In Switzerland and within the EU, only products that meet the basic health and safety requirements or the state of knowledge and technology may be placed on the market. For machinery, the requirements in Switzerland are regulated by the Product Safety Act (PrSG) with implementation by the Machinery Ordinance (MaschV), which is largely based on the EU Machinery Directive 2006/42/EC.
Pictures: Examples for machinery according to Machinery Directive 2006/42/EG
The definition of a completed machinery covers a wide range and is for example defined as “an assembly, fitted with or intended to be fitted with a drive system other than directly applied human or animal effort, consisting of linked parts or components, at least one of which moves, and which are joined together for a specific application”.
The Machinery Directive 2006/42/EC distinguishes between completed and partly completed machines. The characteristic of partly completed machinery is that it is "an assembly which is almost machinery, but which cannot in itself perform a specific application. A drive system is partly completed machinery. Partly completed machinery is only intended to be incorporated into or assembled with other machinery or other partly completed machinery or equipment, thereby forming machinery to which this Directive applies”.
In practice, the question arises as to which work equipment falls within the concept of the machinery, whether it is a completed machinery, partly completed machinery or assemblies of machinery (machinery system) and whether the requirements of the MaschV / Machinery Directive have been met.
Work equipment covered by the machinery definition of the Machinery Directive, is for example:
Pumps (completed or partly completed machinery depending on the delivery condition)
Vessel with agitator
Machine tools (lathes, box column drills, folding machines, ...)
Process plants (process plants of the chemical and pharmaceutical industry, power stations, wastewater treatment plants, paper manufacture plants, ...)
Driven valves (completed or partly completed machinery depending on the supplied condition)
The manufacturer with the corresponding obligations is the person who designs a machine for third-party or for his own use.
The following questions must be asked:
Does the work equipment fall into the Machinery Directive?
Who is the manufacturer of the equipment?
What type of equipment is it (completed machinery, partly completed machinery, assemblies of machinery)?
Which conformity assessment procedure must be applied?
Who performs the conformity assessment procedure?
If the criteria of the machinery definition are met, the manufacturer or his authorized representative shall carry out a conformity assessment procedure in accordance with the Machinery Directive. In order to choose the correct conformity assessment procedure, it is necessary to check whether the machinery is in accordance with Annex IV or Annex VIII.
Annex IV contains a detailed list of equipment, such as sawing machines, planing machines, milling machines or compactors. In addition to the application of harmonised standards and considering the basic safety requirements set out in Annex I to the Machinery Directive, the internal checks on the manufacture of machinery (Annex VIII) and the EC type-examination procedure (Annex IX) shall be applied to this type of machinery.
If the machinery to be evaluated is not listed in Annex IV, the manufacturer or his authorized representative shall carry out the conformity assessment procedure provided for in Annex VIII with internal checks on the manufacture of machinery.
In order to fulfil the obligations, the following tasks must be achieved:
Completion of risk assessment
Application of relevant other EU directives
Application of harmonized standards and consideration of the basic safety requirements set out in Annex I to the Machinery Directive
Preparation of instructions (for completed machinery) or assembly instructions (for partly completed machinery)
Preparation of documentation (specifications, wiring diagrams, drawings, ...)
Preparation of the declaration of conformity and CE marking (special rules in Switzerland)
In practice it is often the case that the necessary documentation is available but the systematic classification of the type of machinery is not done, and who takes over the role of the manufacturer has not been decided.
The requirements of the Machinery Directive provide a systematic approach of proving that the necessary obligations have been met.
Used machinery already on the market has frequently a lower level of safety than required by the Machinery Directive for new machinery on the market. For those cases, retrofitting based on risk assessments according to the latest state of the art is necessary. There is no grandfathering and a risk assessment is required for each individual case. For example, risk assessments for used machinery frequently require the retrofitting of guards for unprotected shafts (examples are fast-rotating shafts on drives of pumps and blowers, lathes, box column drills, ...). Furthermore, it shall be examined for the individual case whether, for example, the retrofitting of an emergency stop is necessary.
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