Before a laser processing machine is used in production within the European Union it must comply with the Machinery (Safety) Directive. In particular, it must meet the essential health and safety requirements set out in Annex 1 of the Directive. This responsibility rests with the manufacturer or supplier of the machine.

In the context of the directive, the 'manufacturer' of a machine is the one who takes it to its highest level of integration i.e. the supplier of a self contained machine or, if the user integrates the machine onto an existing production line, the user himself. For example, if a laser marking unit is provided with open 'tunnels' for the product to enter and leave, it becomes the responsibility of the user to carry out the risk assessment stipulated in the Machinery Directive and to CE mark the machine as a whole (i.e. laser marking unit plus product line). The user will need to consider, among other things, how human access to these tunnels is to be prevented. For example, previously installed pressure pads or fencing may already provide sufficient restriction of access to the marking machine.

In cases where the user plans to complete the integration himself, there is great advantage in stipulating a Declaration of Incorporation in the purchase contract. This declaration from the supplier should include a list of the standards to which the product conforms. This list should include EMC conformity.

Other examples

The Machinery Directive applies only from the time a product is first placed on the market or put into service in the European Economic Area. As a result, it applies if a second hand machine enters the EEA from a country outside the EEA. A common example is of a company based outside the EEA supplying equipment to its UK subsidiary. In this case the UK subsidiary becomes the European importer and must take on the responsibility for ensuring compliance.

One part of the CE marking process is the preparation of a Technical Construction file. In this case, the UK subsidiary should request that the person in the parent company who constructed or purchased the machine, to provide all the necessary information as set out in the Machinery Directive. In this particular example, the parent company could provide the subsidiary with a skeleton file (only) which defines the product, where it was made, who manufactured it, who has the main file, providing that the parent company ensures that the complete file is available.

CE marking procedure

The steps involved are:

1. go though all elements of each relevant harmonised standard and, using ticks and comments, document that the machine complies;
2. produce a documented risk assessment for the use of the machine (if it complies fully with all the relevant standards, then this is a simple matter);
3. prepare a technical construction file as described in the Machinery Directive;
4. CE mark the machine and produce the Declaration.

The PUWE directive

Although machinery that predates the Machinery Directive (before January 1993 for new designs of equipment) will not be CE marked, a series of Workplace Directives, most specifically the Management of Health and Safety at Work and the Provision and Use of Work Equipment (PUWE), address the statutory duties of employers to conduct a risk assessment and to ensure that the work equipment and the systems of work are safe, as far as reasonably practicable, suitable, properly maintained etc. The user has a legal obligation to consider the working conditions and the risks to the health and safety of the machine operators. The user is required to assess not only the equipment (for suitability and safety) but also the location in which the equipment is to be used, and to ensure that the equipment (particularly its safety-related parts) is adequately maintained.

As with the Machinery Directive, the PUWE Directive provides a detailed list of essential safety requirements and a hierarchy of protection measures:

1. Fixed enclosing guards;
2. Other guards or protection devices;
3. Protection appliances (jigs, fixtures, PPE);
4. Information, instruction, training and supervision.

This risk assessment is significantly reduced for CE marked equipment or equipment supplied with a Declaration of Incorporation. In practice, the end result is often almost the same as CE marking.

Pro Laser undertakes safety audits, risk assessments and the preparation of conformance reports and other documentation for laser installations, as part of an overall CE certification procedure and for complying with the PUWE regulations.