Safety documentation of the machine and the partly completed machine

The technical file of the machine

The Machine Technical File is a set of documents that allows the manufacturer to demonstrate to the control authorities the conformity of the machine with the Essential Safety Requirements of the Machinery Directive 2006/42/CE.+

The Technical File constitutes the documentation of the CE marking and concerns the design, manufacture and operation of the machine. The language of the Technical Dossier must be one or more official languages of the European Community. The language of the Technical File must be one or more official languages of the European Community.

The content of the Technical File is given by the list of documents of the Machinery Directive 2006/42/EC Annex VII A. These include risk analysis, design documents, schematic drawings, calculations, tests, machine tests, inspections of purchased materials and production process control procedures. The Technical File shall not normally include detailed plans or any other information, unless knowledge of those plans and information is essential for the verification of compliance with the essential safety requirements.

From the date of manufacture of the machinery or the last unit produced in the case of mass production, the Technical File shall be available to the competent authorities of the Member States for at least 10 years. The Technical File must be available since failure to submit the technical file following a request from the competent authorities may constitute a sufficient reason to doubt the conformity of the machinery in question with the essential safety requirements and health protection.

The instruction manual of the machine

The instruction manual is a document that provides users with all the information necessary for the safe use of the machine. The manufacturer or his authorized representative assumes responsibility for these instructions.

The instructions accompanying the machinery must be original or, in the case of translation, must be a translation into another language of the original instructions; in this case the original instructions must be attached. The instruction manual is a document that provides users with all the information necessary for the safe use of the machine. The manufacturer or his authorised representative shall be responsible for the instruction manual.

Machinery Directive 2006/42/CE Annex I, § 1.7.4 provides the general principles of drafting and the content of the instructions. It is mandatory to provide the instruction manual together with the machine.

The CE plate of the machine

The CE plate shall provide a list of information for the identification of the machinery and shall be provided by the manufacturer or his authorised representative. Each machine must bear legibly and indelibly at least the indications required by the Machinery Directive 2006/42/CE Annex I § 1.7.3, including:

name and full address of the manufacturer,
designation of the machinery,
“CE” marking,
series or type designation,
serial number if any,
year of construction.

Machinery designed for use in potentially explosive atmospheres shall bear the appropriate marking and full information on the type of machinery and what is necessary for safe use. The mass of a component of machinery which is moved during use by lifting equipment must be indicated legibly and indelibly.

It is mandatory to provide the CE plate together with the car.

The CE declaration of conformity of the machine

The CE declaration of conformity is the legal certification by the manufacturer that the machine complies with the RESS by the Machinery Directive. The declaration of conformity shall state that the machine meets the necessary health and safety requirements, excluding any components added subsequently.

The declaration of conformity shall contain the elements listed in Machinery Directive 2006/42/EC Annex II 1. A. It is mandatory to provide the CE declaration of conformity together with the machine.

The technical file of the partly completed machine

The Technical File of the quasi–machine, just like the Technical File of the machine, is a set of documents that allows the manufacturer to demonstrate to the control authorities the conformity of the machine with the Essential Safety Requirements of the Machinery Directive 2006/42/CE. The Technical File shall be used to verify the conformity of the partly completed machine with the RESS, in particular where a check cannot be performed by visual inspection.

The content of the Technical File is given by the list of documents listed in the Machinery Directive 2006/42/EC Annex VII B. The same criteria apply for the preparation of the Technical File of the machine as regards language and storage.

Instructions for the assembly of the quasi-machine

The instructions for the assembly of the partly completed machine, similar to the machine instruction manual, constitute a document describing the conditions to be met for the correct incorporation into the final machine. The responsibility for the instructions lies with the manufacturer or his authorised representative.

The preparation of the assembly instructions must also follow the principles listed in the Machinery Directive 2006/42/CE Annex I § 1.7.4. Instructions must be original or translated from original instructions.

It is mandatory to provide assembly instructions together with the machine.

The declaration of incorporation of the quasi-machine

The manufacturer or his authorized representative certifies the conformity of the machine with the Machinery Directive with the declaration of incorporation, which contains what is indicated in the Machinery Directive 2006/42/EC Annex II 1. B.

It is mandatory to provide the declaration of incorporation together with the quasi-machine.

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