Food processing machinery - Filling machines and auxiliary machines - Safety and hygiene requirements

1.1 This document applies for:
- filling machines with cylinder and piston,
- filling machines with feed intake hopper, feeder and loading device,
- auxiliary machines for filling machines.
This document does not apply to filling machines with cylinder and manual operation.
This document deals with all significant hazards, hazardous situations and events relevant to machines, appliances and machinery, when they are used as intended and under the conditions foreseen by the manufacturer and also the reasonable foreseeable misuse (see Clause 4).
These significant hazards, hazardous situations and events exist during the whole life of filling machines.
This document is not applicable to filling machines and auxiliary machines which are manufactured before the date of publication of this document by CEN.
Filling machines described in this document are no forming, filling and sealing machines as described in EN 415-3. Clipping machines are not covered by this document.
1.2 This document covers the following types of filling machines and auxiliary machines:
1.2.1 Filling machines with cylinder
- Filling machines with cylinder consist of piston, closing cover, machine frame accessory drive parts and electrical and hydraulic components.
- The material being processed will be fed by hand into the cylinder.
The distance H1 from the floor (standing area) to the middle of the discharge port (filling horn) is
> 975 mm (see Figure 1).
- Filling machines with cylinder will be switched on or off by a knee-operated lever switch.
- Filling machines with cylinder can be fitted with;
- divider slide valve,
- divider rotating valve.
1.2.2 Filling machines with feed intake hopper
- Filling machines with feed hopper intake (with or without infeed auger) consist of feeder on discharge side of the feed intake hopper, machine frame, accessory drive parts and electric, electronic or pneumatic components, depending on machine type.

Nahrungsmittelmaschinen - Füllmaschinen und Vorsatzmaschinen - Sicherheits- und Hygieneanforderungen

Diese Norm gilt für
-   Füllmaschinen mit Zylinder und Kolben
-   Füllmaschinen mit Einfülltrichter, Förderwerk und Beschickungseinrichtung
-   Vorsatzmaschinen für Füllmaschinen
Diese Norm ist nicht anwendbar auf Füllmaschinen mit Zylinder und Handbetrieb.
Diese Norm behandelt alle signifikanten Gefährdungen, Gefährdungssituationen und Gefährdungsereignisse, die auf die Maschinen, Geräte und Anlagen zutreffen, wenn sie bestimmungsgemäß und entsprechend den vorhersehbaren Bedingungen des Herstellers verwendet werden (siehe Abschnitt 4).
Diese signifikanten Gefährdungen, Gefährdungssituationen und Gefährdungsereignisse sind während der gesamten Lebensdauer der Füllmaschinen vorhanden.
Dieses Dokument gilt nicht für Füllmaschinen und Vorsatzmaschinen, die hergestellt wurden, bevor CEN dieses Dokument veröffentlichte.
Die in dieser Norm behandelten Füllmaschinen sind keine Form , Füll  und Verschließmaschinen im Sinne der EN 415 3. Clipmaschinen werden in dieser Norm nicht behandelt.

Machines pour les produits alimentaires - Machines à pousser et machines auxiliaires - Prescriptions relatives à la sécurité et à l'hygiène

1.1   Le présent document s’applique aux :
-   machines à pousser à cylindre et piston ;
-   machines à pousser avec trémie d’alimentation, dispositif d’amenée et dispositif de chargement ;
-   machines auxiliaires pour machines à pousser.
La présente norme ne s’applique pas aux machines à pousser à cylindre et fonctionnement manuel.
!Le présent document traite de tous les phénomènes dangereux, situations et événements dangereux significatifs spécifiques aux machines et équipements, lorsqu'ils sont utilisés normalement et dans des conditions de mauvaises utilisation raisonnablement prévisibles par le fabricant (voir Article 4)."
Ces phénomènes dangereux significatifs, situations et événements dangereux existent tout au long de la durée de vie des machines à pousser.
Le présent document ne s’applique pas aux machines à pousser et machines auxiliaires fabriquées avant la date de publication du présent document par le CEN.
Les machines à pousser, décrites dans la présente norme, ne sont pas les machines à former, à pousser et à emballer décrites dans l’EN 415-3. Les machines à attacher ne sont pas couvertes par la présente norme.
1.2   La présente norme couvre les types suivants de machines à pousser et machines auxiliaires :
1.2.1   Machines à pousser à cylindre
-   Les machines à pousser à cylindre sont constituées d’un piston, d’un couvercle de fermeture, d’un bâti, d’organes d’entraînement des accessoires et de composants électriques et hydrauliques ;
-   le produit à traiter est amené manuellement dans le cylindre ;
La distance H1 depuis le sol (emplacement de maintien) jusqu’au milieu du point de sortie (cornet de remplissage) est  975 mm (voir Figure 1).
-   les machines à pousser à cylindre sont mises en marche ou arrêtées au moyen d’un interrupteur à levier commandé par le genou ;
-   les machines à pousser à cylindre peuvent être équipées de :
-   tiroir coulissant ;
-   tiroir rotatif.

Stroji za predelavo hrane - Polnilniki in pomožni stroji - Varnostne in higienske zahteve (vključno z dopolnilom A1)

1.1 Dokument velja za:
- polnilnike z valjem in batom;
- polnilnike z lijakom za polnjenje, glavnim dovodom in napravo za polnjenje;
- pomožne stroje za polnilnike.
Ta dokument ne velja za polnilnike z valjem in ročnim upravljanjem.
Ta dokument obravnava vse velike nevarnosti, nevarne situacije in primere, ki se tičejo strojev in naprav, kadar se uporabljajo, kot je predvideno, in pod pogoji, ki jih razumno predvidi proizvajalec, ter tudi razumno predvidljivo napačno uporabo (glej točko 4).
Te velike nevarnosti, nevarne situacije in primeri obstajajo v celotni življenjski dobi polnilnikov.
Ta dokument ne velja za polnilnike in pomožne stroje, ki so bili izdelani pred datumom, ko je CEN objavil ta dokument.
Polnilniki, opisani v tem dokumentu, niso oblikovalne, polnilne in zapiralne naprave, ki so opisane v EN 415-3. Ta dokument ne zajema naprav za prirezovanje.
1.2 Ta dokument zajema naslednje vrste polnilnikov in pomožnih strojev:
1.2.1 Polnilniki z valjem
- Polnilnike z valjem sestavlja bat, zapiralni pokrov, pomožni pogonski deli ogrodja stroja ter električne in hidravlične komponente.
- Obdelovani material se ročno polni v valj.
Razdalja H1 od tal (območje stanja) do sredine odprtine za praznjenje (polnilni rog) je
> 975 mm (glej sliko 1).
- Polnilniki z valjem se vključijo ali izključijo z vzvodnim stikalom, ki se upravlja s kolenom.
- Polnilnike z valjem je mogoče opremiti z:
- drsnim ventilom razdelilnika;
- rotirajočim ventilom razdelilnika.
1.2.2 Polnilniki z lijakom za polnjenje
- Polnilniki z lijakom za polnjenje (s polnilnim svedrom ali brez njega) tvorijo glavni dovod na strani za praznjenje lijaka za polnjenje, ogrodje stroja, dodatni pogonski deli in električne, elektronske ali pnevmatske komponente, glede na vrsto stroja.

General Information

Status
Withdrawn
Publication Date
05-Jun-2011
Withdrawal Date
24-Nov-2014
Technical Committee
Current Stage
9900 - Withdrawal (Adopted Project)
Start Date
19-Nov-2014
Due Date
12-Dec-2014
Completion Date
25-Nov-2014

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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Nahrungsmittelmaschinen - Füllmaschinen und Vorsatzmaschinen - Sicherheits- und HygieneanforderungenMachines pour les produits alimentaires - Machines à pousser et machines auxiliaires - Prescriptions relatives à la sécurité et à l'hygièneFood processing machinery - Filling machines and auxiliary machines - Safety and hygiene requirements67.260Tovarne in oprema za živilsko industrijoPlants and equipment for the food industryICS:Ta slovenski standard je istoveten z:EN 12463:2004+A1:2011SIST EN 12463:2004+A1:2011en,fr,de01-julij-2011SIST EN 12463:2004+A1:2011SLOVENSKI
STANDARDSIST EN 12463:20041DGRPHãþD



SIST EN 12463:2004+A1:2011



EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 12463:2004+A1
February 2011 ICS 67.260 Supersedes EN 12463:2004English Version
Food processing machinery - Filling machines and auxiliary machines - Safety and hygiene requirements
Machines pour les produits alimentaires - Machines à pousser et machines auxiliaires - Prescriptions relatives à la sécurité et à l'hygiène
Nahrungsmittelmaschinen - Füllmaschinen und Vorsatzmaschinen - Sicherheits- und Hygieneanforderungen This European Standard was approved by CEN on 2 February 2004 and includes Amendment 1 approved by CEN on 18 Dezember 2010.
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 12463:2004+A1:2011: ESIST EN 12463:2004+A1:2011



EN 12463:2004+A1:2011 (E) 2 Contents Page Foreword .3Introduction .41Scope .52Normative references . 103Terms and definitions . 114List of significant hazards . 145Safety and hygiene requirements and/or protective measures . 216Verification of safety and hygiene requirements and/or protective measures . 457Information for use . 47Annex A (normative)
Noise test code for filling machines and auxiliary machines (grade 2) . 51A.1Determination of the emission sound pressure level . 51A.2Installation and mounting conditions . 51A.3Operating conditions . 51A.4Measurement . 51A.5Information to be recorded . 52A.6Information to be reported . 52A.7Declaration and verification of the noise emission values . 52Annex B (normative)
Design principles to ensure the cleanability of Filling machines and
auxiliary machines . 53B.1Definition . 53B.2Materials of construction . 54B.3Design . 54Annex C (normative)
Common hazards for food processing machines and reduction
requirements applicable to Filling machines and auxiliary machines . 58C.1Cutting hazards . 58C.2Risks from cleaning . 58C.3External influences on electrical equipment . 58C.4Hazards due to cleaning substances . 58C.5Hazards from neglecting use of PPE . 59C.6Hazard from noise. 59Annex ZA (informative)
!!!!Relationship between this European Standard and the Essential Requirements of EU Directive 2006/42/EC"""" . 60Bibliography . 61 SIST EN 12463:2004+A1:2011



EN 12463:2004+A1:2011 (E) 3 Foreword This document (EN 12463:2004+A1:2011) has been prepared by Technical Committee CEN/TC 153 "Machinery intended for use with foodstuffs and feed", the secretariat of which is held by DIN. 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 August 2011, and conflicting national standards shall be withdrawn at the latest by August 2011. 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 2010-12-18. This document supersedes EN 12463:2004. 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 EU Directive(s). For relationship with EU Directives, see informative Annex ZA, which is an integral part of this document. It is one of a series of standards for meat processing machinery, in compliance with
!EN 1672-2:2005+A1:2009", Annex C. This European Standard also contains a bibliography. 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. SIST EN 12463:2004+A1:2011



EN 12463:2004+A1:2011 (E) 4 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 hazardous 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 12463:2004+A1:2011



EN 12463:2004+A1:2011 (E) 5 1 Scope 1.1 This document applies for:  filling machines with cylinder and piston,  filling machines with feed intake hopper, feeder and loading device,  auxiliary machines for filling machines. This document does not apply to filling machines with cylinder and manual operation. !This document deals with all significant hazards, hazardous situations and events relevant to machines, appliances and machinery, when they are used as intended and under the conditions foreseen by the manufacturer and also the reasonable foreseeable misuse (see Clause 4)." These significant hazards, hazardous situations and events exist during the whole life of filling machines. This document is not applicable to filling machines and auxiliary machines which are manufactured before the date of publication of this document by CEN. Filling machines described in this document are no forming, filling and sealing machines as described in
EN 415-3. Clipping machines are not covered by this document. 1.2 This document covers the following types of filling machines and auxiliary machines: 1.2.1 Filling machines with cylinder  Filling machines with cylinder consist of piston, closing cover, machine frame accessory drive parts and electrical and hydraulic components.  The material being processed will be fed by hand into the cylinder. The distance H1 from the floor (standing area) to the middle of the discharge port (filling horn) is > 975 mm (see Figure 1).  Filling machines with cylinder will be switched on or off by a knee-operated lever switch.  Filling machines with cylinder can be fitted with;  divider slide valve,  divider rotating valve. 1.2.2 Filling machines with feed intake hopper  Filling machines with feed hopper intake (with or without infeed auger) consist of feeder on discharge side of the feed intake hopper, machine frame, accessory drive parts and electric, electronic or pneumatic components, depending on machine type.  The material being processed will be fed by hand into the feeding hopper of the filling machine.  Processing of larger quantities of filling material and the height of the filling machine with feed intake hopper can make it necessary to provide a loading device. The loading device is covered by this document. SIST EN 12463:2004+A1:2011



EN 12463:2004+A1:2011 (E) 6  The distance H1 from the floor (standing area) to the middle of the discharge port (filling horn) is > 975 mm (see Figure 2).  Filling machines will be switched on or off by knee-operated lever switches or hand operated switches and/or remote control signals.  Filling machines with feed intake hopper can be equipped with;  divider device,  cover or photoelectric guard at the mouth of the feed intake hopper,  pressure activated trip bar or light barrier at the hopper edge,  divided feed intake hopper,  plough or counter auger,  interlocked step or interlocked ladder,  two hand control at the mouth of the feed intake hopper,  loading device. SIST EN 12463:2004+A1:2011



EN 12463:2004+A1:2011 (E) 7
H1 > 975 mm H1 > 975 mm Key Key 1 2 3 4 5 6 7 filling horn divider rotating valve/divider rotating valve closing cover piston cylinder drive mechanism ON / OFF switch, hood 1234567891011feed intake hopper feeder filling horn ON / OFF switch,
hood step, interlocked intermediate step drive mechanism loading device transport car locking device lifting device Figure 1 — Assembly of a filling machine with
piston Figure 2 — Assembly of a filling machine with feedintake hopper and loading device 1.2.3 Auxiliary machines  Auxiliary machines consist of devices for filling, portioning, twisting, displacing, forming, mincing and of a drive system.  Auxiliary machines do not operate independently. These machines will be actuated directly or by filling machines (see Figures 3 to 9).  Auxiliary machines will be switched on or off by knee operated lever switches or hand operated switches and/or remote control signals.  Auxiliary machines can be fitted with;  dividing device,  hanging device. SIST EN 12463:2004+A1:2011



EN 12463:2004+A1:2011 (E) 8
Key 1 2 3 inlet outlet feeder Figure 3 — Auxiliary twisting machine Figure 4 — Auxiliary portioning and hanging line
Figure 5 — Auxiliary portioning and hanging line Figure 6 — Auxiliary portioning and hanging line
SIST EN 12463:2004+A1:2011



EN 12463:2004+A1:2011 (E) 9
Key 1 2 3 inlet
outlet forming device 456 base forming device conveyor belt Figure 7 —
Forming devices
Key Key 1 2 3 4 drive shaft set of cutting tools feed intake canal nut/plate 1 2 3 4 drive shaft cutting tools feed intake canal locking/plate Figure 8 — Ancillary mincing machine driven by the
filling machines Figure 9 — Ancillary mincing machine with direct drive 1.3 Intended use During the production of this document the following assumptions were made: SIST EN 12463:2004+A1:2011



EN 12463:2004+A1:2011 (E) 10 Filling machines are installed in a sufficiently lighted place. They are used only by designated and skilled operators. Filling machines are not foreseen to be cleaned with pressurized water (e.g. tap water). 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 574:1996+A1:2008, Safety of machinery — Two-hand control devices — Functional aspects — Principles for design EN 614-1, Safety of machinery — Ergonomic design principles — Part 1: Terminology and general principles EN 953:1997+A1:2009, Safety of machinery — Guards — General requirements for the design and construction of fixed and movable guards EN 1005-1, Safety of machinery — Human physical performance — Part 1: Terms and definitions EN 1005-2, Safety of machinery — Human physical performance — Part 2: Manual handling of machinery and component parts of machinery EN 1005-3, Safety of machinery — Human physical performance — Part 3: Recommended force limits for machinery operation EN 1088:1995+A2:2008, Safety of machinery — Interlocking devices associated with guards — Principles for design and selection EN 1672-2:2005+A1:2009, Food processing machinery — Basic concepts — Part 2: Hygiene requirements EN 13288:2005+A1:2009, Food processing machinery — Bowl lifting and tilting machines — Safety and hygiene requirements EN 60204-1:2006, Safety of machinery — Electrical equipment of machines — Part 1: General requirements (IEC 60204-1:2005, modified) EN 60529, Degrees of protection provided by enclosures (IP code) (IEC 60529:1989) EN 61496-1, Safety of machinery — Electro-sensitive protective equipment — Part 1: General requirements and tests (IEC 61496-1:2004, modified) EN ISO 3744:2010, Acoustics — Determination of sound power levels and sound energy levels of noise sources using sound pressure — Engineering methods for an essentially free field over a reflecting plane (ISO 3744:2010) EN ISO 4287, Geometrical product specifications (GPS) — Surface texture: Profile method — Terms, definitions and surface texture parameters (ISO 4287:1997) EN ISO 4871:2009, Acoustics — Declaration and verification of noise emission values of machinery and equipment (ISO 4871:1996) SIST EN 12463:2004+A1:2011



EN 12463:2004+A1:2011 (E) 11 EN ISO 11201:2010, Acoustics — Noise emitted by machinery and equipment — Determination of emission sound pressure levels at a work station and at other specified positions in an essentially free field over a reflecting plane with negligible environmental corrections (ISO 11201:2010) EN ISO 11688-1, Acoustics — Recommended practice for the design of low-noise machinery and equipment — Part 1: Planning (ISO/TR 11688-1:1995) EN ISO 12100:2010, Safety of machinery — General principles for design — Risk assessment and risk reduction (ISO 12100:2010) 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 13855, Safety of machinery — Positioning of safeguards with respect to the approach speeds of parts of the human body (ISO 13855:2010) EN ISO 13857:2008, Safety of machinery — Safety distances to prevent hazard zones being reached by upper and lower limbs (ISO 13857:2008)" 3 Terms and definitions !For the purposes of this document, the terms and definitions given in EN ISO 12100:2010 and the following apply." 3.1 twisting device device to separate one portion from the next by twisting 3.2 divider rotating valve rotatable closing component 3.3 divider device divider rotating valve, a divider slide valve 3.4 divider slide valve movable closing plate 3.5 hanger device device to suspend or transport the product 3.6 hanger movable unit to convey the product onto a hanger device 3.7 ejector/extractor device for detaching the set of cutting tools and the worm 3.8 extraction claw tool for detaching the set of cutting tools and the worm SIST EN 12463:2004+A1:2011



EN 12463:2004+A1:2011 (E) 12 3.9 design height height of the feed intake hopper edge measured from the floor 3.10
loading device lift-tilt device for lifting and tilting of transport cars or containers 3.11
casing brake device for retaining and braking the product casing on the filling horn 3.12 casing holding device device for holding and sealing product casings onto or in connection with the filling horn 3.13 casing clamp device for centring and clamping the shirred product casing 3.14 feed intake hopper container for receiving products to be processed with safety function 3.15 locking device device for locking the transport car or container in the loading device 3.16 feeder unit for product transport 3.17 plough fixed curve-shaped counter-component to the infeed auger 3.18 divided hopper feed intake hopper with a disconnecting point in the upper hopper part 3.19
protecting device against tilting device to prevent lifting or toppling over of the machine 3.20
design dimension sum of dimensions measured from the floor (standing area), in the case of steps, intermediate steps or ladders from the standing area to the feed intake hopper edge and from the feed intake hopper edge to the first danger point in the feed intake hopper
3.21 piston moving part for pressing out the product 3.22 light barrier optical-electric safety component SIST EN 12463:2004+A1:2011



EN 12463:2004+A1:2011 (E) 13 3.23 blade cutting tool with one or several blades 3.24 rotating head hinged installation with one or more filling horns 3.25 trip bar movable device with safety function 3.26 worm casing casing for holding the worm and the set of cutting tools 3.27 set of cutting tools rough-cutter, blade and hole plate for size reduction of product 3.28 protective hood movable safety device on the discharge outlet 3.29 hinged arm movable part of the lift-tilt device 3.30 counter auger fixed counter-component to the infeed auger 3.31 transport car mobile device for holding the processed or to the processed product 3.32
cutting device device (e.g. knife, wire, scissor) for the cutting of portions filled into product casings 3.33 overtravelling guard device for automatic movement stopping 3.34
removal device for
removing the product in the product casing 3.35 closing Cover closing plate with safety function at the opening of the cylinder 3.36 lock nut device for locking the set of cutting tools in the cutting chamber 3.37
infeed auger rotating conveying element in the feed intake hopper SIST EN 12463:2004+A1:2011



EN 12463:2004+A1:2011 (E) 14 4 List of significant hazards
4.1 General This clause and Annex C contains all the significant hazards, hazardous situations and events, as far as they are dealt with in this document, identified by a risk assessment as significant for this type of machine and which require action identified to eliminate or reduce risk. Before using this document it is important to carry out a risk assessment according to
!EN ISO 12100" of the filling machines and auxiliary machines to check that it has identified all significant hazards, hazardous situations and events in this clause. 4.2 Mechanical hazards 4.2.1 Filling machines with cylinder
4.2.1.1 - Zone 1 Piston at outlet in the cylinder (see Figure 10) Hazard of crushing or severing of fingers or hand 4.2.1.2 - Zone 2 Divider or twisting device in the outlet of the cylinder or filling horn side (see Figure 10) Hazard of crushing or severing of fingers 4.2.1.3 - Zone 3 Free running piston in cylinder (see Figure 10) Hazard of crushing of fingers or hand Hazard of impact on parts of the body when the piston is ejected 4.2.2 Filling machines with feed intake hopper
4.2.2.1 - Zone 4 Rotating infeed auger and fixed plough or fixed curve-shaped counter auger in feed intake hopper (see
Figure 11) Hazard of crushing of fingers or hand 4.2.2.2
- Zone 5 Rotating feeder on discharge side of feed intake hopper (see Figure 11) Hazard of severing of fingers 4.2.2.3
- Zone 6 Rotating feeder on the side of the filling horn (see Figure 11) SIST EN 12463:2004+A1:2011



EN 12463:2004+A1:2011 (E) 15 Hazard of severing of fingers
Key Key 1 2 3 22 zone 1 zone 2 zone 3 zone 22 456789102223zone 4 zone 5 zone 6 zone 7 zone 8 zone 9 zone 10 zone 22 zone 23 Figure 10 — Filling machine with cylinder and
piston - danger zones Figure 11 — Filling machine with feed intake hopper - danger zones
4.2.3 Loading device on filling machines
4.2.3.1 - Zone 7 Space below transport carriage or container (see Figure 11) Hazards to the body by trapping or crushing on floor level during descent Hazards to the body by impact during uncontrolled descent e.g. in the case of mechanical malfunction SIST EN 12463:2004+A1:2011



EN 12463:2004+A1:2011 (E) 16 4.2.3.2 - Zone 8 Path of movement of transport carriage or container (see Figure 11) Hazards to the body by impact from moving components Hazards to fingers or hand by crushing or shearing between moving and stationary components 4.2.3.3 - Zone 9 Drive elements and (where used) pulleys, chains or wire ropes (see Figure 11) Hazards to fingers or hand by drawing-in, shearing, crushing or entanglement 4.2.3.4 - Zone 10 Discharge area (see Figure 11) Hazards to fingers or hand impact or crushing from loading device 4.2.4 Auxiliary machines 4.2.4.1 General Portioning, dividing, twisting, crimping, hanging, forming and mincing devices 4.2.4.2 - Zone 11 Casing clamp (see Figure 12) Hazards of crushing of fingers 4.2.4.3 - Zone 12 Portioning, twisting and crimping device (see Figure 12) Hazards of crushing or severing of fingers 4.2.4.4 - Zone 13 Hanger (see Figure 12) Hazards of crushing of fingers 4.2.4.5 - Zone 14 Transport device (see Figure 12) Hazards of crushing of fingers SIST EN 12463:2004+A1:2011



EN 12463:2004+A1:2011 (E) 17
Key 11 12 13 14 22 zone 11 zone 12 zone 13 zone 14 zone 22 Figure 12 — Auxiliary, twisting and hanging line - danger zones 4.2.4.6 - Zone 15 Feeder (see Figure 13) Hazards of crushing or severing of fingers 4.2.4.7 - Zone 16 Rotating head or pivoting twisting mechanism (see Figure 14) Hazards of crushing of fingers or the hand 4.2.4.8 - Zone 17 Filling horn and casing brake (see Figure 14) Hazards of crushing or severing of fingers
SIST EN 12463:2004+A1:2011



EN 12463:2004+A1:2011 (E) 18
Key Key 15 22 zone 15 zone 22 161718zone 16 zone 17 zone 18
Figure 13 — Auxiliary twisting machine-danger zones Figure14—Auxiliary, dividing and hanging line, rotating head, casing brake, separation device- danger zones
4.2.4.9 - Zone 18 Separator and cutting device (see Figure 14) Hazards of severing of fingers 4.2.4.10 - Zones 19 and 20 Forming device (see Figure 15) Hazards of crushing or severing of fingers Continuous conveyor belt and drive and return pulley Hazards of crushing, shearing or drawing-in of fingers or hand SIST EN 12463:2004+A1:2011



EN 12463:2004+A1:2011 (E) 19
Key 19 20 zone 19 zone 20
Figure 15 — Forming devices - danger zones 4.2.4.11 - Zone 21 Outlet at attached mincing machine, rotating blade behind hole plate (see Figures 16 and 17) Hazard of shearing of fingers
Key
Key 21 22 zone 21 zone 22 21 22 zone 21 zone 22 Figure 16 — Ancillary mincing machine with direct drive by the filling machine Figure 17 — Ancillary mincing machine with direct drive SIST EN 12463:2004+A1:2011



EN 12463:2004+A1:2011 (E) 20 4.2.5 Drive units Zone 22 Drives of rotating machine components (see Figures 10 to 17) Hazards of drawing-in of fingers or hand 4.2.6 Machine components, e.g. cover on feed intake hopper edge Zone 23 Unintended shutting of closing machine components and intended closing of machine components (see
Figure 11) Hazards of crushing of fingers or the hand 4.3 Electrical hazards 4.3.1 Direct or indirect contact with live parts Hazard from electric shock to the body 4.3.2 Electrical components with insufficient safety level Hazard of mechanical injury to the body due to malfunction 4.4 Hazard from loss of stability Hazard to the body by impact or crushing, if the machine, loading device or auxiliary machine topples over 4.5 Noise hazard Filling machines and auxiliary machines generate noise which can result in hearing damage, in accidents due to interference with speech communication and interference with the perception of acoustic signals 4.6 Hazards from non-compliance with ergonomic principles  Unhealthy body posture or excessive physical effort;  Inadequate consideration of human hand/arm or foot/leg anatomy by design of machines. Hazard of physical injury 4.7 Hazards from non-compliance with hygiene principles 4.7.1 Microbial causes Hazard (spoilage) of foodstuff Hazard of damage to health of the user through food poisoning Infection of the operator SIST EN 12463:2004+A1:2011



EN 12463:2004+A1:2011 (E) 21 4.7.2 Chemical causes Contamination of foodstuff by residues of cleaning and disinfecting agents which can injure the consumer Hazard of damage to health of the user through internal etching 4.7.3 Physical causes Foreign bodies originating from raw materials, machinery or other sources which can injure the consumer 5 Safety and hygiene requirements and/or protective measures 5.1 General Filling machines and auxiliary machines shall comply with the safety requirements and/or protective measures of this clause and Annex C of this document. In addition, they shall be designed according to the principles of !EN ISO 12100" for hazards relevant but not significant, which are not dealt with by this document (e.g. sharp edges). NOTE For hazards which are to be reduced by the application of a B- standard such as EN 614:1995, EN 953,
EN 1050, EN 1088, EN 1672-2, EN 60204-1, EN ISO 4287, !EN ISO 13849-1", !EN ISO 13857" etc. the manufacturer should carry out a risk assessment to establish the requirements of that standard which are to be applied. This specific risk assessment is part of the general risk assessment of the machine. Where reducing the risk is by the physical arrangement or positioning of the machine the manufacturer shall include in the Information for use a reference to the reduction means to be provided, and to any limiting value of the requirement, and, if appropriate, to the means of verification. Where reducing the risk is by a safe system of working the machinery, the manufacturer shall include in the Information for use details of the system and of the training elements required by the operating personnel. 5.2 Mechanical hazards 5.2.1 Filling- and auxiliary machines shall be designed and constructed in accordance with Annex C and the conditions mentioned below. !Fixing systems for fixed guards or for demountable parts of the machine casing (i.e. designed as fixed guards) shall remain attached to the guards or to the machine when the guards are removed." 5.2.2 !The interlocking system shall comply with 4.2.1 of EN 1088:1995+A2:2008, and the safety related parts of the control system shall present at least a performance level “c” in accordance with
EN ISO 13849-1:2008." 5.2.3 Additionally the interlocking devices shall be built inside the machine housing and correspond to 5.7 of !EN 1088:1995+A2:2008". This is required  to fulfil hygienic requirements,  to protect against mechanical damages,  to protect again
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