SIST EN ISO 14121-1:2007
Safety of machinery - Risk assessment - Part 1: Principles (ISO 14121-1:2007)
Safety of machinery - Risk assessment - Part 1: Principles (ISO 14121-1:2007)
This part of ISO 14121 establishes general principles intended to be used to meet the risk reduction objectives established in ISO 12100-1:2003, Clause 5. These principles of risk assessment bring together knowledge and experience of the design, use, incidents, accidents and harm related to machinery in order to assess the risks posed during the relevant phases of the life cycle of a machine. This part of ISO 14121 provides guidance on the information that will be required to enable risk assessment to be carried out. Procedures are described for identifying hazards and estimating and evaluating risk. It also gives guidance on the making of decisions relating to the safety of machinery and on the type of documentation required to verify the risk assessment carried out. It is not applicable to risks posed to domestic animals, property or the environment.
Sicherheit von Maschinen - Risikobeurteilung - Teil 1: Leitsätze (ISO 14121-1:2007)
Dieser Teil von ISO 14121 stellt allgemeine Leitsätze auf, die genutzt werden können, um die in ISO 12100 1:2003, Abschnitt 5, festgelegten Ziele zur Risikominderung zu erreichen. Diese Leitsätze zur Risikobeurteilung tragen Kenntnisse und Erfahrungen über die Konstruktion, den Einsatz, das Zwischenfall- und Unfallgeschehen sowie über Schäden im Zusammenhang mit Maschinen zusammen, um in den relevanten Phasen der Lebensdauer einer Maschine dargestellte Risiken beurteilen zu können.
Dieser Teil von ISO 14121 gibt eine Anleitung über die Informationen, die für die Durchführung einer Risikobeurteilung notwendig sind. Es werden Verfahren zur Identifizierung von Gefährdungen sowie zur Risikoeinschätzung und bewertung beschrieben.
Dieser Teil von ISO 14121 stellt außerdem eine Handlungshilfe für Entscheidungen bereit, die im Zusammenhang mit der Sicherheit von Maschinen zu treffen sind, sowie zur Art der Dokumentation, anhand derer die vorgenommene Risikobeurteilung nachzuweisen ist.
Dieser Teil von ISO 14121 ist nicht anwendbar auf Risiken in Bezug auf Haustiere, Eigentum oder die Umwelt.
Sécurité des machines - Appréciation du risque - Partie 1: Principes (ISO 14121-1:2007)
L'ISO 14121-1:2007 établit les principes généraux utiles pour atteindre les objectifs de réduction du risque spécifiés dans l'ISO 12100-1:2003, Article 5. Ces principes généraux sont dénommés appréciation du risque par laquelle la connaissance et l'expérience de la conception, de l'utilisation, des incidents, des accidents et des dommages liés à la machine sont rassemblées dans le but d'apprécier les risques au cours de toutes les phases de la vie de la machine.
L'ISO 14121-1:2007 donne des indications sur l'information nécessaire pour permettre d'effectuer l'appréciation du risque. Elle décrit des procédures d'identification des phénomènes dangereux et d'estimation et d'évaluation des risques. Elle donne également des conseils sur les décisions à prendre en matière de sécurité des machines et sur le type de documentation nécessaire pour vérifier l'appréciation du risque qui a été menée.
Elle ne traite pas des risques de préjudices causés aux animaux, aux biens ou à l'environnement.
Varnost strojev - Ocena tveganja - 1. del: Načela (ISO 14121-1:2007)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 14121-1:2007
01-november-2007
9DUQRVWVWURMHY2FHQDWYHJDQMDGHO 1DþHOD ,62
Safety of machinery - Risk assessment - Part 1: Principles (ISO 14121-1:2007)
Sicherheit von Maschinen - Risikobeurteilung - Teil 1: Leitsätze (ISO 14121-1:2007)
Sécurité des machines - Appréciation du risque - Partie 1: Principes (ISO 14121-1:2007)
Ta slovenski standard je istoveten z: EN ISO 14121-1:2007
ICS:
13.110 Varnost strojev Safety of machinery
SIST EN ISO 14121-1:2007 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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EUROPEAN STANDARD
EN ISO 14121-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2007
ICS 13.110 Supersedes EN 1050:1996
English Version
Safety of machinery - Risk assessment - Part 1: Principles (ISO
14121-1:2007)
Sécurité des machines - Appréciation du risque - Partie 1: Sicherheit von Maschinen - Risikobeurteilung - Teil 1:
Principes (ISO 14121-1:2007) Leitsätze (ISO 14121-1:2007)
This European Standard was approved by CEN on 4 August 2007.
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 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 CEN Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, 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
© 2007 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14121-1:2007: E
worldwide for CEN national Members.
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EN ISO 14121-1:2007 (E)
Contents Page
Foreword.3
2
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EN ISO 14121-1:2007 (E)
Foreword
This document (EN ISO 14121-1:2007) 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 March 2008, and conflicting national standards shall be withdrawn at
the latest by March 2008.
This document supersedes EN 1050:1996.
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).
For relationship with EC Directive(s), see informative Annex ZA and 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, Bulgaria, Cyprus, Czech
Republic, Denmark, Estonia, Finland, 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 14121-1:2007 has been approved by CEN as a EN ISO 14121-1:2007 without any
modification.
3
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EN ISO 14121-1:2007 (E)
Annex ZA
(informative)
Relationship between this International Standard and the Essential Requirements of
EU Directive 98/37/EC, amended by Directive 98/79/EC
This International 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 98/37/EC, Machinery, amended by Directive 98/79/EC.
Once this standard is cited in the Official Journal of the European Communities 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 EC Directives may be applicable to the product(s) falling within
the scope of this standard.
4
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EN ISO 14121-1:2007 (E)
Annex ZB
(informative)
Relationship between this International Standard and the Essential Requirements of
EU Directive 2006/42/EC
This International Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide one means of conforming to Essential Requirements of
the New Approach Directive 2006/42/EC on machinery.
Once this standard is cited in the Official Journal of the European Communities 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.
5
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INTERNATIONAL ISO
STANDARD 14121-1
First edition
2007-09-01
Safety of machinery — Risk
assessment —
Part 1:
Principles
Sécurité des machines — Appréciation du risque —
Partie 1: Principes
Reference number
ISO 14121-1:2007(E)
©
ISO 2007
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ISO 14121-1:2007(E)
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ii © ISO 2007 – All rights reserved
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ISO 14121-1:2007(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 1
4 General principles. 4
4.1 Basic concepts. 4
4.2 Information for risk assessment . 5
5 Determination of limits of machinery . 6
5.1 General. 6
5.2 Use limits . 7
5.3 Space limits . 7
5.4 Time limits . 7
5.5 Other limits . 8
6 Hazard identification. 8
7 Risk estimation . 9
7.1 General. 9
7.2 Elements of risk . 9
7.3 Aspects to be considered during risk estimation . 12
8 Risk evaluation. 13
8.1 General. 13
8.2 Achievement of adequate risk reduction . 14
8.3 Comparison of risks . 15
9 Documentation. 15
Annex A (informative) Examples of hazards, hazardous situations and hazardous events. 16
Bibliography . 28
© ISO 2007 – All rights reserved iii
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ISO 14121-1:2007(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 14121-1 was prepared by Technical Committee ISO/TC 199, Safety of machinery.
This first edition of ISO 14121-1 cancels and replaces ISO 14121:1999, of which it constitutes a technical
revision.
ISO 14121 consists of the following parts, under the general title Safety of machinery — Risk assessment:
⎯ Part 1: Principles
⎯ Part 2: Practical guidance and examples of methods [Technical Report]
iv © ISO 2007 – All rights reserved
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ISO 14121-1:2007(E)
Introduction
The structure of safety standards in the field of machinery is as follows.
a) Type-A standards (basic standards) give basic concepts, principles for design, and general aspects that
can be applied to machinery.
b) Type-B standards (generic safety standards) deal with one or more safety aspect(s) or one or more
type(s) of safeguards 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-hands controls, interlocking devices, pressure sensitive
devices, guards).
c) Type-C standards (machine safety standards) deal with detailed safety requirements for a particular
machine or group of machines.
This part of ISO 14121 is a type-A standard as stated in ISO 12100-1.
When provisions of a type-C standard are different from those which are stated in type-A or type-B standards,
the provisions of the type-C standard take precedence over the provisions of the other standards for machines
that have been designed and built according to the provisions of the type-C standard.
The purpose of this type-A standard is to describe principles for a consistent systematic procedure for risk
assessment as stated in ISO 12100-1:2003, Clause 5.
This part of ISO 14121 gives guidance for decisions related to the design of machinery and will assist in the
preparation of consistent and appropriate type-B and type-C standards, so that machines can be produced that
are safe for their intended use in accordance with the methodology given in ISO 12100.
Annex A gives, in separate tables, examples of hazards, hazardous situations and hazardous events, so as to
clarify these concepts and assist the designer in the process of hazard identification.
The practical use of a number of methods for each stage of risk assessment is described ISO/TR 14121-2,
which also gives some guidance on how the selection of protective measures (in accordance with ISO 12100)
can reduce the different elements of risk in relation to Figure 2 of this part of ISO 14121.
This part of ISO 14121 can be incorporated in training courses and manuals where appropriate to give basic
instruction on risk assessment.
© ISO 2007 – All rights reserved v
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INTERNATIONAL STANDARD ISO 14121-1:2007(E)
Safety of machinery — Risk assessment —
Part 1:
Principles
1 Scope
This part of ISO 14121 establishes general principles intended to be used to meet the risk reduction objectives
established in ISO 12100-1:2003, Clause 5. These principles of risk assessment bring together knowledge
and experience of the design, use, incidents, accidents and harm related to machinery in order to assess the
risks posed during the relevant phases of the life cycle of a machine.
This part of ISO 14121 provides guidance on the information that will be required to enable risk assessment to
be carried out. Procedures are described for identifying hazards and estimating and evaluating risk.
It also gives guidance on the making of decisions relating to the safety of machinery and on the type of
documentation required to verify the risk assessment carried out.
It is not applicable to risks posed 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 12100-1:2003, Safety of machinery — Basic concepts, general principles for design — Part 1: Basic
terminology, methodology
ISO 12100-2:2003, Safety of machinery — Basic concepts, general principles for design — Part 2: Technical
principles and specifications
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
harm
physical injury or damage to health
[ISO 12100-1:2003, definition 3.5]
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ISO 14121-1:2007(E)
3.2
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 can 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)
[ISO 12100-1:2003, definition 3.6]
3.3
hazard zone
danger zone
any space within and/or around machinery in which a person can be exposed to a hazard
[ISO 12100-1:2003, definition 3.10]
3.4
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.
3.5
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.
[ISO 12100-1:2003, definition 3.9]
3.6
intended use of a machine
use of a machine in accordance with the information provided in the instructions for use
[ISO 12100-1:2003, definition 3.22]
3.7
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
NOTE 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.
[ISO 12100-1:2003, definition 3.1]
3.8
malfunction
failure of a machine to perform an intended function
NOTE For examples, see ISO 12100-1:2003, 5.3 b), item 2).
2 © ISO 2007 – All rights reserved
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ISO 14121-1:2007(E)
3.9
protective measure
measure intended to achieve risk reduction
NOTE 1 It is implemented:
⎯ by the designer (inherently safe design, safeguarding and complementary protective measures, information for use);
⎯ 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 2 See ISO 12100-1:2003, Figure 1.
[ISO 12100-1:2003, definition 3.18]
3.10
reasonably foreseeable misuse
use of a machine in a way not intended by the designer, but which may result from readily predictable human
behaviour
[ISO 12100-1:2003, definition 3.23]
3.11
residual risk
risk remaining after protective measures have been taken
NOTE See ISO 12100-1:2003, Figure 1.
[ISO 12100-1:2003, definition 3.12]
3.12
risk
combination of the probability of occurrence of harm and the severity of that harm
[ISO 12100-1:2003, definition 3.11]
3.13
risk analysis
combination of the specification of the limits of the machine, hazard identification and risk estimation
[ISO 12100-1:2003, definition 3.14]
3.14
risk assessment
overall process comprising a risk analysis and a risk evaluation
[ISO 12100-1:2003, definition 3.13]
3.15
risk estimation
definition of likely severity of harm and probability of its occurrence
[ISO 12100-1:2003, definition 3.15]
3.16
risk evaluation
judgement, on the basis of risk analysis, of whether the risk reduction objectives have been achieved
[ISO 12100-1:2003, definition 3.16]
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ISO 14121-1:2007(E)
3.17
task
specific activity performed by one or more persons on or in the vicinity of the machine during its lifecycle
4 General principles
4.1 Basic concepts
Risk assessment is a series of logical steps to enable, in a systematic way, the analysis and evaluation of the
risks associated with machinery. Risk assessment is followed, whenever necessary, by risk reduction as
described in ISO 12100-1:2003, Clause 5. Iteration of this process can be necessary to eliminate hazards as
far as practicable and to adequately reduce risks by the implementation of protective measures.
Risk assessment includes the following (see Figure 1):
a) risk analysis:
1) determination of the limits of the machinery (see Clause 5);
2) hazard identification (see Clause 6);
3) risk estimation (see Clause 7);
b) risk evaluation (see Clause 8).
Risk analysis provides information required for the risk evaluation, which in turn allows judgements to be
made about whether or not risk reduction is required.
These judgments shall be supported by a qualitative, or where appropriate, a quantitative, estimate of the risk
associated with the hazards present on the machinery
NOTE A quantitative approach can be appropriate when useful data is available. However, a quantitative approach is
restricted by the useful data that are available and/or the limited resources of those conducting the risk assessment.
Therefore, in many applications, only qualitative risk estimation will be possible.
The risk assessment shall be conducted so that it is possible to document the procedure that has been
followed and the results that have been achieved (see Clause 9).
4 © ISO 2007 – All rights reserved
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ISO 14121-1:2007(E)
Figure 1 — Iterative process for reducing risk
4.2 Information for risk assessment
The information for risk assessment should include the following:
a) related to machinery description:
1) user specifications;
2) anticipated machinery specifications, including
i) description of the various phases of the whole life cycle of the machinery,
ii) design drawings or other means of establishing the nature of the machinery, and
iii) required energy sources and how they are supplied;
© ISO 2007 – All rights reserved 5
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ISO 14121-1:2007(E)
3) documentation on previous designs of similar machinery, if relevant;
4) information for use of the machinery, as available;
b) related to regulations, standards and other applicable documents:
1) applicable regulations;
2) relevant standards;
3) relevant technical specifications;
4) safety data sheets;
c) related to experience of use:
1) any accident, incident or malfunction history of the actual or similar machinery;
2) the history of damage to health resulting, for example, from emissions (noise, vibration, dust, fumes,
etc.), chemicals used or materials processed by the machinery.
NOTE An incident that has occurred and resulted in harm can be referred to as an “accident”, whereas an
incident that has occurred and that did not result in harm can be referred to as a “near miss” or “dangerous
occurrence”.
d) Relevant ergonomic principles (see ISO 12100-2:2003, 4.8).
The information shall be updated as the design develops or when modifications to the machine are required.
Comparisons between similar hazardous situations associated with different types of machinery are often
possible, provided that sufficient information about hazards and accident circumstances in those situations is
available.
The absence of an accident history, a small number of accidents or low severity of accidents should not be
taken as a presumption of a low risk.
For quantitative analysis, data from data bases, handbooks, laboratories or manufacturers’ specifications may
be used, provided that there is confidence in the suitability of the data. Uncertainty associated with these data
shall be indicated in the documentation (see Clause 9).
5 Determination of limits of machinery
5.1 General
Risk assessment begins with the determination of the limits of the machinery, taking into account all the
phases of the machinery life. This means that the characteristics and performances of the machine or a series
of machines in an integrated process, and the related people, environment and products, should be identified
in terms of the limits of machinery as given in 5.2 to 5.6.
6 © ISO 2007 – All rights reserved
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ISO 14121-1:2007(E)
5.2 Use limits
Use limits includes the intended use and the reasonably foreseeable misuse. Aspects to be taken into account
include the following:
a) the different machine operating modes and the different intervention procedures for the users (including
interventions required by malfunctions of the machine use);
b) the use of the machinery (e.g. industrial, non-industrial and domestic) by persons identified by sex, age,
dominant hand usage, or limiting physical abilities (e.g. visual or hearing impairment, size, strength) — if
specific information is not available, the manufacturer should take into account general information about
the intended user population (e. g. appropriate anthropometric data);
c) the anticipated levels of training, experience or ability of users such as
1) operators,
2) maintenance personnel or technicians,
3) trainees and apprentices, and
4) the general public;
d) exposure of other persons to the hazards associated with the machinery where it can be reasonably
foreseen, including
1) operators working in the vicinity, e.g. operators of adjacent machinery (i.e. persons likely to have a
good awareness of the specific hazards),
2) non-operator employees in the vicinity, e.g. administration staff (i.e. persons with little awareness of
specific hazards but likely to have a good awareness of site safety procedures, authorized routes
etc.), and
3) non-employees in the vicinity, e.g. visitors (i.e. persons likely to have very little awareness of the
machine hazards or the site safety procedures), members of the public including children, where
applicable.
5.3 Space limits
Aspects to be taken into account include
a) range of movement;
b) space requirements for persons to interact with the machine, e.g. during operation and maintenance;
c) human interaction, e.g. “operator-machine” interface; and
d) “machine-power supply” interface.
5.4 Time limits
Aspects to be taken into account include
a) the “life limit” of the machinery and/or of some of its components (e.g. tooling, parts that can wear,
electromechanical components), taking into account its intended use and reasonably foreseeable misuse;
and
b) recommended service intervals.
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ISO 14121-1:2007(E)
5.5 Other limits
Examples of other limits:
a) environmental — recommended minimum and maximum temperatures, whether the machine can be
operated indoors or outdoors, in dry or wet weather, in direct sunlight, tolerance to dust and wet, etc.;
b) housekeeping — level of cleanliness required;
c) properties of the material(s) to be processed.
6 Hazard identification
Following the determination of the limits of the machinery (see Clause 5), the essential step in any machine
risk assessment is the systematic identification of reasonably foreseeable hazards, hazardous situations
and/or hazardous events during all phases of the machine life cycle, i.e.:
a) transport, assembly and installation;
b) commissioning;
c) use;
d) de-commissioning, dis
...
SLOVENSKI oSIST prEN ISO 14121-1:2006
PREDSTANDARD
januar 2006
Varnost strojev – Ocena tveganja – 1. del: Načela (ISO/DIS 14121-1:2005)
(istoveten prEN ISO 14121-1:2005)
Safety of machinery - Risk assessment - Part 1: Principles (ISO/DIS 14121-1:2005)
ICS 13.110 Referenčna številka
oSIST prEN ISO 14121-1:2006(en)
© Standard je založil in izdal Slovenski inštitut za standardizacijo. Razmnoževanje ali kopiranje celote ali delov tega dokumenta ni dovoljeno
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EUROPEAN STANDARD
DRAFT
prEN ISO 14121-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2005
ICS Will supersede EN 1050:1996
English Version
Safety of machinery - Risk assessment - Part 1: Principles
(ISO/DIS 14121-1:2005)
Sécurité des machines - Appréciation du risque - Partie 1:
Principes (ISO/DIS 14121-1:2005)
This draft European Standard is submitted to CEN members for parallel enquiry. It has been drawn up by the Technical Committee
CEN/TC 114.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN 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, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to
provide supporting documentation.
: This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
Warning
shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2005 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN ISO 14121-1:2005: E
worldwide for CEN national Members.
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prEN ISO 14121-1:2005 (E)
Foreword
This document (prEN ISO 14121-1:2005) 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 document is currently submitted to the parallel Enquiry.
This document will supersede EN 1050:1996.
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 ZA, which is an integral part of
this document.
Endorsement notice
The text of ISO 14121-1:2005 has been approved by CEN as prEN ISO 14121-1:2005 without
any modifications.
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prEN ISO 14121-1:2005 (E)
ANNEX ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 98/37 EEC
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 98/37 EEC.
Once this standard is cited in the Official Journal of the European Communities 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 given in Table ZA. confers, within the
limits of the scope of this standard, a presumption of conformity with the corresponding
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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DRAFT INTERNATIONAL STANDARD ISO/DIS 14121-1
ISO/TC 199 Secretariat: DIN
Voting begins on: Voting terminates on:
2005-09-29 2006-03-01
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION • МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ • ORGANISATION INTERNATIONALE DE NORMALISATION
Safety of machinery — Risk assessment —
Part 1:
Principles
Sécurité des machines — Appréciation du risque —
Partie 1: Principes
(Revision of ISO 14121:1999)
ICS 13.110
ISO/CEN PARALLEL ENQUIRY
The CEN Secretary-General has advised the ISO Secretary-General that this ISO/DIS covers a subject
of interest to European standardization. In accordance with the ISO-lead mode of collaboration as
defined in the Vienna Agreement, consultation on this ISO/DIS has the same effect for CEN
members as would a CEN enquiry on a draft European Standard. Should this draft be accepted, a
final draft, established on the basis of comments received, will be submitted to a parallel two-month FDIS
vote in ISO and formal vote in CEN.
To expedite distribution, this document is circulated as received from the committee secretariat.
ISO Central Secretariat work of editing and text composition will be undertaken at publication
stage.
Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du
secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au
Secrétariat central de l'ISO au stade de publication.
THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHANGE AND MAY NOT BE
REFERRED TO AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN NATIONAL REGULATIONS.
© International Organization for Standardization, 2005
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ISO/DIS 14121-1
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©
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ISO/DIS 14121-1
Contents Page
Foreword .iv
Introduction.v
1 Scope.1
2 Normative references.1
3 Terms and definitions .1
4 General principles .3
4.1 Basic concepts .3
4.2 Information for risk assessment.5
5 Determination of the limits of the machinery .6
6 Hazard identification .7
7 Risk estimation.8
7.1 General .8
7.2 Elements of risk.8
7.3 Aspects to be considered during risk estimation.11
8 Risk evaluation .13
8.1 General .13
8.2 Achievement of adequate risk reduction.13
8.3 Comparison of risks.14
9 Documentation .15
Annex A (informative) Examples of hazards, hazardous situations and hazardous events.16
A.1 General.16
A.2 Examples of hazards.16
A.3 Examples of hazardous situations .21
A.4 Examples of hazardous events.23
Annex ZA (informative) Relationship between this International Standard and the Essential
Requirements of EU Directive 98/37/EC.26
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ISO/DIS 14121-1
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 14121-1 was prepared by Technical Committee ISO/TC 199, Safety of machinery and by Technical
Committee CEN/TC 114, Safety of machinery in collaboration.
This second edition is foreseen to cancel and replace ISO 14121:1999 which has been technically revised.
ISO 14121 consists of the following parts, under the general title Safety of machinery — Risk assessment:
⎯ Part 1: Principles
⎯ Part 2: Practical guidance and examples of methods (Technical Report in preparation):
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ISO/DIS 14121-1
Introduction
The function of this type A standard is to describe principles for a consistent systematic procedure for risk
assessment as introduced in ISO 12100-1:2003, Clause 5.
This International Standard gives guidance for decisions during the design of machinery and will assist in the
preparation of consistent and appropriate type B and type C standards in order to produce machines that are
safe for their intended use in accordance with the methodology in ISO 12100.
The principles and methods given in this International Standard may also be applied to existing machinery.
This International Standard gives in Annex A, in separate tables, examples of hazards, hazardous situations
and hazardous events, in order to clarify these concepts and assist the designer in the process of hazard
identification.
The practical use of a number of methods for each stage of risk assessment is described in a Technical Report
related to this International Standard. ISO/TR 14121-2 also provides practical guidance on risk reduction (in
accordance with ISO 12100) for machinery, giving some guidance on the selection of appropriate protective
measures to achieve adequate risk reduction.
It is recommended that this International Standard is incorporated in training courses and manuals to give
basic instruction on design methods.
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DRAFT INTERNATIONAL STANDARD ISO/DIS 14121-1
Safety of machinery — Risk assessment —
Part 1:
Principles
1 Scope
This International Standard establishes general principles useful in reaching the risk reduction objectives
established in ISO 12100-1:2003, Clause 5. These general principles are known as risk assessment by which
the knowledge and experience of the design, use, incidents, accidents and harm related to machinery is
brought together in order to assess the risks during all phases of the life of the machinery.
This International Standard gives guidance on the information required to allow risk assessment to be carried
out. Procedures are described for identifying hazards and estimating and evaluating risk.
The purpose of this International Standard is to provide guidance for decisions to be made on the safety of
machinery and guidance on the type of documentation required to verify the risk assessment carried out.
This International 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 12100-1: 2003, Safety of machinery – Basic concepts, general principles for design – Part 1: Basic
terminology, methodology
ISO 12100-2: 2003, Safety of machinery – Basic concepts, general principles for design – Part 2: Technical
principles and specifications
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
harm
physical injury or damage to health
[ISO 12100-1: 2003, 3.5]
3.2
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 can appear unexpectedly (e.g. explosion, crushing hazard as a consequence of an uninten-
ded/ unexpected start-up, ejection as a consequence of a breakage, fall as a consequence of acceleration/ deceleration)
[ISO 12100-1: 2003, 3.6]
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ISO/DIS 14121-1
3.3
hazard zone
danger zone
any space within and/or around machinery in which a person can be exposed to a hazard
[ISO 12100-1: 2003, 3.10]
3.4
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.
3.5
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
[ISO 12100-1: 2003, 3.9]
3.6
intended use of a machine
use of a machine in accordance with the information provided in the instructions for use
[ISO 12100-1: 2003, 3.22]
3.7
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 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.
[ISO 12100-1: 2003, 3.1]
3.8
malfunction
failure of performing the intended function by machine
NOTE For examples see ISO 12100-1:2003, 5.2.3.
3.9
protective measure
measure intended to achieve risk reduction, implemented:
– by the designer (inherent design, safeguarding and complementary protective measures, information for
use) and
– by the user (organisation: safe working procedures, supervision, permit-to-work systems; provision and use
of additional safeguards; use of personal protective equipment; training)
NOTE See ISO 12100-1: 2003, Figure 1.
[ISO 12100-1: 2003, 3.18]
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ISO/DIS 14121-1
3.10
reasonably foreseeable misuse
use of a machine in a way not intended by the designer, but which may result from readily predictable human
behaviour
[ISO 12100-1: 2003, 3.23]
3.11
residual risk
risk remaining after protective measures have been taken
NOTE See also ISO 12100-1:2003, Figure 1.
[ISO 12100-1: 2003, 3.12, modified]
3.12
risk
combination of the probability of occurrence of harm and the severity of that harm
[ISO 12100-1: 2003, 3.11]
3.13
risk analysis
combination of the specification of the limits of the machine, hazard identification and risk estimation
[ISO 12100-1: 2003, 3.14]
3.14
risk assessment
overall process comprising a risk analysis and a risk evaluation
[ISO 12100-1: 2003, 3.13]
3.15
risk estimation
defining likely severity of harm and probability of its occurrence
[ISO 12100-1: 2003, 3.15]
3.16
risk evaluation
judgement, on the basis of risk analysis, of whether the risk reduction objectives have been achieved
[ISO 12100-1: 2003, 3.16]
3.17
task
any specific activity that is done on or around the machine during its life cycle
4 General principles
4.1 Basic concepts
Risk assessment is a series of logical steps to enable, in a systematic way, the analysis and evaluation of the
risks associated with machinery. Risk assessment is followed, whenever necessary, by risk reduction as
described in ISO 12100-1: 2003, Clause 5. When this process is repeated, it gives the iterative process for
eliminating hazards as far as practicable and for reducing risks by implementing protective measures.
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ISO/DIS 14121-1
Risk assessment includes (see Figure 1):
a) risk analysis,
1) determination of the limits of the machinery (see Clause 5);
2) hazard identification (see Clause 6);
3) risk estimation (see Clause 7);
b) risk evaluation (see Clause 8).
Risk analysis provides the information required for the risk evaluation, which in turn allows judgements to be
made about whether or not risk reduction is required.
These judgments shall be supported by a qualitative, or where appropriate a quantitative, estimate of the risk
associated with the hazards present on the machinery
NOTE A quantitative approach can be appropriate when useful data is available. However a quantitative approach is
restricted by the amount of useful data that is available and/or the limited resources of those conducting the risk
assessment. Therefore in many applications only qualitative risk assessment will be possible.
The risk assessment shall be conducted so that it is possible to document the procedure that has been
followed and the results that have been achieved (see Clause 9).
Figure 1 – The iterative process to adequately reduce risk
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ISO/DIS 14121-1
4.2 Information for risk assessment
The information for risk assessment should include the following:
a) related to machinery description:
1) user specifications;
2) anticipated machinery specifications, including:
i) description of the various phases of the whole life cycle of the machinery;
ii) design drawings or other means of establishing the nature of the machinery;
iii) required energy sources and how they are supplied.
3) documentation on previous designs of similar machinery;
4) information for use of the machinery, as available.
c) related to regulations, standards and other applicable documents:
1) applicable regulations;
2) relevant standards;
3) relevant technical specifications;
4) safety data sheets.
d) related to experience on the use:
1) any accident, incident or malfunction history of the actual or similar machinery;
NOTE An incident that has occurred and resulted in harm can be referred to as an accident. Whereas an incident
that has occurred and that did not result in harm can be referred to as a near miss or dangerous occurrence.
2) damage to health history resulting for instance from emissions (noise, vibration, dust, fumes, etc.),
chemicals used or materials processed by the machinery.
e) relevant ergonomic principles.
The information shall be updated as the design develops or when modifications are required.
Comparisons between similar hazardous situations associated with different types of machinery are often
possible, provided that sufficient information about hazards and accident circumstances in those situations is
available.
NOTE The absence of an accident history, a small number of accidents or low severity of accidents should not be
taken as an presumption of a low risk.
For quantitative analysis, data from data bases, handbooks, laboratories and manufacturers' specifications
may be used provided that there is confidence in the suitability of the data. Uncertainty associated with this
data shall be indicated in the documentation (see Clause 9).
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ISO/DIS 14121-1
5 Determination of the limits of the machinery
Risk assessment begins with the specification of the limits of the machinery. This means that the
characteristics and performances of the machine or a series of machines in an integrated process, and the
related people, environment and products should be identified in terms of:
a) use limits, including the intended use and the reasonably foreseeable misuse. Aspects to be taken into
account are, for example:
b) the different machine operating modes and the different intervention procedures for the users (including
interventions required by malfunctions of the machine use);
1) the use of the machinery (e.g. industrial, non-industrial and domestic) by persons identified by sex,
age, dominant hand usage, or limiting physical abilities (e.g. visual or hearing impairment, size,
strength);
2) the anticipated levels of training, experience or ability of the users such as:
i) operators;
ii) maintenance personnel or technicians;
iii) trainees and apprentices;
iv) general public.
3) exposure of other persons (e.g. children) to the hazards associated with the machinery where it
can be reasonably foreseen:
i) operators working in the vicinity, e.g. operators of adjacent machinery (i.e. persons likely to have
a good awareness of the specific hazards);
ii) non-operator employees in the vicinity, e.g. administration staff (i.e. persons with little awareness
of specific hazards but likely to have a good awareness of site safety procedures, authorised
routes etc.);
iii) non-employees in the vicinity, e.g. visitors (i.e. persons likely to have very little awareness of the
machine hazards or the site safety procedures), members of the public including children, if
applicable.
c) space limits. Aspects to be taken into account are, for example:
1) range of movement;
2) space requirements for installation and maintenance of the machine;
3) human interaction, e.g. "operator-machine" interface;
4) "machine-power supply" interface.
d) time limits, e.g.:
1) the "life limit“ of the machinery and/ or of some of its components (e.g. tools, wear parts, electrical
components), taking into account its intended use and reasonably foreseeable misuse;
2) recommended service intervals.
e) other limits, e.g.:
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ISO/DIS 14121-1
1) environmental – recommended minimum and maximum temperatures, whether can be operated
indoors or outdoors, in dry or wet weather, in direct sunlight, tolerance to dust and wet, etc;
2) housekeeping – level of cleanliness required;
3) properties of processed material.
When determining the limits of the machinery, all the phases of machinery life shall be taken into account.
6 Hazard identification
The essential step in any risk assessment of machinery is the systematic identification of possible hazards,
hazardous situations and hazardous events during all phases of the machine life cycle (see ISO 12100-1,
5.3 a), i.e.
a) construction;
NOTE Regarding this International Standard construction is not the process of manufacturing or production of the
machinery.
b) transport, assembly and installation;
c) commissioning;
d) use;
e) de-commissioning, dismantling and, as far as safety is concerned, disposal.
It is assumed that, when present on machinery, a hazard will sooner or later lead to harm if measures are not
taken to eliminate or protect against them. Only when hazards have been identified, can steps be taken to
eliminate them or reduce risks.
To accomplish this it is necessary to identify the operations to be performed by the machinery and the tasks to
be performed by persons who interact with it.
Task identification should consider all those tasks associated with all the phases of the machine life cycle
listed above. Task identification should also take into account, but not be limited to, the following task
categories:
⎯ setting;
⎯ testing;
⎯ teaching/programming;
⎯ process/tool changeover;
⎯ start-up;
⎯ all modes of operation;
⎯ feeding machine;
⎯ removal of product from machine;
⎯ normal stop;
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ISO/DIS 14121-1
⎯ emergency stop;
⎯ recovery from jam;
⎯ re-start after unscheduled stop;
⎯ faultfinding / trouble-shooting (operator intervention);
⎯ cleaning and housekeeping;
⎯ planned maintenance and repair;
⎯ unplanned maintenance and repair.
All reasonably foreseeable hazards, hazardous situations or hazardous events associated with the various
tasks shall then be identified.
Annex A gives examples of hazards, hazardous situations and hazardous events to assist in this process.
Several methods are available for the systematic identification of hazards. Ex
...
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