March 2012System Integration & Control Systems Design
SICK Automation
When does a substantial and thus CE-relevant transformation apply?
The EU Machinery Directive, MD 2006/42/EC, is addressed to all manufacturers and distributors of machines, including operators that assemble or retrofit existing machines if they implement substantial modifications.
When is a transformation substantial?
The EU guideline for the use of the machinery directive defines a substantial transformation as a transformation that has resulted in a machine that can be considered as ‘new machinery’.
In the Blue Guide of the EU Commission, the aspect of risk is addressed: “if the risk assessment leads to the conclusion that (after retrofitting the machine) the nature of the hazard or the level of risk (emanating from the machine) has increased, then the modified product (machine) should be considered as a new product (machine).”
The party responsible for retrofitting must carry out the entire CE conformity procedure if, through the substantial modification, the retrofit machine becomes a new machine. The GPSG interpretation guide entitled ‘Substantial transformations of machines’ helps to classify the modifications in terms of legal and safety related aspects. It follows from this that a hierarchy of criteria must be met in order for a retrofit machine to become a new machine. The first criterion is the existence of modifications concerning performance, function and safety technology. This is followed by the assessment of whether new danger or increased risk exists. If examination of further criteria reveals that no sufficient technical safety measures on the machine are possible, protective guards cannot be used, the danger of substantial personal injury and damage to property exists, and the probability of an accident is high, new proceedings to evaluate conformity must be carried out. In this connection, it is important that users do not have to take existing safety technology out of service automatically.
What may be used depends on a variety of factors: the safety experts from SICK Automation, an accredited inspection centre, are available to help.
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