AI Assurance DirectoryIndustrial machinery AI — Regulation 2023/1230, ISO 10218 and IEC 61508
Informational only, not professional or legal advice. Facts are linked to the source we checked; statuses can change after the date above.
Regulation (EU) 2023/1230 recital 12 says the regulation should cover the safety risks stemming from new digital technologies. Recital 55 limits extra third-party assessment of safety-function software to systems with a fully or partially self-evolving behaviour using machine learning approaches ensuring safety functions, and not to software incapable of learning or evolving. The Commission may add Annex III AI health-and-safety requirements for Article 6(1) high-risk systems; those delegated acts shall apply by 2 August 2028. The AI Act Service Desk lists the regulation as Annex I Section B item 21.
ISO 10218-1:2025 addresses industrial robots as partly completed machinery. The catalog is not applicable to military (defence), airborne and space robots or medical robots.
IEC 61508-1:2010 remains the basic safety publication for E/E/PE safety functions. Ansys SCADE Suite names KCG as certified for IEC 61508 at SIL 3. Ansys medini analyze names IEC 61508 among the standards it is tailored to. KUKA iiQKA.OS2 names ISO 10218:2025 and the machinery regulations (MACH REG). Universal Robots PolyScope names EN ISO 10218-1:2011, ISO 10218-1:2025 clause 5.1.16 and EU Machinery Regulation (EU 2023/1230).
Sources
- Regulation (EU) 2023/1230 on machinery - EUR-Lex
- ISO 10218-1:2025 - Robotics — Safety requirements — Part 1: Industrial robots - ISO
- IEC 61508-1:2010 - Functional safety of E/E/PE safety-related systems — Part 1 - IEC
- AI Act Service Desk: Annex I - European Commission
- Regulation (EU) 2023/1230 (consolidated 27 July 2026) - EUR-Lex