CE Marking legislation which covers safety requirements for machinery sold within the Single Market
BACKGROUND
Directive 2006/42/ EC (The Machinery Directive) Improving the free movement of machinery within the Single Market with a specific focus on safety.
SUMMARY
Machinery can be described as:
“an assembly, fitted with or intended to be fitted with a drive system other than directly applied human or animal effort, consisting of linked parts or components, at least one of which moves, and which are joined together for a specific application”.
The Directive applies to all machinery and to safety components, it contains a very wide definition of machine; covering products from hand held power tools right through to completely automated industrial production lines. The Directive does apply alongside other Directives and supplements safety standards in areas which are not covered, for example;
A medical product falling under one of the Medical Devices Directives may include a lifting function used to move patients; however this part of the product is not covered in any of the Medical Devices Directives. This aspect of the product would fall under the Machinery Directive.
Essential Health and Safety Requirements
Examples of health and safety requirements include:
- Machinery must be designed and constructed so that it is fitted for its function, and can be operated, adjusted and maintained without putting persons at risk when these operations are carried out under the conditions foreseen but also taking into account any reasonably foreseeable misuse thereof. The aim of measures taken must be to eliminate any risk throughout the foreseeable lifetime of the machinery including the phases of transport, assembly, dismantling, disabling and scrapping.
- In selecting the most appropriate methods, the manufacturer or his authorised representative must apply the following principles, in the order given:
- eliminate or reduce risks as far as possible (inherently safe machinery design and construction),
- take the necessary protective measures in relation to risks that cannot be eliminated,
- inform users of the residual risks due to any shortcomings of the protective measures adopted, indicate whether any particular training is required and specify any need to provide personal protective equipment.
- When designing and constructing machinery and when drafting the instructions, the manufacturer or his authorised representative must envisage not only the intended use of the machinery but also any reasonably foreseeable misuse thereof.
- The machinery must be designed and constructed in such a way as to prevent abnormal use if such use would engender a risk. Where appropriate, the instructions must draw the user’s attention to ways which experience has shown might occur in which the machinery should not be used.
- Machinery must be designed and constructed to take account of the constraints to which the operator is subject as a result of the necessary or foreseeable use of personal protective equipment.
- Machinery must be supplied with all the special equipment and accessories essential to enable it to be adjusted, maintained and used safely.
See Annex I of the Directive for more ful details.
Conformity Assessment Procedures
The conformity of most machinery continues to be certified by the manufacturer himself. The list of categories of machinery subject to particular conformity assessment procedures is set out in Annex IV; however, manufacturers of Annex IV machinery will have a wider choice of procedure:
- or Annex IV machinery designed according to harmonised standards covering all the relevant essential requirements, the manufacturer will be able to certify the conformity of the machinery himself;
- for other Annex IV machinery, the manufacturer will be able to choose between EC type-examination by a Notified Body or approval by a Notified Body of his full quality assurance system.
The Directive includes an obligation for the Member States to monitor the performance of Notified Bodies and to withdraw or suspend the notification if a Body fails to carry out its duties properly.
Please see our CE Marking section for more information on procedures.
Low Voltage Directive (LVD) or Machinery Directive?
(Click on here for more information on LVD)
Certain equipment may satisfy the definition of machinery but also fall under the scope of the LVD. Both Directives are mutually exclusive so a product can apply to one or the other, but never both.
The Machinery Directive explicitly states that the following products fall under the LVD:
- Household appliances intended for domestic use,
- Audio and video equipment,
- Information technology equipment,
- Ordinary office machinery,
- Low-voltage switchgear and control gear,
- Electric motors;
If your product does fall under the Machinery Directive the electrical safety provisions under Annex 1 are actually identical to the rules laid out in LVD, so the safety requirements are exactly the same under both Directives. The only difference will be is that the on the Declaration of Conformity the Machinery Directive will be cited and not the LVD.
MORE INFORMATION
Europa Website:
http://ec.europa.eu/enterprise/sectors/mechanical/documents/legislation/machinery/
http://ec.europa.eu/enterprise/sectors/mechanical/machinery/
CE Marking:
