Plastics and rubber machines - Thermoforming machines - Safety requirements

This European Standard deals with all significant hazards, hazardous situations and events relevant to thermoforming machines for continuous sheets 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.
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.

Kunststoff- und Gummimaschinen - Warmformmaschinen - Sicherheitsanforderungen

Diese Europäische Norm behandelt alle signifikanten Gefährdungen, Gefährdungssituationen und Gefährdungsereignisse, die auf Warmformmaschinen für Folien und Platten aus thermoplastischen Materialien zutreffen, wenn sie bestimmungsgemäß und unter Bedingungen, die vom Hersteller als Fehlanwendung vernünftigerweise vorhersehbar sind, verwendet werden (siehe Abschnitt 4).
Eine Warmformmaschine kann aus einer Formstation oder aus einer Formstation, die mit einer oder mehreren zusätzlichen Baugruppen verbunden ist, bestehen. Diese Norm behandelt folgende Baugruppen:
   Folienabwickeleinrichtung;
   Plattenzuführungseinrichtung;
   Materialeinlauf;
   Transporteinrichtung;
   Heizung;
   Vorheizung;
   Randheizung;
   Beschickungs-/Einlegeeinrichtung für Komponenten;
   Formstation;
   Nachbearbeitungsstation;
   Stapelstation;
   Austragsstation;
   Restfolienwickeleinrichtung;
   Folienschneideinrichtung.
Diese Europäische Norm gilt nicht für Baugruppen, die der Warmformmaschine vor- oder nachgeschaltet sind, und die
   ein eigenes Steuerungssystem haben und/oder
   separat angeordnet sind.
ANMERKUNG 1   Diese Europäische Norm legt die Anforderungen für Maschinen fest, die als Einzelformstation geliefert werden oder die aus einer Vielzahl einzelner Stationen konzipiert sind und wie eine Einzelmaschine betrieben werden. Weitere Baugruppen, die in einem späteren Stadium einbezogen werden, sollten unter Beachtung der relevanten Normen und unter Berücksichtigung jeglicher Gefährdungen, die sich aus dem Zusammenwirken mit der Warmformmaschine ergeben, gesondert betrachtet werden.
Diese Europäische Norm gilt nicht für Baugruppen, die in Form- Füll- und Verschließmaschinen integriert sind. Diese sind in EN 415-3:1999 behandelt.
Diese Europäische Norm gilt nicht für Baugruppen, die Heizungssysteme enthalten, die mit Gas betrieben werden.

Machines pour les matières plastiques et le caoutchouc - Machines de thermoformage - Prescriptions de sécurité

La présente Norme européenne traite de tous les phénomènes dangereux, situations et événements
dangereux significatifs concernant les machines de thermoformage pour film continu et feuilles unitaires de
matière thermoplastique, que ce soit en utilisation normale ou lors de mauvais usages raisonnablement
prévisibles par le fabricant (voir Article 4).
Une machine de thermoformage peut comprendre une seule unité de formage ou une unité de formage
associée à une ou plusieurs unités complémentaires. La présente norme couvre les unités suivantes :
- dérouleur de film ;
- unité d'alimentation feuille à feuille ;
- dispositif d'alimentation de matière ;
- équipement de transfert ;
- unité de chauffage ;
- unité de préchauffage ;
- unité de chauffage des bords ;
- dispositif d’introduction/d’insertion de composants ;
- poste de formage ;
- poste de finition ;-
- poste d'empilage ;
- poste de déchargement ;
- enrouleur de feuille résiduelle ;
- unité de coupe.
La présente Norme européenne ne s'applique pas aux équipements situés en amont ou en aval de la
machine de thermoformage :
- qui sont commandés séparément ; et/ou
- qui sont implantés séparément.
NOTE 1 La présente Norme européenne spécifie les prescriptions relatives aux machines livrées sous forme d’une
seule unité de formage ou sous forme d’un ensemble d’unités destinées à fonctionner comme une seule machine. Il
convient de traiter séparément toute unité supplémentaire ajoutée à un stade ultérieur en appliquant les normes
pertinentes et en prenant en compte tout phénomène dangereux provoqué par l’interaction de cette unité avec la machine
de thermoformage.
La présente Norme européenne ne s'applique pas aux unités qui sont incorporées dans les machines
d'emballage à former, remplir et sceller. Ces unités sont traitées dans l’EN 415-3:1999.
La présente Norme européenne ne s'applique pas aux unités comportant des systèmes de chauffage
alimentés au gaz.

Stroji za predelavo gume in plastike - Stroji za toplotno oblikovanje - Varnostne zahteve

General Information

Status
Withdrawn
Publication Date
27-Oct-2008
Withdrawal Date
20-Nov-2011
Technical Committee
Current Stage
9900 - Withdrawal (Adopted Project)
Start Date
18-Nov-2011
Due Date
11-Dec-2011
Completion Date
21-Nov-2011

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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Stroji za predelavo gume in plastike - Stroji za toplotno oblikovanje - Varnostne zahteveKunststoff- und Gummimaschinen - Warmformmaschinen - SicherheitsanforderungenMachines pour les matières plastiques et le caoutchouc - Machines de thermoformage - Prescriptions de sécuritéPlastics and rubber machines - Thermoforming machines - Safety requirements83.200Oprema za gumarsko industrijo in industrijo polimernih materialovEquipment for the rubber and plastics industriesICS:Ta slovenski standard je istoveten z:EN 12409:2008SIST EN 12409:2008en01-december-2008SIST EN 12409:2008SLOVENSKI
STANDARDSIST EN 12409:20001DGRPHãþD



SIST EN 12409:2008



EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 12409October 2008ICS 83.200Supersedes EN 12409:1999
English VersionPlastics and rubber machines - Thermoforming machines -Safety requirementsMachines pour les matières plastiques et le caoutchouc -Machines de thermoformage - Prescriptions de sécuritéKunststoff- und Gummimaschinen - Warmformmaschinen -SicherheitsanforderungenThis European Standard was approved by CEN on 24 August 2008.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the CEN Management Centre or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2008 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 12409:2008: ESIST EN 12409:2008



EN 12409:2008 (E) 2 Contents Page Foreword.4 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.21 5.2.5 Hydraulic equipment.21 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 5.2.10 Ergonomics.23 SIST EN 12409:2008



EN 12049:2008 (E) 3 5.2.11 Unexpected start up.23 5.2.12 Setting mode.23 5.2.13 Access during production.24 5.2.14 Laser devices.24 5.2.15 Permanent means of access.24 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.30 5.3.7 Finishing station.31 5.3.8 Stacking zone.33 5.3.9 Discharge station.33 5.3.10 Residual sheet winding unit.34 5.3.11 Sheet cutting unit.35 6 Verification of safety requirements and/or protective measures.35 7 Information for use.38 7.1 Marking on the machine.38 7.1.1 Minimum marking.38 7.1.2 Additional markings.39 7.2 Instruction manual.39 7.2.1 General requirements.39 7.2.2 Hot surfaces.39 7.2.3 Use of personal protective equipment.39 7.2.4 Noise declaration.39 7.2.5 Extraction of dusts, fumes or gases.40 7.2.6 Electrostatic phenomena.40 7.2.7 Manual handling.41 7.2.8 Fire prevention.41 7.2.9 Manual intervention at the stacking zone.41 7.2.10 Safe cleaning.41 7.2.11 Use of acknowledge switch.41 7.2.12 Inspection of electrical drives.41 7.2.13 Single sheet feed malfunction.41 Annex A (informative)
Single sheet machine (alternatively material feed from single sheet magazine or continuous sheet roll).42 Annex B (informative)
Continuous sheet machine (combined forming and finishing).43 Annex C (informative)
Continuous sheet machine (separate forming and finishing).44 Annex ZA (informative)
Relationship between this
European
Standard and the Essential Requirements
of EU Directive 98/37/EC.45 Annex ZB (informative)
Relationship between this
European
Standard and the Essential Requirements
of EU Directive 2006/42/EC.46 Bibliography.47
SIST EN 12409:2008



EN 12409:2008 (E) 4 Foreword This document (EN 12409:2008) 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 2009, and conflicting national standards shall be withdrawn at the latest by April 2009. 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 has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EC Directive(s). For relationship with EC Directive(s), see informative Annex ZA and B, which are an integral part of this document. This document supersedes EN 12409:1999. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. SIST EN 12409:2008



EN 12049:2008 (E) 5 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. SIST EN 12409:2008



EN 12409:2008 (E) 6
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. SIST EN 12409:2008



EN 12049:2008 (E) 7 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) SIST EN 12409:2008



EN 12409:2008 (E) 8 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 13849-1:2006, 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 SIST EN 12409:2008



EN 12049:2008 (E) 9 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 SIST EN 12409:2008



EN 12409:2008 (E) 10 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 SIST EN 12409:2008



EN 12049:2008 (E) 11 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 exampl
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