EN ISO 12100-1:2003

SLOVENSKI SIST EN ISO 12100-1:2004

STANDARD
junij 2004
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terminologija, metodologija (ISO 12100-1:2003)
Safety of machinery - Basic concepts, general principles for design - Part 1: Basic
terminology, methodology (ISO 12100-1:2003)
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01.040.13; 13.110
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EUROPEAN STANDARD
EN ISO 12100-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2003
ICS 01.040.13; 13.110 Supersedes EN 292-1:1991
English version
Safety of machinery - Basic concepts, general principles for
design - Part 1: Basic terminology, methodology (ISO 12100-
1:2003)
Sécurité des machines - Notions fondamentales, principes Sicherheit von Maschinen - Grundbegriffe, allgemeine
généraux de conception - Partie 1: Terminologie de base, Gestaltungsleitsätze - Teil 1: Grundsätzliche Terminologie,
méthodologie (ISO 12100-1:2003) Methodologie (ISO 12100-1:2003)
This European Standard was approved by CEN on 9 June 2003.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2003 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 12100-1:2003 E
worldwide for CEN national Members.

CORRECTED 2003-12-17
Foreword
This document (EN ISO 12100-1:2003) has been prepared by Technical Committee ISO/TC 199
"Safety of machinery" in collaboration with Technical Committee CEN/TC 114 "Safety of
machinery", the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of
an identical text or by endorsement, at the latest by May 2004, and conflicting national standards
shall be withdrawn at the latest by May 2004.
This document supersedes EN 292-1:1991.
This document has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association, and supports essential requirements of EU
Directive(s).
For relationship with EU Directive(s), see informative Annex ZB, which is an integral part of this
document.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium, Czech
Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and
the United Kingdom.
Endorsement notice
The text of ISO 12100-1:2003 has been approved by CEN as EN ISO 12100-1:2003 without any
modifications.
NOTE Normative references to International Standards are listed in Annex ZA (normative).
Annex ZA
(normative)
Normative references to international publications
with their relevant European publications
This European Standard incorporates by dated or undated reference, provisions from other
publications. These normative references are cited at the appropriate places in the text and the
publications are listed hereafter. For dated references, subsequent amendments to or revisions of
any of these publications apply to this European Standard only when incorporated in it by
amendment or revision. For undated references the latest edition of the publication referred to
applies (including amendments).
NOTE Where an International Publication has been modified by common modifications, indicated
by (mod.), the relevant EN/HD applies.
Publication Year Title EN Year
ISO 12100-2 2003 Safety of machinery - Basic EN ISO 12100-2 2003
concepts, general principles for
design - Part 2: Technical
principles
Annex ZB
(informative)
Relationship of this document with EC Directives
This document has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association and supports essential requirements of EC
Directive(s) :
Machinery Directive 98/37/EC, amended by Directive 98/79/EC.
Compliance with this document provides one means of conforming with the specific essential
requirements of the Directive concerned and associated EFTA regulations.
WARNING: Other requirements and other EC Directives may be applicable to the product(s)
falling within the scope of this document.
INTERNATIONAL ISO
STANDARD 12100-1
First edition
2003-11-01
Safety of machinery — Basic concepts,
general principles for design —
Part 1:
Basic terminology, methodology
Sécurité des machines — Notions fondamentales, principes généraux
de conception —
Partie 1: Terminologie de base, méthodologie

Reference number
ISO 12100-1:2003(E)
©
ISO 2003
ISO 12100-1:2003(E)
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ii © ISO 2003 – All rights reserved

ISO 12100-1:2003(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope. 1
2 Normative references. 1
3 Terms and definitions. 1
4 Hazards to be taken into account when designing machinery . 8
4.1 General. 8
4.2 Mechanical hazard. 8
4.3 Electrical hazard. 9
4.4 Thermal hazard. 9
4.5 Hazard generated by noise . 10
4.6 Hazards generated by vibration . 10
4.7 Hazards generated by radiation . 10
4.8 Hazards generated by materials and substances . 10
4.9 Hazards generated by neglecting ergonomic principles in machine design . 10
4.10 Slipping, tripping and falling hazards. 11
4.11 Hazard combinations. 11
4.12 Hazards associated with the environment in which the machine is used . 11
5 Strategy for risk reduction . 11
5.1 General provisions. 11
5.2 Specification of the limits of the machine. 12
5.3 Hazard identification, risk estimation and risk evaluation . 12
5.4 Elimination of hazards or reduction of risk by protective measures . 14
5.5 Achievement of risk reduction objectives. 14
Annex A (informative) Schematic representation of a machine . 17
Trilingual index . 18

Bibliography . 33
ISO 12100-1:2003(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 12100-1 was prepared by Technical Committee ISO/TC 199, Safety of machinery.
This edition cancels and replaces ISO/TR 12100-1:1992, which has been technically revised.
This standard results from the revision of EN 292:1991 / ISO/TR 12100:1992, carried out by a Special
Working Group composed of experts from ISO, CEN, IEC and CENELEC.
ISO 12100 consists of the following parts, under the general title Safety of machinery — Basic concepts,
general principles for design:
 Part 1: Basic terminology, methodology, expressing the basic overall methodology to be followed when
designing machinery and when producing safety standards for machinery, together with the basic
terminology related to the philosophy underlying this work;
 Part 2: Technical principles, giving advice on how this philosophy can be applied using available
techniques.
iv © ISO 2003 – All rights reserved

ISO 12100-1:2003(E)
Introduction
The primary purpose of ISO 12100 is to provide designers with an overall framework and guidance to enable
them to produce machines that are safe for their intended use. It also provides a strategy for standard makers.
The concept of safety of machinery considers the ability of a machine to perform its intended function(s)
during its lifecycle where risk has been adequately reduced.
This standard is the basis for a set of standards which has the following structure:
 type-A standards (basic safety standards) giving basic concepts, principles for design, and general
aspects that can be applied to all machinery;
 type-B standards (generic safety standards) dealing with one safety aspect or one type of safeguard that
can be used across a wide range of machinery:
 type-B1 standards on particular safety aspects (e.g. safety distances, surface temperature, noise);
 type-B2 standards on safeguards (e.g. two-hand controls, interlocking devices, pressure sensitive
devices, guards);
 type-C standards (machine safety standards) dealing with detailed safety requirements for a particular
machine or group of machines.
This standard is a type-A standard.
When a type-C standard deviates from one or more provisions dealt with by Part 2 of this standard or by a
type-B standard, the type-C standard takes precedence.
It is recommended that this standard be incorporated in training courses and manuals to convey basic
terminology and general design methods to designers.
ISO/IEC Guide 51 has been taken into account as far as practicable at the time of drafting of this standard.

INTERNATIONAL STANDARD ISO 12100-1:2003(E)

Safety of machinery — Basic concepts, general principles for
design — Part 1: Basic terminology, methodology
1 Scope
This standard defines basic terminology and methodology used in achieving safety of machinery.
The provisions stated in this standard are intended for the designer.
This standard does not deal with damage to domestic animals, property or the environment.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 12100-2:2003, Safety of machinery – Basic concepts, general principles for design – Part 2 : Technical
principles.
3 Terms and definitions
For the purposes of ISO 12100-1 and -2, the following terms and definitions apply.
3.1
machinery
machine
assembly of linked parts or components, at least one of which moves, with the appropriate machine actuators,
control and power circuits, joined together for a specific application, in particular for the processing, treatment,
moving or packaging of a material.
The terms "machinery" and "machine" also cover an assembly of machines which, in order to achieve the
same end, are arranged and controlled so that they function as an integral whole.
NOTE Annex A provides a general schematic representation of a machine.
3.2
reliability (of a machine)
ability of a machine or its components or equipment, to perform a required function under specified conditions
and for a given period of time without failing
3.3
maintainability (of a machine)
ability of a machine to be maintained in a state which enables it to fulfil its function under conditions of
intended use, or restored into such a state, the necessary actions (maintenance) being carried out according
to specified practices and using specified means
ISO 12100-1:2003(E)
3.4
usability (of a machine)
ability of a machine to be easily used thanks to, among others, properties or characteristics that enable its
function(s) to be easily understood.
3.5
harm
physical injury or damage to health
3.6
hazard
potential source of harm
NOTE 1 The term "hazard" can be qualified in order to define its origin (e.g. mechanical hazard, electrical hazard) or
the nature of the potential harm (e.g. electric shock hazard, cutting hazard, toxic hazard, fire hazard).
NOTE 2 The hazard envisaged in this definition:
 either is permanently present during the intended use of the machine (e.g. motion of hazardous moving elements,
electric arc during a welding phase, unhealthy posture, noise emission, high temperature);
 or may appear unexpectedly (e.g. explosion, crushing hazard as a consequence of an unintended / unexpected start-
up, ejection as a consequence of a breakage, fall as a consequence of acceleration / deceleration).
3.7
relevant hazard
hazard which is identified as being present at or associated with the machine
NOTE A relevant hazard is identified as the result of one step of the process described in ISO 14121.
3.8
significant hazard
hazard which has been identified as relevant and which requires specific action by the designer to eliminate or
to reduce the risk according to the risk assessment
3.9
hazardous situation
circumstance in which a person is exposed to at least one hazard. The exposure can immediately or over a
period of time result in harm
3.10
hazard zone
danger zone
any space within and/or around machinery in which a person can be exposed to a hazard
3.11
risk
combination of the probability of occurrence of harm and the severity of that harm
3.12
residual risk
risk remaining after protective measures have been taken (see also figure 1)
NOTE This standard distinguishes:
 the residual risk after protective measures have been taken by the designer;
 the residual risk after all protective measures have been implemented.
2 © ISO 2003 – All rights reserved

ISO 12100-1:2003(E)
3.13
risk assessment
overall process comprising a risk analysis and a risk evaluation
3.14
risk analysis
combination of the specification of the limits of the machine, hazard identification and risk estimation
3.15
risk estimation
defining likely severity of harm and probability of its occurrence
3.16
risk evaluation
judgement, on the basis of risk analysis, of whether the risk reduction objectives have been achieved
3.17
adequate risk reduction
risk reduction at least in accordance with the legal requirements under consideration of the current state of the
art
NOTE Criteria for determining when adequate risk reduction is achieved are given in 5.5.
3.18
protective measure
measure intended to achieve risk reduction, implemented:
 by the designer (inherently safe design, safeguarding and complementary protective measures,
information for use) and
 by the user (organization: safe working procedures, supervision, permit-to-work systems; provision and
use of additional safeguards; use of personal protective equipment; training).
See figure 1.
3.19
inherently safe design measure
protective measure which either eliminates hazards or reduces the risks associated with hazards by changing
the design or operating characteristics of the machine without the use of guards or protective devices
NOTE ISO 12100-2:2003, clause 4, deals with risk reduction by inherently safe design measures.
3.20
safeguarding
protective measure using safeguards to protect persons from the hazards which cannot reasonably be
eliminated or from the risks which cannot be sufficiently reduced by inherently safe design measures
NOTE ISO 12100-2:2003, clause 5, deals with safeguarding.
3.21
information for use
protective measure consisting of communication links (e.g. texts, words, signs, signals, symbols, diagrams)
used separately or in combination, to convey information to the user
NOTE ISO 12100-2:2003, clause 6, deals with information for use.
3.22
intended use of a machine
use of a machine in accordance with the information provided in the instructions for use
ISO 12100-1:2003(E)
3.23
reasonably foreseeable misuse
use of a machine in a way not intended by the designer, but which may result from readily predictable human
behaviour
3.24
safeguard
guard or protective device
3.25
guard
physical barrier, designed as part of the machine, to provide protection
NOTE 1 A guard may act:
 alone; it is then only effective when it is "closed" for a movable guard or "securely held in place" for a fixed guard;
 in conjunction with an interlocking device with or without guard locking; in this case, protection is ensured whatever
the position of the guard.
NOTE 2 Depending on its design, a guard may be called e.g. casing, shield, cover, screen, door, enclosing guard.
NOTE 3 See ISO 12100-2:2003, 5.3.2, and ISO 14120 for types of guards and their requirements.
3.25.1
fixed guard
guard affixed in such a manner (e.g. by screws, nuts, welding) that it can only be opened or removed by the
use of tools or destruction of the affixing means
3.25.2
movable guard
guard which can be opened without the use of tools
3.25.3
adjustable guard
fixed or movable guard which is adjustable as a whole or which incorporates adjustable part(s). The
adjustment remains fixed during a particular operation
3.25.4
interlocking guard
guard associated with an interlocking device so that, together with the control system of the machine, the
following functions are performed:
 the hazardous machine functions "covered" by the guard cannot operate until the guard is closed;
 if the guard is opened while hazardous machine functions are operating, a stop command is given;
 when the guard is closed, the hazardous machine functions "covered" by the guard can operate. The
closure of the guard does not by itself start the hazardous machine functions
NOTE ISO 14119 gives detailed provisions.
3.25.5
interlocking guard with guard locking
guard associated with an interlocking device and a guard locking device so that, together with the control
system of the machine, the following functions are performed:
 the hazardous machine functions "covered" by the guard cannot operate until the guard is closed and
locked;
4 © ISO 2003 – All rights reserved

ISO 12100-1:2003(E)
 the guard remains closed and locked until the risk due to the hazardous machine functions "covered" by
the guard has disappeared;
 when the guard is closed and locked, the hazardous machine functions "covered" by the guard can
operate. The closure and locking of the guard do not by themselves start the hazardous machine
functions
NOTE ISO 14119 gives detailed provisions.
3.25.6
interlocking guard with a start function
control guard
special form of an interlocking guard which, once it has reached its closed position, gives a command to
initiate the hazardous machine function(s) without the use of a separate start control
NOTE ISO 12100-2:2003, 5.3.2.5, gives detailed provisions regarding the conditions of use.
3.26
protective device
safeguard other than a guard
NOTE Examples of protective devices are given in 3.26.1 to 3.26.9.
3.26.1
interlocking device
interlock
mechanical, electrical or other type of device, the purpose of which is to prevent the operation of hazardous
machine functions under specified conditions (generally as long as a guard is not closed)
3.26.2
enabling device
additional manually operated device used in conjunction with a start control and which, when continuously
actuated, allows a machine to function
NOTE IEC 60204–1:1997, 9.2.5.8 gives provisions on enabling devices.
3.26.3
hold-to-run control device
control device which initiates and maintains hazardous machine functions only as long as the manual control
(actuator) is actuated
3.26.4
two-hand control device
control device which requires at least simultaneous actuation by both hands in order to initiate and to maintain
hazardous machine functions, thus providing a protective measure only for the person who actuates it
NOTE ISO 13851 gives detailed provisions.
3.26.5
sensitive protective equipment (SPE)
equipment for detecting persons or parts of persons which generates an appropriate signal to the control
system to reduce risk to the persons detected. The signal may be generated when a person or part of a
person goes beyond a predetermined limit – e.g. enters a hazard zone – (tripping) or while a person is
detected in a predetermined zone (presence sensing), or in both cases
3.26.6
active opto-electronic protective device (AOPD)
device whose sensing function is performed by opto-electronic emitting and receiving elements detecting the
interruption of optical radiation, generated within the device, by an opaque object present in the specified
detection zone
ISO 12100-1:2003(E)
NOTE IEC 61496-2 gives detailed provisions.
3.26.7
mechanical restraint device
device which introduces into a mechanism a mechanical obstacle (e.g. wedge, spindle, strut, scotch) which,
by virtue of its own strength, can prevent any hazardous movement
3.26.8
limiting device
device which prevents a machine or hazardous machine condition(s) from exceeding a designed limit
(e.g.space limit, pressure limit, load moment limit)
3.26.9
limited movement control device
control device, a single actuation of which, together with the control system of the machine, permits only a
limited amount of travel of a machine element
3.27
impeding device
any physical obstacle – e. g. low barrier, rail – which, without totally preventing access to a hazard zone,
reduces the probability of access to this zone by offering an obstruction to free access
3.28
safety function
function of a machine whose failure can result in an immediate increase of the risk(s)
3.29
unexpected start-up
unintended start-up
any start-up which, because of its unexpected nature, generates a hazard. This can be caused by, e. g.:
 a start command which is the result of a failure in, or an external influence on, the control system;
 a start command generated by inopportune action on a start control or other parts of the machine as, e. g.,
a sensor or a power control element;
 restoration of the power supply after an interruption;
 external / internal influences (e.g. gravity, wind, self-ignition in internal combustion engines) on parts of
the machine
NOTE Machine start-up during normal sequence of an automatic cycle is not unintended, but can be considered to be
unexpected from the point of view of the operator. Prevention of accidents in this case involves the use of safeguarding
measures (see ISO 12100-2:2003, clause 5).
[from ISO 14118:2000, 3.2]
3.30
failure to danger
any malfunction in the machinery, or in its power supply, that increases the risk
3.31
fault
the state of an item characterized by inability to perform a required function, excluding the inability during
preventive maintenance or other planned actions, or due to lack of external resources
NOTE 1 A fault is often the result of a failure of the item itself, but may exist without prior failure.
6 © ISO 2003 – All rights reserved

ISO 12100-1:2003(E)
[IEV 191-05-01]
NOTE 2 In the field of machinery, the English term 'fault' is commonly used in accordance with the definition in IEV 191-
05-01, whereas the French term "défaut" and the German term "Fehler" are used rather than the terms "panne" and
"Fehlzustand" that appear in the IEV with this definition.
NOTE 3 In practice, the terms "fault" and "failure" are often used synonymously.
3.32
failure
the termination of the ability of an item to perform a required function
NOTE 1 After failure, the item has a fault.
NOTE 2 "Failure" is an event, as distinguished from "fault", which is a state.
NOTE 3 The concept as defined does not apply to items consisting of software only.
[IEV 191-04-01]
3.33
common cause failures
failures of different items, resulting from a single event, where these failures are not consequences of each
other
NOTE Common cause failures should not be confused with common mode failures.
[IEV 191-04-23]
3.34
common mode failures
failures of items characterized by the same fault mode
NOTE Common mode failures should not be confused with common cause failures, as the common mode failures may
result from different causes.
[IEV 191-04-24]
3.35
emergency situation
hazardous situation needing to be urgently ended or averted
NOTE An emergency situation may arise :
 during normal operation of the machine (e.g. due to human interaction, or as a result from external influences);
 as a consequence of a malfunction or a failure of any part of the machine.
3.36
emergency operation
all actions and functions intended to end or avert an emergency situation
3.37
emergency stop
function which is intended:
 to avert arising or to reduce existing hazards to persons, damage to machinery or to work in progress;
 to be initiated by a single human action
ISO 12100-1:2003(E)
NOTE ISO 13850 gives detailed provisions.
3.38
emission value
numerical value quantifying an emission generated by a machine (e.g. noise, vibration, hazardous substances,
radiation)
NOTE 1 Emission values are part of the information on the properties of a machine and are used as a basis for risk
assessment.
NOTE 2 The term “emission value” should not be confused with “exposure value” which quantifies the exposure of
persons to emissions when the machine is in use. Exposure values can be estimated using the emission values.
NOTE 3 Emission values are preferably measured and their associated uncertainties determined by means of
standardized methods, e.g. to allow comparison between similar machines.
3.39
comparative emission data
set of emission values of similar machines collected for the purpose of comparison
NOTE For noise comparison, see ISO 11689.
4 Hazards to be taken into account when designing machinery
4.1 General
The purpose of this clause is to provide a description of basic hazards with a view to assisting the designer in
identifying the relevant and significant hazards which the machine under consideration can generate and the
hazards associated with the environment in which the machine is intended to be used (see also 5.3).
NOTE See ISO 14121:1999, annex A for a more detailed list of possible hazards and hazardous situations related to
machinery.
4.2 Mechanical hazard
4.2.1 Mechanical hazards associated with a machine, machine parts or surfaces, tools, workpieces, loads,
or projected solid or fluid materials can result in:
 crushing;
 shearing;
 cutting or severing;
 entanglement;
 drawing-in or trapping;
 impact;
 stabbing or puncture;
 friction or abrasion;
—  high pressure fluid injection (ejection hazard).
8 © ISO 2003 – All rights reserved

ISO 12100-1:2003(E)
4.2.2 The mechanical hazards which can be generated by a machine, machine parts (including work
material holding mechanisms), workpieces or loads are conditioned, among other factors, by:
 shape (cutting elements, sharp edges, angular parts, even if they are motionless);
 relative location, which can create crushing, shearing, entanglement zones when elements are moving;
 stability against overturning (considering kinetic energy);
 mass and stability (potential energy of elements which can move under the effect of gravity);
 mass and velocity (kinetic energy of elements in controlled or uncontrolled motion);
 acceleration/deceleration;
 inadequate mechanical strength, which can generate hazardous breakages or bursts;
 potential energy of elastic elements (springs), or of liquids or gases under pressure or vacuum;
 working environment.
4.3 Electrical hazard
This hazard can cause injury or death from electric shock, or burn; these can be caused by:
 contact of persons with:
 live parts, i.e. conductors or conductive parts intended to be energized in normal operation (direct
contact);
 parts which have become live under fault conditions, especially as a result of an insulation failure
(indirect contact);
 approach of persons to live parts, especially in the range of high voltage;
 insulation not suitable for reasonably foreseeable conditions of use;
 electrostatic phenomena such as contact of persons with charged parts;
 thermal radiation;
 phenomena such as projection of molten particles or chemical effects from short-circuits or overloads.
It can also cause falls of persons (or of objects dropped by persons) as a result of the surprise caused by
electric shock.
4.4 Thermal hazard
Thermal hazard can result in:
 burns and scalds from contact with objects or materials with an extreme temperature, flames or
explosions and radiation from heat sources;

health-damaging effects generated by hot or cold work environment.
ISO 12100-1:2003(E)
4.5 Hazard generated by noise
Noise can result in:
 permanent hearing loss;
 tinnitus;
 tiredness, stress;
 other effects such as loss of balance, loss of awareness;
 impairment of speech communication or of the perception of acoustic signals.
4.6 Hazards generated by vibration
Vibration can be transmitted to the whole body (use of mobile equipment) and particularly to hands and arms
(use of hand-held and hand-guided machines).
The most severe vibration (or less severe vibration over a long time) may generate serious disorders (low-
back morbidity and trauma of the spine), severe discomfort resulting from whole-body vibration and vascular
disorders, e.g. white-finger disease, neurological, osteo-articular disorders, resulting from hand-arm vibration.
4.7 Hazards generated by radiation
These hazards, which can have immediate effects (e.g. burns) or long-term effects (e.g. genetic mutations),
are produced by a variety of sources and can be generated by non-ionizing or ionizing radiation:
 electromagnetic fields (e.g. in the low frequency, radio frequency, micro-wave ranges);
 infra-red light, visible light and ultra-violet light;
 laser radiation;
 X and γ rays;
 α, β rays, electron or ion beams, neutrons.
4.8 Hazards generated by materials and substances
Materials and substances processed, used, produced or exhausted by machinery, and materials used to
construct machinery can generate several different hazards:
 hazards resulting from ingestion, contact with the skin, eyes and mucous membranes or inhalation of
fluids, gases, mists, fumes, fibres, dusts or aerosols, having, e.g. a harmful, toxic, corrosive, teratogenic,
carcinogenic, mutagenic, irritant or sensitizing effect;
 fire and explosion hazards;
 biological (e.g. mould) and micro-biological (viral or bacterial) hazards.
4.9 Hazards generated by neglecting ergonomic principles in machine design
Mismatch of machinery with human characteristics and abilities can show itself by:
 physiological effects (e.g. musculo-skeletal disorders) resulting, e.g. from unhealthy postures, excessive
or repetitive efforts;
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ISO 12100-1:2003(E)
 psycho-physiological effects generated by, e.g. mental overload or underload, or stress, arising from the
operation, supervision or maintenance of a machine within the limits of its intended use;
 human errors.
4.10 Slipping, tripping and falling hazards
Neglecting the surface of the floorings and access means may result in injuries from slips, trips or falls.
4.11 Hazard combinations
Some individual hazards which seem to be minor can, when combined with each other, be equivalent to a
significant hazard.
4.12 Hazards associated with the environment in which the machine is used
Where a machine is designed to operate under environmental conditions which can result in hazards (e.g.
temperature, wind, snow, lightning) these hazards shall be taken into account.
5 Strategy for risk reduction
5.1 General provisions
5.1.1 It is assumed that, when present on machinery, a hazard will sooner or later lead to harm if no
protective measure(s) is (are) taken.
5.1.2 Protective measures are a combination of the measures taken by the designer and the user (see
figure 1). Measures which can be incorporated at the design stage are preferable to and generally more
effective than those which are implemented by the user.
5.1.3 Taking into account the experience of users of similar machines and whenever practicable, an
exchange of information with the potential users, the designer shall take the following actions, in the order
indicated below (see figure 2):
 specify the limits and the intended use of the machine (see 5.2);
 identify the hazards and associated hazardous situations (see clause 4 and 5.3);
 estimate the risk, for each identified hazard and hazardous situation (see 5.3);
 evaluate the risk and take decisions about the need for risk reduction (see 5.3);
 eliminate the hazard or reduce the risk associated with the hazard by protective measures (see 5.4 and
5.5);
The first four above indents are related to risk assessment, on which detailed information can be found in
ISO 14121.
5.1.4 The objective to be met is the greatest risk reduction taking into account the four factors below. The
strategy defined above is represented by the flowchart in figure 2. The process is iterative and several
successive applications may be necessary to reduce the risk, making the best use of available technology.
In carrying out this process, it is necessary to take into account in the following order of preference:
 the safety of the machine during all the phases of its lifecycle;
ISO 12100-1:2003(E)
 the ability of the machine to perform its function;
 the usability of the machine;

the manufacturing, operational and dismantling costs of the machine.
NOTE 1 The ideal application of these principles requires knowledge of the use of the machine, the accident history
and health records, available risk reduction techniques, the legal framework in which the machine is to be used.
NOTE 2 A machine design which is acceptable at a particular time may no longer be justifiable when technological
development allows the design of an equivalent machine with lower risk.
5.1.5 For the continued safe operation of a machine, it is important that the protective measures allow its
easy use and do not hinder its intended use. Not doing this could lead to protective measures being by-
passed in order to achieve maximum utility of the machine.
5.1.6 If standardized (or other suitable) measurement methods exist for an emission, they should be used,
in conjunction with existing machinery or prototypes, to determine emission values and comparative emission
data. This makes it possible for the designer:
 to estimate the risk associated with the emissions;
 to evaluate the effectiveness of the protective measures implemented at the design stage;
 to provide potential buyers with quantitative information on emissions in the technical documentation;
 to provide users with quantitative information on emissions in the information for use.
Hazards other than emissions that are described by measurable parameters can be dealt with in a similar
manner.
5.2 Specification of the limits of the machine
The design of the machine begins with the specification of its limits (see also ISO 14121:1999, clause 5):
 use limits:
 the intended use of the machine, including the different machine operating modes, phases of use
and the different intervention procedures for the operators and
 the reasonably foreseeable misuse of the machine;
 space limits (e.g. range of movement, space requirements for installation and maintenance of the
machine, "operator-machine" interface, "machine-power supply" interface);

time limits: the foreseeable "life limit“ of the machine and / or of some of its components (e.g. tools, wear
parts, electrical components), taking into account its intended use.
5.3 Hazard identification, risk estimation and risk evaluation
Having identified the various hazards that can be generated by the machine (permanent hazards and those
which can appear unexpectedly: see 3.6 and clause 4), the designer shall estimate the risk for each hazard,
as far as possible on the basis of quantifiable factors, and finally decide if risk reduction (see 5.4) is required
as a result of the risk evaluation. For this purpose, the designer shall take into account the different operating
modes and intervention procedures, in particular:
a) human interaction during the whole lifecycle of the machine, as described below:
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ISO 12100-1:2003(E)
1) construction;
2) transport, assembly and installation;
3) commissioning;
4) use:
 setting, teaching/programming or process changeover;
 operation;
 cleaning;
 fault finding;
 maintenance;
5) de-commissioning, dismantling and, as far as safety is concerned, disposal;
b) possible states of the machine:
1) the machine performs the intended function (the machine operates normally);
2) the machine does not perform the intended function (i.e. it malfunctions) due to a variety of
reasons, including:
 variation of a property or of a dimension of the processed material or of the workpiece;
 failure of one (or more) of its component parts or services;
 external disturbances (e.g. shocks, vibration, electromagnetic interference);
 design error or deficiency (e.g. software errors);
 disturbance of its power supply;
 surrounding conditions (e.g. damaged floor surfaces);
c) unintended behaviour of the operator or reasonably foreseeable misuse of the machine , e.g.:
 loss of control of the machine by the operator (especially for hand-held or mobile machines);
 reflex behaviour of a person in case of malfunction, incident or failure during the use of the machine;
 behaviour resulting from lack of concentration or carelessness;
 behaviour resulting from taking the "line of least resistance" in carrying out a task;
 behaviour resulting from pressures to keep the machine running in all circumstances;
 behaviour of certain persons (e.g. children, disabled persons).
Risk estimation and evaluation have to be applied after each of the three steps of risk reduction defined in 5.4
and
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