EN 12409:2008+A1:2011
(Main + Amendment)Plastics and rubber machines - Thermoforming machines - Safety requirements
General Information
- Abstract
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.
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.
- Status
- Published
- Publication Date
- 11-Oct-2011
- Technical Committee
- CEN/TC 145 - Rubber and plastics machines - Safety
- Drafting Committee
- CEN/TC 145/WG 10 - Thermoforming machines - Safety
- Current Stage
- 9093 - Decision to confirm - Review Enquiry
- Start Date
- 03-Sep-2025
- Completion Date
- 23-Sep-2026
- Directive
- Harmonized Standard2006/42/EC - Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (recast)OJ Ref: C, C 61 OJ Date: 29-Feb-2012
Overview
EN 12409:2008+A1:2011 - published by CEN - is the European safety standard for thermoforming machines used with continuous sheet or single sheets of thermoplastic materials. It addresses all significant hazards, hazardous situations and events relevant to thermoforming machines when used as intended or under foreseeable misuse. The standard applies to a single forming unit or a combination of forming and auxiliary units designed to operate as one machine, and it includes Amendment 1 (2011).
Covered units include:
- continuous sheet unwind and residual winding units
- single sheet feed and material intake
- conveying, heating, preheating and edge-heating units
- component feeding/inserting, forming, finishing, stacking and discharge stations
- sheet cutting units
Not covered: units with separate control systems or located separately, units integrated into form–fill–seal machines (EN 415-3), and heating systems fuelled by gas.
Key Topics
EN 12409 is a Type C machine-specific safety standard (per EN ISO 12100) and takes precedence over Type A/B standards for machines designed accordingly. Major technical topics and requirements include:
- Risk identification and list of significant hazards: mechanical, electrical, pneumatic, hydraulic, control failures, energy-supply failures.
- Hazard specifics for each unit: e.g., unwind, feed, heating, forming, finishing, stacking, cutting.
- Protective measures and safety requirements: guarding, access control to danger zones, emergency precautions, safe setting and maintenance modes, prevention of unexpected start-up.
- Special risks: hot surfaces, inhalation of dusts/fumes/gases, noise, ergonomics, laser devices, manual handling.
- Verification and validation of safety measures and machine conformity.
- Information for use: marking, instruction manuals, safety labels, noise declarations, cleaning, maintenance and inspection guidance.
- Annexes provide typical machine layouts and an informative link (Annex ZA) to the Essential Requirements of the EU Machinery Directive 2006/42/EC.
Applications and Users
This standard is essential for:
- Machine manufacturers and designers developing thermoforming machines or subsystems.
- Safety engineers and compliance officers conducting risk assessments and CE conformity activities.
- System integrators and machine builders combining forming units with finishing or feeding units.
- Test labs, notified bodies and certification agencies verifying compliance.
- Plant managers and purchasers specifying safety requirements for new equipment.
Practically, EN 12409 guides safe machine design, protective guarding, control/lockout strategies, operator instructions, and documentation needed to meet European machinery safety requirements.
Related Standards
- EN ISO 12100 (general risk assessment and principles)
- EN 415-3 (form–fill–seal machines - excluded here)
- EU Machinery Directive 2006/42/EC (see Annex ZA)
- ATEX guidance (note: thermoforming machines generally fall outside Directive 94/9/EC per the standard)
Keywords: EN 12409:2008+A1:2011, thermoforming machines, safety requirements, plastics and rubber machines, CEN standard, machine safety, risk assessment.
Relations
- Merged From
EN 12409:2008 - Plastics and rubber machines - Thermoforming machines - Safety requirements - Effective Date
- 13-Aug-2011
- Effective Date
- 25-Aug-2026
- Effective Date
- 09-Feb-2026
- Effective Date
- 09-Feb-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
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Frequently Asked Questions
EN 12409:2008+A1:2011 is a standard published by the European Committee for Standardization (CEN). Its full title is "Plastics and rubber machines - Thermoforming machines - Safety requirements". This standard covers: 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. 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.
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. 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.
EN 12409:2008+A1:2011 is classified under the following ICS (International Classification for Standards) categories: 83.200 - Equipment for the rubber and plastics industries. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 12409:2008+A1:2011 has the following relationships with other standards: It is inter standard links to EN 12409:2008, ISO 8598:1996, EN 60529:1991, EN 61496-1:2004, EN ISO 11688-1:1998, EN ISO 14122-3:2001, EN 999:1998, EN ISO 4871:1996, EN 349:1993, EN 1760-1:1997, EN 574:1996, EN ISO 13849-1:2008, EN 2286:1989, EN 982:1996, EN 983:1996. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 12409:2008+A1:2011 is associated with the following European legislation: EU Directives/Regulations: 2006/42/EC; Standardization Mandates: M/BC/CEN/88/13. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
EN 12409:2008+A1:2011 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Kunststoff- 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 12409:2008+A1:2011SIST EN 12409:2008+A1:2011en,fr,de01-december-2011SIST EN 12409:2008+A1:2011SLOVENSKI
STANDARDSIST EN 12409:20081DGRPHãþD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 12409:2008+A1
October 2011 ICS 83.200 Supersedes EN 12409:2008English Version
Plastics and rubber machines - Thermoforming machines - Safety requirements
Machines pour les matières plastiques et le caoutchouc - Machines de thermoformage - Prescriptions de sécurité
Kunststoff- und Gummimaschinen - Warmformmaschinen -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 worldwide for CEN national Members. Ref. No. EN 12409:2008+A1:2011: ESIST EN 12409:2008+A1:2011
Single sheet machine (alternatively material feed from single sheet magazine or continuous sheet roll) . 43Annex B (informative)
Continuous sheet machine (combined forming and finishing) . 44Annex C (informative)
Continuous sheet machine (separate forming and finishing) . 45Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 2006/42/EC . 47Bibliography . 48 SIST EN 12409:2008+A1:2011
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+A1:2011
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+A1:2011
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+A1:2011
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