Harmonized standards are standards that describe how to verify the requirements established by directives in the field of safety, health and environmental protection.
Harmonized technical standards are developed by European standardization bodies: CENELEC for products in the electrical / electronic compartment, FIND for telecommunications products, CEN for products from other sectors.
Harmonized standards determine the suitability of a certain verification method to assume that the product complies 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 full application of the harmonized standards allows the manufacturer to place the product on the market without previously submitting the technical construction file to a notified body.
This allows, independently, the CE certification of the products and the development of the EU Declaration of Conformity .
The producer who is properly equipped can carry out the tests in his own laboratories or will become a reference laboratory.
yes, Directives are required. the manufacturer (if the product is manufactured in the EEA - European Economic Area) or importer (if the product is manufactured outside the EEA) is obliged to prepare a technical file for the CE marking containing the tests to which the product has been submitted.
The tests are specific for each product category and the technical file must be shown at the request of the national supervisory authorities.
the term "voluntary" there is still confusion.
EC directives do not make it mandatory to adopt harmonized standards, however it is always necessary to prove the conformity of the product with the requirements of the directives applicable to the product.
In fact, you can opt for other technical and procedural solutions to meet the essential requirements set out in the Directives. These solutions often require more in-depth technical assessments and the involvement of a notified body. Although more challenging, the latter is the only feasible one in the case of products that, due to their technical characteristics, cannot be evaluated by applying all of the harmonized standards.
The intervention of a notified body is required when all applicable harmonization standards are not fully implemented. The costs in this case are especially due to the fact that non-standard test methods must be evaluated in advance, developed and under development.
The fastest, least expensive and most protective route for the producer is the full adoption of all the harmonized standards applicable to the product. In fact, these are the "recipe" developed and tested over time to verify that the product conforms to directive requirements.
As a China Manufacturer, supplier, factory of electric toothbrush and oral irrigator/water flosser, Shenzhen Relish provides various types of electric toothbrush wholesale, dropshipping and OEM services. You can also wholesale water flosser/oral irrigator from Relish at factory price. We look forward to working with you.