What are the harmonized standards?
The harmonized standards are the rules that describe how to verify the requirements laid down by the directives on safety, health and environmental safeguard.
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 is determined in the harmonised standards?
Harmonised standards determine the suitability of a certain method of verification to presume conformity with directive. These standards are called "harmonised", when their references shall be published in the official journal of the European communities (OJEC) in relation to a directive. The 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. Otherwise, can contact a trusted test lab.
EC directives are mandatory?
Yes, the directives are mandatory. The manufacturer (If the product is 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 do not make it compulsory to adopt harmonized standards, However it is always necessary to demonstrate the conformity of the product with the requirements of the directives applicable to the product. You can choose other technical and procedural solutions to meet the essential requirements laid down by the directives. These solutions typically require more in-depth technical assessments and the involvement of a notified body. Although more challenging, the latter is the only way forward in the case of products which by their characteristics cannot be measured by applying in full the harmonized standards.
When to consult a notified body?
The involvement of a notified body is required when all applicable harmonised standards do not run in full. The costs in this case are more especially since the test methods out of the standard must be previously evaluated, developed and implemented.
What is the fastest way to make the product comply with directives?
The fastest route, cheaper and more protective for the producer is the full adoption of all harmonised standards applicable to the product, These are the recipes developed and tested over time in order to check the conformity of the product with the requirements of the directives.