The essential point is that whoever formally submitsthe application also assumes responsibility for ensuring that the Swedish Rail Agencyreceives all the necessary details.

If several parties are involved, the applicant assumes a coordinating role with respectto the Swedish Rail Agency. Before applying for approval, the applying parties shouldagree 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 Section4.

The description must include a general description of the vehicle, its overall design,construction and performance. Basic functions must be stated, for instancemaximum 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 applicantmay make suggestions. International standards must be followed.

The risk analysis is described in a separate appendix (Appendix 2), which alsoprovides further information about it. The result of the risk analysis should form thebasis for which requirements for the object to be approved are specified, as well asfor design decisions later in the development process. In its assessment, the SwedishRail Agency decides whether the risk analysis presented is sufficiently comprehensiveand 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 isusually drawn up by the contracting entity (or by the manufacturer himself). Thespecification of requirements should be drawn up after a risk analysis has beenconducted, but before design begins. As a recommendation, it should expressfunctional requirements and not specify technical solutions. In addition, it shouldcontain 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 maybe written as normal running text, as mathematical/logical expressions or in the formof a drawing (e.g. plan and profile drawings for infrastructure).

Thevalidation plan describes how conformity of the system to the specification ofrequirements will be demonstrated. Which method should be used: a test, amathematical analysis or a review? Often the validation plan comprises more thanone stage, for example, tests at the factory first, then tests in the field. When testingthe functionality it is especially important to bear in mind unusual situations and totry out several sequences of commands: drive in reverse, change direction, changecommand during execution and so on. The validation plan must be matched toSwedish conditions and must show that trial running can be done in such a way thattraffic safety during trial running is not dependent on the functions to be tested. It isa good idea to write the validation plan in parallel with the specification ofrequirements (since this enhances the quality of the requirements).

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


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Thevalidation report must describe the conducted validation and shows whichrequirements are met and which requirements, for one reason or another, are notmet. Who did the tests, what was the result, how many re-tests? Documentation oftests 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 morethan once). Correct execution of the installation must be documented in a reportfrom the commissioning inspection (stating the version). Any deviations from thestated requirements must be specified, including a description of the consequences.If the contracting entity considers that the deviations mentioned are acceptable, thejustification for this must be stated. The Swedish Rail Agency can accept deviations ifthere 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 objectfor approval satisfies the safety requirements purely technically and that it wasdeveloped in a structured and controlled manner. For example, what safety control

was applied after shortcomings were found during testing? Were subsequent changesmade in a controlled and structured way? Read more in Chapter 5 of SS-EN50129:2003, 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 ofthe system, description of related safety cases, conclusion.

Manuals for installation, operation and maintenance must be available in thelanguage of the users. Manuals must have been reviewed by the end users and theremust be confirmation that they are usable and safe.

The maintenance plan must show how safety is maintained during the entire life ofthe system. It may, for instance, state how often safety inspections and functionchecks are to be carried out during the period of operation.

Documents confirming that the vehicle has been tested in its operatingenvironment may, for instance, take the form of a report on a function test with theaim 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 typeof 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 Swedishrailway infrastructure or track installation. The documentation must contain informationabout- 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 Agencymay 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 anindividual series-manufactured vehicle. As far as possible, these activities should becommon to all vehicles in the series.

A RAM programme and safety plan (RAMS plan) must describe how theapplicant controls functional reliability, availability, maintainability and safety duringall phases of development. For example, how will a need for change be handled inthe operating stage (e.g. updating of safety documents or of the approval objectitself)? What process must be applied when future modifications are needed? If an

accident occurs, how will information about it be disseminated to other owners? TheRAMS plan need not be one document. There may be advantages in dividing it upinto a safety plan and a RAM programme. Compare the requirements of SS-EN50126:1999.

The structure of the hazard log must conform to SS-EN 50129:2003. Thedocument 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 aboutaction have been made and any risk-reducing action taken.


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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 eachstage. Conclusions must be stated.

5.6.3

Time of handing-in of application documents

To reduce the time taken to process applications, documents should be handed innot later than the stated dates/times.

The Swedish Rail Agency is in favour of requested documents being handed in asthey are completed during the development phase. The applicant sends in thecompleted document to the Swedish Rail Agency, which can then work in parallel

with the applicant. In this way, the processing time before commissioning can beshortened. 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 6 The documents in Section 4 should be submitted to the SwedishRail 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, beforepermanent approval.

Chapter 5 Section 7 Before permanent approval, the Swedish Rail Agency may decide ontime-limited approval. The purpose of time-limited approval is to enable applicants to carryout tests in the operating environment and gain the experience needed for permanentapproval.

Normally, the functions to be tested are brakes, track forces, couplings, load securing

and profile. For passenger carriages, doors, fire safety and alarm and evacuationequipment must also be tested. Certain tests must be done in both winter andsummer conditions. After trial running, a report must be written.

The Swedish Rail Agency accepts tests done by accepted companies in and outsideSweden, as well as test reports from independent testing organisations.

When trial operation or operation to gain experience has been conducted and theresult is approved and documented, the Swedish Rail Agency can give permanentapproval.


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5.7 Rail vehicles with valid foreign approvalThese sections of the regulation relate to rail vehicles that come from countriesoutside the EES and Switzerland (e.g. Russia, Romania, Ukraine, Turkey) as well asrail vehicles from EES countries and Switzerland if there is no TSI.

5.7.1 Applications


Appraisal of foreign vehicles by the Swedish Rail Agency is the same as for nationalvehicles. The difference is that for foreign vehicle there is a foreign approval, and theSwedish Rail Agency re-uses the work that was done in the foreign country as far aspossible. The requested information from the applicant must show how testing wasconducted in the foreign country.

On the basis of the list in sub-section 4 of Section 8, the Swedish Rail Agency mayask for any further information required for appraisal of the approval.

5.7.2 Time-limited approval

Chapter 5 Section 8 An application for the approval of a rail vehicle that has beenapproved in another country must consist of: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 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.

Form G5

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 maintenanceof the rail vehicle.6) Documentation certifying the safety-related interaction of the rail vehicle withSwedish 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 controlcentre,

- 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.

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 operatingenvironment 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 trans ort.

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 casethe speed on ATP-equipped lines with other traffic is limited to 80 km/h. Thedistance travelled is also limited, to 50 km (in other words, the traffic is only intendedfor transport to and from a work site). These restrictions are applied in an attempt tocompensate for the increased risk associated with the absence of ATP. Theserestrictions do not apply on closed lines, nor if the vehicle is not travelling under itsown power.

Examples of temporary use are track maintenance with rented vehicles,demonstration of vehicles at trade fairs and exhibitions, and vehicles passing throughSweden on their way to another country.


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5.8.2 Applications

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 inthe Swedish Rail Agencys decision on approval. The Swedish Rail Agency should beinformed 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 maybe 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 ofSection 12) is a report from a completed inspection or action and a date for the nextmaintenance action.

5.8.3 Time of handing-in of application documents

Chapter 5 Section 12 An application for time-limited approval must consist of thefollowing information: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.

Form G6

3) A copy of the other countrys valid approval decision.4) Documentation certifying the safety-related interaction of the rail vehicle with railwayinfrastructure. 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 trackinstallation,- 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 theapproval was issued.

Chapter 5 Section 13 An application for approval should be submitted to the SwedishRail 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 hasbeen simplified since the Swedish Rail Agency considers that the risk of accident issmaller because of restrictions on use, and because the vehicle is maintained andinspected abroad. The fifteen-day period assumes that the application is complete.


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

Agency.

5.9 Railway infrastructureFor railway infrastructure, individual approvals are generally applied; in other words,each object for approval is approved separately. However, the Swedish Rail Agencycan foresee that a simplified approval according to Section 5.9.4 will very commonlyoccur. The reason for individual approvals is that, by their nature, these issues have aunique geographical adaptation. If this is not the case, for example for certain series-manufactured national safety constituents, the Swedish Rail Agency will appraise thefirst safety constituent in the series, after which all subsequent identical safetyconstituents may be put into service without separate approval.

Chapter 5 Section 14 An application for approval must consist of the following

information: Form G81) 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 automaticblock systems.

National safety constituents

A national safety constituent is approved when the subsystem in which it is includedis put into service. For example, the introduction of a new type of switch drive is asafety-affecting modification of the railway infrastructure subsystem, so that approvalby the Swedish Rail Agency is required before it goes into service. A renewednational safety constituent also requires a new approval, if the renewal involvessafety-relevant mechanisms in the railway infrastructure subsystem.

Certain national safety constituents are individual, that is, they are characterised by aunique geographical adaptation (e.g. an interlocking system). Such safety constituents


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require appraisal in each individual case. However, a simplified approval procedurecan 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 aremass-produced and have no geographical adaptation. For such safety constituents,

the Swedish Rail Agency carries out an appraisal when the first safety constituent isput into service. All subsequent safety constituents may then be put into servicewithout separate approval. However, the applicant must inform the Swedish RailAgency about the action taken (this applies to railways but not to tramways andmetros), since this information about the railway infrastructure is needed for theinfrastructure register.

Note, however, that the Swedish Rail Agency does not carry out retrospectiveapprovals, so subsystems that contain national safety constituents that have been inused 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, levelcrossing systems, obstacle detectors, barrier drives, hot box detectors and slopefailure warning systems. Note, however, that if these national safety constituents aremodified and the modification affects safety, the modified subsystem requiresapproval.

Further information about requested information

The description of the railway infrastructure should contain general drawings andtechnical 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 mustalso state the approved systems that are included in the installation, such asinterlocking systems and ATP systems.

The term report oncommissioning inspection refers to a technical inspectionthat is carried out before a railway infrastructure is commissioned and which makessure that it has been constructed in accordance with the required standards andconstruction documents. The report of the commissioning of a railway infrastructuremust show any comments relating to traffic safety made during the inspection. Thereport must also show, with date and initials, that the issues commented on havebeen 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 Agencydemands it, be supplemented by the applicant with the following information:1) A description of the method for producing and testing an individual installation onthe 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 onsafety, for example interlocking systems and automatic block systems, as well asautomatic train control systems. For such projects, the Swedish Rail Agency requiresthe applicant to engage an independent party for safety assessment.

The description of how to produce and test an installation deals, for instance, withthe process that has been decided on for planning an interlocking system. Thisinformation must show that the applicant has taken steps to minimise the risksassociated with planning and testing individual installations.

Manuals for installation, operation and maintenance must be available in thelanguage of the users. Manuals must have been reviewed by the end users and theremust be confirmation that they are usable and safe.

Documents that describe the change control management deal with versionmanagement. Normally, version management covers safety documentation, hardwareand software. It is important that the applicant demonstrates that there is controlover 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 SwedishRail 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

This may be appropriate in cases where wholly unappraised solutions are produced,both when general technical systems and individual components are beingdeveloped.

5.9.4 Simplified approval

Chapter 5 Section 17 Before permanent approval, the Swedish Rail Agencymay 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.

Chapter 5 Section 18 An application for approval will be processed with a simplerapproval procedure if, on an earlier occasion, the Swedish Rail Agency has approvedsimilar railway infrastructure.

The complete process is applied the first time a subsystem (such as a new or changedrailway infrastructure or track installation) is to be commissioned. Large parts of thisappraisal are packaged, specifically parts that are common to similar approvalmatters. The terms simplified processing means that, for all subsequent approvalmatters (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 thatare unique to the approval object in question.

For example, the applicant may have built a railway infrastructure that was approvedby the Swedish Rail Agency before commissioning. If the applicant now buildsfurther 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 asextent, geographical and topological conditions, any risk analysis, and so on). TheSwedish Rail Agency will re-use relevan