BS EN 12409 2008 ICS 83 200 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW BRITISH STANDARD Plastics and rubber machines — Thermoforming machines — Safety requirements +A1 2011[.]
General
This clause outlines the key hazards, hazardous situations, and events identified through risk assessment as significant for this type of machinery, as specified in this European Standard, necessitating actions to eliminate or mitigate risks.
Hazards relating to all units
Mechanical hazards
Crushing, shearing, impact, drawing-in or trapping hazards by dangerous movements of machine parts, for example, platen, dies, clamping frames, drive and power transmission systems.
Hazards due to electrical energy
Hazards due to electrical shock or burns caused by direct or indirect contact with live parts.
Hazards due to failure/malfunction of the control system
Crushing, shearing, impact, drawing-in or trapping hazards due to unexpected movements, unexpected start- up (see also 4.2.12) or continuing operation.
Hazards resulting from failure of an energy supply
Crushing, shearing, impact, drawing-in or trapping hazards due to sudden fall of raised parts due to gravity, for example sheet roll, platen, clamping frame or stacking unit.
Hazards due to failure/malfunction of pneumatic equipment
Impact hazards due to whiplash of hoses resulting from fracture of flexible hoses
Impact, crushing shearing, drawing-in or trapping hazards resulting from unexpected movement of machine parts.
Hazards resulting from failure/malfunction of hydraulic equipment
Impact hazards due to whiplash of hoses resulting from fracture of flexible hoses
Impact, crushing, shearing, drawing-in or trapping hazards resulting from unexpected movement of machine parts
Hazards due to release of fluid under pressure resulting from fracture, for example of a pipe or hose
Slipping or fire hazards resulting from leakage of for example defective seals or damaged flexible hoses.
Hazards resulting from inadequate emergency precautions
Harm caused by an inability to put machinery in a safe condition following an emergency situation.
Hazards resulting from noise
Hazards due to high noise levels which can lead to:
interference with the perception of acoustic signals.
Hazards resulting from inhalation of hazardous dusts, fumes or gases during normal
Health hazards may be caused by the inhalation of hazardous dusts, fumes or gases produced during the heating of plastic sheets.
Hazards due to hot surfaces
Burning hazards due to accidental contact with hot surfaces.
Hazards due to unsuitable ergonomics
Hazards due to strain of the human body resulting from:
emission of hot air from the machine.
Hazards due to unexpected start up
Unexpected movement of machine parts that can result in impact, crushing, shearing or drawing-in or trapping hazards.
Hazards arising when setting the machine
Unexpected movement of machine parts that can result in impact, crushing, shearing or drawing-in or trapping hazards.
Hazards arising from access to finishing area during production
Impact, crushing, shearing or drawing-in or trapping hazards.
Hazards due to permanent means of access
Harm caused by slipping at or falling from working platforms, steps or walkways provided for use with the machine.
Hazards due to laser devices
Hazards due to high intensity radiation can cause eye injury.
Specific hazards and danger zones relating to individual units
Continuous sheet unwind unit
4.3.1.1.1 Hazards during movement of roll loading devices
Impact, crushing or shearing hazards
4.3.1.1.2 Hazards between the sheet rolls and the fixed parts of the unwind unit (e.g supports and frame) during loading
4.3.1.1.3 Hazards between rotating haul-off rolls and by moving parts of haul-off roll drives
Drawing-in or trapping hazards
4.3.1.1.4 Hazards due to sheet rolls and shafts falling from their bearing
4.3.1.1.5 Hazards due to sheet rolls falling from shafts fixed at one end
4.3.1.1.6 Hazards due to instability of the unwind unit causing it to fall over
4.3.1.1.7 Hazards due to sheet unwinding
Cutting hazards due to sharp edges of the sheet
4.3.1.2 Hazards due to electrostatic charges
Hazards due to electrical shock due to discharge of electrostatic charges, which may occur during unwinding of some materials.
Single sheet feed unit
4.3.2.1.1 Hazards during movement of a handling device, sheets or parts of a single sheet magazine
Crushing, shearing, impact, drawing-in or trapping hazards or cutting hazards due to sharp edges of the sheet
4.3.2.1.2 Hazards during the feeding of sheet to a material intake or conveying system
Drawing in or trapping hazards
4.3.2.2 Hazards due to electrostatic charges
Hazards due to electrical shock due to discharge of electrostatic charges, which may occur during separation of some materials.
Material intake
4.3.3.1.1 Hazards during the feeding of sheet to a hold down device
Drawing-in or trapping hazards
4.3.3.1.2 Hazards during release of sheet in the area of a conveying system
4.3.3.1.3 Hazards during movement of a sharp-edged sheet
4.3.3.1.4 Hazards due to moving parts of an adjacent sheet cutting device
Crushing, shearing, impact or cutting hazards
4.3.3.2 Hazards due to electrostatic charges
Hazards due to electrical shock due to discharge of electrostatic charges, which may occur during separation of some materials.
Conveying equipment
4.3.4.1.1 Hazards during the movement of a sharp-edged sheet
4.3.4.1.2 Hazards during movement of chain conveyors equipped with spikes or clamps
Puncture, penetration, cutting, crushing, shearing or drawing-in or trapping hazards
4.3.4.1.3 Hazards during movement of sheet or parts of a conveying system
Impact or drawing-in or trapping hazards
4.3.4.2 Hazards due to electrostatic charges
Hazards due to electrical shock due to discharge of electrostatic charges, which may occur during separation of some materials.
Heating, pre-heating and edge heating
4.3.5.1.1 Hazards during movement of a heating, pre-heating or edge heating device
Crushing, shearing or impact hazards
Hazards exist in the spaces between rotating rolls, such as heating, diverting, or driving rolls, as well as between sheets and rolls, and between fixed machine components and rotating rolls or moving sheets.
Drawing-in or trapping hazards
4.3.5.2 Hazards due to electrical energy
Hazards due to contact with live parts of the heating, pre-heating or edge heating devices
Hazards due to contact with hot parts of the heating, pre-heating or edge heating devices or due to contact with hot sheet
4.3.5.4 Hazards due to inhalation of health hazardous dusts, fumes and gases a) Hazards caused by overheating of material, for example due to:
1) failure of the conveying system;
2) failure of the heating unit retraction/opening system;
3) failure of the heating control system;
4) excessive delay time in/on the heating system;
5) material falling or drooping from the conveying system;
6) energy failure b) Hazards caused by leakage of hydraulic fluids onto hot parts c) Hazards caused by abrasion and perforation during material transport
4.3.5.5 Fire hazard a) Hazards caused by overheating of material, for example due to:
1) failure of the conveying system;
2) failure of the heating unit retraction/opening system;
3) failure of the heating control system;
4) excessive delay time in/on the heating system;
5) material falling or drooping from the conveying system;
6) energy failure b) Hazards caused by leakage of hydraulic fluids onto hot parts.
Forming station
4.3.6.1 Mechanical hazards during movement of linkages, clamping frames, platens, stretching punches, ejectors or component feeding/inserting unit
Crushing, shearing or impact hazards
Hazards due to contact with hot surfaces, for example, moulds, clamping frames, material or pipes.
Finishing station
4.3.7.1 Mechanical hazards during movement of finishing devices such as for example platens, ejectors, rim roll devices or discharge devices
Crushing, shearing, impact hazards or cutting hazards by sharp edges
Hazards due to contact with hot surfaces, for example, moulds, clamping frames, material or pipes
4.3.7.3 Hazards due to inhalation of health hazardous fumes and dust
Hazards caused by overheating of material
Hazards caused by abrasion and perforation during material transport.
Stacking station
4.3.8.1.1 Hazards during movement of machine part, for example stacking cages, stacking discs, staking pallets or slides or discharge devices or during movement of residual sheet
Crushing, shearing or impact hazards or cutting hazards due to sharp edges
4.3.8.1.2 Hazards during movement of part of a conveyor belt
Drawing-in or trapping hazards
4.3.8.2 Hazards due to failure/malfunction of the control system
Hazards due to unexpected start-up or continuing operation
4.3.8.3 Intervention during operation or as a result of a malfunction
Hazards due to moving machine parts, product or residue sheet when manual intervention is necessary during normal operation or as a result of a malfunction
4.3.8.4 Hazards due to electrostatic charges
Hazards due to electrical shock due to discharge of electrostatic charges, which may occur during unwinding of some materials.
Discharge station
4.3.9.1 Mechanical hazards during movement of product or machine parts
Impact, crushing, shearing, drawing-in or trapping hazards or cutting hazards due to sharp edge of the sheet
4.3.9.2 Hazard due to the accessibility of parts of a unit from another unit
Hazards described in 4.3.6, 4.3.7 or 4.3.8 may occur if it is possible to reach the area of the conveying equipment, forming station, finishing station or stacking station from the discharge opening
Hazards due to contact with hot products
4.3.9.4 Hazards due to electrostatic charges
Hazards due to electrical shock due to discharge of electrostatic charges, which may occur during unwinding of some materials.
Residual sheet winding unit
4.3.10.1.1 Hazards during movement of a sharp-edged sheet
4.3.10.1.2 Hazards during winding of residual sheet
Entanglement or drawing-in or trapping hazards
4.3.10.2 Hazards due to electrostatic charges
Hazards due to electrical shock due to discharge of electrostatic charges, which may occur during winding of some materials.
Sheet cutting unit
4.3.11.1.1 Hazards during movement of parts of the cutting unit
Crushing, shearing or impact hazards
4.3.11.1.2 Hazards created by moving or stationary parts of the cutting unit or a sharp-edged sheet
4.3.11.2 Hazards due to failure/malfunction of the control system
Hazards due to unexpected movements of parts of a cutting device
Hazards due to unexpected start-up or continuing operation
5 Safety requirements and/or protective measures
General
Machinery shall comply with the safety requirements and/or protective measures of this clause
In addition, the machine shall be designed according to the principles of EN ISO 12100-2:2003 for relevant but not significant hazards which are not dealt with by this document.
General safety requirements and/or protective measures relating to all units
Access to danger zones
Machines should be designed to minimize access to danger zones through safe design practices and fixed guards When complete prevention is not feasible, access to these areas must be regulated by appropriate safeguards as outlined in sections 5.2.1.2 and 5.2.1.3.
Safety distances to prevent access to danger zones by the upper and the lower limbs shall be in accordance with EN ISO 13857:2008
To avoid crushing of parts of the human body, the minimum distances of EN 349:1993 shall apply
5.2.1.2 !Protective measures when access into a danger zone is required
If access to a danger zone is required then access to danger zones shall be controlled by one of the following protective measures:
Interlocking guards must comply with EN 953:1997, section 3.5, or, if necessary, follow the selection criteria of EN 1088:1995, which includes interlocking guards with guard locking as per EN 953:1997, section 3.6 For safety-related components of the control system, the performance level PLr 'd' outlined in EN ISO 13849-1:2008 is applicable It is essential that opening the interlocking guards halts any dangerous movements.
sensitive protective equipment in accordance with EN ISO 12100-1:2003, 3.26.5 and in accordance with
The PLr 'd' of EN ISO 13849-1:2008 specifies that safety-related parts of the control system must be designed to eliminate hazards before access is granted, as outlined in EN 999:1998 Additionally, the activation of sensitive protective equipment is required to halt any dangerous movements.
for maintenance operations only and where access is required no more than once per shift, fixed guards in accordance with EN 953:1997, 3.2."
5.2.1.3 Additional requirements where whole body access is possible
An acknowledge switch must be installed when there is potential whole body access between guards or sensitive protective equipment and any danger zone This switch is a critical safety component of the control system, ensuring that any failure does not compromise the system's performance level It should be positioned near access points to danger zones and must be operated by the individual exiting the zone before a separate start command can be initiated If a guard is opened or another protective device is triggered after the acknowledge switch is activated but before the start command is given, the start command will be blocked Additionally, the acknowledge switch cannot be activated from within the danger zone, and its location should provide a clear view of the area, with visual aids available if necessary.
When an interlocking guard is open and issues a stop command to the control system, this command cannot be canceled by pressing the acknowledge switch The start command will only take effect after all interlocking guards are closed and the acknowledge switch is activated Additionally, the start command cannot be stored prior to the activation of the acknowledge switch.
An acknowledge switch is unnecessary if its role is fulfilled by an interlocking device that mandates intentional mechanical action from outside the danger zone after the guard is closed Examples include trapped key interlocking devices or plug and socket interlocking devices, which should be positioned for a clear view of the danger zones.
An acknowledge switch is unnecessary when a presence sensing device, like a pressure-sensitive mat compliant with EN 1760-1:1997, is placed within an enclosure to detect individuals between guards or sensitive protective equipment and the associated danger zone Upon activation, this device will inhibit the control system from issuing a start command.
An acknowledge switch is not required when a fixed guard may be used to control access under the restricted conditions described in 5.2.1.2
5.2.1.4 Drive and power transmission systems
To ensure safety, access to hazardous components of drive and power transmission systems, such as shafts, belts, chains, linkages, clutches, and gears, must be restricted through design If complete prevention is not feasible, fixed guards must be installed in compliance with EN 953:1997, section 3.2.
Electrical equipment
The electrical equipment shall be in accordance with EN 60204-1:2006
The supply disconnecting (isolating) devices shall be in accordance with EN 60204-1:2006, 5.3.2 and 5.3.3
Hazards due to unexpected start-up have to be prevented in accordance with EN 1037:1995
The protection against direct contact shall be in accordance with 6.2 of EN 60204-1:2006
The protection against indirect contact shall be in accordance with 6.3 of EN 60204-1:2006
5.2.3 !Unintended gravity fall of raised elements
Machines must be engineered to eliminate risks associated with elevated components falling due to gravity, particularly in cases of power supply failure or malfunctions.
Devices and components designed to prevent gravity falls, as mandated by this European Standard, must support a load of at least 1.2 times the static holding load This static holding load also accounts for additional non-permanent loads, such as molds or other tools.
To safeguard individuals from the risks associated with falling gravity-loaded vertical axes, it is essential to implement the measures outlined in sections 5.2.3.2 and 5.2.3.3 The selection of safety-related performance for holding systems must be based on the assessed risk level.
in case of low frequency access with upper limbs or whole body (e.g for setting and trouble shooting) a
PLr 'c' according to EN ISO 13849-1:2008 shall be selected;
in case of high frequency access with upper limbs or whole body a PLr 'd', category '3' according to
EN ISO 13849-1:2008 shall be selected
For maintenance or mould/tool changes, movable machine platens must be positioned at their lowest point When work requires the platens to be in a different position, movement must be secured using safety devices, such as blocks, placed both above and below the platens These safety blocks should be engineered to withstand at least twice the force generated by the movement of the platens and should be painted in a visible signal color.
In fluid drives, machine axis movement is controlled by a valve, ensuring that motion can only occur while a command signal is active If the command signal is canceled, the movement will cease or may reverse, provided it does not pose additional risks.
To ensure safety against gravity fall hazards, it is essential to implement one or more of the following measures: a controllable non-return valve or shut-off valve connected directly or via a minimum length of steel pipework to the drive element; a friction-locked clamping device; gears with sufficient inherent resistance to prevent unintended movement due to gravity, such as self-locking gears; or a positive-locking pawl that can engage at any height or is interlocked with a guard to prevent access to the danger zone until the pawl is effective Additionally, if a pawl is used on a rotating part, it must function in both directions of rotation to mitigate the risk of gravity falls.
For the safety related performance the requirements of 5.2.3.1 shall apply
NOTE ISO/DIS 5598 contains the vocabulary for all fluid power systems and components
5.2.3.3.1 Raising of elements achieved by using a control system in accordance with PL r 'c'
Where the raising of elements is achieved by using a control system in accordance with PLr 'c' of
According to EN ISO 13849-1:2008, systems must include either gears that inherently resist motion to prevent unintended movement due to gravity, such as self-locking gears, or a drive equipped with a mechanical brake that activates automatically in the event of an energy supply failure This mechanical brake should be designed to hold a load of at least 1.2 times the static holding torque, and its functional capability must be verifiable through manual or automatic checks Additionally, the instruction manual must specify the frequency of brake inspections and outline procedures for determining when adjustments or replacements are necessary.
5.2.3.3.2 Raising of elements achieved by using a control system in accordance with PL r 'd'
Where the raising of elements is achieved by using a control system in accordance with PLr 'd' of
According to EN ISO 13849-1:2008, systems must include either a) two independent mechanical brakes that automatically engage during energy supply failure, each capable of holding a load of at least 1.2 times the total static holding torque, with functional checks required for each brake; b) a mechanical brake paired with a friction-locked clamping device, where both the brake's functionality and clamping efficiency must be individually tested; or c) a positive-locking pawl that can engage at any height to prevent gravity fall hazards, which must also function effectively in both directions if rotation could lead to a fall Testing frequencies for these components should be specified in the instruction manual.
For the safety related performance the requirements of 5.2.3.1 shall apply."
Pneumatic equipment
Pneumatic equipment shall be in accordance with EN 983:1996
Flexible hoses shall be installed so that they do not have contact with moving and/or hot machine parts.
Hydraulic equipment
Hydraulic equipment shall be in accordance with EN 982:1996
Flexible hoses shall be installed so that they do not have contact with moving and/or hot machine parts
Precautions shall be taken to prevent foreseeable leakage of hydraulic fluid causing a slipping hazard at surfaces where operators require access.
Precautions for emergencies
Measures to give protection in emergency situations shall be taken in accordance with EN ISO 12100-2:2003, 5.5.2 and 5.5.3
Emergency stop equipment shall be in accordance with EN ISO 13850:2006 Emergency stop function may be either stop category 0 or 1 in accordance with EN ISO 13850:2006, 4.1.4
Each control station must be equipped with an emergency stop actuator, strategically placed near feed and discharge areas Activating this actuator will halt all hazardous movements, except for those required to mitigate fire risks, such as retracting a heating system.
Noise
perforation of sheet by spiked chain
Intense noise is generated, in particular, by:
5.2.7.2 Noise reduction at source by design
To minimize machine noise emissions, effective design and construction techniques must be employed It is essential to consider existing information and technologies that focus on reducing noise at the source.
NOTE EN ISO 11688-2:2000 gives useful information on noise generation mechanisms in machinery
Current measures to reduce noise at source may be:
choice of low-noise machine components, e g motors, transmission systems, fans, pumps with sound insulation;
use of vibration damping material for vibrating surfaces;
use of elastic transmission to prevent structure-borne noise from propagating from vibrating elements to other machine parts
5.2.7.3 Noise reduction by protective measures
Amongst the measures that may be taken to reduce noise emission are:
acoustic enclosure/screening of noise creating parts;
sound attenuation using insulating material;
use of elastic mounting elements
5.2.7.4 Information connected with noise hazards
Inhalation of hazardous dusts, fumes and gases
Machines must be designed to allow for the connection of suitable extraction systems, as referenced in section 7.2.5 Additionally, the machine's control system should ensure that it cannot operate unless the extraction system is functioning.
If substances are to be processed which may generate dusts, fumes and gases that are hazardous to health, then EN 626-1:1994 applies
Due to the varying characteristics of dust, fumes, and gases based on specific installations and materials utilized, this standard cannot provide more detailed requirements.
Hot surfaces
Protection against contact with hot surfaces in work areas must comply with EN ISO 13732-1:2006 Effective measures include shielding, personal protective equipment, and warning signs Specific requirements for different units are outlined in section 5.3.
Ergonomics
Machine operator working places shall be designed and constructed in accordance with ergonomic requirements, described in EN 614-1.2006
Tools and equipment for handling reels, finished products, and machine parts must be designed to accommodate mechanical handling equipment when the load exceeds 15 kg.
Unexpected start up
Equipment preventing unexpected start up or continuing operation shall be designed and constructed in accordance with EN 1037:1995.
Setting mode
Thermoforming machines must be engineered to allow for machine settings, teaching, process changeovers, fault finding, cleaning, and maintenance to be performed while the production mode safety systems are active or with the machine safely at a standstill, in accordance with EN ISO 12100-2:2003, 5.2.4.
In cases where access to specific units is necessary but the aforementioned conditions cannot be fulfilled, the following requirements must be adhered to while the production mode safety systems are not operational.
A lockable switch must be included to allow for manual control, serving as a safety-related component of the control system It is essential that any unintentional change in the switch's mode does not compromise the performance level of the control system The design and construction of manual control must adhere to the standards outlined in EN ISO 12100-2:2003, specifically sections 4.11.8 and 4.11.9 In cases where reduced speed is the chosen protection measure, the speed must not exceed 25 mm/s.
access to danger zones of adjacent units shall be prevented by suitable measures e g fixed guards in accordance with EN 953:1997, 3.2;
Control devices must comply with EN ISO 12100-1:2003, section 3.26.3, or utilize a two-hand control device as per EN 574:1996, type III C, ensuring operation at a reduced speed not exceeding 25 mm/s.
it shall be possible to control movements of unit parts with opened guards whereby only a single movement is activated
To ensure safety, machines must be designed so that settings and adjustments can be made through interlocking guards at the front, especially when external adjustments are not feasible.
Machinery should be designed to allow for the adjustment or replacement of parts without necessitating unhealthy postures for workers This approach prioritizes ergonomic safety and promotes a healthier work environment.
Access during production
To ensure proper operation, such as verifying correct perforation through visual inspection while the machine is running at production speed, specific requirements must be met when opening an interlocking guard.
the production safeguard shall be an interlocked guard with guard locking in accordance with EN 953, 3.6;
electro-sensitive protective equipment (light curtain) in accordance with EN 61496-1:2004, type 4 shall be positioned behind the interlocking guard;
The interlocking guard will stay locked until the electro-sensitive protective equipment is activated using a key-operated switch If the light curtain is interrupted while the interlocking guard is open, it will at least halt the units or stations that the guard controls.
NOTE This will allow the punching tools to be set at their end position to permit an inspection of the finished product.
Laser devices
Where laser devices, for example laser sensors are used, warning signs shall be provided in close proximity to the device.
Permanent means of access
Working platforms, steps and walkways shall be in accordance with EN ISO 14122-1:2001, EN ISO 14122-2:2001, EN ISO 14122-3:2001 and EN ISO 14122-4:2004 to prevent the risk of slipping, tripping or falling.
Common safeguarding system
If a common safeguarding system, such as a perimeter fence, is used to control access to more than one unit and access to one unit permits access to other units:
all units to which access is possible shall be stopped or otherwise put in a safe condition in accordance with the requirements given in 5.3 for the specific units concerned;
the interlocks or other safety devices controlling access to such units shall be of the most severe performance level and type required in 5.3 for any of the units concerned.
Fixing systems of fixed guards
Fixed guards shall be so designed, that their fixing systems remain attached to the guards or to the machinery when the guards are removed
Quick release systems shall be not used.
Specific safety requirements and/or protective measures relating to individual units
Continuous sheet unwind unit
Safety distances shall be in accordance with EN ISO 13857:2008, Tables 1, 3 and 4
Impact, crushing and shearing hazards due to movement of the roll lifting devices shall be prevented by:
fixed guards in accordance with EN 953:1997, 3.2; or
using a hold to run control device in accordance with EN ISO 12100-1:2003, 3.26.3 whereby the speed of the roll lifting device shall not exceed 25 mm/s; or
using a two hand control in accordance with EN 574:1996, type I
Crushing and shearing hazards between sheet roll support shafts and their bearings during loading shall be prevented by:
using a hold to run control device in accordance with EN ISO 12100-1:2003,3.26.3 whereby the speed of the roll lifting device shall not exceed 25 mm/s; or
using a two hand control in accordance EN 574:1996, type I
To prevent drawing-in or trapping hazards between rotating haul-off rolls and moving parts of haul-off roll drives, fixed guards must be installed in compliance with EN 953:1997, section 3.2.
To prevent impact and crushing hazards from falling sheet rolls and shafts, it is essential to implement safety measures such as bearing shells, retention pins, or locking bolts.
To prevent impact and crushing hazards from sheet rolls that may fall from shafts supported at only one end, it is essential to implement safety measures Utilizing retaining devices like bearing shells, retention pins, or locking bolts can effectively mitigate these risks.
To prevent impact and crushing hazards from the instability of the unwind unit, it is essential to implement effective design measures, such as using anchorages and ensuring sufficient stability to withstand unwinding forces.
Warning signs must be displayed to indicate cutting hazards from sharp edges The manufacturer should advise the use of personal protective equipment, such as gloves, in the instruction manual.
5.3.1.3 Hazards due to electric shock caused by electrostatic phenomena
To prevent hazards from electric shock when using the machine with materials that generate electrostatic charges during unwinding, it is essential to implement safety measures such as earthing or utilizing ionization devices.
NOTE For guidance see PD CLC/TR 50404:2003.
Single sheet feed unit
Safety distances shall be in accordance with EN ISO 13857:2008, Tables 1, 3 and 4
Crushing, shearing and impact hazards caused by movement of handling devices, sheet or parts of a single sheet magazine shall be prevented by:
fixed guards in accordance with EN 953:1997, 3.2; or
protective devices in accordance with 5.2.1.2 and 5.2.1.3
Drawing-in and trapping hazard caused when sheet is fed to a material intake or conveying system shall be prevented by:
fixed guards in accordance with EN 953:1997, 3.2; or
protective devices in accordance with 5.2.1.2 and 5.2.1.3
5.3.2.3 Hazards due to a sticking together of sheets
In certain situations, sheets in a magazine may adhere to one another due to the type of material, causing machine issues To avoid the need for manual intervention, it is essential for the sheet magazine to be equipped with a mechanism for separating the sheets, as outlined in section 7.2.13.
5.3.2.4 Hazards due to electric shock caused by electrostatic phenomena
To ensure safety when using the machine with materials that generate electrostatic charges during sheet feeding, it is essential to implement measures to prevent electric shock hazards This can be achieved through proper earthing or the installation of ionisation devices, as outlined in section 7.2.6.
NOTE For guidance see PD CLC/TR 50404:2003.
Material intake
Safety distances shall be in accordance with EN ISO 13857:2008, Tables 2, 3 and 4
Drawing-in or trapping hazards during feeding of sheet into a holding down device shall be prevented by:
fixed guards in accordance with EN 953:1997, 3.2; or
protective devices in accordance with 5.2.1.2 and 5.2.1.3
If one roll of a two roll material intake system is able to move away from the other roll with a load not exceeding 150 N, additional safeguarding is not required
Crushing or cutting hazards during release of sheet in the area of a conveying system, shall be prevented by:
fixed guards in accordance with EN 953:1997, 3.2; or
protective devices in accordance with 5.2.1.2 and 5.2.1.3
Cutting hazards during movement of a sharp-edged sheet shall be prevented by:
fixed guards in accordance with EN 953:1997, 3.2; or
protective devices in accordance with 5.2.1.2 and 5.2.1.3
5.3.3.2.4 Hazards due to moving parts of adjacent sheet cutting unit
Crushing, shearing or impact hazards during movement of parts of the sheet cutting unit shall be prevented by:
fixed guards in accordance with EN 953:1997, 3.2; or
protective devices in accordance with 5.2.1.2 and 5.2.1.3
Cutting hazards caused by moving or stationary parts of the sheet cutting unit shall be prevented by:
fixed guards in accordance with EN 953:1997, 3.2; or
protective devices in accordance with 5.2.1.2 and 5.2.1.3
5.3.3.3 Hazards due to electric shock caused by electrostatic phenomena
To ensure safety when using the machine with materials that generate electrostatic charges during sheet feeding, it is essential to implement measures to prevent electric shock hazards This can be achieved through proper earthing or the installation of ionisation devices, as outlined in section 7.2.6.
NOTE For guidance see PD CLC/TR 50404:2003.
Conveying equipment
Safety distances shall be in accordance with EN ISO 13857:2008, Tables 1, 3 and 4
Cutting hazards during movement of a sharp-edged sheet shall be prevented by:
fixed guards in accordance with EN 953:1997, 3.2; or
protective devices in accordance with 5.2.1.2 and 5.2.1.3
Puncture, penetration and cutting hazards during movement of chain conveyors equipped with spikes or clamps shall be prevented by:
fixed guards in accordance with EN 953:1997, 3.2; or
protective devices in accordance with 5.2.1.2 and 5.2.1.3
Impact and drawing-in or trapping hazards during movement of the sheet or parts of a conveying system shall be prevented by:
fixed guards in accordance with EN 953:1997, 3.2; or
protective devices in accordance with 5.2.1.2 and 5.2.1.3
5.3.4.3 Hazards due to electric shock caused by electrostatic phenomena
To ensure safety when using the machine with materials that generate electrostatic charges during sheet feeding, it is essential to implement measures to prevent electric shock hazards This can be achieved through proper earthing or the installation of ionisation devices, as outlined in section 7.2.6.
NOTE For guidance see PD CLC/TR 50404:2003.
Heating, pre-heating and edge heating
Safety distances shall be in accordance with EN ISO 13857:2008, Tables 1, 3 and 4
Crushing, shearing or impact hazards during movement of a heating or pre-heating device shall be prevented by:
fixed guards in accordance with EN 953:1997, 3.2; or
protective devices in accordance with 5.2.1.2 and 5.2.1.3
To prevent drawing-in or trapping hazards associated with rotating rolls, such as heating, diverting, or driving rolls, it is essential to implement safety measures that address the risks between the rolls and sheets, as well as between fixed machine parts and moving sheets.
fixed guards in accordance with EN 953:1997, 3.2; or
protective devices in accordance with 5.2.1.2 and 5.2.1.3
5.3.5.3 Hazards due to electrical energy
Access to live parts of the heating elements shall be prevented by enclosures having a minimum degree of protection of IP 20 in accordance with EN 60529:1991 This deviates from EN 60204-1:2006
NOTE This is necessary to ensure free heat dissipation
When hot surfaces cannot be adequately protected as per section 5.2.9, such as when heating elements remain hot after guards are opened, it is essential to install warning signs in suitable locations on the machine to alert users to the potential danger, as referenced in section 7.1.2.
Where necessary the instruction manual shall include indications for the wearing of appropriate personal protection equipment; see also 7.2.2
5.3.5.5 Fire hazards and hazards due to Inhalation of dusts, fumes and gases
To mitigate fire hazards and the risks associated with hazardous dusts, fumes, and gases from material overheating, it is essential to implement effective heating system temperature monitoring and control Additional safety measures include preventing contact between processed materials and heating radiators, utilizing gas or flame detection systems, and having the capability to cut off the heating system Other strategies involve repositioning heating devices, installing protective screens, and incorporating a prearranged device for connecting a fire extinguisher, ensuring comprehensive fire safety protocols are in place.
2) suitable pipe connection between the nozzle(s) and the fire extinguisher (located outside the guards)
It shall be ensured that this happens even in the event of failure of an energy supply
Where necessary the instruction manual shall include details of suitable fire extinguishing equipment; see also 7.2.8
To prevent hydraulic fluid leakage from affecting the heating system, it is essential to implement protective measures, such as covering hydraulic lines and hoses.
Forming station
Safety distances shall be in accordance with EN ISO 13857:2008, Tables 2, 3 and 4
To prevent crushing, shearing, or impact hazards during the movement of machine parts like linkages and clamping frames, it is essential to implement safety measures These measures include the use of fixed guards as specified in EN 953:1997, section 3.2, and interlocking guards in accordance with sections 5.2.1.2 and 5.2.1.3, particularly for the safety-related components of the control system.
1) PLr 'd' of EN ISO 13849-1:2008 applies in case of non-cyclic manual intervention; or
2) PLr 'd', category 3 of EN ISO 13849-1:2008 applies in case of cyclic manual intervention c) electro-sensitive protective equipment in accordance with EN 61496-1:2004, type 4, e.g active opto- electronic protective devices like light beam devices or light curtains."
To prevent crushing, shearing, or impact hazards during the movement of machine parts like linkages and clamping frames, it is essential to implement safety measures These measures include the use of fixed guards as specified in EN 953:1997, section 3.2, and interlocking guards in accordance with sections 5.2.1.2 and 5.2.1.3, particularly for the safety-related components of the control system.
1) PLr 'd' of EN ISO 13849-1:2008 applies in case of non-cyclic manual intervention; or
2) PLr 'd', category 3 of EN ISO 13849-1:2008 applies in case of cyclic manual intervention c) electro-sensitive protective equipment in accordance with EN 61496-1:2004, type 4, e.g active opto- electronic protective devices like light beam devices or light curtains; d) for single sheet machines with manual sheet feed and take-off, where the protective devices in accordance with 5.2.1.3 are not used by:
1) two-hand control devices in accordance with EN 574:1996 type III C; and
2) fixed guards in accordance with EN 953:1997, 3.2 at the sides, the rear and, to the extent that this is necessary to prevent access by a second operator, at the front, whereby for the safety distances of
EN ISO 13857:2008, Tables 2, 3 and 4 apply."
When it is not possible to guard hot surfaces as required by section 5.2.9, such as when dies remain hot after guards are opened, appropriate warning signs must be placed on the machine to alert users to the potential danger, as outlined in section 7.1.2.
Where necessary the instruction manual shall include indications for the wearing of appropriate personal protection equipment; see also 7.2.2.
Finishing station
Safety distances shall be in accordance with EN ISO 13857:2008, Tables 2, 3 and 4
5.3.7.2 Integrated or downstream finishing stations
To prevent crushing, shearing, impact, or cutting hazards from moving machine parts like platens, ejectors, rim roll devices, or discharge devices, it is essential to implement one or more safety measures These include the use of fixed guards as specified in EN 953:1997, section 3.2, and interlocking guards in accordance with sections 5.2.1.2 and 5.2.1.3, which ensure the safety of the control system's critical components.
1) PLr 'd' of EN ISO 13849-1:2008 applies in case of non-cyclic manual intervention; or
2) PLr 'd', category 3 of EN ISO 13849-1:2008 applies in case of cyclic manual intervention; c) electro-sensitive protective equipment in accordance with EN 61496-1:2004, type 4, e.g active opto- electronic protective devices like light beam devices or light curtains."
To prevent crushing, shearing, impact, or cutting hazards from moving machine parts like platens, ejectors, rim roll devices, or discharge devices, it is essential to implement one or more of the following safety measures: a) fixed guards that comply with EN 953:1997, section 3.2; b) interlocking guards as specified in sections 5.2.1.2 and 5.2.1.3, ensuring the safety-related components of the control system are adequately addressed.
1) PLr 'd' of EN ISO 13849-1:2008 applies in case of non-cyclic manual intervention; or
2) PLr 'd', category 3 of EN ISO 13849-1:2008 applies in case of cyclic manual intervention; c) electro-sensitive protective equipment in accordance with EN 61496-1:2004, type 4, e.g active opto- electronic protective devices like light beam devices or light curtains; d) for single sheet machines with manual sheet feed and take-off, where the protective devices in accordance with 5.2.1.3 are not used by:
1) two-hand control devices in accordance with EN 574:1996 type III C; and
2) fixed guards in accordance with EN 953:1997, 3.2 at the sides, the rear and, to the extent that this is necessary to prevent access by a second operator, at the front, whereby for the safety distances of EN ISO 13857:2008, Tables 2, 3 and 4 apply."
When hot surfaces cannot be adequately guarded due to process requirements, it is essential to install warning signs in suitable locations on the machine to alert users to the potential danger, as outlined in section 5.2.9 For further guidance, refer to section 7.1.2.
Where necessary the instruction manual shall include indications for the wearing of appropriate personal protection equipment; see also 7.2.2.
Stacking zone
The stacking height shall be adjustable from outside closed guards with the machine process not interrupted
Safety distances shall be in accordance with EN ISO 13857:2008, Tables 2, 3 and 4
To prevent crushing, shearing, or impact hazards from the movement of machine parts such as stacking cages, stacking discs, pallets, slides, or discharge devices, as well as during the movement of residual sheets, appropriate safety measures must be implemented.
fixed guards in accordance with EN 953:1997, 3.2; or
protective devices in accordance with 5.2.1.2 and 5.2.1.3
Drawing in or trapping hazards caused by the moving conveyor parts shall be prevented by:
fixed guards in accordance with EN 953:1997, 3.2; or
protective devices in accordance with 5.2.1.2 and 5.2.1.3
5.3.8.4 Intervention during operation or as a result of a malfunction
In situations where manual intervention is required in the stacking zone, all other movements must be halted to ensure safety while conveying the sheet for adjustments Design measures should effectively prevent access to danger zones between the moving residual sheet and machine components, as well as restrict reaching into adjacent hazardous areas, in compliance with safety standards.
5.3.8.5 Hazards due to electric shock caused by electrostatic phenomena
To ensure safety when using the machine with materials that generate electrostatic charges during sheet feeding, it is essential to implement measures to prevent electric shock hazards This can be achieved through proper earthing or the installation of ionisation devices, as outlined in section 7.2.6.
NOTE For guidance see PD CLC/TR 50404:2003.
Discharge station
Safety distances shall be in accordance with EN ISO 13857:2008, Tables 1, 3 and 4
Discharge stations must be designed to prevent access to danger zones in nearby units If this is not feasible, applicable safety requirements and protective measures for those units must be implemented.
To prevent hazards from the movement of products or machine parts, it is essential to limit the maximum force to 75 N, the kinetic energy to 4 J, or the contact pressure to 50 N/cm² when access is possible.
Information shall be given in the instruction manual to wear personal protection equipment, e g gloves against cutting hazards due to sharp edges; see also 7.2.3
Information shall be given in the instruction manual to wear personal protection equipment, e g gloves against hot products; see also 7.2.2.
Residual sheet winding unit
Safety distances shall be in accordance with EN ISO 13857:2008, Tables 1, 3 and 4
Cutting hazards due to movement of a sharp-edged sheet shall be prevented by:
fixed guards in accordance with EN 953:1997, 3.2; or
protective devices in accordance with 5.2.1.2 and 5.2.1.3
Entanglement, drawing-in or trapping during winding of residual sheet shall be prevented by:
fixed guards in accordance with EN 953:1997, 3.2; or
protective devices in accordance with 5.2.1.2 and 5.2.1.3
The tension in any continuous sheet not protected by fixed guards or other protective devices shall not exceed
150 N or the surface pressure shall not exceed 50 N/cm 2 This may be achieved, for example by one or a combination of the following measures:
an appropriate design of the drive mechanism;
pressure limitation in pneumatic systems
5.3.10.3 Hazards due to electric shock caused by electrostatic phenomena
To ensure safety when using the machine with materials that generate electrostatic charges during winding, it is essential to implement measures to prevent electric shock hazards This can be achieved through proper earthing or the use of ionization devices, as outlined in section 7.2.6.
NOTE For guidance see PD CLC/TR 50404:2003.
Sheet cutting unit
Safety distances shall be in accordance with EN ISO 13857:2008, Tables 2, 3 and 4
Crushing, shearing or impact hazards during movement of parts of the sheet cutting unit shall be prevented by:
fixed guards in accordance with EN 953:1997, 3.2; or
protective devices in accordance with 5.2.1.2 and 5.2.1.3
Cutting hazards caused by moving or stationary parts of the sheet cutting unit shall be prevented by:
fixed guards in accordance with EN 953:1997, 3.2; or
protective devices in accordance with 5.2.1.2 and 5.2.1.3
6 Verification of safety requirements and/or protective measures
Type tests shall be used to verify the safety requirements and/or protective measures in accordance with Table 1
Functional testing involves validating the performance and effectiveness of guards and protective devices according to the provided usage information, safety plans, circuit diagrams, and the requirements outlined in clause 5 of this standard, along with other referenced standards.
"Design validation" means verifying that the design meets the safety specifications of this standard
Clause Visual inspection Measurement Functional test Design validation
Clause Visual inspection Measurement Functional test Design validation
Clause Visual inspection Measurement Functional test Design validation
Marking on the machine
Minimum marking
The machine shall be marked at least with the following information:
name and address of the manufacturer and supplier;
designation of series or type;
business name and full address of the authorised representative (where applicable).
Additional markings
Warning signs must be placed in areas where machine parts or materials are hot, particularly if their surface temperature exceeds the limits set by EN ISO 13732-1:2006 and cannot be safeguarded against accidental contact due to process requirements.
If necessary to ensure safe use of the machine, marking shall also include instructions about commissioning, operation, setting, maintenance, cleaning, dismantling and the requirement to wear personal protective equipment.
Instruction manual
General requirements
Each machine will come with an instruction manual that includes essential information required for marking the machine as specified in section 7.1, along with basic operational details.
EN ISO 12100-2:2003, 6.5.1 and the information required by 7.2.2 to 7.2.13.
Hot surfaces
To ensure safety and prevent accidental contact with hot surfaces, it is crucial to implement specific safety measures This includes being aware of machine parts, hot plates, and sheet materials that have surface temperatures exceeding the established limit values Proper precautions must be taken to minimize the risk of burns or injuries from these hot components.
EN ISO 13732-1:2006, e g personal protective equipment such as gloves.
Use of personal protective equipment
Instructions on the requirements and use of personal protection equipment, e g safety gloves shall be given
Warning shall be given of the hazard of drawing in associated with intake gaps greater than 4 mm, particularly when safety gloves are worn.
Noise declaration
The declared noise emission values shall be given together with the following minimum information that describe the conditions under which the noise was measured:
the mounting and operating conditions of the machinery during noise emission measurement;
the position on a path at 1 m from the surface of the machinery and 1,6 m above the floor or the access platform where the A-weighted emission sound pressure level is a maximum;
the criteria on which the noise declaration is based (i.e EN ISO 4871:1996)
The chosen measurement methods shall be indicated:
EN ISO 11201:1995 or EN ISO 11204:1995 for the determination of emission sound pressure level at the work station(s);
EN ISO 3744:1995 for the determination of sound power level of the complete machine
The following operating conditions shall be indicated: a) for continuous sheet machines:
1) maximum possible forming cycles in cycles/minute;
2) cycles per minute during the test for each station;
3) number of parts per cycle per station;
4) material: i) type; ii) thickness; iii) width; b) for single sheet machines:
1) cycle time for one sheet during the test in minutes;
2) material: i) type; ii) thickness; iii) sheet dimensions
It shall be stated whether the measurement was carried out with or without forced air cooling
NOTE For machines operated without material (dry cycle) the noise emission level can be higher than for those machines operated with material
Main sources of noise in use during the test shall be declared
Details of main sources of noise shall be given, for example:
Declaration and verification of noise emission values shall be made in accordance with EN ISO 4871:1996
The noise declaration shall be a dual number declaration as defined in EN ISO 4871:1996, i.e the measured value and the measurement uncertainty shall be indicated separately.
Extraction of dusts, fumes or gases
Instructions about locations on the machine where extraction systems shall be connected in order to avoid the release of dusts, fumes or gases hazardous to health.
Electrostatic phenomena
Information about electric energy which may be present due to electrostatic phenomena generated during unwinding, winding or separation of some materials and instructions for its elimination
Instructions shall be provided for the provision of earthing connections to prevent hazards due to the accumulation of electrostatic charge.
Manual handling
Instructions shall be given on the need to use mechanical handling equipment, either supplied as part of the machine or otherwise necessary for handling loads with a mass exceeding 15 kg.
Fire prevention
Instructions about fire protection measures required within heating equipment Instruction that, if easily inflammable materials are to be processed, for example nitro-cellulose, a suitable extinguishing system shall be installed.
Manual intervention at the stacking zone
Instructions that if, for operational reasons, a manual intervention is required at the stacking zone, during continuous sheet transport, then only specially trained personnel shall carry out this operation.
Safe cleaning
Indications about how the machine can be cleaned safely.
Use of acknowledge switch
The acknowledge switch is essential for ensuring safety when whole body access is possible behind guards or protective devices It serves as a critical control mechanism, allowing operators to confirm their awareness of the machine's status before proceeding Proper use of the acknowledge switch is vital to prevent accidental activation and ensure a secure working environment.
When electrical drives are used to raise elements, the following inspection requirements shall be given:
For drives equipped with mechanical brakes, it is essential to establish a regular frequency for brake inspections Additionally, a clear procedure should be outlined to determine when adjustments or part replacements are necessary, along with a defined method for making these adjustments.
When dealing with two independent mechanical brakes, it is essential to establish a testing frequency to evaluate the functionality of each brake This includes defining the minimum conditions required for their continued use and outlining the assessment methods to be employed.
In the case of a mechanical brake paired with a friction-locked clamping device, it is essential to conduct tests to evaluate the brake's functionality and the clamping efficiency The minimum requirements for ongoing use and the assessment methods must be clearly defined.
Single sheet feed malfunction
To ensure safety and efficiency, it is essential to provide relevant information, including the identification of additional equipment such as air nozzles This helps minimize the risk of single sheets failing to separate during machine feeding, thereby reducing the potential for accidents caused by unintended access to hazardous areas for manual sheet separation.
The manufacturer shall declare the maximum weight of the moulds and tools that can be fitted to the machine."
Single sheet machine (alternatively material feed from single sheet magazine or continuous sheet roll)
Figure A.1 — Example of a single sheet machine (alternatively material feed from single sheet magazine or continuous sheet roll)
Continuous sheet machine (combined forming and finishing)
Figure B.1 — Example of a continuous sheet machine (combined forming and finishing)
Continuous sheet machine (separate forming and finishing)
Figure C.1 — Example of a continuous sheet machine (separate forming and finishing)
Relationship between this European Standard and the Essential
Requirements of EU Directive 2006/42/EC
This European Standard was developed under a mandate from the European Commission and the European Free Trade Association to ensure compliance with the Essential Requirements of the New Approach Directive 2006/42/EC.
Once the standard is published in the Official Journal of the European Union and adopted as a national standard by at least one Member State, adhering to its normative clauses provides a presumption of conformity with the Essential Requirements of the Directive and related EFTA regulations, within the standard's scope.
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard
[1] EN ISO 11688-2:2000, Acoustics — Recommended practice for the design of low-noise machinery and equipment — Part 2: Introduction to the physics of low-noise design (ISO/TR 11688-2:1998)
[2] ISO/DIS 5598:2004, Fluid power systems and components — Vocabulary
[3] PD CLC/TR 50404:2003, Electrostatics Code of practice for the avoidance of hazards due to static electricity
[4] EN 415-3:1999, Safety of packaging machines — Part 3: Form, fill and seal machines
Directive 94/9/EC, established by the European Parliament and Council on March 23, 1994, aims to harmonize the laws of Member States regarding equipment and protective systems designed for use in potentially explosive atmospheres This directive ensures safety and compliance across Europe, facilitating the use of such equipment in hazardous environments.