The Machinery Directive, which came into force on the New Edition on 29-12-2009, defines a “machine” as a set of mechanical parts, of which at least one part has movment generated by a non-human force, and this force may already be present Or be applied at a later time.
All this with good peace of those who would like their products to be labeled as “not machinery”, just because there is still no engine or the plug is missing, like for example, if a pump became a machine only in the exact moment when the electrician add the engine to the pump, leaving to the poor electrician the responsability of the CE marking. Aren’t they sneaky?
The new Machinery Directive imposes that, all the machines and almost machines, are CE marked in order to be sold in the European market , this applies to both new and used.
The Manufacture or his authorized agent are required to affix the marking and at least one of this two has to be legally registered within the European Community, in the absence of this condition, the registration is a responsibility of the importer.
So let’s see how we proceed to affix the CE mark on a machine.
The New Machinery Directive indicates that already during the first phase of design there are certain regulations to comply with in order for the product to be safe, so it is logical that the machine will be built safely, if the designer plans to analyze the dangers and eliminate or reduce the risks to the lowest possible level.
So, in the design phase, a document called “risk analysis” should be produced, which highlights the possible dangers associated with the machine, interventions designed to reduce the risk and eventually indicate residual risks. Risk analysis should preferably involve an experienced technician, preferably outside the organization, to ensure an independent and objective vision.
At this stage, it is of crucial importance to consider the “Essential Requirements for Safety and Health”, which are listed in a chapter of the Machinery Directive and which identify the main aspects of risk to be taken into consideration during design and Construction of the machine.
From design phase than follow the actual building phase during which, obviously, it has to be taking into account the results of the previous risk analysis so that this is respected.
At the construction stage, all the criteria and methods must be adopted to safely construct the machine and it can be demonstrated that the manufactured product meets the requirements of the design.
Obviously it is not enough to “work well” you need to be able to demonstrate it, and every organization will adopt the procedures which are the most convenient and practical for them, the only thing certain is that these procedures need to be formalized, which means, written consistently and in respect of the rules eg. ISO 9001-2008.
To build a machine, it is necessary to have drawings, system diagrams, circuit diagrams, in each case the documentation has to illustrate to those who manufacture how is composed and how the machine is built.
Of course you also need to know who and when the machine was built and to do so there must be the identification through the serial number.
After being constructed and tested with its report showing the test results, the machine may be placed on the market only if accompanied by a end user and maintenance instruction manual, on which inside the declaration of Conformance has to be either printed or attached, and so has to be a reproduction of the label.
The label with the CE mark and other data required by the Machinery Directive must be applied to the machinery and the markings must be indelible according to a criterion of resistance to cancellation also provided for by the regulation.
– Declaration of conformity of the machine
– instruction use manual based on the model
– copy of the CE label template
– Documentation regarding the Production for the traceability of the machine
– Documentation of the tests
However, all other documents must be made available at the request of the authority:
– the technical file
– data of supplies of all materials and components
– documented production procedures
WARNING! THE SELF MADE IS DANGEROUS, THE SECURITY OF ALL THE PERSONS INVOLVED IN THE CONSTRUCTION, INSTALLATION AND USE OF THE MACHINE IS PART OF THIS PROCESS.