Commission Decision of 9 November 2010 on modules for the procedures for assessment of conformity, suitability for use and EC verification to be used in the technical specifications for interoperability adopted under Directive 2008/57/EC of the European Parliament and of the Council (notified under document C(2010) 7582) (Text with EEA relevance) (2010/713/EU)

Article 3 Definitions

For the purposes of this Decision, the following definitions shall apply:

1.

‘technical specification for interoperability’ (TSI) means a specification adopted in accordance with Directive 2008/57/EC by which each subsystem or part subsystem is covered in order to meet the essential requirements and ensure the interoperability of the rail system;

2.

‘vehicle’ means a railway vehicle that runs on its own wheels on railway lines, with or without traction. A vehicle is composed of one or more structural and functional subsystems or parts of such subsystems;

3.

‘subsystems’ means the result of the division of the rail system, as shown in Annex II to Directive 2008/57/EC;

4.

‘interoperability constituents’ means any elementary component, group of components, sub-assembly or complete assembly of equipment incorporated or intended to be incorporated into a subsystem, upon which the interoperability of the rail system depends directly or indirectly. The concept of a ‘constituent’ covers both tangible objects and intangible objects such as software;

5.

‘applicant’ means contracting entity or manufacturer;

6.

‘contracting entity’ means any entity, whether public or private, which orders the design and/or construction or the renewal or upgrading of a subsystem. This entity may be a railway undertaking, an infrastructure manager or a keeper, or the concession holder responsible for carrying out a project;

7.

‘notified bodies’ means the bodies which are responsible for assessing the conformity or suitability for use of the interoperability constituents or for appraising the ‘EC’ procedure for verification of the subsystems;

8.

‘harmonised standard’ means any European standard adopted by one of the European standardisation bodies listed in Annex I to Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services(1) in connection with a mandate by the Commission drawn up in accordance with the procedure referred to in Article 6(3) of that Directive, which, by itself or together with other standards, provides a solution as regards compliance with a legal provision;

9.

‘placing in service’ means all the operations by which a subsystem or a vehicle is put into its design operating state;

10.

‘placing on the market’ means the first making available of an interoperability constituent on the Union market;

11.

‘manufacturer’ means any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under his name or trademark;

12.

‘authorised representative’ means any natural or legal person established within the Union who has received a written mandate from a manufacturer or a contracting entity to act on their behalf in relation to specified tasks;

13.

‘conformity assessment’ means the process demonstrating whether requirements specified in the relevant TSI relating to an interoperability constituent have been fulfilled;

14.

‘assessment of suitability for use’ means the process demonstrating whether requirements for suitability for use specified in the relevant TSI relating to an interoperability constituent have been fulfilled;

15.

‘EC verification’ means the procedure referred to in Article 18 of Directive 2008/57/EC whereby a notified body checks and certifies that the subsystem complies with Directive 2008/57/EC, relevant TSI(s) and with the other regulations deriving from the Treaty, and may be put into operation.

(1)

OJ L 204, 21.7.1998, p. 37.