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Risk level: high Title III — High-Risk AI Systems Standards and Conformity

Article 40 — Harmonised Standards and Results of Standardisation

Harmonised standards and standardisation deliverables 1. High-risk AI systems or general-purpose AI models 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 in accordance with Regulation (EU) No 1025/2012 shall be presumed to be in conformity with the requirements...

Article 40
Harmonised standards and standardisation deliverables
1. High-risk AI systems or general-purpose AI models 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 in accordance with
Regulation (EU) No 1025/2012 shall be presumed to be in conformity with the requirements set out in Section 2 of this
Chapter or, as applicable, with the obligations set out in of Chapter V, Sections 2 and 3, of this Regulation, to the extent that
those standards cover those requirements or obligations.
2. In accordance with Article 10 of Regulation (EU) No 1025/2012, the Commission shall issue, without undue delay,
standardisation requests covering all requirements set out in Section 2 of this Chapter and, as applicable, standardisation
requests covering obligations set out in Chapter V, Sections 2 and 3, of this Regulation. The standardisation request shall
also ask for deliverables on reporting and documentation processes to improve AI systems’ resource performance, such as
reducing the high-risk AI system’s consumption of energy and of other resources during its lifecycle, and on the
energy-efficient development of general-purpose AI models. When preparing a standardisation request, the Commission
shall consult the Board and relevant stakeholders, including the advisory forum.
When issuing a standardisation request to European standardisation organisations, the Commission shall specify that
standards have to be clear, consistent, including with the standards developed in the various sectors for products covered by
the existing Union harmonisation legislation listed in Annex I, and aiming to ensure that high-risk AI systems or
general-purpose AI models placed on the market or put into service in the Union meet the relevant requirements or
obligations laid down in this Regulation.
The Commission shall request the European standardisation organisations to provide evidence of their best efforts to fulfil
the objectives referred to in the first and the second subparagraph of this paragraph in accordance with Article 24 of
Regulation (EU) No 1025/2012.
3. The participants in the standardisation process shall seek to promote investment and innovation in AI, including
through increasing legal certainty, as well as the competitiveness and growth of the Union market, to contribute to
strengthening global cooperation on standardisation and taking into account existing international standards in the field of
AI that are consistent with Union values, fundamental rights and interests, and to enhance multi-stakeholder governance
ensuring a balanced representation of interests and the effective participation of all relevant stakeholders in accordance with
Articles 5, 6, and 7 of Regulation (EU) No 1025/2012.

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