Chapter IIIHigh-Risk
Article 40
Harmonised Standards and Standardisation Deliverables
Plain-Language Summary
Mandates the development of harmonised standards for high-risk AI. Where harmonised standards are published in the Official Journal, providers complying with them are presumed to meet the corresponding requirements of the AI Act.
Keywords
harmonised standardsstandardisationEuropean standardisation organisationspresumption of conformitytechnical standards
Legal Text
Article 40 — Harmonised Standards and Standardisation Deliverables 1. High-risk AI systems which are in conformity with harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union shall be presumed to be in conformity with the requirements set out in Section 2 of this Chapter, to the extent those standards cover those requirements. 2. The Commission shall, without undue delay, issue standardisation requests to the relevant European standardisation organisations for the drafting of harmonised standards that satisfy the requirements referred to in Articles 8 to 15 in conformity with Regulation (EU) No 1025/2012. 3. The European standardisation organisations shall adopt harmonised standards within the deadline set in the standardisation request. They shall in particular identify appropriate approaches and processes for validating high-risk AI systems and testing relevant aspects of high-risk AI systems, such as accuracy, robustness and cybersecurity.