- accident
means an unwanted or unintended sudden event or a specific chain of such events which have harmful consequences;
- accreditation
means an attestation by a national accreditation body that a conformity assessment body meets the requirements set by designated standards and, where applicable, any additional requirements including those set out in relevant sectoral schemes, to carry out a specific conformity assessment activity;
- actors
means all parties which are, directly or through contractual arrangements, involved in the application of this Regulation;
- approved body
has the meaning provided in regulation 2 of the Railways (Interoperability) Regulations 2011;
- 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;
- authority carrying out railway safety functions
means an authority established in a member State in accordance with article 16.1 of the Directive or Article 16.1 of the Recast Safety Directive.”
- barrier
means a technical, operational or organisational risk control measure outside the system under assessment that either reduces the frequency of occurrence of a hazard or mitigates the severity of the potential consequence of that hazard;
- catastrophic accident
means an accident typically affecting a large number of people and resulting in multiple fatalities;
- causes
means actions, omissions, events or conditions, or a combination thereof, which led to the accident or incident;
- certification body
has the meaning provided in regulation 2 of the Railways and Other Guided Transport (Safety) Regulations 2006;
- code of practice
means a written set of rules that, when correctly applied, can be used to control one or more specific hazards;
- common safety methods
(“CSMs”) means the methods developed to describe how safety levels and achievement of safety targets and compliance with other safety requirements are assessed;
- conformity assessment body
means a body that performs conformity assessment activities including calibration, testing, certification and inspection;
- critical accident
means an accident typically affecting a very small number of people and resulting in at least one fatality;
- cross-border service
means a service for the carriage of passengers or goods by way of the tunnel system;
- cross-border UK-issued ECM certificate
means a certificate issued in the United Kingdom to an entity in charge of maintenance by an accredited or recognised body or by a safety authority in accordance with the retained 2019 EU ECM Regulation;”
- designated body
has the meaning provided in regulation 2 of the Railways (Interoperability) Regulations 2011;
- designated standard
has the meaning provided in Article 3A;
- entity in charge of maintenance
means an entity in charge of maintenance of a vehicle, and registered as such in the National Vehicle Register;
- fatalities and weighted serious injuries
(“FWSIs”) means a measurement of the consequences of significant accidents combining fatalities and serious injuries, where 1 serious injury is considered statistically equivalent to 0.1 fatalities;
- hazard
means a condition that could lead to an accident;
- hazard identification
means the process of finding, listing and characterising hazards;
- 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;
- highly improbable
means an occurrence of failure at a frequency less than or equal to 10-9 per operating hour;
- improbable
means an occurrence of failure at a frequency less than or equal to 10-7 per operating hour;
- incident
means any occurrence, other than an accident, associated with the operation of trains and affecting the safety of operation;
- infrastructure manager
means any body or undertaking that is responsible in particular for establishing and maintaining railway infrastructure, or a part thereof, as defined in Article 3 of Directive 91/440/EEC, which may also include the management of infrastructure control and safety systems.
- 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;
- Intergovernmental Commission
has the meaning provided in section 49(1) of the Channel Tunnel Act 1987;
- investigation
means a process conducted for the purpose of accident and incident prevention which includes the gathering and analysis of information, the drawing of conclusions, including the determination of causes and, when appropriate, the making of safety recommendations;
- level crossing users
means all persons using a level crossing to cross a railway line by any means of transportation or by foot;
- maintenance workshop
means a mobile or fixed entity composed of staff, including those with management responsibility, tools and facilities organised to deliver maintenance of vehicles, parts, components or sub-assemblies of vehicles;
- management system
means either a safety management system as defined in the Railways and Other Guided Transport Systems (Safety) Regulations 2006, or the system of maintenance of entities in charge of maintenance complying with requirements laid down in paragraph 3 of Regulation 18A of the Railways and Other Guided Transport Systems (Safety) Regulations 2006 or paragraph 55B of the Schedule to the Channel Tunnel (Safety) (Amendment) Order 2013;
- monitoring
means the arrangements put in place by railway undertakings, infrastructure managers or entities in charge of maintenance to check their management system is correctly applied and effective;
- national accreditation body
means the sole body in the United Kingdom that performs accreditation in accordance with Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9th July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93;
- national reference value
(“NRV”) means a reference measure indicating the maximum tolerable level for a railway risk category;
- national rule
means NTRs as defined in regulation 2 of the Railways (Interoperability) Regulations 2011 and national safety rules as defined in regulation 2 of the Railways (Safety Management) Regulations (Northern Ireland) 2006;
- national safety authority
means one or both of— (a) a safety authority;
- NTSN
has the meaning provided in regulation 2 of the Railways (Interoperability) Regulations 2011;
- others
means all persons who are not passengers, staff or employees including the staff of contractors, level crossing users or unauthorised persons on railway premises;
- passenger train-km
means the unit of measure representing the movement of a passenger train over one kilometre;
- passenger-km
means the unit of measure representing the transport of one passenger by rail over a distance of one kilometre;
- proposer
means one of the following— (a) a railway undertaking or an infrastructure manager;
- railway system
means the totality of the subsystems in Northern Ireland for structural and operational areas, as defined in paragraph 2(1) to 2(7) of Annex II to Directive 2008/57/EC, as well as the management and operation of the system as a whole;
- railway undertaking
means a public or private undertaking, licensed according to applicable legislation, the activity of which is to provide transport of goods and/or passengers by rail on the basis that the undertaking must ensure traction;
- recognised standardisation body
means any one of the following organisations— a the European Committee for Standardisation (CEN);
- 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);
- 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;
- release to service
means the assurance given to the fleet maintenance manager by the entity delivering the maintenance that maintenance has been delivered according to the maintenance orders;
- retained 2019 EU ECM Regulation
means Commission Implementing Regulation (EU) 2019/779 laying down detailed provisions on a system of certification of entities in charge of maintenance of vehicles pursuant to Directive (EU) 2016/798 of the European Parliament and of the Council and repealing Commission Regulation (EU) No 445/2011, as it has effect in the UK after IP completion day;”
- return to operation
means the assurance, based on a release to service, given to the user, such as a railway undertaking or a keeper, by the entity in charge of maintenance that all appropriate maintenance works have been completed and the wagon, previously removed from operation, is in a condition to be used safely, possibly subject to temporary restrictions of use. 4 1 The maintenance system is to be composed of the following functions— a the management function, which supervises and coordinates the maintenance functions referred to in paragraphs (b) to (d) and ensures the safe state of the freight wagon in the railway system;
- 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 acceptance criteria
means the terms of reference by which the acceptability of a specific risk is assessed;
- 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;
- risk analysis
means systematic use of all available information to identify hazards and to estimate the risk;
- risk assessment
means the overall process comprising a risk analysis and a risk evaluation;
- risk category
means one of the railway risk categories specified by Article 7(4)(a) and (b) of the Directive;
- 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;
- risk evaluation
means a procedure based on the risk analysis to determine whether an acceptable level of risk has been achieved;
- risk management
means the systematic application of management policies, procedures and practices to the tasks of analysing, evaluating and controlling risks;
- risk to society as a whole
means the collective risk to all categories of persons listed in Article 7(4)(a) of the Directive;
- safety
means freedom from unacceptable risk of harm;
- safety acceptance
means the status given to the change by the proposer based on the safety assessment report provided by the assessment body;
- safety assessment report
means the document containing the conclusions of the assessment performed by an assessment body on the system under assessment;
- safety enhancement plan
means a plan to implement the organisational structure, responsibilities, procedures, activities, capabilities and resources required to reduce the risk for one or more risk categories;
- safety management system
means the organisation and arrangements established by an infrastructure manager or a railway undertaking to ensure the safe management of its operations;
- 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;
- safety requirements
means the safety characteristics (qualitative or quantitative, or when needed both qualitative and quantitative) necessary for the design, operation (including operational rules) and maintenance of a system in order to meet legal or company safety targets;
- staff or employees including the staff of contractors
means any persons whose employment is in connection with a railway and is at work at the moment of the accident;
- 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;
- systematic failure
means a failure that occurs repeatedly under some particular combination of inputs or under some particular environmental or application conditions;
- systematic fault
means an inherent fault in the specification, design, manufacturing, installation, operation or maintenance of the system under assessment;
- technical specification
means a document that prescribes technical requirements to be fulfilled by a product, process, service or system and which lays down one or more of the following— a the characteristics required of a product, including— i levels of quality, performance, interoperability, environmental protection, health, safety or dimensions;
- technical system
means a product or an assembly of products including the design, implementation and support documentation;
- track-km
means the length measured in kilometres of the railway network where each track of a multiple track railway line is to be counted;
- train-km
means the unit of measure representing the movement of a train over one kilometre;
- unauthorised persons on railway premises
means any persons present on railway premises where such presence is forbidden, with the exception of level crossing users;
- vehicle
means a railway vehicle suitable for circulation on its own wheels on railway lines, with or without traction.