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This Directive applies to all machinery and safety components. A machine is defined as "an assembly of linked parts or components, at least one of which moves...". There are exclusions such as military equipment, machines which are already covered by other, more specific, directives and equipment which falls within the scope of the Low Voltage Directive. The Regulations are enforced in the UK by the Health and Safety Executive for machinery used in the workplace, and the Trading Standards Service for machinery used at home. Penalties for non-compliant machinery can be severe.
The vast majority of machinery may be self-certified by the manufacturer who must meet the administrative and protection requirements of the Directive. The essential protection requirements demand that machine manufacturers identify the hazards their products contain and assess the risks these hazards present to users. Any risks identified must be reduced to as low a level as is practicable. Detailed requirements are laid out in a series of safety standards. The administrative provisions of the Directive require manufacturers to produce a Technical File, sign a Declaration of Conformity and label the product with certain markings.
Annex IV contains a list of about 15 types of machine which are subject to special procedures. These must either be made fully in accordance with the provision of the standard, or be subjected to type examination by a Notified Body.
Manufacturers of partly completed machines intended to be incorporated into another machine or which cannot function unless built into a production line must sign a 'Declaration of Incorporation'. This basically states that the machinery is incomplete and must be made to fully conform with the requirements of the Directive before it is brought into service.
In the European Union and in many other markets, machinery cannot be put into service without having gone through a conformity assessment process carried out by an Independent Notified Body. This process encompasses both the equipment and its components, according to complex harmonized standards. Across the European Union (EU), the installation of new machinery is subject to the 98/37/EC Directive, which defines precise rules for CE Marking, based on a number of machine operation health and safety requirements.
An approval process must be applied by an Independent Notified Body to ensure the safety of machinery (including its safety components) and to prevent potential dangers from occurring. In relation to this directive, it is mandatory to obtain the compliance declaration and authorization of CE Marking.
Machinery listed in Machinery Directive
- Circular saws (single or multi-blade) for working with wood and analogous materials or for working with meat and analogous materials.
- Sawing machines with fixed tool during operation, having a fixed bed with manual feed of the workpiece or with a demountable power feed.
- Sawing machines with fixed tool during operation, having a manually operated reciprocating saw-bench or carriage.
- Sawing machines with fixed tool during operation, having a built-in mechanical feed device for the work-pieces, with manual loading and/or unloading.
- Sawing machines with movable tool during operation, with a mechanical feed device and manual loading and/or unloading.
- Hand-fed surface planing machines for woodworking.
- Thicknessers for one-side dressing with manual loading and/or unloading for woodworking.
- Band-saws with a fixed or mobile bed and band-saws with a mobile carriage, with manual loading and/or unloading, for working with wood and analogous materials or for working with meat and analogous materials.
- Combined machines of the types referred to in 1 to 4 and 7 for working with wood and analogous materials.
- Hand-fed tenoning machines with several tool holders for woodworking.
- Hand-fed vertical spindle moulding machines for working with wood and analogous materials.
- Portable chainsaws for woodworking.
- Presses, including press-brakes, for the cold working of metals, with manual loading and/or unloading, whose movable working parts may have a travel exceeding 6 mm and a speed exceeding 30 mm/s.
- Injection or compression plastics-moulding machines with manual loading or unloading.
- Injection or compression rubber-moulding machines with manual loading or unloading.
- Machinery for underground working of the following types:
- machinery on rails: locomotives and brake-vans,
- hydraulic-powered roof supports,
- internal combustion engines to be fitted to machinery for underground working.
- Manually-loaded trucks for the collection of household refuse incorporating a compression mechanism.
- Guards and detachable transmission shafts with universal.
- Vehicles servicing lifts.
- Devices for the lifting of persons involving a risk of falling from a vertical height of more than three metres.
- Machines for the manufacture of pyrotechnics.
Machinery excluded by Machinery Directive (i.e. Other directive(s) may apply.)
- Machinery whose only power source is directly applied manual effort, unless it is a machine used for lifting or lowering loads,
- Machinery for medical use used in direct contact with patients,
- Special equipment for use in fairgrounds and/or amusement parks,
- Steam boilers, tanks and pressure vessels,
- Machinery specially designed or put into service for nuclear purposes which, in the event of failure, may result in an emission of radioactivity,
- Radioactive sources forming part of a machine,
- Storage tanks and pipelines for petrol, diesel fuel, inflammable liquids and dangerous substances,
- Means of transport, i.e. vehicles and their trailers intended solely for transporting passengers by air or on road, rail or water networks, as well as means of transport in so far as such means are designed for transporting goods by air, on public road or rail networks or on water. Vehicles used in the mineral extraction industry shall not be excluded,
- Seagoing vessels and mobile offshore units together with equipment on board such vessels or units,
- Cableways, including funicular railways, for the public or private transportation of persons,
- Agricultural and forestry tractors, as defined in Article 1(1) of Directive 74/150/EEC (7)
- Machines specially designed and constructed for military or police purposes,
- Lifts which permanently serve specific levels of buildings and constructions, having a car moving between guides which are rigid and inclined at an angle of more than 15 degrees to the horizontal and designed for the transport of:
- persons and goods;:
- goods alone if the car is accessible, that is to say, a person may enter it without difficulty, and fitted with controls situated inside the car or within reach of a person inside,
- Means of transport of persons using rack and pinion rail mounted vehicles,
- Mine winding gear,
- Theatre elevators,
- Construction site hoists intended for lifting persons or persons and goods.
For most machinery or safety components the responsible person must assemble a technical file. For listed machinery or safety components manufactured in accordance with transposed harmonised standards the responsible person must follow the procedures below:
- Provide a Notified Body with a copy of the Technical File for the Notified Body to record and keep.
- Provide a Notified Body with a copy of the Technical File for the Notified Body to review and certificate.
- Submit an example of the machinery or safety component to a Notified Body for EC type examination.
- For listed machinery or safety components not manufactured in accordance with transposed harmonised standards the responsible person must submit an example of the machinery or safety component to a Notified Body for EC type examination.
The application for EC type-examination shall be lodged by the manufacturer or by his authorised representative established in the Community, with a single notified body in respect of an example of the machinery.
The application shall include:
- the name and address of the manufacturer or his authorised representative established in the Community and the place of manufacture of the machinery.
- a technical file comprising at least:
- an overall drawing of the machinery together with drawings of the control circuits,
- full detailed drawings, accompanied by any calculation notes, test results, etc., required to check the conformity of the machinery with the essential health and safety requirements,
- a description of methods adopted to eliminate hazards presented by the machinery and a list of standards used,
- a copy of the instructions for the machinery,
- for series manufacture, the internal measures that will be implemented to ensure that the machinery remains in conformity with the provisions of the Directive.
It shall be accompanied by a machine representative of the production planned or, where appropriate, a statement of where the machine may be examined.
The documentation referred to above does not have to include detailed plans or any other specific information as regards the sub-assemblies used for the manufacture of the machinery unless knowledge of them is essential for verification of conformity with the basic safety requirements.
FAQ - Frequently Asked Questions
Is compliance with the 98/37/EC directive enough to apply CE marking on machinery?
Every manufacturer needs to make sure that the machine(s) they wants to sell on the European market is/are compliant, not just with the EU 98/37/EC Directive, but also with all other directives which may apply to it. Bureau Veritas has developed a multi-directive approach to help clients manage these requirements efficiently.
What about the new EU 2006/42/EC directive? Is it replacing the 98/37/EC one?
This new directive will replace the 98/37/EC Directive at the end of 2009. Bureau Veritas will provide its clients with the necessary guidance throughout this change process.
How Pro Can Help You
Testing at PRO laboratory, you can:
- save your money and reduce the time to European market;
- eliminate your oversea shipment cost;
- gain knowledge and updates of European Directives and Standards;
- get more confident of your product before test for we offer construction review;
- rapidly and closely cooperate with our testing engineer while testing is undergo;
- control your CE Marking schedule;
- confidently declare EC conformity.
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