Harmonised standards (AI Act)
European technical standards that, when followed, give a presumption that a high-risk AI system meets the AI Act requirements.
The AI Act says what must be achieved (risk management, quality data, documentation…) but not how in detail. That "how" is set out in harmonised standards: technical standards requested by the Commission and drafted by the European standardisation bodies (CEN and CENELEC, in their JTC 21 committee).
Their big advantage is the presumption of conformity (Article 40): if a system meets a harmonised standard published in the Official Journal, it is presumed to meet the requirements that standard covers. They address risk management, data quality, logging, accuracy, cybersecurity and quality management systems, such as EN 18286.
If standards are delayed, the Commission can adopt common specifications (Article 41). Tracking them is essential for high-risk providers.
Reference: Arts. 40-41 AI Act
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← Back to the glossaryUpdated: October 2026 · Informational content, not legal advice.