The machine has been defined in the regulation as; " ... other than partially completed machines, to refer to the products specified in the first paragraph of Article 2, equipped or intended to be equipped with a drive system other than direct human or animal power application, at least one of the related pieces or parts is mobile and for a certain application purpose. a collection of parts assembled and of them; only having no or ready to install components required for connection to the field of use or a source of energy and motion and capable of working only when mounted on a transport vehicle or installed in a building or structure, or achieve the same result the assembly of partially completed machine parts arranged and controlled to operate as a whole for the purpose of working in order to work as a whole and the assembly of parts consisting of at least one movable linked parts and components for lifting purposes and whose power source is manpower directly applied. "

 

     Conformity evaluation processes of the machines are as follows;

The manufacturer or his authorized representative applies one of the conformity assessment procedures to certify the conformity of the machines.

If the machinery is not included in Annex IV, the manufacturer or his authorized representative shall carry out the conformity assessment process with the internal controls in the machinery manufacture specified in Annex VIII.

For machines included in the list given in Annex IV and manufactured in accordance with the harmonized standards specified in the second paragraph of Article 9, provided that these standards include all relevant basic health and safety rules, the manufacturer or his authorized representative;

a) procedures for assessing conformity with internal controls in the manufacture of machinery specified in Annex VIII; or

b) Internal control procedures in machinery manufacture specified in paragraph 3 of Annex VIII, as well as the EC Type examination procedure given in Annex IX; or

c) Complete quality assurance procedures specified in Annex X

So, what information should the technical file which manufacturers need to create include in it?

The technical file should contain the following information unless stated otherwise:

- A general description of the machine,

- A general drawing of the relevant machine and drawings of the control circuits, as well as appropriate descriptions and explanations to understand the operation of the machine,

- Fully detailed drawings with necessary calculations, test results, documents to confirm the compliance of the machine with basic safety and health requirements,

- Documentation on the risk assessment showing the actions followed, including:

- List of basic health and safety requirements applied to the machine,

- Description of the protective measures applied to eliminate identified hazards or reduce risks, or, where appropriate, an indication of the irreversible risks associated with the machine,

- Standards and other technical specifications used and display of the basic health and safety rules covered by these standards,

- Any technical report containing the results of the tests carried out by the manufacturer or an organization selected by the manufacturer or its authorized representative,

- A copy of the instructions for the machine,

- Where applicable, the Manufacturer's Declaration for partially completed machines and the relevant assembly instructions for such machines,

- Where appropriate, copies of EC Declarations of Conformity for the machine and other products fitted on this machine,

- A copy of the EC Declaration of Conformity

- For mass production, internal measures that will be carried out in order to secure the conformity of the Regulation to the provisions.

In addition, the manufacturer should carry out the necessary research and experiments on the completed machinery, parts, or equipment in order to determine that it has the ability to safely assemble and put into service due to its design and construction. Relevant reports and results should be included in the technical file.