Commission Decision of 21 December 2007 concerning the technical specification of interoperability relating to ‘persons with reduced mobility’ in the trans-European conventional and high-speed rail system (notified under document C(2007) 6633) (Text with EEA relevance) (2008/164/EC) (repealed) (c. 164)

ANNEXES (TO THE TSI) Scope: Whole Subsystems Aspect: Accessibility for Persons with Reduced Mobility

ANNEX A

Reserved

ANNEX B

Reserved

ANNEX C Assessment of Maintenance Arrangements: Conformity Assessment Procedure (Annex F4)

ANNEX D Assessment of interoperability constituents

D.1 Scope

This annex indicates the assessment of conformity and suitability for use for interoperability constituents.

D.2 Characteristics

The characteristics of the interoperability constituents to be assessed in the different phases of design, development and production are marked by X in Table D.1.

Table D.1

Assessment of Interoperability Constituents

1	2	3	4	5
Interoperability Constituents and Characteristics to be assessed	Assessment in the following phase
	Design and development phase			Production phase
	Design review and/or Design examination	Review of manufacturing process	Type test	Verification of conformity to type
4.1.2.11.2 and 4.1.2.12.2 Visual passenger information equipment	X		X	X
4.1.2.21.2 Boarding devices	X		X	X
4.1.2.4 Tactile pushbuttons	X		X	X
4.1.2.7.2 Baby changing unit	X		X	X
4.1.2.11 Tactile signage	X		X	X
4.1.2.9.2 Ticket vending machines	X		X	X
4.2.2.6 Toilet modules	X		X	X
4.2.2.8.3 Visual passenger information equipment	X		X	X
4.2.2.3, 4.2.2.6 and 4.2.2.11 Passenger alarm devices	X		X	X
4.2.2.12.3 Boarding devices	X		X	X
4.2.2.4 Pushbuttons	X		X	X
4.2.2.6.3.2 Baby changing unit	X		X	X
4.2.2.8.1, 4.2.2.8.2 and Annex N Visual Information and signage	X		X	X

ANNEX E Assessment of the subsystems

E.1 Scope

This annex indicates the assessment of conformity of the subsystems

E.2 Characteristics and modules

The sub-system characteristics to be assessed in the different phases of design, development and production are marked by X in Table E.1 for Infrastructure subsystem and Table E.2 for Rolling Stock subsystem.

Table E.1

Assessment of the Infrastructure subsystem (constructed and supplied as single entity)

1	2	3	4	5
Characteristics to be assessed	Design and development phase	Production phase
	Design review and/or design examination	Construction assembling, mounting	Assembly (before putting into service)	Validation under full operation conditions
4.1.2.2 Parking facilities for PRM	X		X
4.1.2.3 Obstacle-free routes
4.1.2.3.1 General	X		X
4.1.2.3.2 Route identification	X		X
4.1.2.4 Doors and entrances	X		X
4.1.2.5 Floor surfaces	X		X
4.1.2.6 Transparent obstacles	X		X
4.1.2.7 Toilets	X		X
4.1.2.8 Furniture and free-standing devices	X		X
4.1.2.9 Ticketing/Counter or vending machine/Information counter/Ticket control machine/Turnstiles/Customer Assistance points	X		X
4.1.2.10 Lighting	X		X
4.1.2.11 Visual information: signposting, pictograms, dynamic information	X		X	X
4.1.2.12 Spoken information	X		X	X
4.1.2.13 Emergency exits, alarms	X		X	X
4.1.2.14 Geometry of bridges and subways	X		X
4.1.2.15 Stairs	X		X
4.1.2.16 Handrails	X		X
4.1.2.17 Ramps, escalators, lifts, travelators	X		X
4.1.2.18.1 Platform height	X		X
4.1.2.18.2 Platform offset	X
4.1.2.18.3 Track layout along the platforms	X
4.1.2.19 Platform width and edge of platform	X		X
4.1.2.20 End of platform	X		X
4.1.2.21 Boarding aid devices for passengers using wheelchairs	X		X
4.1.2.22 Level track crossing at stations	X		X

Table E.2

Assessment of the Rolling Stock subsystem (constructed and supplied as serial products)

1	2	3	4
Characteristics to be assessed	Design and development phase		Production phase
	Design review and/or design examination	Type Test	Routine Test
4.2.2.2 Seats
4.2.2.2.1 General	X	X
4.2.2.2.1 Priority Seats General	X	X
4.2.2.2.2.2 Uni-directional seats	X	X
4.2.2.2.3.3 Facing seats arrangement	X	X
4.2.2.3 Wheelchair spaces	X	X
4.2.2.4 Doors
4.2.2.4.1 General	X	X
4.2.2.4.2 Exterior doors	X	X
4.2.2.4.3 Interior doors	X	X
4.2.2.5 Lighting		X
4.2.2.6 Toilets
4.2.2.6.1 General	X	X
4.2.2.6.2 Standard toilet	X	X
4.2.2.6.3 Universal toilet	X	X
4.2.2.7 Clearways	X	X
4.2.2.8 Customer Information
4.2.2.8.1 General	X	X
4.2.2.8.2 Information (signage)	X	X
4.2.2.8.2 Information (route description and seat reservation))	X	X
4.2.2.9 Height changes	X	X
4.2.2.10 Handrails	X	X
4.2.2.11 Wheelchair Accessible sleeping accommodation	X	X
4.2.2.12 Step position for vehicle access and egress
4.2.2.12.1 General requirements	X
4.2.2.12.2 Access/egress steps	X
4.2.2.12.3.5 Moveable steps	X	X	X
4.2.2.12.3.6 Portable ramps	X	X
4.2.2.12.3.7 Semi automatic ramps	X	X	X
4.2.2.12.3.8 Bridging plates	X	X	X
4.2.2.12.3.9 On-board lifts	X	X	X

ANNEX F Procedures for assessment of conformity and suitability for use

F.1. List of the modules

Modules for Interoperability Constituents:

• Module A: Internal production control

• Module A1: Internal design control with product verification

• Module B: Type examination

• Module C: Conformity to type

• Module D: Production quality management system

• Module F: Product verification

• Module H1: Full quality management system

• Module H2: Full quality management system with design examination

• Module V: Type validation by in service experience (Suitability for use)

Modules for Subsystems:

• Module SB: Type examination

• Module SD: Product quality management system

• Module SF: Product verification

• Module SG: Unit verification

• Module SH2: Full quality management system with design examination

Module for Maintenance Arrangements:

• Module Conformity Assessment Procedure

F.2. Modules for Interoperability Constituents

F.2.1. Module A: Internal production control

1. This module describes the procedure whereby the manufacturer or his authorised representative established within the Community, who carries out the obligations laid down in point 2, ensures and declares that the interoperability constituent concerned satisfies the requirements of the TSI that apply to it.

2. The manufacturer shall establish the technical documentation described in point 3.

3. The technical documentation shall enable the conformity of the interoperability constituent with the requirements of the TSI to be assessed. It shall, as far as relevant for such assessment, cover the design, manufacture, maintenance and operation of the interoperability constituent. So far as relevant for the assessment, the documentation shall contain:

• a general description of the interoperability constituent

• conceptual design and manufacturing information, for example drawings and schemes of components, subassemblies, circuits, etc.

• descriptions and explanations necessary for the understanding of the design and manufacturing information, maintenance and the operation of the interoperability constituent

• the technical specifications including European specifications(1) with relevant clauses, applied in full or in part,

• description of the solutions adopted to meet the requirements of the TSI, where the European specifications have not been applied in full,

• results of design calculations made, examinations carried out, etc,

• test reports.

4. The manufacturer shall take all the measures necessary in order that the manufacturing process ensures compliance of each manufactured interoperability constituent with the technical documentation referenced in point 3 and with the requirements of the TSI that apply to it.

5. The manufacturer or his authorised representative established within the Community shall draw up a written declaration of conformity for the interoperability constituent. The content of this declaration has to include at least the information indicated in Annex IV (3) and in Article 13 -3 of Directives 01/16/EC. The EC declaration of conformity and the accompanying documents shall be dated and signed.

The declaration shall be written in the same language as the technical documentation and shall contain the following:

• the Directive references (Directives 01/16/EC and other directives to which the interoperability constituent may be subject),

• the name and address of the manufacturer or his authorised representative established within the Community (give trade name and full address and in the case of an authorised representative also give the trade name of the manufacturer or constructor),

• description of interoperability constituent (make, type etc.)

• description of the procedure (module) followed in order to declare conformity,

• all the relevant descriptions met by the interoperability constituent and in particular its conditions of use,

• reference to this TSI and to any other applicable TSI, and where appropriate reference to European specifications,

• identification of the signatory empowered to enter into commitments on behalf of the manufacturer or of his authorised representative established within the Community.

6. The manufacturer or his authorised representative shall keep a copy of the EC declaration of conformity with the technical documentation for a period of 10 years after the last interoperability constituent has been manufactured.

Where neither the manufacturer nor his authorised representative is established within the Community, the obligation to keep the technical documentation available is the responsibility of the person who places the interoperability constituent in the Community market.

7. If additional to the EC declaration of conformity, an EC declaration for suitability for use for the interoperability constituent is required by the TSI, this declaration has to be added after being issued by the manufacturer under the conditions of module V.

F.2.2. Module A1: Internal Design Control with Production Verification

1. This module describes the procedure whereby the manufacturer or his authorised representative established within the Community, who carries out the obligations laid down in point 2, ensures and declares that the interoperability constituent concerned satisfies the requirements of the TSI that apply to it.

2. The manufacturer shall establish the technical documentation described in point 3.

3. The technical documentation shall enable the conformity of the interoperability constituent with the requirements of the TSI to be assessed.

The technical documentation shall also give evidence that the design of the interoperability constituent, already accepted before the implementation of the present TSI, is in accordance with the TSI and that the interoperability constituent has been used in service in the same area of use.

It shall, as far as relevant for such assessment, cover the design, manufacture, maintenance and operation of the interoperability constituent. So far as relevant for the assessment, the documentation shall contain:

• a general description of the interoperability constituent and its conditions of use,

• conceptual design and manufacturing information, for example drawings and schemes of components, subassemblies, circuits, etc.

• descriptions and explanations necessary for the understanding of the design and manufacturing information, maintenance and the operation of the interoperability constituent,

• the technical specifications including European specifications(2) with relevant clauses, applied in full or in part,

• descriptions of the solutions adopted to meet the requirements of the TSI, where the European specifications have not been applied in full,

• results of design calculations made, examinations carried out, etc,

• test reports,

4. The manufacturer shall take all the measures necessary in order that the manufacturing process ensures compliance of each manufactured interoperability constituent with the technical documentation referenced in point 3 and with the requirements of the TSI that apply to it.

5. The notified body, chosen by the manufacturer, shall carry out the appropriate examinations and tests in order to verify the conformity of the manufactured interoperability constituents with the type described in the technical documentation referenced in point 3 and with the requirement of the TSI. The manufacturer(3) can choose one of the following procedures:

5.1. Verification by examination and testing of every product

5.1.1. Each product shall be individually examined and appropriate tests shall be carried out in order to verify the product conformity with the type described in the technical documentation and the requirements of the TSI that apply to it. When a test is not set out in the TSI (or in an European Standard quoted in the TSI), the relevant European Specifications or equivalent tests are applicable

5.1.2. The notified body shall draw up a written certificate of conformity for the approved products relating to the tests carried out.

5.2. Statistical verification

5.2.1. The manufacturer shall present his products in the form of homogeneous lots and shall take all measures necessary in order that the manufacturing process ensures the homogeneity of each lot produced.

5.2.2. All interoperability constituents shall be available for verification in the form of homogeneous lots. A random sample shall be drawn from each lot. Each interoperability constituents in a sample shall be individually examined and appropriate tests shall be carried out to ensure the product conformity with the type described in the technical documentation and the requirements of the TSI which apply to it and to determine whether the lot is accepted or rejected. When a test is not set out in the TSI (or in an European Standard quoted in the TSI), the relevant European Specifications or equivalent tests are applicable

5.2.3. The statistical procedure shall use appropriate elements (statistical method, sampling plan etc), depending on the characteristics to be assessed, as specified in the TSI.

5.2.4. In the case of accepted lots, the notified body shall draw up a written certificate of conformity relating to the tests carried out. All interoperability constituents in the lot may be placed on the market except those interoperability constituents from the sample, which were found not to be in conformity.

5.2.5. If a lot is rejected, the notified body or the competent authority shall take appropriate measures to prevent placing that lot on the market. In the event of frequent rejection of lots the notified body shall suspend the statistical verification.

6. The manufacturer or his authorised representative established within the Community shall draw up the EC declaration of conformity of the interoperability constituent.

The content of this declaration shall include at least the information indicated in Annex IV (3) and in Article 13 -3 of Directive 01/16/EC. The EC declaration of conformity and the accompanying documents shall be dated and signed.

The declaration shall be written in the same language as the technical documentation and shall contain the following:

• the Directive references (Directives 01/16/EC and other directives to which the interoperability constituent may be subject),

• the name and address of the manufacturer or his authorised representative established within the Community (give trade name and full address and in the case of an authorised representative also give the trade name of the manufacturer or constructor),

• description of interoperability constituent (make, type, etc)

• description of the procedure (module) followed in order to declare conformity,

• all of the relevant descriptions met by the interoperability constituent and in particular any conditions of use,

• name and address of notified body (bodies) involved in the procedure followed in respect of conformity and date of certificates together with the duration and conditions of validity of the certificates,

• reference to the TSI and any other applicable TSI and where appropriate reference to European specifications,

• identification of the signatory empowered to enter into commitments on behalf of the manufacturer or of his authorised representative established within the Community.

The certificate to be referred to is the certificate of conformity as mentioned in point 5. The manufacturer or his authorised representative established within the Community shall ensure that he is able to supply the notified body's certificates of conformity on request

7. The manufacturer or his authorised representative shall keep a copy of the EC declaration of conformity with the technical documentation for a period of 10 years after the last interoperability constituent has been manufactured.

Where neither the manufacturer nor his authorised representative is established within the Community, the obligation to keep the technical documentation available is the responsibility of the person who places the interoperability constituent in the Community market.

8. If additional to the EC declaration of conformity, an EC declaration for suitability for use for the interoperability constituent is required by the TSI, this declaration has to be added after being issued by the manufacturer under the conditions of module V.

F.2.3. Module B: Type Examination

1. This module describes that part of the procedure by which a notified body ascertains and attests that a type, representative of the production envisaged, meets the provisions of the TSI that apply to it.

2. The application for the EC type-examination shall be lodged by the manufacturer or his authorised representative established within the Community.

The application shall include:

• the name and address of the manufacturer and also, if the application is lodged by the authorised representative, his name and address,

• a written declaration that the same application has not been lodged with any other notified body,

• the technical documentation, as described in point 3.

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

A type may cover several versions of the Interoperability Constituent provided that the differences between the versions do not affect the provisions of the TSI.

The notified body may request further specimens if needed for carrying out the test programme.

If no type tests are requested within the type examination procedure, and the type is sufficiently defined by the technical documentation, as described in point 3, the notified body shall agree that no specimens are placed at its disposal.

3. The technical documentation shall enable the conformity of the interoperability constituent with the requirements of the TSI to be assessed. It shall, as far as relevant for such assessment, cover the design, manufacture, maintenance and operation of the interoperability constituent.

The technical documentation shall contain:

• a general type-description,

• conceptual design and manufacturing information, for example drawings, schemes of components, sub-assemblies, circuits, etc.,

• descriptions and explanations necessary for the understanding of the design and manufacturing information, maintenance and the operation of the interoperability constituent,

• conditions of integration of the interoperability constituent in its system environment (sub-assembly, assembly, subsystem) and the necessary interface conditions,

• conditions for use and maintenance of the interoperability constituent (restrictions of running time or distance, wear limits etc),

• the technical specifications, including European specifications(4) with relevant clauses, applied in full or in part,

• description of the solutions adopted to meet the requirements of the TSI in cases where the European specifications have not been applied in full,

• results of design calculations made, examinations carried out, etc.,

• test reports,

4. The notified body shall:

4.1. examine the technical documentation,

4.2. verify that any specimen(s) required for tests has (have) been manufactured in conformity with the technical documentation, and carry out or have carried out the type tests in accordance with the provisions of the TSI and/or the relevant European specifications,

4.3. where a design review is requested in the TSI, perform an examination of the design methods, the design tools and the design results to evaluate their capability to fulfil the requirements for conformity for the interoperability constituent at the completion of the design process,

4.4. where a review of the manufacturing process is requested in the TSI, perform an examination of the manufacturing process devised for manufacturing the interoperability constituent, to evaluate its contribution to product conformity, and/or examine the review carried out by the manufacturer at the completion of the design process,

4.5. 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;

4.6. perform or have performed the appropriate examinations and necessary tests in accordance with points 4.2., 4.3. and 4.4 to establish whether, where the manufacturer has chosen to apply the relevant European specifications, these have actually been applied;

4.7. perform or have performed the appropriate examinations and necessary tests in accordance with points 4.2., 4.3. and 4.4. to establish whether, where the relevant European specifications have not been applied, the solutions adopted by the manufacturer meet the requirements of the TSI;

4.8. agree with the applicant the location where the examinations and necessary tests will be carried out.

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 manufacturer, conclusions of the examination, conditions for its validity and the necessary data for identification of the approved type.

The time period of validity shall be no longer than 5 years.

A list of the relevant parts of the technical documentation shall be annexed to the certificate and a copy kept by the notified body.

If the manufacturer or his authorised representative established within the Community is denied a type-examination certificate, the notified body shall provide detailed reasons for such denial.

Provision shall be made for an appeals procedure.

6. The applicant shall inform the notified body that holds the technical documentation concerning the type-examination certificate of all modifications to the approved product which may affect the conformity with the requirements of the TSI or the prescribed conditions for use of the product. In such cases the interoperability constituent shall receive additional approval from the notified body that issued the EC type examination certificate. In this case, the notified body shall perform only those examinations and tests that are relevant and necessary to the changes. The additional approval shall be given either in the form of an addition to the original type-examination certificate, or, by the issue of a new certificate after withdrawal of the old one.

7. If no modifications as in point 6 have been made, the validity of an expiring certificate can be extended for another period of validity. The applicant will apply for such a prolongation by a written confirmation that no such modifications have been made, and the notified body issues a prolongation for another period of validity as in point 5, if no contrary information exists. This procedure can be reiterated.

8. Each notified body shall communicate to the other notified bodies the relevant information concerning the type-examination certificates and additions issued, withdrawn or refused.

9. The other notified bodies shall receive, on request, copies of the type-examination certificates issued and/or their additions. The annexes to the certificates (see § 5) shall be kept at the disposal of the other notified bodies.

10. The manufacturer or his authorised representative established within the Community shall keep with the technical documentation copies of type-examination certificates and their additions for a period of 10 years after the last interoperability constituent has been manufactured. Where neither the manufacturer nor his authorised representative is established within the Community, the obligation to keep the technical documentation available is the responsibility of the person who places the interoperability constituent on the Community market.

F.2.4. Module C: Conformity to Type

1. This module describes that part of the procedure whereby the manufacturer or his authorised representative established within the Community ensures and declares that the interoperability constituent 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.

2. The manufacturer shall take all measures necessary to ensure that the manufacturing process ensures compliance of each manufactured interoperability constituent with the type as described in the EC type examination certificate and with the requirements of the TSI that apply to it.

3. The manufacturer or his authorised representative established within the Community shall draw up an EC declaration of conformity for the interoperability constituent.

The content of this declaration has to include at least the information indicated in Annex IV (3) and in Article 13 -3 of Directive 01/16/EC. The EC declaration of conformity and the accompanying documents shall be dated and signed.

The declaration shall be written in the same language as the technical documentation and shall contain the following:

• the Directive references (Directive 01/16/EC and other directives to which the interoperability constituent may be subject),

• the name and address of the manufacturer or his authorised representative established within the Community (give trade name and full address and in the case of an authorised representative also give the trade name of the manufacturer or constructor),

• description of interoperability constituent (make, type etc.)

• description of the procedure (module) followed in order to declare conformity,

• all the relevant descriptions met by the interoperability constituent and in particular its conditions of use,

• name and address of notified body (bodies) involved in the procedure followed in respect of type examination conformity and date of the EC type examination certificate (and its additions) together with the duration and conditions of validity of the certificate,

• reference to the TSI and to any other applicable TSI, and where appropriate reference to European specifications(5),

• identification of the signatory empowered to enter into commitments on behalf of the manufacturer or of his authorised representative established within the Community.

4. The manufacturer or his authorised representative established within the Community shall keep a copy of the EC declaration of conformity for a period of 10 years after the last interoperability constituent has been manufactured.

Where neither the manufacturer nor his authorised representative is established within the Community, the obligation to keep the technical documentation available is the responsibility of the person who places the interoperability constituent on the Community market.

5. If additional to the EC declaration of conformity an EC declaration of suitability for use for the interoperability constituent is required by the TSI, this declaration has to be added after being issued by the manufacturer under the conditions of module V.

F.2.5. Module D: Production Quality Management System

1. This module describes the procedure whereby the manufacturer or his authorised representative established within the Community who satisfies the obligations of point 2 ensures and declares that the interoperability constituent 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.

2. The manufacturer shall operate an approved quality management system for production, final product inspection and testing as specified in point 3 and is subject to monitoring as specified in point 4.

3. Quality management system

3.1. The manufacturer shall lodge an application for assessment of his quality management system with a notified body of his choice, for the interoperability constituents concerned.

The application shall include:

• all relevant information for the product category representative for the interoperability constituents envisaged,

• the documentation concerning the quality management system,

• the technical documentation of the approved type and a copy of the type-examination certificate, issued after the completion of the type examination procedure of module B.

• a written declaration that the same application has not been lodged with any other notified body,

3.2. The quality management system shall ensure compliance of the interoperability constituents with the type as described in the type-examination certificate and with the requirements of the TSI that apply to them. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quality management system documentation shall permit a consistent interpretation of the quality programmes, plan, manuals and records.

It shall contain in particular an adequate description of:

• the quality objectives and the organisational structure,

• responsibilities and powers of the management with regard to product quality,

• the manufacturing, quality control and quality management techniques, processes and systematic actions that will be used,

• the examinations, checks and tests that will be carried out before, during and after manufacture, and the frequency with which they will be undertaken,

• the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.,

• the means to monitor the achievement of the required product quality and the effective operation of the quality management system.

3.3. The notified body assesses the quality management system to determine whether it satisfies the requirements of point 3.2. It presumes compliance with these requirements if the manufacturer implements a quality system for production, final product inspection and testing in respect of the Standard EN/ISO 9001-2000, which take into consideration the specificity of the interoperability constituent for which it is implemented.

When the manufacturer operates a certified quality management system, the notified body shall take this into account in the assessment.

The audit shall be specific for the product category, which is representative for the interoperability constituent. The auditing team shall have at least one member experienced as an assessor in the product technology concerned. The evaluation procedure shall include an inspection visit to the manufacturer's premises.

The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

3.4. The manufacturer 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.

The manufacturer or his authorised representative established within the Community shall keep the notified body that has approved the quality management system informed of any intended updating of the quality management system.

The notified body shall evaluate the modifications proposed and decide whether the amended quality management system will still satisfy the requirements of point 3.2 or whether a re-assessment is required.

It shall notify its decision to the manufacturer. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

4. Surveillance of the quality management system under the responsibility of the notified body.

4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality management system.

4.2. The manufacturer shall allow the notified body entrance for inspection purposes to the locations of manufacture, inspection and testing, and storage and shall provide it with all necessary information, in particular:

• the quality management system documentation,

• the quality records such as inspection reports and tests data, calibration data, qualification reports of the personnel concerned, etc.

4.3. The notified body shall periodically carry out audits to make sure that the manufacturer maintains and applies the quality management system and shall provide an audit report to the manufacturer.

The frequency of the audits shall be at least once a year.

When the manufacturer operate a certified quality management system, the notified body shall take this into account in the surveillance.

4.4. Additionally the notified body may pay unexpected visits to the manufacturer. During such visits the notified body may carry out, or cause to be carried out, tests to verify that the quality management system is functioning correctly, if necessary. The notified body shall provide the manufacturer with a visit report and, if a test has taken place, with a test report.

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

The other notified bodies may receive on request copies of the quality management system approvals issued.

6. The manufacturer shall, for a period of 10 years after the last product has been manufactured, keep at the disposal of the national authorities:

• the documentation referenced to in the second indent of point 3.1,

• the updating referenced to in the second paragraph of point 3.4,

• the decisions and reports from the notified body in the final paragraph of points 3.4, 4.3 and 4.4.

7. The manufacturer or his authorised representative established within the Community shall draw up the EC declaration of conformity of the interoperability constituent.

The content of this declaration shall include at least the information indicated in Annex IV (3) and in Article 13 -3 of Directive 01/16/EC. The EC declaration of conformity and the accompanying documents shall be dated and signed.

The declaration shall be written in the same language as the technical documentation and shall contain the following:

• the Directive references (Directive 01/16/EC and other directives to which the interoperability constituent may be subject),

• the name and address of the manufacturer or his authorised representative established within the Community (give trade name and full address and in the case of an authorised representative also give the trade name of the manufacturer or constructor),

• description of the interoperability constituent (make, type, etc)

• description of the procedure (module) followed in order to declare conformity,

• all of the relevant descriptions met by the interoperability constituent and in particular any conditions of use,

• name and address of notified body (bodies) involved in the procedure followed in respect of conformity and date of certificates together with the duration and conditions of validity of the certificates,

• reference to the TSI and any other applicable TSI and where appropriate reference to European specification(6),

• identification of the signatory empowered to enter into commitments on behalf of the manufacturer or of his authorised representative established within the Community.

The certificates to be referred to are:

• the quality management system approval indicated in point 3,

• the type-examination certificate and its additions,

8. The manufacturer or his authorised representative established within the Community shall keep a copy of the EC declaration of conformity for a period of 10 years after the last interoperability constituent has been manufactured.

Where neither the manufacturer nor his authorised representative is established within the Community, the obligation to keep the technical documentation available is the responsibility of the person who places the interoperability constituent on the Community market.

9. If additional to the EC declaration of conformity an EC declaration of suitability for use for the interoperability constituent is requested in the TSI, this declaration has to be added, after being issued by the manufacturer under the conditions of Module V.

F.2.6. Module F: Product Verification

1. This module describes the procedure whereby a manufacturer or his authorised representative established within the Community checks and attests that the interoperability constituent concerned and subject to the provisions of point 3 is in conformity with the type as described in the EC type examination certificate and satisfies the requirements of the TSI that apply to it.

2. The manufacturer shall take all measures necessary in order that the manufacturing process ensures conformity of each interoperability constituent with the type as described in the type-examination certificate and with the requirements of the TSI that apply to it.

3. The notified body shall carry out the appropriate examinations and tests in order to check the conformity of the interoperability constituent with the type as described in the EC type examination certificate and with the requirements of the TSI. The manufacturer(7) can choose either an examination and testing of every interoperability constituent as specified in point 4 or an examination and testing of interoperability constituents on a statistical basis, as specified in point 5.

4. Verification by examination and testing of every interoperability constituent

4.1. Each product shall be individually examined and appropriate tests shall be carried out in order to verify the product conformity with the type as described in the type-examination certificate and with the requirements of the TSI that apply to it. When a test is not set out in the TSI, (or in an European Standard quoted in the TSI), the relevant European Specifications(8), or equivalent tests are applicable.

4.2. The notified body shall draw up a written certificate of conformity for the approved products relating to the tests carried out.

4.3. The manufacturer or his authorised representative shall ensure that he is able to supply the notified body's certificates of conformity on request.

5. Statistical verification

5.1. The manufacturer shall present his interoperability constituents in the form of homogeneous lots and shall take all measures necessary in order that the manufacturing process ensures the homogeneity of each lot produced.

5.2. All interoperability constituents shall be available for verification in the form of homogeneous lots. A random sample shall be drawn from each lot. Each interoperability constituents in a sample shall be individually examined and appropriate tests shall be carried out to ensure the product conformity with the type as described in the type-examination certificate and with the requirements of the TSI which apply to it and to determine whether the lot is accepted or rejected. When a test is not set out in the TSI (or in an European Standard quoted in the TSI), the relevant European Specifications or equivalent tests are applicable.

5.3. The statistical procedure shall use appropriate elements (statistical method, sampling plan etc), depending on the characteristics to be assessed, as specified in the TSI.

5.4. In the case of accepted lots, the notified body shall draw up a written certificate of conformity relating to the tests carried out. All interoperability constituents in the lot may be placed on the market except those interoperability constituents from the sample, which were found not to be in conformity.

If a lot is rejected, the notified body or the competent authority shall take appropriate measures to prevent placing of that lot on the market. In the event of frequent rejection of lots the notified body shall suspend the statistical verification.

5.5. The manufacturer or his authorised representative established within the Community shall ensure that he is able to supply the notified body's certificates of conformity on request.

6. The manufacturer or his authorised representative established within the Community shall draw up the EC declaration of conformity of the interoperability constituent.

The content of this declaration shall include at least the information indicated in Annex IV (3) and in Article 13 -3 of Directive 01/16/EC. The EC declaration of conformity and the accompanying documents shall be dated and signed.

The declaration shall be written in the same language as the technical documentation and shall contain the following:

• the Directive references (Directive 01/16/EC and other directives to which the interoperability constituent may be subject),

• the name and address of the manufacturer or his authorised representative established within the Community (give trade name and full address and in the case of an authorised representative also give the trade name of the manufacturer or constructor),

• description of interoperability constituent (make, type, etc)

• description of the procedure (module) followed in order to declare conformity,

• all of the relevant descriptions met by the interoperability constituent and in particular any conditions of use,

• name and address of notified body (bodies) involved in the procedure followed in respect of conformity and date of certificates together with the duration and conditions of validity of the certificates,

• reference to the TSI and any other applicable TSI and where appropriate reference to European specifications,

• identification of the signatory empowered to enter into commitments on behalf of the manufacturer or of his authorised representative established within the Community.

The certificates to be referred to are:

• the type-examination certificate and its additions,

• the certificate of conformity as mentioned in points 4 or 5.

7. The manufacturer or his authorised representative established within the Community shall keep a copy of the EC declaration of conformity for a period of 10 years after the last interoperability constituent has been manufactured.

Where neither the manufacturer nor his authorised representative is established within the Community, the obligation to keep the technical documentation available is the responsibility of the person who places the interoperability constituent on the Community market.

8. If additional to the EC declaration of conformity an EC declaration of suitability for use for the interoperability constituent is requested in the TSI, this declaration has to be added, after being issued by the manufacturer under the conditions of Module V.

F.2.7. Module H1: Full Quality Management System

1. This module describes the procedure whereby the manufacturer or his authorised representative established within the Community who satisfies the obligations of point 2, ensures and declares that the interoperability constituent concerned satisfies the requirements of the TSI that apply to it.

2. The manufacturer shall operate an approved quality management system for design, production and final product inspection and testing as specified in point 3 and shall be subject to surveillance as specified in point 4.

3. Quality management system

3.1. The manufacturer shall lodge an application for assessment of his quality management system with a notified body of his choice, for the interoperability constituents concerned.

The application shall include:

• all relevant information for the product category representative for the interoperability constituent envisaged,

• the quality management system's documentation.

• a written declaration that the same application has not been lodged with any other notified body,

3.2. The quality management system shall ensure compliance of the interoperability constituent with the requirements of the TSI that apply to it. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality management system documentation shall ensure a common understanding of the quality policies and procedures such as quality programmes, plans, manuals and records.

It shall contain in particular an adequate description of:

• the quality objectives and the organisational structure,

• responsibilities and powers of the management with regard to design and product quality,

• the technical design specifications, including European specifications(9), that will be applied, and, where the European specifications will not be applied in full, the means that will be used to ensure that the requirements of the TSI that apply to the interoperability constituent will be met,

• the design control and design verification techniques, processes and systematic actions that will be used when designing the interoperability constituents pertaining to the product category covered,

• the corresponding manufacturing, quality control and quality management system techniques, processes and systematic actions that will be used,

• the examinations, checks and tests that will be carried out before, during and after manufacture, and the frequency with which they will be undertaken,

• the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.,

• the means to monitor the achievement of the required design and product quality and the effective operation of the quality management system.

The quality policies and procedures shall cover in particular the assessment phases as design review, review of manufacturing process and type tests, as they are specified in the TSI, for the different characteristics and performances of the interoperability constituent.

3.3. The notified body shall assess the quality management system to determine whether it satisfies the requirements of point 3.2. It presumes compliance with these requirements if the manufacturer implements a quality system for design, production, final product inspection and testing in respect of the Standard EN/ISO 9001-2000, which take into consideration the specificity of the interoperability constituent for which it is implemented.

When the manufacturer operates a certified quality management system, the notified body shall take this into account in the assessment.

The audit shall be specific for the product category, which is representative for the interoperability constituent. The auditing team shall have at least one member experienced as an assessor in the product technology concerned. The evaluation procedure shall include an assessment visit to the manufacturer's premises.

The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

3.4. The manufacturer 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.

The manufacturer or his authorised representative established within the Community shall keep the notified body that has approved the quality management system informed of any intended updating of the quality management system.

The notified body shall evaluate the modifications proposed and decide whether the amended quality management system will still satisfy the requirements of point 3.2 or whether a re-assessment is required.

It shall notify its decision to the manufacturer. The notification shall contain the conclusions of the evaluation and the reasoned assessment decision.

4. Surveillance of the quality management system under the responsibility of the notified body

4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality management system.

4.2. The manufacturer shall allow the notified body entrance for inspection purposes to the locations of design, manufacture, inspection and testing, and storage, and shall provide it with all necessary information, including particular:

• the quality management system documentation,

• the quality records as foreseen by the design part of the quality management system, such as results of analyses, calculations, tests, etc.,

• the quality records as foreseen by the manufacturing part of the quality management system, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.

4.3. The notified body shall periodically carry out audits to make sure that the manufacturer maintains and applies the quality management system and shall provide an audit report to the manufacturer. When the manufacturer operates a certified quality management system, the notified body shall take this into account in the surveillance.

The frequency of the audits shall be at least once a year.

4.4. Additionally the notified body may pay unexpected visits to the manufacturer. At the time of such visits, the notified body may carry out tests or have them carried out in order to check the proper functioning of the quality management system where necessary. It shall provide the manufacturer with a visit report and, if a test has been carried out, with a test report.

5. The manufacturer shall, for a period of 10 years after the last product has been manufactured, keep at the disposal of the national authorities:

• the documentation referenced to in the second indent of the second subparagraph of point 3.1,

• the updating referenced in the second subparagraph of point 3.4,

• the decisions and reports from the notified body in the final subparagraph of points 3.4, 4.3 and 4.4.

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

The other notified bodies may receive on request copies of the quality management system approvals and additional approvals issued.

7. The manufacturer or its authorised representative established within the Community shall draw up the EC Declaration of conformity of the interoperability constituent.

The content of this declaration shall include at least the information indicated in Annex IV (3) and in Article 13 -3 of Directive 01/16/EC. The EC declaration of conformity and the accompanying documents shall be dated and signed.

The declaration shall be written in the same language as the technical documentation and shall contain the following:

• the Directive references (Directive 01/16/EC and other directives to which the interoperability constituent may be subject)

• the name and address of the manufacturer or his authorised representative established within the Community (give trade name and full address and in the case of an authorised representative also give the trade name of the manufacturer or constructor),

• description of interoperability constituent (make, type, etc)

• description of the procedure (module) followed in order to declare conformity,

• all of the relevant descriptions met by the interoperability constituent and in particular its conditions of use,

• name and address of notified body (bodies) involved in the procedure followed in respect of conformity, and date of certificate together with the duration and conditions of validity of the certificate,

• reference to the TSI and to any other applicable TSI and where appropriate to European specifications,

• identification of the signatory empowered to enter into commitments on behalf of the manufacturer or of his authorised representative established within the Community.

The certificate to be referred to is:

• the Quality management system approvals indicated in point 3.

8. The manufacturer or his authorised representative established within the Community shall keep a copy of the EC declaration of conformity for a period of 10 years after the last interoperability constituent has been manufactured.

Where neither the manufacturer nor his authorised representative is established within the Community, the obligation to keep the technical documentation available is the responsibility of the person who places the interoperability constituent on the Community market.

9. If additional to the EC declaration of conformity an EC declaration of suitability for use for the interoperability constituent is requested in the TSI, this declaration has to be added, after being issued by the manufacturer under the conditions of Module V.

F.2.8. Module H2: Full Quality Management System With Design Examination

1. This module describes the procedure whereby a notified body carries out an examination of the design of an interoperability constituent and the manufacturer or his authorised representative established within the Community who satisfies the obligations of point 2 ensures and declares that the interoperability constituent concerned satisfies the requirements of the TSI that apply to it.

2. The manufacturer shall operate an approved quality management system for design, production and final product inspection and testing as specified in point 3 and shall be subject to surveillance as specified in point 4.

3. Quality management system

3.1. The manufacturer shall lodge an application for assessment of his quality management system with a notified body of his choice, for the interoperability constituents concerned.

The application shall include:

• all relevant information for the product category representative for the interoperability constituent envisaged,

• the quality management system's documentation.

• a written declaration that the same application has not been lodged with any other notified body,

3.2. The quality management system shall ensure compliance of the interoperability constituent with the requirements of the TSI that apply to it. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality management system documentation shall ensure a common understanding of the quality policies and procedures such as quality programmes, plans, manuals and records.

It shall contain in particular an adequate description of:

• the quality objectives and the organisational structure,

• responsibilities and powers of the management with regard to design and product quality,

• the technical design specifications, including European specifications(10), that will be applied, and, where the European specifications will not be applied in full, the means that will be used to ensure that the requirements of the TSI that apply to the interoperability constituent will be met,

• the design control and design verification techniques, processes and systematic actions that will be used when designing the interoperability constituents pertaining to the product category covered,

• the corresponding manufacturing, quality control and quality management system techniques, processes and systematic actions that will be used,

• the examinations, checks and tests that will be carried out before, during and after manufacture, and the frequency with which they will be undertaken,

• the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.,

• the means to monitor the achievement of the required design and product quality and the effective operation of the quality management system.

The quality policies and procedures shall cover in particular the assessment phases, such as design review, review of manufacturing processes and type tests, as they are specified in the TSI, for different characteristics and performances of the interoperability constituent.

3.3. The notified body shall assess the quality management system to determine whether it satisfies the requirements of point 3.2. It presumes compliance with these requirements if the manufacturer 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 interoperability constituent for which it is implemented.

When the manufacturer operates a certified quality management system, the notified body shall take this into account in the assessment.

The audit shall be specific for the product category, which is representative for the interoperability constituent. The auditing team shall have at least one member experienced as an assessor in the product technology concerned. The evaluation procedure shall include an assessment visit to the manufacturer's premises.

The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision.

3.4. The manufacturer 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.

The manufacturer or his authorised representative established within the Community shall keep the notified body that has approved the quality management system informed of any intended updating of the quality management system.

The notified body shall evaluate the modifications proposed and decide whether the amended quality management system will still satisfy the requirements of point 3.2 or whether a re-assessment is required.

It shall notify its decision to the manufacturer. The notification shall contain the conclusions of the evaluation and the reasoned assessment decision.

4. Surveillance of the quality management system under the responsibility of the notified body

4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality management system.

4.2. The manufacturer shall allow the notified body entrance for inspection purposes to the locations of design, manufacture, inspection and testing, and storage, and shall provide it with all necessary information, including:

• the quality management system documentation,

• the quality records as foreseen by the design part of the quality management system, such as results of analyses, calculations, tests, etc.,

• the quality records as foreseen by the manufacturing part of the quality management system, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.

4.3. The notified body shall periodically carry out audits to make sure that the manufacturer maintains and applies the quality management system and shall provide an audit report to the manufacturer. When the manufacturer operates a certified quality management system, the notified body shall take this into account in the surveillance.

The frequency of the audits shall be at least once a year.

4.4. Additionally the notified body may pay unexpected visits to the manufacturer. At the time of such visits, the notified body may carry out tests or have them carried out in order to check the proper functioning of the quality management system where necessary. It shall provide the manufacturer with a visit report and, if a test has been carried out, with a test report.

5. The manufacturer shall, for a period of 10 years after the last product has been manufactured, keep at the disposal of the national authorities:

• the documentation referenced in the second indent of the second subparagraph of point 3.1,

• the updating referenced to in the second subparagraph of point 3.4,

• the decisions and reports from the notified body in the final subparagraph of points 3.4, 4.3 and 4.4.

6. Design examination

6.1. The manufacturer shall lodge an application for examination of the design of the interoperability constituent with a notified body of his choice

6.2. The application shall enable the design, manufacture, maintenance and operation of the interoperability constituent to be understood, and shall enable conformity with the requirements of the TSI to be assessed.

It shall include:

• a general type-description,

• the technical design specifications, including European specifications, with relevant clauses, that have been applied in full or in part,

• any necessary supporting evidence for their adequacy, in particular where the European specifications and the relevant clauses have not been applied.,

• the test programme

• conditions for integration of the interoperability constituent in its system environment (sub-assembly, assembly, subsystem) and the necessary interface conditions,

• conditions for use and maintenance of the interoperability constituent (restrictions of running time or distance, wear limits etc),

• a written declaration that the same application has not been lodged with any other notified body,

6.3. The applicant shall present the results of tests(11), including type tests when required, carried out by its appropriate laboratory or on their behalf.

6.4. The notified body shall examine the application and assess the results of the tests. Where the design meets the provisions of the TSI that apply to it, the notified body shall issue an EC design examination certificate to the applicant. The certificate shall contain the conclusions of the examination, conditions for its validity, the necessary data for identification of the approved design and, if relevant, a description of the product's functioning.

The time period of validity shall be no longer than 5 years.

6.5. The applicant shall keep the notified body that has issued the EC design examination certificate informed of all modifications to the approved design, which may affect the conformity with the requirements of the TSI or the prescribed conditions for use of the interoperability constituent. In such cases the interoperability constituent shall receive additional approval from the notified body that issued the EC design examination certificate. In this case, the notified body shall perform only those examinations and tests that are relevant and necessary to the changes. The additional approval shall be given in the form of an addition to the original EC design examination certificate.

6.6. If no modifications as in point 6.4. have been made, the validity of an expiring certificate can be extended for another period of validity. The applicant will apply for such a prolongation by a written confirmation that no such modifications have been made, and the notified body issues a prolongation for another period of validity as in point 6.3. if no contrary information exists. This procedure can be reiterated.

7. 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.

The other notified bodies may receive on request copies of:

• the quality management system approvals and additional approvals issued and

• the EC design examination certificates and additions issued.

8. The manufacturer or his authorised representative established within the Community shall draw up the EC declaration of conformity of the interoperability constituent.

The content of this declaration shall include at least the information indicated in Annex IV (3) and in Article 13 -3 of Directive 01/16/EC. The EC declaration of conformity and its accompanying documents shall be dated and signed.

The declaration shall be written in the same language as the technical documentation and shall contain the following:

• the Directive references (Directive 01/16/EC and other directives to which the interoperability constituent may be subject),

• the name and address of the manufacturer or his authorised representative established within the Community (give trade name and full address and in the case of an authorised representative also give the trade name of the manufacturer or constructor),

• description of interoperability constituent (make, type, etc)

• description of the procedure (module) followed in order to declare conformity,

• all of the relevant descriptions met by the interoperability constituent and in particular any conditions of use,

• name and address of notified body (bodies) involved in the procedure followed in respect of conformity and date of certificates together with the duration and conditions of validity of the certificates,

• reference to the TSI and any other applicable TSI and where appropriate to European specifications,

• identification of the signatory empowered to enter into commitments on behalf of the manufacturer or of his authorised representative established within the Community.

The certificates to be referred to are:

• the quality management system approval and surveillance reports indicated in point 3 and 4,

• the EC design examination certificate and its additions.

9. The manufacturer or his authorised representative established within the Community shall keep a copy of the EC declaration of conformity for a period of 10 years after the last interoperability constituent has been manufactured.

Where neither the manufacturer nor his authorised representative is established within the Community, the obligation to keep the technical documentation available is the responsibility of the person who places the interoperability constituent on the Community market.

10. If additional to the EC declaration of conformity an EC declaration of suitability for use for the interoperability constituent is requested in the TSI, this declaration has to be added, after being issued by the manufacturer under the conditions of Module V.

F.2.9. Module V: Type-Validation By In Service Experience (Suitability For Use)

1. This module describes that part of the procedure by which a notified body ascertains and attests that a specimen, representative of the production envisaged, meets the provisions of the TSI that apply to it for suitability for use, by type validation as demonstrated through in service experience(12).

2. The manufacturer, or his authorised representative established within the Community, shall lodge the application for the type-validation by in service experience with a notified body of his choice.

The application shall include:

• the name and address of the manufacturer and also, if the application is lodged by the authorised representative, his name and address,

• a written declaration that the same application has not been lodged with any other notified body,

• the technical documentation, as described in point 3,

• the programme for validation by in service experience, as described in point 4,

• the name and address of the company(ies) (infrastructure managers and/or railway enterprises), with which the applicant has obtained an agreement to contribute to a suitability for use assessment by in service experience

• by operating the interoperability constituent in service,

• by monitoring the in service behaviour and

• by issuing a report about in service experience,

• the name and the address of the company undertaking the maintenance of the interoperability constituent during the time period or running distance required for in service experience,

• an EC declaration of conformity for the interoperability constituent and,

• if module B is required in the TSI, an EC type examination certificate,

• if module H2 is required in the TSI, an EC design examination certificate.

The applicant shall place at the disposal of the company(ies), undertaking the operation of the interoperability constituent in service a specimen or a sufficient number of specimens, representative of the production envisaged and hereinafter called ‘type’. A type may cover several versions of the interoperability constituent provided that the differences between the versions are all covered by EC declarations of conformity and certificates as mentioned above.

The notified body may request further specimens if needed for carrying out the validation by in service experience to be put in service.

3. The technical documentation shall enable the assessment of the product with the requirements of the TSI. The documentation shall cover the operation of the interoperability constituent, and, as far as relevant for such assessment, cover also the design, manufacture and maintenance.

The technical documentation shall contain

• a general type-description,

• the technical specification, against which the performance and in service behaviour of the interoperability constituent is to be assessed (relevant TSI and/or European Specifications with relevant clauses),

• conditions of integration of the interoperability constituent in its system environment (sub-assembly, assembly, subsystem) and the necessary interface conditions,

• conditions for use and maintenance of the interoperability constituent (restrictions of running time or distance, wear limits etc),

• descriptions and explanations necessary for the understanding of the design, manufacture and operation of the interoperability constituent;

and, as far as is relevant for assessment,

• conceptual design and manufacturing drawings,

• results of design calculations made and examinations carried out,

• test reports.

If the TSI requires further information for the technical documentation, this shall be included.

A list of the European specifications referenced to in the technical documentation, applied in full or in part, shall be attached.

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

• the required performance or behaviour in service of the interoperability constituent under trial,

• the installation arrangements,

• the duration of the programme — either time or distance -

• the operating conditions and the service programme expected,

• the maintenance programme,

• the special in service tests, if any, to be performed,

• the batch size of the specimens — if more than one,

• the inspection programme (nature, number and frequency of inspections, documentation),

• criteria for tolerable defects and their impact on the programme,

• the information to be included in the report of the company operating the interoperability constituent in service (see point 2).

5. The notified body shall:

5.1. Examine the technical documentation and the programme for validation by in service experience,

5.2. Verify that the type is representative and has been manufactured in conformity with the technical documentation,

5.3. Verify that the programme for validation by in service experience is well adapted to assess the required performance and in service behaviour of the interoperability constituent,

5.4. Agree with the applicant the programme and the location where the inspections and necessary tests will be carried out and the body performing the tests (notified body or other competent laboratory),

5.5. Monitor and inspect the progress of in service running, operation and maintenance of the interoperability constituent,

5.6. Evaluate the report, to be issued by the company (ies) (infrastructure managers and/or railway enterprises) operating the interoperability constituent, and all other documentation and information, gained during the procedure (test reports, maintenance experience etc),

5.7. Assess, if the in service behaviour meets the requirements of the TSI.

6. Where the type meets the provisions of the TSI, the notified body shall issue a suitability for use certificate to the applicant. The certificate shall contain the name and address of the manufacturer, conclusions of the validation, conditions for its validity and the necessary data for identification of the approved type.

The time period of validity shall be no longer than 5 years.

A list of the relevant parts of the technical documentation shall be annexed to the certificate and a copy kept by the notified body.

If the applicant is denied a suitability for use certificate, the notified body shall provide detailed reasons for such denial.

Provision shall be made for an appeals procedure.

7. The applicant shall inform the notified body that holds the technical documentation concerning the suitability for use certificate of all modifications to the approved product which shall receive additional approval where such changes may affect the suitability for use or the prescribed conditions for use of the product. In this case, the notified body shall perform only those examinations and tests, that are relevant and necessary to the changes. The additional approval shall be given in the form of an addition to the original suitability for use certificate, or by issue of a new certificate issued after withdrawal of the old certificate.

8. If no modifications as in point 7 have been made, the validity of an expiring certificate can be extended for another period of validity. The applicant will apply for such a prolongation by a written confirmation that no such modifications have been made, and the notified body issues a prolongation for another period of validity as in point 6, if no contrary information exists. This procedure can be reiterated.

9. Each notified body shall communicate to the other notified bodies the relevant information concerning the suitability for use certificates issued, withdrawn or refused.

10. The other notified bodies shall be provided on request with copies of the suitability for use certificates issued and/or their additions. The annexes to the certificates shall be kept at the disposal of the other notified bodies.

11. The manufacturer or his authorised representative established within the Community shall draw up the EC declaration of suitability for use of the interoperability constituent.

The content of this declaration shall include at least the information, indicated in Annex IV (3) and in Article 13 -3 of Directive 01/16/EC. The EC declaration of suitability for use and the accompanying documents shall be dated and signed.

The declaration shall be written in the same language as the technical documentation and shall contain the following:

• the Directive references (Directive 01/16/EC),

• the name and address of the manufacturer or his authorised representative established within the Community (give trade name and full address and in the case of an authorised representative also give the trade name of the manufacturer or constructor),

• description of interoperability constituent (make, type, etc)

• all of the relevant descriptions met by the interoperability constituent and in particular any conditions of use,

• name and address of notified body (bodies) involved in the procedure followed in respect of suitability for use and date of suitability for use certificate together with the duration and conditions of validity of the certificate,

• reference to this TSI and to any other applicable TSI, and where appropriate reference to European specification,

• identification of the signatory empowered to enter into commitments on behalf of the manufacturer or of his authorised representative established within the Community.

12. The manufacturer or his authorised representative established within the Community shall keep a copy of the EC declaration of suitability for use for a period of 10 years after the last interoperability constituent has been manufactured.

Where neither the manufacturer nor his authorised representative is established within the Community, the obligation to keep the technical documentation available is the responsibility of the person who places the interoperability constituent on the Community market.

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 or rolling stock subsystem, representative of the production envisaged,

• complies with this TSI and any other applicable TSI, which demonstrate that the essential requirements(13) of Directive 01/16/EC have been met

• complies with the other regulations deriving from the Treaty.

The type examination defined by this module could include specific assessment phases — design review, type test or review of manufacturing process, which are specified in the relevant TSI.

2. The contracting entity(14) shall lodge an application for EC verification (through type examination) of the subsystem with a notified body of his choice.

The application shall include:

• name and address of the contracting entity or its authorised representative

• the technical documentation, as described in point 3.

3. The applicant shall place at the disposal of the notified body a specimen of the subsystem(15), representative of the production envisaged and hereinafter called ‘type’.

A type may cover several versions of the subsystem provided that the differences between the versions do not affect the provisions of the TSI.

The notified body may request further specimens if needed for carrying out the test programme.

If so required for specific test or examination methods and specified in the TSI or in the European specification(16) referenced to in the TSI, a specimen or specimens of a subassembly or assembly or a specimen of the subsystem in a pre-assembled condition shall to be provided.

The technical documentation and specimen(s) shall enable the design, manufacture, installation, maintenance and operation of the subsystem to be understood, and shall enable conformity with the provisions of the TSI to be assessed.

The technical documentation shall include:

• a general description of the subsystem, overall design and structure,

• the infrastructure or rolling stock register, including all information as specified in the TSI

• conceptual design and manufacturing information, for example drawings, schemes of components, subassemblies, assemblies, circuits, etc.,

• descriptions and explanations necessary for the understanding of the design and manufacturing information, the maintenance and the operation of the subsystem,

• the technical specifications, including European specifications, that have been applied,

• any necessary supporting evidence for the use of the above specifications, in particular where European specifications and the relevant clauses have not been applied in full,

• a list of the interoperability constituents to be incorporated into the subsystem,

• copies of the EC declarations of conformity or suitability for use of interoperability constituents and all the necessary elements defined in annex VI of the directives,

• evidence of conformity with the other regulations deriving from the treaty (including certificates)

• technical documentation regarding the manufacture and the assembly of the subsystem,

• a list of manufacturers, involved in the subsystem's design, manufacturing, assembly and installation,

• conditions for use of the subsystem (restrictions of running time or distance, wear limits etc),

• conditions for maintenance and technical documentation regarding the maintenance of the subsystem

• any technical requirement that shall be taken into account during production, maintenance or operation of the subsystem

• results of design calculations made, examinations carried out, etc.,

• test reports.

If the TSI requires further information for the technical documentation, this shall be included.

4. The notified body shall:

4.1. Examine the technical documentation,

4.2. Verify that the specimen(s) of the subsystem or of assemblies or subassemblies of the subsystem, has (have) been manufactured in conformity with the technical documentation, and carry out or have carried out the type tests in accordance with the provisions of the TSI and the appropriate European specifications. Such manufacture shall be verified using an appropriate assessment module.

4.3. Where a design review is requested in the TSI, perform an examination of the design methods, the design tools and the design results to evaluate their capability to fulfil the requirements for conformity for the subsystem at the completion of the design process

4.4. 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;

4.5. Perform or have performed the appropriate examinations and necessary tests in accordance with points 4.2. and 4.3 to establish where the relevant European specifications have been chosen, these have actually been applied;

4.6. Perform or have performed the appropriate examinations and necessary tests in accordance with point 4.2. and 4.3. to establish whether the solutions adopted meet the requirements of the TSI when the appropriate European specifications have not been applied.

4.7. Agree with the applicant the location where the examinations and necessary tests will be carried out.

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.

A list of the relevant parts of the technical documentation shall be annexed to the certificate and a copy kept by the notified body.

If the contracting entity is denied a type-examination certificate, the notified body shall provide detailed reasons for such denial.

Provision shall be made for an appeals procedure.

6. Each notified body shall communicate to the other notified bodies the relevant information concerning the type-examination certificates issued, withdrawn or refused

7. The other notified bodies may receive on request copies of the type-examination certificates issued and/or their additions. The annexes to the certificates shall be kept at the disposal of the other notified bodies.

8. The contracting entity shall keep with the technical documentation copies of type-examination certificates and any additions throughout the service life of the subsystem. It shall be sent to any member state which so requests.

9. During the production phase, the applicant shall inform the notified body that holds the technical documentation concerning the type-examination certificate of all modifications which may affect the conformity with the requirements of the TSI or the prescribed conditions for use of the subsystem. The subsystem shall receive additional approval in such cases. In this case, the notified body shall perform only those examinations and tests, those are relevant and necessary to the changes. This additional approval may be given either in the form of an addition to the original type-examination certificate, or by issue of a new certificate after withdrawal of the old certificate.

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 or rolling stock subsystem, for which already a type-examination certificate has been issued by a notified body,

• complies with this TSI and any other applicable TSI, which demonstrate that the essential requirements(17) of Directive 01/16/EC have been met

• complies with the other regulations deriving from the Treaty,

and may be placed in service.

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

• the type examination certificate issued prior to the assessment remains valid for the subsystem subject to the application,

• the contracting entity(18) and the main contractor involved are satisfying the obligations of point 3.

The ‘main contractor’ refers to companies, whose activities contribute to fulfil the essential requirements of the TSI. It concerns:

• the company responsible for the whole subsystem project (including in particular responsibility for subsystem integration),

• other companies only involved in a part of the subsystem project, (performing for example assembly or installation of the subsystem).

It does not refer to manufacturer sub contractors supplying components and interoperability constituents.

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.

When the contracting entity itself is responsible for the whole subsystem project (including in particular responsibility for subsystem integration), or the contracting entity is directly involved in the production (including assembly and installation), it has to operate an approved quality management system for those activities, which shall be subject to surveillance as specified in point 6.

If a main contractor is responsible for the whole subsystem project (including in particular responsibility for subsystem integration), it shall operate in any case an approved quality management system for manufacture and final product inspection and testing, which shall be subject to surveillance as specified in point 6.

4. EC verification procedure

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.

The application shall enable the design, manufacture, assembly, 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.

4.2. The application shall include:

• name and address of the contracting entity or its authorised representative

• the technical documentation regarding the approved type, including the type examination certificate, as issued after completion of the procedure defined in module SB,

and, if not included in this documentation,

• a general description of the subsystem, its overall design and structure,

• the technical specifications, including European specifications(19), that have been applied,

• any necessary supporting evidence for the use of the above specifications, in particular where these European specifications, and the relevant clauses have not been applied in full. This supporting evidence shall include the results of tests carried out by the appropriate laboratory of the manufacturer or on his behalf.

• the infrastructure or rolling stock register, including all information as specified in the TSI,

• the technical documentation regarding the manufacture and the assembly of the subsystem,

• evidence of conformity to other regulations deriving from the treaty (including certificates) for the production phase

• a list of the interoperability constituents to be incorporated into the subsystem,

• copies of the EC declarations of conformity or suitability for use with which the constituents shall be provided, and all the necessary elements defined in annex VI of the directives,

• a list of manufacturers, involved in the subsystem's design, manufacturing, assembly and installation,

• the demonstration, that all stages, as mentioned under point 5.2, are covered by quality management systems of the contracting entity, if involved, and/or of the main contractor, and the evidence of their effectiveness,

• indication of the notified body, responsible for the approval and surveillance of these quality management systems.

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

If the notified body considers the type examination certificate no longer remains valid or is not appropriate and that a new type examination is necessary, it shall justify its decision.

5. 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.

The application shall include:

• all relevant information for the subsystem envisaged,

• the quality management system documentation.

• the technical documentation of the approved type and a copy of the type examination certificate, issued after the completion of the type examination procedure of module SB.

For those only involved in a part of the subsystem project, the information to be provided is only that for the relevant part.

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.

All the elements, requirements and provisions adopted by the applicant(s) shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality management system documentation shall ensure a common understanding of the quality policies and procedures such as quality programmes, plans, manuals and records.

It shall contain in particular an adequate description of the following items for all applicant(s):

• the quality objectives and the organisational structure,

• the corresponding manufacturing, quality control and quality management techniques, processes and systematic actions that will be used,

• the examinations, checks and tests that will be carried out before, during and after manufacture, assembly and installation, and the frequency with which they will be carried out,

• the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.,

and also for the contracting entity or the main contractor responsible for the whole subsystem project:

• responsibilities and powers of the management with regard to overall subsystem quality, including in particular the subsystem integration management.

The examinations, tests and checking shall cover all of the following stages:

• structure of subsystem, including, in particular, civil-engineering activities, constituent assembly, final adjustment,

• final testing of the subsystem,

• and, where specified in the TSI, the validation under full operation conditions.

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)(20).

If the conformity of the subsystem with the type as described in the type-examination certificate and the compliance of the subsystem with the requirements of the TSI is based on more than one quality management system, the notified body shall examine in particular,

• if the relations and interfaces between the quality management systems are clearly documented

• and if overall responsibilities and powers of the management for the compliance of the whole entire subsystem for the main contractor are sufficiently and properly defined.

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.

When an applicant operates a certified quality management system, the notified body shall take this into account in the assessment.

The audit shall be specific for the subsystem concerned, taking into consideration the specific contribution of the applicant to the subsystem. The auditing team shall have at least one member experienced as an assessor in the subsystem technology concerned. The evaluation procedure shall include an assessment visit to the applicant's premises.

The decision shall be notified to the applicant. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

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.

They shall keep the notified body that has approved the quality management system, informed of any significant change that will affect the fulfilment of the TSI requirements by the subsystem.

The notified body shall evaluate the modifications proposed and decide whether the amended quality management system will still satisfy the requirements referenced in point 5.2 or whether a re-assessment is required.

lt shall notify its decision to the applicant. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

6. Surveillance of the quality management system(s) under the responsibility of the notified body

6.1. The purpose of surveillance is to make sure that the contracting entity, if involved, and the main contractor, duly fulfil the obligations arising out of the approved quality management system(s).

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:

• the quality management system documentation, including the particular means implemented to ensure that:

• for the contracting entity or main contractor, responsible for the whole subsystem project,

overall responsibilities and powers of the management for the compliance of the whole entire subsystem are sufficiently and properly defined,

• for each applicant,

the quality management system is correctly managed for achieving integration at subsystem level,

• the quality records as foreseen by the manufacturing part (including assembly and installation) of the quality management system, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.

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.

The frequency of the audits shall be at least once a year, with at least one audit during the time period of performing relevant activities (manufacture, assembly or installation) of the subsystem being the subject of the EC verification procedure mentioned under point 8.

6.4. Additionally the notified body may pay unexpected visits to the relevant sites of the applicant(s). At the time of such visits, the notified body may conduct complete or partial audits and may carry out or cause to be carried out tests, in order to check the proper functioning of the quality management system where necessary. It shall provide the applicant(s) with an inspection report and also, audit and/or test reports, as appropriate.

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:

• to be ensured that correct management of interfaces between the different quality management systems relating to subsystem integration has been performed,

• to collect, in liaison with the contracting entity, the necessary elements for the assessment to guarantee the consistency and the overall supervision of the different quality management systems.

This co ordination includes the rights of the notified body:

• to receive all documentation (approval and surveillance), issued by the other notified bodies,

• to witness the surveillance audits in point 6.3,

• to initiate additional audits as in point 6.4 under its responsibility and together with the other notified bodies.

7. The notified body as referenced in point 5.1. shall have entrance for inspection purposes, audit and surveillance to the locations of building sites, production workshops, locations of assembly and installations, storage areas and where appropriate, prefabrication and testing facilities and, more general, to all premises which it considers necessary in order to carry out its tasks, in accordance with the applicant's specific contribution to the subsystem project.

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:

• the documentation referenced in the second indent of the second subparagraph of point 5.1,

• the updating referenced in the second subparagraph of point 5.5,

• the decisions and reports from the notified body, which are, referenced in points 5.4, 5.5 and 6.4.

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.

The EC declaration of verification and the accompanying documents shall be dated and signed. The declaration shall be written in the same language of the technical file and shall contain at least the information included in Annex V of the Directive.

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:

• all necessary documents relating to the characteristics of the subsystem,

• a list of interoperability constituents incorporated into the subsystem,

• copies of the EC declarations of conformity and, where appropriate, of the EC declarations of suitability for use, which said constituents shall be provided in accordance with Article 13 of the Directive, accompanied, where appropriate, by the corresponding documents (certificates, quality management system approvals and surveillance documents) issued by the notified bodies,

• all elements relating to the maintenance, the conditions and limits for use of the subsystem,

• all elements relating to the instructions concerning servicing, constant or routine monitoring, adjustment and maintenance,

• the type-examination certificate for the subsystem and the accompanying technical documentation as defined in the module SB,

• evidence of conformity with other regulations deriving from the treaty (including certificates)

• certificate of conformity of the notified body as mentioned under point 9, accompanied by corresponding verification and/or calculation notes and countersigned by itself, stating that the project complies with the Directive and the TSI, and mentioning, where appropriate, reservations recorded during performance of the activities and not withdrawn. The certificate should also be accompanied by the inspection and audit reports drawn up in connection with the verification, as mentioned in points 6.3 and 6.4 and in particular:

• the infrastructure or rolling stock register, including all information as specified in the TSI.

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

The other notified bodies may receive on request copies of the quality management system approvals issued.

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

The contracting entity within the Community shall keep a copy of the technical file throughout the service life of the subsystem and for a further period of three years; it shall be sent to any other Member State which so requests.

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 or rolling stock subsystem, for which a type-examination certificate has already been issued by a notified body,

• complies with this TSI and any other applicable TSI, which demonstrate that the essential requirements(21) of Directive 01/16/EC have been met

• complies with the other regulations deriving from the Treaty

and may be placed into service

2. The contracting entity(22) shall lodge an application for EC verification (through product verification) of the subsystem with a notified body of his choice.

The application shall include :

• The name and address of the contracting entity or its authorised representative

• the technical documentation.

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.

The notified body shall carrying out the procedure under the condition that the type examination certificate issued prior to the assessment remains valid for the subsystem subject to the application.

4. The contracting entity shall take all measures necessary in order that the manufacturing process (including assembly and integration of interoperability constituents by main contractor(23) when employed) ensures conformity of the subsystem with the type as described in the type-examination certificate and with the requirements of the TSI that apply to it.

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.

The application shall include:

• the technical documentation regarding the approved type, including the type examination certificate, as issued after completion of the procedure defined in module SB,

and, if not included in this documentation,

• a general description of the subsystem, overall design and structure,

• the infrastructure or rolling stock register, including all information as specified in the TSI,

• conceptual design and manufacturing information, for example drawings, schemes of components, subassemblies, assemblies, circuits, etc.,

• the technical documentation regarding the manufacture and the assembly of the subsystem,

• the technical specifications, including European specifications(24), that have been applied,

• any necessary supporting evidence for the use of the above specifications, in particular where these European specifications and the relevant clauses have not been applied in full,

• evidence of conformity to other regulations deriving from the treaty (including certificates) for the production phase

• a list of the Interoperability Constituents, to be incorporated into the subsystem,

• copies of the EC declarations of conformity or suitability for use with which said constituents shall be provided and all the necessary elements defined in annex VI of the directives,

• a list of manufacturers involved in the subsystem's design, manufacture, assembly and installation,

If the TSI requires further information for the technical documentation, this shall be included.

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

If the notified body considers the type examination certificate no longer remains valid or is not appropriate and that a new type examination is necessary, it shall justify its decision.

The notified body shall carry out the appropriate examinations and tests in order to check the conformity of the subsystem with the type, as described in the type examination certificate and with the requirements of the TSI. The notified body shall examine and testing of every subsystem manufactured as a serial product, as specified in point 4

7. Verification by examination and testing of every subsystem (as a serial product)

7.1. The notified body shall carry out the tests, examinations and verifications, to ensure conformity of the subsystems, as serial products as provided for in the TSI. The examinations, tests and checking shall extend to the stages as provided for in the TSI.

7.2. Each subsystem (as serial product) shall be individually examined, tested and verified(25) in order to verify its conformity with the type as described in the type-examination certificate and the requirements of the TSI that apply to it. When a test is not set out in the TSI, (or in a European Standard quoted in the TSI), the relevant European Specifications or equivalent tests are applicable.

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.

The notified body shall have entrance for testing and verification purposes to production workshops, locations of assembly and installations, and where appropriate, prefabrication and testing facilities in order to carry out its tasks as provided for in the TSI.

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.

These NB activities shall be based on the type examination and the tests, verifications and checks carried out on all serial products as indicated in point 7 and required in the TSI and/or in the relevant European specifications.

The EC declaration of verification and the accompanying documents shall be dated and signed. The declaration shall be written in the same language of the technical file and shall contain at least the information included in Annex V of the Directive.

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:

• all necessary documents relating to the characteristics of the subsystem

• the infrastructure or rolling stock register, including all information as specified in the TSI,

• the list of interoperability constituents incorporated into the subsystem,

• copies of the EC declarations of conformity and, where appropriate, of the EC declarations of suitability for use, which the constituents shall be provided in accordance with Article 13 of the Directive, accompanied, where appropriate, by the corresponding documents (certificates, quality management system approvals and surveillance documents) issued by the notified bodies,

• all elements relating to the maintenance, the conditions and limits for use of the subsystem,

• all elements relating to the instructions concerning servicing, constant or routine monitoring, adjustment and maintenance,

• the type-examination certificate for the subsystem and accompanying technical documentation, as defined in the module SB

• certificate of conformity of the notified body as mentioned in point 9, accompanied by corresponding calculation notes and countersigned by itself, stating that the project complies with the directive and the TSI, and mentioning, where appropriate, reservations recorded during performance of activities and not withdrawn. The certificate should also be accompanied, if relevant, by the inspection and audit reports drawn up in connection with the verification.

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

The contracting entity shall keep a copy of the technical file throughout the service life of the subsystem and for a further period of three years; it shall be sent to any other Member State which so requests.

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 or rolling stock subsystem

• complies with this TSI and any other applicable TSI, which demonstrate that the essential requirements(26) of Directive 01/16/EC have been met

• complies with the other regulations deriving from the Treaty,

and may be placed in service.

2. The contracting entity(27) shall lodge an application for EC verification (through unit verification) of the subsystem with a notified body of his choice.

The application shall include:

• name and address of the contracting entity or its authorised representative

• the technical documentation.

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.

The technical documentation shall include:

• a general description of the subsystem, its overall design and structure,

• the infrastructure or rolling stock register, including all information as specified in the TSI,

• conceptual design and manufacturing information, for example drawings, schemes of components, sub-assemblies, assemblies, circuits, etc.,

• descriptions and explanations necessary for the understanding of the design and manufacturing information, the maintenance and the operation of the subsystem,

• the technical specifications, including European specifications(28), that have been applied,

• any necessary supporting evidence for the use of the above specifications, in particular where European specifications and the relevant clauses have not been applied in full,

• a list of the interoperability constituents to be incorporated into the subsystem,

• copies of the EC declarations of conformity or suitability for use with which said constituents shall be provided and all the necessary elements defined in annex VI of the directives,

• evidence of conformity with other regulations deriving from the treaty (including certificates)

• technical documentation regarding the manufacture and the assembly of the subsystem,

• a list of manufacturers involved in the subsystem's design, manufacturing, assembly and installation,

• conditions for use of the subsystem (restrictions of running time or distance, wear limits etc),

• conditions for maintenance and technical documentation regarding the maintenance of the subsystem,

• any technical requirement that shall be taken into account during production, maintenance or operation of the subsystem,

• results of design calculations made, examinations carried out, etc.,

• all other appropriate technical evidences, which can demonstrate that previous checking or tests have been successfully performed, under comparable conditions, by independent and competent bodies

If the TSI requires further information for the technical documentation, this shall be included.

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.

The notified body shall examine the subsystem and verify that the appropriate and necessary tests to establish whether, where the relevant European specifications have been chosen, these have actually been applied or whether the solutions adopted meet the requirements of the TSI when the appropriate European specifications have not been applied.

The examinations, tests and checks shall extend to the following stages as provided for in the TSI:

• overall design

• structure of the subsystem, including, in particular and when relevant, civil-engineering activities, constituent assembly, overall adjustments

• final testing of the subsystem

• and, whenever specified in the TSI, the validation under full operational conditions.

The notified body may take into account evidence of examinations, checking or tests that have been successfully performed, under comparable conditions by other bodies(29) or by (or on the behalf of) the applicant, when this is specified by the relevant TSI. The notified body will then decide as to whether it shall use the results of these checks or tests.

The evidences gathered by the notified body shall be suitable and sufficient to show the conformity with the requirement of the TSI and that all required and appropriate checks and tests have been carried out.

Any evidence to be used that originates from other parties shall be considered prior to any tests or checks being carried out, since the notified body may wish to undertake any assessment, witnessing or review of the tests or checks at the time they are performed.

The extent of such other evidence shall be justified by documented analysis using, among others, the factors listed below(30). This justification shall be included in the technical file.

In all case the notified body keeps the final responsibility of them.

5. The notified body shall agree with the contracting entity the locations where the tests will be carried out and shall agree that final subsystem tests and, whenever required in the TSI, tests in full operating conditions, are carried out by the contracting entity under direct supervision and attendance of the notified body.

6. The notified body shall have entrance for testing and verification purposes to the locations of design, building sites, production workshops, locations of assembly and installations, and where appropriate, prefabrication and testing facilities in order to carry out its tasks as provided for in the TSI.

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.

The EC declaration of verification and the accompanying documents shall be dated and signed. The declaration shall be written in the same language as the technical file and shall contain at least the information included in Annex V of the Directive.

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:

• all necessary documents relating to the characteristics of the subsystem

• the list of interoperability constituents incorporated into the subsystem,

• copies of the EC declarations of conformity and, where appropriate, of the EC declarations of suitability for use, which the constituents shall be provided in accordance with Article 13 of the Directive, accompanied, where appropriate, by the corresponding documents (certificates, quality management system approvals and surveillance documents) issued by the notified bodies,

• all elements relating to the maintenance, the conditions and limits for use of the subsystem,

• all elements relating to the instructions concerning servicing, constant or routine monitoring, adjustment and maintenance,

• certificate of conformity of the notified body as mentioned in point 7, accompanied by verification and/or corresponding calculation notes and countersigned by itself, stating that the project complies with the directive and the TSI, and mentioning, where appropriate, reservations recorded during performance of activities and not withdrawn; the certificate should also be accompanied, if relevant, by the inspection and audit reports drawn up in connection with the verification,

• evidence of conformity with other regulations deriving from the treaty (including certificates)

• the infrastructure or rolling stock register, including all information as specified in the TSI.

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

The contracting entity shall keep a copy of the technical file throughout the service life of the subsystem and for a further period of three years; it shall be sent to any other Member State which so requests.

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 or rolling stock subsystem

• complies with this TSI and any other applicable TSI, which demonstrate that the essential requirements(31) of Directive 01/16/EC have been met

• complies with the other regulations deriving from the Treaty and may be placed in service

2. The notified body shall carry out the procedure, including a design examination of the subsystem, under the condition, that the contracting entity(32) and the main contractor involved are satisfying the obligations of point 3.

The ‘main contractor’ refers to companies, whose activities contribute to fulfil the essential requirements of the TSI. It concerns the company:

• responsible for the whole subsystem project (including in particular responsibility for subsystem integration),

• other companies involved only in a part of the subsystem project (performing for example design, assembly or installation of the subsystem).

It does not refer to manufacturer sub contractors supplying components and interoperability constituents.

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

The main contractor responsible for the whole subsystem project (including in particular responsibility for subsystem integration), shall operate in any case an approved quality management system for design, manufacture and final product inspection and testing, which shall be subject to surveillance as specified in point 6.

In the case that the contracting entity itself is responsible for the whole subsystem project (including in particular responsibility for subsystem integration) or that the contracting entity is directly involved in the design and/or production (including assembly and installation), it shall operate an approved quality management system for those activities, which shall be subject to surveillance as specified in point 6.

Applicants which are only involved in assembly and installation, are permitted to operate only an approved quality management system for manufacture and final product inspection and testing

4. EC verification procedure

4.1. The contracting entity shall lodge an application for EC verification of the subsystem (through full quality management system with design examination), including co ordination of surveillance of the quality management systems as in points 5.4. and 6.6., with a notified body of its choice. The contracting entity shall inform the manufacturers involved of his choice and of the application.

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.

The application shall include:

• name and address of the contracting entity or its authorised representative,

• the technical documentation including:

  • a general description of the subsystem, overall design and structure,

  • the technical design specifications, including European specifications(33), that have been applied,

  • any necessary supporting evidence for the use of the above specifications, in particular where the European specificationsand the relevant clauses have not been applied in full,

  • the test programme,

  • the infrastructure or rolling stock register, including all information as specified in the TSI,

  • the technical documentation regarding the manufacture, the assembly of the subsystem,

  • a list of the interoperability constituents to be incorporated into the subsystem,

  • copies of the EC declarations of conformity or suitability for use with which the constituents shall be provided and all the necessary elements defined in annex VI of the directives,

  • evidence of conformity to other regulations deriving from the treaty (including certificates),

  • a list of all manufacturers, involved in the subsystem's design, manufacturing, assembly and installation,

  • conditions for use of the subsystem (restrictions of running time or distance, wear limits etc),

  • conditions for maintenance and technical documentation regarding the maintenance of the subsystem,

  • any technical requirement that shall be taken into account during production, maintenance or operation of the subsystem,

• the explanation, of how all stages, as mentioned in point 5.2, are covered by quality management systems of the main contractor and/or of the contracting entity, if involved, and the evidence of their effectiveness,

• indication of the notified body (ies) responsible for the approval and surveillance of these quality management systems.

4.3. The contracting entity shall present the results of examinations, checking and tests(34) including type tests when required, carried out by its appropriate laboratory or on their behalf.

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.

If the contracting entity is denied a design examination certificate, the notified body shall provide detailed reasons for such denial.

Provision shall be made for an appeals procedure.

4.5. During the production phase, the applicant shall inform the notified body that holds the technical documentation concerning the design examination certificate of all modifications which may affect the conformity with the requirements of the TSI or the prescribed conditions for use of the subsystem. The subsystem shall receive additional approval in such cases. In this case, the notified body shall perform only those examinations and tests, those are relevant and necessary to the changes. This additional approval may be given either in the form of an addition to the original design examination certificate, or by issue of a new certificate after withdrawal of the old certificate.

5. 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.

The application shall include:

• all relevant information for the subsystem envisaged,

• the quality management system documentation.

For those only involved in a part of the subsystem project, the information to be provided is only that for the relevant part.

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.

The quality management system(s), for other contractors, has (have) to ensure compliance of their relevant contribution to the subsystem, with the requirements of the TSI.

All the elements, requirements and provisions adopted by the applicants shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality management system documentation shall ensure a common understanding of the quality policies and procedures such as quality programmes, plans, manuals and records.

The system shall contain in particular an adequate description of the following items:

• for all applicants:

  • the quality objectives and the organisational structure,

  • the corresponding manufacturing, quality control and quality management techniques, processes and systematic actions that will be used,

  • the examinations, checking and tests that will be carried out before, during and after design, manufacture, assembly and installation and the frequency with which they will be carried out,

  • the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.,

• for the main contractor, as far as relevant for its contribution to the design of the subsystem:

  • the technical design specifications, including European specifications that will be applied and, where the European specifications will not be applied in full, the means that will be used to ensure that the requirements of the TSI that apply to the subsystem will be met,

  • the design control and design verification techniques, processes and systematic actions that will be used when designing the subsystem,

  • the means to monitor the achievement of the required design and subsystem quality and the effective operation of the quality management systems in all phases including production.

• and also for the contracting entity or the main contractor responsible for the whole subsystem project:

  • responsibilities and powers of the management with regard to overall subsystem quality, including in particular the subsystem integration management.

The examinations, tests and checking shall cover all of the following stages:

• overall design,

• structure of the subsystem, including, in particular, civil-engineering activities, constituent assembly, final adjustment,

• final testing of the subsystem,

• and, where specified in the TSI, the validation under full operation conditions.

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)(35).

If the compliance of the subsystem with the requirements of the TSI is based on more than one quality management system, the notified body shall examine in particular,

• if the relations and interfaces between the quality management systems are clearly documented

• and if overall responsibilities and powers of the management for the compliance of the whole entire subsystem for the main contractor are sufficiently and properly defined.

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.

When an applicant operates a certified quality management system, the notified body shall take this into account in the assessment.

The audit shall be specific for the subsystem concerned, taking into consideration the specific contribution of the applicant to the subsystem. The auditing team shall have at least one member experienced as an assessor in the subsystem technology concerned. The evaluation procedure shall include an assessment visit to the applicant's premises.

The decision shall be notified to the applicant. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

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.

They shall keep the notified body that has approved their quality management system informed of any significant change that will affect the fulfilment of the requirements by the subsystem.

The notified body shall evaluate any modifications proposed and decide whether the amended quality management system will still satisfy the requirements of point 5.2 or whether a re-assessment is required.

It shall notify its decision to the applicant. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

6. Surveillance of the quality management system(s) under the responsibility of the notified body

6.1. The purpose of surveillance is to make sure that the contracting entity, if involved, and the main contractor duly fulfil the obligations arising out of the approved quality management system(s).

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:

• the quality management system documentation, including the particular means implemented to ensure that

• for the contracting entity or the main contractor, responsible for the whole subsystem project,

  • overall responsibilities and powers of the management for the compliance of the whole entire subsystem are sufficiently and properly defined,

• for each applicant,

  • the quality management system is correctly managed for achieving integration at subsystem level,

• the quality records as foreseen by the design part of the quality management system, such as results of analyses, calculations, tests, etc.,

• the quality records as foreseen by the manufacturing part (including assembly, installation and integration) of the quality management system, such as inspection reports and test data, calibration data, competency records of the personnel concerned, etc.

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.

The frequency of the audits shall be at least once a year, with at least one audit during the time period of performing the relevant activities (design, manufacture, assembly or installation) for the subsystem being the subject of the EC verification procedure mentioned in point 4.

6.4. Additionally the notified body may pay unexpected visits to the sites mentioned in point 5.2 of the applicant(s). At the time of such visits, the notified body may conduct complete or partial audits and may carry out or cause to be carried out tests in order to check the proper functioning of the quality management system where necessary. It shall provide the applicant(s) with an inspection report and audit and/or test reports as appropriate.

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:

• to be ensured that correct management of interfaces between the different quality management systems relating to subsystem integration has been performed.

• to collect, in liaison with the contracting entity, the necessary elements for the assessment to guarantee the consistency and the overall supervision of the different quality management systems.

This co ordination includes the right of the notified body

• to receive all documentation (approval and surveillance), issued by the other notified body(s),

• to witness the surveillance audits as in point 5.4.,

• to initiate additional audits as in point 5.5. under its responsibility and together with the other notified body(s).

7. The notified body as referenced under point 5.1. shall have entrance for inspection purposes, audit and surveillance to the locations of design, building sites, production workshops, locations of assembly and installation, storage areas and where appropriate, prefabrication or testing facilities and, more general, to all premises which it considers necessary for its task, in accordance with the applicant's specific contribution to the subsystem project.

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:

• the documentation referenced in the second indent of the second subparagraph of point 5.1,

• the updating referenced in the second subparagraph of point 5.5,

• the decisions and reports from the notified body which are referenced in the points 5.4, 5.5 and 6.4

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.

The EC declaration of verification and the accompanying documents shall be dated and signed. The declaration shall be written in the same language of the technical file and shall contain at least the information included in Annex V of the Directive.

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:

• all necessary documents relating to the characteristics of the subsystem

• the list of interoperability constituents incorporated into the subsystem,

• copies of the EC declarations of conformity and, where appropriate, of the EC declarations of suitability for use, which the constituents shall be provided in accordance with Article 13 of the Directive, accompanied, where appropriate, by the corresponding documents (certificates, quality management system approvals and surveillance documents) issued by the notified bodies,

• evidence of conformity to other regulations deriving from the treaty (including certificates)

• all elements relating to the maintenance, the conditions and limits for use of the subsystem,

• all elements relating to the instructions concerning servicing, constant or routine monitoring, adjustment and maintenance

• certificate of conformity of the notified body as mentioned under point 9, accompanied by corresponding verification and/or calculation notes and countersigned by itself, stating that the project complies with the Directive and the TSI, and mentioning, where appropriate, reservations recorded during performance of the activities and not withdrawn.

  The certificate should also be accompanied, if relevant, by the inspection and audit reports drawn up in connection with the verification, as mentioned in points 6.4. and 6.5.;

• the infrastructure or rolling stock register, including all information as specified in the TSI.

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.

The other notified bodies may receive on request copies of:

• the quality management system approvals and additional approvals issued and

• the EC design examination certificates and additions issued

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

The contracting entity shall keep a copy of the technical file throughout the service life of the subsystem and for a further period of three years; it shall be sent to any other Member State which so requests.

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

This is an open point.

ANNEX G

Reserved

ANNEX H

Reserved

ANNEX I

Reserved

ANNEX J

Reserved

ANNEX K

Reserved

ANNEX L Aspects not specified in the PRM TSI and for which European Rules apply or notification of National Rules is required

Infrastructure

Parking facilities for PRM (clause 4.1.2.2) (this includes, but is not limited to: — the number of spaces, access, location, dimensions, materials, colours, signing and lighting).

Tactile path (clause 4.1.2.3.2)

Slip resistance of floor surfaces (clause 4.1.2.5)

Dimensions and equipment of toilets for wheelchair users (clause 4.1.2.7.1)

Station forecourt lighting (clause 4.1.2.10)

Emergency lighting (clause 4.1.2.10)

Visual information (clause 4.1.2.11.1)

Safety Information and Safety Instructions (clause 4.1.2.11.1)

Warning, prohibition and mandatory actions signs (clause 4.1.2.11.1)

Emergency exits and alarms (clause 4.1.2.13)

Width requirement according to passenger flows (clause 4.1.2.14)

Staircases (clause 4.1.2.15)

Ramps (clause 4.1.2.17)

Escalators (clause 4.1.2.17)

Travelators (clause 4.1.2.17)

Minimum structure gauge (clause 4.1.2.18.2)

Track gauge widening (clause 4.1.2.18.2)

Danger area on platforms definition and tactile marking (clause 4.1.2.19)

Use of level track crossings (clause 4.1.2.22)

Organisation of the transport of wheelchair users by an accessible means between a non accessible station and the next accessible station on the same route (clause 4.1.4)

Rolling Stock

Customer Information (clause 4.2.2.8.1)

Safety Information and Safety Instructions (clause 4.2.2.8.1)

Warning, prohibition and mandatory actions signs (clause 4.2.2.8.1)

Definitions

Measurement of light reflectance (clause 4.3)

National standard Braille (clause 4.3)

ANNEX M Transportable Wheelchair

M.1 Scope

This annex identifies the maximum engineering limits for a transportable wheelchair.

M.2 Characteristics

The minimum technical requirements are:

• Basic Dimensions

  • Width of 700 mm plus 50 mm min each side for hands when moving

  • Length of 1 200 mm plus 50 mm for feet

• Wheels

  • The smallest wheel shall accommodate a gap of dimensions 75 mm horizontal and 50 mm vertical

• Height

  • 1 375 mm max including a 95th %ile male occupant

• Turning circle

  • 1 500 mm

• Weight

  • Fully laden weight of 200 kg for wheelchair and occupant (including any baggage)

• Obstacle height that can be overcome and ground clearance

  • Obstacle height that can be overcome 50 mm (max)

  • Ground clearance 60 mm (min)

• Maximum safe slope on which the wheelchair will remain stable:

  • Shall have dynamic stability in all directions at an angle of 6 degrees

  • Shall have static stability in all directions (including with brake applied) at an angle of 9 degrees

ANNEX N PRM Signage

N.1 Scope

This annex identifies specific signage for use on both infrastructure and rolling stock.

N.2 Infrastructure signs

Infrasstructure PRM signage dimensions shall be calculated according to the formula:

The minimum size of the enclosure of the written and graphic symbols shall be according to the formula: Reading distance in mm divided by 250, multiplied by 1,25 = frame size in mm, where a frame is utilised.

N.3 Rolling stock signs

The minimum tile size of rolling stock interior PRM signs shall be 60 mm.

The minimum tile size of rolling stock exterior PRM signs shall be 85 mm.

N.4 International wheelchair sign

The sign conforming to the international symbol for the ‘provision for the disabled or handicapped persons’ in accordance with ISO 7000:2004 symbol 0100,which identifies wheelchair accessible areas, shall meet the following criteria:

Symbol	Background
RAL 9003 Signal white	RAL 5022 Night blue
NCS S 0500-N	NCS S 6030-R70B
C0 M0 Y0 K0	Pantone 274 EC (C100 M100 Y0 K38)

N.5 Inductive loop sign

The sign indicating where inductive loops are fitted shall comply with figure 1 and the following:

Symbol	Background
RAL 9003 Signal white	RAL 5022 Night blue
NCS S 0500-N	NCS S 6030-R70B
C0 M0 Y0 K0	Pantone 274 EC (C100 M100 Y0 K38)

N.6 Call for assistance/call for information sign

The sign indicating where there is a call for assistance or call for information facility shall comply with figure 2 and the following:

Symbol	Background
RAL 9003 Signal white	RAL 5022 Night blue
NCS S 0500-N	NCS S 6030-R70B
C0 M0 Y0 K0	Pantone 274 EC (C100 M100 Y0 K38)

N.7 Emergency call sign

The sign indicating where there is an Emergency call device shall comply with figure 3 and the following:

Symbol	Background
RAL 9003 Signal white	Green
NCS S 0500-N	according
C0 M0 Y0 K0	ISO 3864-1:2002 chapter 11

N.8 Priority seating signs

Symbol	Background
RAL 9003 Signal white	RAL 5022 Night blue
NCS S 0500-N	NCS S 6030-R70B
C0 M0 Y0 K0	Pantone 274 EC (C100 M100 Y0 K38)

(1)

The definition of an European specification is indicated in the directives 96/48/EC and 01/16/EC. The guide for application of HS TSIs explains the way to use the European Specifications.

(2)

The definition of an European specification is indicated in the directives 96/48/EC and 01/16/EC. The guide for application of HS TSIs explains the way to use the European Specifications.

(3)

When necessary, the manufacturer's discretion may be limited for specific constituents. In this case, the relevant verification process required for the interoperability constituent is specified in the TSI (or in its annexes).

(4)

The definition of an European specification is indicated in the directives 96/48/EC and 01/16/EC. The guide for application of HS TSIs explains the way to use the European Specifications.

(5)

The definition of an European specification is indicated in the directives 96/48/EC and 01/16/EC. The guide for application of HS TSIs explains the way to use the European Specifications.

(6)

The definition of an European specification is indicated in the directives 96/48/EC and 01/16/EC. The guide for application of HS TSIs explains the way to use the European Specifications.

(7)

The manufacturer's discretion may be limited in specific TSIs.

(8)

The definition of an European specification is indicated in the directives 96/48/EEC and 01/16/EC. The guide for application of HS TSIs explains the way to use the European Specifications.

(9)

The definition of an European specification is indicated in the directives 96/48/EC and 01/16/EC. The guide for application of HS TSIs explains the way to use the European Specifications.

(10)

The definition of an European specification is indicated in the directives 96/48/EC and 01/16/EC. The guide for application of HS TSIs explains the way to use the European Specifications.

(11)

The presentation of the results of the tests can be at the same time as the application or later.

(12)

During the time of in service experience, the IC is not placed on the market.

(13)

The essential requirements are reflected in the technical parameters, interfaces and performance requirements, which are set out in Chapter 4 of the TSI.

(14)

In the module, ‘the contracting entity’ means ‘the subsystem contracting entity, as defined in the directive. or his authorised representative established within the Community’.

(15)

The relevant section of a TSI may define specific requirements in this regard.

(16)

The definition of an European specification is indicated in the directives 96/48/EC and 01/16/EC. The guide for application of HS TSIs explains the way to use the European Specifications.

(17)

The essential requirements are reflected in the technical parameters, interfaces and performance requirements, which are set out in Chapter 4 of the TSI.

(18)

In the module, ‘the contracting entity’ means ‘the subsystem contracting entity, as defined in the directive. or his authorised representative established within the Community’.

(19)

The definition of an European specification is indicated in the directives 96/48/EC and 01/16/EC. The guide for application of HS TSIs explains the way to use the European Specifications.

(20)

For the rolling stock TSI, the notified body may participate to the final in service test of locomotives or train set in the conditions specified in the relevant chapter of the TSI.

(21)

The essential requirements are reflected in the technical parameters, interfaces and performance requirements, which are set out in Chapter 4 of the TSI.

(22)

In the module, ‘the contracting entity’ means ‘the subsystem contracting entity, as defined in the directive. or his authorised representative established within the Community’.

(23)

The ‘main contractor’ refers to companies, whose activities contribute to fulfil essential requirements of the TSI. It concerns the company that can be responsible for the whole subsystem project or other companies only involved in a part of the subsystem project, (performing for example assembly or installation of the subsystem).

(24)

The definition of an European specification is indicated in the directives 96/48/EC and 01/16/EC. The guide for application of HS TSIs explains the way to use the European Specifications.

(25)

In particular, for the rolling stock TSI, the notified body will participate in the final in service testing of rolling stock or train set. This will be indicated in the relevant chapter of the TSI.

(26)

The essential requirements are reflected in the technical parameters, interfaces and performance requirements, which are set out in Chapter 4 of the TSI.

(27)

In the module, ‘the contracting entity’ means ‘the subsystem contracting entity, as defined in the directive. or his authorised representative established within the Community’.

(28)

The definition of an European specification is indicated in the directives 96/48/EC and 01/16/EC. The guide for application of HS TSIs explains the way to use the European Specifications.

(29)

The conditions to entrust checking and tests must be similar than the conditions, respected by a notified body to subcontract activities (see § 6.5 of the Blue Guide on the New Approach).

(30)

The notified body shall investigate the various parts of the subsystem work and establish before, during and on completion of the work:

• the risk and safety implications of the subsystem and its various parts

• the use of existing equipment and systems:

  • used identically as before

  • used before but adapted for use in the new work

• the use of existing designs, technologies, materials and production techniques.

• the arrangements for design, production, testing and commissioning

• the operational and service duty

• previous approvals from other competent bodies

• the accreditations of other involved bodies:

  • it is permissible for the nb to take account of valid accreditation to EN45004, providing that no conflict of interest exists, that accreditation covers the testing being performed and that accreditation is current.

  • where no formal accreditation exists, the nb shall confirm that the systems for control of competence, independence, testing and material handling processes, facilities and equipment and other processes relevant to the contribution to the subsystem are controlled.

  • in all cases, the notified body shall consider the appropriateness of the arrangements and decide the level of witnessing required

• the use of homogenous lots and systems consistent with module f.

(31)

The essential requirements are reflected in the technical parameters, interfaces and performance requirements, which are set out in Chapter 4 of the TSI.

(32)

In the module, ‘the contracting entity’ means ‘the subsystem contracting entity, as defined in the directive or his authorised representative established within the Community’.

(33)

The definition of an European specification is indicated in the directives 96/48/EC and 01/16/EC. The guide for application of HS TSIs explains the way to use the European Specifications.

(34)

The presentation of the results of the tests can be at the same time as the application or later.

(35)

In particular, for the rolling stock TSI, the notified body will participate in the final in service testing of rolling stock or train set. This will be indicated in the relevant chapter of the TSI.