The Need for Systematic Approaches in Risk Assessment of Safety-Critical AI-Applications in Machinery

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.