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conventional and high-speed rail system (notified under document C(2007) 6633) (Text with EEA relevance) (2008/164/EC) (repealed)

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(1).

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.

(1)

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