| Does It Apply To My Products? |
The extent of the CE mark directives introduced within the European Union cover a wide-ranging group of products. Directives have already been issued including:
- Machinery
- Telecommunications
- Gas Appliances
- Medical Devices
- Pressure Vessels
- In-Vitro Diagnostic Medical Devices
- Pressure Equipment
- Low Voltage Products (50 - 1000V AC and 75 - 1500V DC)
- Electromagnetic Compatibility
- Recreational Pleasure Craft
- Personal Protective Equipment
- Toys
Further Directives are to become mandatory in the future covering
- Construction Products
- Hot Water Boilers
- Additional Telecommunications Equipment
- Some types of weighing machines
There are also many other regulations, specifications and standards concerned with fire, health and environmental hazards which have to be complied with. The European Community is steadily replacing national rules and regulations with European wide directives. The CE Mark can only be used on products which meet all the appropriate Directives. If an exporter can show a product meets the appropriate European Directive then the products can be sold freely throughout Europe. Atlantic Bridge Limited has been set up to assist exporters to Europe to meet these Europe wide safety standards.
A list of directives can be viewed from here » click to review them «
As a general guide line, if your equipment complies with any of the following headings it is likely to require to be CE marked to meet the legal requirements of the European Union covering sales within the EU.
- Operates by electricity
- Operates by gas
- Information Technology hardware
- Telecommunications equipment
- Safety equipment
- Personal protective clothing and other similar personal safety devices
- Medical Devices
- Custom written software for the operation of medical devices
Some directives exclude products of certain categories, however, this is usually because they have their own specific directive. In addition to which some products may be covered by more than one directive e.g. Electrical equipment may be covered by both the Low voltage and EMC Directives.
You can download some standard extracts from some of the guidance documents below. The source is the UK Government Department of Trade and Industry and covers advice issued on the directives for machinery, low voltage, electromagnetic compatibility and gas appliances.
Atlantic Bridge Ltd provides a product assessment service. We will assess your products provide you with a report, and a list of the relevant CE marking directives that you will need to meet to satisfy European Regulations. This report will additionally identify the steps you will need to implement to enable you to comply with the CE marking regulations for sales within Europe.
electro
THE ELECTROMAGNETIC
COMPATIBILITY REGULATIONS 1992 - (S.11992/2372)
DIRECTIVE 89/336 and 92/31
Entry into force: 28 October 1992
Primary legislation: the European Communities Act 1972
Coverage: apparatus liable to cause electromagnetic disturbance or the performance of which is liable to be affected by such disturbance.
'Apparatus' is defined, for the purposes of the Regulations, as an electrical or electronic appliance or system consisting of a finished product or products having an intrinsic function which is intended for the end user, and is supplied or intended for supply or taken into service or intended to be taken into service as a single commercial unit.
'Electromagnetic disturbance' is defined as 'any electromagnetic phenomenon which may degrade the performance of a device, unit of equipment or system. An electromagnetic disturbance may be electromagnetic noise, an unwanted signal or a change to the propagation medium itself'. Thus all electromagnetic frequencies are involved and all electromagnetic phenomena as set out in Annex A of this document and Schedule 2 of the Regulations.
A signal or emission which is a necessary function, or a consequence of the operation, of applicable apparatus shall not be taken to be electromagnetic disturbance under the terms of the EMC Regulations if, in relation to that apparatus, that signal or emission is permitted and does not exceed the limits specified by:
- The applicable EMC European harmonised standard; or
- A technical report or technical certificate issued by a competent body for the purposes of a technical construction file; or
- An EC type examination certificate issued by a notified body (in the case of radio communications transmitting equipment); or
- A term, provision or limitation of a license granted under Section 1 of the 1949 Wireless Telegraphy Act, or regulations made under that section of the Act; or
- Where the applicable apparatus is an item of radio-communication transmitting equipment, or apparatus other than wireless telegraphy apparatus which operates by emitting electromagnetic radiation in the radio frequency spectrum, the permitted signal or emission does not exceed the limits specified by regulations made under Section 10 of the 1949 Wireless Telegraphy Act concerning radio frequency spectrum planning or implementation of European Community obligations.
If applicable, go to next section
lowvoltage
The Low Voltage Electrical
Equipment (Safety) Regulations 1989 came into force on 1
June 1989.
Directive ref 73/23 and 93/68
PRODUCTS AFFECTED
The Regulations apply to all electrical equipment, except for those exemptions shown below (including any electrical apparatus or device), that is designed or adapted for use between 50 and 1,000 volts (in the case of alternating current) or 73 and 1.500 volts (in the case of direct current).
This is much wider in scope than the earlier Electrical Equipment (Safety) Regulations 1973 covering not only domestic equipment but also equipment for use at work. Electrical equipment to which these Regulations apply. therefore, may also be covered by the Health and Safety at Work Act 1974 and the Electricity at Work Regulations 1989.
The Regulations also cover the supply of the component parts of electrical equipment which, if used as intended, result in the equipment failing to comply with the Regulations.
EXEMPTIONS
The Regulations do not apply to:
- Equipment for use in an explosive atmosphere
- Equipment for radiology and medical purposes
- Electricity supply maters
- Plugs. socket outlets and adaptors for domestic use
- Fence controllers
- Parts for goods lifts and passenger lifts
- Specialised 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- Electrical equipment supplied for export to a country which is not a
member of the European Community
SUPPLIERS AFFECTED
The regu1ations apply to all persons in the business supply chain whether or not die business is one of supplying electrical equipment. They affect:
- Manufacturers
- Importers
- Wholesalers
- Retailers (including mail order traders)
- Persons who hire out electrical equipment
Persons (including auctioneers) who sell second hand electrical equipment in the course of trade.
If applicable, go to next section
machine
The Supply of Machinery (Safety)
Regulations 1992 (S.l.1992/3073) as amended
(S.l.1994/2063)c
Machinery Directive
89/392 and 91/368 and 93/44 Entry into force: 1 January 1993 Coverage:
MACHINERY DESCRIBED AS:
An assembly of linked parts or components, at least one of which moves, with the appropriate actuators, control and power circuits, joined together for a specific application, in particular for the processing, treatment, moving or packaging of a material;
An assembly of machines which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole; and interchangeable equipment modifying the function of a machine which is supplied 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;
SAFETY COMPONENTS FOR MACHINERY, DESCRIBED AS:
Components which are supplied separately to fulfill a safety function when in use and the failure or malfunctioning of which endangers the safety or health of exposed persons.
If applicable, go to next section
gas
THE GAS APPLIANCES (Safety) REGULATIONS 1992
(S.I. 711) Directive 90/396
THIS DIRECTIVE SHALL APPLY TO :
"Appliances burning gaseous fuels used for cooking heating, hot water production, refrigeration, lighting or washing and having, where applicable, a normal water temperature not exceeding 105C hereinafter referred to as 'appliances'.
Forced draught burners and heating bodies to be equipped with such burners will also be considered as appliances,"
APPLIANCES:
Safety devices. controlling devices or regulating devices and sub-assemblies. other than forced draught burners and heating bodies to be equipped with such burners separately marketed for trade use and designed to be incorporated into an appliance burning gaseous fuel or assembled to constitute such an appliance, hereinafter referred to as 'fittings'.
Appliances specifically designed for use in industrial processes carried out on industrial premises are excluded from the scope defined in paragraph 1.
For the purposes of this Directive, 'gaseous fuel' means any fuel which is in a gaseous state at a temperature of 15C under a pressure of 1 bar.
For the purposes of this Directive, an appliance is said to be 'normally used' when it is correctly installed and regularly serviced in accordance with the manufacturer's instructions, used with a normal variation in the gas quality and a normal fluctuation in the supply pressure, and used in accordance with its intended purpose or in a way that can be reasonably foreseen.
If applicable, go to next section
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Acknowledgements: UK Government Department of Trade and Industry
Atlantic Bridge Limited,
Atlantic House, PO Box 4800, Earley, Reading, Berkshire, RG5 4GB, England. Email: info@atlanticbridge.co.uk
Telephone : +44 (0) 118.969.7047 Fax : +44 (0) 118.901.4411 Devizes Office
Telephone : +44 (0) 1380.848170 Fax : +44 (0) 1380.840152