SIST CEN Vodilo 414:2017
(Main)Safety of machinery - Rules for the drafting and presentation of safety standards
Safety of machinery - Rules for the drafting and presentation of safety standards
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.
Sicherheit von Maschinen - Regeln für die Abfassung und Gestaltung von Sicherheitsnormen
Sécurité des machines - Règles pour l'élabotation et la présentation des normes de sécurité
Varnost strojev - Pravila za načrtovanje in predstavljanje varnostnih standardov
Ta dokument podaja pravila za načrtovanje in predstavljanje evropskih standardov, ki obravnavajo varnost naprav, ter njihovih revizij, s čimer se želi predvsem zagotoviti doslednost in sprejemljivo kakovost različnih standardov, ki so v pripravi.
Podaja tudi zahteve glede meril za izbiro novih delovnih elementov ter postopke za pripravo, oblikovanje in revizijo standardov na učinkovit način.
Ta dokument podaja dodatne zahteve k 3. delu notranjih predpisov CEN/CENELEC, ko je to potrebno v skladu s posebnimi zahtevami za standarde o varnosti strojev.
Ta dokument je primarno namenjen načrtovanju standardov tipa C. Uporablja se tudi za načrtovanje standardov tipa B, vendar razlike v obliki teh standardov preprečujejo splošno uporabo tega standarda. Ko se zahteve nanašajo izključno na standarde tipa B, je to izrecno navedeno.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2017
9DUQRVWVWURMHY3UDYLOD]DQDþUWRYDQMHLQSUHGVWDYOMDQMHYDUQRVWQLKVWDQGDUGRY
Safety of machinery - Rules for the drafting and presentation of safety standards
Sicherheit von Maschinen - Regeln für die Abfassung und Gestaltung von
Sicherheitsnormen
Sécurité des machines - Règles pour l'élabotation et la présentation des normes de
sécurité
Ta slovenski standard je istoveten z: CEN Guide 414:2017
ICS:
01.120 Standardizacija. Splošna Standardization. General
pravila rules
13.110 Varnost strojev Safety of machinery
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
CEN
GUIDE
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
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
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
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.
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).
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
Note 1 to entry: See EN ISO 12100:2010, Introduction.
3.2.1
type-B1 standard
type-B standard on particular safety aspects (for example, safety distances, surface temperature, noise)
Note 1 to entry: See EN ISO 12100:2010, Introduction.
3.2.2
type-B2 standard
type-B standard on safeguards (for example, two-hand control devices, interlocking devices, pressure-
sensitive devices, guards)
Note 1 to entry: See EN ISO 12100:2010, Introduction.
3.3
type-C standard
machine safety standard
standard dealing with detailed safety requirements for a particular machine or group of machines
Note 1 to entry: See EN ISO 12100:2010, Introduction.
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.
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
1)
achieve adequate risk reduction.
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.
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.
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;
— 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.
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.
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.
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.
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.
2)
As a minimum requirement, the following statement 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.
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.
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 []
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.
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.
6.7 Safety requirements and/or protective/risk reduction measures
6.7.1 This
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