Manufacturer:

Machine: Compiler of file: Date: Version:

Title Technical construction file for assembly of machines

Module: Risk analysis for machine — interpretation
1 The machine under assessment

2 Assumptions made (e.g. loads, strength, safety factors)

3 Information on which the risk assessment was based

Data used and its sources (e.g. accident history, experience in
3.1
risk reduction for similar machines)

The uncertainty linked to the data used and its influence on

the risk assessment
3.2

The risk reduction objectives that must be achieved by

protective measures which need to be referenced to the
4
standards or other provisions used in the choice of these
measures

5 Used method, matrix etc.

Persons and their position present for the implementation of
6
the risk analysis
7 Data for the implementation of the risk analysis
8 Person for approval of the risk analysis
 Manufacturer:
Installation: Issued by: Date: Version:

Title: Technical construction file for machines

Module: Limits of RI&E
Risk assessment (risk estimation and risk evaluation) and risk reduction
Machine: Method: Date:
Sources: Analyst:
Phase: Version:

Definition of limits for the machine

Hazardous zones (please describe the various hazardous zones for the machine
in question):
1
2
3

1 Limits for use

1.A.1 Different operating modes of the machine:
1
2
1.A.2 Different intervention procedures for the users:
1
2
3
1.B Use of the machine:

1.C The supposed level of training, experience or skills of users, such as:
1.C.1 Operating personnel:
1.C.2 Maintenance personnel or technicians:
1.C.3 Apprentices:
1.C.4 General public:
Other persons who could be exposed to the hazards linked to the machine, insofar as this can be reasonably
1.D
envisaged, such as:
1.D.1 Operating personnel who work in the vicinity
1.D.2 Other personnel who work in the vicinity
Other persons in the vicinity who are not employed
1.D.3
there
2 Spatial limits
2.A Room for manoeuvre:

2.B Space required for persons working at the machine, e.g. during operation and maintenance:

2.C Human interaction, e.g. the area of overlap between operator and machine:

2.D The area of overlap between machine and power supply:

3 Time limits
The “service life” of the machine and/or its defined elements (e.g. tools, parts subject to wear and tear, electro-
3.A mechanical components):

3.B Recommended maintenance periods:

4 Other limits
4.A Environment

4.B “Housekeeping” — the required level of cleanliness

4.C Properties of the material to be processed or the materials to be processed

 Manufacturer:

Department: Issued by: Date: Version:

Title
Module: Risk analysis

Initial risk analysis Risk analysis after risk reduction

Activity Hazardous circumstances Safety signage ISO 3864-2 Risk estimation Risk reduction Risk estimation after risk reduction

No. Activity Hazard Hazardous situation Hazardous event Possible injury Measures provided Heading (caution, Sign Legend Sign S E P A R Possible additional measures Selected measures S E P A R Note
warning, danger) 1 2
(ISO 7010) (optional)

A. Subpart
A1

A2

A3

A4

A5

B. Subpart

B1

B2

B3

B4

B5

C. Subpart

C1

C2

C3

C4

C5

D. Subpart

D1

D2

D3
D4

D5

E. Subpart

E1

E2

E3

E4

E5
 Risk index calculation

Exposure
Severity
Probability of hazardous
event occurring

P1 P2 P3

E1 1 1 1 1 2 2
S1
E2 1 1 1 1 2 2
E1 2 2 2 3 3 4
S2
E2 3 4 4 5 5 6
A1 A2 A1 A2 A1 A2
Possibility of preventing or reducing
injury/damage
S Severity of possible injury/damage
Minor injury (usually reversible), e.g. grazes, cuts, bruising, slight wound with first aid
S1 care
Serious injury (usually irreversible injury, permanent disability, death etc.) e.g. broken
bones, crushed limbs, wounds with stitching, serious musculoskeletal problems, fatal
S2 accidents
E Exposure to and/or frequency of the hazard

E1 Two times or less per shift or less than 15 minutes cumulative exposure per shift

E2 More than two times per shift or more than 15 minutes cumulative exposure per shift
P Probability of hazardous event occurring

P1 Well considered technology, recognised, reputable safety technology, robust equipment

P2 Technical failures or problems recorded in the last two years:
* nonconformant human behaviour by well-trained persons who are aware of the risks
and who have more than six months experience at the workplace
P3 Regular technical failures (every six months or more frequently):
* nonconformant human behaviour by an untrained person with less than six months
experience at the workplace
* similar accident/incident recorded in the company during the last ten years
A Possibility of preventing or reducing injury/damage
A1 Possible under certain conditions:
* If parts move at a speed of less than 0.25 m/s AND the exposed employee is familiar
with the risks and the signs of a dangerous situation or the avoidance of a hazardous
event
* dependent on particular conditions (temperature, noise, ergonomics etc.)
A2 Impossible
Risk index Colour code as shown in the risk evaluation (priorities index):
1 2 Lowest priority (priority 3)
3 4 Medium priority (priority 2)
5 6 Highest priority (priority 1)
No Type or Examples of hazards ISO 12100
group

Causea Possible consequencesb Part Part

1:2003 2:2003

1 Mechanical —    Accelerate/decelerate (kinetic —    Being run over; 4.2.1 4.2.1
hazards energy);
—    Sharp parts; —    Being discarded; 4.2.2 4.2.2
—    Moving part approaches —    Getting trapped; 4.10 4.3 a)
stationary part;
—    Cutting parts; —    Cutting or cutting off; 4.3 b)
—    Elastic parts; —    Pulled in or confined; 4.6
—    Falling objects; —    Getting stuck; 4.10
—    Gravity (potential energy); —    Rub or graze oneself; 5.1
5.2
—    Height above base; 5.3
—    High pressure; 5.5.2
—    Mobility of the machine; —    Bumping; 5.5.4
—    Moving parts; —    Injection; 5.5.5
—    Rotating parts; 5.5.6
—    Rough, smooth surface; —    Slip, trip or fall; 6.1
—    Sharp edges; —    Pierce or drill through; 6.3
—    Stability; 6.4
—    Vacuum. —    Asphyxiation. 6.5
2 Electrical —    Arc flash; —    Burning; 4.3 4.9
hazards —    Electromagnetic phenomena; 5.2
—    Electrostatic phenomena; —    Consequences for medical implants; 5.3.2
—    Electrically live parts; —    Electrocution 5.5.4
—    Insufficient distance from high- —    Falling, being discarded; 6.4
voltage parts;
—    Overloading; —    Fire; 6.5
—    Parts which become live due to a —    Ejection of molten particles;
fault;
—    Electrical shock.
—    Short circuit;
—    Thermal radiation.
3 Thermal —    Explosion; —    Burning; 4.4 4.4 b)
hazards —    Flames; —    Burning; 4.8.4
—    Objects or materials at high or low 5.2.7
temperatures;
—    Freezing; [Link]
—    Radiation from heat sources. —    Injury due to radiation from heat 5.4.5
sources;

4 Hazards —    Cavitation phenomena; —    Discomfort; 4.5 4.2.2

due to —    Exhaust system; —    Unconsciousness; 4.3 c)
noise —    Gas leak at high velocity; —    Balance disorder; 4.4 c)
—    Manufacturing process (punching, —    Permanent hearing loss; 4.8.4
cutting, etc.);
—    Moving parts; —    Psychological stresses; 5.1
—    Scraping surfaces; —    Tinnitus; [Link]
—    Out-of-balance rotating parts; —    Fatigue; 5.4.2
—    Hissing pneumatics; 6.3
—    Worn parts. 6.5.1 c)
5 Hazards —    Cavitation phenomena; —    Discomfort; 4.6 4.2.2
due to —    Faulty alignment of moving parts; —    Lower back pain; 4.3 c)
vibrations
—    Mobile equipment; —    Neurological disorders; 4.8.4
—    Scraping surfaces; —    Joint complaints; [Link]
—    Out-of-balance rotating parts; 5.4.3
—    Vibrating equipment; 6.5.1 c)

—    Worn parts.

6 Hazards —    Ionising radiation; —    Burning; 4.7 4.2.2
due to —    Low-frequency electromagnetic 4.3 c)
radiation radiation;
—    Optical radiation (infrared, visible —    Consequences for reproductive [Link]
and ultraviolet), including laser potential;
beams;
—    High-frequency electromagnetic —    Genetic mutations; 5.4.5
radiation.
—    Headache, insomnia, etc. 6.5.1 c)

7 Hazards —    Aerosol; —    Breathing problems, asphyxiation; 4.8 4.2.2

due to —    Biological and microbiological —    Cancer; 4.3 b)
materials (viral or bacterial) substances;
and —    Flammable substances; —    Fire; 4.3 c)
substances —    Dust; —    Hypersensitivity. 4.4 a)
—    Explosive substances; —    Explosion; 4.4 b)
—    Fibres; —    Infections; 5.1
—    Flammable substances/materials; —    Fire; [Link]

—    Liquid; —    Poisoning; 5.4.5

—    Smoke; —    Poisoning; 5.4.4
—    Gas; —    Explosion; 6.5.1 c)

—    Mist or vapour; —    Breathing problems, asphyxiation; 6.5.1 g)

—    Oxidising substances. —    Explosion;

8 Ergonomic —    Access; —    Discomfort; 4.9 4.2.1
hazards —    Design or placement of indicating 4.7
instruments and screens;
—    Design, placement or marking of —    Burning; 4.8
control devices;
—    Exertion; —    Psychological stresses; 4.11.8
—    Flickering, blinding, shadowing —    Fatigue; 5.2.1
effect, stroboscopic effects;
—    Local lighting; [Link]
—    Mental overload/underload;
—    Body posture;
—    Repetitive activities;
—    Visibility.
9 Hazards —    Dust or mist/vapour; —    Breathing problems, asphyxiation; 4.12 4.6
from the —    Electromagnetic disturbances; 4.11.11
machine —    Lightning strike; —    Burning; 5.2.1
environme —    Moisture; —    Slipping, falling; 6.5.1 b)
nt
—    Contamination; —    Slipping, falling;

—    Snow; —    Slipping, falling;

—    Temperature; —    Minor ailments such as a cold;
 nt

—    Water; —    Slipping, falling;

—    Wind; —    Minor ailments such as a cold;
—    Lack of oxygen. —    Breathing problems, asphyxiation;
10 Combinatio —    E.g. repetitive activities —    E.g. dehydration, inattentiveness, heat 4.11 -
n of -        Exertion stroke.
hazards -        High ambient temperature.
a
A cause of hazards can have more potential consequences.
b
For each type of hazard or group of hazards, some potential consequences can be connected to more than one cause
 Phases in the
service life of the Examples of tasks
machine
Transport —    Lifting;
—    Loading;
—    Packing;
—    Transporting;
—    Unloading;
—    Unpacking.
Assembly and —    Settings for the machine and its components;
installation — —    Assembly of the machine;
Commissioning —    Connections to drainage systems
(e.g. exhaust system, waste water installation);
—    Connection to energy supply
(e.g. electricity, compressed air);
—    Demonstration;
—    Supplying, filling, loading of auxiliary materials
(e.g. lubricating oil, grease, adhesive);
—    Placement of guards;
—    Securing, anchoring;
—    Preparation for the installation (e.g. foundation, vibration isolators);
—    Unloaded test runs;
—    Inspecting;
—    Test runs under (maximum) load.
Adjusting —    Adjusting and setting protective features and other components;
—    Adjusting and setting or checking operating parameters of the machine
Instruction/ (e.g. speed, pressure, power, spacing);
programming —    Securing work pieces;
and/or process —    Feeding, filling and loading of raw materials;
change —    Functional tests, test runs;
—    Attaching, changing and adjusting tools;
—    Checking the program;
—    Checking the end product.
In operation —    Securing work pieces;
—    Control/supervision;
—    Activating the machine;
—    Feeding, filling and loading of raw materials;
—    Manual loading and unloading;
—    Minor adjustments and settings of operating parameters of the machine
(e.g. speed, pressure, power, spacing);
—    Minor interventions during operation (e.g. removal of waste, removal of
faults, local cleaning);
—    Manually operating control devices;
—    Restarting the machine after a stop/interruption;
—    Monitoring;
—    Checking the end product.
Cleaning, —    Adjustments;
maintenance —    Cleaning, disinfecting;
—    Disassembly/removal of parts, components, features of the machine;

—    Cleaning;
—    Switching off energy supply and rendering without power;
—    Lubricating;
—    Replacing tools;
 —    Replacing worn parts;
—    Readjusting;
—    Topping up fluids;
—    Checking components of the machine.
Tracing and —    Adjustments;
eliminating —    Disassembly/removal of parts, components, features of the machine;
defects
—    Tracing defects;
—    Switching off energy supply and rendering without power;
—    Elimination of faults from controlling and protective features;
—    Removal of blockages;
—    Repairing;
—    Replacing parts, components, features of the machine;
—    Rescuing trapped persons;
—    Resetting;
—    Checking parts, components, features of the machine.
Decommissioning —    Disconnecting from energy supply and rendering without power;
Dismantling —    Dismantling;
—    Removing;
—    Loading;
—    Packing;
—    Transporting;
—    Unloading.
COMMENT These tasks may relate to the entire machine or parts of it.
 ISO 12100-
2:2003
Cause related to... Hazardous event
(usable
references)
Form and/or surface condition of —    Contact with rough surfaces; 4.2.1
accessible parts of the machine —    Contact with sharp edges and
corners, protruding parts.
Moving parts of the machine —    Contact with moving parts; 4.2, 4.14, 4.15
—    Contact with rotating open ends. 5.1 to 5.3
5.5.2 to 5.5.4
6.3 to 6.5
Kinetic energy and/or potential —    Falling or ejection of objects 4.3, 4.5
energy (gravity) of the machine, parts
of the machine, tools and
used/processed/treated materials

4.10 to 4.12
5.2.1, 5.2.2,
5.2.7, 5.3
5.5.2, 5.5.4,
5.5.5
6.4, 6.5

Stability of the machine and/or parts —    Loss of stability 4.3 a) and b) 4.6
of the machine
5.2.6, 5.2.7
6.3 to 6.5
Mechanical strength of machine —    Breakage during operation 4.3 a) and b)
parts, tools etc.
4.11, 4.13
5.2, 5.2.7
5.3.1 to 5.3.3
5.5.2, 6.4, 6.5
Pneumatic/hydraulic systems —    Relocation of moving parts; 4.3 a) and b)
—    Release of air or liquid under high 4.10, 4.13
pressure;
5.2.7
—    Uncontrolled movements. 5.3.1 to 5.3.3
5.5.4, 6.4, 6.5

Electrical equipment —    Direct contact; 4.4 a)

—    Disruptive discharge; 4.9, 4.12
—    Arc flash; 5.2, 5.3,
—    Fire; 5.5.4
—    Indirect contact; 6.4, 6.5
—    Short circuit.
 Category Sign ISO 7010 number ISO 7010 Sign description

Safe Condition E020 Emergency stop button

Mandatory M001 General mandatory sign

Refer to instruction
Mandatory M002
manual/booklet

Mandatory M003 Wear ear protection

Mandatory M004 Wear eye protection

Connect an earth terminal

Mandatory M005
to the ground

Disconnect mains plug

Mandatory M006
from electrical outlet

Opaque eye protection

Mandatory M007
must be worn

Mandatory M008 Wear safety footwear

Mandatory M009 Wear protective gloves

Mandatory M010 Wear protective clothing

Mandatory M011 Wash your hands

Mandatory M012 Use handrail

Mandatory M013 Wear face shield

Mandatory M014 Wear head protection

Mandatory M015 Wear high visibility clothing

Mandatory M016 Wear a mask

Wear respiratory
Mandatory M017
protection

Mandatory M018 Wear safety harness

Mandatory M019 Wear welding mask

Mandatory M020 Wear safety belts

Disconnect before carrying

Mandatory M021
out maintenance or repair

Mandatory M022 Use barrier cream

Mandatory M023 Use footbridge

Mandatory M024 Use this walkway

 Infants must be protected
Mandatory M025
with opaque eye protection

Mandatory M026 Use protective apron

Mandatory M027 Check guard

Mandatory M028 Keep locked

Mandatory M029 Sound horn

Mandatory M030 Use litter bin

Use table saw

Mandatory M031
adjustable guard

Wear anti-static footwear

Mandatory M032

Close and secure hatches

Mandatory M037
in launch sequence

Mandatory M038 Start engine in launch sequence

Mandatory M044 Start air supply in launch sequence

Mandatory M046 Secure gas cylinders

Use self-contained
Mandatory M047
breathing appliance

Mandatory M048 Use gas detector

Mandatory M053 Wear personal flotation devices

Prohibition P001 General prohibition sign

Prohibition P002 No smoking

No open flame; Fire,

Prohibition P003 open ignition source and
smoking prohibited

Prohibition P004 No thoroughfare

Prohibition P005 Not drinking water

No access for fork lift

Prohibition P006 trucks and other industrial
vehicles

No access for people with

Prohibition P007 active implanted cardiac
devices

No metallic articles or
Prohibition P008
watches

Prohibition P009 No climbing

Prohibition P010 Do not touch

Do not extinguish with

Prohibition P011
water

Prohibition P012 No heavy load

No activated mobile
Prohibition P013
phones

No access for persons

Prohibition P014
with metallic implants

Prohibition P015 No reaching in

Prohibition P016 Do not spray with water

Prohibition P017 No pushing

Prohibition P018 No sitting

Prohibition P019 No stepping on surface

Do not use lift in the event

Prohibition P020
of fire

Prohibition P021 No dogs

Prohibition P022 No eating or drinking

Prohibition P023 Do not obstruct

Prohibition P024 Do not walk or stand here

Do not use this

Prohibition P025
incomplete scaffold
 Do not use this device in a
Prohibition P026
bathtub, shower or water-filled reservoir

Do not use this lift for

Prohibition P027
people

Prohibition P028 Do not wear gloves

Prohibition P029 No photography

Prohibition P030 Do not tie knots in rope

Do not alter the state of

Prohibition P031
the switch

Do not use for face

Prohibition P032
grinding

Do not use for wet

Prohibition P033
grinding

Do not use with hand-held

Prohibition P034
grinding machine

Prohibition P035 Do not wear metal-studded footwear

Prohibition P036 No children allowed

Prohibition P039 Hot works prohibited

Prohibition P041 No leaning against

Prohibition P042 Not for pregnant women

Not for people in the state

Prohibition P043
of intoxication

Use of smart glasses

Prohibition P044
prohibited

Prohibition P048 No running

Warning W001 General warning

Warning W002 Warning — Explosive material

Warning — Radioactive material or

Warning W003
ionizing radiation

Warning W004 Warning — Laser beam

Warning —
Warning W005
Non-ionizing radiation

Warning W006 Warning — Magnetic field

Warning W007 Warning — Floor-level obstacle

Warning W008 Warning — Drop (fall)

Warning —
Warning W009
Biological hazard

Warning — Low temperature/freezing

Warning W010
conditions

Warning W011 Warning — Slippery surface

Warning —
Warning W012
Electricity

Warning — Fork lift trucks and other industrial

Warning W014
vehicles

Warning W015 Warning — Overhead load

Warning W016 Warning — Toxic material

Warning W017 Warning — Hot surface

Warning —
Warning W018
Automatic start-up

Warning W019 Warning — Crushing

Warning —
Warning W020
Overhead obstacles

Warning W021 Warning — Flammable materials

Warning —
Warning W022
Sharp elements

Warning W023 Warning — Corrosive substance

Warning —
Warning W024
Crushing of hands

Warning W025 Warning — Counter rotating rollers

Warning —
Warning W026
Battery charging
Warning W027 Warning — Optical radiation

Warning W028 Warning — Oxidizing substance

Warning W029 Warning — Pressurized cylinder

Warning — Hand crushing between

Warning W030
press brake tool

Warning — Hand crushing between

Warning W031
press brake tool and material

Warning —
Warning W032
Rapid movement of workpiece in press brake

Warning W033 Warning — Barbed wire

Warning W035 Warning — Falling objects

Warning — Run over by remote

Warning W037 operator controlled
machine

Warning W038 Warning — Sudden loud noise

Warning W039 Warning — Falling ice

Warning W040 Warning — Roof avalanche

Warning W041 Warning — Asphyxiating atmosphere

Warning W042 Warning — Arc flash