Commission Decision of 20 December 2007 concerning a technical specification for interoperability relating to the ‘infrastructure’ sub-system of the trans-European high-speed rail system (notified under document number C(2007) 6440) (Text with EEA relevance) (2008/217/EC) (repealed)

1. Introductory Text

2. Article 1. . . . . . . . . . ....

3. Article 2. . . . . . . . . . ....

4. Article 3. . . . . . . . . . ....

5. Article 4. . . . . . . . . . ....

6. Article 5. . . . . . . . . . ....

7. Article 6. . . . . . . . . . ....

8. Article 7. . . . . . . . . . ....

9. Article 8. . . . . . . . . . ....

10. Article 9. . . . . . . . . . ....

11. 1. ANNEX

       DIRECTIVE 96/48/EC — INTEROPERABILITY OF THE TRANS-EUROPEAN HIGH SPEED RAIL SYSTEM

       1. 1. INTRODUCTION

          1. 1.1 Technical scope

          2. 1.2 Geographical scope

          3. 1.3 Content of this TSI

       2. 2. DEFINITION OF THE INFRASTRUCTURE DOMAIN/SCOPE OF APPLICATION

          1. 2.1. Definition of the infrastructure domain

          2. 2.2 Functions and aspects of the domain within the scope of...

             1. 2.2.1 To guide the train

                1. Plain line track

                2. Switches and crossings

                3. Stabling tracks

             2. 2.2.2 To support the train

                1. Plain line track and switches and crossings

                2. Structures supporting the track

             3. 2.2.3 To allow free and safe passage of a train within...

                1. Structure gauge and distance between track centres

                2. Civil engineering works and lineside structures

             4. 2.2.4 To allow passengers boarding and alighting from trains stopped in...

                1. Passengers' platform

                2. People with reduced mobility

             5. 2.2.5 To ensure safety

             6. 2.2.6 To respect the environment

             7. 2.2.7 To maintain the train

       3. 3. ESSENTIAL REQUIREMENTS

          1. 3.1 General

          2. 3.2. Essential requirements for the Infrastructure domain

             1. 3.2.1 General requirements

             2. 3.2.2 Requirements specific to the infrastructure domain

          3. 3.3 Meeting the essential requirements by the specifications of the Infrastructure...

             1. 3.3.1 Safety

             2. 3.3.2 Reliability and availability

             3. 3.3.3 Health

             4. 3.3.4 Environmental protection

             5. 3.3.5 Technical compatibility

          4. 3.4 Elements of the Infrastructure domain corresponding to the essential requirements...

       4. 4. DESCRIPTION OF THE INFRASTRUCTURE DOMAIN

          1. 4.1 Introduction

          2. 4.2 Functional and technical specifications of the domain

             1. 4.2.1 General provisions

             2. 4.2.2 Nominal track gauge

             3. 4.2.3 Minimum infrastructure gauge

                1. Lines of category I

                2. Lines of categories II and III

             4. 4.2.4 Distance between track centres

                1. Lines of categories I, II and III

             5. 4.2.5 Maximum rising and falling gradients

                1. Lines of category I

                2. Lines of categories II and III

             6. 4.2.6 Minimum radius of curvature

             7. 4.2.7 Track cant

                1. Lines of category I, II and III

             8. 4.2.8 Cant deficiency

                1. 4.2.8.1 Cant deficiency on plain track and on the through route...

                2. 4.2.8.2 Abrupt change of cant deficiency on diverging track of switches...

                   1. Lines of categories I, II and III

             9. 4.2.9 Equivalent conicity

                1. 4.2.9.1 Definition

                2. 4.2.9.2 Design values

                3. 4.2.9.3 In service values

                   1. 4.2.9.3.1 Minimum values of mean track gauge

                   2. 4.2.9.3.2 Actions to be taken in case of ride instability

             10. 4.2.10 Track Geometrical Quality and limits on isolated defects

                 1. 4.2.10.1 Introduction

                 2. 4.2.10.2 Definitions

                 3. 4.2.10.3 Immediate action, intervention, and alert limits

                 4. 4.2.10.4 Immediate action limit

                    1. 4.2.10.4.1 Track twist — isolated defects — zero to peak value...

                    2. 4.2.10.4.2 Variation of gauge — isolated defects — nominal gauge to...

             11. 4.2.11 Rail inclination

                 1. Lines of category I, II and III

             12. 4.2.12 Switches and crossings

                 1. 4.2.12.1 Means of detection and locking

                 2. 4.2.12.2 Use of swing noses

                 3. 4.2.12.3 Geometrical characteristics

                    1. Lines of category I, II and III

             13. 4.2.13 Track resistance

                 1. 4.2.13.1 Lines of category I

                    1. Vertical loads

                    2. Longitudinal loads

                    3. Lateral loads

                 2. 4.2.13.2 Lines of category II and III

             14. 4.2.14 Traffic load on structures

                 1. Lines of categories I, II and III

                    1. 4.2.14.1 Vertical loads

                    2. 4.2.14.2 Dynamic analysis

                    3. 4.2.14.3 Centrifugal forces

                    4. 4.2.14.4 Nosing forces

                    5. 4.2.14.5 Actions due to traction and braking (longitudinal loads)

                    6. 4.2.14.6 Longitudinal forces due to interaction between structures and track

                    7. 4.2.14.7 Aerodynamic actions from passing trains on line side structures

                    8. 4.2.14.8 Application of the requirements of EN1991-2:2003

             15. 4.2.15 Global track stiffness

                 1. Lines of category I, II and III

             16. 4.2.16 Maximum pressure variations in tunnels

                 1. 4.2.16.1 General requirements

                    1. Lines of category I

                    2. Lines of categories II and III

                 2. 4.2.16.2 Piston effect in underground stations

             17. 4.2.17 Effect of crosswinds

             18. 4.2.18 Electrical characteristics

             19. 4.2.19 Noise and vibration

             20. 4.2.20 Platforms

                 1. 4.2.20.1 Access to the platform

                    1. Lines of category I

                    2. Lines of category II and III

                 2. 4.2.20.2 Usable length of the platform

                    1. Lines of category I, II and III

                 3. 4.2.20.3 Usable width of the platform

                 4. 4.2.20.4 Platform height

                    1. Lines of category I, II and III

                 5. 4.2.20.5 Distance from the centre of the track

                 6. 4.2.20.6 Track layout along the platforms

                    1. Lines of category I

                    2. Lines of category II and III

                 7. 4.2.20.7 Prevention of electric shock on platforms

                    1. Lines of category I, II and III

                 8. 4.2.20.8 Characteristics linked to the access of people with reduced mobility....

                    1. Lines of category I, II and III

             21. 4.2.21 Fire safety and safety in railway tunnels

             22. 4.2.22 Access to or intrusion into line installations

             23. 4.2.23 Lateral space for passengers and onboard staff in the event...

                 1. 4.2.23.1 Lateral space alongside tracks

                 2. 4.2.23.2 Escape walkways in tunnels

             24. 4.2.24 Distance Markers

             25. 4.2.25 Stabling tracks and other locations with very low speed

                 1. 4.2.25.1 Length

                 2. 4.2.25.2 Gradient

                 3. 4.2.25.3 Radius of curvature

             26. 4.2.26 Fixed installations for servicing trains

                 1. 4.2.26.1 Toilet discharge

                 2. 4.2.26.2 Train external cleaning facilities

                 3. 4.2.26.3 Water restocking equipment

                 4. 4.2.26.4 Sand restocking equipment

                 5. 4.2.26.5 Refuelling

             27. 4.2.27 Ballast pick-up

          3. 4.3 Functional and technical specification of the interfaces

             1. 4.3.1 Interfaces with the rolling stock subsystem

             2. 4.3.2 Interfaces with the energy subsystem

             3. 4.3.3 Interfaces with the control-command and signalling subsystem

             4. 4.3.4 Interfaces with the operation subsystem

             5. 4.3.5 Interfaces with the SRT TSI

          4. 4.4 Operating rules

             1. 4.4.1 Execution of works

             2. 4.4.2 Notices given to railway undertakings

             3. 4.4.3 Protection of workers against aerodynamic effects

          5. 4.5 Maintenance rules

             1. 4.5.1 Maintenance plan

             2. 4.5.2 Maintenance requirements

          6. 4.6 Professional competences

          7. 4.7 Health and safety conditions

          8. 4.8 Register of infrastructure and European register of authorised types of...

       5. 5. INTEROPERABILITY CONSTITUENTS

          1. 5.1 Definition

             1. 5.1.1 Innovative solutions

             2. 5.1.2 Novel solutions for track subassembly

          2. 5.2 List of constituents

          3. 5.3 Constituents performances and specifications

             1. 5.3.1 The rail

                1. Lines of categories I, II and III

                2. 5.3.1.1 Railhead profile

                3. 5.3.1.2 Design linear mass

                4. 5.3.1.3 Steel grade

                   1. (a) Plain line

                   2. (b) Switches and crossings

             2. 5.3.2 The rail fastening systems

             3. 5.3.3 Track sleepers and bearers

             4. 5.3.4 Switches and crossings

             5. 5.3.5 Water filling connector

       6. 6. ASSESSMENT OF CONFORMITY AND/OR SUITABILITY FOR USE OF THE CONSTITUENTS...

          1. 6.1. Interoperability Constituents

             1. 6.1.1. Conformity and suitability for use assessment procedures

                1. 6.1.1.1 Consistency with subsystem requirements.

                2. 6.1.1.2 . . . . . . . . . ....

                3. 6.1.1.3 Compliance with specific technical requirements

             2. 6.1.2 Definition of ‘Established’, ‘novel’ and ‘innovative’ interoperability constituents

             3. 6.1.3. Procedures to be applied for established and novel interoperability constituents...

             4. 6.1.4. Procedures to be applied for innovative interoperability constituents

             5. 6.1.5 Application of modules

             6. 6.1.6 Assessment methods for interoperability constituents

                1. 6.1.6.1 Interoperability constituents subject to other Community Directives

                2. 6.1.6.2 Assessment of fastening system

                3. 6.1.6.3 Type validation by in-service experience (suitability for use)

          2. 6.2 Infrastructure Subsystem

             1. 6.2.1 General provisions

             2. 6.2.2 Reserved

             3. 6.2.3 Innovative solutions

             4. 6.2.4 Application of modules

                1. 6.2.4.1 Application of module SH2

                2. 6.2.4.2 Application of module SG

             5. 6.2.5 Technical solutions giving presumption of conformity at design phase

                1. 6.2.5.1 Assessment of track resistance

                2. 6.2.5.2 Assessment of equivalent conicity

             6. 6.2.6 Particular requirements for conformity assessment

                1. 6.2.6.1 Assessment of minimum infrastructure gauge

                2. 6.2.6.2 Assessment of minimum value of mean track gauge

                3. 6.2.6.3 Assessment of track stiffness

                4. 6.2.6.4 Assessment of rail inclination

                5. 6.2.6.5 Assessment of maximum pressure variation in tunnels

                6. 6.2.6.6 Assessment of noise and vibrations

          3. 6.3 Assessment of conformity when speed is used as a migration...

          4. 6.4 Assessment of maintenance plan

          5. 6.5 Assessment of maintenance subsystem

          6. 6.6 Interoperable Constituents Not Holding an EC Declaration

             1. 6.6.1 General

             2. 6.6.2 The Transition Period

             3. 6.6.3 The Certification of Subsystems Containing Non-Certified Interoperability Constituents during the...

                1. 6.6.3.1 Conditions

                2. 6.6.3.2 Notification

                3. 6.6.3.3 Lifecycle Implementation

             4. 6.6.4 Monitoring Arrangements

       7. 7. IMPLEMENTING THE INFRASTRUCTURE TSI

          1. 7.1. Application of this TSI to High-Speed lines to be put...

          2. 7.2. Application of this TSI to High-Speed lines already in service...

             1. 7.2.1. Classification of works

             2. 7.2.2. Parameters and specifications concerning civil engineering

             3. 7.2.3. Parameters and characteristics concerning track construction

             4. 7.2.4. Parameters and characteristics concerning miscellaneous equipment and maintenance facilities

             5. 7.2.5. Speed as migration criterion

          3. 7.3. Specific cases

             1. 7.3.1. Particular features on the German network

                1. 7.3.1.1 Lines of category I

                   1. P cases

                      1. Maximum falling and rising gradients

                   2. T cases

                2. 7.3.1.2 Lines of category II and III

                   1. P cases

                   2. T cases

             2. 7.3.2. Particular features on the Austrian network

                1. 7.3.2.1 Lines of category I

                   1. P cases

                      1. Minimum length of passenger platform

                   2. T cases

                2. 7.3.2.2 Lines of category II and III

                   1. P cases

                      1. Minimum length of passenger platform

                   2. T cases

             3. 7.3.3. Particular features on the Danish network

                1. P cases

                   1. Minimum length of passenger platforms and stabling tracks

                2. T cases

             4. 7.3.4. Particular features on the Spanish network

                1. 7.3.4.1 Lines of category I

                   1. P cases

                      1. Track gauge

                2. 7.3.4.2 Lines of category II and III

                   1. P cases

                      1. Track gauge

                      2. Track centre distance

                   2. T cases

             5. 7.3.5. Particular features on the Finnish network

                1. 7.3.5.1 Lines of category I

                   1. P cases

                      1. Track gauge

                      2. Minimum infrastructure gauge

                      3. Equivalent conicity

                      4. Free wheel passage in switches

                      5. Fixed nose protection

                      6. Free wheel passage at crossing nose

                      7. Free wheel passage at check/wing rail entry

                      8. Minimum flange way width

                      9. Excess height of check rail

                      10. Platform length

                      11. Distance of platform edge from the centre of the track...

                   2. T cases

                2. 7.3.5.2 Lines of category II and III

                   1. P cases

                   2. T cases

             6. 7.3.6. Particular features on the British network

                1. 7.3.6.1 Lines of category I

                   1. P cases

                   2. T Cases

                2. 7.3.6.2 Lines of category II

                   1. P cases

                      1. Minimum infrastructure gauge (section 4.2.3)

                         1. 1. The UK1 (Issue 2) profiles

                         2. 2. UK1[A] Profile

                         3. 3. UK1[B] Profile

                         4. 4. UK1[D] Profile

                         5. 5. Calculation of overthrow on curves

                      2. Distance between track centres (section 4.2.4)

                      3. Platforms (section 4.2.20)

                         1. 1. Platform height

                         2. 2. Platform horizontal distance (platform offset)

                         3. 3. Minimum platform length

                   2. T Cases

                3. 7.3.6.3 Lines of category III

                   1. P cases

                   2. T Cases

             7. 7.3.7. Particular features on the Hellenic network

                1. 7.3.7.1 Lines of category I

                   1. P cases

                   2. T cases

                2. 7.3.7.2 Lines categories II and III

                   1. P cases

                      1. Structure gauge

                      2. Minimum length of passenger platforms and stabling tracks

                      3. Track gauge

                   2. T cases

             8. 7.3.8. Particular features on Ireland and Northern Ireland networks

                1. P cases

                   1. Structure gauge

                   2. Track gauge

                   3. Minimum radius of curvature

                   4. Minimum length of passenger platforms and stabling tracks

                   5. Platform height

                   6. Distance between track centres

             9. 7.3.9. Particular features on the Italian network

                1. 7.3.9.1 Lines of category I, II and III

                   1. Distance of the platform from the centre of the track...

                      1. P cases

                      2. T cases

             10. 7.3.10. Particular features on the Netherlands network

                 1. 7.3.10.1 Lines of category I

                    1. P cases

                    2. T cases

                 2. 7.3.10.2 Lines of category II and III

                    1. P cases

                    2. T cases

             11. 7.3.11. Particular features on the Portuguese network

                 1. 7.3.11.1 Lines of category I

                    1. P cases

                    2. T cases

                 2. 7.3.11.2 Lines of category II and III

                    1. P cases

                    2. T cases

             12. 7.3.12. Particular features on the Swedish network

                 1. 7.3.12.1 Lines of category I

                    1. P cases

                       1. Minimum platform length

                       2. Stabling tracks: minimum length

                       3. Platforms — distance from centre of track

                    2. T cases

                 2. 7.3.12.2 Lines of category II

                    1. P cases

                    2. T cases

                       1. Platform height

                 3. 7.3.12.3 Lines of category III

                    1. P cases

                    2. T cases

                       1. Platform height

             13. 7.3.13. Particular features on the Polish network

                 1. P cases

                    1. Structure gauge

          4. 7.4. TSI Revision

          5. 7.5. Agreements

             1. 7.5.1. Existing agreements

             2. 7.5.2. Future agreements

       8. ANNEX A

          Interoperability constituents of the infrastructure domain

          1. A.1. Scope

          2. A.2. Characteristics to be assessed for ‘established’ interoperability constituents.

          3. A.3 Characteristics to be assessed for ‘novel’ Interoperability constituents

       9. ANNEX B1

          Assessment of the infrastructure subsystem

          1. B1.1. Scope

          2. B1.2. Characteristics and modules

       10. ANNEX B2

           Assessment of the maintenance subsystem

           1. B2.1. Scope

           2. B2.2. Characteristics

       11. ANNEX C

           Assessment procedures

           1. Modules for Interoperability Constituents

              1. Module A: Internal Production Control

                 1. 1. . . . . . . . . . ....

                 2. 2. . . . . . . . . . ....

                 3. 3. The technical documentation shall enable the conformity of the interoperability...

                 4. 4. . . . . . . . . . ....

                 5. 5. The manufacturer or his authorised representative established within the Community...

                 6. 6. The manufacturer or his authorised representative shall keep a copy...

                 7. 7. . . . . . . . . . ....

              2. Module A1: Internal Design Control with Production Verification

                 1. 1. . . . . . . . . . ....

                 2. 2. . . . . . . . . . ....

                 3. 3. The technical documentation shall enable the conformity of the interoperability...

                 4. 4. . . . . . . . . . ....

                 5. 5. . . . . . . . . . ....

                 6. 5.1 . . . . . . . . . ....

                 7. 5.1.1 . . . . . . . . . ....

                 8. 5.1.2 . . . . . . . . . ....

                 9. 5.2 . . . . . . . . . ....

                 10. 5.2.1 . . . . . . . . . ....

                 11. 5.2.2 . . . . . . . . . ....

                 12. 5.2.3 . . . . . . . . . ....

                 13. 5.2.4 . . . . . . . . . ....

                 14. 5.2.5 . . . . . . . . . ....

                 15. 6. The manufacturer or his authorised representative established within the Community...

                 16. 7. The manufacturer or his authorised representative shall keep a copy...

                 17. 8. . . . . . . . . . ....

              3. Module B: Type Examination

                 1. 1. . . . . . . . . . ....

                 2. 2. The application for the EC type-examination shall be lodged by...

                 3. 3. The technical documentation shall enable the conformity of the interoperability...

                 4. 4. . . . . . . . . . ....

                 5. 4.1 . . . . . . . . . ....

                 6. 4.2 . . . . . . . . . ....

                 7. 4.3 . . . . . . . . . ....

                 8. 4.4 . . . . . . . . . ....

                 9. 4.5 . . . . . . . . . ....

                 10. 4.6 . . . . . . . . . ....

                 11. 4.7 . . . . . . . . . ....

                 12. 4.8 . . . . . . . . . ....

                 13. 5. Where the type meets the provisions of the TSI, the...

                 14. 6. . . . . . . . . . ....

                 15. 7. . . . . . . . . . ....

                 16. 8. . . . . . . . . . ....

                 17. 9. . . . . . . . . . ....

                 18. 10. . . . . . . . . . ....

              4. Module D: Production Quality Management System

                 1. 1. . . . . . . . . . ....

                 2. 2. . . . . . . . . . ....

                 3. 3. . . . . . . . . . ....

                 4. 3.1 The manufacturer shall lodge an application for assessment of his...

                 5. 3.2 The quality management system shall ensure compliance of the interoperability...

                 6. 3.3 The notified body assesses the quality management system to determine...

                 7. 3.4 The manufacturer shall undertake to fulfil the obligations arising out...

                 8. 4. . . . . . . . . . ....

                 9. 4.1 . . . . . . . . . ....

                 10. 4.2 The manufacturer shall allow the notified body entrance for inspection...

                 11. 4.3 The notified body shall periodically carry out audits to make...

                 12. 4.4 . . . . . . . . . ....

                 13. 5. Each notified body shall communicate to the other notified bodies...

                 14. 6. The manufacturer shall, for a period of 10 years after...

                 15. 7. The manufacturer or his authorised representative established within the Community...

                 16. 8. The manufacturer or his authorised representative established within the Community...

                 17. 9. . . . . . . . . . ....

              5. Module F: Product Verification

                 1. 1. . . . . . . . . . ....

                 2. 2. . . . . . . . . . ....

                 3. 3. . . . . . . . . . ....

                 4. 4. . . . . . . . . . ....

                 5. 4.1 . . . . . . . . . ....

                 6. 4.2 . . . . . . . . . ....

                 7. 4.3 . . . . . . . . . ....

                 8. 5. . . . . . . . . . ....

                 9. 5.1 . . . . . . . . . ....

                 10. 5.2 . . . . . . . . . ....

                 11. 5.3 . . . . . . . . . ....

                 12. 5.4 In the case of accepted lots, the notified body shall...

                 13. 5.5 . . . . . . . . . ....

                 14. 6. The manufacturer or his authorised representative established within the Community...

                 15. 7. The manufacturer or his authorised representative established within the Community...

                 16. 8. . . . . . . . . . ....

              6. Module H 1: Full Quality Management System

                 1. 1. . . . . . . . . . ....

                 2. 2. . . . . . . . . . ....

                 3. 3. . . . . . . . . . ....

                 4. 3.1. The manufacturer shall lodge an application for assessment of his...

                 5. 3.2. The quality management system shall ensure compliance of the interoperability...

                 6. 3.3. The notified body shall assess the quality management system to...

                 7. 3.4. The manufacturer shall undertake to fulfil the obligations arising out...

                 8. 4. . . . . . . . . . ....

                 9. 4.1. . . . . . . . . . ....

                 10. 4.2. The manufacturer shall allow the notified body entrance for inspection...

                 11. 4.3. The notified body shall periodically carry out audits to make...

                 12. 4.4. . . . . . . . . . ....

                 13. 5. The manufacturer shall, for a period of 10 years after...

                 14. 6. Each notified body shall communicate to the other notified bodies...

                 15. 7. The manufacturer or its authorised representative established within the Community...

                 16. 8. The manufacturer or his authorised representative established within the Community...

                 17. 9. . . . . . . . . . ....

              7. Module H2: Full Quality Management System With Design Examination

                 1. 1. . . . . . . . . . ....

                 2. 2. . . . . . . . . . ....

                 3. 3. . . . . . . . . . ....

                 4. 3.1. The manufacturer shall lodge an application for assessment of his...

                 5. 3.2. The quality management system shall ensure compliance of the interoperability...

                 6. 3.3. The notified body shall assess the quality management system to...

                 7. 3.4. The manufacturer shall undertake to fulfil the obligations arising out...

                 8. 4. . . . . . . . . . ....

                 9. 4.1. . . . . . . . . . ....

                 10. 4.2. The manufacturer shall allow the notified body entrance for inspection...

                 11. 4.3. The notified body shall periodically carry out audits to make...

                 12. 4.4. . . . . . . . . . ....

                 13. 5. The manufacturer shall, for a period of 10 years after...

                 14. 6. . . . . . . . . . ....

                 15. 6.1. . . . . . . . . . ....

                 16. 6.2. The application shall enable the design, manufacture, maintenance and operation...

                 17. 6.3 . . . . . . . . . ....

                 18. 6.4. The notified body shall examine the application and assess the...

                 19. 6.5. . . . . . . . . . ....

                 20. 6.6. . . . . . . . . . ....

                 21. 7. Each notified body shall communicate to the other notified bodies...

                 22. 8. The manufacturer or his authorised representative established within the Community...

                 23. 9. The manufacturer or his authorised representative established within the Community...

                 24. 10. . . . . . . . . . ....

              8. Module V: Type-Validation By In Service Experience (Suitability For Use)...

                 1. 1. . . . . . . . . . ....

                 2. 2. The manufacturer, or his authorised representative established within the Community,...

                 3. 3. The technical documentation shall enable the assessment of the product...

                 4. 4. The programme for the validation by in service experience shall...

                 5. 5. . . . . . . . . . ....

                 6. 5.1. . . . . . . . . . ....

                 7. 5.2. . . . . . . . . . ....

                 8. 5.3. . . . . . . . . . ....

                 9. 5.4. . . . . . . . . . ....

                 10. 5.5. . . . . . . . . . ....

                 11. 5.6. . . . . . . . . . ....

                 12. 5.7. . . . . . . . . . ....

                 13. 6. Where the type meets the provisions of the TSI, the...

                 14. 7. . . . . . . . . . ....

                 15. 8. . . . . . . . . . ....

                 16. 9. . . . . . . . . . ....

                 17. 10. . . . . . . . . . ....

                 18. 11. The manufacturer or his authorised representative established within the Community...

                 19. 12. The manufacturer or his authorised representative established within the Community...

           2. Modules for the EC Verification of Subsystems

              1. Module SH2: Full Quality Management System with Design Examination

                 1. 1. This module describes the EC verification procedure whereby a notified...

                 2. 2. The notified body shall carry out the procedure, including a...

                 3. 3. For the subsystem that is subject of the EC verification...

                 4. 4. . . . . . . . . . ....

                 5. 4.1 . . . . . . . . . ....

                 6. 4.2 The application shall enable the design, manufacture, assembly, installation, maintenance...

                 7. 4.3 . . . . . . . . . ....

                 8. 4.4 The notified body shall examine the application concerning the design...

                 9. 4.5 . . . . . . . . . ....

                 10. 5. . . . . . . . . . ....

                 11. 5.1 The contracting entity, if involved, and the main contractor, when...

                 12. 5.2 For the contracting entity or the main contractor responsible for...

                 13. 5.3 The notified body chosen by the contracting entity shall examine,...

                 14. 5.4 The notified body referenced in point 5.1. shall assess the...

                 15. 5.5 The contracting entity, if involved, and the main contractor shall...

                 16. 6. . . . . . . . . . ....

                 17. 6.1 . . . . . . . . . ....

                 18. 6.2 The contracting entity, if involved, and the main contractor shall...

                 19. 6.3 The notified body shall periodically carry out audits to make...

                 20. 6.4. . . . . . . . . . ....

                 21. 6.5 The notified body chosen by the contracting entity and responsible...

                 22. 7. . . . . . . . . . ....

                 23. 8. The contracting entity, if involved, and the main contractor shall,...

                 24. 9. Where the subsystem meets the requirements of the TSI, the...

                 25. 10. The notified body chosen by the contracting entity shall be...

                 26. 11. Each notified body shall communicate to the other notified bodies...

                 27. 12. The records accompanying the certificate of conformity shall be lodged...

              2. Module SG: Unit Verification

                 1. 1. This module describes the EC verification procedure whereby a notified...

                 2. 2. The contracting entity shall lodge an application for EC verification...

                 3. 3. The technical documentation shall enable the design, manufacture, installation and...

                 4. 4. The notified body shall examine the application and the technical...

                 5. 5. . . . . . . . . . ....

                 6. 6. . . . . . . . . . ....

                 7. 7. Where the subsystem meets the requirements of the TSI, the...

                 8. 8. The notified body shall be responsible for compiling the technical...

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

       12. ANNEX D

           Items to be included in the Infrastructure Register concerning the infrastructure domain

           1. . . . . . . . . . ....

           2. . . . . . . . . . ....

           3. . . . . . . . . . ....

           4. . . . . . . . . . ....

           5. . . . . . . . . . ....

           6. . . . . . . . . . ....

           7. . . . . . . . . . ....

       13. ANNEX H

           List of open points

           1. . . . . . . . . . ....

           2. . . . . . . . . . ....

           3. . . . . . . . . . ....

           4. . . . . . . . . . ....

       14. ANNEX I

           Definition of terms used in the HS INS TSI