What are harmonized technical standards?
Harmonized standards are standards that describe how to verify the requirements set by directives on safety, health and environmental protection.
The wording "harmonized standard" is synonymous with "harmonized standard".
Who develops the harmonized standards?
The harmonized technical standards are developed by the European Standardization Bodies: CENELEC for products in the electrical/electronic sector, ETSI for products in the telecommunications sector, CEN for products from other sectors.
What is determined in the harmonized standards?
Harmonized standards determine the suitability of a certain verification method to presume product conformity with the directive.
These standards are called "harmonized" when their references are published in the Official Journal of the European Communities (GUCE) in relation to a directive.
The complete application of the harmonized standards allows the manufacturer to place the product on the market without previously submitting the technical manufacturing dossier to a notified body.
This allows you to independently carry out the CE certification of the products and the editorial team of EU declaration of conformity.
The manufacturer who is suitably equipped can carry out the tests in his own laboratories, otherwise he can contact a trusted laboratory.
Are the EC Directives mandatory in nature?
Yes, the Directives are mandatory. The manufacturer (if the product is manufactured in the EEA - European Economic Area) or the importer (if the product is manufactured outside the EEA) is obliged to draw up a technical file for the CE marking containing the tests to which the product has been subjected .
The tests are specific for each product category and the technical file must be presented upon request to the national supervisory authorities.
Are CE standards voluntary?
There is still confusion about the term "voluntary".
The EC Directives do not make it mandatory to adopt harmonized standards, however it is always necessary to demonstrate the compliance of the product with the requirements of the directives applicable to the product.
In fact, it is possible to choose other technical and procedural solutions to comply with the essential requirements established by the directives. These solutions typically require more in-depth technical evaluations and the involvement of a Notified Body. Although more demanding, the latter is the only way forward in the case of products which, due to their technical characteristics, cannot be assessed by applying the harmonized standards in full.
When to contact a Notified Body?
The intervention of a notified body is necessary when all applicable harmonized standards are not fully implemented. The costs in this case are higher especially because the non-standard test methods must be previously evaluated, developed and fine-tuned.
What is the fastest route to obtaining the CE mark?
The fastest, least expensive and most protective path for the manufacturer is the full adoption of all the harmonized standards applicable to the product, these in fact are the "recipes" developed and tested over time to verify the conformity of the product with the requirements of the directives.
Sicom Testing offers a complete service for CE certification of the products.
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