What Requirements Does the Machinery Directive Set

Machinery Directive and the Manual

    Gavel on product documentation with EU flag background, symbolising European product liability law and compliance.

    It is important that not only your product, but also your manual complies with legislation and regulations. Various standards and directives may include requirements related to the manual.

    In this article, you will read about the scope of the Machinery Directive (2006/42/EC) and find an overview of several articles from the directive that relate to documentation. This concerns the revised version from 2009.

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    Table of Contents

    Scope of the Machinery Directive 2006/42/EC

    The Machinery Directive defines the following as machinery:

    • an assembly, fitted with or intended to be fitted with a drive system other than directly applied human or animal effort, consisting of linked parts or components, at least one of which moves, and which are joined together for a specific application,
    • an assembly referred to in the first indent, missing only the components to connect it on site or to sources of energy and motion,
    • an assembly referred to in the first and second indents, ready to be installed and able to function as it stands only if mounted on a means of transport, or installed in a building or a structure, 
    • assemblies of machinery referred to in the first, second and third indents or partly completed machinery referred to in point (g) which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole,
    • an assembly of linked parts or components, at least one of which moves and which are joined together, intended for lifting loads and whose only power source is directly applied human effort;

    The Machinery Directive applies to the following products: 

    a) machinery;
    b) interchangeable equipment;
    c) safety components;
    d) lifting accessories;
    e) chains, ropes and webbing;
    f) removable mechanical transmission devices;
    g) partly completed machinery.

    A number of products are excluded from the Machinery Directive, such as fairground rides, weapons, seagoing vessels and most means of transport. Specific directives have been developed for these types of products. For a complete overview of excluded machinery, refer to the directive.

    Examples of products covered by Directive 2006/42/EC include:

    • Industrial machinery (e.g. packaging machines, production lines, presses) 
    • Metal and woodworking machines (e.g. lathes, milling machines, saws) 
    • Transport and handling equipment (e.g. conveyors, palletising machines) 
    • Powered hand tools (e.g. circular saws, drills)

    What the Directive States Regarding Documentation

    The Machinery Directive states, among other things, the following about the manual:

    Note: Always read the full directive to ensure complete understanding and to review all relevant requirements.

    ANNEX I Paragraph 1.7.4All 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 must be drafted in accordance with the principles set out below.
    ANNEX I Paragraph 1.7.4.1a) The instructions must be drafted in one or more official Community languages. The words ‘Original instructions’ must appear on the language version(s) verified by the manufacturer or his authorised representative.
    b) Where no ‘Original instructions’ exist in the official language(s) of the country where the machinery is to be used, a translation into that/those language(s) must be provided by the manufacturer or his authorised representative or by the person bringing the machinery into the language area in question. The translations must bear the words ‘Translation of the original instructions’. 
    c) The contents of the instructions must cover not only the intended use of the machinery but also take into account any reasonably foreseeable misuse thereof.
    d) In the case of machinery intended for use by non-professional operators, the wording and layout of the instructions for use must take into account the level of general education and acumen that can reasonably be expected from such operators.
    ANNEX I Paragraph 1.7.4.2Each instruction manual must contain, where applicable, at least the following information: 
    a) the business name and full address of the manufacturer and of his authorised representative;
    b) the designation of the machinery as marked on the machinery itself, except for the serial number (see section 1.7.3);
    c) the EC declaration of conformity, or a document setting out the contents of the EC declaration of conformity, showing the particulars of the machinery, not necessarily including the serial number and the signature;
    d) a general description of the machinery;
    e) the drawings, diagrams, descriptions and explanations necessary for the use, maintenance and repair of the machinery and for checking its correct functioning;
    f) a description of the workstation(s) likely to be occupied by operators;
    g) a description of the intended use of the machinery;
    h) warnings concerning ways in which the machinery must not be used that experience has shown might occur;
    i) assembly, installation and connection instructions, including drawings, diagrams and the means of attachment and the designation of the chassis or installation on which the machinery is to be mounted;
    j) instructions relating to installation and assembly for reducing noise or vibration;
    k) instructions for the putting into service and use of the machinery and, if necessary, instructions for the training of operators;
    l) information about the residual risks that remain despite the inherent safe design measures, safeguarding and complementary protective measures adopted;
    m) instructions on the protective measures to be taken by the user, including, where appropriate, the personal protective equipment to be provided;
    n) the essential characteristics of tools which may be fitted to the machinery;
    o) the conditions in which the machinery meets the requirement of stability during use, transportation, assembly, dismantling when out of service, testing or foreseeable breakdowns;
    p) instructions with a view to ensuring that transport, handling and storage operations can be made safely, giving the mass of the machinery and of its various parts where these are regularly to be transported separately;
    q) the operating method to be followed in the event of accident or breakdown; if a blockage is likely to occur, the operating method to be followed so as to enable the equipment to be safely unblocked;
    r) the description of the adjustment and maintenance operations that should be carried out by the user and the preventive maintenance measures that should be observed;
    s) instructions designed to enable adjustment and maintenance to be carried out safely, including the protective measures that should be taken during these operations;
    t) the specifications of the spare parts to be used, when these affect the health and safety of operators;u) the following information on airborne noise emissions:
    — the A-weighted emission sound pressure level at workstations, where this exceeds 70 dB(A); where this level does not exceed 70 dB(A), this fact must be indicated,
    — the peak C-weighted instantaneous sound pressure value at workstations, where this exceeds 63 Pa (130 dB in relation to 20 μPa),
    — the A-weighted sound power level emitted by the machinery, where the A-weighted emission sound pressure level at workstations exceeds 80 dB(A).
    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.
    In the case of very large machinery, instead of the A-weighted sound power level, the A-weighted emission sound pressure levels at specified positions around the machinery may be indicated.
    Where the harmonised standards are not applied, sound levels must be measured using the most appropriate method for the machinery. Whenever sound emission values are indicated the uncertainties surrounding these values must be specified. The operating conditions of the machinery during measurement and the measuring methods used must be described.Where the workstation(s) are undefined or cannot be defined, A-weighted sound pressure levels must be measured at a distance of 1 metre from the surface of the machinery and at a height of 1,6 metres from the floor or access platform. The position and value of the maximum sound pressure must be indicated.
    Where specific Community Directives lay down other requirements for the measurement of sound pressure levels or sound power levels, those Directives must be applied and the corresponding provisions of this section shall not apply;
    v) where machinery is likely to emit non-ionising radiation which may cause harm to persons, in particular persons with active or non-active implantable medical devices, information concerning the radiation emitted for the operator and exposed persons.
    ANNEX I Paragraph 2.1.2The 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.
    ANNEX I Paragraph 2.2.1.1The instructions must give the following information concerning vibrations transmitted by portable hand-held 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.
    ANNEX I Paragraph 2.2.2.2The instructions must give the necessary information regarding:
    — the accessories and interchangeable equipment that can be used with the machinery,
    — the suitable fixing or other impacted elements to be used with the machinery,
    — where appropriate, the suitable cartridges to be used.

    For the remaining points, please contact Manualise.

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