Plastics and Rubber Machines - Thermoforming Machines - Safety Requirements

BRITISH STANDARD BS EN 12409:2008
+A1:2011
Plastics and
rubber machines
— Thermoforming
machines — Safety
requirements
ICS 83.200
NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW

BS EN 12409:2008+A1:2011
National foreword
This British Standard is the UK implementation of

EN 12409:2008+A1:2011. It supersedes BS EN 12409:2008 which is
withdrawn.
The start and finish of text introduced or altered by amendment is
indicated in the text by tags. Tags indicating changes to CEN text
carry the number of the CEN amendment. For example, text altered by
CEN amendment A1 is indicated by !".
The UK participation in its preparation was entrusted by Technical
Committee MCE/3, Safeguarding of machinery, to Subcommittee
MCE/3/2, Rubber and plastics machine - Safety.
A list of organizations represented on this committee can be obtained
on request to its secretary.
This publication does not purport to include all the necessary
provisions of a contract. Users are responsible for its correct
application.
Compliance with a British Standard cannot confer immunity
from legal obligations.
This British Standard Amendments/corrigenda issued since publication

was published under the
authority of the Standards
Policy and Strategy Date Comments
Committee on 31 October
2008
30 November 2011 Implementation of CEN amendment A1:2011
© BSI 2011
ISBN 978 0 580 72955 3

EUROPEAN STANDARD EN 12409:2008+A1
NORME EUROPÉENNE
EUROPÄISCHE NORM October 2011
ICS 83.200 Supersedes EN 12409:2008
English Version
Plastics and rubber machines - Thermoforming machines -

Safety requirements
Machines pour les matières plastiques et le caoutchouc - Kunststoff- und Gummimaschinen - Warmformmaschinen -
Machines de thermoformage - Prescriptions de sécurité Sicherheitsanforderungen
This European Standard was approved by CEN on 24 August 2008 and includes Amendment 1 approved by CEN on 29 August 2011.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same
status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION

COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 12409:2008+A1:2011: E
worldwide for CEN national Members.
BS EN 12409:2008+A1:2011
EN 12409:2008+A1:2011 (E)
Contents Page
Foreword ..............................................................................................................................................................4
Introduction .........................................................................................................................................................5
1 Scope ......................................................................................................................................................6
2 Normative references ............................................................................................................................7
3 Terms and definitions ...........................................................................................................................8
4 List of significant hazards ................................................................................................................. 11
4.1 General ................................................................................................................................................. 11
4.2 Hazards relating to all units ............................................................................................................... 11
4.2.1 Mechanical hazards ............................................................................................................................ 11
4.2.2 Hazards due to electrical energy....................................................................................................... 11
4.2.3 Hazards due to failure/malfunction of the control system ............................................................. 11
4.2.4 Hazards resulting from failure of an energy supply........................................................................ 11
4.2.5 Hazards due to failure/malfunction of pneumatic equipment ........................................................ 11
4.2.6 Hazards resulting from failure/malfunction of hydraulic equipment ............................................ 12
4.2.7 Hazards resulting from inadequate emergency precautions ......................................................... 12
4.2.8 Hazards resulting from noise ............................................................................................................ 12
4.2.9 Hazards resulting from inhalation of hazardous dusts, fumes or gases during normal
operation .............................................................................................................................................. 12
4.2.10 Hazards due to hot surfaces .............................................................................................................. 12
4.2.11 Hazards due to unsuitable ergonomics ........................................................................................... 12
4.2.12 Hazards due to unexpected start up ................................................................................................. 12
4.2.13 Hazards arising when setting the machine ...................................................................................... 12
4.2.14 Hazards arising from access to finishing area during production ................................................ 13
4.2.15 Hazards due to permanent means of access ................................................................................... 13
4.2.16 Hazards due to laser devices ............................................................................................................ 13
4.3 Specific hazards and danger zones relating to individual units .................................................... 13
4.3.1 Continuous sheet unwind unit .......................................................................................................... 13
4.3.2 Single sheet feed unit ......................................................................................................................... 14
4.3.3 Material intake ..................................................................................................................................... 14
4.3.4 Conveying equipment ........................................................................................................................ 14
4.3.5 Heating, pre-heating and edge heating ............................................................................................ 15
4.3.6 Forming station ................................................................................................................................... 16
4.3.7 Finishing station ................................................................................................................................. 16
4.3.8 Stacking station .................................................................................................................................. 16
4.3.9 Discharge station ................................................................................................................................ 17
4.3.10 Residual sheet winding unit .............................................................................................................. 17
4.3.11 Sheet cutting unit................................................................................................................................ 18
5 Safety requirements and/or protective measures ........................................................................... 18
5.1 General ................................................................................................................................................. 18
5.2 General safety requirements and/or protective measures relating to all units ............................ 18
5.2.1 Access to danger zones ..................................................................................................................... 18
5.2.2 Electrical equipment ........................................................................................................................... 19
5.2.3 !Unintended gravity fall of raised elements" ........................................................................... 20
5.2.4 Pneumatic equipment ........................................................................................................................ 22
5.2.5 Hydraulic equipment .......................................................................................................................... 22
5.2.6 Precautions for emergencies ............................................................................................................ 22
5.2.7 Noise .................................................................................................................................................... 22
5.2.8 Inhalation of hazardous dusts, fumes and gases ........................................................................... 23
5.2.9 Hot surfaces ........................................................................................................................................ 23
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5.2.10 Ergonomics .......................................................................................................................................... 24

5.2.11 Unexpected start up ............................................................................................................................ 24
5.2.12 Setting mode ........................................................................................................................................ 24
5.2.13 Access during production .................................................................................................................. 24
5.2.14 Laser devices ....................................................................................................................................... 25
5.2.15 Permanent means of access .............................................................................................................. 25
5.2.16 Common safeguarding system .......................................................................................................... 25
5.2.17 Fixing systems of fixed guards .......................................................................................................... 25
5.3 Specific safety requirements and/or protective measures relating to individual units ............... 25
5.3.1 Continuous sheet unwind unit ........................................................................................................... 25
5.3.2 Single sheet feed unit ......................................................................................................................... 26
5.3.3 Material intake ...................................................................................................................................... 27
5.3.4 Conveying equipment ......................................................................................................................... 28
5.3.5 Heating, pre-heating and edge heating ............................................................................................. 29
5.3.6 Forming station ................................................................................................................................... 31
5.3.7 Finishing station .................................................................................................................................. 32
5.3.8 Stacking zone ...................................................................................................................................... 33
5.3.9 Discharge station ................................................................................................................................ 34
5.3.10 Residual sheet winding unit ............................................................................................................... 34
5.3.11 Sheet cutting unit ................................................................................................................................ 35
6 Verification of safety requirements and/or protective measures ................................................... 36
7 Information for use .............................................................................................................................. 39
7.1 Marking on the machine ..................................................................................................................... 39
7.1.1 Minimum marking ................................................................................................................................ 39
7.1.2 Additional markings ............................................................................................................................ 40
7.2 Instruction manual .............................................................................................................................. 40
7.2.1 General requirements ......................................................................................................................... 40
7.2.2 Hot surfaces ......................................................................................................................................... 40
7.2.3 Use of personal protective equipment .............................................................................................. 40
7.2.4 Noise declaration ................................................................................................................................. 40
7.2.5 Extraction of dusts, fumes or gases ................................................................................................. 41
7.2.6 Electrostatic phenomena .................................................................................................................... 41
7.2.7 Manual handling .................................................................................................................................. 42
7.2.8 Fire prevention ..................................................................................................................................... 42
7.2.9 Manual intervention at the stacking zone ......................................................................................... 42
7.2.10 Safe cleaning ....................................................................................................................................... 42
7.2.11 Use of acknowledge switch ................................................................................................................ 42
7.2.12 !Inspection of electrical drives" ................................................................................................. 42
7.2.13 Single sheet feed malfunction ........................................................................................................... 42
7.2.14 !Static holding load" .................................................................................................................... 42
Annex A (informative) Single sheet machine (alternatively material feed from single sheet
magazine or continuous sheet roll) ................................................................................................... 43
Annex B (informative) Continuous sheet machine (combined forming and finishing) ............................. 44
Annex C (informative) Continuous sheet machine (separate forming and finishing) ............................... 45
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 2006/42/EC ........................................................................................ 47
Bibliography ...................................................................................................................................................... 48
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EN 12409:2008+A1:2011 (E)
Foreword
This document (EN 12409:2008+A1:2011) has been prepared by Technical Committee CEN/TC 145 “Plastics
and rubber machines”, the secretariat of which is held by UNI.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by April 2012, and conflicting national standards shall be withdrawn at the
latest by April 2012.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document includes Amendment 1, approved by CEN on 2011-08-29.
The start and finish of text introduced or altered by amendment is indicated in the text by tags ! ".
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EC Directive(s).
!For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this
document."
This document supersedes !EN 12409:2008".
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and United Kingdom.
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EN 12409:2008+A1:2011 (E)
Introduction
This document is a type C standard as stated in EN ISO 12100.
The machinery concerned and the extent to which hazards, hazardous situations and events are covered are
indicated in the scope of this document.
When provisions of this type C standard are different from those which are stated in type A or B standards, the
provisions of this type C standard take precedence over the provisions of the other standards, for machines
that have been designed and built according to the provisions of this type C standard.
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EN 12409:2008+A1:2011 (E)
1 Scope
This European Standard deals with all significant hazards, hazardous situations and events relevant to
thermoforming machines for continuous sheet and single sheets of thermoplastics materials, when they are
used as intended and under conditions of misuse which are foreseeable by the manufacturer (see Clause 4).
A thermoforming machine may consist of a forming unit or a forming unit linked to one or more additional
units. This standard covers the following units:
 continuous sheet unwind unit;
 single sheet feed unit;
 material intake;
 conveying equipment;
 heating unit;
 preheating unit;
 edge heating unit;
 component feeding/inserting unit;
 forming station;
 finishing station;
 stacking station;
 discharge station;
 residual sheet winding unit;
 sheet cutting unit.
This European standard does not apply to units mounted upstream or downstream of the thermoforming
machine:
 which have a separate control system; and/or
 are located separately.
NOTE 1 This European Standard specifies requirements for machines supplied as a single forming unit or a number of
units designed to operate as a single machine. Additional units that may be introduced at a later stage should be
considered separately applying relevant standards and taking into account any hazards arising through their interaction
with the thermoforming machine.
This European Standard does not apply to units which are integrated into form, fill and seal machines. These
are covered in EN 415-3:1999.
This European standard does not apply to units which incorporate heating systems which are fuelled by gas.
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NOTE 2 Thermoforming machines generally do not create explosive atmospheres. In principle they therefore
correspond with line F of Table 2 of the ATEX Guideline and consequently do not fall within the scope of Directive
94/9/EC.
This European Standard is not applicable to thermoforming machines which are manufactured before the date
of its publication as EN.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
EN 349:1993, Safety of machinery — Minimum gaps to avoid crushing of parts of the human body
EN 574:1996, Safety of machinery — Two-hand control devices — Functional aspects — Principles for design
EN 614-1:2006, Safety of machinery — Ergonomic design principles — Part 1: Terminology and general
principles
EN 626-1:1994, Safety of machinery — Reduction of risks to health from hazardous substances emitted by
machinery — Part 1: Principals and specifications for machinery manufacturers
EN 953:1997, Safety of Machinery — Guards — General requirements for the design and construction of fixed
and movable guards
EN 982:1996, Safety of machinery — Safety requirements for fluid power systems and their components —
Hydraulics
EN 983:1996, Safety of machinery — Safety requirements for fluid power systems and their components —
Pneumatics
EN 999:1998, Safety of machinery — The positioning of protective equipment in respect of approach speeds
of parts of the human body
EN 1037:1995, Safety of machinery — Prevention of unexpected start-up
EN 1088:1995, Safety of machinery — Interlocking devices associated with guards — Principals for design
and selection
EN 1760-1:1997, Safety of machinery — Pressure sensitive protective devices — Part 1: General principles
for the design and testing of pressure sensitive mats and pressure sensitive floors
EN 60204-1:2006, Safety of machinery — Electrical equipment of machines — Part 1: General requirements

(IEC 60204-1:2005, modified)
EN 60529:1991, Degrees of protection provided by enclosures (IP Code) (IEC 60529:1989)
EN 61496-1:2004, Safety of machinery — Electro-sensitive protective equipment — Part 1: General

requirements and tests (IEC 61496-1:2004, modified)
EN ISO 3744:1995, Acoustics — Determination of sound power levels of noise sources using sound
pressure — Engineering method in an essentially free field over a reflecting plane (ISO 3744:1994)
EN ISO 4871:1996, Acoustics — Declaration and verification of noise emission values of machinery and
equipment (ISO 4871:1996)
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EN ISO 11201:1995, Acoustics — Noise emitted by machinery and equipment — Measurement of emission
sound pressure levels at a work station and at other specified positions — Engineering method in an
essentially free field over a reflecting plane (ISO 11201:1995)
EN ISO 11204:1995, Acoustics — Noise emitted by machinery and equipment — Measurement of emission
sound pressure levels at a work station and at other specified positions — Method requiring environmental
corrections (ISO 11204:1995)
EN ISO 11688-1:1998, Acoustics — Recommended practice for the design of low-noise machinery and
equipment — Part 1: Planning (ISO/TR 11688-1:1995)
EN ISO 12100-1:2003, Safety of Machinery — Basic concepts, general principles for design — Part 1: Basic
terminology, methodology (ISO 12100-1:2003)
EN ISO 12100-2:2003, Safety of Machinery — Basic concepts, general principles for design — Part 2:
Technical principles (ISO 12100-2:2003)
EN ISO 13732-1:2006, Ergonomics of the thermal environment — Methods for the assessment of human
responses to contact with surfaces — Part 1: Hot surfaces (ISO 13732-1:2006)
!EN ISO 13849-1:2008", Safety of machinery —Safety-related parts of control systems — Part 1:
General principles for design (ISO 13849-1:2006)
EN ISO 13850:2006, Safety of machinery — Emergency stop — Principles for design (ISO 13850:2006)
EN ISO 13857:2008, Safety of machinery – Safety distances to prevent hazard zones being reached by upper
and lower limbs (ISO 13857:2008)
EN ISO 14122-1:2001, Safety of machinery — Permanent means of access to machinery — Part 1: Choice of
fixed means of access between two levels (ISO 14122-1:2001)
EN ISO 14122-2:2001, Safety of machinery — Permanent means of access to machinery — Part 2: Working
platforms and walkways (ISO 14122-2:2001)
EN ISO 14122-3:2001, Safety of machinery — Permanent means of access to machinery — Part 3: Stairs,
stepladders and guard-rails (ISO 14122-3:2001)
EN ISO 14122-4:2004, Safety of machinery — Permanent means of access to machinery — Part 4: Fixed
ladders (ISO 14122-4:2004)
3 Terms and definitions

For the purposes of this document, the terms and definitions given in EN ISO 12100-1:2003 and the following
apply.
3.1
thermoforming machine
machine which renders thermoplastic sheet material formable, by heating, and deforms it either by using
vacuum or compressed air with or without the use of a stretching aid, for example, a stretching punch
3.2
continuous sheet unwind unit
unit where a continuous sheet roll is clamped and unwound as required by the manufacturing process
3.3
sheet roll
continuous sheet wound on a core with or without an integral shaft
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3.4
single sheet feed unit
unit which consists of a single sheet magazine and a handling device that picks up sheets individually and
feeds them into the material intake of the thermoforming machine
3.5
material intake
unit where the orientation and guidance of continuous sheet or single sheets takes place before being
grasped by conveying equipment
3.6
conveying equipment
device equipped with spikes or clamps, which conveys continuous sheet, or single sheets, in cycles, between
various units of a thermoforming machine
EXAMPLE Chain conveyor.
3.7
heating unit
device which heats the thermoplastic material prior to forming
EXAMPLE Heating radiators, contact heating plates, contact heating rolls or hot air installations.
NOTE The heating may be integrated into the forming station.
3.8
pre-heating unit
device which heats the thermoplastic material upstream of the heating system
EXAMPLE Heating radiators, contact heating plates, contact heating rolls or hot air installations.
3.9
edge heating unit
device which heats the edges of the continuous sheet or single sheets before they are grasped by the
conveying equipment
EXAMPLE Radiators, contact heating plates or hot air installations.
3.10
component feeding/inserting unit
device for feeding/inserting components other than sheet material
3.11
forming station
unit where thermoplastic continuous sheet or single sheets are formed and that includes all devices which:
 actuate closing, clamping and opening of moulds;
 serve as forming aids, e. g. stretching punches, pre blow boxes etc.;
 locate or clamp thermoplastic sheet during the forming process
3.12
mould
component in which the continuous sheet or a single sheet is formed
3.13
stretching punch
mechanical aid to support the forming process
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3.14
clamping frame
frame clamping the continuous sheet or single sheet at the edges during the forming process
3.15
platen
part of the machine to which a mould is fixed
3.16
ejector
device used to push the finished formed parts out of the mould
3.17
finishing station
one or more units where formed parts are punched, cut out, locally formed e. g. rim rolled, or mechanically
worked using a tool
NOTE The finishing station may be combined with the forming station.
3.18
stacking station
unit where formed or cut-out parts are stacked to form larger units prior to removal from the machine
3.19
stacking cage
device receiving and stacking the finished parts
3.20
stacking loader
device pressing the finished parts into the stacking cage
3.21
stacking unloader
device pushing the finished and stacked formed parts out of the stacking cage
3.22
discharge station
zone where formed sheet or formed parts, either individually or in larger units, are discharged from the
thermoforming machine
3.23
residual sheet winding unit
unit where residual sheet, from the finishing station, is wound up
3.24
sheet cutting unit
guillotine or other cutting device which cuts sheet in the longitudinal or transverse direction
NOTE Sheet may, for example, be cut either before or after the forming station, so as to split formed parts, or after
the finishing station, so as to improve scrap handling.
3.25
whole body access
access where there is sufficient space for an operator to remain in an enclosed area with interlocked guards
closed and/or other protective devices initiated to prevent access
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3.26
acknowledge switch
manually operated switching mechanism, e. g. a key switch, by which the control system is informed, after the
opening and closing of guards and/or the actuation of other protective devices, that a danger zone where
whole body access is possible is clear before the machine can be started
3.27
cyclic manual intervention
intervention by the operator during each working cycle
3.28
non-cyclic manual intervention
intervention which occurs only occasionally during the machine operation, e. g. intervention for machine
adjustment during continuous operation in automatic mode
4 List of significant hazards
4.1 General
This clause contains all the significant hazards, hazardous situations and events, as far as they are dealt with
in this European Standard, identified by risk assessment as significant for this type of machinery and which
require action to eliminate or reduce the risk.
4.2 Hazards relating to all units
NOTE Hazards and danger zones specific to individual units are described in 4.3.
4.2.1 Mechanical hazards
Crushing, shearing, impact, drawing-in or trapping hazards by dangerous movements of machine parts, for
example, platen, dies, clamping frames, drive and power transmission systems.
4.2.2 Hazards due to electrical energy
Hazards due to electrical shock or burns caused by direct or indirect contact with live parts.
4.2.3 Hazards due to failure/malfunction of the control system
Crushing, shearing, impact, drawing-in or trapping hazards due to unexpected movements, unexpected start-
up (see also 4.2.12) or continuing operation.
4.2.4 Hazards resulting from failure of an energy supply
Crushing, shearing, impact, drawing-in or trapping hazards due to sudden fall of raised parts due to gravity, for
example sheet roll, platen, clamping frame or stacking unit.
4.2.5 Hazards due to failure/malfunction of pneumatic equipment
 Impact hazards due to whiplash of hoses resulting from fracture of flexible hoses.
 Impact, crushing shearing, drawing-in or trapping hazards resulting from unexpected movement of
machine parts.
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4.2.6 Hazards resulting from failure/malfunction of hydraulic equipment
 Impact hazards due to whiplash of hoses resulting from fracture of flexible hoses.
 Impact, crushing, shearing, drawing-in or trapping hazards resulting from unexpected movement of
machine parts.
 Hazards due to release of fluid under pressure resulting from fracture, for example of a pipe or hose.
 Slipping or fire hazards resulting from leakage of for example defective seals or damaged flexible hoses.
4.2.7 Hazards resulting from inadequate emergency precautions
Harm caused by an inability to put machinery in a safe condition following an emergency situation.
4.2.8 Hazards resulting from noise
Hazards due to high noise levels which can lead to:
 hearing impairment;
 interference with speech communication;
 interference with the perception of acoustic signals.
4.2.9 Hazards resulting from inhalation of hazardous dusts, fumes or gases during normal operation
Health hazards may be caused by the inhalation of hazardous dusts, fumes or gases produced during the
heating of plastic sheets.
4.2.10 Hazards due to hot surfaces
Burning hazards due to accidental contact with hot surfaces.
4.2.11 Hazards due to unsuitable ergonomics
Hazards due to strain of the human body resulting from:
 unsuitable body position;
 repetitive actions;
 lifting excessive loads;
 emission of hot air from the machine.
4.2.12 Hazards due to unexpected start up
Unexpected movement of machine parts that can result in impact, crushing, shearing or drawing-in or trapping
hazards.
4.2.13 Hazards arising when setting the machine
Unexpected movement of machine parts that can result in impact, crushing, shearing or drawing-in or trapping
hazards.
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4.2.14 Hazards arising from access to finishing area during production
Impact, crushing, shearing or drawing-in or trapping hazards.
4.2.15 Hazards due to permanent means of access
Harm caused by slipping at or falling from working platforms, steps or walkways provided for use with the
machine.
4.2.16 Hazards due to laser devices
Hazards due to high intensity radiation can cause eye injury.
4.3 Specific hazards and danger zones relating to individual units
4.3.1 Continuous sheet unwind unit
4.3.1.1 Mechanical hazards
4.3.1.1.1 Hazards during movement of roll loading devices
Impact, crushing or shearing hazards.
4.3.1.1.2 Hazards between the sheet rolls and the fixed parts of the unwind unit (e.g. supports and
frame) during loading
Crushing or shearing hazards.
4.3.1.1.3 Hazards between rotating haul-off rolls and by moving parts of haul-off roll drives
Drawing-in or trapping hazards.
4.3.1.1.4 Hazards due to sheet rolls and shafts falling from their bearing
Impact or crushing hazards.
4.3.1.1.5 Hazards due to sheet rolls falling from shafts fixed at one end
4.3.1.1.6 Hazards due to instability of the unwind unit causing it to fall over
4.3.1.1.7 Hazards due to sheet unwinding
Cutting hazards due to sharp edges of the sheet.
4.3.1.2 Hazards due to electrostatic charges
Hazards due to electrical shock due to discharge of electrostatic charges, which may occur during unwinding
of some materials.
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4.3.2 Single sheet feed unit
4.3.2.1.1 Hazards during movement of a handling device, sheets or parts of a single sheet magazine
Crushing, shearing, impact, drawing-in or trapping hazards or cutting hazards due to sharp edges of the
sheet.
4.3.2.1.2 Hazards during the feeding of sheet to a material intake or conveying system
Drawing in or trapping hazards.
Hazards due to electrical shock due to discharge of electrostatic charges, which may occur during separation
of some materials.
4.3.3 Material intake
4.3.3.1.1 Hazards during the feeding of sheet to a hold down device
4.3.3.1.2 Hazards during release of sheet in the area of a conveying system
Crushing or cutting hazards.
4.3.3.1.3 Hazards during movement of a sharp-edged sheet
Cutting hazards.
4.3.3.1.4 Hazards due to moving parts of an adjacent sheet cutting device
Crushing, shearing, impact or cutting hazards.
of some materials.
4.3.4 Conveying equipment
4.3.4.1.1 Hazards during the movement of a sharp-edged sheet
Cutting hazards.
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4.3.4.1.2 Hazards during movement of chain conveyors equipped with spikes or clamps
Puncture, penetration, cutting, crushing, shearing or drawing-in or trapping hazards.
4.3.4.1.3 Hazards during movement of sheet or parts of a conveying system
Impact or drawing-in or trapping hazards.
of some materials.
4.3.5 Heating, pre-heating and edge heating
4.3.5.1.1 Hazards during movement of a heating, pre-heating or edge heating device
Crushing, shearing or impact hazards.
4.3.5.1.2 Hazards in the areas between rotating rolls (for example heating, diverting or driving rolls) or
between sheet and rolls or between fixed machine parts and rotating rolls or moving sheet
4.3.5.2 Hazards due to electrical energy
Hazards due to contact with live parts of the heating, pre-heating or edge heating devices.
4.3.5.3 Burning hazard
Hazards due to contact with hot parts of the heating, pre-heating or edge heating devices or due to contact
with hot sheet.
4.3.5.4 Hazards due to inhalation of health hazardous dusts, fumes and gases
a) Hazards caused by overheating of material, for example due to:
1) failure of the conveying system;
2) failure of the heating unit retraction/opening system;
3) failure of the heating control system;
4) excessive delay time in/on the heating system;
5) material falling or drooping from the conveying system;
6) energy failure.
b) Hazards caused by leakage of hydraulic fluids onto hot parts.
c) Hazards caused by abrasion and perforation during material transport.
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4.3.5.5 Fire hazard
a) Hazards caused by overheating of material, for example due to:
1) failure of the conveying system;
2) failure of the heating unit retraction/opening system;
3) failure of the heating control system;
4) excessive delay time in/on the heating system;
5) material falling or drooping from the conveying system;
6) energy failure.
b) Hazards caused by leakage of hydraulic fluids onto hot parts.
4.3.6 Forming station
4.3.6.1 Mechanical hazards during movement of linkages, clamping frames, platens, stretching
punches, ejectors or component feeding/inserting unit
4.3.6.2 Burning hazards
Hazards due to contact with hot surfaces, for example, moulds, clamping frames, material or pipes.
4.3.7 Finishing station
4.3.7.1 Mechanical hazards during movement of finishing devices such as for example platens,
ejectors, rim roll devices or discharge devices
Crushing, shearing, impact hazards or cutting hazards by sharp edges.
Hazards due to contact with hot surfaces, for example, moulds, clamping frames, material or pipes.
4.3.7.3 Hazards due to inhalation of health hazardous fumes and dust
 Hazards caused by overheating of material.
 Hazards caused by abrasion and perforation during material transport.
4.3.8 Stacking station
4.3.8.1.1 Hazards during movement of machine part, for example stacking cages, stacking discs,
staking pallets or slides or discharge devices or during movement of residual sheet
Crushing, shearing or impact hazards or cutting hazards due to sharp edges.
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4.3.8.1.2 Hazards during movement of part of a conveyor belt
4.3.8.2 Hazards due to failure/malfunction of the control system
Hazards due to unexpected start-up or continuing operation.
4.3.8.3 Intervention during operation or as a result of a malfunction
Hazards due to moving machine parts, product or residue sheet when manual intervention is necessary during
normal operation or as a result of a malfunction.
of some materials.
4.3.9 Discharge station
4.3.9.1 Mechanical hazards during movement of product or machine parts
Impact, crushing, shearing, drawing-in or trapping hazards or cutting hazards due to sharp edge of the sheet.
4.3.9.2 Hazard due to the accessibility of parts of a unit from another unit
Hazards described in 4.3.6, 4.3.7 or 4.3.8 may occur if it is possible to reach the area of the conveying
equipment, forming station, finishing station or stacking station from the discharge opening.
Hazards due to contact with hot products.
of some materials.
4.3.10 Residual sheet winding unit
4.3.10.1.1 Hazards during movement of a sharp-edged sheet
Cutting hazards.
4.3.10.1.2 Hazards during winding of residual sheet
Entanglement or drawing-in or trapping hazards.
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Hazards due to electrical shock due to discharge of electrostatic charges, which may occur during winding of
some materials.
4.3.11 Sheet cutting unit
4.3.11.1.1 Hazards during movement of parts of the cutting unit
4.3.11.1.2 Hazards created by moving or stationary parts of the cutting unit or a sharp-edged sheet
Cutting hazards.
4.3.11.2 Hazards due to failure/malfunction of the control system
 Hazards due to unexpected movements of parts of a cutting device.
 Hazards due to unexpected start-up or continuing operation.
5 Safety requirements and/or protective measures
5.1 General
Machinery shall comply with the safety requirements and/or protective measures of this clause.
In addition, the machine shall be designed according to the principles of EN ISO 12100-2:2003 for relevant but
not significant hazards which are not dealt with by this document.
5.2 General safety requirements and/or protective measures relating to all units
NOTE Requirements for specific units given in 5.3 may replace, extend or modify the general requirements and/or
measures of 5.2. In such cases the requirements of 5.3 take precedence over those in 5.2.
5.2.1 Access to danger zones
5.2.1.1 General
Machines shall be designed and constructed as far as possible such that there is no access to danger zones,
e. g. by safe machine design, fixed guards. When this is not possible, access to danger zones shall be
controlled by safeguards in accordance with 5.2.1.2 and 5.2.1.3.
Safety distances to prevent access to danger zones by the upper and the lower limbs shall be in accordance
with EN ISO 13857:2008.
To avoid crushing of parts of the human body, the minimum distances of EN 349:1993 shall apply.
5.2.1.2 !Protective measures when access into a danger zone is required
If access to a danger zone is required then access to danger zones shall be controlled by one of the following
protective measures:
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 interlocking guards in accordance with EN 953:1997, 3.5 or, if necessary in accordance with the choice
criteria of EN 1088:1995, interlocking guards with guard locking in accordance with EN 953:1997, 3.6; for
safety related parts of the control system PLr 'd' of EN ISO 13849-1:2008 shall apply. Opening the
interlocking guards shall stop dangerous movements;
 sensitive protective equipment in accordance with EN ISO 12100-1:2003, 3.26.5 and in accordance with
PLr 'd' of EN ISO 13849-1:2008 for the safety related parts of the control system, positioned such that the
hazard is eliminated before access is possible, (see EN 999:1998). Actuating the sensitive protective
equipment shall stop dangerous movements;
 for maintenance operations only and where access is required no more than once per shift, fixed guards
in accordance with EN 953:1997, 3.2."
5.2.1.3 Additional requirements where whole body access is possible
An acknowledge switch shall be provided when whole body access is possible between guards or sensitive
protective equipment and any danger zone they enclose. The acknowledge switch shall be designed as a
safety related part of the control system. Any failure/malfunction of the acknowledge switch shall not lead to a
degradation of the performance level of the related control system. The acknowledge switch shall be located
in the immediate vicinity of any access point to the danger zones. The switch shall need to be operated by the
person leaving the danger zone before the start command can be given by a separate switch. If a guard is
opened or other protective device is activated between the operation of the acknowledge switch and the
provision of a start command the initiation of a start command shall be prevented. It shall not be possible to
actuate an acknowledge switch from the danger zone. The position from which the acknowledge switch is
actuated shall allow a good overview of the danger zone and, if required, aids to vision shall be provided.
When an interlocking guard is open, and gives a stop command to the control system, it shall not be possible
to cancel this command by actuating the acknowledge switch. The start command shall only become effective
once all interlocking guards are closed and the acknowledge switch has been actuated. It shall not be possible
to store the start command before actuating the acknowledge switch.
An acknowledge switch is not required if its function is substituted by an interlocking device requiring
deliberate mechanical action from outside the danger zone after closing the guard, e. g. a trapped key
interlocking device or plug and socket interlocking device, located at a position where there is a clear view of
the danger zones.
An acknowledge switch is not required when a presence sensing device such as a pressure sensitive mat in
accordance with EN 1760-1:1997 is situated inside the enclosure such that it detects the presence of a person
between guards or sensitive protective equipment and the danger zone they enclose. When activated the
presence sensing device shall prevent a start command by the control system.
An acknowledge switch is not required when a fixed guard may be used to control access under the restricted
conditions described in 5.2.1.2.
5.2.1.4 Drive and power transmission systems
Access to dangerous movements of drive and power transmission systems including, for example, shafts,
belts, chains, linkages, clutches and gears shall be prevented by design. If this cannot be achieved completely
access shall be prevented by fixed guards in accordance with EN 953:1997, 3.2.
5.2.2 Electrical equipment
5.2.2.1 General
The electrical equipment shall be in accordance with EN 60204-1:2006.
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5.2.2.2 Supply disconnecting (isolating) device
The supply disconnecting (isolating) devices shall be in accordance with EN 60204-1:2006, 5.3.2 and 5.3.3.
5.2.2.3 Unexpected start-up
Hazards due to unexpected start-up have to be prevented in accordance with EN 1037:1995.
See also EN 60204-1:2006, 5.4.
5.2.2.4 Protection against direct contact
The protection against direct contact shall be in accordance with 6.2 of EN 60204-1:2006.
5.2.2.5 Protection against indirect contact
The protection against indirect contact shall be in accordance with 6.3 of EN 60204-1:2006.
5.2.3 !Unintended gravity fall of raised elements
5.2.3.1 General
Machines shall be designed and constructed such that there is no danger resulting from raised elements
falling due to gravity, e.g. in the event of failure of energy supply or fault.
Devices and their associated components used to prevent gravity fall that are required by this European
Standard shall be capable of holding a load of at least the 1,2 × the static holding load. Static holding load also
includes additional, non permanent, loads like moulds or other tools. See 7.2.14.
In order to protect persons against fall of gravity-loaded axes (vertical axes) the measures specified in 5.2.3.2
and 5.2.3.3 shall apply. The safety related performance of holding systems shall be selected according to the
risk:
 in case of low frequency access with upper limbs or whole body (e.g. for setting and trouble shooting) a
PLr 'c' according to EN ISO 13849-1:2008 shall be selected;
 in case of high frequency access with upper limbs or whole body a PLr 'd', category '3' according to
EN ISO 13849-1:2008 shall be selected.
For maintenance or for mould/tool changing the movable machine platens shall be brought to the lowest
possible position. For work that has to be carried out with the platens in another position any movement of the
movable platens shall be blocked by means of devices, e.g. safety blocks, inserted below and above the
movable platens. These devices or blocks shall be designed to resist at least 2 × the force produced by the
platens movement and painted in a signal colour.
5.2.3.2 Fluid drives
For fluid drives the movement of the machine axes shall be stopped by a valve such that any movement can
only be initiated or maintained as long as a command signal is maintained. Cancelling the command signal
shall stop the movement or possibly reverse it if this does not create further hazards.
In addition, one or a combination of the following shall be used:
a) a controllable non-return valve or a shut-off valve, which is fixed directly or if this is not possible by a
minimum length of steel pipework to the drive element, e.g. cylinder;
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b) a friction-locked clamping device;
c) gears that have sufficient inherent resistance to motion to prevent unintended unpowered movement
under gravitational forces, e.g. self-locking gear;
d) a positive-locking pawl that shall either be engageable at any height of the parts creating the gravity fall
hazard or interlocked with an interlocking guard with guard locking so that access to the danger zone is
prevented until the pawl is effective. When a pawl is applied to a rotating part, it shall act in both direction
of rotation if rotation in either direction could cause a gravity fall.
For the safety related performance the requirements of 5.2.3.1 shall apply.
NOTE ISO/DIS 5598 contains the vocabulary for all fluid power systems and components.
5.2.3.3 Electrical drives
5.2.3.3.1 Raising of elements achieved by using a control system in accordance with PLr 'c'
Where the raising of elements is achieved by using a control system in accordance with PLr 'c' of
EN ISO 13849-1:2008, the following systems shall be implemented:
a) gears that have sufficient inherent resistance to motion to prevent unintended unpowered movement
under gravitational forces, e.g. self-locking gear; or
b) a drive with a mechanical brake, which becomes effective automatically in the case of a failure of the
energy supply. The mechanical brake shall be designed with a brake holding load of at least 1,2 × the
static holding torque. The functional capability of the brake shall be capable of being checked either
manually or automatically. The frequency of brake inspection shall be indicated in the instruction manual
together with a procedure to determine when adjustment or replacement of parts are necessary (see also
7.2.12).
5.2.3.3.2 Raising of elements achieved by using a control system in accordance with PLr 'd'
Where the raising of elements is achieved by using a control system in accordance with PLr 'd' of
EN ISO 13849-1:2008, the following systems shall be implemented:
a) a drive with two mechanical brakes independent from each other, which become effective automatically in
the case of a failure of the energy supply. Each mechanical brake shall be designed so that its brake
holding load without the assistance of the other brake is at least 1,2 × the total static holding torque in
normal operation, i.e. each brake shall be capable of supporting the static load. The functional capability
shall be capable of being checked for each brake, either manually or automatically. The frequency of the
brake testing shall be indicated in the instruction manual (see also 7.2.12); or
b) a mechanical brake in combination with a friction-locked clamping device. The functional capability of the
brake and the efficiency of the clamping function shall be capable of being checked individually, either
manually or automatically. The frequency of the tests to determine the functional capability of the brake
and the efficiency of the clamping function shall be indicated in the instruction manual (see also 7.2.12);
or
c) a positive-locking pawl that shall either be engagable at any height of the parts creating the gravity fall
hazard or interlocked with an interlocking guard with guard locking so that access to the danger zone is
prevented until the pawl is effective. When a pawl is applied to a rotating part, it shall act in both direction
of rotation if rotation in either direction could cause a gravity fall.
For the safety related performance the requirements of 5.2.3.1 shall apply."
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5.2.4 Pneumatic equipment
Pneumatic equipment shall be in accordance with EN 983:1996.
Flexible hoses shall be installed so that they do not have contact with moving and/or hot machine parts.
5.2.5 Hydraulic equipment
Hydraulic equipment shall be in accordance with EN 982:1996.
Flexible hoses shall be installed so that they do not have contact with moving and/or hot machine parts.
Precautions shall be taken to prevent foreseeable leakage of hydraulic fluid causing a slipping hazard at
surfaces where operators require access.
5.2.6 Precautions for emergencies
Measures to give protection in emergency situations shall be taken in accordance with EN ISO 12100-2:2003,
5.5.2 and 5.5.3.
Emergency stop equipment shall be in accordance with EN ISO 13850:2006. Emergency stop function may
be either stop category 0 or 1 in accordance with EN ISO 13850:2006, 4.1.4.
One emergency stop actuator shall be fitted at each control station and at positions close to feed and
discharge areas. When activated all dangerous movements shall be stopped except those necessary to
prevent a fire hazard. For example it may be necessary to withdraw a heating system.
5.2.7 Noise
5.2.7.1 Main sources of noise
 Drive motors;
 power transmission systems;
 pneumatic systems;
 vacuum systems;
 ventilators;
 hydraulic systems;
 control valves;
 pipework;
 perforation of sheet by spiked chain.
Intense noise is generated, in particular, by:
 forming stations;
 finishing stations.
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5.2.7.2 Noise reduction at source by design
Noise emissions of the machine shall be reduced through suitable design and construction. Account shall be
taken of the available information and technology for reducing noise at source, see for example
EN ISO 11688-1:1998.
NOTE EN ISO 11688-2:2000 gives useful information on noise generation mechanisms in machinery.
Current measures to reduce noise at source may be:
 choice of low-noise machine components, e. g. motors, transmission systems, fans, pumps with sound
insulation;
 use of vibration damping material for vibrating surfaces;
 use of elastic transmission to prevent structure-borne noise from propagating from vibrating elements to
other machine parts.
5.2.7.3 Noise reduction by protective measures
Amongst the measures that may be taken to reduce noise emission are:
 acoustic enclosure/screening of noise creating parts;
 silencers;
 sound attenuation using insulating material;
 vibration-free installation;
 use of elastic mounting elements.
5.2.7.4 Information connected with noise hazards
See 7.2.4.
5.2.8 Inhalation of hazardous dusts, fumes and gases
Machines shall be designed and constructed such that appropriate extraction systems may be connected; see
also 7.2.5. The control system of the machine shall be designed such that the machine cannot be run without
the extraction system in operation.
If substances are to be processed which may generate dusts, fumes and gases that are hazardous to health,
then EN 626-1:1994 applies.
NOTE Because the nature of dusts, fumes and gases will depend on each installation and the materials used, it is
not possible to give more detailed requirements in this standard.
5.2.9 Hot surfaces
Protection shall be given in accordance with EN ISO 13732-1:2006 against contact of parts of the body with
hot surfaces in areas where people have to work or may pass by. Suitable measures are e. g. shielding,
personal protective equipment or warning signs. Requirements for specific units are given in 5.3.
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5.2.10 Ergonomics
Machine operator working places shall be designed and constructed in accordance with ergonomic
requirements, described in EN 614-1.2006.
Tools, equipment for handling reels, finished products and machine parts, which foreseeably have to be
moved or replaced, shall be so designed that the use of mechanical handling equipment is possible if the
mass of the loads exceeds 15 kg.
See 7.2.7.
5.2.11 Unexpected start up
Equipment preventing unexpected start up or continuing operation shall be designed and constructed in
accordance with EN 1037:1995.
5.2.12 Setting mode
Thermoforming machines shall be designed such that machine setting, teaching, process changeover, fault
finding, cleaning and maintenance can be carried out with the production mode safety systems effective or the
machine safely set to standstill (see also EN ISO 12100-2:2003, 5.2.4).
If access is required to certain units and it is not possible to meet the above conditions, then the following
requirements shall apply while the production mode safety systems are ineffective:
 a lockable switch shall be provided which enables manual control. The lockable switch shall be designed
as a safety related part of the control system. An unintentional mode change of the lockable switch may
not lead to a degradation of the performance level of the related control system. Manual control shall be
designed and constructed in accordance with EN ISO 12100-2:2003, 4.11.8 and 4.11.9. If the protection
measure selected is reduced speed, then this speed shall not exceed 25 mm/s;
 access to danger zones of adjacent units shall be prevented by suitable measures e. g. fixed guards in
accordance with EN 953:1997, 3.2;
 a hold to run control devices in accordance with EN ISO 12100-1:2003, 3.26.3 or a two hand control
device in accordance with EN 574:1996, type III C at a reduced speed not exceeding 25 mm/s shall be
used;
 it shall be possible to control movements of unit parts with opened guards whereby only a single
movement is activated.
So far as is reasonably practicable, when setting and adjustment cannot be carried out from outside protective
guards, the machine shall be designed such that setting and adjustment can be carried out using the
interlocking guards at the front of the machine.
So far as is reasonably practicable, machinery shall be designed such that the adjustment or replacement of
machine parts can be made without requiring an unhealthy posture of the persons carrying out the work.
5.2.13 Access during production
When it is necessary to check the correct operation (e. g. checking correct perforation by visual inspection) by
opening an interlocking guard with the machine running at production speed, the following requirements shall
apply:
 the production safeguard shall be an interlocked guard with guard locking in accordance with EN 953,
3.6;
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 electro-sensitive protective equipment (light curtain) in accordance with EN 61496-1:2004, type 4 shall be
positioned behind the interlocking guard;
 the interlocking guard shall remain locked until the electro-sensitive protective equipment is activated by
means of a key operated switch. Subsequent interruption of the light curtain with the interlocking guard
open shall at least stop the units or stations to which the interlocking guard gives access.
NOTE This will allow the punching tools to be set at their end position to permit an inspection of the finished
product.
5.2.14 Laser devices
Where laser devices, for example laser sensors are used, warning signs shall be provided in close proximity
to the device.
5.2.15 Permanent means of access
Working platforms, steps and walkways shall be in accordance with EN ISO 14122-1:2001, EN ISO 14122-
2:2001, EN ISO 14122-3:2001 and EN ISO 14122-4:2004 to prevent the risk of slipping, tripping or falling.
5.2.16 Common safeguarding system
If a common safeguarding system, such as a perimeter fence, is used to control access to more than one unit
and access to one unit permits access to other units:
 all units to which access is possible shall be stopped or otherwise put in a safe condition in accordance
with the requirements given in 5.3 for the specific units concerned;
 the interlocks or other safety devices controlling access to such units shall be of the most severe
performance level and type required in 5.3 for any of the units concerned.
5.2.17 Fixing systems of fixed guards
Fixed guards shall be so designed, that their fixing systems remain attached to the guards or to the machinery
when the guards are removed.
Quick release systems shall be not used.
5.3 Specific safety requirements and/or protective measures relating to individual units
5.3.1 Continuous sheet unwind unit
5.3.1.1 Safety distances
Safety distances shall be in accordance with EN ISO 13857:2008, Tables 1, 3 and 4.
5.3.1.2.1
Impact, crushing and shearing hazards due to movement of the roll lifting devices shall be prevented by:
 fixed guards in accordance with EN 953:1997, 3.2; or
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 using a hold to run control device in accordance with EN ISO 12100-1:2003, 3.26.3 whereby the speed of
the roll lifting device shall not exceed 25 mm/s; or
 using a two hand control in accordance with EN 574:1996, type I.
5.3.1.2.2
Crushing and shearing hazards between sheet roll support shafts and their bearings during loading shall be
prevented by:
 using a hold to run control device in accordance with EN ISO 12100-1:2003,3.26.3 whereby the speed of
the roll lifting device shall not exceed 25 mm/s; or
 using a two hand control in accordance EN 574:1996, type I.
5.3.1.2.3
Drawing-in or trapping hazards between rotating haul-off rolls and/or by moving parts of haul-off roll drives
shall be prevented by fixed guards in accordance with EN 953:1997, 3.2.
5.3.1.2.4
Impact and crushing hazards due to sheet rolls and shafts falling from their bearing shall be prevented, for
example by the use of a retaining device such as bearing shells, retention pins or locking bolts.
5.3.1.2.5
Impact and crushing hazards due to sheet rolls falling from shafts, which are supported only at one end, shall
be prevented, for example by the use of a retaining device such as bearing shells, retention pins or locking
bolts.
5.3.1.2.6
Impact and crushing hazards due to instability of the unwind unit causing it to fall over shall be prevented by
design, e. g. by using anchorages, being sufficiently stable to withstand unwinding forces.
5.3.1.2.7
Warning signs shall be used to warn about cutting hazard due to sharp edges. The manufacturer shall
recommend the wearing of personal protective equipment, e. g. gloves, in the instruction manual; see 7.2.3.
5.3.1.3 Hazards due to electric shock caused by electrostatic phenomena
If the machine is to be used with materials which accumulate electrostatic charges during unwinding, then
measures shall be taken to prevent hazards due to electric shock, for example by earthing or use of ionisation
devices; see 7.2.6.
NOTE For guidance see PD CLC/TR 50404:2003.
5.3.2 Single sheet feed unit
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5.3.2.2.1
Crushing, shearing and impact hazards caused by movement of handling devices, sheet or parts of a single
sheet magazine shall be prevented by:
 protective devices in accordance with 5.2.1.2 and 5.2.1.3.
5.3.2.2.2
Drawing-in and trapping hazard caused when sheet is fed to a material intake or conveying system shall be
prevented by:
5.3.2.3 Hazards due to a sticking together of sheets
According to the type of material, sometimes in the sheet magazine sheets may stick together which leads to
machine trouble. In such cases, the sheet magazine shall have equipment for separation of the sheets in
order to prevent manual intervention; see 7.2.13.
If the machine is to be used with materials which accumulates electrostatic charges during sheet feeding, then
measures shall be taken to prevent hazards due to electric shock, for example by earthing or the use of
ionisation devices; see 7.2.6.
5.3.3 Material intake
5.3.3.2.1
Drawing-in or trapping hazards during feeding of sheet into a holding down device shall be prevented by:
If one roll of a two roll material intake system is able to move away from the other roll with a load not
exceeding 150 N, additional safeguarding is not required.
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5.3.3.2.2
Crushing or cutting hazards during release of sheet in the area of a conveying system, shall be prevented by:
5.3.3.2.3
Cutting hazards during movement of a sharp-edged sheet shall be prevented by:
5.3.3.2.4 Hazards due to moving parts of adjacent sheet cutting unit
5.3.3.2.4.1
Crushing, shearing or impact hazards during movement of parts of the sheet cutting unit shall be prevented
by:
5.3.3.2.4.2
Cutting hazards caused by moving or stationary parts of the sheet cutting unit shall be prevented by:
 design; or
5.3.4 Conveying equipment
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5.3.4.2.1
Cutting hazards during movement of a sharp-edged sheet shall be prevented by:
5.3.4.2.2
Puncture, penetration and cutting hazards during movement of chain conveyors equipped with spikes or
clamps shall be prevented by:
5.3.4.2.3
Impact and drawing-in or trapping hazards during movement of the sheet or parts of a conveying system shall
be prevented by:
5.3.5 Heating, pre-heating and edge heating
5.3.5.2.1
Crushing, shearing or impact hazards during movement of a heating or pre-heating device shall be prevented
by:
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5.3.5.2.2
Drawing-in or trapping hazards caused by rotating rolls (for example heating rolls, diverting rolls or driving
rolls) or between sheet and rolls or between fixed machine parts and rotating rolls or moving sheet shall be
prevented by:
5.3.5.3 Hazards due to electrical energy
Access to live parts of the heating elements shall be prevented by enclosures having a minimum degree of
protection of IP 20 in accordance with EN 60529:1991. This deviates from EN 60204-1:2006.
NOTE This is necessary to ensure free heat dissipation.
If hot surfaces cannot be guarded in accordance with 5.2.9, e. g. because heating elements could be hot after
opening of guards, warning signs shall be provided at appropriate positions on the machine to warn of the
danger; see also 7.1.2.
Where necessary the instruction manual shall include indications for the wearing of appropriate personal
protection equipment; see also 7.2.2.
5.3.5.5 Fire hazards and hazards due to Inhalation of dusts, fumes and gases
Fire hazards and hazardous dusts, fumes and gases, due to overheating of materials, shall be limited by
heating system temperature monitoring and control and in addition by one of the following measures:
a) the prevention of contact between the material being processed and heating radiators;
b) gas or flame detection;
c) cutting off the heating system;
d) for heating: moving the device out of position;
e) inserting protective screens;
f) installing a prearranged device in order to connect a fire extinguisher; this device shall be (minimum):
1) nozzle(s);
2) suitable pipe connection between the nozzle(s) and the fire extinguisher (located outside the guards).
It shall be ensured that this happens even in the event of failure of an energy supply.
Where necessary the instruction manual shall include details of suitable fire extinguishing equipment; see also
7.2.8.
Measures shall be taken to prevent hydraulic fluid leakage coming into contact with the heating system. This
can, for example, be achieved by covering the hydraulic lines and/or hoses.
See also 5.2.8.
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EN 12409:2008+A1:2011 (E)
5.3.6 Forming station
5.3.6.2.1 !Continuous sheet machines
Crushing, shearing or impact hazards during movement of machine parts such as linkages, clamping frames,
platens, stretching punches or component feeding/inserting units shall be prevented by one or a combination
of the following measures:
a) fixed guards in accordance with EN 953:1997, 3.2;
b) interlocking guards in accordance with 5.2.1.2 and 5.2.1.3, whereby for the safety related parts of the
control system:
1) PLr 'd' of EN ISO 13849-1:2008 applies in case of non-cyclic manual intervention; or
2) PLr 'd', category 3 of EN ISO 13849-1:2008 applies in case of cyclic manual intervention.
c) electro-sensitive protective equipment in accordance with EN 61496-1:2004, type 4, e.g. active opto-
electronic protective devices like light beam devices or light curtains."
5.3.6.2.2 !Single sheet machines
Crushing, shearing or impact hazards during movement of machine parts such as linkages, clamping frames,
platens, stretching punches or component feeding/inserting units shall be prevented by one or a combination
of the following measures:
control system:
2) PLr 'd', category 3 of EN ISO 13849-1:2008 applies in case of cyclic manual intervention
electronic protective devices like light beam devices or light curtains;
d) for single sheet machines with manual sheet feed and take-off, where the protective devices in
accordance with 5.2.1.3 are not used by:
1) two-hand control devices in accordance with EN 574:1996 type III C; and
2) fixed guards in accordance with EN 953:1997, 3.2 at the sides, the rear and, to the extent that this is
necessary to prevent access by a second operator, at the front, whereby for the safety distances of
EN ISO 13857:2008, Tables 2, 3 and 4 apply."
31
BS EN 12409:2008+A1:2011
EN 12409:2008+A1:2011 (E)
When hot surfaces, which are necessary for process reasons, cannot be guarded in accordance with 5.2.9,
e.g. because dies could be hot after opening of guards, warning signs shall be provided at appropriate
positions on the machine to warn of the danger; see also 7.1.2.
5.3.7 Finishing station
5.3.7.2 Integrated or downstream finishing stations
5.3.7.2.1 Mechanical hazards
5.3.7.2.1.1 !Continuous sheet machines
Crushing, shearing, impact or cutting hazards during movement of machine parts such as platens, ejectors,
rim roll devices or discharge devices shall be prevented by one or a combination of the following measures:
control system:
2) PLr 'd', category 3 of EN ISO 13849-1:2008 applies in case of cyclic manual intervention;
electronic protective devices like light beam devices or light curtains."
5.3.7.2.1.2 !Single sheet machines
Crushing, shearing, impact or cutting hazards during movement of machine parts such as for example
platens, ejectors, rim roll devices or discharge devices shall be prevented by one or a combination of the
following measures:
control system:
2) PLr 'd', category 3 of EN ISO 13849-1:2008 applies in case of cyclic manual intervention;
electronic protective devices like light beam devices or light curtains;
d) for single sheet machines with manual sheet feed and take-off, where the protective devices in
accordance with 5.2.1.3 are not used by:
32
BS EN 12409:2008+A1:2011
EN 12409:2008+A1:2011 (E)
1) two-hand control devices in accordance with EN 574:1996 type III C; and
2) fixed guards in accordance with EN 953:1997, 3.2 at the sides, the rear and, to the extent that this
is necessary to prevent access by a second operator, at the front, whereby for the safety distances
of EN ISO 13857:2008, Tables 2, 3 and 4 apply."
5.3.7.2.2 Burning hazards
When hot surfaces, which are necessary for process reasons, cannot be guarded, in accordance with 5.2.9,
warning signs shall be provided at appropriate positions on the machine to warn of the danger. See also 7.1.2.
5.3.8 Stacking zone
5.3.8.1 Adjustment of stacking height
The stacking height shall be adjustable from outside closed guards with the machine process not interrupted.
5.3.8.3.1
Crushing, shearing or impact hazards caused by the movement of machine parts, for example stacking cages,
stacking discs, staking pallets or slides or discharge devices or during movement of residual sheet shall be
prevented by:
5.3.8.3.2
Drawing in or trapping hazards caused by the moving conveyor parts shall be prevented by:
5.3.8.4 Intervention during operation or as a result of a malfunction
If manual intervention in the stacking zone is necessary and the sheet must continue to be conveyed, e. g. for
setting or adjusting, all other movements in the stacking zone have to be stopped. Access to danger zones
between the moving residual sheet and parts of the machine shall be prevented by design. Reaching into
adjacent hazardous zones shall be prevented in accordance with 5.2.1; see also 7.2.9.
33
BS EN 12409:2008+A1:2011
EN 12409:2008+A1:2011 (E)
5.3.9 Discharge station
5.3.9.2.1
Discharge stations shall be designed such that access to danger zones in adjacent units is prevented. If this is
not possible, the safety requirements and/or protective measures for those units shall apply.
5.3.9.2.2
Hazards due to the movement of product or machine parts shall be prevented by limiting to a maximum force
of 75 N or kinetic energy of 4 J or contact pressure of 50 N/cm² if access is possible.
5.3.9.2.3
Information shall be given in the instruction manual to wear personal protection equipment, e. g. gloves
against cutting hazards due to sharp edges; see also 7.2.3.
Information shall be given in the instruction manual to wear personal protection equipment, e. g. gloves
against hot products; see also 7.2.2.
5.3.10 Residual sheet winding unit
5.3.10.2.1
Cutting hazards due to movement of a sharp-edged sheet shall be prevented by:
34
BS EN 12409:2008+A1:2011
EN 12409:2008+A1:2011 (E)
5.3.10.2.2
Entanglement, drawing-in or trapping during winding of residual sheet shall be prevented by:
The tension in any continuous sheet not protected by fixed guards or other protective devices shall not exceed
2
150 N or the surface pressure shall not exceed 50 N/cm . This may be achieved, for example by one or a
combination of the following measures:
 an appropriate design of the drive mechanism;
 slipping clutches;
 pressure limitation in pneumatic systems.
If the machine is to be used with materials which accumulates electrostatic charges during winding, then
measures shall be taken to prevent hazards due to electric shock, for example by earthing or use of ionisation
devices; see 7.2.6.
5.3.11 Sheet cutting unit
5.3.11.2.1
Crushing, shearing or impact hazards during movement of parts of the sheet cutting unit shall be prevented
by:
5.3.11.2.2
Cutting hazards caused by moving or stationary parts of the sheet cutting unit shall be prevented by:
 design; or
35
BS EN 12409:2008+A1:2011
EN 12409:2008+A1:2011 (E)
6 Verification of safety requirements and/or protective measures

Type tests shall be used to verify the safety requirements and/or protective measures in accordance with
Table 1.
"Functional testing" includes verifying the function and efficiency of the guards and protective devices on the
basis of descriptions given in the information for use; safety related plans and circuit diagrams; the
requirements given in clause 5 of this standard and the other quoted standards.
"Design validation" means verifying that the design meets the safety specifications of this standard.
36
BS EN 12409:2008+A1:2011
EN 12409:2008+A1:2011 (E)
Table 1 — Verification methods
Clause Visual inspection Measurement Functional test Design validation

5.2.1.1 X X X X
5.2.1.2 X X X
5.2.1.3 X X X
5.2.1.4 X X X X
5.2.2.1 X X X X
5.2.2.2 X X X X
5.2.2.3 X X X X
5.2.2.4 X X X X
5.2.2.5 X X X X
5.2.3.1 X X X
5.2.3.2 X X X
!5.2.3.3.1 X X X X
5.2.3.3.2 X X X X"
5.2.4 X X X
5.2.5 X X X
5.2.6 X X X
5.2.7 X X X X
5.2.8 X X
5.2.9 X X X X
5.2.10 X X X
5.2.11 X X X
5.2.12 X X X X
5.2.13 X X X X
5.2.14 X X X
5.2.15 X
5.2.16 X X X
5.2.17 X X
5.3.1.1 X
5.3.1.2.1 X X X
5.3.1.2.2 X X X X
5.3.1.2.3 X
5.3.1.2.4 X X
5.3.1.2.5 X X
5.3.1.2.6 X X X
5.3.1.2.7 X
37
BS EN 12409:2008+A1:2011
EN 12409:2008+A1:2011 (E)
Table 1 — Verification methods (continued)

5.3.1.3 X X X
5.3.2.1 X
5.3.2.2.1 X X X
5.3.2.2.2 X X X
5.3.2.3 X X X
5.3.3.1 X
5.3.3.2.1 X X X
5.3.3.2.2 X X X
5.3.3.2.3 X X X
5.3.3.2.4.1 X X X
5.3.3.2.4.2 X X X
5.3.3.3 X X X
5.3.4.1 X
5.3.4.2.1 X X X
5.3.4.2.2 X X X
5.3.4.2.3 X X X
5.3.4.3 X X X
5.3.5.1 X
5.3.5.2.1 X X X
5.3.5.2.2 X X X
5.3.5.3 X X
5.3.5.4 X X
5.3.5.5 X X X
5.3.6.1 X
5.3.6.2.1 X X X
5.3.6.2.2 X X X
5.3.6.3 X X
5.3.7.1 X
5.3.7.2.1.1 X X X
5.3.7.2.1.2 X X X
5.3.7.2.2 X X
38
BS EN 12409:2008+A1:2011
EN 12409:2008+A1:2011 (E)
Table 1 — Verification methods (concluded)

5.3.8.1 X X
5.3.8.2 X
5.3.8.3.1 X X X
5.3.8.3.2 X X X
5.3.8.4 X X
5.3.8.5 X X X
5.3.9.1 X
5.3.9.2.1 X X
5.3.9.2.2 X X
5.3.9.2.3 X
5.3.9.3 X X
5.3.10.1 X
5.3.10.2.1 X X X
5.3.10.2.2 X X X X
5.3.10.3 X X X
5.3.11.1 X
5.3.11.2.1 X X X
5.3.11.2.2 X X X
7 Information for use
7.1 Marking on the machine
7.1.1 Minimum marking
The machine shall be marked at least with the following information:
 name and address of the manufacturer and supplier;
 mandatory marks;
 designation of series or type;
 serial or machine number;
 year of construction;
 designation of the machinery;
 business name and full address of the authorised representative (where applicable).
39
BS EN 12409:2008+A1:2011
EN 12409:2008+A1:2011 (E)
7.1.2 Additional markings
Warning signs shall be affixed in areas of hot machine parts or hot material, if their surface temperature
exceeds the limit values of EN ISO 13732-1:2006 and if they cannot be protected against accidental contact
by appropriate protective devices for process reasons.
If necessary to ensure safe use of the machine, marking shall also include instructions about commissioning,
operation, setting, maintenance, cleaning, dismantling and the requirement to wear personal protective
equipment.
7.2 Instruction manual
7.2.1 General requirements
An instruction manual shall be provided with each machine. It shall include as a minimum the information
required to be marked on the machine in accordance with 7.1, the basic information in accordance with
EN ISO 12100-2:2003, 6.5.1 and the information required by 7.2.2 to 7.2.13.
7.2.2 Hot surfaces
Instructions about safety measures which have to be taken to avoid accidental contact with hot parts, e. g.
machine parts, hot plates, sheet material, with surface temperatures exceeding the limit values indicated in
EN ISO 13732-1:2006, e. g. personal protective equipment such as gloves.
7.2.3 Use of personal protective equipment
Instructions on the requirements and use of personal protection equipment, e. g. safety gloves shall be given.
Warning shall be given of the hazard of drawing in associated with intake gaps greater than 4 mm, particularly
when safety gloves are worn.
7.2.4 Noise declaration
The declared noise emission values shall be given together with the following minimum information that
describe the conditions under which the noise was measured:
 the mounting and operating conditions of the machinery during noise emission measurement;
 the position on a path at 1 m from the surface of the machinery and 1,6 m above the floor or the access
platform where the A-weighted emission sound pressure level is a maximum;
 the criteria on which the noise declaration is based (i.e. EN ISO 4871:1996).
The chosen measurement methods shall be indicated:
 EN ISO 11201:1995 or EN ISO 11204:1995 for the determination of emission sound pressure level at the
work station(s);
 EN ISO 3744:1995 for the determination of sound power level of the complete machine.
The following operating conditions shall be indicated:
a) for continuous sheet machines:
1) maximum possible forming cycles in cycles/minute;
2) cycles per minute during the test for each station;
40
BS EN 12409:2008+A1:2011
EN 12409:2008+A1:2011 (E)
3) number of parts per cycle per station;
4) material:
i) type;
ii) thickness;
iii) width;
b) for single sheet machines:
1) cycle time for one sheet during the test in minutes;
2) material:
i) type;
ii) thickness;
iii) sheet dimensions.
It shall be stated whether the measurement was carried out with or without forced air cooling.
NOTE For machines operated without material (dry cycle) the noise emission level can be higher than for those
machines operated with material.
Main sources of noise in use during the test shall be declared.
Details of main sources of noise shall be given, for example:
 number;
 power consumption;
 flow rate;
 pressure;
 type.
Declaration and verification of noise emission values shall be made in accordance with EN ISO 4871:1996.
The noise declaration shall be a dual number declaration as defined in EN ISO 4871:1996, i.e. the measured
value and the measurement uncertainty shall be indicated separately.
7.2.5 Extraction of dusts, fumes or gases
Instructions about locations on the machine where extraction systems shall be connected in order to avoid the
release of dusts, fumes or gases hazardous to health.
7.2.6 Electrostatic phenomena
Information about electric energy which may be present due to electrostatic phenomena generated during
unwinding, winding or separation of some materials and instructions for its elimination.
41
BS EN 12409:2008+A1:2011
EN 12409:2008+A1:2011 (E)
Instructions shall be provided for the provision of earthing connections to prevent hazards due to the
accumulation of electrostatic charge.
7.2.7 Manual handling
Instructions shall be given on the need to use mechanical handling equipment, either supplied as part of the
machine or otherwise necessary for handling loads with a mass exceeding 15 kg.
7.2.8 Fire prevention
Instructions about fire protection measures required within heating equipment. Instruction that, if easily
inflammable materials are to be processed, for example nitro-cellulose, a suitable extinguishing system shall
be installed.
7.2.9 Manual intervention at the stacking zone
Instructions that if, for operational reasons, a manual intervention is required at the stacking zone, during
continuous sheet transport, then only specially trained personnel shall carry out this operation.
7.2.10 Safe cleaning
Indications about how the machine can be cleaned safely.
7.2.11 Use of acknowledge switch
Information about the purpose of the acknowledge switch that may be required when whole body access is
possible behind guards or other protective devices and how it should be used.
7.2.12 !Inspection of electrical drives
When electrical drives are used to raise elements, the following inspection requirements shall be given:
 in the case of a drive with a mechanical brake, the frequency of brake inspections, the procedure to
determine when adjustment or replacement of parts is necessary and the method for adjustment;
 in the case of two mechanical brakes independent from each other, the frequency of brake testing to
determine the functional capability of each brake; the minimum conditions for continued use and the
method of assessment shall be given;
 in the case of a mechanical brake in combination with a friction-locked clamping device, the frequency of
the tests to be carried out to determine the functional capability of the brake and the efficiency of the
clamping function; the minimum conditions for continued use and the method of assessment shall be
given."
7.2.13 Single sheet feed malfunction
When appropriate information shall be given, including an indication of additional devices that may be
required, e. g. air nozzles, to minimise the possibility of single sheets failing to separate when fed into the
machine to prevent risk of harm arising from unintended access to danger zones to manually separate sheets.
7.2.14 !Static holding load
The manufacturer shall declare the maximum weight of the moulds and tools that can be fitted to the
machine."
42
BS EN 12409:2008+A1:2011
EN 12409:2008+A1:2011 (E)
Annex A
(informative)
Single sheet machine (alternatively material feed from single sheet

magazine or continuous sheet roll)
Key
1 Continuous sheet unwind unit
2 Material intake
3 Sheet cutting unit
4 Conveying equipment
5 Single sheet feed unit
6 Heating unit
7 Forming station
8 Finishing station
9 Discharge station
Figure A.1 — Example of a single sheet machine (alternatively material feed from single sheet
magazine or continuous sheet roll)
43
BS EN 12409:2008+A1:2011
EN 12409:2008+A1:2011 (E)
Annex B
(informative)
Continuous sheet machine (combined forming and finishing)
Key
1 Continuous sheet unwinding unit
2 Material intake
3 Preheating unit
5 Heating unit
6 Forming and finishing unit
7 Stacking station
8 Discharge station
9 Residual sheet unwind unit
Figure B.1 — Example of a continuous sheet machine (combined forming and finishing)
44
BS EN 12409:2008+A1:2011
EN 12409:2008+A1:2011 (E)
Annex C
(informative)
Continuous sheet machine (separate forming and finishing)
Key
1 Continuous sheet unwind unit
2 Material intake
3 Edge heating unit
4 Heating unit
6 Forming station
7 Finishing station
8 Stacking station
9 Discharge station
10 Residual sheet winding unit
Figure C.1 — Example of a continuous sheet machine (separate forming and finishing)
45
BS EN 12409:2008+A1:2011
EN 12409:2008+A1:2011 (E)
!deleted text"
46
BS EN 12409:2008+A1:2011
EN 12409:2008+A1:2011 (E)
Annex ZA
(informative)
Relationship between this European Standard and the Essential

Requirements of EU Directive 2006/42/EC
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 2006/42/EC.
Once this standard is cited in the Official Journal of the !European Union" under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the normative
clauses of this standard confers, within the limits of the scope of this standard, a presumption of conformity
with the relevant Essential Requirements of that Directive and associated EFTA regulations.
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
47
BS EN 12409:2008+A1:2011
EN 12409:2008+A1:2011 (E)
Bibliography
[1] EN ISO 11688-2:2000, Acoustics — Recommended practice for the design of low-noise machinery and
equipment — Part 2: Introduction to the physics of low-noise design (ISO/TR 11688-2:1998)
[2] ISO/DIS 5598:2004, Fluid power systems and components — Vocabulary
[3] PD CLC/TR 50404:2003, Electrostatics. Code of practice for the avoidance of hazards due to static
electricity
[4] EN 415-3:1999, Safety of packaging machines — Part 3: Form, fill and seal machines
[5] Directive 94/9/EC of the European Parliament and the Council of 23 March 1994 on the approximation of
the laws of the Member States concerning equipment and protective systems intended for use in
potentially explosive atmospheres
48
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BS EN 12409:2008
+A1:2011
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BRITISH STANDARD BS EN 12409:2008

NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW

This British Standard is the UK implementation of

This British Standard Amendments/corrigenda issued since publication

ISBN 978 0 580 72955 3

ICS 83.200 Supersedes EN 12409:2008

Plastics and rubber machines - Thermoforming machines -

EUROPEAN COMMITTEE FOR STANDARDIZATION

Management Centre: Avenue Marnix 17, B-1000 Brussels

5.2.10 Ergonomics .......................................................................................................................................... 24

This document includes Amendment 1, approved by CEN on 2011-08-29.

This document supersedes !EN 12409:2008".

 continuous sheet unwind unit;

 single sheet feed unit;

 edge heating unit;

 component feeding/inserting unit;

 residual sheet winding unit;

 sheet cutting unit.

 which have a separate control system; and/or

 are located separately.

EN 1037:1995, Safety of machinery — Prevention of unexpected start-up

EN 60204-1:2006, Safety of machinery — Electrical equipment of machines — Part 1: General requirements

EN 60529:1991, Degrees of protection provided by enclosures (IP Code) (IEC 60529:1989)

EN 61496-1:2004, Safety of machinery — Electro-sensitive protective equipment — Part 1: General

3 Terms and definitions

EXAMPLE Chain conveyor.

NOTE The heating may be integrated into the forming station.

EXAMPLE Radiators, contact heating plates or hot air installations.

 actuate closing, clamping and opening of moulds;

 serve as forming aids, e. g. stretching punches, pre blow boxes etc.;

 locate or clamp thermoplastic sheet during the forming process

4 List of significant hazards

4.2 Hazards relating to all units

4.2.1 Mechanical hazards

4.2.2 Hazards due to electrical energy

4.2.3 Hazards due to failure/malfunction of the control system

4.2.4 Hazards resulting from failure of an energy supply

4.2.5 Hazards due to failure/malfunction of pneumatic equipment

4.2.6 Hazards resulting from failure/malfunction of hydraulic equipment

4.2.7 Hazards resulting from inadequate emergency precautions

4.2.8 Hazards resulting from noise

Hazards due to high noise levels which can lead to:

 interference with speech communication;

 interference with the perception of acoustic signals.

4.2.10 Hazards due to hot surfaces

Burning hazards due to accidental contact with hot surfaces.

4.2.11 Hazards due to unsuitable ergonomics

Hazards due to strain of the human body resulting from:

 unsuitable body position;

 lifting excessive loads;

 emission of hot air from the machine.

4.2.12 Hazards due to unexpected start up

4.2.13 Hazards arising when setting the machine

4.2.14 Hazards arising from access to finishing area during production

Impact, crushing, shearing or drawing-in or trapping hazards.

4.2.15 Hazards due to permanent means of access

4.2.16 Hazards due to laser devices

Hazards due to high intensity radiation can cause eye injury.

4.3 Specific hazards and danger zones relating to individual units

4.3.1 Continuous sheet unwind unit

4.3.1.1 Mechanical hazards

4.3.1.1.1 Hazards during movement of roll loading devices

Impact, crushing or shearing hazards.