This standard is part of a series of standards comprising the following parts: — EN 415-1, Packaging machines safety — Part 1: Terminology and classification of packaging machines and a
General
Before using this document, the manufacturer shall establish that the hazards on his machine correspond to the hazards described in this document.
Mechanical hazards
Moving parts
Packaging machines often feature moving components that pose several mechanical hazards, such as crushing, shearing, cutting, entanglement, friction, impact, drawing-in, and trapping Notably, some of these risks can remain even after the power is turned off, due to factors like stored energy or gravity.
Slip, trip and fall hazards
Slip accidents may happen when liquids or solids, such as lubricants, packaging materials, or products, spill onto traffic routes, workstations, or access points around machinery.
Trip accidents can happen when machine parts extend beyond the frame at low levels or when cables and pipes are installed without addressing potential tripping hazards.
Falls may occur if people climb or stand on parts of the machine above floor level, e.g for magazine loading, size changing, maintenance or cleaning.
Loss of stability
Unstable packaging machines can lead to serious crushing and impact injuries if they move unexpectedly or topple over This loss of stability often occurs during machine operation.
2) if the machine footings are unstable;
3) if the centre of gravity of the machine is high or close to the boundary of the base area;
4) if someone stands on the machine;
5) when the machine is positioned on a slope; b) while the machine is being moved, for example:
1) if suitable lifting instructions are not provided;
2) when the volume and shape of the machine could suggest a position of the centre of gravity different from the actual centre of gravity;
3) on machines fitted with wheels when the machine is being moved on a slope or uneven surface.
Hazards from guards
Guards may present crushing, shearing and impact hazards when they open or close or are handled if they have a high mass or move under gravity or power.
Pneumatic and hydraulic equipment
Pneumatic and hydraulic systems pose significant hazards, including crushing, shearing, and fluid injection risks Even when power is disconnected, stored energy in these systems can lead to unexpected movements Additionally, hydraulic and pneumatic oils can create fire hazards and contaminate products Moreover, a failure in hose assemblies can result in dangerous whiplash incidents.
Hazards from electrical equipment
Electrical equipment on machines poses risks of electric shock and burns, especially when combustible materials are present, leading to potential fire hazards Additionally, electrical systems can ignite flammable substances, creating an explosive atmosphere.
If liquids, e.g product spillage or cleaning agents like water, come into contact with the electrical conductors, there is a risk of electric shock.
Hazards from electrostatic phenomena
Electric shock hazards may occur when machine components or materials become electrostatically charged, such as a plastic guide rail rubbed by moving products or plastic film unwinding from a reel This electrostatic discharge poses a risk of ignition in environments with flammable substances or explosive atmospheres Additionally, it can create dangers for individuals with either inactive or active implantable medical devices.
Thermal hazards
Hot Surfaces
Parts of the machine, e.g sealing mechanisms and drive motors, which have a high surface temperature, may cause burning hazards
The burning hazard will usually continue to exist for a period of time after power has been disconnected.
Cold surfaces
Parts of the machine or products, e.g on packaging machines for frozen product, which have a very low surface temperature, may cause burning hazards
The frostbite hazard will usually continue to exist for a period of time after power has been disconnected.
Noise
Noise generated by packaging machines can result in:
— other effects such as loss of balance, loss of awareness;
— inability to hear acoustic warning signals.
Radiation
Low frequency radio and microwaves are utilized in applications such as induction sealing, while infrared, visible light, and ultraviolet light are employed for inspecting containers Lasers serve purposes like measuring or marking packages and labels, but they pose significant risks, including burn injuries, particularly to the eyes, which can lead to blindness Additionally, lasers can ignite flammable materials, potentially causing fires or explosions, and the decomposition products from laser interaction with packaging materials may pose health hazards For further information on laser-related risks, refer to EN ISO 11553-1 X and gamma rays are used for product inspection and irradiation, but corrosion or mechanical damage to sealed radioactive sources can lead to the release of hazardous radiation Alpha and beta rays, along with electron ion or neutron beams, are also employed for inspecting packages.
Ionizing and non-ionizing radiation can cause hazards for persons with inactive or active implantable medical devices or cause harm to human cells like damage to skin.
Hazards from products and materials
Hazards generated by products
Packaging machines are essential for packing various products, including those that may pose hazards to operators or nearby individuals during normal operation Additionally, the risk increases if a package containing a hazardous substance is damaged while in the machine.
The product poses several hazards, including the ingestion or inhalation of harmful substances such as insecticides and aggressive chemicals, as well as pharmaceuticals Additionally, there is a risk of fire or explosion due to flammable liquids and dusty products Biological hazards, including vaccines, and the potential for impact from ejected products are also concerns Lastly, electric shock may occur from electrostatic discharges, particularly when products rub against plastic guide rails.
Hazards generated by packaging materials
Packaging machines utilize various materials that pose several hazards, including the inhalation of harmful smoke, gases, or vapors from overheating or burning materials, as well as unpleasant dust from paper Additionally, handling packaging materials can lead to cuts from sharp edges of films, straps, or paper There is also a risk of fire due to the overheating of combustible materials like plastic films and paper Furthermore, electric shocks may occur from electrostatic discharges, particularly at mechanisms involving plastic film reels or sheet feeding.
Hazards due to neglecting ergonomic principles
Hazards to safety and health, such as fatigue, mental stress, strain injuries, and occupational diseases, can arise during various activities involving packaging machines Key risks include operating the machines with poor posture or unnatural movements, inadequate design of controls, and excessive effort Cleaning and maintaining machines under insufficient lighting also contribute to these hazards Additionally, loading packaging materials and products often involves bad posture and fatigue, while changing sizes or products can lead to similar issues Overall, improper handling and maintenance of machines can significantly impact worker safety and health.
Hazards due to neglecting hygienic design principles
In machines designed for packaging food, cosmetics, pharmaceuticals, and other hygiene-sensitive products, the risk of product contamination can arise from the use of unsuitable contact materials, construction methods, or lubricants Ensuring that no contaminating substances or improper conditions come into contact with the product is crucial for maintaining safety and quality.
Hazards caused by failures
General
Packaging machines can pose several hazards, including mechanical risks from uncontrolled lowering or falling of components, unexpected locking of brakes, and failure to stop movements due to braking function malfunctions Additionally, hazards may arise from unexpected assembly movements when power is restored or due to stored energy There are also mechanical and chemical risks associated with the unexpected release of substances, as well as fire or explosion hazards resulting from the inability to halt heating functions.
Failure of power supplies
The hazards mentioned in 4.12.1 can arise by failures of the power supplies as loss or restoration of energy or fluctuation of the power supplies See also 4.9.1.
Failure of safety related parts of control systems
Hazards can arise if components in safety related parts of control systems fail Failures may occur due to mechanical damage, contact failure, electronic component failure
Systematic faults in programmable systems can result in significant safety risks, including unexpected activation of moving parts, improper sequencing of operations, and failure to halt machinery as intended Additionally, malfunctions triggered by external disturbances, such as electromagnetic interference, may create hazardous conditions.
Failure of electronic drive systems
Failure to disconnect the power supply of an electronic drive system after a safety-related stop, such as when guards are open, poses a risk of unexpected start-up This can lead to mechanical hazards if the control system malfunctions or is affected by external disturbances like electromagnetic interference.
Adjustable speed electrical power drive systems have an increased risk because of their working principle and high acceleration.
Hazards caused by the presence of stored energy
Stored energy can pose significant hazards, leading to unexpected movements in machinery This can occur due to several factors, including the machine's operational requirements, inadequate automatic energy release mechanisms, and failures in energy dissipating devices caused by misalignment, assembly errors, aging, or lack of maintenance Additionally, operator errors stemming from insufficient information or failure to follow procedures can contribute to these risks Accessibility and identification issues regarding energy dissipation means can further exacerbate the situation Design flaws, such as components that can move under gravity or the presence of tension and compression springs, also play a role Lastly, product jams can trigger unintended movements when jammed items are removed.
Hazards due to remote diagnostics or control
Hazardous situations can arise if it is possible to control a machine from a remote location or alter the software of a machine from a remote location
Unexpected startup hazards can arise when guards are removed, interlocking systems can be bypassed from a remote location, or unauthorized individuals gain access to the machine's controls remotely.
Reasonably foreseeable misuse
Reasonably foreseeable misuse is the use of a machine in a way that is not intended by the manufacturer and which can easily be anticipated because of known human behaviour
If the machine can operate independently in different hazard zones, the complete stop of the whole machine can reduce the machine efficiency This could encourage users to defeat guards
NOTE 1 Foreseeable misuse can for example be:
− defeating of guards or protective equipment because of improper design of the machine;
− behaviour that results from the quest for convenience or efficiency (use the way of least resistance);
− access through apertures not intended for access
NOTE 2 Reasons for defeating guards can for example be:
− time delay between the stop and the restart of the production;
− distance from the operator's position to the next safe means of access;
− available items which can be used as a step with the consequence of the possibility of climbing over the guard.
Hazards from specific elements or processes of packaging machines
Cutting devices
Mechanical cutting devices pose cutting or shearing hazards during normal operation, when power supplies are isolated but the mechanism moves unexpectedly due to stored energy, when operators touch exposed cutting surfaces while threading film, and during handling for setup, cleaning, or maintenance.
Sealing devices
Mechanical sealing devices present a crushing hazard: a) when the machine is in normal operation; b) when the machine’s power supplies are isolated the mechanism moves unexpectedly due to stored energy
Heated sealing devices present a burning hazard during normal operation They also present a burning hazard for a period of time after power has been disconnected from the device
There is a risk of electrical insulation in heating elements breaking down giving rise to an electric shock hazard
Excessive heat from sealing devices can pose a fire risk if packaging materials are in prolonged contact or if the temperature settings are too high This risk is heightened by potential failures in temperature control, leading to unexpected increases in heat.
Certain materials, such as polyester film, can give off hazardous fumes if they are overheated by the sealing device.
Film reel unwind mechanisms
Film reel unwind mechanisms pose several significant hazards, including the risk of crushing or impact injuries from reels that rotate at high speeds and may stop suddenly Additionally, heavy reels supported on rollers can create drawing-in hazards, while the film's edges present cutting risks There is also a potential for drawing-in hazards when the film is passed over rollers, as well as shearing hazards between the film compensator and the fixed components of the film reel mandrel Lastly, an impact hazard may occur if the film breaks, causing the film compensator to move unexpectedly.
Conveyors
Certain conveyors are designed for use where operators may stand or walk on them, which introduces risks of slipping, tripping, and falling, particularly during cleaning, maintenance, and troubleshooting Additionally, there is a danger of falling if a conveyor starts automatically while someone is on it.
Drawing-in and entanglement hazards, especially of hair, can occur when persons are exposed below a conveyor (e.g during cleaning, trouble-shooting or maintenance)
Drawing-in or trapping hazards can be generated by in-running nips and where traction elements pass over rollers, wheels or fixed parts of the conveyor frame
Insufficient stability of fixed construction parts or guards can lead to additional hazards, particularly when they are subjected to foreseeable mechanical strain from conveyed products or packs This instability may result in deformation or increased gaps between moving and fixed components due to abrasion or other influences.
4.16.4.2 Belt and slat-band conveyors
In-running nips can create drawing-in or trapping hazards when belts move over rollers or fixed components of the conveyor frame, particularly at junctions This risk is heightened when a subsequent conveyor is stationary, rotates at a slower speed, or has reduced friction compared to the preceding conveyor.
Figure 1 — Junction of belt conveyors
Drawing-in or trapping hazards can be generated by in-running nips between rotating rollers of roller conveyors and their substructure or machine parts
Screw conveyors present drawing in, entanglement, shearing and crushing hazards
Conveyors pose general hazards, but those equipped with carriers introduce specific risks such as entanglement, drawing-in, shearing, and crushing These dangers are particularly prevalent at points where carriers exit or enter the machine frame or when they pass by fixed components, as illustrated in Figure 2.
Handles and hand-wheels
Manual operation of machines using handles or hand-wheels can pose significant hazards, including impact, friction, or entanglement risks These dangers arise when the handle or hand-wheel is powered, or when it moves unexpectedly due to stored energy from sources such as eccentric masses or springs.
Errors in operation of manual or electronic hand wheels can cause hazardous movement of the machine.
Size or product changing
Packaging machines are designed to accommodate various product and pack sizes, but size changes can introduce several hazards These include the exposure of hazard zones when components are adjusted, potential ergonomic risks from handling change parts, and mechanical hazards that may occur during powered size or product adjustments.
Hot melt adhesive equipment
Machines utilizing hot melt adhesive present burning hazards due to contact with hot surfaces, as well as scalding risks from the adhesive itself Additionally, when introducing cold adhesive into molten adhesive, there is a potential for scalding from splashes of the hot material.
Machines that apply pressurized adhesive through jetting or spraying onto packaging materials pose a risk of scalding This hazard can occur if the glue gun is misaligned or during maintenance activities.
The hot melt adhesive may generate unpleasant fumes, particularly if it is overheated If the adhesive is overheated there is a risk of it catching fire.
Modified atmosphere packaging
Packaging machines often utilize specialized atmospheres to extend the shelf life of products, employing gases such as oxygen, nitrogen, and carbon dioxide However, these gases pose certain hazards: oxygen can increase the risk of fire and explosion, particularly in machines with oil-lubricated rotary vane vacuum pumps if oxygen levels exceed 21% Nitrogen can lead to asphyxiation or fatigue due to lowered oxygen levels, while carbon dioxide can cause respiratory paralysis from intoxication.
5 Safety requirements and/or protective measures
General
Packaging machinery must adhere to the safety requirements and protective measures outlined in this clause Furthermore, the design of the machine should align with the principles of EN ISO 12100:2010, addressing relevant but not significant hazards that are not covered by this document.
The hazards associated with a particular machine can differ based on its operational principles, the product's type, size, and weight, the packaging materials used, any auxiliary equipment connected to the machine, and the surrounding environment in which it operates.
When choosing protective measures throughout the life cycle, prioritize the following hierarchy: first, eliminate or minimize risks through inherently safe machinery design; second, implement necessary protective measures for risks that cannot be eliminated; and finally, inform users about any residual risks associated with the protective measures, including the need for specific training and personal protective equipment.
The following requirements apply to all packaging machines where the equivalent hazard exists.
Requirements to minimize mechanical risks
Protective measures against risks from moving parts
5.2.1.1 Inherently safe design – physical aspects
An effective approach to inherently safe design involves minimizing forces, pressure, and energy to levels that prevent injuries Relevant values applicable to this method are detailed in informative Annex B.
If the values given in Annex B are not applicable, the values for energy shall not exceed 4 J in general and
10 J if the motion is reversed The movement shall automatically be reversed within 1 s when a resistance is detected
Crushing hazards can be considered as eliminated when the distance between moving and fixed parts and between one moving part and another is dimensioned in compliance with EN 349
NOTE 1 The safety distances for crushing may be ineffective in case of drawing-in
To minimize the risk of entanglement and friction from rotating shaft ends, it is essential that they are smooth, free of protruding parts, and do not extend more than one-quarter of their diameter beyond the machine.
20 mm, whichever is the smaller
NOTE 2 The measures indicated above may not be applicable or effective in all circumstances For example the methods for elimination of entanglement and friction hazards as described above may not be effective where clothes or personal protective equipment with high friction are used, e.g rubber gloves Subsequent clauses of this document indicate situations where these measures are known to be effective
5.2.1.2 Fixed or interlocking movable guards a) Moving parts shall be safeguarded by fixed or interlocking movable guards complying with this clause and 5.2.1.3, 5.2.1.4, 5.10.2, 5.16.3 and EN 953 Where no specific choice for a type of guard is specified in this document, the guards shall be chosen using EN 953 b) Unless otherwise specified in this document the guards shall be dimensioned and positioned so that the safety distances comply with those specified in Clause 4 and Annexes A and B of EN ISO 13857:2008 c) Unless otherwise specified in other parts of EN 415 open topped distance guards shall be at least
2 000 mm high from the floor or other access platform
NOTE This measure is against climbing over a guard by using easily available means
The distance from the upper edge of the guard to the nearest hazard zone must adhere to EN ISO 13857:2008, Table 2 Additionally, if there is a gap between the guard and the floor for purposes such as cleaning or removing products, specific requirements must be met.
1) if the gap is less than or equal to 20 mm the safety distances to the nearest hazard zones shall comply with EN ISO 13857:2008, Table 4;
2) where the gap is greater than 20 mm but less than or equal to 40 mm, the safety distances to the nearest dangers zones shall be at least 550 mm where access is not foreseeable, the safety distance can be reduced to 130 mm;
3) where the gap is greater than 40 mm but less than or equal to 240 mm the safety distance to the nearest hazard zones shall be at least: i) 850 mm, if the height of the lowest hazard zone is lower than or equal to 300 mm above the lower edge of the guard; ii) 550 mm, if the height of the lowest hazard zone is higher than 300 mm above the lower edge of the guard
NOTE List entry 3) applies only when access to the hazard zone by lower limbs is not reasonably foreseeable
In all other cases EN ISO 13857:2008, Table 7 applies
4) where the gap is greater than 240 mm, a guard complying to a) of this subclause shall be fixed underneath the machine (see Figure 3) or one of the protective measures indicated in 5.2.1.3 shall be used, or all hazard zones which could be reached shall be safeguarded individually according to a) and b) of this subclause; e) Where there is a risk of parts or products being ejected from the machine the guards and their position shall be designed to contain these parts or products;
To ensure safety in machines with whole body access, it is essential that individuals can exit the hazard zone, which can be achieved through interlocking movable guards that can be opened from inside the machine or via an aperture equipped with an Emergency Stop Device (ESPE) Additionally, when opening an interlocking movable guard poses a risk, it must be equipped with a guard locking device that adheres to EN ISO 14119:2013, preventing access while hazards are present Furthermore, movable guards should be interlocked with devices that comply with the same standard and be installed according to Clause 5, ensuring that all safety-related components of interlocking systems meet the requirements outlined in section 5.15.
If it is necessary to remove fixed guards regularly (e.g for maintenance, cleaning) the fixing systems shall remain attached to the guard or the machinery when the guard is removed
Apertures in guards for loading or discharging products or packaging components must be carefully designed, positioned, and sized to prevent individuals from reaching into hazardous areas and to discourage full body access whenever possible.
Safety requirements for preventing access to a hazard zone through an aperture depend on several factors, including the dimensions and height of the aperture from the nearest access platform, the shape of the guarding surrounding the aperture, and whether a conveyor is present within the aperture.
Three main types of aperture are defined as shown in Figure 4: a) small apertures, designated as “S”; b) medium apertures designated as “Ma)”, “Mb)” and “Mc)”; c) large apertures designated as “L”
For conveyors with entry or exit apertures larger than small apertures (S) as specified in section 5.2.1.3.2, it is recommended that the guards be tunnel-shaped If access to areas behind these tunnel guards is required frequently, they should be designed to be movable and interlocked in accordance with section 5.2.1.2.
Access to all machine parts requiring regular or foreseeable maintenance must be facilitated by one or more interlocking movable guards or apertures that comply with ESPE standards outlined in section 5.15 These designated apertures ensure that operators do not need to reach into the safeguarded zone through unintended openings Clear instructions must be provided to specify the intended means of access.
The requirements for safeguarding apertures with guards shall be chosen depending on their dimensions as indicated in Figure 4
Table 1 outlines the safety distances required for medium-sized apertures, based on their dimensions, assuming that the cross section of any potential tunnel matches that of the aperture.
When the distance between the access platform and the lower edge of an aperture is 1,600 mm or more, and there is no anticipated need for access to the entry or exit point for tasks such as troubleshooting, maintenance, or cleaning, additional safeguarding is not necessary However, compliance with EN ISO 13857:2008, Table 2 is required Additionally, conveyors and other installations, including guards, must be designed to prevent individuals from climbing to the aperture.
M dimensions of medium-sized apertures
S dimensions of small apertures w clear width of the aperture h clear height of the aperture
Figure 4 — Entry or exit points - dimensions of apertures
Table 1 — Safety distances for medium-sized apertures
Apertures without a conveyor or tunnel guard (see Figure 5)
Apertures with bent tunnel guards with or without a conveyor (see Figure 6 and Figure 7)
Apertures with a conveyor but without a tunnel guard (see Figure 8)
Apertures with a conveyor and a tunnel guard (see Figure 9 and Figure 10)
Minimum tunnel and conveyor length l (see Figure 6 to Figure 10)
Mb) s ≥ 1 200 s + s2 ≥ 900 for 135° ≥ α ≥ 90°, else: column 1 applies for s2 ≥ 300 s ≥ 1 000 s ≥ 900 l ≥ 500
Mc) 5.2.1.3.12 applies s ≥ 1 100 for 135° ≥ α ≥ 90°, else: column 1 applies s ≥ 1 400 s ≥ 1 100 l ≥ 1 000
Requirements to prevent slip, trip and fall hazards
5.2.2.1 Measures to minimize slip hazards
The machine's design must reduce the likelihood of liquids or solids spilling onto traffic routes, workstations, or access points If spills are unavoidable, the manufacturer is required to provide containment solutions, such as drip trays, and to outline the best methods for spill removal in the accompanying instructions.
5.2.2.2 Measures to minimize trip hazards
The machine's design must eliminate low-level assemblies that could create trip hazards If avoidance is not feasible, the manufacturer is required to install railings or alternative barriers to direct individuals away from these hazards.
The manufacturer shall describe, in the instructions, how cables and pipes associated with the machine shall be supported and laid so they do not create a trip hazard
5.2.2.3 Measures to minimize fall hazards – means of access
The machine's design must enable operation, cleaning, and maintenance from floor level If this is not feasible, the manufacturer must ensure safe access for operations above floor level, providing a permanent means of access For routine cleaning or maintenance, a suitable and preferably permanent access method is required Non-permanent access solutions are acceptable if they reduce risks, such as hygiene concerns or if they facilitate easier access to other machine components.
Permanent means of access shall comply with EN ISO 14122-1:2001, 5.2 and be selected according to
According to EN ISO 14122-1:2001, section 5.3, working platforms and walkways must comply with EN ISO 14122-2 standards Additionally, stairs, stepladders, and guard-rails should adhere to EN ISO 14122-3 It is important to note that ladders are prohibited in situations where individuals cannot maintain a two-handed grip during access.
Where non-permanent means of access are used they shall be chosen following the criteria and requirements given in EN ISO 14122-1
Manufacturers must provide essential information regarding the safe use of non-permanent means, including required space, dimensions of traffic pathways, methods for securing or stabilizing access to the machine, appropriate storage when not in use, and potential hazards associated with improper placement of the access means.
Stability of machines
The manufacturer shall provide information in the instructions on how to move the machine as well as moveable parts and special equipment delivered with the machine safely
On machines fitted with wheels, at least two wheels shall be fitted with locking devices to ensure that the machine does not move unexpectedly when it is in use
If it is foreseeable that someone will stand on the machine, the manufacturer shall design the machine or its fixings to ensure stability in this situation
The manufacturer shall provide information in the instructions on how to move the machine safely
Machines fitted with wheels shall be designed so that they do not move or tilt in a static test while they are placed on a 10° slope independent of its orientation.
Prevention of hazards from movable guards
Moveable guards, whether powered, gravity-operated, or utilizing stored energy, must be designed for safety in accordance with section 5.2.1.1 Alternatively, they should be equipped with safety devices that restrict the forces exerted by the guards to the specified limits outlined in section 5.2.1.1.
Supply disconnecting (isolating) device
The machine must have easily identifiable and accessible disconnection devices for each type of energy Isolation switches should be clearly labeled to indicate their operation method and must include a locking feature to secure them in the off position.
This device shall be selected from those listed in EN 60204-1:2006, 5.3.2 and comply with 5.3.3 and 5.3.4 of that standard At least one such device shall be attached to the machine
Devices for isolating the electrical equipment shall be provided in accordance with EN 60204-1:2006, 5.5 and 5.6
The actuator for the supply disconnection device must adhere to EN 61310-3 standards and should be mounted on the machine or positioned within a nearby electrical enclosure that is integral to the machine's electrical equipment.
The isolation valves shall comply with EN ISO 4414:2010, 5.2.8, and EN ISO 4413:2010, 5.4.7.2.1.
Pneumatic and hydraulic equipment
All pneumatic components and piping shall conform to the requirements of EN ISO 4413 All hydraulic components and piping shall conform to the requirements of EN ISO 4414
Where control functions are performed by hydraulic or pneumatic systems, these circuits shall comply with the requirements of 5.14 and 5.15
In machines designed for packing food, cosmetics, pharmaceuticals, or other products at risk of contamination, it is crucial that the design prevents hydraulic or pneumatic lubricating oils from coming into contact with the products.
Electrical equipment
General
Electrical equipment shall comply with EN 60204-1 In the places where EN 60204-1 provides various options, the options stated below shall be used.
Protection against electric shock
Electric shock by direct contact shall be prevented by choosing one of the methods described in
EN 60204-1:2006, 6.2 and electric shock by indirect contact shall be prevented by choosing one of the methods described in 6.3 of that standard.
Degree of protection
When selecting the protection level for electrical enclosures, it is essential to consider the operating environment of the machine and the expected cleaning methods for both the machine and its surroundings.
EN 60204-1:2006, 11.3 Examples of suitable protection levels as defined by EN 60529 are given in Table 2 and Table 3
Table 2 — Examples for selecting the degree of protection for dusty environments
Dusty Environment Required degree of protection
Conducting dusts e.g carbon powder, aluminium powder IP 6X
NOTE Other measures will be required if the equipment is expected to be working in a potentially explosive atmosphere
Table 3 — Examples for selecting the degree of protection for different cleaning methods using water
Method of cleaning Required degree of protection
Cleaning with damp cloth IP X4
Cleaning with low pressure water (as defined by EN 60529:1991, Table VIII.8) IP X5
Cleaning with medium pressure water (as defined by EN 60529:1991, Table VIII.8) IP X6
According to EN 60529, the tests for electrical enclosures are specifically designed for water exposure Consequently, if cleaning involves fluids other than water or if the water contains detergents, a higher Ingress Protection (IP) rating than what is specified in EN 60529 and Table 3 may be required.
Using fluids other than water for machine cleaning can diminish the protective level of an electrical enclosure over time Manufacturers must consider this factor in their choice of materials, construction methods, and maintenance guidelines.
Electrostatic phenomena
Manufacturers of packaging machines must equip their devices with adequate earth bonding or static elimination systems to prevent hazardous levels of static electricity This equipment is essential to ensure that electrostatic discharges do not cause injuries or ignite potentially explosive atmospheres or combustible materials.
Thermal hazards
Hot surfaces
The external temperature of exposed machine components, such as guards, control panels, and electric motors, must remain below the burn thresholds specified in EN ISO 13732-1:2008, section 4.2, to prevent the risk of burns based on material types and contact durations.
To reduce the risk of accidental contact with machine parts that exceed burn thresholds outlined in EN ISO 13732-1, manufacturers must implement safety measures such as insulation and safeguards against unintentional contact Additionally, it is essential to place the specified warning sign from section 7.3.4 on the exterior of the machine or near the hot components.
Even after implementing safety measures, if there remains a risk of contact with hot surfaces, the instructions must clearly indicate this risk Additionally, it should outline precautions to prevent burn injuries, such as the use of gloves or other personal protective equipment.
Cold surfaces
NOTE This paragraph is relevant especially where surfaces with temperatures less than 5 °C can occur
The external temperature of exposed machine components, such as guards, must remain above levels that could lead to frostbite, adhering to specific thresholds based on material types and contact durations.
To reduce the risk of accidental contact with machine parts that have temperatures below the frostbite thresholds outlined in EN ISO 13732-3, manufacturers must implement insulation or protective measures Additionally, it is essential to display the warning sign specified in section 7.3.5 on the exterior of the machine or near the cold components.
If residual risks remain or if there is a need to handle cold surfaces, the instructions must clearly outline these risks along with recommended measures to prevent frostbite injuries, such as wearing gloves, using personal protective equipment, or utilizing insulated tools.
Noise reduction
The primary sources of noise in packaging machines include drive mechanisms, vacuum pumps, and compressed air exhaust Additionally, noise can arise from products, such as glass bottles and cans, colliding with each other or with machine parts Other contributors to noise are packaging materials like unreeling straps or films, mechanisms striking one another during processes like welding, and conveyors.
To effectively minimize or eliminate noise at the source, several measures can be implemented These include designing mechanisms to prevent contact between components, utilizing rubber rollers, and opting for timing belts over chains Additionally, using helical gears instead of straight cut gears, limiting the running speed or pressure of machines, and incorporating vibration isolators are essential strategies Fitting air exhausts with silencers, applying damping materials to vibrating metal surfaces, and installing acoustic absorptive materials within machinery casings further contribute to noise reduction Lastly, the installation of partial or full acoustic enclosures can significantly enhance sound control.
NOTE Additional design measures can be found in EN ISO 11688-1
The criterion for assessing the efficiency of noise reduction measures is the actual noise emission values of the machine and not the nature of the reduction measure itself.
Radiation
General
Manufacturers must ensure that machines with radiation sources or radiation-generating equipment effectively contain radiation hazards The goal is to eliminate any harmful effects on operators or nearby individuals, or at the very least, reduce them to a non-hazardous level, in accordance with EN 12198-3 standards.
To effectively contain low frequency, radio frequency, and microwaves, the use of Faraday cages is essential For managing infrared, visible light, and ultraviolet light—such as in container inspections—light baffles should be employed.
When radiation guards need to be opened for installation, adjustment, or maintenance, the manufacturer must provide detailed protective measures in the instructions This includes guidelines for energy disconnection and dissipation, the use of personal protective equipment, and safety measures to protect individuals near the machine.
The emission of radiation shall be assessed using the principles of EN 12198-1 The assessment shall include all phases of life cycle of the machine For measuring radiation EN 12198-2 applies.
Laser radiation
Laser equipment on packaging machines shall comply with EN 60825-1
Lasers used for product marking or cutting packaging must be designed to ensure that, even if misaligned, the emitted laser radiation does not exceed the accessible emission level for class 1 lasers as outlined in EN 60825-1:2007, Table 1 Comprehensive details regarding the laser type, power, and safe usage instructions must be included in the product documentation Additionally, the machine should be clearly labeled with the emitted laser class, and both the laser and its containment must display the laser class of the source.
Machines utilizing laser radiation must be equipped with automatic systems to extract decomposition products at their source These systems should safely direct the products outdoors or filter them to prevent any release into the work area Refer to section 5.10.1 for additional information.
In addition, EN ISO 11553-1:2008, 5.3.2 applies.
Measures to control hazards generated by products, substances and materials
Measures to control hazards generated by substances
When hazardous substances are anticipated to be used with the machine, such as for cleaning or disinfection, or if these substances may accumulate during operation, the manufacturer must identify the nature of the hazard and implement control measures in accordance with EN 626-1 to mitigate the risk.
1) minimize hazards by using the least hazardous substance;
2) minimize hazards by using the least hazardous procedure;
3) to supply any necessary ancillary equipment e.g dust, aerosol or fume extraction and monitoring devices;
4) measures to ensure that no hazardous amounts of hazardous substances build up in the vicinity of the machine;
5) wherever technically possible measures to ensure that during short time intervention the operator is not exposed to hazardous amounts of hazardous substances;
6) provide information on how to install the ancillary equipment and operate, clean and maintain the machine without risks to health or safety including detailed information about the use of suitable personal protection equipment where there is a residual risk of hazardous substances c) verify the effectiveness of the measures by suitable methods which the manufacturer shall determine following the procedures stated in EN 626-2
NOTE The hierarchy of and examples for measures are given in EN 626–1:1994+A1:2008, Annex A.
Measures to control hazards generated by products
When designing machines for packing potentially hazardous products, manufacturers must identify hazards and control methods, clearly specify prohibited product characteristics, and create safe handling systems to minimize risks Compliance with EN 626-1 and EN 626-2 is essential to reduce spillage of hazardous substances, while EN 13478 principles should be followed for combustible products Additionally, machines should include guards to contain falling or ejected products, and necessary ancillary equipment for dust or fume extraction Manufacturers must provide installation and maintenance information to ensure safety, verify the effectiveness of safety measures as per EN 626-2, and establish protocols for safely managing hazardous substances in case of energy supply failure.
5.10.2.2 Requirements to prevent hazards from ejected or falling products
To mitigate the risk of impact or crushing from ejected products, such as those falling from stacks or tilting, manufacturers must implement safety measures These may include using sensor controls to align products before packing, employing support or hold-down devices during the packing process, or adopting other effective strategies.
Guards must be strong enough to hold products or packs that are ejected or fall, and they should be designed to allow for the safe retrieval of any fallen or ejected items.
The guidelines will detail the safe procedures for lowering and releasing products, isolating power supplies, and safely discharging stored energy prior to long-term interventions such as cleaning or maintenance.
The requirements in 5.10.2.2.2 and 5.10.2.2.3 apply in the following circumstances:
— where the potential energy of a single product falling from the loading mechanism exceeds 10 J; or
— where the products are made from glass; or
— where the shape of the products is likely to cause an injury if they are dropped; or
— where dropping the products is likely to release a hazardous substance contained in the products
5.10.2.2.2 Interventions during operation with power supplies active
To prevent hazards from falling products, several measures must be implemented: a) products should be securely held during operator intervention, or b) safely deposited with energy supplies isolated and stored energy dissipated Access to the hazard zone must be restricted through guard locking until these operations are completed; c) alternatively, a device that prevents falling products should be automatically or manually positioned before entering the hazard zone, interlocked to ensure operator safety d) Other equivalent methods may also be employed to achieve the same safety outcomes.
The instructions shall detail the correct use of the devices and additional measures if necessary
5.10.2.2.3 Partial or total failure of an energy supply
In the event of an energy supply failure, such as electricity, hydraulic pressure, or compressed air, machine design must ensure that products are securely held using springs or pneumatic mechanisms, or that guards and controls prevent operator access to hazard zones until products are safely lowered If these options are not feasible, an audible warning must be activated, allowing sufficient time for operators to exit the hazard zone before product release Additionally, machines should be equipped with warning signs to inform operators of the risks associated with power failures and the necessity of quick evacuation when alarms sound, in accordance with EN ISO 12100:2010, 6.4.3.
When handling products that may release hazardous substances upon dropping, it is recommended to prefer option a) Option c) is not permissible, while option b) may only be utilized if the machine has a safe method for extracting or removing the hazardous substance without requiring the operator to enter the hazard zone.
To minimize crushing or shearing hazards caused by products moving past fixed machine parts or guards, several measures can be implemented: a) design adjustments should adhere to the safety distances outlined in EN 349; b) a pressure-sensitive edge that complies with EN ISO 13856-2 can be installed on the fixed part; c) an interlocked hinged guard that meets the requirements of 5.2.1.3.9, which opens in the direction of the product's movement, can also be utilized.
Measures to control hazards generated by packaging materials
When a machine is designed to use potentially hazardous packaging materials, the manufacturer must identify the hazards and control methods, clearly specify in the instructions which packaging materials are prohibited, and create a safe handling system in accordance with relevant standards.
1) on machines using materials that can give off fumes which are hazardous to health, limit the reasons the manufacturer shall design the machine in accordance with EN 626-1 and EN 626-2 and provide fume extraction equipment as described in d);
2) on machines using packaging materials that produce excessive amounts of dust design the machine in accordance with EN 626-1 and EN 626-2 and provide dust extraction equipment as described in d);
3) on machines using materials with sharp edges, which can cause cut injuries guard exposed edges on the machine against accidental contact and recommend in the instructions the use of gloves when handling the material;
4) on machines using materials that can ignite if overheated, the design of the control system shall minimize the risk of the packaging material catching fire This may involve designing the control system so that the heated sealing devices do not remain in contact with the packaging material when the machine is stopped The principles of EN 13478 apply;
5) on machines handling glass containers the design shall ensure that people are protected from broken or flying glass;
6) on machines using packaging materials that can generate electrostatic charges provide suitable earth bonding and static elimination equipment See also 5.6 d) supply any necessary ancillary equipment e.g dust, or fume extraction equipment designed in accordance with EN 626-1 and EN 626-2; e) provide information on how to install the ancillary equipment and operate, clean and maintain the machine without risks to health or safety; f) verify the effectiveness of the measures by suitable methods which the manufacturer shall determine following the procedures stated in EN 626-2.