Search, find and obtain harmonised standards in an easy, intuitive and convenient way
Genorma.com offers you a very convenient and easy way to identify, find and obtain harmonised standards or European standards providing presumption of conformity regarding EU Directives and regulations, as well as other European and international standards supporting the application and compliance with relevant pieces of EU legislation.
What are harmonised standards? What is a harmonised standard?
Harmonised standards are an important cornerstone of the Single European Market for industrial and consumer products. According to the recent EU Strategy on Standardisaton: 'Standards are at the core of the EU single market. Over the last 30 years, the European Standardisation System has delivered more than 3600 harmonised standards allowing companies to demonstrate compliance with EU law, plus many more European standards and technical specifications to promote inter-operability, the safety of EU citizens and protection of the environment'.
They are also amongst the most used and implemented standards in Europe. For instance, the famous Quality Management System standard (EN ISO 9001) is a harmonised standard that is implemented by millions of companies all over the world and certified by more than one million organizations.
Harmonised standards are useful in a wide range of applications: they support product safety, environmental performance, accredited conformity assessment, public procurement, or market surveillance, just to mention some of them.
Regulation (EU) 1025/2012 on European standardisation defines harmonised standards as European standards adopted on the basis of a request made by the European Commission for the application of Union harmonisation legislation (in particular, the so-called New Legislative Framework Directives and Regulations and other New Approach legislation).
This means that any European standard that is developed in the context of a standardisation request for the application of Union harmonisation legislation is a harmonised standard.
Many people believe that all harmonised standards provide presumption of conformity in the context of New Legislative Framework / New Approach Directives and Regulations, but this is not strictly and legally true. Only some of the harmonised standards provide such legal effect, and this is an important concept to clarify.
Which harmonised standards confer presumption of conformity?
Taking into account the provisions of Article 10 of Regulation (EU) 1025/2012 on European Standardisation, and considering relevant articles of the different New Legislative Framework pieces of legislation, presumption of conformity with the applicable requirements in the corresponding European Union harmonisation legislation is conferred by harmonised standards the reference of which has been cited in the Official Journal of the European Union (OJEU) in support of the application of such legislation.
In other words, to provide presumption of conformity, a European standard has to be developed in the context of a standardisation request (associated with a New Legislative Framework /New Approach Directive or Regulation) and has to be cited in the Official Journal in the context of such Union harmonisation Directive or Regulation.
How can I know if a standard is a Harmonised standard? Which standards are harmonised standards? Which standards provide presumption of conformity?
As explained above, not all harmonised standards provide presumption of conformity, but they can be used to assess the safety or level of alignment of products with the requirements in the corresponding Union legislation. Only those harmonised standards, the reference of which has been cited in the Official Journal in support of relevant Directives or Regulations provide presumption of conformity for products conforming to such standards.
Genorma.com provides you with updated summaries of lists of harmonised standards for the different New Legislative Framework Directives and regulations (see also at the end of this page), so you can easily check the status of any standard.
Currently, the following updated summaries of the lists of harmonised standards providing presumption of conformity according to relevant requirements in support of the application of the EU legislation are provided:
- Summary of the standards providing presumption of safety according to the General Product Safety Directive (GPSD) - Directive 2001/95/EC. Please note these standards are not called "harmonised standards" but perform a similar function under GPSD.
- Summary of the list of harmonised standards providing presumption of conformity under the Low Voltage Directive (LVD) - Directive 2014/35/EU.
- Summary of the list of harmonised standards providing presumption of conformity under the Machinery Safety Directive (MD) - Directive 2006/42/EC.
- Summary of the list of harmonised standards providing presumption of conformity under the Medical Devices Regulation (MDR) - Regulation 2017/745.
- Summary of the list of harmonised standards providing presumption of conformity under the In Vitro Diagnostics Medical Devices Regulation (IVDR) - Regulation 2017/746.
- Summary of the list of harmonised standards providing presumption of conformity under the Electromagnetic Compatibility Directive - Directive 2014/30/EU.
- Summary of the list of harmonised standards providing presumption of conformity under the potentially explosive atmospheres Directive (ATEX) - Directive 2014/34/EU.
- Summary of the list of harmonised standards providing presumption of conformity under the Recreational Craft Directive - Directive 2013/53/EU.
- Summary of the list of harmonised standards providing presumption of conformity under the Pressure Equipment Directive - Directive 2014/68/EU
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