What are the harmonized standards?
Are the rules that specify, for each requirement set by the directive, the characteristics of safety of products and related tests in which must be carried out.
By whom are processed the harmonized standards?
Harmonised standards are drawn up by the European standards organisations: CENELEC electrical/electronic industry products, ETSI for products in the telecommunications sector, CEN for the products of other sectors.
What determine harmonised standards?
Harmonised standards determine the suitability of a certain method of verification to presume conformity with directive. These standards are called "harmonised", When references are published in the official journal of the European communities (OJEC) in relation to a directive. L ’ full application of harmonised standards allows the producer to place the product on the market without subjecting the technical construction file to a notified body. Also allows the manufacturer, If suitably equipped, to carry out internal audits in test labs. Should it be can turn to a trusted test lab.
EC directives are mandatory?
Yes, the directives are mandatory. The manufacturer (If manufactured in the EEA – European Economic Area) or importer (If the product is imported) is obliged to draw up a technical dossier containing the tests to which the product has been subjected. The tests are specific for each product category and the technical file must be produced on demand to the national supervisory authorities.
EC rules are voluntary?
On the term “volunteer” There is still confusion. EC directives does not make it obligatory to respect harmonised standards HOWEVER it is always necessary to demonstrate the conformity of the product with the requirements of the directive by adopting other technical specifications. Is voluntary, then, l ’ application of the standard but not the ’ obligation to prove their products ' conformance to harmonised standards. In a complex and constantly evolving technological product market, write rules is not easy. Although there is a constant update (on average every two years), There can always be produced which for some specific technical characteristic cannot be assessed following harmonized standards in full. For this reason, the directives do not make it compulsory to apply harmonised standards provided that proves the compliance of the product with the requirements of the directive. If you don't follow all applicable harmonized standards, the procedure becomes more complicated and requires the involvement of a notified body ’.
When to consult a notified body?
L ’ involvement of a notified body is required when you are not running in full all applicable harmonized standards. The costs in this case are more especially because the test method out from standard must first be developed and then developed.
What is the fastest way to make the product comply with directives?
The fastest route, cheaper and more protective for the manufacturer's full application of harmonised standards or recipes developed and tested to presumption of conformity with the requirements of the directives.