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07/12/2009
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A report on the updated Machinery Directive and the software developed to assist conformance with it and other regulatory requirements
 It now looks certain that the updated Machinery Directive 98/37/EC and EN ISO 13849 really will supersede 98/37/EC and EN 954-1 on December 29th. And while it is unlikely that many manufacturers will be prosecuted for contravening the regulations, breaches deemed likely to contravene health and safety or any that lead to actual injury accidents or deaths will submerge those involved in a whole load of trouble.
Most of the changes, once they are understood, are pretty sensible. For example, the fixing systems for guards must remain attached to the guards when removed. This is to avoid screws or other fasteners getting lost once a guard is taken off. It is quite common to see several screws missing on guards that have been removed in the past.
This can be easily be taken care of by using only captive screws. But it is something that designers need to be aware of. Other important changes include machines that come into the scope of the Directive that did not do so before, and machines which are now excluded, because they are covered by other Directives. There are also a lot of changes relating to controls, starting and stopping, and the need to calculate mean times between potentially dangerous failure events.
Paul Laidler, proprietor of Laidler Associates, says: "Industry is very unprepared for the Directive."
However, virtual reality software that has been specially written for them by Teesside University for training purposes is helping to overcome many of the potential problems.
Jean Colombel, director life sciences industry for Dassault Systemes, says: "Dassault's Enovia PLM has been used for a decade by leading medical device manufacturers. To help them address their biggest challenges of innovation and compliance."
But while the medical device field is especially subject to regulations and the risk of litigation, the rest of manufacturing industry is not far behind. "If you get a complaint, you need to be able to locate everything of relevance ASAP," he says. "In the case of products manufactured subject to European Directives, the first line of defence is the legally required technical file showing that all the relevant regulations have been addressed and conformed to."
At one time, if a manufacturer did not have this they were given time to generate it. But, as Laidler explains: "If you can't produce one when asked, you will attract penalties."
This means that it has to exist, and the easiest way to make sure it does is to generate it as the design develops. This is a task which a PLM system greatly assists in, as it provides the means to keep track of all documents and design processes, and make them quick to find and access.
Colombel concludes: "Somebody has to be in charge of implementing regulations. Such people can then put rules into the system.
"For example, attaching a constraint to guard fasteners so fasteners have to be remain attached. Conformance may then be ensured from two directions, one that advises designers of rules that they have to conform to when they do certain things. The second is a 'change control process' so that design managers can ensure that conformance is being maintained.
For specific cases of implementing all the changes to the Machinery Directive, 'A practical guide to machinery safety' can be downloaded free from the Laidler website.
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Author
Tom Shelley
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