Where can I find harmonized standards?
The references of harmonized standards must be published in the Official Journal of the European Union. The purpose of this website is to provide access to the latest lists of references of harmonized standards and other European standards published in the Official Journal of the European Union (OJEU).
How many Harmonised standards are there?
It promotes standards, as a way to better regulation. There are more than 20.000 standards in the catalogue of European standards. A harmonised standard (EN) is a European standard developed by one of the European standardisation organisations CEN, CENELEC, or ETSI on request of the European Commission.
Which standards are Harmonised?
A harmonised standard is a European standard developed by a recognised European Standards Organisation: CEN, CENELEC, or ETSI. It is created following a request from the European Commission to one of these organisations.
How do I know if a standard is Harmonised?
Harmonized standards are those European standards whose references have been published in the Official Journal of the European Communities with respect to a particular directive. They can then be used to derive a presumption of conformity with the essential requirements of that directive.
Is ISO 13485 a harmonized standard?
The updated version of the EU quality system standard EN ISO 13485, which is relevant for the whole of the medtech industry, is now formally recognized as a “harmonized” standard in the context of the EU’s Medical Device Regulation.
Is ISO 20417 harmonized?
ISO 20417:2021 is also on the list of standards to be harmonized under the EU Medical Device Regulation (MDR). It is intended to replace EN 1041:2008+A1:2013, which described the requirements for the information to be provided under the EU Medical Device Directive (MDD).
Is ISO 14971 harmonized?
Regulatory requirements for risk management EN ISO 14971:2012 is harmonized to the European Medical Device Directives (AIMDD, IVDD and MDD), which allows presumption of conformity to the Directives.
What relationship do Harmonised European standards have with regard to the machinery directive?
Harmonised standards are one of the means to provide presumption of conformity with theessential health and safety requirements as defined in Annex I of the Machinery Directive. These harmonized standards are very important for machine manufacturers.
Is ISO 15223 a harmonized standard?
It should be noted that EN ISO 15223-1:2016 is harmonized to the Directives only. ISO 20417 includes additional details on how to meet the Regulation GSPRs with cross-reference to standardized formats. Harmonization will provide further insight for manufacturers as to how this standard supports conformity to the GSPRs.
Has ISO 14971 2019 been harmonized?
While this important standard is not currently harmonised (i.e. not published in the Official Journal), the version awaiting harmonisation, EN ISO 14971:2019+A11:2021, includes two informative Annexes that are an integral part of the standard.
What is a harmonisation directive?
Harmonisation, also known as standardisation or approximation, refers to the determination of EU-wide legally binding standards to be met in all Member States. The creation of an internal market, which has been one of the main objectives of the EU, requires the harmonisation of some rules concerning inter-State trade.