SLOVENSKI STANDARD

SIST EN ISO 12100:2011

01-februar-2011

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SIST EN ISO 12100-1:2004
SIST EN ISO 12100-1:2004/A1:2010
SIST EN ISO 12100-2:2004
SIST EN ISO 12100-2:2004/A1:2010
SIST EN ISO 14121-1:2007

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(ISO 12100:2010)
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Safety of machinery - General principles for design - Risk assessment and risk reduction

SIST EN ISO 12100:2011

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Sicherheit von Maschinen - Allgemeine Gestaltungsleitsätze - Risikobewertung und
f41f6fa24bfd/sist-en-iso-12100-2011
Risikominderung (ISO 12100:2010)

Sécurité des machines - Principes généraux de conception - Appréciation du risque et

réduction du risque (ISO 12100:2010)

Ta slovenski standard je istoveten z: EN ISO 12100:2010

ICS:
13.110 Varnost strojev Safety of machinery

SIST EN ISO 12100:2011 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
 SIST EN ISO 12100:2011

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 SIST EN ISO 12100:2011

EUROPEAN STANDARD EN ISO 12100

NORME EUROPÉENNE
EUROPÄISCHE NORM November 2010

ICS 13.110 Supersedes EN ISO 12100-1:2003, EN ISO 12100-

2:2003, EN ISO 14121-1:2007

English Version

Safety of machinery - General principles for design - Risk

assessment and risk reduction (ISO 12100:2010)

Sécurité des machines - Principes généraux de conception Sicherheit von Maschinen - Allgemeine
- Appréciation du risque et réduction du risque (ISO Gestaltungsleitsätze - Risikobewertung und
12100:2010) Risikominderung (ISO 12100:2010)

This European Standard was approved by CEN on 9 October 2010.

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 CEN-CENELEC 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
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under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same
status as the official versions.
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CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
SIST EN
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, ISO 12100:2011
Switzerland and United Kingdom.
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EUROPEAN COMMITTEE FOR STANDARDIZATION

COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels

© 2010 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 12100:2010: E
worldwide for CEN national Members.
 SIST EN ISO 12100:2011

EN ISO 12100:2010 (E)

Contents Page

Foreword ..............................................................................................................................................................3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EC Directive 2006/42/EC ..........................................................................................4

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 SIST EN ISO 12100:2011

EN ISO 12100:2010 (E)

Foreword
This document (EN ISO 12100:2010) 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 2011, and conflicting national standards shall be withdrawn at the
latest by November 2013.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.

This document supersedes EN ISO 12100-1:2003, EN ISO 12100-2:2003, EN ISO 14121-1:2007.

This second edition cancels and replaces ISO 12100-1:2003, ISO 12100-1:2003/Amd. 1: 2009, ISO 12100-
2:2003, ISO 12100-2:2003/Amd. 1: 2009 and ISO 14121-1:2007 of which it constitutes a consolidation without
technical changes. Documentation (e.g. risk assessment, type-C standards) based on these replaced
documents need not be updated or revised.

This document has been prepared under a mandate given to CEN by the European Commission and the
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European Free Trade Association, and supports essential requirements of EU Directive(s).
(standards.iteh.ai)
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document.

According to the CEN/CENELEC Internal SISTRegulations,

EN ISO 12100:2011
the national standards organizations of the following
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countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, f41f6fa24bfd/sist-en-iso-12100-2011
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.

Endorsement notice

The text of ISO 12100:2010 has been approved by CEN as a EN ISO 12100:2010 without any modification.

3
 SIST EN ISO 12100:2011

EN ISO 12100:2010 (E)

Annex ZA
(informative)

Relationship between this European Standard and the Essential

Requirements of EC Directive 2006/42/EC

This European Standard has been prepared under a mandate given to CEN by the European Commission
[and the European Free Trade Association] to provide a means of conforming to Essential Requirements of
the New Approach Directive Machinery, 2006/42/EC.

Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the normative clauses of
this standard confers, within the limits of the scope of this standard, a presumption of conformity with the
relevant Essential Requirements of that Directive and associated EFTA regulations.

WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.

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 SIST EN ISO 12100:2011

INTERNATIONAL ISO
STANDARD 12100

First edition
2010-11-01

Safety of machinery — General principles

for design — Risk assessment and risk
reduction
Sécurité des machines — Principes généraux de conception —
Appréciation du risque et réduction du risque

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Reference number
ISO 12100:2010(E)

© ISO 2010
 SIST EN ISO 12100:2011

ISO 12100:2010(E)

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© ISO 2010
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
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 SIST EN ISO 12100:2011

ISO 12100:2010(E)

Contents Page

Foreword .............................................................................................................................................................v
Introduction........................................................................................................................................................vi
1 Scope ......................................................................................................................................................1
2 Normative references............................................................................................................................1
3 Terms and definitions ...........................................................................................................................1
4 Strategy for risk assessment and risk reduction...............................................................................9
5 Risk assessment .................................................................................................................................12
5.1 General .................................................................................................................................................12
5.2 Information for risk assessment........................................................................................................12
5.3 Determination of limits of machinery ................................................................................................13
5.3.1 General .................................................................................................................................................13
5.3.2 Use limits..............................................................................................................................................13
5.3.3 Space limits..........................................................................................................................................14
5.3.4 Time limits ............................................................................................................................................14
5.3.5 Other limits...........................................................................................................................................14
5.4 iTeh STANDARD PREVIEW
Hazard identification ...........................................................................................................................14
5.5 Risk estimation ....................................................................................................................................16
5.5.1 (standards.iteh.ai)
General .................................................................................................................................................16
5.5.2 Elements of risk...................................................................................................................................17
5.5.3 Aspects to be considered during SISTrisk
EN ISO estimation............................................................................19
12100:2011
5.6 Risk evaluation ....................................................................................................................................21
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5.6.1 General .................................................................................................................................................21
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5.6.2 Adequate risk reduction .....................................................................................................................21
5.6.3 Comparison of risks............................................................................................................................21
6 Risk reduction......................................................................................................................................22
6.1 General .................................................................................................................................................22
6.2 Inherently safe design measures.......................................................................................................23
6.2.1 General .................................................................................................................................................23
6.2.2 Consideration of geometrical factors and physical aspects ..........................................................23
6.2.3 Taking into account general technical knowledge of machine design .........................................24
6.2.4 Choice of appropriate technology .....................................................................................................25
6.2.5 Applying principle of positive mechanical action............................................................................25
6.2.6 Provisions for stability........................................................................................................................25
6.2.7 Provisions for maintainability ............................................................................................................26
6.2.8 Observing ergonomic principles .......................................................................................................26
6.2.9 Electrical hazards ................................................................................................................................27
6.2.10 Pneumatic and hydraulic hazards .....................................................................................................27
6.2.11 Applying inherently safe design measures to control systems .....................................................28
6.2.12 Minimizing probability of failure of safety functions .......................................................................33
6.2.13 Limiting exposure to hazards through reliability of equipment .....................................................33
6.2.14 Limiting exposure to hazards through mechanization or automation of loading (feeding)/
unloading (removal) operations.........................................................................................................34
6.2.15 Limiting exposure to hazards through location of setting and maintenance points outside
danger zones .......................................................................................................................................34
6.3 Safeguarding and complementary protective measures ................................................................34
6.3.1 General .................................................................................................................................................34
6.3.2 Selection and implementation of guards and protective devices..................................................35
6.3.3 Requirements for design of guards and protective devices...........................................................40
6.3.4 Safeguarding to reduce emissions....................................................................................................43

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 SIST EN ISO 12100:2011

ISO 12100:2010(E)

6.3.5 Complementary protective measures............................................................................................... 44

6.4 Information for use ............................................................................................................................. 46
6.4.1 General requirements......................................................................................................................... 46
6.4.2 Location and nature of information for use ..................................................................................... 46
6.4.3 Signals and warning devices............................................................................................................. 46
6.4.4 Markings, signs (pictograms) and written warnings....................................................................... 47
6.4.5 Accompanying documents (in particular — instruction handbook) ............................................. 48
7 Documentation of risk assessment and risk reduction.................................................................. 51
Annex A (informative) Schematic representation of a machine.................................................................. 52
Annex B (informative) Examples of hazards, hazardous situations and hazardous events .................... 53
Annex C (informative) Trilingual lookup and index of specific terms and expressions used in
ISO 12100............................................................................................................................................. 63
Bibliography ..................................................................................................................................................... 75

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 SIST EN ISO 12100:2011

ISO 12100:2010(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 was prepared by Technical Committee ISO/TC 199, Safety of machinery.

This first edition of ISO 12100 cancels and replaces ISO 12100-1:2003, ISO 12100-2:2003 and
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ISO 14121-1:2007, of which it constitutes a consolidation without technical change. It also incorporates the
Amendments ISO 12100-1:2003/Amd.1:2009 and ISO 12100-2:2003/Amd.1:2009. Documentation (e.g. risk
(standards.iteh.ai)
assessment, type-C standards) based on these replaced documents need not be updated or revised.
SIST EN ISO 12100:2011
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© ISO 2010 – All rights reserved v

 SIST EN ISO 12100:2011

ISO 12100:2010(E)

Introduction
The primary purpose of this International Standard is to provide designers with an overall framework and
guidance for decisions during the development of machinery to enable them to design machines that are safe
for their intended use. It also provides a strategy for standards developers and will assist in the preparation of
consistent and appropriate type-B and type-C standards.

The concept of safety of machinery considers the ability of a machine to perform its intended function(s)
during its life cycle where risk has been adequately reduced.

This International 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 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 (for example, safety distances, surface temperature,
noise);

⎯
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type-B2 standards on safeguards (for example, two-hand controls, interlocking devices, pressure-
sensitive devices, guards); (standards.iteh.ai)
⎯ type-C standards (machine safety standards) dealing
SIST EN with detailed safety requirements for a particular
ISO 12100:2011
machine or group of machines.
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This International Standard is a type-A standard.

When a type-C standard deviates from one or more technical provisions dealt with by this International
Standard or by a type-B standard, the type-C standard takes precedence.

It is desirable that this International Standard be referred to 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 International
Standard.

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 SIST EN ISO 12100:2011

INTERNATIONAL STANDARD ISO 12100:2010(E)

Safety of machinery — General principles for design — Risk

assessment and risk reduction

1 Scope
This International Standard specifies basic terminology, principles and a methodology for achieving safety in
the design of machinery. It specifies principles of risk assessment and risk reduction to help designers in
achieving this objective. These principles are based on knowledge and experience of the design, use,
incidents, accidents and risks associated with machinery. Procedures are described for identifying hazards
and estimating and evaluating risks during relevant phases of the machine life cycle, and for the elimination of
hazards or the provision of sufficient risk reduction. Guidance is given on the documentation and verification of
the risk assessment and risk reduction process.

This International Standard is also intended to be used as a basis for the preparation of type-B or type-C
safety standards.

It does not deal with risk and/or damage to domestic animals, property or the environment.
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NOTE 1 Annex B gives, in separate tables, examples of hazards, hazardous situations and hazardous events, in order
(standards.iteh.ai)
to clarify these concepts and assist the designer in the process of hazard identification.

NOTE 2 The practical use of a number ofSIST

methods for each
EN ISO stage of risk assessment is described in ISO/TR 14121-2.
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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.

IEC 60204-1:2005, Safety of machinery — Electrical equipment of machines — Part 1: General requirements

3 Terms and definitions

For the purposes of this document, the following terms and definitions apply.

3.1
machinery
machine
assembly, fitted with or intended to be fitted with a drive system consisting of linked parts or components, at
least one of which moves, and which are joined together for a specific application

NOTE 1 The term “machinery” also covers 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 2 Annex A provides a general schematic representation of a machine.

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 SIST EN ISO 12100:2011

ISO 12100:2010(E)

3.2
reliability
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
ability of a machine to be maintained in a state which enables it to fulfil its function under conditions of
intended use, or to be restored to such a state, with the necessary actions (maintenance) being carried out
according to specified practices and using specified means

3.4
usability
ability of a machine to be easily used owing 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 (for example, mechanical hazard, electrical
hazard) or the nature of the potential harm (for example, electric shock hazard, cutting hazard, toxic hazard, fire hazard).
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NOTE 2 The hazard envisaged by this definition either
(standards.iteh.ai)
⎯ is permanently present during the intended use of the machine (for example, motion of hazardous moving elements,
electric arc during a welding phase, unhealthy posture,
SIST ENnoise
ISO emission,
12100:2011high temperature), or
⎯ can appear unexpectedly (forhttps://standards.iteh.ai/catalog/standards/sist/d01f2e5d-eb28-48be-a422-
example, explosion, crushing hazard as a consequence of an unintended/unexpected
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start-up, ejection as a consequence of a breakage, fall as a consequence of acceleration/deceleration).

NOTE 3 The French term “phénomène dangereux” should not be confused with the term “risque”, which was
sometimes used instead in the past.

3.7
relevant hazard
hazard which is identified as being present at, or associated with, the machine

NOTE 1 A relevant hazard is identified as the result of one step of the process described in Clause 5.

NOTE 2 This term is included as basic terminology for type-B and type-C standards.

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

NOTE This term is included as basic terminology for type-B and type-C standards.

3.9
hazardous event
event that can cause harm

NOTE A hazardous event can occur over a short period of time or over an extended period of time.

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ISO 12100:2010(E)

3.10
hazardous situation
circumstance in which a person is exposed to at least one hazard

NOTE The exposure can result in harm immediately or over a period of time.

3.11
hazard zone
danger zone
any space within and/or around machinery in which a person can be exposed to a hazard

3.12
risk
combination of the probability of occurrence of harm and the severity of that harm

3.13
residual risk
risk remaining after protective measures have been implemented

NOTE 1 This International Standard distinguishes

⎯ the residual risk after protective measures have been implemented by the designer,
⎯ the residual risk remaining after all protective measures have been implemented.

NOTE 2 See also Figure 2.

3.14
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risk estimation (standards.iteh.ai)
defining likely severity of harm and probability of its occurrence

3.15 SIST EN ISO 12100:2011

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combination of the specification of the f41f6fa24bfd/sist-en-iso-12100-2011
limits of the machine, hazard identification and risk estimation

3.16
risk evaluation
judgment, on the basis of risk analysis, of whether the risk reduction objectives have been achieved

3.17
risk assessment
overall process comprising a risk analysis and a risk evaluation

3.18
adequate risk reduction
risk reduction that is at least in accordance with legal requirements, taking into consideration the current state
of the art

NOTE Criteria for determining when adequate risk reduction is achieved are given in 5.6.2.

3.19
protective measure
measure intended to achieve risk reduction, implemented

⎯ by the designer (inherently safe design, safeguarding and complementary protective measures,
information for use) and/or

⎯ by the user (organization: safe working procedures, supervision, permit-to-work systems; provision and
use of additional safeguards; use of personal protective equipment; training)

NOTE See Figure 2.

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