Article 1
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.