# 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), Article 1

Extent: E+W+S+N.I.

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.

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Source: https://www.legislation.gov.uk/eur/2015/1136/article/1 (the official version)
Page: https://openlegislation.uk/eu-regulation-2015-1136/article-1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.