
COMMISSION DECISION of 20 December 2007 concerning the technical specification of interoperability relating to ‘safety in railway tunnels’ in the trans-European conventional and high-speed rail system (notified under document number C(2007) 6450) (Text with EEA relevance) (2008/163/EC) (repealed) 

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Article 1 
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Article 2 
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Article 3 
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Article 4 
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ANNEX
DIRECTIVE 2001/16/EC — INTEROPERABILITY OF THE TRANS-EUROPEAN CONVENTIONAL RAIL SYSTEM
DIRECTIVE 96/48/EC ON THE INTEROPERABILITY OF THE TRANS-EUROPEAN HIGH-SPEED RAIL SYSTEM
TECHNICAL SPECIFICATION FOR INTEROPERABILITY
Subsystems: ‘Infrastucture’, ‘Energy’, ‘Operations and traffic management’, ‘Control-Command and signalling’, ‘Rolling Stock’
Aspect: ‘Safety in railway tunnels’
1. INTRODUCTION 
 1.1. Technical scope 
 1.1.1. Tunnel safety as a part of general safety 

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 1.1.2. Tunnel length 

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 1.1.3. Fire safety categories of passenger rolling stock 

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 1.1.3.1. Rolling stock for tunnels up to 5 km in length 

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 1.1.3.2. Rolling stock for all tunnels 

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 1.1.3.3 Rolling stock in tunnels with underground stations 

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 1.1.4. Underground stations 

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 1.1.5. Dangerous goods 

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 1.1.6. Particular safety requirements in member states 

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 1.1.7. Risk scope, risks that are not covered by this TSI 

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 1.2. Geographical scope 

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 1.3. Content of this TSI 

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2. DEFINITION OF ASPECT/SCOPE 
 2.1. General 

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 2.2. The risk scenarios 

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 2.2.1. ‘Hot’ incidents: Fire, explosion followed by fire, emission of toxic smoke or gases. 

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 2.2.2. ‘Cold’ incidents: collision, derailment 

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 2.2.3. Prolonged stop 

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 2.2.4. Exclusions 

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 2.3. The role of rescue services 

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3. ESSENTIAL REQUIREMENTS 

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 3.1. Essential requirements as set out in Directive 2001/16/EC 

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 3.2. Detailed essential requirements related to tunnel safety 

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4. CHARACTERISATION OF THE SUBSYSTEM 
 4.1. Introduction 

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 4.2. Functional and technical specifications of the subsystems 

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 4.2.1. Overview of the specifications 
Subsystem Infrastructure 

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Subsystem Energy 

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Subsystem control-command and signalling 

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Subsystem rolling stock 

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Operating Rules 

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Maintenance Rules 

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Professional Qualifications 

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Health and Safety Conditions 

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 4.2.2. Subsystem Infrastructure 

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 4.2.2.1. Installation of switches and crossings 

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 4.2.2.2. Prevent unauthorised access to emergency exits and equipment rooms 

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 4.2.2.3. Fire protection requirements for structures 

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 4.2.2.4. Fire safety requirements for building material 

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 4.2.2.5. Fire detection 

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 4.2.2.6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4.2.2.6.1. Definition of safe area 

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 4.2.2.6.2. General 

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 4.2.2.6.3. Lateral and/or vertical emergency exits to the surface. 

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 4.2.2.6.4. Cross-passages to the other tube 

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 4.2.2.6.5. Alternative technical solutions 

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 4.2.2.7. Escape walkways 

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 4.2.2.8. Emergency lighting on escape routes 

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 4.2.2.9. Escape signage 

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 4.2.2.10. Emergency communication 

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 4.2.2.11. Access for rescue services 

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 4.2.2.12. Rescue areas outside tunnels 

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 4.2.2.13. Water supply 

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 4.2.3. Subsystem Energy 

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 4.2.3.1. Segmentation of overhead line or conductor rails 

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 4.2.3.2. Overhead line or conductor rail earthing 

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 4.2.3.3. Electricity supply 

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 4.2.3.4. Requirements for electrical cables in tunnels 

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 4.2.3.5. Reliability of electrical installations 

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 4.2.4. Subsystem control-command and signalling 

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 4.2.4.1. Hot axle box detectors 

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 4.2.5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4.2.5.1. Material properties for rolling stock 

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 4.2.5.2. Fire extinguishers for passenger rolling stock 

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 4.2.5.3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4.2.5.3.1. Running capability 

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 4.2.5.3.2. Driver's protection 

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 4.2.5.3.3. Fire protection for trains with passengers and freight or road vehicles 

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 4.2.5.4. Fire barriers for passenger rolling stock 

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 4.2.5.5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4.2.5.5.1. General objectives and required running capability for passenger trains 

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 4.2.5.5.2. Requirements for brakes 

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 4.2.5.5.3. Requirement for traction 

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 4.2.5.6. On board fire detectors 

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 4.2.5.7. Communication means on trains 

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 4.2.5.8. Emergency brake override 

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 4.2.5.9. Emergency lighting system in the train 

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 4.2.5.10. Switching off of air conditioning in the train 

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 4.2.5.11. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4.2.5.11.1. Passengers’ emergency exits 

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 4.2.5.11.2. Passenger access door 

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 4.2.5.12. Rescue service's information and access 

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 4.3. Functional and technical specifications of the interfaces 
 4.3.1. General 

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 4.3.2. Interfaces with the Infrastructure subsystem 

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 4.3.2.1. Escape walkways 

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 4.3.2.2. Inspection of tunnel condition 

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 4.3.3. Interfaces with the Energy subsystem 

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 4.3.3.1. Sectioning of traction energy supply systems 

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 4.3.4. Interfaces with the Control-Command-Signalling subsystem 

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 4.3.5. Interfaces with the Traffic Management and Operation subsystem 

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 4.3.5.1. Tunnel emergency plan and exercises 

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 4.3.5.2. Route book 

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 4.3.5.3. Provisions of on-train safety and emergency information to passengers 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4.3.5.4. Tunnel specific competence of the train crew and other staff 

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 4.3.6. Interfaces with the rolling stock subsystem 

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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4.3.6.1. Material properties for rolling stock 

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 4.3.6.2. Other rolling stock specifications 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4.3.7. Interfaces with the PRM subsystem 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4.3.7.1. Escape walkways 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4.4. Operating rules 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4.4.1. Checking the condition of trains and appropriate actions 

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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4.4.1.1. Before the train commences its service. 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4.4.1.2. While the train is running 

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 4.4.1.2.1. Safety-relevant equipment 

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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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 4.4.1.2.2. Hot axle box incidents 

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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4.4.2. Emergency rule 

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 4.4.3. Tunnel emergency plan and exercises 

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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4.4.3.1. Content 

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 4.4.3.2. Identification 

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 4.4.3.3. Exercises 

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 4.4.4. Isolation and Earthing procedures 

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 4.4.5. Route Book 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4.4.6. Provision of on-train safety and emergency information to passengers 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4.4.7. Co-ordination between tunnel control centres 

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 4.5. Maintenance rules 

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 4.5.1. Inspection of tunnel condition 

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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4.5.2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4.5.2.1. Passenger rolling stock 

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 4.5.2.2. Freight rolling stock 

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 4.6. Professional qualifications 

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 4.6.1. Tunnel specific competence of the train crew and other staff 

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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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 4.7. Health and safety conditions 

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 4.7.1. Self-rescue device 

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 4.8. Register of infrastructure and European register of authorised types of vehicles 

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5. INTEROPERABILITY CONSTITUENTS 

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6. ASSESSMENT OF CONFORMITY AND/OR SUITABILITY FOR USE OF THE CONSTITUENTS AND VERIFICATION OF THE SUBSYSTEM 
 6.1. Interoperability constituents 

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 6.2. Subsystems 
 6.2.1. Conformity assessment (general) 

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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 6.2.2. Conformity assessment procedures (modules) 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 6.2.3. Existing solutions 

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 6.2.4. Innovative solutions 

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 6.2.5. Assessment of maintenance 

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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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 6.2.6. Assessment of operational rules 

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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 6.2.7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 6.2.7.1. Installation of switches and crossings 

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 6.2.7.2. Prevent unauthorised access to emergency exits and equipment rooms 

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 6.2.7.3. Fire protection requirements for structures 

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 6.2.7.4. Facilities for self-rescue, rescue and evacuation in the event of an incident 

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 6.2.7.5. Access and equipment for rescue services 

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 6.2.7.6. Reliability of electrical installations 

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 6.2.7.7. Hot axle box detectors 

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 6.2.8. Additional requirements for assessment of specifications concerning the RU 

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 6.2.8.1. Rescue service's information and access 

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 6.2.8.2. Self-rescue device 

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7. IMPLEMENTATION 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 7.1. Application of this TSI to subsystems to be put into service 
 7.1.1. General 

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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 7.1.2. Newly built rolling stock constructed to an existing design 

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 7.1.3. Existing rolling stock intended to run in new tunnels 

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 7.2. Application of this TSI to subsystems already in service 
 7.2.1. Introduction 

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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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 7.2.2. Upgrade and renewal measures for tunnels of more than 1 km, subsystems INS and ENE 

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 7.2.2.1. INS 

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 7.2.2.2. ENE 

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 7.2.3. Upgrade and renewal measures for the subsystems CCS, OPE, RST 

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 7.2.3.1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 7.2.3.2. OPE: 

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 7.2.3.3. RST (Passenger rolling stock) 

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 7.2.4. Other existing tunnels 

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 7.3. TSI revision 

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 7.4. Exceptions for national, bilateral, multilateral or multinational agreements 
 7.4.1. Existing agreements 

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 7.4.2. Future agreements or modification of existing agreements 

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 7.5. Specific cases 
 7.5.1. Introduction 

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 7.5.2. List of specific cases 

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ANNEX A
INFRASTRUCTURE REGISTER
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ANNEX B
ROLLING STOCK REGISTER
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ANNEX C
OPEN POINTS
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ANNEX D
THE RELATIONSHIP BETWEEN INCIDENT TYPES AND MEASURES
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A Hot incident 

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B Cold incident 

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C Prolonged stop 

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ANNEX E
ASSESSMENT OF THE SUBSYSTEMS
E.1 Scope 

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E.2 Characteristics and modules 

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ANNEX F
MODULES FOR THE EC VERIFICATION OF SUBSYSTEMS
F.1. List of the modules 

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F.2. Modules for Interoperability Constituents 

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F.3. Modules for the EC Verification of Subsystems 
 F.3.1. Module SB: Type Examination 
 1. This module describes the EC verification procedure whereby a notified body checks and certifies at the request of an contracting entity or its authorised representative established within the Community, that a type of an infrastructure, energy, control-command or rolling stock subsystem, representative of the production envisaged, 

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 2. The contracting entity shall lodge an application for EC verification (through type examination) of the subsystem with a notified body of his choice. 

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 3. The applicant shall place at the disposal of the notified body a specimen of the subsystem, representative of the production envisaged and hereinafter called ‘type’. 

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 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4.1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4.2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4.3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4.4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4.5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4.6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4.7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 5. Where the type meets the provisions of the TSI, the notified body shall issue a type-examination certificate to the applicant. The certificate shall contain the name and address of the contracting entity and the manufacturer(s) indicated in the technical documentation, conclusions of the examination, conditions for its validity and the necessary data for identification of the approved type. 

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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 9. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 F.3.2. Module SD: Production Quality Management System 
 1. This module describes the EC verification procedure whereby a notified body checks and certifies, at the request of an contracting entity or its authorised representative established within the Community, that an infrastructure, energy or rolling stock subsystem, for which already a type-examination certificate has been issued by a notified body, 

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 2. The notified body carries out the procedure, under the condition, that: 

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 3. For the subsystem that is subject of the EC verification procedure, the contracting entity, or the main contractor when employed, shall operate an approved quality management system for manufacture and final product inspection and testing as specified in point 5 and which shall be subject to surveillance as specified in point 6. 

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 4.1. The contracting entity shall lodge an application for EC verification of the subsystem (through production quality management system), including co-ordination of the surveillance of the quality management systems, as under point 5.3 and 6.5. with a notified body of its choice. The contracting entity shall inform the manufacturers involved of this choice and of the application. 

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 4.3. The notified body shall fist examine the application concerning the validity of the type examination and the type examination certificate. 

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Quality management system 
 5.1. The contracting entity, if involved, and the main contractor, when employed, shall lodge an application for assessment of their quality management systems with a notified body of their choice. 

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 5.2. For the contracting entity or the main contractor responsible for the whole subsystem project, the quality management systems shall ensure overall compliance of the subsystem with the type as described in the type-examination certificate and overall compliance of the subsystem with the requirements of the TSI. For other contractors, their quality management system(s) has (have) to ensure compliance of their relevant contribution to the subsystem with the type as described in the type-examination certificate and with the requirements of the TSI. 

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 5.3. The notified body chosen by the contracting entity shall examine, if all stages of the subsystem as mentioned under point 5.2 are sufficiently and properly covered by the approval and surveillance of the quality management system(s) of the applicant(s). 

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 5.4. The notified body referenced to in point 5.1. shall assess the quality management system to determine whether it satisfies the requirements referenced in point 5.2. It presumes compliance with these requirements if the applicant implements a quality system for production, final product inspection and testing in respect of the Standard EN/ISO 9001-2000, which takes into consideration the specificity of the subsystem for which it is implemented. 

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 5.5. The contracting entity, if involved, and the main contractor shall undertake to fulfil the obligations arising out of the quality management system as approved and to uphold it so that it remains adequate and efficient. 

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 6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 6.1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 6.2. The contracting entity, if involved, and the main contractor shall send to the notified body referenced in point 5.1 (or have sent) all the documents needed for that purpose including the implementation plans and technical records concerning the subsystem (as far as relevant for the specific contribution of the applicants to the subsystem), in particular: 

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 6.3. The notified body shall periodically carry out audits to make sure that the contracting entity, if involved, and the main contractor, maintain and apply the quality management system and shall provide an audit report to them. When those operate a certified quality management system, the notified body shall take this into account in the surveillance. 

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 6.4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 6.5. The notified body chosen by the contracting entity and responsible for the EC verification, if not carrying out the surveillance of all the quality management system(s) concerned, shall co ordinate the surveillance activities of any other notified body responsible for that task, in order: 

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 7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 8. The contracting entity, if involved, and the main contractor shall, for a period of 10 years after the last subsystem has been manufactured, keep at the disposal of the national authorities: 

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 9. Where the subsystem meets the requirements of the TSI, the notified body shall then, based on the type examination and the approval and surveillance of the quality management system(s), draw up the certificate of conformity intended for the contracting entity, who shall in turn draw up the EC declaration of verification intended for the supervisory authority in the Member State within which the subsystem is located and/or operates. 

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 10. The notified body chosen by the contracting entity shall be responsible for compiling the technical file that has to accompany the EC declaration of verification. The technical file shall include at least the information indicated in the Art 18 (3) of the Directive, and in particular as follows: 

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 11. Each notified body shall communicate to the other notified bodies the relevant information concerning the quality management system approvals issued, withdrawn or refused. 

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 12. The records accompanying the certificate of conformity shall be lodged with the contracting entity. 

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 F.3.3. Module SF: Product Verification 
 1. This module describes the EC verification procedure whereby a notified body checks and certifies at the request of an contracting entity or its authorised representative established within the Community, that an infrastructure, energy or rolling stock subsystem, for which a type-examination certificate has already been issued by a notified body, 

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 2. The contracting entity shall lodge an application for EC verification (through product verification) of the subsystem with a notified body of his choice. 

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 3. Within that part of the procedure the contracting entity checks and attests that the subsystem concerned is in conformity with the type as described in the type examination certificate and satisfies the requirements of the TSI that apply to it. 

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 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 5. The application shall enable the design, manufacture, installation, maintenance and operation of the subsystem to be understood, and shall enable conformity with the type as described in the type-examination certificate and the requirements of the TSI to be assessed. 

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 6. The notified body shall first examine the application concerning the validity of the type examination and the type examination certificate. 

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 7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 7.1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 7.2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 8. The notified body shall agree with the contracting entity (and the main contractor) the locations where the tests will be carried out and shall agree that final testing of the subsystem and, whenever required in the TSI, tests or validation under full operating conditions, are carried out by the contracting entity under direct supervision and attendance of the notified body. 

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 9. Where the subsystem meets the requirements of the TSI, the notified body shall draw up the certificate of conformity intended for the contracting entity, which in turn draws up the EC declaration of verification intended for the supervisory authority in the Member State where the subsystem is located and/or operates. 

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 10. The notified body shall be responsible for compiling the technical file that has to accompany the EC declaration of verification. The technical file shall include at least the information indicated in Art.18 (3) of the Directives, and in particular as follows: 

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 11. The records accompanying the certificate of conformity shall be lodged with the contracting entity. 

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 F.3.4. Module SG: Unit verification 
 1. This module describes the EC verification procedure whereby a notified body checks and certifies, at the request of an contracting entity or its authorised representative established within the Community, that an infrastructure, energy, control-command or rolling stock subsystem 

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 2. The contracting entity shall lodge an application for EC verification (through unit verification) of the subsystem with a notified body of his choice. 

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 3. The technical documentation shall enable the design, manufacture, installation and operation of the subsystem to be understood, and shall enable conformity assessment with the requirements of the TSI. 

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 4. The notified body shall examine the application and the technical documentation, and identify the elements which have been designed in accordance with the relevant provisions of the TSI and the European specifications, as well as the elements which have been designed without applying the relevant provisions of those European specifications. 

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 5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 7. Where the subsystem meets the requirements of the TSI, the notified body shall then, based on the tests, verifications and checks carried out as required in the TSI and/or in the relevant European specifications, draw up the certificate of conformity intended for the contracting entity, who shall in turn draw up the EC declaration of verification intended for the supervisory authority in the Member State where the subsystem is located and/or operates. 

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 8. The notified body shall be responsible for compiling the technical file that has to accompany the EC declaration of verification. The technical file has to include at least the information indicated in Art.18 (3) of the Directive, and in particular as follows: 

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 9. The records accompanying the certificate of conformity shall be lodged with the contracting entity 

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 F.3.5. Module SH2: Full Quality Management System with Design Examination 
 1. This module describes the EC verification procedure whereby a notified body checks and certifies, at the request of an contracting entity or its authorised representative established within the Community, that an infrastructure, energy, control-command or rolling stock subsystem 

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 2. The notified body shall carry out the procedure, including a design examination of the subsystem, under the condition, that the contracting entity and the main contractor involved are satisfying the obligations of point 3. 

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 3. For the subsystem that is subject of the EC verification procedure, the contracting entity or the main contractor, when employed, shall operate an approved quality management system for design, manufacture and final product inspection and testing as specified in point 5 and which shall be subject to surveillance as specified in point 6 

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 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4.1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4.2. The application shall enable the design, manufacture, assembly, installation, maintenance and operation of the subsystem to be understood, and shall enable conformity with the requirements of the TSI to be assessed. 

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 4.3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4.4. The notified body shall examine the application concerning the design examination and assess the results of the tests. Where the design meets the provisions of the Directive and of the TSI that apply to it shall issue a design examination certificate to the applicant. The certificate shall contain the conclusions of the design examination, conditions for its validity, the necessary data for identification of the design examined and, if relevant, a description of the subsystem's functioning. 

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 4.5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 5.1. The contracting entity, if involved, and the main contractor, when employed, shall lodge an application for assessment of their quality management systems with a notified body of their choice. 

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 5.2. For the contracting entity or the main contractor responsible for the whole subsystem project, the quality management system shall ensure overall compliance of the subsystem with the requirements of the TSI. 

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 5.3. The notified body chosen by the contracting entity shall examine, if all stages of the subsystem as mentioned in point 5.2 are sufficiently and properly covered by the approval and surveillance of the quality management system(s) of the applicant(s). 

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 5.4. The notified body referenced in point 5.1. shall assess the quality management system to determine whether it satisfies the requirements of point 5.2. It presumes compliance with these requirements if the applicant implements a quality system for design, production, final product inspection and testing in respect of the Standard EN/ISO 9001-2000, which takes into consideration the specificity of the subsystem for which it is implemented. 

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 5.5. The contracting entity, if involved, and the main contractor shall undertake to fulfil the obligations arising out of the quality management system as approved and to uphold it so that it remains adequate and efficient. 

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 6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 6.1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 6.2. The contracting entity, if involved, and the main contractor shall send the notified body referenced in point 5.1. (or have sent) all the documents needed for that purpose and in particular the implementation plans and technical records concerning the subsystem (as far as relevant for the specific contribution of the applicant to the subsystem), including: 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 6.3. The notified body shall periodically carry out audits to make sure that the contracting entity, if involved, and the main contractor maintain and apply the quality management system and shall provide an audit report to them. When they operate a certified quality management system, the notified body shall take this into account in the surveillance. 

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 6.4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 6.5. The notified body chosen by the contracting entity and responsible for the EC verification, if not carrying out the surveillance of all the quality management system(s) concerned as under point 5, shall co ordinate the surveillance activities of any other notified bodies responsible for that task, in order: 

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 7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 8. The contracting entity, if involved, and the main contractor shall, for a period of 10 years after the last subsystem has been manufactured, keep at the disposal of the national authorities: 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 9. Where the subsystem meets the requirements of the TSI, the notified body shall then, based on the design examination and the approval and surveillance of the quality management system (s), draw up the certificate of conformity intended for the contracting entity, who shall in turn draw up the EC declaration of verification intended for the supervisory authority in the Member State within which the subsystem is located and/or operates. 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 10. The notified body chosen by the contracting entity shall be responsible for compiling the technical file that has to accompany the EC declaration of verification. The technical file shall include at least the information indicated in Art. 18 (3) of The Directive, and in particular as follows: 

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 11. Each notified body shall communicate to the other notified bodies the relevant information concerning the quality management system approvals and the EC design examination certificates, which it has issued, withdrawn or refused. 

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 12. The records accompanying the certificate of conformity shall be lodged with the contracting entity 

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F.4. Assessment of Maintenance Arrangements: Conformity Assessment Procedure 

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ANNEX G
GLOSSARY
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