Harmonized Standards Presumption of Conformity

European standards (norms), are usually based on lEC standards. For example EMC standard EN 61000-4-2 (Immunity to Electrostatic Discharge) is based on lEC 1000-4-2, and product safety standard EN 60335 (Safety of Household Appliances) is based on lEC 335. All European standards (ENs) go through rigorous review by any and all interested parties. National authorities, whose primary responsibility is public safety, participate in the review process. 

National enforcement authorities are obliged to recognize that products in conformity with harmonized standards ( EN listed in OJEC) and transposed into national standards are presumed to conform to the ERs of the directives. 

When a product becomes suspect the national enforcement authority will typically use the EN or equivalent national standards (usually with the help of a notified body) to evaluate the product s conformity or lack thereof. Taking any route other than the harmonized standards approach may work against diose who do not conform with the recognized standards, since compliance with these standards is universally recognized and expected by the enforcement authorities, notified bodies, and customers. 

Meeting the rules set out in the European standards is the minimum criterion, and most manufacturers should not only meet but also endeavor to exceed these requirements. Even when the product conforms to the relevant standards, the authorities are not barred from taking the appropriate actions against manufacturers where there is evidence that a product is dangerous (see General Product Safety in Chapter 2). 

Notes The above quotes are taken word for word from the relevant EU Directives. The LVD, EMC, and Machinery Directives are amended by 93/68/EEC adding the CE Marking. Directive 90/683/EEC, mentioned in 73/23/EEC, is replaced by 93/465/EEC. Lohbeck. 

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