1. RINA & SINTEF Assessor på et grenseoverskridende prosjekt, Femern del2 Thor Myklebust Sertifiseringsleder, SINTEF 2014-11-18 13: 00 – 14: 15 Sikkerhetskonferansen, DK 1

2. 2 Assessor ovn a cross-border project: Femern Agenda Femern project. RINA and SINTEF Expectations: Work performed: Relationship to: Femern AS Trafikstyrelsen EBA (Eisenbahn-Bundesamt)

3. 3 The parties involved and tasks Femern A/S as: Proposer of a change in the meaning of the Regulation 352/2009 Applicant in the context of the interoperability National Safety Authorities: Trafikstyrelsen and EBA RINA & SINTEF as: Notified Body applying the EC verification procedure to verify interoperability requirements as stated in the Directive 2008/57/EC Assessment Body for assessing the risk management process of Femern (as Proposer) as stated in the EU Reg. 352/2009. 402/2013 later in the project

4. 4 The parties involved and tasks

5. 5 RINA information RINA Acting as international Ship Classification and Industrial Certification Body since 1861, RINA provides professional services dedicated to:  Railway and infrastructure managers  Rolling stock and equipment suppliers  Maintenance entities.

6. 6 RINA information RINA - ISA projects since 2003 - Appointed as NoBo in 2003 - CSM (common safety methods) assessment body since 2009 - Participates actively in NB-Rail Accreditations/recognition: Accredited Certification body since 1991 Accredited Type A inspection body since 2011 RINA railway certification laboratory accredited since 2013

7. 7 SINTEF information SINTEF is the largest independent research organisation in Scandinavia Leading expertise in the natural sciences and technology, environment, health and social science 2100 employees from 70 countries Annual sales of NOK 3 billion (EUR 400 mill) Customers from 60 countries A non-commercial foundation

8. 8 SINTEF information Technical evaluations of Railway systems since 1975 ISA projects since 1994 Appointed as NoBo in 2003 CSM assessment body since 2012 Participate actively in NB-Rail Plenary meetings (3X/year) ERTMS sub group meetings (3X/year) Issue “ERTMS sub group User guide” 3 times a year

9. 9 Expectations RINA and SINTEF expect this large and long project will be both informative and challenging We expect that the Femern project will lead to - better understanding of the two countries railway construction and use - that two Notified Bodies better get to know each other - better understanding of different aspects of the regulations, TSIs and standards - understanding and experience which can be used in other cross-border projects. - that RINA and SINTEF can get other large projects in the future

10. 10 Work performed The Femern project is in the tendering phase. From an assessment point of view the conceptual design (provided by Femern A/S) has been assessed as NoBo. The CSM process applied to the project has been assessed until now focusing on the system definition, the hazard classification and identification and risk evaluation. This is an iterative assessment and continue along the project.

11. 11 Work performed Deliverables RINA and SINTEF: LooP CSM assessment report TSI compliance reports ISV (Intermediate Statement of Verification)

12. 12 Work performed ISV (Intermediate Statement of Verification) Used to verify certain stages ISV's issued for the design phase: Signalling Energy Infrastructure Tunnel (conditionally)

13. 13 The ISV content is composed of: List of applicable EU Directives Subject of the verification Applicable TSIs Issued Body Validity Annex with features of the assessed subsystem ISV content

14. 14 Work performed A specific assessment has been carried out regarding the tunnel safe area concept and solution. Still open points in the LooP (List of open Points) related to "safe area"

15. 15 Work performed

16. 16 Work performed **

17. 17 Applicable requirements (WHAT and WHY) European specific requirements in the field of railway system: Related to the interoperability TSI’s (Technical Specification for Interoperability) Related to safety Application of a Risk Management process (Common Safety Methods Reg. 352/2009) when a significant change occurs with impact on the railway safety. National Requirements: National Notified Technical Rules (NNTR) for Denmark and Germany (to cover TSI open points, derogations or specific cases). National Notified Safety Rules (NNSR).

18. 18 Relationship to Femern AS Styrelsen EBA

19. RINA & SINTEF Questions? 19