# Commission Implementing Regulation (EU) No 402/2013 of 30 April 2013 on the common safety method for risk evaluation and assessment and repealing Regulation (EC) No 352/2009 (Text with EEA relevance), Division 2.5.7: The risk associated with the failures of functions of technical systems referred to in point 2.5.5 shall be considered as acceptable if the following requirements are also fulfilled:

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

(a)Compliance with the applicable ... design targets has been demonstrated;
(b)The associated systematic failures and systematic faults are controlled in accordance with safety and quality processes commensurate with the ... design target applicable to the technical system under assessment and defined in commonly acknowledged relevant standards;
(c)The application conditions for the safe integration of the technical system under assessment into the railway system shall be identified and registered in the hazard record in accordance with point 4. In accordance with point 1.2.2, these application conditions shall be transferred to the actor responsible for the demonstration of the safe integration.

---
Source: https://www.legislation.gov.uk/eur/2013/402/annex/I/division/2/division/2.5/division/2.5.7 (the official version)
Page: https://openlegislation.uk/eu-regulation-2013-402/annex-I/division-2/division-2.5/division-2.5.7
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.