English
New goods
Description
The EU machinery production sector, consisting of 1/3 of the World markets, is one of the biggest and the most competitive sectors with its 170,000 companies and over 3.3 million employees. Minimizing the accident risk caused by the use of machinery is one of the essential policies of the EU. CE marking on a machine demonstrates that that piece of machinery is in conformity with the health and safety requirements enforced by 2006/42/EC, and it can be marketed in the EEA. The Machinery Directive covers machinery, interchangeable equipment, safety components, lifting accessories, chains, ropes and webbing, removable mechanical transmission devices and partly completed machinery.
If the product is from one of the 23 risky categories as defined in the Directive and is not in conformity with the harmonised standard which covers all essential health and safety requirements, then a notified body must carry out the conformity assessment activity. If the Notified Body is persuaded of the conformity of the product, it issues a certificate, what we call a EU-Type Examination Certificate or a Full Quality Assurance Certificate, thus confirms conformity.
Whatever the role of the notified body is, the manufacturer must draw up a EU Declaration of Conformity and a technical file, and these requirements are legally binding.
The technical file to be prepared by the manufacturer should comprise the following information and documents:
- General definition of the machinery
- A detailed documentation on the construction of the machinery including drawings of the machinery and its parts,
- Calculations, experiment results and detailed drawings to prove the conformity of the machinery with the essential requirements,
- Electrical safety – LVD test reports,
Risk evaluation of the machinery and the following documents:
- List of the essential requirements to be implemented on the machinery,
- Explanations of the preventive actions
- Standards to be used and the documents of essential requirements covered by these standards,
- A copy of the instructions for the machinery
- EC declarations of conformity for the components used in the manufacturing of the machinery where necessary,
- Copy of the EC Declaration of Conformity
In addition to these, the manufacturer must carry out the necessary tests on components, fittings or the completed machinery, and the relevant reports should be included in the technical file. The manufacturer or his authorised representative is requested to keep copies of the technical documentation as well.
At the end of a successful evaluation, the technical documentation must be adequate to demonstrate the products are in conformity with the essential requirements of the directive and contain the following:
- Name and address of the manufacturer or his authorised representative,
- Name and address of the person authorised to prepare the technical file and residing in Turkey or the member states.
- Definition of the machinery including coding, function, model, type, serial number and trademark.
- Declaration of conformity to the essential requirements of this Directive (2006/42/EC) and/or other relevant directives
- Where applicable, the name, address and ID number of the Notified Body performing the EU-Type Examination as stated in Annex IX and the number of the EU-Type Examination Certificate
- Where applicable, the name, address and ID number of the Notified Body attesting the Full Quality Assurance System as stated in Annex X
- Where applicable, reference to the harmonized standards as stated in Article 9, Paragraph 2 of the Directive
- Where applicable, reference to other technical standards and specifications
- Place and date of declaration
- ID information and signature of the person authorized to prepare the declaration by the manufacturer or his authorized representative.
