Machinery Directive (2006/42/EC) and your Manual

Please note!

Always read the entire Machinery Directive for complete understanding.
Always be up-to-date with harmonised standards. Standards provide information about how your product can meet the technical requirements of the Machinery Directive.

The scope of the Machinery Directive

The Machinery Directive defines machinery as follows:

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.

Next to the above descriptions, the Machinery Directive applies to:

interchangeable equipment;
safety components;
lifting accessory;
chains, ropes and webbing;
removable mechanical transmission devices;
partly completed machiner.

Several products are excluded from the Machinery Directive, such as fairground amusements, weapons, seagoing vessels and most vehicles. Separate guidelines are written for these kind of products.

The Machinery Directive about instructions

The articles mentioned below contain specific requirements regarding the instructions:

ANNEX I

Essential health and safety requirements relating to the the design and construction of machinery

GENERAL PRINCIPLES

The manufacturer of machinery or his authorised representative must ensure that a risk assessment is carried out in order to determine the health and safety requirements which apply to the machinery. The machinery must then be designed and constructed taking into account the results of the risk assessment.

By the iterative process of risk assessment and risk reduction referred to above, the manufacturer or his authorised representative shall:

determine the limits of the machinery, which include the intended use and any reasonably foreseeable misuse thereof,
identify the hazards that can be generated by the machinery and the associated hazardous situations,
estimate the risks, taking into account the severity of the possible injury or damage to health and the probability of its occurrence,
evaluate the risks, with a view to determining whether risk reduction is required, in accordance with the objective of this Directive,
eliminate the hazards or reduce the risks associated with these hazards by application of protective measures, in the order of priority established in section 1.1.2(b).

1. ESSENTIAL HEALTH AND SAFETY REQUIREMENTS

1.1. GENERAL REMARKS

1.1.2. Principles of safety integration

Machinery must be designed and constructed so that it is fitted for its function, and can be operated, adjusted and maintained without putting persons at risk when these operations are carried out under the conditions foreseen but also taking into account any reasonably foreseeable misuse thereof. The aim of measures taken must be to eliminate any risk throughout the foreseeable lifetime of the machinery including the phases of transport, assembly, dismantling, disabling and scrapping.
In selecting the most appropriate methods, the manufacturer or his authorised representative must apply the following principles, in the order given:
– eliminate or reduce risks as far as possible (inherently safe machinery design and construction),
– take the necessary protective measures in relation to risks that cannot be eliminated
– inform users of the residual risks due to any shortcomings of the protective measures adopted, indicate whether any particular training is required and specify any need to provide personal protective equipment.
When designing and constructing machinery and when drafting the instructions, the manufacturer or his authorised representative must envisage not only the intended use of the machinery but also any reasonably foreseeable misuse thereof. The machinery must be designed and constructed in such a way as to prevent abnormal use if such use would engender a risk. Where appropriate, the instructions must draw the user’s attention to ways — which experience has shown might occur — in which the machinery should not be used.
Machinery must be designed and constructed to take account of the constraints to which the operator is subject as a result of the necessary or foreseeable use of personal protective equipment.
Machinery must be supplied with all the special equipment and accessories essential to enable it to be adjusted, maintained and used safely.

1.1.5. Design of machinery to facilitate its handling

Machinery, or each component part thereof, must:

be capable of being handled and transported safely
be packaged or designed so that it can be stored safely and without damage

During the transportation of the machinery and/or its component parts, there must be no possibility of sudden movements or of hazards due to instability as long as the machinery and/or its component parts are handled in accordance with the instructions.

(…)

1.3. ROTECTION AGAINST MECHANICAL HAZARDS

1.3.1. Risk of loss of stability

Machinery and its components and fittings must be stable enough to avoid overturning, falling or uncontrolled movements during transportation, assembly, dismantling and any other action involving the machinery.

If the shape of the machinery itself or its intended installation does not offer sufficient stability, appropriate means of anchorage must be incorporated and indicated in the instructions.

1.3.2. Risk of break-up during operation

The various parts of machinery and their linkages must be able to withstand the stresses to which they are subject when used.

The durability of the materials used must be adequate for the nature of the working environment foreseen by the manufacturer or his authorised representative, in particular as regards the phenomena of fatigue, ageing, corrosion and abrasion.

The instructions must indicate the type and frequency of inspections and maintenance required for safety reasons. They must, where appropriate, indicate the parts subject to wear and the criteria for replacement.

(…)

1.3.7. Risks related to moving parts

The moving parts of machinery must be designed and constructed in such a way as to prevent risks of contact which could lead to accidents or must, where risks persist, be fitted with guards or protective devices.

All necessary steps must be taken to prevent accidental blockage of moving parts involved in the work. In cases where, despite the precautions taken, a blockage is likely to occur, the necessary specific protective devices and tools must, when appropriate, be provided to enable the equipment to be safely unblocked.

The instructions and, where possible, a sign on the machinery shall identify these specific protective devices and how they are to be used.

1.5. RISKS DUE TO OTHER HAZARDS

1.5.4. Errors of fitting

Errors likely to be made when fitting or refitting certain parts which could be a source of risk must be made impossible by the design and construction of such parts or, failing this, by information given on the parts themselves and/or their housings. The same information must be given on moving parts and/or their housings where the direction of movement needs to be known in order to avoid a risk. Where necessary, the instructions must give further information on these risks.

(…)

1.7. INFORMATION

1.7.4. Instructions

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 must be drafted in accordance with the principles set out below.

1.7.4.1. General principles for the drafting of instructions

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.

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’.

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.

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.

1.7.4.2. Contents of the instructions

IEach instruction manual must contain, where applicable, at least the following information:

the business name and full address of the manufacturer and of his authorised representative;
the designation of the machinery as marked on the machinery itself, except for the serial number (see section 1.7.3);
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;
a general description of the machinery;
the drawings, diagrams, descriptions and explanations necessary for the use, maintenance and repair of the machinery and for checking its correct functioning;
a description of the workstation(s) likely to be occupied by operators;
a description of the intended use of the machinery;
warnings concerning ways in which the machinery must not be used that experience has shown might occur;
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;
instructions relating to installation and assembly for reducing noise or vibration;
instructions for the putting into service and use of the machinery and, if necessary, instructions for the training of operators;
information about the residual risks that remain despite the inherent safe design measures, safeguarding and complementary protective measures adopted;
instructions on the protective measures to be taken by the user, including, where appropriate, the personal protective equipment to be provided;
the essential characteristics of tools which may be fitted to the machinery;
the conditions in which the machinery meets the requirement of stability during use, transportation, assembly, dismantling when out of service, testing or foreseeable breakdowns;
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;
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;
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;
instructions designed to enable adjustment and maintenance to be carried out safely, including the protective measures that should be taken during these operations;
the specifications of the spare parts to be used, when these affect the health and safety of operators;
the following informaton on airbordne 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 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;
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.

1.7.4.3. Sales literature

Sales literature describing the machinery must not contradict the instructions as regards health and safety aspects. Sales literature describing the performance characteristics of machinery must contain the same information on emissions as is contained in the instructions.

2. SUPPLEMENTARY ESSENTIAL HEALTH AND SAFETY REQUIREMENTS FOR CERTAIN CATEGORIES OF MACHINERY

2.1. FOODSTUFFS MACHINERY AND MACHINERY FOR COSMETICS OR PHARMACEUTICAL PRODUCTS

2.2. PORTABLE HAND-HELD AND/OR HAND-GUIDED MACHINERY

2.2.1. General

2.2.1.1. Instructions

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.

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.

2.2.2. Portable fixing and other impact machinery

2.2.2.1. General

2.2.2.2. Instructions

The instructions must give the following information concerning vibrations transmitted by portable handheld and hand-guided machinery:

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.

3. SUPPLEMENTARY ESSENTIAL HEALTH AND SAFETY REQUIREMENTS TO OFFSET HAZARDS DUE TO THE MOBILITY OF MACHINERY

3.6. INFORMATION AND INDICATIONS

3.6.3. Instructions

3.6.3.1. Vibrations

The instructions must give the following information concerning vibrations transmitted by the machinery to the hand-arm system or to the whole body:

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 highest root mean square value of weighted acceleration to which the whole body is subjected, if it exceeds 0,5 m/s2. Where this value does not exceed 0,5 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.

Where harmonised standards are not applied, the vibration must be measured using the most appropriate measurement code for the machinery concerned.

The operating conditions during measurement and the measurement codes used must be described.

3.6.3.2. Multiple uses

The instructions for machinery allowing several uses depending on the equipment used and the instructions for the interchangeable equipment must contain the information necessary for safe assembly and use of the basic machinery and the interchangeable equipment that can be fitted.

4. SUPPLEMENTARY ESSENTIAL HEALTH AND SAFETY REQUIREMENTS TO OFFSET HAZARDS DUE TO LIFTING OPERATIONS

4.1. GENERAL

4.1.2. Protection against mechanical hazards

4.1.2.1. Risks due to lack of stability

Machinery must be designed and constructed in such a way that the stability required by section 1.3.1 is maintained both in service and out of service, including all stages of transportation, assembly and dismantling, during foreseeable component failures and also during the tests carried out in accordance with the instruction handbook. To that end, the manufacturer or his authorised representative must use the appropriate verification methods.

4.4. INSTRUCTIONS

4.4.1. Lifting accessories

Each lifting accessory or each commercially indivisible batch of lifting accessories must be accompanied by instructions setting out at least the following particulars:

the intended use;
the limits of use (particularly for lifting accessories such as magnetic or vacuum pads which do not fully comply with section 4.1.2.6(e));
instructions for assembly, use and maintenance;
the static test coefficient used

4.4.2. Lifting machinery

Lifting machinery must be accompanied by instructions containing information on:

the technical characteristics of the machinery, and in particular:
- the maximum working load and, where appropriate, a copy of the load plate or load table described in the second paragraph of section 4.3.3.
- the reactions at the supports or anchors and, where appropriate, characteristics of the tracks,
- where appropriate, the definition and the means of installation of the ballast;
the contents of the logbook, if the latter is not supplied with the machinery;
advice for use, particularly to offset the lack of direct vision of the load by the operator;
where appropriate, a test report detailing the static and dynamic tests carried out by or for the manufacturer or his authorised representative;
for machinery which is not assembled on the premises of the manufacturer in the form in which it is to be used, the necessary instructions for performing the measures referred to in section 4.1.3 before it is first put into service.

ANNEX VII

A. Technical file for machinery

This part describes the procedure for compiling a technical file. The technical file must demonstrate that the machinery complies with the requirements of this Directive. It must cover the design, manufacture and operation of the machinery to the extent necessary for this assessment. The technical file must be compiled in one or more official Community languages, except for the instructions for the machinery, for which the special provisions of Annex I, section 1.7.4.1 apply.

The technical file shall comprise the following:

(…)

a copy of the instructions for the machinery;

What requirements does the machinery directive impose on the manual?

The scope of the Machinery Directive

The Machinery Directive about instructions