machinery directive issues - ukwf
TRANSCRIPT
Machinery Directive Issues
CE Marking & Product Safety Consultancy
Nick Williams, Conformance Ltd.
Presentation to the UKWF 14 Oct 2010
Conformance - CE marking and product safety consultancy
Selected topics from the New Machinery Directive
Relationship with the Low Voltage Directive
Lifting equipment
Partly Completed Machinery
Co-ordinated machinery
Conformance - CE marking and product safety consultancy
Machinery Safety Directive 2006/42/EC
Replaces 98/37/EC (which itself replaces 89/392/EC)
Came into force on 29 December 2009
No transition period
Already been amended by 2009/12/EC (“The Pesticides Amendment”)
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Machinery Safety Directive – Main changes Clarifies the scope, and relationship with other directives Introduces some equipment not previously covered:
Lifts
Nail guns
New requirements for risk assessment and documentation
Better treatment of Partly Completed Machinery
No major changes in the technical requirements
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The Low Voltage Directive
Safety of all electrical equipment operating at voltages between 50V - 1000V ac (75V - 1500V dc)
Exclusions Equipment covered by ATEX Medical devices R&TTE Domestic plugs and sockets
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Machinery Directive – requirements for electrical equipment: 2006/42/EC Annex 1, pt 1.5.1.
“Where machinery has an electricity supply, it must be designed, constructed and equipped in such a way that all hazards of an electrical nature are or can be prevented.
The safety objectives set out in Directive 73/23/EEC shall apply to machinery. However, the obligations concerning conformity assessment and the placing on the market and/or putting into service of machinery with regard to electrical hazards are governed solely by this Directive”.
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Machinery Directive exclusions
2006/42/EC Article 1 (2)k:
electrical and electronic products falling within the following areas, insofar as they are covered by [The Low Voltage Directive]: household appliances intended for domestic use, audio and video equipment, information technology equipment, ordinary office machinery, low-voltage switchgear and control gear, electric motors;
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Machinery/LVD relationship
One or the other but never both
Most commercial/professional products with moving parts will need to be treated as machinery
The flexibility which used to be in 98/37/EC for a manufacturer to decide when a product presents mainly electrical risks is no longer present in 2006/42/EC
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‘machinery’
Scope (2006/42/EC Article 1)
Lifting accessories, chains, ropes, webbing
“an assembly of linked parts or components, at least one of which moves and which are joined together, intended for lifting loads and whose only power source is directly applied human effort;
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‘machinery’ Definitions (article 2)
‘lifting accessory’ means a component or equipment not attached to the lifting machinery, allowing the load to be held, which is placed between the machinery and the load or on the load itself, or which is intended to constitute an integral part of the load and which is independently placed on the market; slings and their components are also regarded as lifting accessories;
‘chains, ropes and webbing’ means chains, ropes and webbing designed and constructed for lifting purposes as part of lifting machinery or lifting accessories;
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Partly completed machinery
Definition (2006/42/EC Article 2 (g)): “means an assembly which is almost machinery but which
cannot in itself perform a specific application. A drive system is partly completed machinery. Partly completed machinery is only intended to be incorporated into or assembled with other machinery or other partly completed machinery or equipment, thereby forming machinery to which this Directive applies.”
If it will undergo a further risk conformity assessment procedure then it is partly completed machinery
Otherwise, it is complete machinery and must be CE marked
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Complete machinery
CE marked machinery must comply with all EHSRs when placed on the market or brought into service (machinery made for maker’s own use must be treated the same as
machinery supplied to a customer)
Instructions must ensure that the end user/assembler puts the machine together in a way which ensures all EHSRs are complied with
Complete machines supplied as kits need to be CE marked
A machine lacking only its drive system must be CE marked
CE mark Declaration of Conformity
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Declaration of Incorporation
“this machine does not comply with the directive and must be made to comply before it is put into service”
Used to be used as an excuse by manufacturers for not doing anything
2006/42/EC – now explicitly required to do same type of assessment as for complete machine
Must provide information on what EHSRs have been addressed, residual risks, information to go on DofI
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Declaration of Incorporation Identification of manufacturer, machinery and responsible person etc, as for
complete machinery
List of EHSRs which have been applied
Declaration that the technical documentation is completed in accordance with Annex VII(B)
Declaration of compliance with other Directives, where applicable
“an undertaking to transmit, in response to a reasoned request by the national authorities, relevant information on the partly completed machinery. This shall include the method of transmission and shall be without prejudice to the intellectual property rights of the manufacturer of the partly completed machinery”
Declaration that the machinery is incomplete and must not be put into service, etc.
Name and address of person authorised to compile the Technical File
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Assemblies of machinery
2006/42/EC Article 2 (a): “’Machinery’ means… assemblies of machinery… or partly
completed machinery… which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole”.
So a production line needs to be assessed as a whole as well as/instead of just as individual machines
If machines are already CE marked, generally can focus on the interfaces
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Key messages
Need to choose between Machinery and LVD Much equipment which was previously CE marked under the
LVD will now need to be CE marked under the Machinery Directive
Products which are used to suspend a load are machinery
Products with moving parts designed to be incorporated into other machinery may need a Declaration of Incorporation rather than a Declaration of Conformity
Someone needs to take responsibility for the complete installation