Implementing Regulation (EU) No 402/2013 is amended as follows:

Article 3 is amended as follows:

point (9) is replaced by the following:

“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;’

point (23) is replaced by the following:

“catastrophic accident” means an accident typically affecting a large number of people and resulting in multiple fatalities;’

the following points (32) to (37) are added:

“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;

“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;

“critical accident” means an accident typically affecting a very small number of people and resulting in at least one fatality;

“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.’

Annex I is amended in accordance with the Annex to this Regulation.

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 ANNEX