Common Directives for CE Marking

List of Directvives

What is a Directive? An European directive can be regarded as an European law, and - unlike it's name may assume - is legally binding for everyMember State of the European Union. Through transposition into the national legislation of the Member States, persons and companies are subject to the requirements of the European directives. The CE marking Directives are documents published by the European Commission that lay out the protection requirements (design safety) and the administrative requirements for products intended to be manufactured or imported into the EU. Different EU directives are as follows: Directive No. Directive Title 2006/95/EC Low Voltage Equipment Directive (LVD) 90/396/EEC Appliances burning gaseous fuels 2000/9/EC Cableway installations designed to carry persons 89/106/EEC Construction products 2004/108/EC Electro Magnetic Compatibility (EMC) 94/9/EC Equipment & protective systems in potentially explosive atmosphere 93/15/EEC Explosives for civil uses 95/16/EC Lifts 98/37/EC Machinery safety 2004/22/EEC Measuring instruments 90/385/EEC Medical devices: Active implantable 93/42/EEC Medical devices: General 98/79/EC Medical devices: In vitro diagnostic 92/42/EEC New hot-water boilers fired with liquid or gaseous fluids 90/384/EEC Non-automatic weighing instruments 94/62/EC Packaging and packaging waste 89/686/EEC Personal protective equipment 97/23/EC Pressure equipment 1999/5/EC Radio and telecommunications terminal equipment 94/25/EC Recreational craft 87/404/EEC Simple pressure vessels 88/378/EEC Toys safety Directive 73/23/EEC -- Low Voltage Electrical Equipment (LVD): The "Electrical Equipment" means any equipment designed for use with a voltage rating of between 50 and 1000 V for alternating current (A.C.)and between 75 and 1500 V for direct current (D.C.). Therefore, this Directive is called often "Low Voltage Directive" which applies to the vast majority of electrical equipment in everyday use. The Electrical Equipment may be placed on the market only if it does not endanger the safety of persons, domestic animals or property. Today, when manufacturers are faced with highly competitive markets, shortening product life cycles and continuing economic pressures, they are turning to independent certification agencies to provide the confidence and market advantage that is vital to their business needs. The certification agencies assist by issuing certificates in a recognized format. CE Marking will indicate that the equipment complies with the requirements of all relevant directives. The manufacturers or brand name or trade mark should be clearly printed on the electrical equipment or, where that is not possible, on the packaging. The electrical equipment, together with its component parts should be made in such a way as to ensure that it can be safely and properly assembled and connected. The electrical equipment should be so designed and manufactured as to ensure that protection against the hazards is assured providing that the equipment is used in applications for which it was made and is adequately maintained. Some of the common products which are covered in Low Voltage Directive (LVD) - 2006/95/EC are as follows: § Information Technology Equipments § Telecommunication Equipments § Laboratory, Test & Measurement Equipments § Control Equipments § Household Appliances § Audio/Video Equipments § Industrial Electronic Equipments EQUIPMENT AND PHENOMENA OUTSIDE THE SCOPE OF THE DIRECTIVE 1. Electrical equipment for use in an explosive atmosphere 2. Electrical equipment for radiology and medical purposes 3. Electrical parts for goods and passenger lifts 4. Electricity meters 5. Plugs and socket outlets for domestic use 6. Plugs and socket outlets for domestic use 7. Electric fence controllers 8. Radio-electrical interference 9. Specialized electrical equipment, for use on ships, aircraft or railways, which complies with the safety provisions drawn up by international bodies in which the Member States participate. Directive 98/37/EC – Machinery Directive (MD): Definitions There are mainly three definitions of machines as follows: “An assembly of linked parts or components, at least one of which moves, with the aid of power, joined together for a specific application, in particular for the processing, treatment, moving or packaging of a material…” is called machinery. “An assembly of machines which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole” “Interchangeable equipment modifying the function of a machine, which is placed on the market for the purpose of being assembled with a machine or a series of different machines or with a tractor by the operator himself in so far as this equipment is not a spare part or a tool.” Procedure § Inspection and Testing to the applicable, European Harmonized Standards § Compilation of Technical Construction File (TCF) § Drawing up of the Manufacturer’s Declaration of Conformity (MDoC) § If the machine falls under Annexure IV of MD, Notified Body is required, otherwise, there is no involvement of any third party § Annual Product Surveillance Directive 93/42/EEC -- Medical Devices: A Medical Device is defined in Directive (93/42/EEC) as: Any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for the proper application, intended by the manufacturer to be used for human beings for the purpose of: o Diagnosis, prevention, monitoring, treatment or alleviation of a disease, an injury or a handicap. o Investigation, replacement or modification of the anatomy or of a physiological process. o Control of conception The following products are excluded from the scope of the Directive: o In vitro diagnostic devices o Active implantable devices covered by Directive 90/385/EEC o Medicinal products covered by Directive 65/65/EEC o Cosmetic products covered by Directive 76/768/EEC o Personal protective equipment covered by Directive 89/686/EEC o Tissues or cells of human origin o Viable tissue or cells of animal origin Directive 88/378/EEC -- Toys Directive: Definition “A 'toy' shall mean any product or material designed or clearly intended for use in play by children of less than 14 years of age. …” Procedure § Inspection and Testing to the applicable, European Harmonized Standards § Compilation of Technical Construction File (TCF) § Drawing up of the Manufacturer’s Declaration of Conformity (MDoC) § If toys do not conform, in whole or in part, to the prescribed standards, a Notified Body is required to confirm that the toys conform to the essential requirements prescribed in the directive, otherwise, there is no involvement of any third party § Annual Product Surveillance Directive 2004/108/EC -- Electromagnetic Compatibility (EMC): Every electrical device emits radio noise. CE marking requires that the emissions should be within limits. Emissions are of two types, conducted emissions and radiated emissions. Similarly, sensitive electronic equipment should be capable of operating in EM noise environment, without serious degradation of performance. Tests include, electrostatic discharge, transient overvoltage, surge tests, etc. Procedure § Testing to the applicable, European Harmonized Standards § Compilation of Technical Construction File (TCF) § Drawing up of the Manufacturer’s Declaration of Conformity (MDoC) § Certification under EMC is entirely under Certification Body and there is no role of Notified Body § Annual Product Surveillance Directive 89/106/EEC -- Construction Products: 1. The Construction Products Directive contains essential requirements relating to "materials intended for construction". 2. 'Construction product' means any product which is produced for incorporation in a permanent manner in construction works, including both buildings and civil engineering works. 3. Construction works including both buildings and civil engineering works. 4. The EC mark signifies that products satisfy the requirements of this directive. 5. It is for the manufacturer, or his agent established in the Community, to take responsibility for affixing the EC mark on the product itself, on a label attached to it, on its packaging, or on the accompanying commercial documents. 6. The manufacturer, or his agent established in the Community, shall be responsible for the attestation that products are in conformity with the requirements of a technical specification 7. Where it is established that the EC mark has been affixed to a product which does not satisfy, or no longer satisfies, this Directive, the Member State in which conformity was attested shall ensure that, if necessary, the use of the EC mark is forbidden and unsold products are withdrawn, or marks obliterated, until such time as the product concerned is brought back to conformity.

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