The revised Machinery Directive 2006/42/EC does not introduce any radical changes compared with the old Machinery Directive 98/37/EC but aims at consolidating the achievements of the Machinery Directive in terms of free circulation and safety of machinery while improving its application. Thus, the provisions of the new Directive became applicable on 29th December 2009.
For further details on the new 2006/42/EC Directive, please consult Structure of Directive, Scope of Directive, Compliance with the Directive or Obelis’ services page.
The MSD 2006/42/EC Directive applies to all machinery and to safety components. A machine is defined as “an assembly … of linked parts or components, at least one of which moves…”. Clearly this definition encompasses a very large range of machines, from simple hand-held power tools through to complete automated industrial production lines.
There are some exclusions from the Directive – for example motor vehicles used on public roads (which are covered by Directive MVD 2007/46/EC), weapons and machines which are already covered by other, more specific, directives (e.g. lifts and toys – which are covered by TSD 2009/48/EC). It is also possible for the Machinery Directive to apply alongside other directives when there are hazards which the more specific directive does not fully cover, for example the lifting function of medical devices used to move patients. Certain specific types of equipment which fit the definition of machinery but are also within the scope of the Low Voltage Directive are also excluded from the Machinery Directive on the grounds that the risks they present are mainly electrical in nature. These include “ordinary office machinery” and “household appliances for domestic use”.
Secondhand machinery which was first used within the European Economic Area prior to the date of the implementation of the old directive (i.e. before 1 January 1995) is excluded from having to comply with new Directive. However, if that machinery is refurbished or upgraded so that its original specification is changed, it will have to be made to comply with the full requirements of the Directive.
Any machinery which was manufactured before 1 January 1995 must be made to comply with the directive if it subsequently brought into Europe from outside just as would any newer machinery manufactured outside the EU.
Equipment manufactured for the manufacturer’s own use is not excluded from the requirements, but may be subject to slightly lesser obligations with respect to marking and documentation.
In addition to the products within the scope of MSD 98/37/EC, MSD 2006/42/EC now also includes the following products:
- Escalators and mechanical walkways;
- Construction-site hoists;
- Elevators with max. = 0,15 m/s2;
- Partly completed machinery;
- Lifting accessories (chains, ropes and webbing);
- Stage elevators (not for persons);
- Road vehicles with max. 25 km/h;
- Removable mechanical-transmission devices;
- Two/three-wheel motor vehicles with max. 6 km/h.
This new Directive 2006/42/EC makes key changes to the Declaration of Conformity. The person who is authorized to compile the Technical File must be established in the European Community. Where appropriate, there must be a statement confirming Declaration of Conformity with other applicable directives. And there is no longer a separate declaration for safety components, and the declaration must be typewritten or handwritten in capital letters.
There are also significant additions and changes to the essential health and safety requirements (EHSRs) that will affect machine design, including requirements for guarding and control systems. Some of the safety devices that fall under the scope of the Directive include, as already mentioned, control devices for calling lifting appliances and anti-fall devices for hoists, plus monitoring devices for loading and movement control in lifting machinery – as well as solenoid valves controlling dangerous movements of machinery.
Control systems, says the Directive, must be designed and constructed in a way that will prevent a hazardous situation arising. Manual controls must be clearly visible and identifiable, and the use of pictograms is recommended. And an operator must, from each control position, be able to ensure that no one is in the danger zone – even if that means that the machinery can be controlled only from positions in one or more predetermined zones or locations.
Starting is covered as well; the Directive states that it must be possible to start machinery only by the voluntary action of a manual control provided for that purpose. The restarting of a machine or a change in operating conditions may however be effected by the voluntary action of a device other than the manual control provided for that purpose, unless this would lead to a dangerous situation. There are obviously many more issues contained within the new Machinery Directive, and it is vital that business organizations move in good time to make sure that they comply. But it is worth underlining here that in terms of control integrity, there are other European Standards in force that are also relevant.
EN 954-1 Safety of Machinery – Safety Related Parts of Control Systems, the standard that previously applied to all safety-related parts of control systems will be replaced by two standards that co-exist. The original standard will remain valid until November 2011 to provide a period of transition to the new version. People that design and install electronic safety systems can choose between the requirements of either EN ISO 13849-1 or EN/IEC 62061, and still fully comply with the European Machinery Directive.
In general terms, EN ISO 13849-1 takes a four-stage approach to the design of safety-related control systems:
- Perform a risk assessment (EN ISO 14121);
- For the identified risks, allocate the safety measure (Performance Level or PL);
- Devise a system architecture that is suitable for the PL;
- Validate the design to check that it meets the requirements of the initial risk assessment.