cen_414

CEN
GUIDE
414
Safety of machinery – Rules for the

drafting and presentation of safety
standards
Edition 3, 2017-10-11
Supersedes CEN Guide 414:2014
European Committee for Standardization
Avenue Marnix, 17
B – 1000 Brussels
Tel: +32 2 550 08 11
Fax: +32 2 550 08 19
www.cen.eu
CEN Guide 414:2017 (E)
Contents Page
European foreword .......................................................................................................................................................5

Introduction .....................................................................................................................................................................6
1 Scope ....................................................................................................................................................................7
2 Normative references ....................................................................................................................................7
3 Terms and definitions ....................................................................................................................................7
4 General principles ...........................................................................................................................................9
4.1 All safety standards.........................................................................................................................................9
4.2 Type-B standards .......................................................................................................................................... 10
4.3 Type-C standards .......................................................................................................................................... 10
4.3.1 General ............................................................................................................................................................. 10
4.3.2 Mandatory provisions ................................................................................................................................. 11
4.3.3 Provisions with added value .................................................................................................................... 11
4.4 Need for a type-B standard........................................................................................................................ 12
4.5 Deviations in a type-C standard............................................................................................................... 12
5 Principles to be considered before and during drafting process ................................................ 12
5.1 General ............................................................................................................................................................. 12
5.2 Determination of necessity for standardization and/or revision............................................... 13
5.3 Definition of scope........................................................................................................................................ 13
5.4 Identification of hazards, hazardous situations or hazardous events ...................................... 14
5.5 Estimation and evaluation of risk(s) generated by hazard(s) ..................................................... 14
5.5.1 Risk estimation .............................................................................................................................................. 14
5.5.2 Risk evaluation .............................................................................................................................................. 14
5.6 Identification of risk reduction objectives .......................................................................................... 14
5.7 Determination of safety requirements and/or protective/risk reduction measures
for eliminating hazards and/or limiting risks ................................................................................... 15
5.8 Verification of compliance with safety requirements and/or protective/risk
reduction measures ..................................................................................................................................... 15
6 Format of a safety standard ...................................................................................................................... 15
6.1 General ............................................................................................................................................................. 15
6.2 Foreword ......................................................................................................................................................... 16
6.3 Introduction.................................................................................................................................................... 16
6.4 Scope ................................................................................................................................................................. 17
6.5 Normative references ................................................................................................................................. 18
6.6 Terms and definitions [symbols and abbreviated terms] ............................................................. 19
6.7 Safety requirements and/or protective/risk reduction measures ............................................ 20
6.8 Verification of the safety requirements and/or protective/risk reduction measures ....... 21
6.9 Information for use ...................................................................................................................................... 22
6.9.1 General ............................................................................................................................................................. 22
6.9.2 Signals and warning devices ..................................................................................................................... 22
6.9.3 Accompanying documents (in particular: instruction handbook) ............................................. 22
6.9.4 Marking ............................................................................................................................................................ 22
6.10 Annexes ............................................................................................................................................................ 23
6.10.1 General ............................................................................................................................................................. 23
6.10.2 Normative annexes ...................................................................................................................................... 23
3
6.10.3 Informative annexes ................................................................................................................................... 23

6.10.4 Bibliography .................................................................................................................................................. 26
(normative) Procedure to be followed if type-B standards do not exist ............................... 27
(informative) Model format of a type-C European draft standard ........................................... 28
(informative) Guidance on extension of transition period ......................................................... 40
C.1 General ............................................................................................................................................................. 40
C.2 Exceptional extension of the date of withdrawal ............................................................................. 40
C.3 Consequences for European Standards to be cited in the Official Journal of the
European Union ............................................................................................................................................ 40
(informative) Examples of significant hazards, hazardous situations, hazardous
events and their relation to the Essential Requirements of the Machinery Directive
2006/42/EC .................................................................................................................................................... 42
Bibliography ................................................................................................................................................................. 49
4
European foreword
This document (CEN Guide 414:2017) has been prepared by Technical Committee CEN/TC 114 "Safety
of machinery", the secretariat of which is held by DIN.
This document is intended for use by Technical Committees writing type B and type C standards in the
field of Safety of Machinery (as defined in 3.2 and 3.3).
It gives the rules for the presentation of standards requested by CEN/BT in the programme mandated
from the European Commission in support of the "Machinery Directive" (Directive 2006/42/EU).
This document supersedes CEN Guide 414:2014.
The revision of CEN Guide 414 takes into account ISO Guide 78:2012, relevant ISO/IEC Directives,
CEN/CENELEC Internal Regulations, resolutions and guidance of CEN/BT, and the CEN Business
Operations Support System. It is also the result of feedback from TCs and WGs using the first edition of
CEN Guide 414:2014 when revising type B and type C standards.
The main changes with respect to the second edition (CEN Guide 414:2014) are as follows:
a) The introductory wording to Clause 2 and Clause 3 has been updated in accordance with the
CEN/CENELEC Internal Regulations, Part 3:2017.
b) 5.2, item b) has been deleted.
c) 6.10 has been updated and re-numbered.
d) Annex B has been updated by introducing the generic template for Annex Z… amended in
accordance with decision CEN/BT 23/2016.
e) In Table D.1 the reference to EN ISO 12100 has been stated more precisely.
f) All cross references to the CEN/CENELEC Internal Regulations, Part 3 have been updated with
regard to the edition of February 2017.
5
Introduction
As a response to the increased global trade in machinery, the relevant CEN/CENELEC Technical
Committees have undertaken publication of a series of related machinery safety standards. It has thus
been necessary to develop rules for the preparation, drafting and presentation of such safety standards,
supplementing the CEN/CENELEC Internal Regulations, Part 3, which sets out general principles and
requirements for all European Standards.
This document provides those rules. It is intended for use by Technical Committees writing type-B and
type-C standards in the field of safety of machinery (as defined in 3.2 and 3.3). It both makes use of, and
refers to, the principles and concepts established in EN ISO 12100, and also takes into account, as far as
possible, ISO/IEC Guide 51.
European Standards prepared according to this Guide are intended as a means for supporting European
regulations, in particular, the "Machinery Directive" (Directive 2006/42/EC).
6
1 Scope
This document presents rules for the drafting and presentation of European Standards dealing with
machinery safety and their revisions, primarily to achieve consistency and acceptable quality of the
various standards to be prepared.
It also gives requirements on the criteria for the selection of new work items and for procedures to
prepare, produce or revise standards in an efficient and effective way.
This document gives requirements that are additional to the CEN/CENELEC Internal Regulations,
Part 3, when this is necessary owing to the special requirements of machinery safety standards.
This document is primarily intended for the drafting of type-C standards. It is also applicable to the
drafting of type-B standards; however, the foreseeable variation in the format of these standards
prevents general application. When its requirements are specific to type-B standards, this is indicated.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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.
EN ISO 12100:2010, Safety of machinery — General principles for design — Risk assessment and risk
reduction (ISO 12100:2010)
CEN/CENELEC Internal Regulations, Part 3:2017, Principles and rules for the structure and drafting of
CEN and CENELEC documents (ISO/IEC Directives, Part 2:2016, modified)
3 Terms and definitions

For the purposes of this document, the terms and definitions given in the CEN/CENELEC Internal
Regulations, Part 3 and EN ISO 12100, and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
3.1
type-A standard
basic safety standard
standard giving basic concepts, principles for design and general aspects that can be applied to
machinery
Note 1 to entry: See EN ISO 12100:2010, Introduction.
3.2
type-B standard
generic safety standard
standard dealing with one safety aspect or one type of safeguard that can be used across a wide range of
machinery
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3.2.1
type-B1 standard
type-B standard on particular safety aspects (for example, safety distances, surface temperature, noise)
3.2.2
type-B2 standard
type-B standard on safeguards (for example, two-hand control devices, interlocking devices, pressure-
sensitive devices, guards)
3.3
type-C standard
machine safety standard
standard dealing with detailed safety requirements for a particular machine or group of machines
Note 2 to entry: The term "group of machines" means machines having a similar intended use and similar
hazards, hazardous situations or hazardous events.
3.4
relevant hazard
hazard which is identified as being present at or associated with the machine
Note 1 to entry: A relevant hazard is identified as the result of one step of the process described in
EN ISO 12100:2010, Clause 5.
Note 2 to entry: This term is included as basic terminology for type B- and type C-standards.
[SOURCE: EN ISO 12100:2010, 3.7]
3.5
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 1 to entry: This term is included as basic terminology for type B- and type C-standards.
[SOURCE: EN ISO 12100:2010, 3.8]
3.6
added value
more detailed description or specification of a requirement than in existing, less specific, documents,
according to the structure prescribed in EN ISO 12100
Note 1 to entry: A type-B standard gives added value to the requirements of type-A standards, while a type-C
standard gives added value to the requirements of type-A and type-B standards.
Note 2 to entry: The added value results from the design requirements applied to the product, by consensus of
the interested parties, when the standard was prepared.
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Key
a These hazards are listed in EN ISO 12100:2010, Annex B.
b See 6.10.3.1.
Figure 1 — Dealing with hazards of a particular machine or group of machines
4 General principles
4.1 All safety standards
The CEN/CENELEC Internal Regulations, Part 3 and EN ISO 12100 shall be used in conjunction with this
document when preparing a new safety standard or revising an existing one.
A safety standard shall not contradict the basic concepts and general principles for design stated in a
type-A standard, but can deviate from specific requirements. The overall purpose of the type-A
standard is to provide manufacturers, designers, etc. with the strategy or framework necessary to
achieve adequate risk reduction. 1)
In general, the standards should not repeat or paraphrase the text of other reference standards;
however, for better understanding of safety standards, it is acceptable to repeat a basic definition or
concept, the scope of the standard, and/or a basic requirement given in EN ISO 12100.
NOTE For the purposes of this document, the terms "protective measure" (see EN ISO 12100:2010, 3.19) and
"risk reduction measure" are synonymous and defined as any action or means used to eliminate hazards and/or
reduce risks.
1) A definition of adequate risk reduction is given in EN ISO 12100:2010, 3.18.
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4.2 Type-B standards
They shall
a) deal either with one safety aspect (type-B1 standard) or a safeguard (type-B2 standard),
b) for type-B1 standards, define the basic principles of the safety topic and define by data and/or
methodology how these can be applied to type-C standards, including, where relevant, the means of
verification,
c) for type-B2 standards, give the performance requirements for the design and construction of the
safeguard together with the means of verification, and
d) establish, as necessary and practicable, performance requirements (for example, types or

performance levels) based on the application.
NOTE Possible reasons for establishing different performance requirements are:
— the severity of the possible harm from the considered hazard,
— the frequency and duration of the hazardous situation,
— the probability of occurrence of a hazardous event, and
— the possibility to avoid or limit the harm.
4.3 Type-C standards

4.3.1 General
Type-C standards should deal with all the significant hazards concerning one type of machine or one
group of machines in one standard, as follows.
a) By reference to relevant and applicable type-B standards (see 6.7.4).
1) Any type-B standard available as a draft standard (stage 40.20) may be used as a reference
standard on the condition that the reference is dated.
2) When type-B standards offer a choice between various solutions (for example,
EN ISO 13857:2008 offers the alternative of Table 1 for low risks and Table 2 for high risks, for
reaching over protective structures), the type-C standard shall state which solution(s) shall be
used.
b) By reference to other standards (such as another type-C standard) where such significant hazards
are adequately dealt with (see 4.4).
c) By specifying safety requirements in the standard, when reference to other standards is not
possible or not sufficient and where risk assessment and priorities show this is required (see 5.4 to
5.6).
d) By dealing as far as possible with objectives rather than design details to minimize restrictions on
design.
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4.3.2 Mandatory provisions
Type-C standards shall clearly establish the following:
— the scope (see 5.3 and 6.4);
— the significant hazard(s) (see 6.10.3.1);
— the requirements prescribing protective/risk reduction measures that add value to relevant
subclauses of EN ISO 12100:2010, Clause 6, originating from the significant hazard(s) (see 4.3.3, 5.7
and 6.7);
— the means of verifying the protective/risk reduction measures (see 5.8 and 6.8);
— information for use (see 6.9).
This means that, wherever possible, a type-C standard should deal with all significant hazards,
hazardous situations or hazardous events identified as arising from the use of the machine. The
justifiable exception to this comprehensive treatment of significant hazards, hazardous situations or
hazardous events is where a type-C standard deals with one or more hazard(s) that are sufficiently
important to require special treatment. Where a type-C standard deals with specific hazard(s), this
should be indicated clearly in the title and scope (for example, Safety of textile machines — Measurement
of noise). These standards may be produced as a series of parts forming a complete standard or as
several discrete standards that could be combined at a subsequent revision.
Where it is decided not to deal with all significant hazards, hazardous situations or hazardous events
(for example, by lack of knowledge or because this will cause an unacceptable delay in the drafting of
the standard) this shall be clearly indicated in the scope (see 6.4.2).
A special case requiring careful consideration are those type-C standards dealing with "common
requirements". Common requirements are defined as those requirements adding value to existing type-
A or type-B standards that can be used to minimize or eliminate a risk occurring across the range of
defined machines and that can be applied to all or most of these machines. Any machines not covered by
a particular aspect of a common requirement should be identified as an exclusion. Too many exclusions
from any common requirement would indicate that it is not common. The standard dealing with
"common requirements" should not contain unspecific general principles.
4.3.3 Provisions with added value
It is a basic principle that type-C standards shall contain sufficient added value to the requirements of
existing type-A and type-B standards. Added value will normally consist of a description of specific
protective/risk reduction measure(s) dealing with the significant hazard, hazardous situation or
hazardous event. However, this may also include reference to type-B standards or to other reference
standards (see 6.7).
In the absence of a published type-B standard, common requirement standard or other reference
standard, the following options are available:
— repeat in full the relevant sections of the draft type-B standard, draft common requirement
standard, or any other suitable technical document;
— refer to the relevant section of a draft standard identified by number and date of issue;
11
— refer to a technical specification produced by a professional organization - this can be done

following the specific policy on normative references;
— seek help from the TC/WG (technical committee/working group) preparing the relevant type-B
standard;
— provide self-drafted data/specification.
Dealing with a significant hazard by direct reference to the relevant subclauses of EN ISO 12100:2010,
Clause 6 is only acceptable
a) where this reference gives sufficient requirements (particularly the Information for use clause, see
6.9), and
b) if the drafting of requirements would cause an unacceptable delay in the preparation of the
standard.
However, in the case of b):
— it shall be stated in the scope that the hazard concerned is not dealt with in the current version of
the standard;
— the TC shall make every effort to complete as soon as possible the drafting of the needed
requirements.
4.4 Need for a type-B standard
The creation of a type-B standard (see 6.10.2) shall be considered when requirements appropriate to
more than one type of machine or one group of machines have been identified.
4.5 Deviations in a type-C standard
When a type-C standard deviates from one of several aspects or requirements dealt with by a type-A or
type-B standard, then the existing type-C standard shall take precedence over the type-A or type-B
standard (see 6.3.2).
The reason for any deviation shall be carefully justified and kept by the responsible body in the
standardization file or, in case of comments at draft stage (40.20), in the CRM (comments resolution
meeting) file.
5 Principles to be considered before and during drafting process

5.1 General
Whereas the Machinery Directive 2006/42/EC states in its Annex I Essential Requirements, the general
methodology for safety of machinery specified in EN ISO 12100 is based on the consideration of
significant hazards basically without any specific reference to the Essential Requirements of
Directive 2006/42/EC. Annex D gives as far as possible examples of significant hazards, hazardous
situations, hazardous events and their relation to this Essential Requirements.
Before a standard is drafted, the need for it shall have been established, using the criteria given in 5.2.
NOTE The result of the procedure can provide information which can be used in the scope (see 5.3).
During the drafting process and the revision of a standard, the procedure given in 5.3 to 5.8 shall be
carried out in the order indicated, in order to provide information that will allow an appropriate
standard to be drafted.
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5.2 Determination of necessity for standardization and/or revision
The need for standardization and/or for the revision of an existing standard and the respective
priorities shall be determined from the answers to the questions posed in 5.2 a) to 5.2 k), as applicable.
a) Is there a demand for European Standards arising from interested bodies (relevant market players
such as regulatory bodies, manufacturers’ associations, employees’ or employers’ associations,
trade unions, accident prevention organizations or consumer organizations)?
b) Is there a need for a standard (for example, terminology) to support other safety standards?
c) Are there significant hazards, hazardous situations or hazardous events generating risk to the
safety or health of persons? See EN ISO 12100:2010, 5.4.
d) If a new technology is to be standardized, is it sufficiently stable and established in the market and
can it be therefore considered as state-of-the-art?
e) Is there, or will there be in the foreseeable future, a sufficient number of related machines or
safeguards to justify the production of a standard?
f) Are there national standards/specifications giving specific requirements, either directly or by

reference to another document, which can be barriers to international trade?
g) Are there proven professional, national or international documents or other documents available to
give a reasonable expectation of positive and rapid results?
h) Is there sufficient expertise, collective knowledge and experience for standardization?
i) Is there sufficient availability of experts (in principle from at least five members), project leader
and support (secretariat, financial resources)?
j) Is there sufficient feedback on the use of the existing safety standard?
k) Has the state of the art changed such that the existing safety standard has become at least partly
obsolete?
5.3 Definition of scope
The precise limits of the machine or group of machines to be standardized shall be established and shall
include the following (see EN ISO 12100:2010, 5.3):
a) definition of the machine or group of similar machines;
b) determination of the intended use of the machine (see EN ISO 12100:2010, 3.23);
c) determination of the space limits (see EN ISO 12100:2010, 5.3.3);
d) determination of the foreseeable "life limit", when applicable;
e) definition of the field of application.
Any machines and/or hazards not covered by the standard shall be clearly stated in the scope.
The various phases in the life of the machine to be dealt with in the standard shall be established. See
EN ISO 12100:2010, 5.4.
13
5.4 Identification of hazards, hazardous situations or hazardous events
Considering EN ISO 12100:2010, especially its Annex B, as guidance:
a) identify the hazards that the machine is likely to generate;
b) identify the various hazardous situations for each hazard, taking into account the different
operating modes of the machine and the different intervention procedures for the operators as well
as the reasonably foreseeable misuse;
c) identify the hazardous events which can lead to harm.
Particular attention should be paid to the fact that the list given in EN ISO 12100:2010, Annex B, is not
exhaustive, especially in as far as it concerns the hazardous situations.
5.5 Estimation and evaluation of risk(s) generated by hazard(s)

5.5.1 Risk estimation
The risk shall be estimated by combining the following steps.
a) Estimate the severity of the possible harm for the hazard under consideration.
b) Estimate the probability of occurrence of that harm which is a function of
1) the exposure of persons to the hazard (for example, frequency, duration),
2) the probability of occurrence of a hazardous event,
3) the technical and human possibilities to avoid or limit the harm.
5.5.2 Risk evaluation
After the risk estimation, a risk evaluation shall be carried out to determine:
— if risk reduction is required;
— whether the risk reduction objectives have been achieved.
5.6 Identification of risk reduction objectives
The following steps shall be carried out using the result of the procedures according to 5.4 and 5.5:
a) define risk reduction objectives in terms of reduction of the severity of the harm and/or the
probability of that harm;
b) identify the relevant clauses of EN ISO 12100 applicable for each significant hazard, hazardous
situation or hazardous event;
c) determine for each significant hazard whether it is sufficient to refer to other standards for safety
requirements and/or protective/risk reduction measures, or whether there is a need for specific
safety requirements and/or protective/risk reduction measures.
The entire above process should preferably be recorded and kept by the responsible body in the
standardization file, for example, in a table.
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5.7 Determination of safety requirements and/or protective/risk reduction measures

for eliminating hazards and/or limiting risks
The risk reduction process according to 5.6 shall be carried out in the following order (three-step
method as described in EN ISO 12100:2010, Figure 1):
a) by inherently safe design (see EN ISO 12100:2010, 6.2);
b) by safeguarding (see EN ISO 12100:2010, 6.3);
c) by information for use (see EN ISO 12100:2010, 6.4).
The principle — for the various phases of the "life" of the machine — is to eliminate the hazard or
reduce the risk as much as possible by inherently safe design without relying on guards or other
methods of safeguarding. If this is not practicable, other means should be defined to ensure safety.
NOTE For the drafting of safety requirements and for protective/risk reduction measures for eliminating
hazards and/or limiting risks, see 6.7.3.
5.8 Verification of compliance with safety requirements and/or protective/risk

reduction measures
For each safety requirement and/or protective/risk reduction measure identified and determined in
accordance with 5.6 and 5.7 (except if it is self-evident), a method of verification shall be established
a) by testing (for example, functional test of a two-hand control, strength test of a guard, stability test),
b) by measurement (for example, measurement of noise emission),
c) by calculation (for example, position of the centre of gravity), or
d) by any other method of verification, if testing and calculation are not adequate (for example, by
visual inspection).
It shall be determined
— whether adequate testing/calculating methods (or other methods of verification) are available in
another standard, or
— whether it is necessary to draft such methods.
NOTE For the drafting of requirements for verification, see 6.8.
6 Format of a safety standard

6.1 General
The format of a safety standard shall comply with the CEN/CENELEC Internal Regulations, Part 3 (see
model format given in Annex B of this document) and the specific requirements for safety standards on
machinery given in 6.2 to 6.10.
The model format given in Annex B is intended to help standards developers and to provide for a
consistent presentation for all type-C standards according to Clause 6.
15
6.2 Foreword
The Foreword is an unnumbered mandatory element. It shall be in accordance with the

CEN/CENELEC Internal Regulations, Part 3:2017, Clause 12.
If relevant, the significant technical changes in relation to the previous edition shall be stated.
As a minimum requirement, the following statement 2) shall be inserted in each mandated standard:
"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 Z [appropriate letter(s)], which is (are) an
integral part of this document".
In case of revision or amendment of a standard, the standard makers shall consider the transition
period of application of the previous and the revised standard or amendment. The transition period
shall be defined in the enquiry document (prEN – stage 40.20). See Annex C for additional guidance on
consideration of the transition period.
6.3 Introduction
6.3.1 Although the Introduction is an optional element according to the CEN/CENELEC Internal
Regulations, Part 3, it is an unnumbered mandatory element in machinery safety standards. It shall be
in accordance with the CEN/CENELEC Internal Regulations, Part 3:2017, Clause 13.
When a subject of a type-B standard is covered by EN ISO 12100, reference shall be made to the
relevant clause of EN ISO 12100.
6.3.2 At least the following statement shall be inserted in each type-C standard:
"This document is a type-C standard as stated in EN ISO 12100.
This document is of relevance, in particular, for the following stakeholder groups representing the market
players with regard to machinery safety:
— machine manufacturers (small, medium and large enterprises);
— health and safety bodies (regulators, accident prevention organizations, market surveillance etc.).
Others can be affected by the level of machinery safety achieved with the means of the document by the
above-mentioned stakeholder groups:
— machine users/employers (small, medium and large enterprises);
— machine users/employees (e.g. trade unions, organizations for people with special needs);
— service providers, e.g. for maintenance (small, medium and large enterprises);
— consumers (in case of machinery intended for use by consumers).
2) These sentences are taken from CEN BOSS. In case of modification of the guidance given by CEN BOSS, the
current version of that guidance should take precedence over this document.
16
The above-mentioned stakeholder groups have been given the possibility to participate at the drafting
process of this document.
The machinery concerned and the extent to which hazards, hazardous situations or hazardous events are
covered are indicated in the Scope of this document.
When requirements of this type-C standard are different from those which are stated in type-A or type-B
standards, the requirements of this type-C standard take precedence over the requirements of the other
standards for machines that have been designed and built according to the requirements of this type-C
standard."
6.3.3 At least the following statement shall be inserted in each type-B standard:
"This document is a type-B standard as stated in EN ISO 12100.
This document is of relevance, in particular, for the following stakeholder groups representing the market
players with regard to machinery safety:
— machine manufacturers (small, medium and large enterprises);
— health and safety bodies (regulators, accident prevention organizations, market surveillance etc.);
Others can be affected by the level of machinery safety achieved with the means of the document by the
above-mentioned stakeholder groups:
— machine users/employers (small, medium and large enterprises);
— machine users/employees (e.g. trade unions, organizations for people with special needs);
— service providers, e.g. for maintenance (small, medium and large enterprises);
— consumers (in case of machinery intended for use by consumers).
The above-mentioned stakeholder groups have been given the possibility to participate at the drafting
process of this document.
In addition, this document is intended for standardization bodies elaborating type-C standards.
The requirements of this document can be supplemented or modified by a type-C standard.
For machines that are covered by the scope of a type-C standard and have been designed and built
according to the requirements of that standard, the requirements of that type-C standard take
precedence."
6.4 Scope
6.4.1 The Scope is a mandatory element. It shall be in accordance with the CEN/CENELEC Internal
Regulations, Part 3:2017, Clause 14, and shall be drafted using the result of the procedure according to
5.3 of this document. It shall be numbered as Clause 1.
17
6.4.2 The Scope shall indicate, when applicable, the following:
a) the limits of the machine, preferably by physical characteristics and taking into account aspects
such as intended use as well as reasonably foreseeable misuse (see EN ISO 12100:2010, 3.23, 3.24
and 5.3);
b) whether protective/risk reduction measures dealt with in the standard account for all or only some
of the significant hazards.
This applies to hazards arising during the various phases of the “life” of the machine as described in
EN ISO 12100:2010, 5.4. The significant hazards dealt with in the standard (see 3.5 and Figure 1)
shall be mentioned, as appropriate,
1) by listing them in the Scope, when they are few, or
2) by a statement in the Scope that they are dealt with in the standard (see 6.10.3.1).
In the case of 2), above, those significant hazards not dealt with shall also be mentioned in the
Scope.
c) whether additional designed-in protective/risk reduction measures are taken into consideration
for certain types of machines (e.g. hygiene requirements for food-processing machinery).
The scope shall indicate that the standard is not applicable to machinery or machinery components
which are manufactured before the date of publication of the standard. As a minimum requirement, the
following statement shall be inserted in Scope:
"This document is not applicable to [<precisely state the machinery or machinery components here>]
manufactured before the date of its publication."
6.5 Normative references
This clause is a mandatory element. It shall be in accordance with the CEN/CENELEC Internal
Regulations, Part 3:2017, Clause 15, and shall be numbered as Clause 2.
a) Only documents (standards) to which normative reference is made in the text of the safety
standard shall be listed in this clause. Therefore, at least the following shall always be referenced:
EN ISO 12100:2010, Safety of machinery — General principles for design — Risk assessment and risk
reduction
Normative references in the text of a standard need to be made using the verbal form “shall”,
signifying a requirement.
EXAMPLE "This shall be in accordance with EN 12345-201x, Clause 6."
When a reference is made only for information, it shall be introduced by the phrase "see EN ..." and
the standard referenced shall be listed, not in this clause, but in a bibliography (see 6.10.4).
This document, even though applicable to the drafting and presentation of the safety standard, shall
not be given as a normative reference.
18
b) References to standardization documents shall be in accordance with the CEN/CENELEC Internal

Regulations, Part 3:2017, Clause 10, and should be dated in accordance with 10.5 of those Internal
Regulations.
When a normative reference, e.g. to an ISO/IEC International Standard, is required, the safety
standard shall
— either reproduce the text of the normatively referenced document, in the main body of the
safety standard or in a normative annex, clearly indicating its origin by "(extract from
ISO/IEC ...)", or
— make dated reference to a specific clause(s) or subclause(s) of the referenced document

(without reproducing it), or
— make dated (preferably) or undated reference to the whole of the normatively referenced
document, if applicable — for example, in cases where the subject of the normatively
referenced document is an applicable test method.
In principle, the referenced documents shall be documents published either by CEN, CENELEC, ISO
or IEC. Documents published by other bodies may be referred to in a normative manner provided
that the criteria listed in the CEN/CENELEC Internal Regulations, Part 3:2017, Clause 15, are met
(see 4.3.3).
6.6 Terms and definitions [symbols and abbreviated terms]
6.6.1 This clause is a mandatory element. It shall be in accordance with the CEN/CENELEC Internal
Regulations, Part 3:2017, Clauses 16 and 17, and shall be numbered as Clause 3.
6.6.2 The terms and definitions given in EN ISO 12100 shall be used. Therefore, at least the following
statement shall be given as the first, introductory, paragraph to the terms and definitions clause in each
type-B and type-C standard:
"For the purposes of this document, the terms and definitions given in EN ISO 12100 apply."
6.6.3 The terms and definitions given in relevant type-B and type-C standards should be used as far as
applicable. For new terms and definitions, the association of the word "safety" with the name of a
component or a device should be avoided. A recommended approach is to replace, where possible, the
word "safety" by an indication of the objective or characteristic.
EXAMPLE "Active optoelectronic protective device" instead of "safety light curtain".
6.6.4 When there is need to define symbols or abbreviations (especially for test methods), this
conditional element shall be included in accordance with the CEN/CENELEC Internal Regulations,
Part 3:2017, Clause 17.
19
6.7 Safety requirements and/or protective/risk reduction measures
6.7.1 This clause is a mandatory element. It shall be in accordance with CEN/CENELEC Internal
Regulations, Part 3:2017, Clause 4 and 5.4 to 5.8.
As a minimum requirement, the following statement shall appear in this clause in each type-C standard:
"Machinery shall comply with the safety requirements and/or protective/risk reduction measures of this
clause. In addition, the machine shall be designed according to the principles of EN ISO 12100:2010 for
relevant but not significant hazards which are not dealt with by this document."
This clause should be structured based on the result from 5.6, except for Information for use-related
issues, which shall be dealt with in a specific clause (see 6.9).
6.7.2 All safety standards shall contain such a clause, stating the safety requirements and/or
protective/risk reduction measures to be met to reduce the effect of all hazards determined in
accordance with 5.6 b) and c), and which are to be mentioned in the standard. The safety requirements
and protective/risk reduction measures shall be defined in accordance with 5.7.
Protective/risk reduction measures to avoid or minimize harm shall be defined, directly or by reference
to another standard and/or to the Information for use clause, for all the significant hazards dealt with.
6.7.3 The safety requirements and/or protective/risk reduction measures specified shall be expressed
in terms of verifiable performance with regard to safety, using performance characteristics
(parameters), together with their values, rather than merely descriptive characteristics.
To minimize restraint on design, safety standards should specify requirements in terms of the objective
to be met and then define the means for achieving it, such as by giving examples or defining test
specifications. The safety requirements and/or protective/risk reduction measures shall be sufficiently
precise to allow verifications.
NOTE In many type-C standards, it can be necessary to define acceptable means of achieving the objective,
such as particular types of protective/risk reduction measures, in order to ensure that the safety requirements
and/or protective/risk reduction measures will be adequate, or to give examples of well-known and proven
solutions for reaching and maintaining the level of safety.
More than one solution for reducing the risk may be given if allowing the same objective of risk
reduction to be reached.
Measures in terms of objectives, and measures defined by data, limits, results and requirements giving
the practical means for achieving the objectives, may be given together or in separate subclauses.
6.7.4 Where requirements contained in relevant type-A or type-B standards are used, reference shall
be made to them in accordance with 4.3.
Where type-B standards are not yet available and general requirements (valid for several types of
machines) are included in the type-C standard, these requirements shall preferably be included in
normative annexes of the type-C standard (see Annex A).
When measures given in another standard are used, specific reference shall be made to that standard.
6.7.5 Type-B standards shall give added value (more specific and/or more detailed requirements) to
the requirements of type-A standards and type-C standards shall give added value to the requirements
of type-A and type-B standards. See 4.3.3 for more details on added value.
20
6.7.6 Protective/risk reduction measures shall be laid down in precise and clearly understandable
terms such that they
a) ensure that the objective is met,
b) are technically correct and precise,
c) are unequivocal as to whether a measure is optional or mandatory, using verbal forms in

accordance with the CEN/CENELEC Internal Regulations, Part 3:2017, Clause 7, and
d) can be verified in accordance with 5.8 and 6.8.
Subjective terms or words should not be used unless they are defined in the standard or are consistent
with the method of verification.
6.8 Verification of the safety requirements and/or protective/risk reduction measures
6.8.1 Each safety standard shall contain, either in a separate clause or together with the relevant
measures, the method to be used to verify conformity with the measures given in accordance with 6.7,
unless the methods for verification are self-evident.
The standard shall not contain any instruction on who shall carry out the verification (see
CEN/CENELEC Internal Regulations, Part 3: 2017, Clause 33).
The method of verification shall be related to the nature of the safety requirements and/or
protective/risk reduction measures, and shall follow the procedure according to 5.8.
If the methods of verification are to be put in a separate clause, the order of presentation should be the
same as that of the safety requirements and/or protective/risk reduction measures and there shall be a
link between the two.
Priority should be given to the use of existing and standardized methods of verification (as defined in
standardization documents) by reference.
When drafting a new method of verification which is not specific to the machine itself (e.g.
measurement of dust suction efficiency in a standard on belt sanding machines), this method shall
appear either in a normative annex (see 6.10.2), or in a separate part of the standard, or even in a
separate standard, so that reference can be made to it in another safety standard.
6.8.2 The wording of methods of verification shall be sufficiently precise to ensure reproducible
results. The structure relating to measurement and test methods given in the CEN/CENELEC Internal
Regulations, Part 3:2017, Clause 18 shall be followed. If there are several test methods for one safety
requirement and/or protective/risk reduction measure, the test method(s) to be used shall be
indicated.
Calculation methods, for example, could be appropriate when only destructive testing is possible and
for special types of safety requirements and/or protective/risk reduction measures, such as those
concerning stability.
Where testing and calculation methods are not practicable for technical reasons or would cause
excessive costs compared to the risk reduction that would be achieved, other methods can be more
appropriate. Verification may be by inspection, or by examination when sufficiently precise (e.g.
inspection to check the colour of warning signs and marking).
21
6.9 Information for use

6.9.1 General
This clause is a mandatory element and shall be numbered. The safety standard shall make reference to
EN ISO 12100:2010, 6.4, and shall contain additional requirements about the information for use for
machines within the scope of the standard.
NOTE As these safety standards deal with machinery design, the Information for use clause is the only one in
which the standards developer can provide instructions on installation and use of the machinery in relation to
residual risks.
6.9.2 Signals and warning devices
Where safety signals or pictograms are fitted to the machine, they shall be described in this clause. The
safety signals or pictograms already defined in relevant standardization documents should be used (e.g.
EN 61310).
6.9.3 Accompanying documents (in particular: instruction handbook)
6.9.3.1 General
As the instructions are a mandatory part of the machine, each type-C standard shall contain the
requirement that the manufacturer provide an instruction handbook. The type-C standard shall make
reference to EN ISO 12100:2010, 6.4.5, and shall give specific information (e.g. intended use, reasonably
foreseeable misuse, training, systems of work and personal protective equipment) to be included in the
handbook, compiled from the results of the procedures according to 5.2 to 5.7 of this document.
NOTE The instructions are normally the only means available to the user providing information on the use of
the machine including maintenance interventions.
6.9.3.2 Noise
If noise is applicable, the requirements concerning both noise emission measurement and declaration
shall be specified in a normative annex or by reference to a specific standard (Noise Test Code) or at
least by reproducing the corresponding requirements of 1.7.4.2 u) in Annex I of the Machinery Directive
2006/42/EC.
Further guidance on the drafting of noise clauses is given in EN 1746.
6.9.3.3 Vibration
If vibration is applicable, the requirements concerning both vibration emission measurement and
declaration shall be specified in a normative annex or by reference to a specific standard (Vibration Test
Code) or at least by reproducing the corresponding requirements of 2.2.1.1 and 3.6.3.1 in Annex I of the
Machinery Directive 2006/42/EC.
Further guidance on the drafting of vibration clauses is given in EN 12786.
6.9.4 Marking
All safety standards shall require at least the marking as specified in EN ISO 12100:2010, 6.4.4.
22
6.10 Annexes
6.10.1 General
Annexes shall be in accordance with the CEN/CENELEC Internal Regulations, Part 3:2017, Clause 20.
6.10.2 Normative annexes
When it is foreseeable that certain parts of the safety standard could be applicable to other documents
(e.g. test methods), these parts shall be included as normative annexes.
NOTE This form of presentation can assist referencing by other documents and allows easier conversion of
those parts into a type-B standard at a later date (see 4.4).
6.10.3 Informative annexes
6.10.3.1 List of significant hazards
When 6.4.2 b) 2) applies, the list of significant hazards shall be given in an informative annex, titled List
of significant hazards.
This annex shall present, for defined danger zones, all the significant hazards, significant hazardous
situations (circumstances that lead to exposure of a person to these hazards) and significant hazardous
events identified during the risk assessment and covered by this standard. It should also refer to the
particular subclause of the Safety requirements and/or protective/risk reduction measures clause (see
6.7) and, if appropriate, that of the Information for use clause (see 6.9) in which the hazard, hazardous
situation or hazardous event is dealt with.
The list of significant hazards, hazardous situations or hazardous events should preferably follow the
order given in EN ISO 12100:2010, Annex B, but not reproduce it. It is not appropriate to list all possible
hazards, hazardous situations or hazardous events as described in EN ISO 12100, indicating those dealt
with and those not dealt with.
6.10.3.2 Significant technical changes between this standard and the previous edition
This annex shall be drafted only in cases where the significant technical changes from one edition to the
next are not stated in the Foreword of the revised standard. See 6.2.
6.10.3.3 Annex Z [appropriate letter]
6.10.3.3.1 General
Each mandated standard shall contain for each EU New Approach Directive dealt with an Annex Z
[followed by a letter to be precised] (informative) about the relationship between the standard and the
essential requirements of the relevant EU Directive (see 6.2).
NOTE This annex being always located as last annex of the standard, it will normally be called “ZA”. However,
if one or more European annexes exist after an adopted International standard, the letter A will be replaced by the
letter following the previous European annexes (e.g. if there is an Annex ZD, the annex about the relationship to an
EU Directive becomes Annex ZE).
Annex Z shall be drafted in accordance with the format given in 6.10.3.3.2.
The table format shown in Table Z...1 should be used and its content can be accommodated to one of the
possible cases as prescribed in the following options.
23
Option A.1 = standard covering all relevant ERs (significant hazards) by applying all clauses of the
standard;
Option A.2 = standard covering all relevant ERs (significant hazards) by applying all clauses of the
standard except some clauses;
Option B.1 = standard covering all relevant ERs (significant hazards) except one/or a few by applying
all clauses of the standard;
Option B.2 = standard covering all relevant ERs (significant hazards) except one/or a few by applying
all clauses of the standard except some clauses;
Option C = to declare a more detailed correspondence between the ERs covered and the relevant
clauses in the standard; in this case, the table would contain as many rows as needed. Where it is
possible that in certain cases, only a limited set of ERs is covered by the standard, this option can then
be used to identify this limited set of ERs is covered.
6.10.3.3.2 Format
Annex Z…
(informative)
Relationship between this European Standard and the essential requirements of

Directive 2006/42/EC aimed to be covered
This European Standard has been prepared under a Commission’s standardization request "M/396
Mandate to CEN and CENELEC for Standardisation in the field of machinery" to provide one voluntary
means of conforming to essential requirements of Directive 2006/42/EC of the European Parliament
and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (recast).
Once this standard is cited in the Official Journal of the European Union under that Directive,
compliance with the normative clauses of this standard given in Table Z….1 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.
Table Z….1 – Correspondence between this European Standard and Annex I of

Directive 2006/42/EC
Essential Requirements of Clause(s)/sub-clause(s) of this EN Remarks/Notes
Directive
Option A.1: All normative clauses For relation of normative clauses
Within the limits of the scope all of this standard to significant
relevant essential requirements are hazards/relevant essential
covered requirements of 2006/42/EC see
informative annex XX „List of
significant hazards“ of this
standard in combination with
annex D “Examples of significant
hazards, hazardous situations,
hazardous events and their
relation to the Essential
Requirements of the Machinery
Directive 2006/42/EC” of
CEN Guide 414
(https://boss.cen.eu/ref/CEN_414.pdf).
24
Option A.2: All normative clauses except clause(s) For relation of normative clauses
Within the limits of the scope all yyy 3) (except clause(s) yyy3)) of this
relevant essential requirements are standard to significant
covered hazards/relevant essential
requirements of 2006/42/EC see
CEN Guide 414
Option B.1: All normative clauses For relation of normative clauses

Within the limits of the scope all of this standard to significant
relevant essential requirements with hazards/relevant essential
the exception of essential requirements of 2006/42/EC see
requirement(s) xxx are covered informative annex XX „List of
CEN Guide 414
Option B.2: All normative clauses except clause(s) For relation of normative clauses
Within the limits of the scope all yyy3) (except clause(s) yyy1)) of this
relevant essential requirements with standard to significant
the exception of essential hazards/relevant essential
requirement(s) xxx are covered requirements of 2006/42/EC see
CEN Guide 414
Option C [The relevant normative clauses linked

[Per row: an essential requirement] to the individual essential requirement]
3) In cases where certain normative clauses of the standard do cover other aspects than those providing
presumption of conformity
25
WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European
Standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2 — Other Union legislation may be applicable to the product(s) / [service(s)] / […] falling
within the scope of this standard.
6.10.4 Bibliography
Standards or documents that give only information, or which have served as references in the
preparation of the standard, shall appear in a Bibliography in accordance with the
CEN/CENELEC Internal Regulations, Part 3:2017, Clause 21, and not in the Normative references clause.
Documents that are not publicly available shall not be referenced.
26
(normative)
Procedure to be followed if type-B standards do not exist
Where possible, type-B standards should be prepared first, so that reference can be made to them when
preparing type-C standards for specific machines. When a type-C standard needs to use type-B
requirements and such standards do not exist, the type-C standard shall give those requirements in
annexes. Where this method is adopted, the annexes can be withdrawn when revising the standard and
the references in the standard changed to the relevant type-B standard.
In order to facilitate this approach, the following procedure shall be used.
a) All type-C working groups shall be able to obtain information about the on-going work in type-A
and type-B working groups and of all existing type-A and type-B standards including drafts.
b) If type-C working groups need to formulate type-B requirements, due to a lack of existing type-B
standards, the relevant type-B working groups and/or relevant technical committees on safety of
machinery shall be involved.
c) Where applicable, type-C working-group experts should participate in relevant type-B working
groups and should influence the creation and content of type-B standards.
d) Type-B requirements in type-C standards shall be placed in annexes.
27
(informative)
Model format of a type-C European draft standard
Contents Sommaire Inhalt

Page Page Seite
Foreword Avant-propos Vorwort
Introduction Introduction Einleitung
1 Scope 1 Domaine d'application 1 Anwendungsbereich
2 Normative references 2 Références normatives 2 Normative Verweisungen
3 Terms and definitions 3 Termes et définitions 3 Begriffe
4 Safety requirements and/or 4 Prescriptions de sécurité et/ou mesures 4 Sicherheitsanforderungen und/oder
protective/risk reduction measures de prévention/réduction du risque Schutz-/ Risikominderungsmaßnahmen
5 Verification of safety requirements 5 Vérification des prescriptions de sécurité 5 Feststellung der Übereinstimmung mit
and/or protective/risk reduction measures et/ou des mesures de prévention/réduction den Sicherheitsanforderungen und /oder
des risques Schutz-/ Risikominderungsmaßnahmen
6 Information for use 6 Informations pour l'utilisation 6 Benutzerinformation
Additional clauses, if needed Articles supplémentaires, s’il y a lieu Zusätzliche Abschnitte, falls erforderlich
Annex A (normative) Annexe A (normative) Anhang A (normativ)
………. ………. ……….
Annex B (informative) Annexe B (informative) Anhang B (informativ)
………. ………. ……….
Annex C (informative) Annexe C (informative) Anhang C (informativ)
List of significant hazards Liste des phénomènes dangereux significatifs Liste der signifikanten Gefährdungen
Annex D (informative) Annexe D (informative) Anhang D (informativ)
Significant technical changes between this Modifications techniques significatives entre Signifikante technische Änderungen dieser
European Standard and the previous edition la présente Norme Européenne et l’édition Europäischen Norm gegenüber der
précédente Vorgängerausgabe
Annex ZA (informative) Annex ZA (informative) Anhang ZA (informativ)
Relationship between this European Standard Relation entre la présente Norme Européenne Zusammenhang zwischen dieser
and the essential requirements of Directive et les exigences essentielles concernées de la Europäischen Norm und den grundlegenden
2006/42/EC aimed to be covered Directive 2006/42/CE visant à être couvert Anforderungen der abzudeckenden
Richtlinie 2006/42/EG
Bibliography Bibliographie Literaturhinweise
28
Foreword Avant-propos Vorwort

[See CEN/CENELEC Internal Regulations, [Voir le Règlement Intérieur du CEN/CENELEC, [Siehe CEN/CENELEC Geschäftsordnung,
Part 3:2017, Clause 12] Partie 3:2017, Article 12] Teil 3:2017,Abschnitt 12]
This document (EN …: < year > ) has been Le présent document (EN …: < année > ) a été Dieses Dokument (EN …: < Jahr > ) wurde vom
prepared by CEN/TC.../WG.. élaboré par le Comité Technique CEN/TC.../WG... Technischen Komitee CEN/TC .../WG ... erarbeitet.
This European Standard shall be given the status La présente Norme européenne devra recevoir le Diese Europäische Norm muss den Status einer
of a national standard, either by publication of an statut de norme nationale, soit par publication nationalen Norm erhalten, entweder durch
identical text or by endorsement, at the latest by d'un texte identique, soit par entérinement, au Veröffentlichung eines identischen Textes oder
[date of availability] and conflicting national plus tard en [date de disponibilité], et toutes les durch Anerkennung bis [Datum der Verfügbar-
standards shall be withdrawn at the latest by normes nationales en contradiction devront être keit], und etwaige entgegenstehende nationale
[date of withdrawal 4) . retirées au plus tard en [date de retrait]. Normen müssen bis [Datum der Zurückziehung]
zurückgezogen werden.
This document has been prepared under a Le présent document a été élaboré dans le cadre Dieses Dokument wurde unter einem Mandat
mandate given to CEN by the European d'un mandat donné au CEN par la Commission erarbeitet, das die Europäische Kommission und
Commission and the European Free Trade Européenne et l'Association Européenne de Libre die Europäischen Freihandelszone dem CEN
Association and supports essential requirements Échange et vient à l'appui des exigences erteilt haben, und unterstützt grundlegende
of EU Directive(s). essentielles de la (des) Directive(s) UE. Anforderungen der EU-Richtlinien.
For relationship with EU Directive(s), see Pour les relations avec la (les) directive(s) UE, Zum Zusammenhang mit EU-Richtlinien siehe
informative Annex Z [appropriate letter(s)], which voir l'Annexe Z [lettre appropriée] informative, informativen Anhang Z[entsprechende Buch-
is (are) an integral part of this document. qui fait partie intégrante du présent document. stabe(n)], welche(r) Bestandteil(e) dieses
Dokuments ist/sind.
Introduction Introduction Einleitung
This document is a type-C standard as stated in Le présent document est une norme de type C tel Diese Norm ist eine Typ C-Norm wie in
EN ISO 12100. que mentionné dans l'EN ISO 12100. EN ISO 12100 angegeben.
This document is of relevance, in particular, for Le présent document concerne, en particulier, les Dieses Dokument ist insbesondere für die
the following stakeholder groups representing groupes de parties prenantes suivants, folgenden Interessentengruppen von Relevanz,
the market players with regard to machinery représentant les acteurs du marché dans le die die Marktakteure im Hinblick auf die Sicher-
safety: domaine de la sécurité des machines: heit von Maschinen repräsentieren:
— machine manufacturers (small, medium and — fabricants de machines (petites, moyennes et — Maschinenhersteller (kleine, mittlere und
large enterprises); grandes entreprises); große Unternehmen);
— health and safety bodies (regulators, accident — organismes de santé et de sécurité (autorités — Organisationen des Arbeits- und
prevention organizations, market réglementaires, organismes de prévention Gesundheitsschutzes (Gesetzgeber,
surveillance, etc.). des risques professionnels, surveillance du Unfallversicherungen, Marktaufsicht usw.).
marché, etc.).
4) The European Commission will generally use the "date of withdrawal" of the new edition as the "date of cessation of presumption of conformity of the
superseded standard" (transition period).
29
Others can be affected by the level of machinery D'autres partenaires peuvent être concernées par Andere interessierte Kreise können durch das in
safety achieved with the means of the document le niveau de sécurité des machines atteint à l’aide diesem Dokument (durch die oben genannten
by the above-mentioned stakeholder groups: du document par les groupes de parties interessierten Kreise) festgeschriebene
prenantes mentionnés ci dessus: Sicherheitsniveau betroffen sein. Es handelt sich
dabei um:
— machine users/employers (small, medium — utilisateurs de machines/employeurs — Maschinenanwender/Arbeitgeber (kleine,
and large enterprises); (petites, moyennes et grandes entreprises); mittlere und große Unter-nehmen);
— machine users/employees (e.g. trade unions, — utilisateurs de machines/salariés (par — Maschinenanwender/Arbeitnehmer
organizations for people with special needs); exemple syndicats de salariés, organisations (z B. Gewerkschaften, Organisationen für
représentant des personnes ayant des Personen mit spezifischen Bedürfnissen);
besoins particuliers);
— service providers, e.g. for maintenance — prestataires de services, par exemple — Dienstleistungsanbieter (kleine, mittlere und
(small, medium and large enterprises); sociétés de maintenance (petites, moyennes große Unternehmen);
et grandes entreprises);
— consumers (in the case of machinery — consommateurs (dans le cas de machines — Verbraucher (falls die behandelten
intended for use by consumers) destinées à être utilisées par des Maschinen für die Nutzung durch
consommateurs). Verbraucher bestimmt sind).
The above-mentioned stakeholder groups have Les groupes de parties prenantes mentionnés ci- Den oben genannten interessierten Kreisen
been given the possibility to participate at the dessus ont eu la possibilité de participer à wurde die Möglichkeit eingeräumt, sich an der
drafting process of this document. l'élaboration du présent document. Erarbeitung dieses Dokuments zu beteiligen.
The machinery concerned and the extent to which Les machines concernées et l'étendue des Auf die betreffenden Maschinen und die
hazards, hazardous situations or hazardous phénomènes dangereux, situations dangereuses behandelten Gefährdungen, Gefährdungs-
events are covered are indicated in the Scope of ou événements dangereux couverts sont indiqués situationen und Gefährdungsereignisse wird im
this document. dans le domaine d'application du présent Anwendungsbereich dieses Dokumentes
document. hingewiesen.
When requirements of this type-C standard are Lorsque des prescriptions de la présente norme Für Maschinen, die nach den Festlegungen dieser
different from those which are stated in type-A or de type C sont différentes de celles énoncées dans Typ C-Norm konzipiert und gebaut worden sind,
type-B standards, the requirements of this type-C les normes de type A ou de type B, les gilt: Wenn die Festlegungen in dieser Typ C-Norm
standard take precedence over the requirements prescriptions de la présente norme de type C ont von den Festlegungen in Typ A- oder Typ B-
of the other standards for machines that have priorité sur celles des autres normes pour les Normen abweichen, haben die Festlegungen
been designed and built according to the machines ayant été conçues et fabriquées suivant dieser Typ C-Norm Vorrang gegenüber den
requirements of this type-C standard. les prescriptions de la présente norme de type C. Festlegungen der anderen Normen.
30
1 Scope 1 Domaine d'application 1 Anwendungsbereich

This document specifies… Le présent document spécifie… Diese Norm legt ….fest.
It is applicable to… Il s'applique aux .... Diese Norm gilt für ….
and/or et/ou und/oder
It is not applicable to… Il ne s'applique pas aux .... Diese Norm gilt nicht für ….
This document deals with all significant hazards, Le présent document traite tous les phénomènes Diese Norm behandelt alle signifikanten
hazardous situations or hazardous events dangereux, situations dangereuses ou Gefährdungen, Gefährdungssituationen oder
relevant to… machinery, when it is used as événements dangereux significatifs qui sont Gefährdungsereignisse, die auf die ... Maschinen,
intended and under conditions of misuse which pertinents pour les machines ..., lorsqu'elles sont Geräte, Anlagen zutreffen, wenn sie bestim-
are reasonably foreseeable by the manufacturer. utilisées normalement et dans les conditions de mungsgemäß und unter Bedingungen, die vom
mauvais usage raisonnablement prévisible par le Hersteller als Fehlanwendung vernünftigerweise
fabricant. vorhersehbar sind, verwendet werden.
[or] [ou] [oder]
This document deals with all significant hazards, Le présent document traite tous les phénomènes Diese Norm behandelt alle signifikanten
hazardous situations or hazardous events with dangereux, situations dangereuses ou Gefährdungen, Gefährdungssituationen oder
the exception of … relevant to … machinery, when événements dangereux significatifs, à l'exception Gefährdungsereignisse, mit Ausnahme
it is used as intended and under conditions of de ..., qui sont pertinents pour les machines ..., derjenigen, die auf die ... Maschinen, Geräte,
misuse which are reasonably foreseeable by the lorsqu'elles sont utilisées normalement et dans Anlagen zutreffen, wenn sie bestimmungsgemäß
manufacturer. les conditions de mauvais usage raisonnablement und unter Bedingungen, die vom Hersteller als
prévisible par le fabricant. Fehlanwendung vernünftigerweise vorhersehbar
sind, verwendet werden.
[or] [ou] [oder]
This document deals with the following Le présent document traite les phénomènes Diese Norm behandelt die folgenden signifikanten
significant hazards, hazardous situations or dangereux, situations dangereuses ou Gefährdungen, Gefährdungssituationen oder
hazardous events relevant to.... machinery, when événements dangereux significatifs suivants qui Gefährdungsereignisse, die auf die ... Maschinen,
it is used as intended and under conditions of sont pertinents pour les machines ...., lorsqu'elles Geräte, Anlagen zutreffen, wenn sie bestim-
misuse which are reasonably foreseeable by the sont utilisées normalement et dans les conditions mungsgemäß und unter Bedingungen, die vom
manufacturer: de mauvais usage raisonnablement prévisible par Hersteller als Fehlanwendung vernünftigerweise
— [details] le fabricant: vorhersehbar sind, verwendet werden:
— — [préciser] — [genau]
—. — —
—. —.
This document is not applicable to …precise the Ce document ne s'applique pas aux ...préciser les Diese Norm gilt nicht für ...., die vor
machinery or machinery components here … machines ou composants de machine ... fabriqués Veröffentlichung dieser EN hergestellt wurden.
manufactured before the date of its publication. avant sa date de publication.
31
2 Normative references 2 Références normatives 2 Normative Verweisungen

The following documents are referred to in the Les documents suivants cités dans le texte Die folgenden Dokumente werden im Text in
text in such a way that some or all of their content constituent, pour tout ou partie de leur contenu, solcher Weise in Bezug genommen, dass einige
constitutes requirements of this document. For des exigences du présent document. Pour les Teile davon oder ihr gesamter Inhalt
dated references, only the edition cited applies. références datées, seule l'édition citée s'applique. Anforderungen des vorliegenden Dokuments
For undated references, the latest edition of the Pour les références non datées, la dernière darstellen. Bei datierten Verweisungen gilt nur
referenced document (including any édition du document de référence (y compris les die in Bezug genommene Ausgabe. Bei
amendments) applies. éventuels amendements) s’applique. undatierten Verweisungen gilt die letzte Ausgabe
des in Bezug genommenen Dokuments
(einschließlich aller Änderungen).
EN ISO 12100:2010, Safety of machinery — EN ISO 12100:2010, Sécurité des machines — EN ISO 12100:2010, Sicherheit von Maschinen –
General principles for design — Risk assessment Principes généraux de conception — Appréciation Allgemeine Gestaltungsleitsätze –
and risk reduction du risque et réduction du risque Risikobeurteilung und Risikominderung
3 Terms and definitions 3 Termes et définitions 3 Begriffe
For the purposes of this document, the terms and Pour les besoins du présent document, les termes Für die Anwendung dieses Dokuments gelten die
definitions given in EN ISO 12100:2010 [and …] et définitions donnés dans l'EN ISO 12100:2010 Begriffe nach EN ISO 12100:2010 [und…] [sowie
[and the following] apply. [et…] [ainsi que les suivants] s'appliquent. die Folgenden].
ISO and IEC maintain terminological databases for L'ISO et l'IEC tiennent à jour des bases de données ISO und IEC stellen terminologische Datenbanken
use in standardization at the following addresses: terminologiques destinées à être utilisées en für die Verwendung in der Normung unter den
normalisation, consultables aux adresses folgenden Adressen bereit:
suivantes:
— IEC Electropedia: available at — IEC Electropedia: disponible à l'adresse — IEC Electropedia: unter
http://www.electropedia.org/ http://www.electropedia.org/
http://www.electropedia.org/
— ISO Online browsing platform: available at — ISO Online browsing platform: disponible à — ISO Online Browsing Platform: unter
l'adresse http://www.iso.org/obp http://www.iso.org/obp
http://www.iso.org/obp
4 Safety requirements and/or 4 Prescriptions de sécurité et/ou mesures 4 Sicherheitsanforderungen und/oder
protective/risk reduction measures de prévention/réduction des risques Schutz-/Risikominderungs-maßnahmen
Machinery shall comply with the safety Les machines doivent être conformes aux exigen- Maschinen müssen den Sicherheitsanforderungen
requirements and/or protective/risk reduction ces de sécurité et/ou aux mesures de prévention/ und/oder Schutz-/Risikominderungsmaßnahmen
measures of this clause. réduction des risques du présent article. dieses Abschnittes entsprechen.
In addition, the machine shall be designed De plus, les machines doivent être conçues selon Außerdem muss die Maschine im Hinblick auf
according to the principles of EN ISO 12100:2010 les principes de l'EN ISO 12100:2010 pour les relevante aber nicht signifikante Gefährdungen,
for relevant but not significant hazards which are phénomènes dangereux pertinents mais non die nicht in diesem Dokument behandelt werden,
not dealt with by this document. significatifs qui ne sont pas traités dans le présent entsprechend den Leitsätzen der EN
document. ISO 12100:2010 konstruiert werden.
5 Verification of safety requirements 5 Vérification des prescriptions et/ou 5 Feststellung der Übereinstimmung mit
and/or protective/risk reduction measures mesures de prévention/ réduction des risques den Sicherheits-anforderungen und/oder
32
Schutz-/Risikominderungsmaßnahmen
6 Information for use 6 Informations pour l'utilisation 6 Benutzerinformation
Additional clauses, if needed Articles supplémentaires, s’il y a lieu. Zusätzliche Abschnitte, falls erforderlich
Annex A Annexe A Anhang A
(normative) (normative) (normativ)
Annex B Annexe B Anhang B
(informativ) (informative) (informativ)
Annex C Annexe C Anhang C
(informative) (informative) (informativ)
List of significant hazards Liste des phénomènes dangereux significatifs Liste der signifikanten Gefährdungen
Annex D Annexe D Anhang D
Significant technical changes between this Modifications techniques significatives entre Signifikante technische Änderungen dieser
standard and the previous edition la présente norme et l’édition précédente Europäischen Norm gegenüber der
Vorgängerausgabe
[Only in cases where the significant technical [Uniquement dans le cas où ces modifications [Nur in den Fällen, in denen signifikante technische
changes are not stated in the Foreword.] techniques significatives ne sont pas signalées dans Änderungen nicht im Vorwort angegeben sind.]
l’avant-propos.]
33
Annex ZA Annexe ZA Anhang ZA

Relationship between this European Standard Relation entre la présente Norme européenne Zusammenhang zwischen dieser
and the essential requirements of Directive et les exigences essentielles concernées de la Europäischen Norm und den grundlegenden
2006/42/EC aimed to be covered Directive 2006/42/CE visant à être couvert Anforderungen der abzudeckenden
Richtlinie 2006/42/EG
This European Standard has been prepared under La présente Norme européenne a été élaborée en Diese Europäische Norm wurde im Rahmen eines
a Commission’s standardization request „M/396 réponse à la demande de normalisation “M/396 von der Europäischen Kommission erteilten
Mandate to CEN and CENELEC for Standardisation Mandat adressé au CEN et au CENELEC Normungsauftrages „M/396 Auftrag an CEN und
in the field of machinery“ to provide one concernant des travaux de normalisation dans le CENELEC betreffend die Normung im Bereich
voluntary means of conforming to essential domaine des machines” de la Commission Maschinen“ erarbeitet, um ein freiwilliges Mittel
requirements of Directive 2006/42/EC of the européenne afin d'offrir un moyen volontaire de zur Erfüllung der grundlegenden Anforderungen
European Parliament and of the Council of 17 May se conformer aux exigences essentielles de la der Richtlinie 2006/42/EG des Europäischen
2006 on machinery, and amending Directive Directive 2006/42/CE du Parlement Européen et Parlaments und des Rates vom 17. Mai 2006 über
95/16/EC (recast). du Conseil du 17 mai 2006 relative aux machines Maschinen und zur Änderung der Richtlinie
Once this standard is cited in the Official Journal et modifiant la directive 95/16/CE (refonte). 95/16/EG (Neufassung) bereitzustellen.
of the European Union under that Directive, Une fois la présente norme citée au Journal Sobald diese Norm im Amtsblatt der
compliance with the normative clauses of this officiel de l’Union européenne au titre de ladite Europäischen Union im Sinne dieser Richtlinie in
standard given in Table ZA.1 confers, within the Directive, la conformité aux articles de cette Bezug genommen worden ist, berechtigt die
limits of the scope of this standard, a presumption norme indiqués dans le Tableau ZA.1 confère, Übereinstimmung mit den in Tabelle ZA.1
of conformity with the corresponding essential dans les limites du domaine d’application de la aufgeführten normativen Abschnitten dieser
requirements of that Directive and associated norme, présomption de conformité aux exigences Norm innerhalb der Grenzen des
EFTA regulations. essentielles de ladite Directive et de la Anwendungsbereiches dieser Norm zur
réglementation AELE associée. Vermutung der Konformität mit den
entsprechenden grundlegenden Anforderungen
der Richtlinie und den zugehörigen EFTA
Vorschriften.
34
Table ZA.1 –Correspondence between this Tableau ZA.1 – Correspondance entre la Tabelle ZA.1 – Zusammenhang zwischen dieser
European Standard and Annex I of présente Norme Européenne et l'Annexe I Europäischen Norm und Anhang I der Richtlinie
Directive 2006/42/EC de la Directive 2006/42/CE 2006/42/EG
Essential Clause(s)/ Remarks/ Exigence Article(s)/ Remarques/ Grundlegende Abschnitt(e)/ Erläuterungen/
Requirement of subclause(s) Notes Essentielle paragraph(es) Notes Anforderung Unter- Anmerkungen
Directive of this EN de la de la présente der Richtlinie abschnitt(e)
Directive EN dieser EN
Option A.1: All normative For relation of normative Option A.1: Tous les articles Pour les relations Option A.1: Alle normativen Hinsichtlich des
Within the limits clauses clauses of this standard to Dans les normatifs entre des clauses Innerhalb der Abschnitte Zusammenhangs der
of the scope all significant limites du normatives de la Grenzen des normativen Abschnitte
relevant hazards/relevant domaine présente norme et des Anwendungsber dieser Norm zu
essential essential requirements of d’application phénomènes eiches sind alle signifikanten
requirements are 2006/42/EC see toutes les dangereux /exigences relevanten Gefährdungen/rele-vanten
covered informative annex XX „List exigences essentielles grundlegenden grundlegenden
of significant hazards“ of essentielles applicables de Anforderungen Anforderungen der
this standard in applicables 2006/42/CE voir behandelt 2006/42/EG siehe Anhang
combination with annex D sont indiquées annexe informative XX „Liste der signifikanten
“Examples of significant XX "Liste des Gefährdungen“ dieser
hazards, hazardous phénomènes Norm in Verbindung mit
situations, hazardous dangereux" de cette Anhang D „Beispiele für
events and their relation norme en signifikante
to the Essential combinaison avec Gefährdungen,
Requirements of the l'annexe D " Exemples Gefährdungs-situationen,
Machinery Directive de phénomènes Gefährdungs-ereignisse
2006/42/EC” of dangereux, de und deren Zusammenhang
CEN Guide 414 situations mit den Grundlegenden
(https://boss.cen.eu/ref/C dangereuses, Anforderungen der
EN_414.pdf). d’événements Maschinenrichtlinie
dangereux 2006/42/EG„ von CEN
significatifs et leur Guide 414
relation avec les (https://boss.cen.eu/ref/C
Exigences Essentielles EN_414.pdf).
de la Directive
2006/42/CE relative
aux machines" du
Guide 414 CEN
(https://boss.cen.eu/
ref/CEN_414.pdf)
35
Option A.2: All normative For relation of Option A.2: Tous les articles Pour les relations Option A.2: Alle normativen Hinsichtlich des
Within the limits clauses except normative clauses Dans les normatifs à entre des clauses Innerhalb der Abschnitte mit Zusammenhangs der
of the scope all clause(s) (except clause(s) limites du l’exception des normatives (à Grenzen des Ausnahme von normativen Abschnitte
relevant yyy*) yyy*)) of this standard domaine articles yyy*) l'exception des Anwendungs- yyy*) dieser Norm (mit
essential to significant d’application articles yyy*)) de bereiches sind Ausnahme von yyy*))
requirements are hazards/relevant toutes les la présente norme alle relevanten zu signifikanten
covered essential requirements exigences et des phénomènes grundlegenden Gefährdungen/rele-
of 2006/42/EC see essentielles dangereux Anforderungen vanten grundlegenden
informative annex XX applicables /exigences behandelt Anforderungen der
„List of significant sont indiquées essentielles 2006/42/EG siehe
hazards“ of this applicables de Anhang XX „Liste der
standard in combination 2006/42/CE voir signifikanten
with annex D “Examples annexe informative Gefährdungen“ dieser
of significant hazards, XX "Liste des Norm in Verbindung mit
hazardous situations, phénomènes Anhang D „Beispiele für
hazardous events and dangereux" de cette signifikante
their relation to the norme en Gefährdungen,
Essential Requirements combinaison avec Gefährdungs-
of the Machinery l'annexe D " situationen,
Directive 2006/42/EC” Exemples de phéno- Gefährdungs-ereignisse
of CEN Guide 414 mènes dangereux, und deren
(https://boss.cen.eu/ref de situations Zusammenhang mit den
/CEN_414.pdf). dangereuses, Grundlegenden
d’événements Anforderungen der
dangereux signi- Maschinenrichtlinie
ficatifs et leur 2006/42/EG„ von CEN
relation avec les Guide 414
Exigences Essen- (https://boss.cen.eu/ref/
tielles de la CEN_414.pdf).
Directive
2006/42/CE
relative aux
machines" du Guide
414 CEN
(https://boss.cen.eu
/ref/CEN_414.pdf)
36
Option B.1: All normative For relation of Option B.1: Tous les articles Pour les relations Option B.1: Alle normativen Hinsichtlich des
Within the limits clause normative clauses of this Dans les normatifs entre des clauses Innerhalb der Abschnitte Zusammenhangs der
of the scope all standard to significant limites du normatives de la Grenzen des normativen Abschnitte
relevant hazards/relevant domaine présente norme et Anwendungs- dieser Norm zu
essential essential requirements d’application des phénomènes bereiches sind signifikanten
requirements of 2006/42/EC see toutes les dangereux alle relevanten Gefährdungen/rele-
with the informative annex XX exigences /exigences grundlegenden vanten grundlegenden
exception of „List of significant essentielles essentielles Anforderungen Anforderungen der
essential hazards“ of this applicables applicables de mit Ausnahme 2006/42/EG siehe
requirement(s) standard in combination sont indiquées 2006/42/CE voir der grund- Anhang XX „Liste der
xxx are covered with annex D “Examples à l’exception annexe informative legenden signifikanten
of significant hazards, des XX "Liste des phéno- Anforderung(e Gefährdungen“ dieser
hazardous situations, exigences mènes dangereux" n) xxx Norm in Verbindung mit
hazardous events and essentielles de cette norme en behandelt Anhang D „Beispiele für
their relation to the xxx combinaison avec signifikante
Essential Requirements l'annexe D " Gefährdungen,
of the Machinery Exemples de phéno- Gefährdungssituati-
Directive 2006/42/EC” mènes dangereux, onen, Gefährdungs-
of CEN Guide 414 de situations dange- ereignisse und deren
(https://boss.cen.eu/ref reuses, d’événe- Zusammenhang mit den
/CEN_414.pdf). ments dangereux Grundlegenden
signify-catifs et leur Anforderungen der
relation avec les Maschinenrichtlinie
Exigences Essen- 2006/42/EG„ von CEN
tielles de la Guide 414
Directive (https://boss.cen.eu/ref/
2006/42/CE CEN_414.pdf).
relative aux
machines" du Guide
414 CEN
/ref/CEN_414.pdf)
37
Option B.2: All normative For relation of Option B.2: Tous les articles Pour les relations Option B.2: Alle normativen Hinsichtlich des
clauses except normative clauses normatifs à entre des clauses Abschnitte mit Zusammenhangs der
Within the limits Dans les normatives (à Innerhalb der
of the scope all clause(s) (except clause(s) limites du l’exception des Grenzen des Ausnahme von normativen Abschnitte
l'exception des
relevant yyy*) yyy*)) of this standard domaine articles yyy*) articles yyy*))de la Anwendungs- yyy*) dieser Norm (mit
essential to significant d’application présente norme et bereiches sind Ausnahme von yyy*))
hazards/relevant des phénomènes zu signifikanten
requirements toutes les alle relevanten
essential requirements dangereux Gefährdungen/relevante
with the exigences /exigences grundlegenden
exception of of 2006/42/EC see essentielles essentielles Anforderungen n grundlegenden
essential informative annex XX applicables applicables de mit Ausnahme Anforderungen der
requirement(s) „List of significant sont indiquées 2006/42/CE voir 2006/42/EG siehe
der grund-
hazards“ of this annexe informative Anhang XX „Liste der
xxx are covered à l’exception XX "Liste des legenden
standard in combination des Anforde- signifikanten
phénomènes
with annex D “Examples exigences dangereux" de cette rung(en) xxx Gefährdungen“ dieser
of significant hazards, essentielles norme en behandelt Norm in Verbindung mit
hazardous situations, combinaison avec Anhang D „Beispiele für
xxx
hazardous events and l'annexe D " signifikante
Exemples de
their relation to the phénomènes Gefährdungen,
Essential Requirements dangereux, de Gefährdungssituationen,
of the Machinery situations Gefährdungsereignisse
Directive 2006/42/EC” dangereuses, und deren
of CEN Guide 414 d’événements Zusammenhang mit den
dangereux
(https://boss.cen.eu/ref Grundlegenden
significatifs et leur
/CEN_414.pdf). relation avec les Anforderungen der
Exigences Maschinenrichtlinie
Essentielles de la 2006/42/EG„ von CEN
Directive Guide 414
2006/42/CE (https://boss.cen.eu/ref/
relative aux CEN_414.pdf).
machines" du Guide
414 CEN
/ref/CEN_414.pdf)
38
Option C: The relevant Option C: [L’article Option C: [Die relevanten

[Per row: an normative [Une exigence normatif [Je Zeile: eine normativen
essential clauses linked essentielle par pertinent en grundlegende Abschnitte, die
requirement] to the ligne] lien avec Anforderung.] sich auf die
individual l’exigence jeweilige
essential essentielle grundlegende
requirement] particulière] Anforderung
beziehen]
*) In cases where certain normative clauses of the standard *) Dans les cas où certains articles normatifs traitent *) In Fällen, bei denen sich bestimmte normative Abschnitte
do cover other aspects than those providing presumption d’autres aspects que ceux donnant présomption de der Norm mit Aspekten beschäftigen, die keine
of conformity. conformité Vermutungswirkung auslösen.
WARNING 1 — Presumption of conformity stays AVERTISSEMENT 1 — La présomption de WARNHINWEIS 1 — Die Konformitäts-vermutung

valid only as long as a reference to this European conformité demeure valable tant que la bleibt nur bestehen, so lange die Fundstelle dieser
Standard is maintained in the list published in the référence de la présente Norme européenne Europäischen Norm in der im Amtsblatt der
Official Journal of the European Union. Users of this figure dans la liste publiée au Journal officiel de Europäischen Union veröffent-lichten Liste erhalten
standard should consult frequently the latest list l'Union européenne. Il est recommandé aux bleibt. Anwender dieser Norm sollten regelmäßig
published in the Official Journal of the European utilisateurs de la présente norme de consulter die im Amtsblatt der Europäischen Union zuletzt
Union. régulièrement la dernière liste publiée au veröffentlichte Liste einsehen.
Journal officiel de l'Union européenne.
WARNING 2 — Other Union legislation may be AVERTISSEMENT 2 — D'autres dispositions WARNHINWEIS 2 — Für Produkte /
applicable to the product(s) / [service(s)] / […] de la législation de l’Union européenne [Dienstleistungen] / […], die in den
falling within the scope of this standard. peuvent être applicables aux produits / Anwendungsbereich dieser Norm fallen, können
[services] / […] relevant du domaine weitere Rechtsvorschriften der EU anwendbar sein.
d'application de la présente norme.
Bibliography Bibliographie Literaturhinweise
39
(informative)
Guidance on extension of transition period
C.1 General
When a European Standard (EN) is approved, implementation is compulsory for all CEN National
Members from EEA countries.
European Standards (EN) will be implemented by the CEN National Members within a period expressed
in months from the date of availability (dav) of the EN. This is normally three months for the date of
announcement (doa), six months for the date of publication (dop) and six months for the date of
withdrawal (dow).
The date of withdrawal (dow) is by definition the latest date by which any national standard conflicting
with an EN shall be withdrawn. It is a date common to all CEN National Members.
C.2 Exceptional extension of the date of withdrawal

To allow the industry (manufacturers) to make an ordered conversion to the new EN it should be
considered by the responsible TC if an extension of the transition period (dow later than dav + 6
months), is justified and should be therefore requested.
As a first step a transition period, if necessary, should be proposed by the standardization body (e.g.
WG) in charge of elaborating the draft standard and be included in the document intended for CEN
Enquiry using the following wording:
"A transition period of X months (dav + 6 months + X extra months) is proposed."
After the CEN Enquiry the responsible TC should decide on an extended transition period (dow later
than dav + 6 months up to maximum of dav + 36 months) in accordance with the CEN BOSS Guidance
document “Date of withdrawal.
C.3 Consequences for European Standards to be cited in the Official Journal of the
European Union
European Standards can be listed in the 'Official Journal of the European Union' (OJEU) under one or
more New Approach directives. In practice, this means that a product manufactured according to a
European Standard, the reference of which is cited in the OJEU under a New Approach directive, is
presumed to comply with the essential requirements of that directive (this is called 'presumption of
conformity').
When a European Standard that is cited in the OJEU is replaced by a new version (also to be cited in the
OJEU under the same directive), the European Commission (EC) will generally use the dow of that new
version as the 'Date of cessation of presumption of conformity of the superseded standard'. This date
marks the end of the period during which both the old and the new version of the standard can be used
to claim 'presumption of conformity' to the essential requirements of the relevant directive. After that
date, 'presumption of conformity' can no longer be claimed for a product manufactured according to the
old version of the standard.
40
It should be noted that extending the dow does not lead to an automatic extension of the 'Date of
cessation of presumption of conformity of the superseded standard', for standards that have already
been sent to the EC for citation in the OJEU. When it is deemed necessary to extend the 'Date of
cessation of presumption of conformity of the superseded standard' for such standards, CCMC should
be contacted for guidance. 5) For the process for requesting and deciding on a dow later than dav +
6 months see CEN BOSS.
5) This Annex is based on the guidance document "Date of withdrawal" from CEN BOSS. In case of modification of
the guidance given by CEN BOSS, the current version of that guidance takes precedence over this Annex.
41
(informative)
Examples of significant hazards, hazardous situations, hazardous events

and their relation to the Essential Requirements of the Machinery Directive
2006/42/EC
Whereas the Machinery Directive 2006/42/EC states in its Annex I Essential Requirements, the general
methodology for safety of machinery specified in EN ISO 12100 is based on the consideration of
significant hazards basically without any specific reference to the Essential Requirements of
Directive 2006/42/EC. As there is not always an obvious linkage from the Essential Requirements to
the significant hazards, hazardous situations, hazardous events they are based on, Table D.1 provides as
far as possible examples of significant hazards, hazardous situations, hazardous events and their
relation to this Essential Requirements.
Table 1 — Examples of significant hazards, hazardous situations, hazardous events and their
relation to the Essential Requirements of the Machinery Directive 2006/42/EC
Group Significant hazard in accordance with Directive 2006/42/EC, Annex I
EN ISO 12100:2010, Table B.1
General, for many machines relevant
1 Mechanical hazards
1.1 Due to machine parts or workpieces, e.g. 1.3.3 Risks due to falling or ejected objects
— by potential energy (falling objects, height from
the ground, gravity)
— by kinetic energy (acceleration, deceleration, 1.3.7 Risks related to moving parts
moving/rotating elements)
— by mechanical strength (break-up) 1.1.3 Materials and products
1.3.2 Risk of break-up during operation
1.2 by stored energy, e.g.: 1.3.9 Risks of uncontrolled movements
— elastic elements (springs) 1.5.3 Energy supply other than electricity
1.6.3 Isolation of energy sources
1.3 Crushing 1.3 Protection against mechanical hazards
1.4 Shearing 1.3 Protection against mechanical hazards
1.5 Cutting or severing 1.3.4 Risks due to surfaces, edges or angles
1.6 Entanglement 1.3 Protection against mechanical hazards
1.7 Drawing-in or trapping 1.3 Protection against mechanical hazards
1.8 Impact 1.3 Protection against mechanical hazards
1.9 Stabbing or puncture 1.3 Protection against mechanical hazards
1.10 Friction or abrasion 1.3.4 Risks due to surfaces, edges or angles
1.11 Injection 1.3.2 Risk of break-up during operation
1.12 Slipping, tripping and falling 1.5.15 Risk of slipping, tripping or falling
1.13 Instability 1.1.5 Design of machinery to facilitate its
handling
1.3.1 Risk of loss of stability
42

EN ISO 12100:2010, Table B.1
2 Electrical hazards
2.1 Touching live parts 1.5.1 Electricity supply
2.2 Parts which have become live under fault conditions 1.5.1 Electricity supply
2.3 Not enough distance to live parts under high voltage 1.5.1 Electricity supply
2.4 Electrostatic phenomena 1.5.2 Static electricity
2.5 Electromagnetic phenomena 1.2.1 Safety and reliability of control
systems
2.6 Projection of molten particles 1.5.5 Extreme temperatures
2.7 Short-circuit 1.5.1 Electricity supply
2.8 Overload 1.5.1 Electricity supply
2.9 Thermal radiation 1.5.1 Electricity supply
3 Thermal hazards
3.1 Burn, scald 1.5.5 Extreme temperatures
1.5.6 Fire
1.5.7 Explosion
3.2 Frostbite 1.5.5 Extreme temperatures
3.3 Radiation of heat sources 1.5.5 Extreme temperatures
3.4 Dehydration 1.5.5 Extreme temperatures
4 Noise hazards
4.1 Permanent hearing loss, tinnitus 1.5.8 Noise
4.2 As a consequence of an interference with speech 1.5.8 Noise
communication or with acoustic signals.
4.3 Physiological impairment (e.g. loss of balance, loss 1.5.8 Noise
of awareness)
5 Vibration hazards
5.1 Vibrations transmitted to the operator when sitting 1.1.8 Seating
during operation
5.2 Portable hand-held and/or hand-guided machinery 1.5.9 Vibrations
(e.g. vascular disorder, neurological disorder)
5.3 In conjunction with a rigid position (e.g. trauma of 1.5.9 Vibrations
the spine, osteo-articular disorder, low-back
morbidity)
6 Radiation hazards
6.1 Low frequency electromagnetic radiation 1.5.10 Radiation
6.2 Radio frequency electromagnetic radiation 1.5.10 Radiation
1.5.11 External radiation
6.3 Optical radiation (infrared, visible and ultraviolet) 1.5.10 Radiation
6.4 Laser 1.5.12 Laser radiation
6.5 Ionizing radiation source 1.5.10 Radiation
1.5.11 External radiation
43

EN ISO 12100:2010, Table B.1
7 Material/ substance hazards
7.1 Hazards from contact with inhalation of harmful 1.1.3 Materials and products
fluids, gases, mists, fumes and dusts 1.5.13 Emissions of hazardous materials
and substances
1.6.5 Cleaning of internal parts
7.2 Fire 1.5.6 Fire
7.3 Explosion 1.5.7 Explosion
7.4 Biological and microbiological (viral or bacterial) 1.1.3 Materials and products
agent 1.6.5 Cleaning of internal parts
2.1 Foodstuff Machinery and Machinery for
cosmetics or pharmaceutical products
7.5 Use/application of pesticides 2.4 Machinery for pesticide application
8 Ergonomic hazards
8.1 Unhealthy postures or excessive effort 1.1.5 Design of machinery to facilitate its
handling
1.1.6 Ergonomics
8.2 Inadequate consideration of anatomy 1.1.6 Ergonomics
1.6.2 Access to operating positions and
servicing points
2.2 Portable hand-held and/or hand-guided
machinery
8.3 Insufficient means for evacuation/emergency exit 1.1.7 Operating positions
8.4 Inadequate local lighting 1.1.4 Lighting
8.5 Design or location of indicators and visual displays 1.7.1 Information and warnings on the
units machinery
8.6 Design, location or identification of control devices 1.2.2 Control devices
8.7 Flicker, dazzling, shadow, stroboscopic effect 1.1.4 Lighting
8.8 Mental overload/underload 1.1.6 Ergonomics
1.6.4 Operator intervention
8.9 Human error during operation 1.1.6 Ergonomics
1.2.1 Safety and reliability of control
systems
1.2.2 Control devices
1.2.5 Selection of control or operating
modes
1.5.4 Errors of fitting
1.7 Information
8.10 Repetitive activity 1.1.6 Ergonomics
9 Hazards associated with the environment in which the machine is used
9.1 Lightning 1.5.16 Lightning
9.2 Moisture 1.1.3 Material and products
systems
1.1.7 Operating positions
44

EN ISO 12100:2010, Table B.1
9.3 Pollution 1.1.3 Material and products
systems
9.4 Snow, water, wind, temperature 1.1.3 Material and products
systems
9.5 Exhaust gas/ lack of oxygen at workplace 1.1.7 Operating positions
9.6 Dust and fog 1.1.7 Operating positions
10
10.1 Failure/disorder of the control system and control 1.2.1 Safety and reliability of control
circuits systems
1.2.3 Starting
1.2.4 Stopping
1.2.5 Selection of control or operating
modes
10.2 Restoration of energy supply after an interruption 1.2.3 Starting
1.2.6 Failure of the power supply
10.3 Software error 1.2.1 Safety and reliability of control
systems
10.4 Failure of the power supply 1.2.6 Failure of the power supply
11 Combination of hazards
11.1 — for example, repetitive activity + effort + high 1.1.5 Design of machinery to facilitate its
environmental temperature handling
1.1.6 Ergonomics
1.6.2 Access to operating positions and
servicing point
1.6.4 Operator intervention
1.5.5 Extreme temperatures
11.2 — for example, dismantling of heavy guards + 1.3 Protection against mechanical hazards
painful effort 1.1.6 Ergonomics
12 Hazards due to:
— assembly and installation
— setting
— cleaning
— fault-finding
— maintenance
12.1 Maintenance 1.6.1 Machinery maintenance
12.2 Insufficient means of access during use, setting and 1.6.2 Access to operating positions and
maintenance servicing points
12.3 Cleaning inside the machine 1.6.4 Operator intervention
12.4 Being trapped in a machine 1.5.14 Risk of being trapped in a machine
45

EN ISO 12100:2010, Table B.1
Supplementary, for certain categories of machinery
13 Hazards due to contamination of: foodstuffs, cosmetics or pharmaceutical products
13.1 Unsuitable material 2.1 Foodstuffs machinery and machinery
cosmetics or pharmaceutical products
14 Hazards due to portable machinery — hand-held and/or hand-guided machinery
14.1 Instability 2.2 Portable hand-held and/or hand-guided
machinery
14.2 Accidental starting/or continued operation 2.2 Portable hand-held and/or hand-guided
machinery
14.3 Accidental start 2.2 Portable hand-held and/or hand-guided
machinery
15 Hazards due to working with wood and material with similar physical characters
15.1 Ejection of workpieces 1.3 Protection against mechanical hazards
2.3 Machinery for working wood and
material with similar physical characters
Supplementary, due to the mobility of machinery
16 Hazards related to travelling function
16.1 Movement when starting the engine 3.3.2 Starting/moving
3.3.4 Movement of pedestrian-controlled
machinery
16.2 Movement without a driver at the driving position 3.3.2 Starting/moving
16.3 Movement without all parts in safe position 3.3.2 Starting/moving
16.4 Excessive speed of pedestrian controlled machinery 3.3.4 Movement of pedestrian-controlled
machinery
16.5 Insufficient ability of machinery to be slowed down, 3.3.3 Travelling function
stopped and immobilized 3.3.5 Control circuit failure
17 Hazards linked to work position (including driving station) on the machine
17.1 Fall of persons during access to or at/from the work 3.4.5 Means of access
position 3.4.7 Transmission of power between self-
propelled machinery (or tractor) and recipient
machinery
17.2 Fire (lack of extinguishing means) 3.5.2 Fire
17.3 Mechanical hazards at the work position, such as: 3.2.1 Driving position
— contact with the wheels 3.4.3 Roll-over and tip-over
— rollover and overturning 3.4.5 Means of access
— slipping during access 3.4.4 Falling objects
— fall of objects, penetration by objects 3.3.4 Movement of pedestrian-controlled
— contact of persons with machine parts or tools machinery
(pedestrian controlled machines
17.4 Insufficient visibility from the work position 3.2.1 Driving position
17.5 Inadequate seating 3.2.2 Seating
18 Hazards due to the control system
18.1 Inadequate location of manual controls 3.3.1 Control devices
3.4.5 Means of access
46

EN ISO 12100:2010, Table B.1
18.2 Inadequate design of manual controls and their 3.3.1 Control devices
mode of operation 3.3.3 Travelling function
19 Hazards due to the power source and the transmission of power
19.1 Engine and batteries 3.4.2 Moving transmission parts
3.5.1 Batteries
19.2 Transmission of power between machines 3.4.7 Transmission of power between self-
propelled machinery (or tractor) and recipient
machinery
19.3 Couplings and towings 3.4.6 Towing devices
20 Hazards from/to third persons
20.1 Unauthorized start-up/use 3.3.2 Starting/moving
20.2 Drift of a part away from its stopping position 3.3.3 Travelling function
20.3 Lack or inadequacy of visual or acoustic warning 3.6.1 Signs, signals and warnings
means
21 Hazards due to insufficient instruction for the driver/operator
21.1 Insufficient instruction for the driver/operator 3.6 Information and Indications
Supplementary, due to lifting operations
22 Mechanical hazards caused by load falls, collisions, machine tipping
22.1 Lack of stability 4.1.2.1 Risks due to lack of stability
22.2 Uncontrolled loading, overloading, overturning 4.2.2 Loading control
moments exceeded 4.3.3 Lifting machinery
4.4.2 Lifting machinery
22.3 Uncontrolled amplitude of movements 4.1.2.6a) Control of movements
4.2.1 Control of movements
22.4 Unexpected/unintended movement of loads 4.1.2.6c) Control of movements
22.5 Inadequate holding devices/accessories 4.1.2.6e) Control of movements
4.4.1 Lifting accessories
22.6 Collision of more than one machine 4.1.2.6b) Control of movements
22.7 Access of persons to load support 4.3.3 Lifting machinery
22.8 Derailment 4.1.2.2 Machinery running on guide rails and
rail tracks
22.9 Insufficient mechanical strength of parts 4.1.2.3 Mechanical strength
22.10 Inadequate design of pulleys and drums 4.1.2.4 Pulleys, drums, wheels, ropes and
chains
22.11 Inadequate selection of chains, ropes, lifting and 4.1.2.4 Pulleys, drums, wheels, ropes and
accessories and their inadequate integration into chains
the machine 4.1.2.5 Lifting accessories and their
components
4.3.1 Chains, ropes and webbing
4.3.2 Lifting accessories
22.12 Lowering of the load under the control of friction 4.1.2.6d) Control of movements
brake
47

EN ISO 12100:2010, Table B.1
22.13 Abnormal conditions of assembly/use/maintenance 4.4.1 Lifting accessories
4.4.2d) Lifting machinery
4.4.2e) Lifting machinery
22.14 Effect of load on persons (impact by load or 4.1.2.6b) Control of movements
counterweight) 4.1.2.7 Movements of loads during handling
4.1.2.8 Machinery serving fixed landings
23 Hazards linked to driver/operator position
23.1 Insufficient visibility from driver position 4.1.2.7 Movements of loads during handling
4.4.2c) Lifting machinery
Supplementary, for machinery intended for underground work
24.1 Lack of stability of powered roof supports 5.1 Risks due to lack of stability
24.2 Failing accelerator or brake control of machinery 5.3 Control devices
running on rails
24.3 Failing or lack of deadman`s control of machinery 5.3 Control devices
running on rails 5.4 Stopping
25 Ergonomic hazards
25.1 Restricted movements of persons 5.2 Movement
26 Hazards associated with the environment in which the machine is used
26.1 Fire and explosion 5.5 Fire
26.2 Emission of dust, gases, etc. 5.6 Exhaust emissions
Supplementary, for machinery presenting particular hazards due to the lifting of persons
27.1 Due to: 6.1.1 Mechanical strength
— inadequate mechanical strength 6.1.2 Loading control for machinery
— inadequate working coefficients moved by power other than human strength
— failing of loading control
27.2 Failing of controls in person carrier (function, 6.2 Control devices
priority)
27.3 Overspeed of person carrier 6.3.1 Risks due to movements of the
carrier
6.4.1 Risks to persons in or on the carrier
27.4 Falling of persons from person carrier 6.3.2 Risk of persons falling from the
carrier
6.4.1 Risks to persons in or on the carrier
Hazards not be by eliminated or reduced by inherently safe design measures or safeguarding and/or
complementary protective measures
— — 1.7 Information
48
Bibliography
[1] EN 1746, Safety of machinery — Guidance for the drafting of the noise clauses of safety standards
[2] EN 12786, Safety of machinery — Requirements for the drafting of the vibration clauses of safety
standards
[3] EN 61310 (all parts), Safety of machinery — Indication, marking and actuation
[4] EN ISO 13857:2008, Safety of machinery — Safety distances to prevent hazard zones being
reached by upper and lower limbs
[5] CEN BOSS. Date of withdrawal, Guidance document

http://www.cen.eu/boss/supporting/Guidance%20documents/dow/Pages/default.aspx
[6] ISO/IEC Guide 51, Safety aspects — Guidelines for their inclusion in standards
[7] International Organization for Standardization (ISO) European Committee for Standardization
(CEN), Agreement on technical co-operation between ISO and CEN (Vienna Agreement)
[8] International Organization for Standardization (ISO) European Committee for Standardization
(CEN), Agreement on technical co-operation between ISO and CEN (Vienna Agreement) —
Guidelines for the implementation of the agreement on technical co-operation between ISO and
CEN (Vienna Agreement)
[9] United Nations, Economic and Social Council, Economic Commission for Europe (UN/ECE),
UNECE Recommendation "L", An international model for technical harmonization based on good
regulatory practice for the preparation, adoption and application of technical regulations via the
use of international standards
49

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CEN

Safety of machinery – Rules for the

European foreword .......................................................................................................................................................5

6.10.3 Informative annexes ................................................................................................................................... 23

This document supersedes CEN Guide 414:2014.

b) 5.2, item b) has been deleted.

c) 6.10 has been updated and re-numbered.

3 Terms and definitions

• ISO Online browsing platform: available at http://www.iso.org/obp

Note 1 to entry: See EN ISO 12100:2010, Introduction.

Note 1 to entry: See EN ISO 12100:2010, Introduction.

Note 1 to entry: See EN ISO 12100:2010, Introduction.

Note 1 to entry: See EN ISO 12100:2010, Introduction.

Note 1 to entry: See EN ISO 12100:2010, Introduction.

[SOURCE: EN ISO 12100:2010, 3.7]

[SOURCE: EN ISO 12100:2010, 3.8]

Figure 1 — Dealing with hazards of a particular machine or group of machines

1) A definition of adequate risk reduction is given in EN ISO 12100:2010, 3.18.

4.2 Type-B standards

d) establish, as necessary and practicable, performance requirements (for example, types or

NOTE Possible reasons for establishing different performance requirements are:

— the severity of the possible harm from the considered hazard,

— the frequency and duration of the hazardous situation,

— the probability of occurrence of a hazardous event, and

— the possibility to avoid or limit the harm.

4.3 Type-C standards

a) By reference to relevant and applicable type-B standards (see 6.7.4).

4.3.2 Mandatory provisions

Type-C standards shall clearly establish the following:

— the scope (see 5.3 and 6.4);

— the significant hazard(s) (see 6.10.3.1);

— information for use (see 6.9).

4.3.3 Provisions with added value

— refer to a technical specification produced by a professional organization - this can be done

4.4 Need for a type-B standard

4.5 Deviations in a type-C standard

5 Principles to be considered before and during drafting process

5.2 Determination of necessity for standardization and/or revision

f) Are there national standards/specifications giving specific requirements, either directly or by

h) Is there sufficient expertise, collective knowledge and experience for standardization?

j) Is there sufficient feedback on the use of the existing safety standard?

5.3 Definition of scope

a) definition of the machine or group of similar machines;

c) determination of the space limits (see EN ISO 12100:2010, 5.3.3);

d) determination of the foreseeable "life limit", when applicable;

e) definition of the field of application.

5.4 Identification of hazards, hazardous situations or hazardous events

Considering EN ISO 12100:2010, especially its Annex B, as guidance:

a) identify the hazards that the machine is likely to generate;

c) identify the hazardous events which can lead to harm.

5.5 Estimation and evaluation of risk(s) generated by hazard(s)

The risk shall be estimated by combining the following steps.

b) Estimate the probability of occurrence of that harm which is a function of

1) the exposure of persons to the hazard (for example, frequency, duration),

2) the probability of occurrence of a hazardous event,

3) the technical and human possibilities to avoid or limit the harm.

5.5.2 Risk evaluation

— if risk reduction is required;

— whether the risk reduction objectives have been achieved.

5.6 Identification of risk reduction objectives