Proceedings of the
35th European Safety and Reliability Conference (ESREL2025) and
the 33rd Society for Risk Analysis Europe Conference (SRA-E 2025)
15 – 19 June 2025, Stavanger, Norway
The Need for Systematic Approaches in Risk Assessment of Safety-Critical AI-Applications in Machinery
1Federal Institute for Occupational Safety and Health (BAuA), Germany.
2Fraunhofer Institute for Experimental Software Engineering IESE, Germany.
3Federal Network Agency (Bundesnetzagentur), Germany.
ABSTRACT
The integration of artificial intelligence (AI) into safety-critical machinery applications in industrial environments presents substantial challenges for conformity assessment and safety certification. Unlike traditional control systems, AI's data-driven nature and non-trivial behaviour complicates the assurance of compliance with established safety standards. This contribution highlights the specific challenges with respect to the new European Machinery Regulation (2023) and the AI Act (2024). We present corresponding developments in standardisation and research and discuss to what extent safety cases can underpin the safety evaluation and conformity assessment for today's applications in industry.
Keywords: Risk assessment, AI, Assurance case, Safety case, Machinery.
