ERA-GUI-100.pdf - Europa

Guide for the application of the Art 14 (a) of the Safety Directive and Commission Regulation (EU) No 445/2011
on a system of certification of entities in charge of maintenance for freight wagons – VERSION 1.0
assessment.
Needs to update or not update the maintenance file for other reasons than strictly safety:
• Technological evolution
• Modification of applicable legislation (other than safety)
• Performance targets (such as availability, reliability)
Proposals of update (or no change) of the maintenance documentation if necessary.
Whenever the needs (related to safety or not), a safety risk assessment of the proposal and
of its implementation has to be performed.
Implementation of the proposed update of the maintenance documentation
‣ Taking of decisions on the proposed updates (or no change) of the maintenance file.
10.3 Where does the technical file come from?
As stated in the Article 18 (3) of the Interoperability Directive 2008/57/EC: “The notified body shall
be responsible for compiling the technical file that has to accompany the ‘EC’ declaration of
verification. This technical file must contain all the necessary documents relating to the
characteristics of the subsystem and, where appropriate, all the documents certifying conformity of
the interoperability constituents. It should also contain all the elements relating to the conditions
and limits of use and to the instructions concerning servicing, constant or routine monitoring,
adjustment and maintenance.” For the DeBo section and the CSM-sections of the Technical File,
the DeBo and CSM-Assessment Body are responsible in similar form. The format of a Technical
File has been standardised within RFU-STR-011.
For vehicles compliant with TSIs, the initial development of the maintenance file is based on the
technical file (Refer to section 4 of annex VI of the Interoperability Directive and on the APIS. The
content of the technical file is described in detail in the relevant TSIs.
As interoperability doesn’t cover all the technical characteristics of a wagon but only the ones
making the wagon compliant with the essential requirements through the applicable TSIs, there
may be additional technical information that has to be provided to the ECM. This additional
technical information is requested contractually between the applicant and the manufacturer of the
wagon.
10.4 Where can I find the technical file?
For vehicles compliant with TSIs, the initial development of the maintenance file is based on the
technical file (Refer to section 4 of annex VI of the Interoperability Directive[3]) and on the APIS.
The content of the technical file is described in detail in the relevant TSIs.
As interoperability doesn’t cover all the technical characteristics of a wagon but only the ones
making the wagon compliant with the essential requirements through the applicable TSIs, there
may be additional technical information that has to be provided to the ECM. This additional
technical information is requested contractually between the applicant and the manufacturer of the
wagon.
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