Definitions

For the purpose of this Regulation the definitions in Article 3 of Directive 2004/49/EC apply.

The following definitions also apply:

‘risk’ means the frequency of occurrence of accidents and incidents resulting in harm (caused by a hazard) and the degree of severity of that harm;

‘risk analysis’ means systematic use of all available information to identify hazards and to estimate the risk;

‘risk evaluation’ means a procedure based on the risk analysis to determine whether an acceptable level of risk has been achieved;

‘risk assessment’ means the overall process comprising a risk analysis and a risk evaluation;

‘safety’ means freedom from unacceptable risk of harm;

‘risk management’ means the systematic application of management policies, procedures and practices to the tasks of analysing, evaluating and controlling risks;

‘interfaces’ means all points of interaction during a system or subsystem life cycle, including operation and maintenance where different actors of the rail sector will work together in order to manage the risks;

‘actors’ means all parties which are, directly or through contractual arrangements, involved in the application of this Regulation;

‘safety requirements’ means the safety characteristics (qualitative or quantitative) of a system and its operation (including operational rules) and maintenance necessary in order to meet legal or company safety targets;

‘safety measures’ means a set of actions either reducing the frequency of occurrence of a hazard or mitigating its consequences in order to achieve and/or maintain an acceptable level of risk;

‘proposer’ means one of the following:

a railway undertaking or an infrastructure manager which implements risk control measures in accordance with Article 4 of Directive 2004/49/EC;

an entity in charge of maintenance which implements measures in accordance with Article 14a(3) of Directive 2004/49/EC;

a contracting entity or a manufacturer which invites a notified body to apply the ‘EC’ verification procedure in accordance with Article 18(1) of Directive 2008/57/EC or a designated body according to Article 17(3) of that Directive;

an applicant for an authorisation for the placing in service of structural sub-systems;

‘safety assessment report’ means the document containing the conclusions of the assessment performed by an assessment body on the system under assessment;

‘hazard’ means a condition that could lead to an accident;

‘assessment body’ means the independent and competent external or internal individual, organisation or entity which undertakes investigation to provide a judgement, based on evidence, of the suitability of a system to fulfil its safety requirements;

‘risk acceptance criteria’ means the terms of reference by which the acceptability of a specific risk is assessed; these criteria are used to determine that the level of a risk is sufficiently low that it is not necessary to take any immediate action to reduce it further;

‘hazard record’ means the document in which identified hazards, their related measures, their origin and the reference to the organisation which has to manage them are recorded and referenced;

‘hazard identification’ means the process of finding, listing and characterising hazards;

‘risk acceptance principle’ means the rules used in order to arrive at the conclusion whether or not the risk related to one or more specific hazards is acceptable;

‘code of practice’ means a written set of rules that, when correctly applied, can be used to control one or more specific hazards;

‘reference system’ means a system proven in use to have an acceptable safety level and against which the acceptability of the risks from a system under assessment can be evaluated by comparison;

‘risk estimation’ means the process used to produce a measure of the level of risks being analysed, consisting of the following steps: estimation of frequency, consequence analysis and their integration;

‘technical system’ means a product or an assembly of products including the design, implementation and support documentation; the development of a technical system starts with its requirements specification and ends with its acceptance; although the design of relevant interfaces with human behaviour is considered, human operators and their actions are not included in a technical system; the maintenance process is described in the maintenance manuals but is not itself part of the technical system;

‘catastrophic consequence’ means fatalities and/or multiple severe injuries and/or major damage to the environment resulting from an accident;

‘safety acceptance’ means status given to the change by the proposer based on the safety assessment report provided by the assessment body;

‘system’ means any part of the railway system which is subjected to a change whereby the change may be of a technical, operational or organisational nature;

‘notified national rule’ means any national rule notified by Member States under Council Directive 96/48/EC ( 7 ) or, Directive 2001/16/EC of the European Parliament and of the Council ( 8 ) and Directives 2004/49/EC and 2008/57/EC;

‘certification body’ means a certification body as defined in Article 3 of Regulation (EU) No 445/2011;

‘conformity assessment body’ means a conformity assessment body as defined in Article 2 of Regulation (EC) No 765/2008;

‘accreditation’ means accreditation as defined in Article 2 of Regulation (EC) No 765/2008;

‘national accreditation body’ means a national accreditation body as defined in Article 2 of Regulation (EC) No 765/2008;

‘recognition’ means an attestation by a national body other than the national accreditation body that the assessment body meets the requirements set out in Annex II to this Regulation to carry out the independent assessment activity specified in Article 6(1) and (2).

COMMISSION IMPLEMENTING REGULATION (EU) No 402/2013 of 30 April 2013 on the common safety method for risk evaluation and assessment and repealing Regulation (EC) No 352/2009 ANNEX I Appendix ANNEX II ANNEX III