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Harmonised standard

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A European standard adopted on a Commission standardisation request. Under the AI Act, conformity with one whose reference is published in the Official Journal gives a presumption of conformity with the requirements it covers; publication by CEN-CENELEC alone does not 1. As of 2026-09-24, none is yet cited 2.

Developed in
ch. 22, How presumption of conformity works
Chapters
ch. 08, Regulatory Map · ch. 22, Principles & Standards
Contrast with
Common specifications · Harmonized Structure (ISO)
Source
2 numbered references, listed below

Where it is used

12 chapters of the Body of Knowledge use the term. Each link opens the first section that does.

  • Presumption of conformity

    The legal effect under AI Act Article 40: a high-risk system or GPAI model that conforms with OJ-cited harmonised standards is presumed to meet the…

  • GPAI Code of Practice

    The voluntary instrument (published 10 July 2025) that general-purpose-AI providers use to demonstrate compliance with their AI Act obligations until…

  • CEN-CENELEC JTC 21

    The joint technical committee of the European standardisation organisations CEN and CENELEC that drafts the AI Act harmonised standards, including EN 18286 on…

  • ISO/IEC 42001

    The ISO/IEC standard (2023) that specifies requirements for an AI management system, certifiable by accredited bodies.

  • AI Act (EU)

    Regulation (EU) 2024/1689, the EU's horizontal, risk-tiered law for AI, amended by the Digital Omnibus.

Sources

  1. [1] Regulation (EU) 2024/1689 (AI Act), consolidated text as amended by Regulation (EU) 2026/1744 (Digital Omnibus on AI, in force 27 Jul 2026; definitions in Art. 3, incl. 3(1), 3(3) to 3(14), 3(14b), 3(20), 3(22), 3(23), 3(29) to 3(32), 3(49), 3(55) to 3(57), 3(60), 3(61), 3(63), 3(68); Arts. 4, 5, 6 (incl. 6(3) third subparagraph, profiling), 9, 10, 11, 13, 14, 15, 17, 22 to 27 (incl. 26(11)), 40, 41, 43, 47, 48, 50, 53 (incl. 53(1)(c)), 55, 57, 60, 72, 73, 86; Annexes I, III, IV). Publications Office of the EU (EUR-Lex). 2026-07-27. https://eur-lex.europa.eu/eli/reg/2024/1689/2026-07-27/eng (verified: primary)
  2. [2] Standardisation of the AI Act (no harmonised standard yet referenced in the Official Journal, so no presumption of conformity from any standard, ISO/IEC 42001 included; page last updated 2026-08-03; none found in the Publications Office index on 2026-09-24). European Commission. 2026-08-03. https://digital-strategy.ec.europa.eu/en/policies/ai-act-standardisation (verified: primary)

Definitions of legal terms paraphrase the cited text, which governs. Dated statements are as of .

Cite this term

García Aibar, J. (2026). Harmonised standard. In AI Governance Engineering: The Thesis & Body of Knowledge (v0.5.0), Glossary. https://doi.org/10.5281/zenodo.22956197. https://aigovernanceengineer.com/glossary/harmonised-standard. CC BY 4.0

BibTeX

@misc{aige2026harmonisedstandard,
  author  = {Jorge García Aibar},
  title   = {{Harmonised standard}},
  note    = {Glossary, AI Governance Engineering: The Thesis \& Body of Knowledge, version 0.5.0},
  year    = {2026},
  doi     = {10.5281/zenodo.22956197},
  url     = {https://aigovernanceengineer.com/glossary/harmonised-standard}
}