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This is the original version (as it was originally adopted).
Article 1.A Technical Specification for Interoperability (‘TSI’) relating to ‘persons with...
Article 2.Member States may still apply Commission Decision 2002/735/EC for those...
Article 3.(1) With regard to those issues classified as ‘Open points’...
TRANS-EUROPEAN CONVENTIONAL AND HIGH-SPEED RAIL SYSTEM
4. CHARACTERISATION OF THE SUBSYSTEMS
4.2.2. Functional and technical specifications
4.2.3. Functional and technical specifications of the interfaces
7. IMPLEMENTATION OF THE PRM TSI
7.1. Application of this TSI to new Infrastructure/Rolling Stock
7.3. Application of this TSI to existing Infrastructure/Rolling Stock
7.5. Rolling Stock operating under national, bilateral, multilateral or international agreements...
Scope: Whole Subsystems Aspect: Accessibility for Persons with Reduced Mobility
Assessment of Maintenance Arrangements: Conformity Assessment Procedure (Annex F4)
Procedures for assessment of conformity and suitability for use
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...
2. The manufacturer shall establish the technical documentation described in point...
3. The technical documentation shall enable the conformity of the interoperability...
4. The manufacturer shall take all the measures necessary in order...
5. The manufacturer or his authorised representative established within the Community...
6. The manufacturer or his authorised representative shall keep a copy...
7. If additional to the EC declaration of conformity, an EC...
F.2.2. Module A1: Internal Design Control with Production Verification
1. This module describes the procedure whereby the manufacturer or his...
2. The manufacturer shall establish the technical documentation described in point...
3. The technical documentation shall enable the conformity of the interoperability...
4. The manufacturer shall take all the measures necessary in order...
5. The notified body, chosen by the manufacturer, shall carry out...
5.1. Verification by examination and testing of every product
5.2.1. The manufacturer shall present his products in the form of...
5.2.2. All interoperability constituents shall be available for verification in the...
5.2.3. The statistical procedure shall use appropriate elements (statistical method, sampling...
5.2.4. In the case of accepted lots, the notified body shall...
6. The manufacturer or his authorised representative established within the Community...
7. The manufacturer or his authorised representative shall keep a copy...
8. If additional to the EC declaration of conformity, an EC...
F.2.3. Module B: Type Examination
1. This module describes that part of the procedure by which...
2. The application for the EC type-examination shall be lodged by...
3. The technical documentation shall enable the conformity of the interoperability...
4.2. verify that any specimen(s) required for tests has (have) been...
4.3. where a design review is requested in the TSI, perform...
4.4. where a review of the manufacturing process is requested in...
4.5. identify the elements which have been designed in accordance with...
4.6. perform or have performed the appropriate examinations and necessary tests...
4.7. perform or have performed the appropriate examinations and necessary tests...
4.8. agree with the applicant the location where the examinations and...
6. The applicant shall inform the notified body that holds the...
8. Each notified body shall communicate to the other notified bodies...
9. The other notified bodies shall receive, on request, copies of...
10. The manufacturer or his authorised representative established within the Community...
F.2.4. Module C: Conformity to Type
1. This module describes that part of the procedure whereby the...
2. The manufacturer shall take all measures necessary to ensure that...
3. The manufacturer or his authorised representative established within the Community...
4. The manufacturer or his authorised representative established within the Community...
5. If additional to the EC declaration of conformity an EC...
F.2.5. Module D: Production Quality Management System
1. This module describes the procedure whereby the manufacturer or his...
2. The manufacturer shall operate an approved quality management system for...
3.1. The manufacturer shall lodge an application for assessment of his...
3.2. The quality management system shall ensure compliance of the interoperability...
3.3. The notified body assesses the quality management system to determine...
3.4. The manufacturer shall undertake to fulfil the obligations arising out...
4. Surveillance of the quality management system under the responsibility of...
4.1. The purpose of surveillance is to make sure that the...
4.2. The manufacturer shall allow the notified body entrance for inspection...
4.3. The notified body shall periodically carry out audits to make...
4.4. Additionally the notified body may pay unexpected visits to the...
5. Each notified body shall communicate to the other notified bodies...
6. The manufacturer shall, for a period of 10 years after...
7. The manufacturer or his authorised representative established within the Community...
8. The manufacturer or his authorised representative established within the Community...
9. If additional to the EC declaration of conformity an EC...
F.2.6. Module F: Product Verification
1. This module describes the procedure whereby a manufacturer or his...
2. The manufacturer shall take all measures necessary in order that...
3. The notified body shall carry out the appropriate examinations and...
4. Verification by examination and testing of every interoperability constituent
5.1. The manufacturer shall present his interoperability constituents in the form...
5.2. All interoperability constituents shall be available for verification in the...
5.3. The statistical procedure shall use appropriate elements (statistical method, sampling...
5.4. In the case of accepted lots, the notified body shall...
5.5. The manufacturer or his authorised representative established within the Community...
6. The manufacturer or his authorised representative established within the Community...
7. The manufacturer or his authorised representative established within the Community...
8. If additional to the EC declaration of conformity an EC...
F.2.7. Module H1: Full Quality Management System
1. This module describes the procedure whereby the manufacturer or his...
2. The manufacturer shall operate an approved quality management system for...
3.1. The manufacturer shall lodge an application for assessment of his...
3.2. The quality management system shall ensure compliance of the interoperability...
3.3. The notified body shall assess the quality management system to...
3.4. The manufacturer shall undertake to fulfil the obligations arising out...
4. Surveillance of the quality management system under the responsibility of...
4.1. The purpose of surveillance is to make sure that the...
4.2. The manufacturer shall allow the notified body entrance for inspection...
4.3. The notified body shall periodically carry out audits to make...
4.4. Additionally the notified body may pay unexpected visits to the...
5. The manufacturer shall, for a period of 10 years after...
6. Each notified body shall communicate to the other notified bodies...
7. The manufacturer or its authorised representative established within the Community...
8. The manufacturer or his authorised representative established within the Community...
9. If additional to the EC declaration of conformity an EC...
F.2.8. Module H2: Full Quality Management System With Design Examination
1. This module describes the procedure whereby a notified body carries...
2. The manufacturer shall operate an approved quality management system for...
3.1. The manufacturer shall lodge an application for assessment of his...
3.2. The quality management system shall ensure compliance of the interoperability...
3.3. The notified body shall assess the quality management system to...
3.4. The manufacturer shall undertake to fulfil the obligations arising out...
4. Surveillance of the quality management system under the responsibility of...
4.1. The purpose of surveillance is to make sure that the...
4.2. The manufacturer shall allow the notified body entrance for inspection...
4.3. The notified body shall periodically carry out audits to make...
4.4. Additionally the notified body may pay unexpected visits to the...
5. The manufacturer shall, for a period of 10 years after...
6.1. The manufacturer shall lodge an application for examination of the...
6.2. The application shall enable the design, manufacture, maintenance and operation...
6.3. The applicant shall present the results of tests, including type...
6.4. The notified body shall examine the application and assess the...
6.5. The applicant shall keep the notified body that has issued...
6.6. If no modifications as in point 6.4. have been made,...
7. Each notified body shall communicate to the other notified bodies...
8. The manufacturer or his authorised representative established within the Community...
9. The manufacturer or his authorised representative established within the Community...
10. If additional to the EC declaration of conformity an EC...
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...
2. The manufacturer, or his authorised representative established within the Community,...
3. The technical documentation shall enable the assessment of the product...
4. The programme for the validation by in service experience shall...
5.1. Examine the technical documentation and the programme for validation by...
5.2. Verify that the type is representative and has been manufactured...
5.3. Verify that the programme for validation by in service experience...
5.4. Agree with the applicant the programme and the location where...
5.5. Monitor and inspect the progress of in service running, operation...
5.6. Evaluate the report, to be issued by the company (ies)...
5.7. Assess, if the in service behaviour meets the requirements of...
7. The applicant shall inform the notified body that holds the...
9. Each notified body shall communicate to the other notified bodies...
10. The other notified bodies shall be provided on request with...
11. The manufacturer or his authorised representative established within the Community...
12. The manufacturer or his authorised representative established within the Community...
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...
2. The contracting entity shall lodge an application for EC verification...
3. The applicant shall place at the disposal of the notified...
4.2. Verify that the specimen(s) of the subsystem or of assemblies...
4.3. Where a design review is requested in the TSI, perform...
4.4. Identify the elements which have been designed in accordance with...
4.5. Perform or have performed the appropriate examinations and necessary tests...
4.6. Perform or have performed the appropriate examinations and necessary tests...
4.7. Agree with the applicant the location where the examinations and...
6. Each notified body shall communicate to the other notified bodies...
7. The other notified bodies may receive on request copies of...
8. The contracting entity shall keep with the technical documentation copies...
9. During the production phase, the applicant shall inform the notified...
F.3.2. Module SD: Production Quality Management System
1. This module describes the EC verification procedure whereby a notified...
2. The notified body carries out the procedure, under the condition,...
3. For the subsystem that is subject of the EC verification...
5.1. The contracting entity, if involved, and the main contractor, when...
5.2. For the contracting entity or the main contractor responsible for...
5.3. The notified body chosen by the contracting entity shall examine,...
5.4. The notified body referenced to in point 5.1. shall assess...
5.5. The contracting entity, if involved, and the main contractor shall...
6. Surveillance of the quality management system(s) under the responsibility of...
6.1. The purpose of surveillance is to make sure that the...
6.2. The contracting entity, if involved, and the main contractor shall...
6.3. The notified body shall periodically carry out audits to make...
6.4. Additionally the notified body may pay unexpected visits to the...
6.5. The notified body chosen by the contracting entity and responsible...
7. The notified body as referenced in point 5.1. shall have...
8. The contracting entity, if involved, and the main contractor shall,...
9. Where the subsystem meets the requirements of the TSI, the...
10. The notified body chosen by the contracting entity shall be...
11. Each notified body shall communicate to the other notified bodies...
12. The records accompanying the certificate of conformity shall be lodged...
F.3.3. Module SF: Product Verification
1. This module describes the EC verification procedure whereby a notified...
2. The contracting entity shall lodge an application for EC verification...
3. Within that part of the procedure the contracting entity checks...
4. The contracting entity shall take all measures necessary in order...
5. The application shall enable the design, manufacture, installation, maintenance and...
6. The notified body shall first examine the application concerning the...
7. Verification by examination and testing of every subsystem (as a...
7.1. The notified body shall carry out the tests, examinations and...
7.2. Each subsystem (as serial product) shall be individually examined, tested...
8. The notified body shall agree with the contracting entity (and...
9. Where the subsystem meets the requirements of the TSI, the...
10. The notified body shall be responsible for compiling the technical...
11. The records accompanying the certificate of conformity shall be lodged...
F.3.4. Module SG: Unit verification
1. This module describes the EC verification procedure whereby a notified...
2. The contracting entity shall lodge an application for EC verification...
3. The technical documentation shall enable the design, manufacture, installation and...
4. The notified body shall examine the application and the technical...
5. The notified body shall agree with the contracting entity the...
6. The notified body shall have entrance for testing and verification...
7. Where the subsystem meets the requirements of the TSI, the...
8. The notified body shall be responsible for compiling the technical...
9. The records accompanying the certificate of conformity shall be lodged...
F.3.5. Module SH2: Full Quality Management System with Design Examination
1. This module describes the EC verification procedure whereby a notified...
2. The notified body shall carry out the procedure, including a...
3. For the subsystem that is subject of the EC verification...
4.1. The contracting entity shall lodge an application for EC verification...
4.2. The application shall enable the design, manufacture, assembly, installation, maintenance...
4.3. The contracting entity shall present the results of examinations, checking...
4.4. The notified body shall examine the application concerning the design...
4.5. During the production phase, the applicant shall inform the notified...
5.1. The contracting entity, if involved, and the main contractor, when...
5.2. For the contracting entity or the main contractor responsible for...
5.3. The notified body chosen by the contracting entity shall examine,...
5.4. The notified body referenced in point 5.1. shall assess the...
5.5. The contracting entity, if involved, and the main contractor shall...
6. Surveillance of the quality management system(s) under the responsibility of...
6.1. The purpose of surveillance is to make sure that the...
6.2. The contracting entity, if involved, and the main contractor shall...
6.3. The notified body shall periodically carry out audits to make...
6.4. Additionally the notified body may pay unexpected visits to the...
6.5. The notified body chosen by the contracting entity and responsible...
7. The notified body as referenced under point 5.1. shall have...
8. The contracting entity, if involved, and the main contractor shall,...
9. Where the subsystem meets the requirements of the TSI, the...
10. The notified body chosen by the contracting entity shall be...
11. Each notified body shall communicate to the other notified bodies...
12. The records accompanying the certificate of conformity shall be lodged...
F.4. Assessment of Maintenance Arrangements: Conformity Assessment Procedure
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