The CE Marking consultancy service we provide includes:
We will handle all aspects of the CE process and guide and advise on any changes which may be necessary to ensure your product is in conformance with all CE requirements.
The machinery directive applies to the following products:
Machinery
Interchangeable equipment
Safety components
Lifting accessories
Chains, ropes and webbing
Removable mechanical transmission devices
Partly completed machinery
The risk assessment must include the following information:
Risk Assessment for partly completed machinery
The risk assessment should include the following information:
The Machinery standards are classified into three different types A, B and C:
A-type standards specify basic concepts, terminology and design principles applicable to all categories of machinery.
B-type standards deal with specific aspects of machinery safety or specific types of safeguard that can be used across a wide range of categories of machinery.
C-type standards provide specifications for a given category of machinery such as, for example, mechanical presses, combine harvesters or compressors.
This section describes categories of machinery that requires assessment of conformity by the manufacturer or by a third party assessment by parties such as the manufacturer’s authorised representative or an EC type examination by a notified body where the notified body makes sure and confirms that the machinery satisfies the provisions of the machinery directive or where the notified body assesses and approves the quality system and monitors its application.
Machinery for underground working of the following types:
The section describes the process of compiling a technical file. The technical file shows that the machinery complies with the Directives requirements. The design, manufacture and operation of the machinery must be described appropriately for this assessment. The technical file must be created in one or more of the official Community Languages except for the machinery instructions.
The technical file contains the following information:
A general description of the machinery is required
The technical drawings should include the following:
The risk assessment must include the following information:
The standards and other technical specifications used which indicate the health and safety requirements covered by these standards
Technical reports which give the results of the manufacturer’s tests or the results of the tests carried out by a body selected by the manufacturer or his authorised representative must be included
A copy of the instructions for the machinery must be included
This is a list of the information that is required in a machines user service manual in one or more official community languages in order for the user to be able to operate the machine, maintain the machine and to deal with health and safety issues:
All machinery must be accompanied by instructions in the official Community language or languages of the Member State in which it is placed on the market and/or put into service.
The instructions accompanying the machinery must be either ‘Original instructions’ or a ‘Translation of the original instructions’, in which case the translation must be accompanied by the original instructions.
By way of exception, the maintenance instructions intended for use by specialised personnel mandated by the manufacturer or his authorised representative may be supplied in only one Community language which the specialised personnel understand.
The instructions for foodstuffs machinery and machinery for use with cosmetics or pharmaceutical products must indicate recommended products and methods for cleaning, disinfecting and rinsing, not only for easily accessible areas but also for areas to which access is impossible or inadvisable.
The instructions must give the following information concerning vibrations transmitted by portable handheld and hand-guided machinery: − the vibration total value to which the hand-arm system is subjected, if it exceeds 2,5 m/s2. Where this value does not exceed 2,5 m/s2, this must be mentioned, − the uncertainty of measurement.
These values must be either those actually measured for the machinery in question or those established on the basis of measurements taken for technically comparable machinery which is representative of the machinery to be produced.
If harmonised standards are not applied, the vibration data must be measured using the most appropriate measurement code for the machinery.
The operating conditions during measurement and the methods used for measurement, or the reference of the harmonised standard applied, must be specified.
The instructions must give the necessary information regarding:
The declaration of incorporation for included partly completed machinery and the assembly instructions for such machinery when appropriate
Copies of the EC declaration of conformity of machinery or other products incorporated into the machinery must be included where appropriate
For series manufacture, the internal measures which will be implemented so that the machinery stays in conformity with the Directives provisions
The manufacturer must carry out research and testing on components, fittings or on the completed machinery in order to determine whether by its design or construction it is possible to assemble and put into service safely. The relevant reports and results must be included in the technical file.
The technical file must be made available to the competent authorities of the Member States for at least 10 years following the date of manufacture of the machinery or, in the case of series manufacture, of the last unit produced.
The technical file does not have to be located within the Community, nor does it have to be permanently available in material form. However, it must be possible to assemble and be made available within a period of time in proportion to its complexity by the person designated in the EC declaration of conformity.
Detailed plans or other specific information does not have to be included in the technical file regarding the subassemblies used for the manufacture of the machinery unless knowledge of them is required for verifying conformity with the health and safety requirements.
If the technical file is not presented to the competent national authorities on request this may be sufficient grounds for doubting the machinery’s conformity to the health and safety requirements.
The EC Declaration of Conformity is a legal statement by the manufacturer or his authorised representative attesting that the machinery concerned complies with all of the relevant provisions of the Machinery Directive.
The CE marking affixed to the machinery and the manufacturer’s EC Declaration of Conformity that shall accompany the machinery are the first elements that can be checked by the market surveillance authorities.
In particular, the EC Declaration of Conformity provides essential information to enable the market surveillance authorities to carry out the necessary checks:
The CE marking shall consist of the initials ‘CE’ taking the following form:
If the CE marking is reduced or enlarged the proportions shown in the above drawing must be respected.
The manufacturer may choose to affix the CE marking visibly, legibly and indelibly to the toy, to an affixed label or to the packaging.
The various components of the CE marking must have substantially the same vertical dimension, which may not be less than 5 mm. The minimum dimension may be waived for small-scale machinery.
The CE marking must be affixed in the immediate vicinity of the name of the manufacturer or his authorised representative, using the same technique.