In a recent court case settlement in Hennepin County, Minnesota, the jury learned that a safety device, similar to the light beams that prevent garage doors from closing on people, had been installed for 10 years in machines destined for Europe but not in those destined for the US market. This difference, considered a key piece of evidence, resulted in crushing of a worker's skull between a moving mechanical arm and a conveyor belt below it, on his third day on the job. The jury awarded the worker $35.3 million in damages in the first phase of the lawsuit.
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Why the difference between the US and European machine? Europe has outlined its essential safety requirements in the Machinery Directive 98/37/EC to which all manufacturers, European and all other countries must legally adhere to when placing machinery on the European market.
Meeting the essential safety requirements relating to the design and construction of machinery and safety components often results in design changes, as became apparent in this legal case.
The European Machinery Directive clearly states a manufacturer's responsibility to eliminate safety risks through a combination of design, guarding, warnings and training. It also adopts US type product liability concepts.
A few of the approximately 48 essential requirements in the Machinery Directive 98/37/EC you may want to read are:
Annex 1, Section 1.2.2(b) states:
Inform users of the residual risks due to any shortcomings of the protection measures adopted, indicate whether any particular training is required and specify any need to provide personal protection equipment.
Annex 1, Section 1.7.2 states:
Where risks remain despite all the measures adopted or in the case of potential risks, which are not evident (for example, electrical cabinets, radioactive sources, bleeding of a hydraulic circuit, hazard in an unseen area, etc) the manufacturer must provide warnings.
Such warnings should preferably use readily understandable pictograms and/or be drawn up in one of the languages of the country in which the machinery is to be used, accompanied, on request, by the languages understood by the operators. This requirement is covered in:
Annex 1, Section 1.7.4 subpart (b) states:
The instructions must be drawn up in one of the community languages by the manufacturer or his authorized representative established in the community. On being put into service, all machinery must be accompanied by a translation of the instructions in
the language of the country in which the machinery is to be used and by the instructions in the original language....By way of derogation from this requirement, the maintenance instructions for use by specialized personnel employed by the manufacturer or his authorized representative established in the community may be drawn up in only one of the community languages
understood by that personnel.
The documentation required to prove that a manufacturer has complied with the machinery directive essential requirements are commonly placed in a "technical file". Upon completion the manufacturer may CE mark the machine. The technical file may be kept at the manufacturers US facility providing it can be delivered in a very brief period of time when requested by the European Authorities. So me manufacturers place their technical file with their independent European Authorized Representative.
For additional information visit: Machinery Technical File
E-mail: qnet@ce-mark.com