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Guidelines for Comprehensive Safety Standards of Machinery
Ministry of Health, Labour and Welfare
Outline of the Guidelines for Comprehensive Safety Standards of Machinery
The Guidelines for Comprehensive Safety Standards of Machinery were established
to help prevent occupational accidents caused by machinery by encouraging
the manufacture, etc., of safe machinery by manufacturers, etc., and the
safe use of machinery by employers. The Guidelines were officially published
as Labor Standard Bureau's Notification No. 501 dated June 1, 2001.
The Guidelines cover standards for safety measures for specific machinery
that has traditionally been highly hazardous as well as for comprehensive
safety measures applicable to all machinery. The safety of machinery can
be improved if the safety measures set forth in these Guidelines are applied
by manufacturers, etc., in the design, manufacture, etc., of machinery,
and by employers in the use of machinery by their workers.
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1. Purpose
- Comprehensive safety standards applicable to all machinery
2. Scope of application
- Manufacturers, etc., that design, manufacture, etc., machinery
- Employers that employ workers to use machinery
3. Terms and definitions
- Machine
- Risk
- Manufacturers, etc.
- Safeguarding devices
- Additional safety measures
- Intended use
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- Hazard
- Risk assessment
- Safety measures
- Safeguards
- Residual risk in manufacturing, etc.
- Reasonably foreseeable misuse
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- Hazardous situation
- Usage information
- Intrinsically safe design
- Safeguarding
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4. Procedures for manufacturers, etc., to reduce the risk of machinery
5. Risk assessment methods
6. Implementation of safety measures by manufacturers, etc.
7. Specific methods, etc., for safety measures implemented by manufacturers,
etc.
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Methods for intrinsically safe design
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Methods for safeguarding against mechanical hazard
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Methods for additional safety measures
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Providing usage information
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Considerations related to safety measures
8. Recording measures taken to reduce risk
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Recording the results of risk assessment
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Recording safety measures taken to reduce risk
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Recording other safety measures
9. Procedures for employers to reduce risk
10. Conditions of ordering machinery
- Placing orders in accordance with these Guidelines
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Improving Machine Safety with the Guidelines for Comprehensive Safety Standards
of Machinery
Figure 1. Procedure for Improving Machinery Safety
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Guidelines for Comprehensive Safety Standards of Machinery
In Japanese
1. Purpose
The Guidelines for Comprehensive Safety Standards of Machinery (hereinafter
referred to as " Guidelines "), in an effort to reduce the risk
of machinery and to improve machinery safety, establish standards for comprehensive
safety measures, etc., applicable to all machinery with respect to the
design, manufacture, etc., of machinery by machinery manufacturers, etc.,
and to the use of machinery by workers of employers. The Guidelines were
established with the purpose of preventing occupational accidents caused
by machinery by encouraging the manufacture, etc., of safe machinery by
manufacturers, etc., and the safe use of machinery by employers.
2. Scope of application
These Guidelines apply to manufacturers, etc., that design, manufacture,
etc., machinery and to employers that employ workers to use machinery concerned.
3. Terms and definitions
These Guidelines use the following terms and definitions
(1) Machine
An item assembled of parts and components for the specific application
of processing, treating, moving, packaging, etc., materials, that has a
mechanical activating mechanism, a control section, and a power section,
and in which at least one of the parts concerned and components move.
(2) Hazard
A source that can cause occupational accidents.
(3) Hazardous situation
A situation in which a worker is exposed to hazard.
(4) Risk
An indicator for evaluating the degree of hazard; comprised of a
combination of the probability of an occupational accident occurring and
the severity of occupational accidents concerned.
(5) Risk assessment
Identifying hazard and hazardous situations using information available,
estimating the risk of hazard and hazardous situations, and determining
whether or not this risk is permissible based on the risk assessment.
(6) Usage information
Information provided by manufacturers, etc., for the purpose of
using machinery safely; provided by posting displays and warning labels,
installing signal devices and warning devices, distributing written instruction
manuals, etc., conducting education and training, and other means.
(7) Manufacturers, etc.
Parties that design, manufacture, or modify machinery, and parties that
import machinery.
(8) Safety measures
Measures to reduce risk (including the elimination of hazard). Safety measures
for manufacturers, etc., include intrinsically safe design, safeguarding,
additional safety measures, and the provision of usage information. Safety
measures for employers include the consolidation of the work structure,
preparation of work procedures, installation of safeguards, provision of
protective equipment, and education and training for workers.
(9) Intrinsically safe design
Safety measures taken to reduce risk through the design of machinery
without the installation of additional safeguards or other such equipment.
(10) Safeguarding devices
Devices such as light beam type safety devices and two-hand tripping
safety devices that are installed on machinery and used either independently
or in combination with guards in order to reduce risk.
(11) Safeguards
Guards and safeguard devices.
(12) Safeguarding
Safety measures taken by installing safeguards.
(13) Additional safety measures
Safety measures taken to avoid, etc., emergency situations that
could potentially lead to occupational accidents (limited to measures other
than intrinsically safe design, safeguarding, and the provision of usage
information).
(14) Residual risk in manufacturing, etc.
Risk that remains after safety measures such as intrinsically safe
design, safeguarding, and additional safety measures have been taken by
manufacturers, etc.
(15) Intended use
The use of a machine according to the purpose and method shown in
the usage information provided by the manufacturer, etc..
(16) Reasonably foreseeable misuse
Use of a machine that is not according to the purpose and method
intended by the manufacturer, etc., which is reasonably foreseeable based
on common behavioral traits of human beings.
4. Procedures for manufacturers, etc., to reduce the risk of machinery
(1) Manufacturers, etc., shall perform risk assessment when
designing, manufacturing, or modifying a machine, or when delivering or
leasing an imported machine (hereinafter referred to as " manufacturing,
etc. ").
(2) Manufacturers, etc., concerning the hazard and hazardous situations
of a machine determined to have higher than tolerable levels of risk based
on the risk assessment in manufacturing, etc., shall implement necessary
safety measures to reduce the risk of machine concerned.
5. Risk assessment methods
- (1) Risk assessment of a machine in manufacturing, etc., shall be
performed according to the following sequence:
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1) Identify the usage situation of the machine.
2) Identify hazard and hazardous situations of the machine.
3) Estimate the risk of the identified hazard and hazardous situations
of the machine.
4) Evaluate the estimated risk and determine the necessity of reducing
this risk.
- (2) Usage situations of a machine include the following:
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1) The machine is used as intended.
2) Situations regarding a program for use of the machine, measures
to address a malfunction, cleaning, inspection, repair, transport, installation,
trial operation, disposal, etc.
3) The machine is broken down, malfunctioning, etc.
4) Reasonably foreseeable misuse of the machine.
5) A worker, etc., is in close proximity to the machine.
6. Implementation of safety measures by manufacturers, etc.
- (1) Safety measures to reduce the risk of a machine shall be implemented
by manufacturers, etc., according to the following sequence:
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1) Implement intrinsically safe design.
2) For risk that cannot be reduced to tolerable levels through intrinsically
safe design, implement necessary safeguarding and additional safety measures.
3) For risk that cannot be reduced to permissible levels through
intrinsically safe design, safeguarding, and additional safety measures,
inform the party receiving or leasing the machine of this risk in the usage
information.
(2) Manufacturers, etc., shall be careful not to create new hazard
or additional risk when implementing safety measures.
7. Specific methods, etc., for safety measures implemented by manufacturers,
etc.
(1) Methods for intrinsically safe design
Manufacturers, etc., shall implement intrinsically safe design based
on the methods prescribed in Attachment 1 as well as other appropriate methods.
(2) Methods for safeguarding against mechanical hazard
Manufacturers, etc., shall safeguard against hazard that result
from the operation of the machine's moving parts based on the methods prescribed
in Attachment 2 as well as other appropriate methods.
(3) Methods for additional safety measures
Manufacturers, etc., shall implement additional safety measures based on
the methods prescribed in Attachment 3 as well as other appropriate methods.
- (4) Providing usage information
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1) Manufacturers, etc., shall provide usage information covering
the matters prescribed in Attachment 4 as well as other information required for the safe use of the machine.
2) Manufacturers, etc., shall provide usage information based on
the methods prescribed in Attachment 5 as well as other appropriate methods.
3) Manufacturers, etc, for risk that can be reduced through equipment
safety measures, shall not provide usage information as a substitute for
implementing equipment safety measures.
(5) Considerations related to safety measures
Manufacturers, etc., when implementing safety measures, shall give
consideration to the matters prescribed in Attachment 6, according to the type of hazard.
8. Recording measures taken to reduce risk
Manufacturers, etc., shall record measures taken to reduce the risk
of a machine based on the results of the machine risk assessment in manufacturing,
etc., the details of safety measures implemented, and other details specified
in these Guidelines.
9. Procedures for employers to reduce risk
(1) Employers that employ workers to use a machine shall verify the
details of usage information provided by manufacturers, etc., and shall
perform risk assessment as circumstances require.
(2) Employers shall implement necessary safety measures based on
usage information or the results of independent risk assessment.
10. Conditions of ordering machinery
Parties placing an order for the manufacture, etc., of a machine
shall consider the conditions of order concerned to ensure that they do
not conflict with the intent of these Guidelines.
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Attachment 1 Methods for Intrinsically Safe Design
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1. Eliminate any sharp edges, corners, protrusions, etc., that present
a potential hazard.
2. In order to prevent hazards that result from pinching a worker's
body part, etc., apply the following in determining the shape, measurements,
etc., and driving force, etc., of the machine:
(1) For sections that have the potential for pinching, either
narrow the section to a point that a body part cannot enter, or widen the
section to a point where it does not pinch.
(2) Reduce the driving force to a point wherein the body is
not injured when pinched.
(3) Reduce the kinetic energy to a point wherein the body is
not injured when impacted.
3. In order to prevent hazards that result from damage, etc., to
the machine, apply the following in determining the strength, etc., of
the machine:
(1) Limit the stress placed on each machine part through the appropriate
strength calculations, etc.
(2) Limit the stress placed on each machine part through overload
protection mechanisms such as safety valves.
(3) Select materials in light of the corrosion, deterioration
from age, wear and tear, etc., that the machine will sustain.
4. Use non-hazardous materials and intrinsically safe techniques
such as those used in intrinsically safe electrical apparatuses for use
in explosive atmospheres.
5. In order to reduce the physical burden on workers, prevent the
occurrence of operating errors, etc., apply the following ergonomic principles:
(1) Make the machine adjustable according to the worker's height,
etc., and ensure work postures and work movements that do not place a heavy
burden on workers.
(2) Have a machine operating cycle and work frequency that
does not place a heavy burden on workers.
(3) When the illumination of the regular work environment is
not adequate, install additional lighting equipment to ensure the level
of illumination required for the particular work.
6. In order to prevent hazards from the breakdown, etc., of control
systems, apply the following in determining control systems:
(1) Use parts and components with a higher degree of reliability.
(2) To start the machine, have the control signal transition
from a low energy state to a high energy state. To stop the machine, have
the control signal transition from a high energy state to a low energy
state.
(3) When the machine is stopped as a result of the operation,
etc., of safeguarding devices, make the machine unable, even when restored
to an operational state, to commence operations without the performance
of restarting procedures.
(4) For sections important to safety, employ safety techniques
such as asymmetric breakdown features, redundant systems, heterogeneous
redundant construction, and automatic monitoring.
(5) For programmable control equipment, make intentional or
negligent program changes difficult.
(6) Implement measures to prevent machine malfunction caused
by electromagnetic noise, and to prevent radiation of unwanted electromagnetic
waves that could potentially cause malfunctions in other machinery.
7. In order to prevent hazardous situations, apply the following:
(1) Perform work from outside the area of operation of moving
machine parts.
(2) Automate the supply of materials to the machine, processing,
the removal of products, etc.
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Attachment 2 Methods for Safeguarding against Mechanical Hazard
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1. For areas that require safeguarding (hereinafter referred to as
" safeguarding areas "), install fixed guards, movable guards,
adjustable guards, light beam safety devices, two-hand tripping safety
devices, or other such safeguards.
2. Apply the following in determining safeguarding areas:
(1) The maximum area of operation of potentially hazardous moving
parts (hereinafter referred to as " maximum operating area ").
(2) An area that ensures the distance required for the safeguard
to function effectively according to the type of safeguard installed.
(3) When workers are required to enter the maximum operating area
in performing their work, an area that ensures the space required to prevent
pinching according to the body part that enters the maximum operating area.
3. When installing safeguards, apply the following according to the
conditions of usage, etc., of the machine:
(1) When workers are not required to enter the safeguarding
area in performing their work, enclose the entire periphery of the safeguarding
area with fixed guards, movable guards, or safeguarding devices such as
light beam safety devices that detect the entrance of a body part and stop
the machine.
- (2) When workers are required to enter the safeguarding area in performing
their work, and when safeguarding by stopping the operation of hazardous
moving parts, apply the following:
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1) Install fixed guards, etc., around the entire periphery of the
safeguarding area except for the entrance for performing work inside the
safeguarding area.
2) Install movable guards or safeguarding devices at the work entrance.
3) When a worker's entire body is able to enter the safeguarding
area via the work entrance, install devices, etc., that detect the worker
inside the safeguarding area.
- (3) Apply the following with respect to guards:
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1) Have no sharp edges, corners, protrusions, etc., that present
a potential hazard.
2) Use materials that will have sufficient strength, not easily corrode,
deteriorate, etc.
3) Use moving parts (e.g., hinges and slides) and fixtures of sufficient
strength to withstand repeated opening and closing, etc.
4) Install equipment to prevent moving parts (e.g., hinges and slides)
from becoming slack or drooping.
5) When mounting guards directly on a machine, mount them by welding
them to the machine or attaching them with bolts, etc., so that they cannot
be removed without tools.
- (4) Apply the following with respect to fixed guards:
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1) Make the entrance for passing products, etc., as small as possible.
2) When a worker's body part can potentially pass through the entrance
and enter the maximum operating area, install tunnel guards of sufficient
length or safeguarding devices at the entrance to prevent a worker's body
part from entering the maximum operating area.
- (5) Apply the following with respect to movable guards:
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1) When the movable guard is not completely closed, hazardous moving
parts cannot be operated.
2) When the movable guard is closed, hazardous moving parts will
not start operating automatically.
3) For movable guards without locking mechanisms (mechanisms that
prevent the guard from opening while hazardous moving parts are operating),
hazardous moving parts stop operating immediately when the movable guard
is opened.
4) For movable guards with locking mechanisms, the guard cannot be
opened until hazardous moving parts stop operating completely.
5) For movable guards designed to not open for a fixed period of
time after taking action to stop the operation of hazardous moving parts,
set this fixed period of time longer than the time required for moving
parts to stop operating.
6) Make locking mechanisms, etc., difficult to render ineffective.
(6) Make adjustable guards (completely adjustable or equipped
with adjustable parts) able to cover the safeguarding area or enclose to
the extent possible the safeguarding area through adjustment, and make
them adjustable without the use of special tools, etc.
- (7) Apply the following with respect to safeguarding devices:
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1) Have sufficient strength and durability to meet the usage conditions.
2) Have higher degree of reliability.
3) Cannot be easily rendered ineffective.
4) Installed to allow the replacement of machinery tools, cleaning,
oiling, adjusting, etc., to be performed without removal.
- (8) Apply the following with respect to the control systems
of safeguarding devices:
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1) The machine can operate only when the safety of workers is confirmed.
2) According to the severity of risk, limits the probability of hazardous
situations occurring as a result of breakdown.
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Attachment 3 Methods for Additional Safety Measures
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1. Add emergency stop functions.
2. Allow for measures to extricate or rescue a worker that has been
restrained by being caught or trapped, etc., in the machine.
3. Allow for measures to cut off the supply of power from the machine's
power supply and measures to remove any stored or residual energy in the
machine.
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Attachment 4 Usage Information Details
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1. Information identifying the manufacturer's name and address, the
machine's model and serial number, and other pertinent information.
2. Information on the intended usage purpose and usage instructions
of the machine.
3. Information on the specifications of the machine.
4. Information on the risk, etc., of the machine.
(1) Design conditions related to the safety of the machine.
(2) Hazard and hazardous situations identified through risk
assessment (limited to residual risk).
(3) Equipment related safety measures to counter hazard and
hazardous situations of the machine (limited to risks that arise or increase
as a result of improper handling, etc., when using the machine).
(4) Personal protective equipment required to reduce residual
risk in manufacturing, etc., and safety measures such as education and
training for workers.
5. Information required for using the machine.
(1) Information on the construction of the machine.
(2) Information on the transport, storage, assembly, installation,
trial operation, etc., of the machine.
(3) Information on the operation of the machine.
(4) Information on the maintenance, etc., of the machine.
(5) Information on breakdown, malfunctioning, etc., of the
machine.
(6) Information on the discontinuation of use, removal, dismantling,
disposal, etc., of the machine.
6. Warnings about foreseeable intentional misuse.
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Attachment 5 Methods for Supplying Usage Information
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1. Apply the following when affixing signs, warning labels, etc:
(1) Affix on the interior, side, top, and other appropriate
locations of the machine.
(2) Use material that will be clearly legible throughout the
life of the machine.
(3) Use material that will not easily peel off.
- (4) Apply the following with respect to signs and warning labels.
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1) Explain the type and details of the hazard.
2) Make details clear and readily understandable.
3) Provide instructions on matters that are either prohibited or
advisable.
4) Be prepared to resupply this information.
2. Apply the following with respect to warning devices:
(1) Use audible and/or visual warning signals as circumstances
require.
(2) Install on the interior, side, top, and other appropriate
locations of the machine.
- (3) Apply the following with respect to warning devices used
to signal machine startup, excessive speed, and other such important warnings.
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1) Transmit signal prior to the occurrence of a hazardous event.
2) No ambiguity.
3) Able to be reliably perceived and recognized, and to be differentiated
from all other signals.
4) A warning that one does not become accustomed to hearing.
5) The signal producing location is easy to check.
3. Apply the following with respect to the delivery of a written
instruction manual, etc:
(1) Provide when the machine is delivered, or at an appropriate time
prior to delivery.
(2) Print on durable material that will remain legible until
the disposal of the machine.
(3) Be prepared to resupply.
4. Provide education and training as needed to persons using the
machine.
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Attachment 6 Considerations Related to Safety Measures
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1. When there is potential hazard of workpieces, tools, waste, etc.,
falling, flying, etc., take measures such as installing guards.
2. When there is potential hazard from the emission of high-pressure
fluids, etc., when using fluids such as oil and air, take measures such
as installing guards to cover hoses and other parts at risk of being damaged.
3. When there is potential hazard from contact, etc., with high or
low temperature sections of a machine, take measures such as installing
guards to cover the high or low temperature sections.
4. When there is potential for fire from using combustible gases,
liquids, etc., take measures such as preventing the machine from overheating.
5. When there is potential for explosion from using combustible gases,
liquids etc., take measures such as preventing a range of concentration
that is capable of exploding.
6. When there is potential hazard from electric shock, take measures
such as installing guards to cover live parts.
7. When there is potential hazard from falling, etc., while working,
etc., in high places, take measures such as installing work floors and
guardrails at the edges of work floors concerned.
8. When there is potential hazard from falling, etc., when moving,
take measures such as installing safe passageways and stairs.
9. When there is potential hazard from slipping and stumbling, etc.,
on work floors, take measures such as installing non-slip material on work
floors concerned.
10. When there is potential for health impairment from harmful substances,
take measures to reduce exposure to harmful substances by sealing the source
of harmful substances, discharging harmful substances that are emitted,
etc.
11. When there is potential for health impairment from ionizing radiation,
laser beams, etc., (hereinafter referred to as " radiation, etc. "),
take measures such as shielding the section producing radiation, etc.,
and reducing the level of radiation, etc., that leaks to the outside.
12. When there is potential for health impairment from noise or vibration,
take measures to reduce the noise or vibration that is produced.
13. To prevent hazards when performing maintenance, etc., on machinery,
take the following measures:
- (1) Perform maintenance, etc., according to the following priority
sequence.
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1) Be able to perform maintenance, etc., outside the safeguarding
area.
2) When it is necessary to perform maintenance within the safeguarding
area, be able to stop the machine prior to performing maintenance, etc.
3) When a machine cannot be stopped prior to performing maintenance,
etc., take necessary measures to reduce the risk of performing maintenance,
etc.
(2) Be able to easily and safely change automated machine parts and
components that must be changed when the content of work changes, that
are susceptible to wear and deterioration, or that otherwise require frequent
changes.
- (3) Apply the following with respect to cutting the power supply:
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1) Be able to cut the power supply completely.
2) Be able to clearly identify the device for cutting the power supply.
3) When necessity dictates that the location of the device to cut
the power supply is not clearly visible to the worker performing work,
be able to lock the device in a position where the power supply is cut.
4) Be able to eliminate potential hazards to workers from stored
or residual energy that remains in the machine's circuits after cutting
the power supply.
14. To prevent hazards in transporting, etc., machinery, take measures
such as installing hooks, etc., for hoisting.
15. To prevent hazards from a machine falling over, etc., take measures
to ensure stability with consideration given to the machine's kinetic energy,
outside force, etc.
16. To prevent hazards when starting machine operations, be able to confirm
prior to starting operations according to the following priority sequence:
(1) Be able to see clearly from the operation control location that
workers are not inside the safeguarding area.
(2) Be able to produce a warning using audible or visual signals
when staring machine operations.
In this case, take measures to prevent workers other than the operator
from starting machine operations, and provide workers with the time and
means to move clear of hazardous locations.
17. To prevent hazards from operational errors, take the following measures
with respect to operation control equipment:
- (1) Apply the following with respect to operation controls.
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1) Be able to easily select, etc., the start, stop, and operation
control modes.
2) Make operation controls clearly identifiable by affixing appropriate
displays when circumstances require (e.g., the possibility of misidentification).
3) Maintain consistency between the direction of operation controls
and the direction of the operations of moving machine parts.
4) Make the operation control quantity and operation control resistance
correspond to the machine operation quantity being performed as a result
of the operation control.
5) When moving machine parts produce hazards as a result of their
operation, make operation possible only through intentional operation control.
6) With operation control equipment that has the function of operating
only when the operation controls are moving, make operation controls automatically
return to a neutral position when movement of the operation controls is
halted as a result of removing a hand from the operation controls, etc.
7) With machines that have no one-to-one correspondence between machine
operations and operation control via keyboard, etc., show clearly on a
display, etc., the machine operations being executed, and be able to cancel
the operation control command prior to the operation if circumstances require.
8) With work that requires the use of protective equipment such as
protective gloves, give consideration to the constraints that their use
places on operation control.
9) Make operation controls such as the emergency stop device strong
enough to withstand the load expected during the operation control.
10) Install the display devices needed for appropriate operation
control in locations that are clearly visible from the operation control
location.
11) Place operation controls in a location that enables quick and reliable
operation control.
12) Install operation control equipment, except emergency stop devices
required inside the safeguarding area and " teaching devices, "
etc., outside the safeguarding area.
- (2) Apply the following with respect to starting devices.
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1) Machinery can only be started through intentional operation of
the starting device.
2) When multiple workers are engaged in operations with machinery
that has multiple starting devices, the ability to operate the machinery
from any one of these starting devices presents a potential hazard to other
workers. In such circumstances, take measures to prevent this hazard by
limiting the startup section to the operation of only one starting device.
- (3) Apply the following with respect to the operation control mode
of machinery.
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1) The selected operation control mode has priority to all other
modes with the exception of emergency stop.
2) Concerning the use of multiple operation control modes that have
different safety levels, provide mode changing devices that can be fixed
by the position of each individual operation control mode.
3) Provide the following functions for modes used when the machine
is operating with guards removed or safeguarding devices cancelled.
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Hazardous moving parts can only be operated by manual operation control
methods.
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When required to maintain continuous operations, hazardous moving parts
can only be operated at reduced speeds, reduced driving force, by step-by-step
operations, etc.
- (4) Apply the following with respect to the regular stopping
device.
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1) A stop order takes precedence over an operate order.
2) When combining multiple machines to operate together, configure
the machines so that when any machine is ordered to stop, other machines
that can potentially increase risk by continuing to run, stop at the same
time.
3) Install on each operation control section a switch to stop part
of or the whole machine.
- (5) Apply the following with respect to emergency stop devices.
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1) Install the required number of emergency stop switches in clearly
visible and readily accessible locations.
2) When operated, the devices are able to stop the machine as quickly
as possible without creating additional risk.
3) When operated, safety devices, etc., are started or can be started
as circumstances require.
4) The stop order remains in effect until performing the operation
for canceling the emergency stop device.
5) An emergency stop device can only be cancelled through a predetermined
cancellation operation.
6) The machine does not restart immediately after the cancellation
operation for the emergency stop device.
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Figure 2. Procedures for Risk Assessment and Safety Measures
for Manufacturers, etc.
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