Harmonised Standards

Simplified Access to EU Harmonised Standards

Harmonised standards are the backbone of the Single European Market, ensuring safety, interoperability, and regulatory compliance across industries. As highlighted in the EU Strategy on Standardisation: “Standards are at the core of the EU single market.” Over the past 30 years, more than 3,600 harmonised standards have been introduced, enabling businesses to comply with EU legislation while enhancing consumer safety and environmental protection.

For Simplified Access to EU Harmonised Standards, Genorma.com provides a centralised platform offering up-to-date listings of harmonised standards, making it easy for businesses and authorities to quickly find the relevant standards.

Why Harmonised Standards Matter

Harmonised standards are among the most widely adopted in Europe. A prime example is the globally recognised Quality Management System standard (EN ISO 9001), implemented by millions of companies worldwide and certified by over one million organizations. These standards play a crucial role in ensuring product safety, environmental sustainability, and regulatory alignment across various sectors, including public procurement and market surveillance.

What Defines a Harmonised Standard?

Under Regulation (EU) 1025/2012, a harmonised standard is a European standard developed in response to a request from the European Commission. These standards facilitate compliance with Union harmonisation legislation, including New Legislative Framework Directives and Regulations. However, not all harmonised standards automatically provide a presumption of conformity with EU laws—only those cited in the Official Journal of the European Union (OJEU) hold this legal status.

Identifying Standards That Confer Presumption of Conformity

A European standard provides presumption of conformity only if:

It is developed as part of a standardisation request linked to a New Legislative Framework Directive or Regulation.

It is officially cited in the OJEU to support the application of the relevant legislation.

To easily determine if a standard is harmonised and whether it grants presumption of conformity, visit Genorma.com—a centralised platform offering up-to-date harmonised standard listings.

Some examples of a series of product-specific harmonised standards

EN 60335 Series - Household and similar electrical appliances - Safety, harmonised under the Low Voltage Directive (LVD - Directive 2014/35/EU) and/or the Machinery Safety Directive (Directive 2006/42/EC on Machinery)
EN 71 Series - Safety of Toys, harmonised under the Toys Safety Directive (Directive 2009/48/EC on the Safety of Toys)
EN 81 Series - Safety rules for the construction and installation of lifts and service lifts, harmonised under the Lifts Directive
EN 13630 Series- Explosives for civil uses (Directive 2014/28/EU for explosives for civil uses)
EN 16910 Series - Railway applications - Rolling stock (Directive 2008/57/EC on the interoperability of the rail system)
EN 1093 Series - Safety of machinery - Evaluation of the emission of airborne hazardous substances (Directive 2006/42/EC on Machinery)
EN 60204 Series - Safety of machinery - electrotechnical - (Directive 2006/42/EC on Machinery)
EN 60598 Series - Luminaires, harmonised under both the LVD (Directive 2014/35/EU for electrical equipment designed for use within certain voltage limits - Low Voltage Directive)
EN 60601 Series, harmonised under the Medical Devices Regulation (Regulation 2017/745 on medical devices)
EN 62368 Series - Audio/video, information and communication technology equipment, harmonised under both the LVD (Directive 2014/35/EU for electrical equipment designed for use within certain voltage limits - Low Voltage Directive) and the Radio Equipment Directive or RED (Directive 2014/53/EU on radio equipment)

Accreditation Harmonised Standards

As we indicated above, some famous management system standards are, in fact, harmonised standards as well. This is the case for standards such as ISO 9001, ISO 14001, and other management system standards.

In addition, many standards are used to establish or assess the requirements for the competence of conformity assessment bodies (testing, calibration, inspection and certification) such as:

EN ISO/IEC 17025:2017 - General requirements for the competence of testing and calibration laboratories
EN ISO/IEC 17065:2012 - Conformity assessment - Requirements for bodies certifying products, processes and services
EN ISO/IEC 17011:2017 - Conformity assessment - Requirements for accreditation bodies accrediting conformity assessment bodies
EN ISO/IEC 17020:2012 - Conformity assessment - Requirements for the operation of various types of bodies performing inspection
EN ISO/IEC 17021-1:2015 - Conformity assessment - Requirements for bodies providing audit and certification of management systems - Part 1: Requirements
EN ISO/IEC 17024:2012 - Conformity assessment - General requirements for bodies operating certification of persons
EN ISO 14064-1:2019 - Greenhouse gases - Part 1: Specification with guidance at the organization level for quantification and reporting of greenhouse gas emissions and removals

Summary of the list of Harmonised Standards under the Recreational Craft Directive

List of Harmonised standards supporting the application of the Recreational Craft Directive (Directive 2013/53/EU) European standards, RCD harmonized standards, RCD standards providing presumption of conformity