Article 1

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

1. (1)

   Article 3 is amended as follows:

   1. (a)

      point (9) is replaced by the following:

      1. (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;’

   2. (b)

      point (23) is replaced by the following:

      1. (23)

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

   3. (c)

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

      1. (32)

         ‘“systematic failure” means a failure that occurs repeatedly under some particular combination of inputs or under some particular environmental or application conditions;

      2. (33)

         “systematic fault” means an inherent fault in the specification, design, manufacturing, installation, operation or maintenance of the system under assessment;

      3. (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;

      4. (35)

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

      5. (36)

         “highly improbable” means an occurrence of failure at a frequency less than or equal to 10^{– 9} per operating hour;

      6. (37)

         “improbable” means an occurrence of failure at a frequency less than or equal to 10^{– 7} per operating hour.’

2. (2)

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