Primer on Standards - OEK - OVE

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ChapterCE Marking, ConformityAssessment & MarketSurveillance under theNew ApproachIdentifying the CE MarkingThe EU’s New Approach to Technical Harmonization and Standards aims to ensurethat only products meeting the requirements set by the EU legislation can circulatewithin the EU. The CE Marking was therefore chosen as an easily identifiable labelto indicate compliance with these requirements. The CE Marking is a declarationof conformity with European legislation designed to show all parties concernedthat a product meets all the appropriate requirements specified by New ApproachDirectives. It may be compared to a passport for entrance into the EU market.CE in the term CE Marking stands for Conformité Européenne (European Conformity)38 CENELEC. <strong>Primer</strong> on Standards
and as stated above, it only applies to products that are governed by at least oneof the New Approach Directives. Nevertheless, it must be stressed that it iscompulsory to affix it on all products for which one of these Directives applies. Ifa product is covered by more than one New Approach Directive, the CE Markingsymbolyzes that the product conforms to all New Approach Directives applyingto it.Harmonized Standards and the Presumption of ConformityThe main feature of harmonized standards is the fact that they grant presumptionof conformity with European legislation and consequently the product can enterthe whole European market without the legal obligation to show any otherequivalent marks or guarantees.Presumption of conformity is the legal principle relating to harmonized standardsthat explains the relationship between the legislative and the standardizationprocesses. Thanks to this interaction, the European Commission and the EuropeanStandards Bodies, CEN, CENELEC and ETSI, cooperate in order to produce harmonizedstandards. A contractual relationship, broadly known as a mandate, is thendeveloped stipulating that the Standards Body will produce standards (electrotechnicalstandards in the case of CENELEC) that will provide a technical solutionor a technical interpretation complying with the essential requirements definedin a given New Approach Directive.When the standard is completed and the conditions of the Commission's mandateare met, the Commission publishes the reference of the standard in the OfficialJournal of the European Communities, OJEC. Once this notice is published, theEuropean Standard, now called European Harmonized Standard, will providepresumption of conformity. A manufacturer using a harmonized standard in thedesign and/or production process of a product is presumed to be in conformitywith the corresponding essential requirements set by the European Directives.The application of harmonized standards, which grant presumption of conformity,remains voluntary in the field of New Approach Directives. Consequently, a productmay be manufactured directly on the basis of the essential requirements. The keyis always this: Applying a standard is voluntary; complying with the law is mandatory.Introduction to the Basic Principles of the CE MarkingThe CE Marking may certainly be called the passport to Europe for products. CE-Marking a product that falls under one of the New Approach Directives is not anoption for the manufacturer, it is simply required by law. All manufacturers,Uncovering the mysteries of standardization in Europe 39
Page 1: Primer on Standard
Page 4 and 5: ContentsIntroductionChapter 1Introd
Page 6 and 7: IntroductionThis primer is intended
Page 8 and 9: ChapterIntroducingCENELECCENELEC, t
Page 10 and 11: CENEL, the European Committee for t
Page 12 and 13: The Central Secretariat handles all
Page 14 and 15: Documents used as a basis for CENEL
Page 16 and 17: ChapterThe EuropeanStandardWhat is
Page 18 and 19: European trade and consumers. Havin
Page 20 and 21: CENELEC Standards are of the highes
Page 22 and 23: ChapterUnderstandingthe CenelecStan
Page 24 and 25: In the case of a European standard
Page 26 and 27: New work arises at European level v
Page 28 and 29: ChapterThe CenelecConformityAssessm
Page 30 and 31: Mutual Recognition Agreements signe
Page 32 and 33: ChapterThe EuropeanStandardization
Page 34 and 35: Legal framework of the New Approach
Page 36 and 37: The Role of European Standards in N
Page 38 and 39: New Approach Directives for which C
Page 42 and 43: egardless of the product’s origin
Page 44 and 45: Some other products, mostly those i
Page 46 and 47: Market are governed by one (or some
Page 48 and 49: manufacturers are often approached
Page 50 and 51: COOPERATING PARTNERSAIECAPIELCEACEC
Page 52: For more information:35 rue de Stas

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