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Article 40

Harmonised Standards

1. High-risk AI systems or general purpose 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 Chapter 2 of this Title or, as applicable, with requirements set out in Article 4a and Article 4b, to the extent those standards cover those requirements.

2. When issuing a standardisation request to European standardisation organisations in accordance with Article 10 of Regulation 1025/2012, the Commission shall specify that standards are coherent, clear and drafted in such a way that they aim to fulfil in particular the following objectives:

  1. ensure that AI systems placed on the market or put into service in the Union are safe and respect Union values and strengthen the Union's open strategic autonomy;
  1. promote investment and innovation in AI, including through increasing legal certainty, as well as competitiveness and growth of the Union market;
  1. enhance multistakeholder governance, representative of all relevant European stakeholders (e.g. industry, SMEs, civil society, researchers);
  1. contribute to strengthening global cooperation on standardisation in the field of AI that is consistent with Union values and interests.

The Commission shall request the European standardisation organisations to provide evidence of their best efforts to fulfil the above objectives.

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