Standards Development

Scope

This document aims to inform organizations for the application of the harmonised standards in support of the AI Act.

This document provides information on the harmonised standards developed by CEN-CENELEC Joint Technical Committee 21, in response to the standardization request by the European Commission (C(2025) 3871). This includes the relationship of the harmonised standards to each other and the AI Act and provides an overview of key terms and definitions and related concepts.

This document is informative and does not contain guidance or requirements. The document will not lead to presumption of conformity. This document will reference European Commission guidelines where appropriate.

This document is aimed at all types of organisations providing high-risk AI systems and who are likely to use the harmonised standards when placing products or services on the EU market.

Note: As work on the harmonised standards is not completed, the information contained in this document is indicative and subject to change.

Purpose

This project aims to inform and enable industry to prepare for the use of the harmonised standards in support of the AI Act. Compliance to harmonised standards provides presumption of conformity to regulation which is one possible way to approach compliance with the AI Act.

The project provides stakeholders with an overview of the different standards developed by JTC 21 in support of the standardization request M/593 and their relationship. The project is answering the European Commission’s request (JTC 21/WG 2 N871 - EC4) to explain the relationship between harmonised standards responding to the harmonization request M/593.

The project will enable industry for the timely preparation for the implementation of the AI Act for high-risk AI systems by:

- Providing an overview and introduction to the harmonized standards: The document will list which standards will be published in support of which standardization requests. The document will gather the scopes as already agreed in the different JTC 21 projects of standards in a single overarching document. The document will introduce the different standards but will not contain any requirements. The document will not lead to presumption of conformity.

- Explaining the relationship between the standards: The document will explain the relationship between different standards so industry can understand the dependencies and evaluate the need for joint implementation. The project will update the architecture of standards to reflect the current state.

It is proposed to develop as fast as possible a deliverable that will inform organisations on what is coming. The project deliverable proposed is a TR, as it can be developed in a very short time span.

This project will not include any requirements and will not lead to presumption of conformity. No new terms and definitions will be introduced. The document can include an overview of key stabilised terms and definitions without giving any interpretation to EU legally defined terms. The TR will centralize and leverage existing content of the standards on which consensus is achieved to provide an overview and introduction to the standards and to explain the relationship between the standards in support of the AI Act.