Seven Steps to a CE Mark: Step 7, Affix the CE Marking

The CE mark may be affixed once the EC declaration of conformity has been issued.

It’s important that CE marking for the complete machine is clearly  distinguishable from any other CE markings, e.g. on components. To  avoid confusion with any other  markings, it is advisable to affix the CE marking for the complete machine to the machine type plate, which should also contain the name and address of the manufacturer.

Seven Steps to a CE Mark: Part Six, Issue the Declaration of Conformity

By issuing the EC declaration of conformity, the manufacturer declares that they have considered all the  directives that apply to the product. The person signing an EC declaration of conformity must be authorized to represent his company. This means that the signatory is legally entitled to execute a legal transaction, such as signing the EC declaration of conformity, on account of their job function.

When an authorized employee of the company adds their valid signature to an EC declaration of conformity, they trigger the liability of the natural responsible person and, if applicable, the company as a legal entity.

The declaration may also be signed by an authorized representative, who is established in the EU.

The new Machinery Directive requires the declaration to name the person authorized to compile the technical documentation. This person must be established in the EU.

CE Marking of Machinery: What is a machine?

For the purposes of the Directive, one definition of a machine is:

An assembly of linked parts or components, at least one of which moves, and which are joined together for a specific application. (see Article 2 of the Machinery Directive)

Example of a machine for the purposes of the Directive.

 

The following are also considered as machines for the purposes of the Machinery Directive:

• An assembly of machines or complex plants (complex plants include production lines and special purpose machinery made up of several machines)
• Safety components (The issue of which components to classify as safety components is very controversial. As yet there is no discernible, uniform trend.)
• Interchangeable equipment that can modify the basic functions of a machine.

There is also a list of exceptions where machinery falls under the scope of the Directive by definition, but for which other statutory provisions generally apply.

The Basis of Machine Safety: Machinery Directive and CE mark

When the Machinery Directive (MD) was ratified in 1993, the aim was to remove trade barriers and enable a free internal market within Europe. After a two-year transition period, the Machinery Directive has been binding in Europe since 01.01.1995. It describes standardized health and safety requirements for interaction between man and machine and replaces the host of individual state regulations that existed on machinery safety. The new Machinery Directive 2006/42/EC has applied since 29.12.2009.

The CE mark stands for “Communauté Européenne”. A manufacturer uses this mark to document the fact that he has considered all the European internal market directives that are relevant to his product and applied all the appropriate conformity assessment procedures. Products that carry the CE mark may be imported and sold without considering national regulations. That’s why the CE mark is also referred to as the “Passport to Europe”.

Generally speaking, all directives in accordance with the new concept (“new approach”) provide for CE marking. Where a product falls under the scope of several directives which provide for CE marking, the marking indicates that the product is assumed to conform with the provisions of all these directives.

Pilz Helps Exporters in Wind Industry Get CE Mark

Wind turbine companies wishing to export to the European Union need to get their products CE marked or they will not be compliant with European law.  A declaration of conformity for wind turbines is necessary because by definition, a wind turbine is a functional machine, and as such it falls within the scope of the Machinery Directive 2006/42/EC.

For this reason wind turbines need to be issued with a declaration of conformity in accordance with Annex IIA of the Machinery Directive and will also be subject to the CE marking process.  The CE marks confirms that a machine conforms to the European directives.

Pilz Automation Safety can guide companies through all the phases en route to CE certification for wind turbines. 

Pilz offers risk analysis as the basis for the declaration of conformity.  This procedure is based on a thorough, competently executed and systematic risk analysis that detects and evaluates potential hazards and then employs appropriate safeguards to reduce these hazards. The result of the risk analysis is then incorporated into the development of an appropriate safety concept.

Pilz offers wind turbine manufacturers comprehensive support in performing the risk analysis.  The risk analysis includes identification of applicable standards, and regulations and best industry practices.  The analysis also includes determination of the limits of the wind turbine, examination of all the hazards throughout the entire lifecycle and all operational phases.  The analysis also contains the recommended approach for reducing risk, based on the current standards.

Also, Pilz engineers have developed a methodology for testing safety-critical elements on wind turbines, based on decades of experience in machine validation. It examines whether the implemented safety measures meet all the requirements. The test applied during validation covers:

• Assessment of the selected components
• Assessment of the implemented designs in comparison with the safety requirements
• Implementation of a function test and fault simulation
• Test of the safety-related software and hardware functions
• Test of the sensor/actuator technology and its wiring
• Production of a test report with detailed information about the results

Pilz spreads cheese safely for Edelweiss

These days, cheese production is largely automated. To guarantee the quality of the cheese that is produced in the industrial manufacturing process, plant and machinery must always be state-of-the-art in terms of technology and safety. An individually tailored safety concept as part of a retrofit ensures that processes are safer and more efficient.

This is how Edelweiss in Kempten Germany manufactures its well-known cheese products such as Milkana or Bresso. To optimize processes and product quality in equal measure, Edelweiss completely modernized three mixing plants used to produce cheese spread. They had been in use for more than 15 years, so some parts no longer complied with current requirements in terms of process and safety technology. Although there were no glaring safety defects, some potential danger zones would not have withstood an inspection in accordance with EN ISO 13849.

Edelweiss decided at an early stage to use Pilz as a partner. When it comes to converting, expanding or modernizing existing plants, Pilz not only offers integrated safety and control solutions with the necessary hardware and software, but also supplies a complete package of services and solutions, from risk analysis to CE marking and declarations of conformity. The process always starts with a reliable, transparent risk assessment.

When selecting the relevant technology, Pilz takes particular care to ensure that the chosen hardware performs the task safely and efficiently. In the case of the mixing plants, the cheese manufacturer designed the circuit diagrams and converted the plant itself, using only safety components from Pilz. Safety checks and plant documentation are the final step; these form the basis for issuing the CE declaration of conformity.

With CE certification Pilz assumes legal responsibility for safety, becoming the machine’s manufacturer. With a manageable expenditure of time and money, the three mixing plants are operating once again at the state of the art, in terms of both process and safety technology. “With Pilz we had a partner who is familiar with every aspect, brings the necessary expertise and provides the relevant services. That was a huge advantage,” says Werner Holderried, Head of the Electrical Engineering Department at Edelweiss, summarizing the outcome.

 ###

Potential assessment procedures in accordance with the Machinery Directive

Not sure how to complete a machinery assessment? Check this out.

The Seven Steps of CE Marking Explained: Step 6- Issue the Declaration of Conformity

Step 6: Issue the declaration of conformity

By issuing the EC declaration of conformity the manufacturer declares that they have considered all the directives that apply to the product. The person signing an EC declaration of conformity must be authorized to represent their company. This means that the signatory is legally entitled to execute a legal transaction, such as signing the EC declaration of conformity, on account of their job function.

When an authorized employee of the company adds their valid signature to an EC declaration of conformity, they trigger the liability of the natural responsible person and, if applicable, the company as a legal entity.

The declaration may also be signed by an authorized representative, who is established in the EU.

The new Machinery Directive requires the declaration to name the person authorised to compile the technical documentation. This person must be established in the EU.

The Seven Steps of CE Marking Explained: Step 4- Perform the Risk Assessment

Step 4: Perform the Risk Assessment

The manufacturer is obliged to carry out a risk analysis to determine all the hazards associated with his machine. The result of this analysis must then be considered in the design and construction of that machine. The contents and scope of a hazard analysis are not specifi ed in a directive, but standards EN ISO 14121 and EN ISO 12100 describe the general procedure.
All relevant hazards must be identifi ed, based on the intended use – taking into consideration all the lifecycles once the machine is placed on the market. All the various groups who come into contact with the machine, such as operating, cleaning or maintenance staff for example, are also considered.
The risk is assessed and evaluated for each hazard. Risk-reducing measures are established in accordance with the state of the art and in compliance with the standards. The residual risk is assessed at the same time: If it is too high, additional measures are required. This iterative process is continued until the necessary safety is achieved.

The Seven Steps of CE Marking Explained: Step 2- Check the Application of Additional Directives

Step 2: Check the application of additional directives

Where machinery is also subject to other EU directives, which cover different aspects but also provide for the affixing of the CE mark, the provisions of these directives must be met before the CE mark is applied. If the machine contains electrical equipment, for example, it will often be subject to the Low Voltage Directive and, possibly, the EMC Directive too.

Seven Steps to a CE Mark

Check out these seven steps to CE marking

New machine or old machine? Does it need to be CE Marked?

When a machine is imported from a third country for use within the EU, that machine must comply with the Machinery Directive when it is placed on the market and when put into service. Anyone who places a machine on the market for the first time within the European Economic Area must have the necessary documentation to establish conformity, or have access to such documentation. This applies whether you are dealing with an “old machine” or new machinery.

My machines are CE marked, do I still need to certify my plant?

On large production lines a machine may often consist of several individual machines assembled together. Even if each of these bears its own CE mark, the overall plant must still undergo a CE certification process.

Do you need to CE certify?

Irrespective of the place and date of manufacture, all machinery used in the European Economic Area for the first time beginning January 1, 1995 is subject to the EU Machinery Directive and as such must be CE certified.

Safety Planning Tip

It’s important that the manufacturer considers the safety aspect early, as the contracts are being formulated or in the components’ requirement manual. The documentation shall not be compiled solely from the point of view of machine performance. The manufacturer is responsible for the whole of the technical documentation and must determine the part that each of his suppliers are to undertake in this process.