S.L. 427.36 Art. 19Infringements and penalties. Cap. 427. Cap. 427.

(1) Any violation of these regulations or provisions and decisions issued in pursuance thereof shall be construed as infringements pursuant to the Product Safety Act.

(2) The penalties applicable shall be those provided for in Part IV of the Product Safety Act. SCHEDULE I

[Regulations 4, 6(1)(a) and (3), 9(1) and (2)]

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

PRINCIPLES manufacturer of machinery or his authorised representative must ensure assessment is carried out in order to determine the health and safety which apply to the machinery. The machinery must then be designed constructed taking into account the results of the risk assessment. iterative process of risk assessment and risk reduction referred to above, 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 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 these regulations, eliminate the hazards or reduce the risks associated with these hazards application of protective measures, in the order of priority established in paragraph 1.1.2(b).

obligations laid down by the essential health and safety requirements when the corresponding hazard exists for the machinery in question when under the conditions foreseen by the manufacturer or his authorised or in foreseeable abnormal situations. In any event, the principles of integration referred to in paragraph 1.1.2 and the obligations concerning machinery and instructions referred to in paragraphs 1.7.3 and 1.7.4

essential health and safety requirements laid down in this Schedule are however, taking into account the state of the art, it may not be possible objectives set by them. In that event, the machinery must, as far as designed and constructed with the purpose of approaching these

Schedule is organised in several parts. The first one is of general scope to all kinds of machinery. The other parts refer to certain kinds of hazards. Nevertheless, it is essential to examine the whole of this order to be sure of meeting all the relevant essential requirements. When being designed, the requirements of the general part and the of one or more of the other parts shall be taken into account, depending of the risk assessment carried out in accordance with point 1 of these Principles. Essential health and safety requirements for the protection of the are applicable only to the machinery referred to in section 2.4.

ESSENTIAL HEALTH AND SAFETY REQUIREMENTS GENERAL REMARKS Definitions For the purpose of this Schedule:

(a) ‘hazard’ means a potential source of injury or damage to

(b) ‘danger zone’ means any zone within and, or around which a person is subject to a risk to his health or safety;

(c) ‘exposed person’ means any person wholly or partially zone;

(d) ‘operator’ means the person or persons installing, operating, maintaining, cleaning, repairing or moving machinery;

(e) ‘risk’ means a combination of the probability and the injury or damage to health that can arise in a hazardous situation;

(f) ‘guard’ means a part of the machinery used specifically protection by means of a physical barrier;

(g) ‘protective device’ means a device (other than a guard) the risk, either alone or in conjunction with a guard;

(h) ‘intended use’ means the use of machinery in accordance information provided in the instructions for use;

(i) ‘reasonably foreseeable misuse’ means the use of machinery not intended in the instructions for use, but which may readily predictable human behaviour. 1.1.2. Principles of safety integration

(a) Machinery must be designed and constructed so that it function, and can be operated, adjusted and maintained persons at risk when these operations are carried conditions foreseen but also taking into account any foreseeable misuse thereof. The aim of measures taken must be to eliminate any risk foreseeable lifetime of the machinery including the phases assembly, dismantling, disabling and scrapping.

(b) In selecting the most appropriate methods, the manufacturer authorised representative must apply the following principles, order given: - eliminate or reduce risks as far as possible (inherently machinery design and construction), - take the necessary protective measures in relation cannot be eliminated, - inform users of the residual risks due to any shortcomings protective measures adopted, indicate whether training is required and specify any need to provide protective equipment.

(c) When designing and constructing machinery and when instructions, the manufacturer or his authorised representative envisage not only the intended use of the machinery reasonably foreseeable misuse thereof. The machinery must be designed and constructed in such prevent abnormal use if such use would engender appropriate, the instructions must draw the user’s attention 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 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. Materials and products materials used to construct machinery or products used or created during its endanger persons' safety or health. In particular, where fluids are used, must be designed and constructed to prevent risks due to filling, use, draining. Lighting must be supplied with integral lighting suitable for the operations where the absence thereof is likely to cause a risk despite ambient normal intensity. must be designed and constructed so that there is no area of shadow cause nuisance, that there is no irritating dazzle and that there are no stroboscopic effects on moving parts due to the lighting.

parts requiring frequent inspection and adjustment, and maintenance areas provided with appropriate lighting.

Design of machinery to facilitate its handling or each component part thereof, must: capable of being handled and transported safely, packaged or designed so that it can be stored safely and without damage. transportation of the machinery and, or its component parts, there must possibility of sudden movements or of hazards due to instability as long as the and, or its component parts are handled in accordance with the weight, size or shape of machinery or its various component parts from being moved by hand, the machinery or each component part either be fitted with attachments for lifting gear, or designed so that it can be fitted with such attachments, or shaped in such a way that standard lifting gear can easily be attached. machinery or one of its component parts is to be moved by hand, it must:

either be easily moveable, or equipped for picking up and moving safely. arrangements must be made for the handling of tools and, or machinery even if lightweight, could be hazardous. Ergonomics intended conditions of use, the discomfort, fatigue and physical and stress faced by the operator must be reduced to the minimum possible, account ergonomic principles such as: - allowing for the variability of the operator's physical strength and stamina, - providing enough space for movements of the parts of body, - avoiding a machine-determined work rate, - avoiding monitoring that requires lengthy concentration, - adapting the man/machinery interface to the foreseeable of the operators.

1.1.7. Operating positions The operating position must be designed and constructed in such a way any risk due to exhaust gases and, or lack of oxygen. If the machinery is intended to be used in a hazardous environment risks to the health and safety of the operator or if the machinery itself hazardous environment, adequate means must be provided to ensure that has good working conditions and is protected against any foreseeable Where appropriate, the operating position must be fitted with an designed, constructed and, or equipped to fulfil the above requirements. must allow rapid evacuation. Moreover, when applicable, an emergency provided in a direction which is different from the usual exit.

1.1.8. Seating Where appropriate and where the working conditions so permit, constituting an integral part of the machinery must be designed for the seats.

If the operator is intended to sit during operation and the operating integral part of the machinery, the seat must be provided with the machinery.

The operator’s seat must enable him to maintain a stable position. the seat and its distance from the control devices must be capable of being the operator. If the machinery is subject to vibrations, the seat must be constructed in such a way as to reduce the vibrations transmitted to the lowest level that is reasonably possible. The seat mountings must stresses to which they can be subjected. Where there is no floor beneath the operator, footrests covered with a slip-resistant material must be provided. 1.2. CONTROL SYSTEMS

1.2.1. Safety and reliability of control systems Control systems must be designed and constructed in such a way hazardous situations from arising. Above all, they must be designed and in such a way that:

- they can withstand the intended operating stresses influences, - a fault in the hardware or the software of the control system lead to hazardous situations, - errors in the control system logic do not lead to hazardous - reasonably foreseeable human error during operation does hazardous situations. attention must be given to the following points:

the machinery must not start unexpectedly, the parameters of the machinery must not change in an uncontrolled way, where such change may lead to hazardous situations, the machinery must not be prevented from stopping if the stop command has already been given, moving part of the machinery or piece held by the machinery must fall or be ejected, automatic or manual stopping of the moving parts, whatever they may be, must be unimpeded, the protective devices must remain fully effective or give a stop command, the safety-related parts of the control system must apply in a coherent way to the whole of an assembly of machinery and, or partly completed machinery.

cable-less control, an automatic stop must be activated when correct control received, including loss of communication.

Control devices Control devices must be: - clearly visible and identifiable, using pictograms where appropriate, - positioned in such a way as to be safely operated without hesitation or loss of time and without ambiguity, - designed in such a way that the movement of the control device is consistent with its effect, - located outside the danger zones, except where necessary for certain control devices such as an emergency stop or a teach pendant, - positioned in such a way that their operation cannot cause additional risk, - designed or protected in such a way that the desired effect, where a hazard is involved, can only be achieved by a deliberate action, - made in such a way as to withstand foreseeable forces; particular attention must be paid to emergency stop devices liable to be subjected to considerable forces. Where a control device is designed and constructed to perform several different actions, namely where there is no one-to-one correspondence, the action to be performed must be clearly displayed and subject to confirmation, where necessary. Control devices must be so arranged that their layout, travel and resistance to operation are compatible with the action to be performed, taking account of ergonomic principles. Machinery must be fitted with indicators as required for safe operation. The operator must be able to read them from the control position. From each control position, the operator must be able to ensure that no one is in the danger zones, or the control system must be designed and constructed in such a way that starting is prevented while someone is in the danger zone.

(f) If neither of these possibilities is applicable, before starts, an acoustic and, or visual warning signal must exposed persons must have time to leave the danger zone machinery starting up.

(g) If necessary, means must be provided to ensure that the be controlled only from control positions located in predetermined zones or locations.

(h) Where there is more than one control position, the control be designed in such a way that the use of one of them precludes of the others, except for stop controls and emergency stops.

(i) When machinery has two or more operating positions, must be provided with all the required control devices operators hindering or putting each other into a hazardous

1.2.3. Starting It must be possible to start machinery only by voluntary actuation device provided for the purpose. The same requirement applies: - when restarting the machinery after a stoppage, whatever - when effecting a significant change in the operating conditions.

However, the restarting of the machinery or a change in operating be effected by voluntary actuation of a device other than the control device for the purpose, on condition that this does not lead to a hazardous situation. For machinery functioning in automatic mode, the starting of the restarting after a stoppage, or a change in operating conditions may without intervention, provided this does not lead to a hazardous situation. Where machinery has several starting control devices and the therefore put each other in danger, additional devices must be fitted to risks. If safety requires that starting and, or stopping must be performed sequence, there must be devices which ensure that these operations are the correct order. 1.2.4. Stopping 1.2.4.1. Normal stop

Machinery must be fitted with a control device whereby the machinery brought safely to a complete stop.

Each workstation must be fitted with a control device to stop some functions of the machinery, depending on the existing hazards, so that is rendered safe. The machinery’s stop control must have priority over the start controls.

Once the machinery or its hazardous functions have stopped, the energy the actuators concerned must be cut off.

1.2.4.2. Operational stop Where, for operational reasons, a stop control that does not cut supply to the actuators is required, the stop condition must be monitored maintained. Emergency stop must be fitted with one or more emergency stop devices to enable impending danger to be averted.

following exceptions apply: machinery in which an emergency stop device would not lessen the risk, either because it would not reduce the stopping time or because it would not enable the special measures required to deal with the risk to be taken, portable hand-held and, or hand-guided machinery. must:

have clearly identifiable, clearly visible and quickly accessible control devices, stop the hazardous process as quickly as possible, without creating additional risks, where necessary, trigger or permit the triggering of certain safeguard movements. operation of the emergency stop device has ceased following a stop command must be sustained by engagement of the emergency stop that engagement is specifically overridden; it must not be possible to device without triggering a stop command; it must be possible to device only by an appropriate operation, and disengaging the device restart the machinery but only permit restarting.

emergency stop function must be available and operational at all times, the operating mode.

stop devices must be a back-up to other safeguarding measures and not them.

Assembly of machinery of machinery or parts of machinery designed to work together, the must be designed and constructed in such a way that the stop controls, emergency stop devices, can stop not only the machinery itself but also equipment, if its continued operation may be dangerous. Selection of control or operating modes or operating mode selected must override all other control or modes, with the exception of the emergency stop.

has been designed and constructed to allow its use in several control modes requiring different protective measures and, or work procedures, fitted with a mode selector which can be locked in each position. Each selector must be clearly identifiable and must correspond to a single control mode.

may be replaced by another selection method which restricts the use functions of the machinery to certain categories of operator.

certain operations, the machinery must be able to operate with a guard removed and, or a protective device disabled, the control or operating must simultaneously: disable all other control or operating modes, - permit the operation of hazardous functions only by control requiring sustained action, - permit the operation of hazardous functions only in conditions while preventing hazards from linked sequences, - prevent any operation of hazardous functions by involuntary action on the machine’s sensors.

If these four conditions cannot be fulfilled simultaneously, operating mode selector must activate other protective measures constructed to ensure a safe intervention zone. In addition, the operator must be able to control operation of working on from the adjustment point. 1.2.6. Failure of the power supply

The interruption, the re-establishment after an interruption or the whatever manner of the power supply to the machinery must not lead situations. Particular attention must be given to the following points:

- the machinery must not start unexpectedly, - the parameters of the machinery must not change in an way when such change can lead to hazardous situations, - the machinery must not be prevented from stopping if the already been given, - no moving part of the machinery or piece held by the machinery fall or be ejected, - automatic or manual stopping of the moving parts, whatever be, must be unimpeded, - the protective devices must remain fully effective or command. 1.3. PROTECTION AGAINST MECHANICAL HAZARDS

1.3.1. Risk of loss of stability Machinery and its components and fittings must be stable enough overturning, falling or uncontrolled movements during transportation, dismantling and any other action involving the machinery.

If the shape of the machinery itself or its intended installation sufficient stability, appropriate means of anchorage must be incorporated 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 stresses to which they are subject when used.

The durability of the materials used must be adequate for the working environment foreseen by the manufacturer or his authorised in particular as regards the phenomena of fatigue, ageing, corrosion and The instructions must indicate the type and frequency of inspections maintenance required for safety reasons. They must, where appropriate, parts subject to wear and the criteria for replacement. Where a risk of rupture or disintegration remains despite the measures concerned must be mounted, positioned and, or guarded in such a way that any be contained, preventing hazardous situations. and flexible pipes carrying fluids, particularly those under high be able to withstand the foreseen internal and external stresses and attached and, or protected to ensure that no risk is posed by a rupture. material to be processed is fed to the tool automatically, the following must be fulfilled to avoid risks to persons: when the workpiece comes into contact with the tool, the latter must have attained its normal working condition, when the tool starts and, or stops (intentionally or accidentally), the feed movement and the tool movement must be coordinated.

due to falling or ejected objects must be taken to prevent risks from falling or ejected objects. due to surfaces, edges or angles their purpose allows, accessible parts of the machinery must have no no sharp angles and no rough surfaces likely to cause injury.

related to combined machinery machinery is intended to carry out several different operations with removal of the piece between each operation (combined machinery), it must and constructed in such a way as to enable each element to be used without the other elements constituting a risk for exposed persons. purpose, it must be possible to start and stop separately any elements that protected. related to variations in operating conditions Where the machinery operations under different conditions of use, it must be designed and such a way that selection and adjustment of these conditions can be safely and reliably.

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

necessary steps must be taken to prevent accidental blockage of moving parts work. In cases where, despite the precautions taken, a blockage is occur, the necessary specific protective devices and tools must, when provided to enable the equipment to be safely unblocked. instructions and, where possible, a sign on the machinery shall identify these protective devices and how they are to be used. Choice of protection against risks arising from moving parts protective devices designed to protect against risks arising from moving selected on the basis of the type of risk. The following guidelines must to make the choice. Moving transmission parts designed to protect persons against the hazards generated by moving parts must be: either fixed guards as referred to in paragraph 1.4.2.1, or - interlocking movable guards as referred to in paragraph 1.4.2.2.

Interlocking movable guards should be used where frequent access 1.3.8.2. Moving parts involved in the process Guards or protective devices designed to protect persons against generated by moving parts involved in the process must be: - either fixed guards as referred to in paragraph 1.4.2.1, or - interlocking movable guards as referred to in paragraph 1.4.2.2, - protective devices as referred to in paragraph 1.4.3, or - a combination of the above.

However, when certain moving parts directly involved in the process made completely inaccessible during operation owing to operations operator intervention, such parts must be fitted with: - fixed guards or interlocking movable guards preventing sections of the parts that are not used in the work, and - adjustable guards as referred to in paragraph 1.4.2.3 restricting to those sections of the moving parts where access is necessary. 1.3.9. Risks of uncontrolled movements When a part of the machinery has been stopped, any drift away from position, for whatever reason other than action on the control devices, prevented or must be such that it does not present a hazard. 1.4. REQUIRED CHARACTERISTICS OF GUARDS AND DEVICES 1.4.1. General requirements Guards and protective devices must:

- be of robust construction, - be securely held in place, - not give rise to any additional hazard, - not be easy to by-pass or render non-operational, - be located at an adequate distance from the danger zone, - cause minimum obstruction to the view of the production - enable essential work to be carried out on the installation replacement of tools and for maintenance purposes by restricting exclusively to the area where the work has to be done, without the guard having to be removed or the protective to be disabled.

In addition, guards must, where possible, protect against the ejection materials or objects and against emissions generated by the machinery.

1.4.2. Special requirements for guards 1.4.2.1. Fixed guards Fixed guards must be fixed by systems that can be opened or removed tools. Their fixing systems must remain attached to the guards or to the machinery the guards are removed. possible, guards must be incapable of remaining in place without their

Interlocking movable guards movable guards must: far as possible remain attached to the machinery when open, designed and constructed in such a way that they can be adjusted only by means of an intentional action. movable guards must be associated with an interlocking device that: prevents the start of hazardous machinery functions until they are closed and gives a stop command whenever they are no longer closed. possible for an operator to reach the danger zone before the risk due to machinery functions has ceased, movable guards must be associated locking device in addition to an interlocking device that: prevents the start of hazardous machinery functions until the guard is closed and locked, and keeps the guard closed and locked until the risk of injury from the hazardous machinery functions has ceased.

movable guards must be designed in such a way that the absence or of their components prevents starting or stops the hazardous functions. Adjustable guards restricting access guards restricting access to those areas of the moving parts strictly the work must be:

adjustable manually or automatically, depending on the type of work involved, and readily adjustable without the use of tools.

Special requirements for protective devices devices must be designed and incorporated into the control system in that: moving parts cannot start up while they are within the operator’s reach, persons cannot reach moving parts while the parts are moving, and the absence or failure of one of their components prevents starting or stops the moving parts. devices must be adjustable only by means of an intentional action. RISKS DUE TO OTHER HAZARDS

Electricity supply machinery has an electricity supply, it must be designed, constructed and such a way that all hazards of an electrical nature are or can be objectives set out in the Low Voltage Electrical Equipment Regulations to machinery. However, the obligations concerning conformity the placing on the market and, or putting into service of machinery with regard to electrical hazards are governed solely by these regulations.

1.5.2. Static electricity Machinery must be designed and constructed to prevent or limit potentially dangerous electrostatic charges and, or be fitted with system.

1.5.3. Energy supply other than electricity Where machinery is powered by source of energy other than electricity, so designed, constructed and equipped as to avoid all potential risks such sources of energy.

1.5.4. Errors of fitting Errors likely to be made when fitting or refitting certain parts which source of risk must be made impossible by the design and construction or, failing this, by information given on the parts themselves and, or The same information must be given on moving parts and, or their housings the direction of movement needs to be known in order to avoid a risk. Where necessary, the instructions must give further information on Where a faulty connection can be the source of risk, incorrect connections made impossible by design or, failing this, by information given on be connected and, where appropriate, on the means of connection. 1.5.5. Extreme temperatures Steps must be taken to eliminate any risk of injury arising from contact proximity to machinery parts or materials at high or very low temperatures. The necessary steps must also be taken to avoid or protect against or very cold material being ejected. 1.5.6. Fire

Machinery must be designed and constructed in such a way as to avoid fire or overheating posed by the machinery itself or by gases, liquids, or other substances produced or used by the machinery. 1.5.7. Explosion

Machinery must be designed and constructed in such a way as to avoid explosion posed by the machinery itself or by gases, liquids, dust, vapours substances produced or used by the machinery. Machinery must comply, as far as the risk of explosion due potentially explosive atmosphere is concerned, with the provisions Community legislation. 1.5.8. Noise Machinery must be designed and constructed in such a way that from the emission of airborne noise are reduced to the lowest level, of technical progress and the availability of means of reducing noise, source.

The level of noise emission may be assessed with reference to emission data for similar machinery.

1.5.9. Vibrations Machinery must be designed and constructed in such a way that from vibrations produced by the machinery are reduced to the lowest technical progress and the availability of means of reducing vibration, in source. of vibration emission may be assessed with reference to comparative for similar machinery. Radiation radiation emissions from the machinery must be eliminated or be levels that do not have adverse effects on persons.

functional ionising radiation emissions must be limited to the lowest level sufficient for the proper functioning of the machinery during setting, cleaning. Where a risk exists, the necessary protective measures must functional non-ionising radiation emissions during setting, operation and be limited to levels that do not have adverse effects on persons. External radiation must be designed and constructed in such a way that external radiation interfere with its operation. Laser radiation equipment is used, the following should be taken into account: laser equipment on machinery must be designed and constructed in such way as to prevent any accidental radiation, laser equipment on machinery must be protected in such a way that effective radiation, radiation produced by reflection or diffusion and secondary radiation do not damage health, optical equipment for the observation or adjustment of laser equipment machinery must be such that no health risk is created by laser radiation.

Emissions of hazardous materials and substances Machinery must be designed and constructed in such a way that risks of inhalation, ingestion, contact with the skin, eyes and mucous membranes and penetration through the skin of hazardous materials and substances which it produces can be avoided. Where a hazard cannot be eliminated, the machinery must be so equipped that hazardous materials and substances can be contained, evacuated, precipitated by water spraying, filtered or treated by another equally effective method. Where the process is not totally enclosed during normal operation of the machinery, the devices for containment and, or evacuation must be situated in such a way as to have the maximum effect.

of being trapped in a machine must be designed, constructed or fitted with a means of preventing a being enclosed within it or, if that is impossible, with a means of help.

of slipping, tripping or falling machinery where persons are liable to move about or stand must be constructed in such a way as to prevent persons slipping, tripping or falling on or off these parts.

Where appropriate, these parts must be fitted with handholds relative to the user and that enable them to maintain their stability.

1.5.16. Lightning Machinery in need of protection against the effects of lightning while must be fitted with a system for conducting the resultant electrical charge 1.6. MAINTENANCE 1.6.1. Machinery maintenance

Adjustment and maintenance points must be located outside danger be possible to carry out adjustment, maintenance, repair, cleaning operations while machinery is at a standstill. If one or more of the above conditions cannot be satisfied for technical measures must be taken to ensure that these operations can be carried paragraph 1.2.5). In the case of automated machinery and, where necessary, other connecting device for mounting diagnostic fault-finding equipment provided.

Automated machinery components which have to be changed frequently capable of being removed and replaced easily and safely. Access to the must enable these tasks to be carried out with the necessary technical accordance with a specified operating method. 1.6.2. Access to operating positions and servicing points Machinery designed and constructed in such a way as to allow access in safety where intervention is necessary during operation, adjustment and maintenance machinery. 1.6.3. Isolation of energy sources

Machinery must be fitted with means to isolate it from all energy isolators must be clearly identified. They must be capable of being reconnection could endanger persons. Isolators must also be capable of where an operator is unable, from any of the points to which he has access, that the energy is still cut off.

In the case of machinery capable of being plugged into an electricity removal of the plug is sufficient, provided that the operator can check the points to which he has access that the plug remains removed. After the energy is cut off, it must be possible to dissipate normally remaining or stored in the circuits of the machinery without risk to persons. As an exception to the requirement laid down in the previous paragraphs, circuits may remain connected to their energy sources in order, for example, parts, to protect information, to light interiors, and related matters. special steps must be taken to ensure operator safety.

1.6.4. Operator intervention Machinery must be so designed, constructed and equipped that operator intervention is limited. If operator intervention cannot be avoided, be possible to carry it out easily and safely.

1.6.5. Cleaning of internal parts The machinery must be designed and constructed in such a way that internal parts which have contained dangerous substances or preparations entering them; any necessary unblocking must also be possible from the is impossible to avoid entering the machinery, it must be designed and such a way as to allow cleaning to take place safely.

INFORMATION Information and warnings on the machinery and warnings on the machinery should preferably be provided in the readily understandable symbols or pictograms. Any written or verbal and warnings must be expressed in the Maltese language or in any other Community language or languages, which may be determined in accordance by the Member State in which the machinery is placed on the market into service and may be accompanied, on request, by versions in any Community language or languages understood by the operators.

Information and information devices information needed to control machinery must be provided in a form that is and easily understood. It must not be excessive to the extent of the operator.

display units or any other interactive means of communication between the the machine must be easily understood and easy to use.

Warning devices health and safety of persons may be endangered by a fault in the unsupervised machinery, the machinery must be equipped in such a way appropriate acoustic or light signal as a warning.

machinery is equipped with warning devices these must be unambiguous perceived. The operator must have facilities to check the operation of devices at all times. requirements of the specific Community legislation concerning colours and must be complied with. Warning of residual risks remain despite the inherent safe design measures, safeguarding and complementary protective measures adopted, the necessary warnings, including devices, must be provided. Marking of machinery machinery must be marked visibly, legibly and indelibly with the following particulars:

the business name and full address of the manufacturer and, where applicable, his authorised representative, designation of the machinery, the CE Marking (see Schedule III), designation of series or type, serial number, if any, the year of construction, that is the year in which the manufacturing process is completed. prohibited to pre-date or post-date the machinery when affixing the CE

Furthermore, machinery designed and constructed for use in explosive atmosphere must be marked accordingly. Machinery must also bear full information relevant to its type and safe use. Such information is subject to the requirements set out in paragraph Where a machine part must be handled during use with lifting equipment, must be indicated legibly, indelibly and unambiguously. 1.7.4. Instructions

All machinery must be accompanied by instructions in the official language or languages of the Member State in which it is placed on the or put into service. The instructions accompanying the machinery must be eit instructions’ or a ‘Translation of the original instructions’, in which translation must be accompanied by the original instructions. By way of exception, the maintenance instructions intended for use personnel mandated by the manufacturer or his authorised representative supplied in only one Community language which the specialised understand. The instructions must be drafted in accordance with the principles

1.7.4.1. General principles for the drafting of instructions

(a) The instructions must be drafted in the Maltese language one or more official Community languages. The words instructions’ must appear on the language version(s) verified manufacturer or his authorised representative.

(b) Where no ‘Original instructions’ exist in the official language(s) country where the machinery is to be used, a translation language(s) must be provided by the manufacturer or representative or by the person bringing the machinery language area in question. The translations must bear ‘Translation of the original instructions’.

(c) The contents of the instructions must cover not only the the machinery but also take into account any reasonably misuse thereof.

(d) In the case of machinery intended for use by non-professional the wording and layout of the instructions for use must take the level of general education and acumen that can expected from such operators. 1.7.4.2. Contents of the instructions Each instruction manual must contain, where applicable, at least information:

(a) the business name and full address of the manufacturer authorised representative;

(b) the designation of the machinery as marked on the machinery except for the serial number (see paragraph 1.7.3);

(c) the EC declaration of conformity, or a document setting out of the EC declaration of conformity, showing the particulars machinery, not necessarily including the serial number signature; 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; description of the workstation(s) likely to be occupied by operators; 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 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 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 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 where the A-weighted emission sound pressure workstations exceeds 80 dB(A). These values must be either those actually measured for in question or those established on the basis of measurements technically comparable machinery which is representative machinery to be produced. In the case of very large machinery, instead of the A-weighted power level, the A-weighted emission sound pressure levels positions around the machinery may be indicated. Where the harmonised standards are not applied, sound measured using the most appropriate method for the Whenever sound emission values are indicated the surrounding these values must be specified. The operating the machinery during measurement and the measuring must be described. Where the workstation(s) are undefined or cannot be weighted sound pressure levels must be measured at a metre from the surface of the machinery and at a height from the floor or access platform. The position and maximum sound pressure must be indicated. Where specific Community legislation lay down other requirements the measurement of sound pressure levels or sound power Community legislation must be applied and the provisions of this section shall not apply;

(v) where machinery is likely to emit non-ionising radiation cause harm to persons, in particular persons with active implantable medical devices, information concerning emitted for the operator and exposed persons. 1.7.4.3. Sales literature

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