Commission Implementing Regulation (EU) 2015/1136 of 13 July 2015 amending Implementing Regulation (EU) No 402/2013 on the common safety method for risk evaluation and assessment (Text with EEA relevance)

Implementing Regulation (EU) No 402/2013 is amended as follows: (1) Article 3 is amended as follows: (a) point (9) is replaced by the following: ‘(9) “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;’ (b) point (23) is replaced by the following: ‘(23) “catastrophic accident” means an accident typically affecting a large number of people and resulting in multiple fatalities;’ (c) the following points (32) to (37) are added: ‘(32) “systematic failure” means a failure that occurs repeatedly under some particular combination of inputs or under some particular environmental or application conditions; (33) “systematic fault” means an inherent fault in the specification, design, manufacturing, installation, operation or maintenance of the system under assessment; (34) “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; (35) “critical accident” means an accident typically affecting a very small number of people and resulting in at least one fatality; (36) “highly improbable” means an occurrence of failure at a frequency less than or equal to 10– 9 per operating hour; (37) “improbable” means an occurrence of failure at a frequency less than or equal to 10– 7 per operating hour.’ (2) Annex I is amended in accordance with the Annex to this Regulation.

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.