SIST EN 415-3:2021
(Main)Safety of packaging machines - Part 3: Form, fill and seal machines; fill and seal machines
Safety of packaging machines - Part 3: Form, fill and seal machines; fill and seal machines
This document establishes safety requirements for the main types of form, fill and seal machines, fill and seal machines and auger fillers, volumetric cup fillers, nett weighers and multi-head weighers which are frequently fitted to these machines.
Form fill and seal machines:
- flow wrapping machine;
- vertical form, fill and seal machine;
- horizontal sachet form, fill and seal machine;
- thermoform, fill and seal machine;
- tubular bag form, fill and seal machine;
- mandrel form, fill and seal machine.
Fill and seal machines:
- pre-made bag, erect, fill and seal machine;
- cup or tub fill and seal machine;
- sack fill and seal machine.
Filling machines commonly fitted to form, fill and seal machines and fill and seal machines:
- auger filler;
- volumetric cup filler;
- nett weigher;
- multi-head weigher.
Other types of form, fill and seal machine which are described in 3.3 have similar hazards to these machines and Clause 4 indicates which clauses of this standard are applicable to these machines.
This document covers the safety requirements for machine design, construction and all phases of life of the machines including installation, commissioning, operation, adjustment, maintenance and cleaning.
This document applies to machines manufactured after the date of issue of this document.
Exclusions
This standard does not apply to:
- blow mould fill and seal machines;
- bulk container fill and seal machines;
- cartoning machines;
- food depositors, including volumetric piston depositors;
- thermoforming machines.
This document does consider hazards due to dust from the products being packed in these machines and modified atmosphere gases, but does not consider other hazards caused by the product being packed.
Sicherheit von Verpackungsmaschinen - Teil 3: Form-, Füll- und Verschließmaschinen; Füll- und Verschließmaschinen
Dieses Dokument stellt Sicherheitsanforderungen für die wichtigsten Arten von Form-, Füll- und Verschließmaschinen, Füll- und Verschließmaschinen und Schnecken-Füllmaschinen, Messbecher-Füllmaschinen, Wäge-Füllmaschinen und Mehrkopfwaagen auf, die oftmals mit solchen Maschinen verbunden sind.
Form-, Füll- und Verschließmaschinen:
- Horizontale Oberfolienschlauchbeutelmaschine;
- Vertikale Schlauchbeutelmaschine;
- Horizontale Siegelrandbeutelform-, füll- und verschließmaschine;
- Thermoform-, -füll- und verschließmaschine;
- Folienschlauchbeutelform-, -füll- und verschließmaschine;
- Dornradform-, -füll- und verschließmaschine.
Füll- und Verschließmaschinen:
- Aufricht-, Füll- und Verschließmaschinen für vorgefertigte Beutel;
- Becher- oder Fass-Füll- und -verschließmaschine;
- Sackfüll- und -verschließmaschine.
Füllmaschinen, die gewöhnlich mit Form-, Füll- und Verschließmaschinen und Füll- und Verschließmaschinen verbunden sind:
- Schnecken-Füllmaschine;
- Messbecher-Füllmaschine;
- Wäge-Füllmaschine;
- Mehrkopfwaage.
Andere Typen von Form-, Füll- und Verschließmaschinen, die in Abschnitt 3.3 beschrieben sind, weisen ähnliche Gefahren wie diese Maschinen auf und Abschnitt 4 legt fest, welche Abschnitte dieser Norm für diese Maschinen gelten.
Dieses Dokument erstreckt sich auf die Sicherheitsanforderungen für Entwurf, Konstruktion und alle Lebenszyklusphasen der Maschinen, einschließlich Montage, Inbetriebnahme, Betrieb, Einstellung, Instandhaltung und Reinigung der Maschinen.
Dieses Dokumentgilt für Maschinen, die nach dem Erscheinungsdatum dieser Norm hergestellt werden.
Ausschlüsse
Diese Norm gilt nicht für:
- Blasform-, füll- und verschließmaschinen;
- Bulkwarenbehälter-Füll- und Verschließmaschinen;
- Kartoniermaschinen;
- Nahrungsmittelportioniermaschinen, einschließlich Kolbenportioniermaschinen;
- Warmformmaschinen.
Dieses Dokument berücksichtigt Gefahren durch Staub aus den in diesen Maschinen verpackten Produkten und Gase modifizierter Atmosphären, jedoch keine anderen, durch das zu verpackende Produkt verursachten Gefahren.
Sécurité des machines d'emballage - Partie 3 : Machines d'emballage à former, remplir et sceller ; machines d'emballage à remplir et sceller
Le présent document établit les prescriptions de sécurité pour les principaux types de machines à former, remplir et sceller et de machines à remplir et sceller ainsi que pour les remplisseurs à hélice, remplisseurs volumétriques à godets, peseurs nets et peseurs à têtes multiples qui sont fréquemment installés sur ces machines.
Machine à former, remplir et sceller :
- machine à envelopper en continu ;
- machine à former, remplir et sceller verticale ;
- machine horizontale à former, remplir et sceller des sachets ;
- machine à thermoformer, remplir et sceller ;
- machine à former, remplir et sceller des sacs tubulaires ;
- machine à former, remplir et sceller sur mandrin.
Machine à remplir et sceller :
- machine à mettre en position, remplir et sceller des poches préfabriquées ;
- machine à remplir et sceller des godets ou coupelles ;
- machine à remplir et sceller des sacs.
Machines de remplissage habituellement installées sur des machines à former, remplir et sceller ainsi que sur des machines à remplir et sceller :
- remplisseur à hélice ;
- remplisseur volumétrique à godets ;
- peseur net ;
- peseur à têtes multiples.
D’autres types de machine à former, remplir et sceller décrits en 3.3 présentent des phénomènes dangereux similaires à ceux observés sur ces machines, et l’Article 4 indique les articles et paragraphes de la présente norme qui s’appliquent à ces types de machines.
Le présent document couvre les prescriptions de sécurité pour la conception et la construction des machines, ainsi que pour l’ensemble des phases de la durée de vie des machines, notamment l’installation, la réception, la mise en route, le réglage, la maintenance et le nettoyage.
Le présent document s'applique aux machines fabriquées après la date de sa publication.
Exclusions
La présente norme ne s'applique pas :
- aux machines de moulage par soufflage, remplissage et fermage ;
- aux machine à remplir et sceller les récipients en vrac ;
- aux encartonneuses ;
- aux doseuses alimentaires, y compris doseuses volumétriques à piston ;
- aux machines de thermoformage.
Le présent document tient compte des phénomènes dangereux liés à la poussière émise par les produits emballés dans ces machines et aux gaz atmosphériques modifiés, mais il ne tient pas compte des autres phénomènes dangereux provoqués par le produit emballé.
Varnost pakirnih naprav - 3. del: Oblikovalne, polnilne in zapiralne naprave; polnilne in zapiralne naprave
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 415-3:2021
01-december-2021
Nadomešča:
SIST EN 415-3:2001+A1:2010
Varnost pakirnih naprav - 3. del: Oblikovalne, polnilne in zapiralne naprave;
polnilne in zapiralne naprave
Safety of packaging machines - Part 3: Form, fill and seal machines; fill and seal
machines
Sicherheit von Verpackungsmaschinen - Teil 3: Form-, Füll- und Verschließmaschinen;
Füll- und Verschließmaschinen
Sécurité des machines d'emballage - Partie 3 : Machines d'emballage à former, remplir
et sceller ; machines d'emballage à remplir et sceller
Ta slovenski standard je istoveten z: EN 415-3:2021
ICS:
55.200 Pakirni stroji Packaging machinery
SIST EN 415-3:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN 415-3:2021
---------------------- Page: 2 ----------------------
SIST EN 415-3:2021
EN 415-3
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2021
EUROPÄISCHE NORM
ICS 55.200 Supersedes EN 415-3:1999+A1:2009
English Version
Safety of packaging machines - Part 3: Form, fill and seal
machines; fill and seal machines
Sécurité des machines d'emballage - Partie 3 : Sicherheit von Verpackungsmaschinen - Teil 3: Form-,
Machines d'emballage à former, remplir et sceller ; Füll- und Verschließmaschinen; Füll- und
machines d'emballage à remplir et sceller Verschließmaschinen
This European Standard was approved by CEN on 6 September 2021.
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, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 415-3:2021 E
worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN 415-3:2021
EN 415-3:2021 (E)
Contents Page
European foreword . 3
Introduction . 5
1 Scope . 6
2 Normative references . 7
3 Terms and definitions . 9
3.1 Definitions of terms . 9
3.2 Definitions of machines covered by this document . 13
3.3 Definitions of machines which have similar hazards to those machines covered by
this document . 20
4 Safety requirements . 24
4.1 General requirements . 24
4.2 Safety requirements for a flow-wrapping machine . 32
4.3 Safety requirements for a vertical form, fill and seal machine . 39
4.4 Safety requirements for a horizontal sachet form, fill and seal machine . 42
4.5 Safety requirements for a thermoform, fill and seal machine . 44
4.6 Safety requirements for a tubular bag form, fill and seal machine . 51
4.7 Safety requirements for a mandrel form, fill and seal machine . 53
4.8 Safety requirements for a pre-made bag fill and close machine . 57
4.9 Safety requirements for a cup or tub fill and seal machine . 59
4.10 Safety requirements for a sack fill and seal machine. 62
4.11 Safety requirements for an auger filler . 67
4.12 Safety requirements for a volumetric cup filler . 69
4.13 Safety requirements for a nett weigher . 71
4.14 Safety requirements for a multi-head weigher . 73
5 Verification of safety requirements . 75
5.1 General . 75
5.2 Visual inspections with the machine stopped . 75
5.3 Measurements with the machine stopped . 76
5.4 Visual inspections with the machine running . 76
5.5 Measurements or tests with the machine running . 76
5.6 Verification procedures . 76
6 Information . 80
6.1 General . 80
6.2 Marking . 80
6.3 Warning of residual risks . 81
6.4 Instructions . 81
Annex A (informative) List of significant hazards . 87
Annex B (normative) Noise test code . 120
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 2006/42/EC aimed to be covered . 123
Bibliography . 127
2
---------------------- Page: 4 ----------------------
SIST EN 415-3:2021
EN 415-3:2021 (E)
European foreword
This document (EN 415-3:2021) has been prepared by Technical Committee CEN/TC 146 “Packaging
machines – Safety”, 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 2022, and conflicting national standards shall be
withdrawn at the latest by April 2022.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document has been prepared under a Standardization Request given to CEN by the European
Commission and the European Free Trade Association, and supports essential requirements of EU
Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this
document.
This document supersedes EN 415-3:1999+A1:2009.
The following significant changes have been made:
— Scope now includes fill and seal machines and multi-head weighers;
— Cartoning machines have been removed from the scope;
— Safety requirements have been rewritten so they are in line with EN 415-10:2014;
— Normative references have been changed to reflect the many changes that have been made to B1 and
B2 standards.
EN 415, Safety of packaging machines consists of the following parts:
— Part 1: Terminology and classification of packaging machines and associated equipment;
— Part 2: Pre-formed rigid container packaging machines;
— Part 4: Palletizers and depalletizers;
— Part 5: Wrapping machines;
— Part 6: Pallet wrapping machines;
— Part 7: Cartoning and case-packing machines;
— Part 8: Strapping machines;
— Part 9: Noise measurement methods for packaging machines, packaging lines and auxiliary equipment,
grade of accuracy 2 and 3;
— Part 10: General requirements.
3
---------------------- Page: 5 ----------------------
SIST EN 415-3:2021
EN 415-3:2021 (E)
Any feedback and questions on this document should be directed to the users’ national standards body.
A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organisations 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, Republic of North
Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United
Kingdom.
4
---------------------- Page: 6 ----------------------
SIST EN 415-3:2021
EN 415-3:2021 (E)
Introduction
Form, fill and seal machines and fill and seal machines are used extensively in Europe, in an increasingly
wide range of industries. They contain many hazards and have the potential to cause serious injury.
This document is a type-C standard as stated in EN ISO 12100.
This document is of relevance, in particular, for the following stakeholder groups representing the market
players with regard to machinery safety:
— machine manufacturers (small, medium and large enterprises);
— health and safety bodies (regulators, accident prevention organizations, market surveillance, etc.).
Others can be affected by the level of machinery safety achieved with the means of the document by the
above-mentioned stakeholder groups:
— machine users/employers (small, medium and large enterprises);
— machine users/employees (e.g. trade unions, organizations for people with special needs);
— service providers, e.g. for maintenance (small, medium and large enterprises);
The above-mentioned stakeholder groups have been given the possibility to participate at the drafting
process of this document. The machinery concerned and the extent to which hazards, hazardous
situations or hazardous events are covered are indicated in the Scope of this document.
When requirements of this type-C standard are different from those which are stated in type-A or type-B
standards, the requirements of this type-C standard take precedence over the requirements of the other
standards for machines that have been designed and built according to the requirements of this type-C
standard.
5
---------------------- Page: 7 ----------------------
SIST EN 415-3:2021
EN 415-3:2021 (E)
1 Scope
This document establishes safety requirements for the main types of form, fill and seal machines, fill and
seal machines and the filling machines which are frequently fitted to these machines.
Form fill and seal machines within the scope of this document are:
— flow wrapping machine;
— vertical form, fill and seal machine;
— horizontal sachet form, fill and seal machine;
— thermoform, fill and seal machine;
— tubular bag form, fill and seal machine;
— mandrel form, fill and seal machine.
Fill and seal machines within the scope of this document are:
— pre-made bag, erect, fill and seal machine;
— cup or tub fill and seal machine;
— sack fill and seal machine.
Filling machines commonly fitted to form, fill and seal machines and fill and seal machines within the
scope of this document are:
— auger filler;
— volumetric cup filler;
— nett weigher;
— multi-head weigher.
Other types of form, fill and seal machine which are described in 3.3 have similar hazards to these
machines and Clause 4 indicates which clauses of this document are applicable to these machines.
This document covers the safety requirements for machine design, construction and all phases of life of
the machines including installation, commissioning, operation, adjustment, maintenance and cleaning.
This document applies to machines manufactured after the date of publication of this document.
This document does not apply to:
— blow mould fill and seal machines;
— bulk container fill and seal machines;
— cartoning machines;
— food depositors, including volumetric piston depositors in the scope of EN 15180;
— thermoforming machines in the scope of EN 12409.
6
---------------------- Page: 8 ----------------------
SIST EN 415-3:2021
EN 415-3:2021 (E)
This document does not consider:
— hazards due to the products packed in these machines, but does consider the hazards caused by
dusts, modified atmosphere gases, and flammable products;
— hazards resulting from the operation of the machines in a potentially explosive atmosphere.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
EN 415-1:2014, Safety of packaging machines — Part 1: Terminology and classification of packaging
machines and associated equipment
EN 415-9:2009, Safety of packaging machines — Part 9: Noise measurement methods for packaging
machines, packaging lines and associated equipment, grade of accuracy 2 and 3
EN 415-10:2014, Safety of packaging machines — Part 10: General Requirements
EN 618:2002+A1:2010, Continuous handling equipment and systems — Safety and EMC requirements for
equipment for mechanical handling of bulk materials except fixed belt conveyors
EN 620:2002+A1:2010, Continuous handling equipment and systems — Safety and EMC requirements for
fixed belt conveyors for bulk materials
EN 1005-2:2003+A1:2008, Safety of machinery — Human physical performance — Part 2: Manual
handling of machinery and component parts of machinery
EN 1127-1:2019, Explosive atmospheres — Explosion prevention and protection — Part 1: Basic concepts
and methodology
EN 1672-2:2020, Food processing machinery — Basic concepts — Part 2: Hygiene and cleanability
requirements
EN 15180:2014, Food processing machinery — Food depositors — Safety and hygiene requirements
EN 60079-14:2014, Explosive atmospheres — Part 14: Electrical installations design, selection and erection
(IEC 60079-14:2013)
EN 60204-1:2018, Safety of machinery — Electrical equipment of machines — Part 1: General requirements
(IEC 60204-1:2018)
EN 60825-4:2006, Safety of laser products — Part 4: Laser guards
EN 61496-1:2013, Safety of machinery — Electro-sensitive protective equipment — Part 1: General
requirements and tests
EN 61496-2:2013, Safety of machinery — Electro-sensitive protective equipment — Part 2: Particular
requirements for equipment using active opto-electronic protective devices (AOPDs) (IEC 61496-2:2013)
EN IEC 61496-3:2019, Safety of machinery — Electro-sensitive protective equipment — Part 3: Particular
requirements for active opto-electronic protective devices responsive to diffuse Reflection (AOPDDR)
(IEC 61496-3:2018)
7
---------------------- Page: 9 ----------------------
SIST EN 415-3:2021
EN 415-3:2021 (E)
EN ISO 4413:2010, Hydraulic fluid power — General rules and safety requirements for systems and their
components (ISO 4413:2010)
EN ISO 4414:2010, Pneumatic fluid power — General rules and safety requirements for systems and their
components (ISO 4414:2010)
EN ISO 7010:2020, Graphical symbols — Safety colours and safety signs — Registered safety signs
(ISO 7010:2019, Corrected version 2020-06)
EN ISO 11688-1:2009, 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 13732-1:2008, 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 13849-1:2015, Safety of machinery — Safety-related parts of control systems — Part 1: General
principles for design (ISO 13849-1:2015)
EN ISO 13850:2015, Safety of machinery — Emergency stop function — Principles for design
(ISO 13850:2015)
EN ISO 13851:2019, Safety of machinery — Two-hand control devices, principles for design and selection.
(ISO 13851:2019)
EN ISO 13854:2019, Safety of machinery — Minimum gaps to avoid crushing of parts of the human body
(ISO 13854:2017)
EN ISO 13855:2010, Safety of machinery — Positioning of safeguards with respect to the approach speeds
of parts of the human body (ISO 13855:2010)
EN ISO 13856-2:2013, Safety of machinery — Pressure-sensitive protective devices — Part 2: General
principles for design and testing of pressure-sensitive edges and pressure-sensitive bars (ISO 13856-2:2013)
EN ISO 13857:2019, Safety of machinery — Safety distances to prevent hazard zones being reached by
upper and lower limbs (ISO 13857:2019)
EN ISO 14119:2013, Safety of machinery — Interlocking devices associated with guards — Principles for
design and selection (ISO 14119:2013)
EN ISO 14120:2015, Safety of machinery — Guards — General requirements for the design and construction
of fixed and movable guards (ISO 14120:2015)
EN ISO 14122-2:2016, Safety of machinery — Permanent means of access to machinery — Part 2: Working
platforms and walkways (ISO 14122-2:2016)
EN ISO 14122-3:2016, Safety of machinery — Permanent means of access to machinery — Part 3: Stairs,
stepladders and guard-rails (ISO 14122-3:2016)
EN ISO 14122-4:2016, Safety of machinery — Permanent means of access to machinery — Part 4: Fixed
ladders (ISO 14122-4:2016)
8
---------------------- Page: 10 ----------------------
SIST EN 415-3:2021
EN 415-3:2021 (E)
EN ISO 14123-1:2015, Safety of machinery — Reduction of risks to health resulting from hazardous
substances emitted by machinery — Part 1: Principles and specifications for machinery manufacturers
(ISO 14123-1:2015)
EN ISO 14123-2:2015, Safety of machinery — Reduction of risks to health resulting from hazardous
substances emitted by machinery — Part 2: Methodology leading to verification procedures (ISO 14123-
2:2015)
EN ISO 14159:2008, Safety of machinery — Hygiene requirements for the design of machinery
(ISO 14159:2002)
ISO 3864-1:2011, Graphical symbols — Safety colours and safety signs — Part 1: Design principles for safety
signs and safety markings
ISO 3864-2:2016, Graphical symbols — Safety colours and safety signs — Part 2: Design principles for
product safety labels
ISO 3864-3:2012, Graphical symbols — Safety colours and safety signs — Part 3: Design principles for
graphical symbols for use in safety signs
3 Terms and definitions
For the purposes of this document, the terms and definitions given in EN ISO 12100:2010,
EN 415-1:2014, EN 415-10:2014 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at https://www.electropedia.org/
— ISO Online browsing platform: available at https://www.iso.org/obp
3.1 Definitions of terms
3.1.1
automatically adjustable guard
movable guard attached to a moveable machine element (e.g. moving side of a pre-made bag magazine)
and a fixed machine element (e.g. machine frame) which moves automatically when the moveable
element is adjusted
Note 1 to entry: An automatically adjustable guard does not comply with this definition unless it has been
dimensioned and positioned using relevant tables of EN ISO 13857:2019.
3.1.2
bag
flat or gusseted flexible container longitudinally seamed and closed at one or both ends made from paper,
plastic film, foil, laminate, etc.
Note 1 to entry: Bags produced on form, fill and seal machines will typically have a seal at both ends and a
longitudinal seal running down the centre of the rear face of the bag.
3.1.3
change parts
machine parts designed to handle a specific product, packaging material or pack size that need to be
changed when the machine is set up to handle a different product, packaging material or pack size
9
---------------------- Page: 11 ----------------------
SIST EN 415-3:2021
EN 415-3:2021 (E)
3.1.4
change part guard
fixed or interlocking guard which has been made to suit one product or pack size and must be changed
every time the product or pack size is changed
Note 1 to entry: A change part guard does not comply with this definition unless it has been dimensioned and
positioned using relevant tables of EN ISO 13857:2019.
3.1.5
cup
tub
thin walled tapered container
3.1.6
deformable material
material which can be formed by the application of pressure alone
3.1.7
food depositor
machine that dispenses a food product in a predetermined volume or shape
3.1.8
film reel
packaging material reel
continuous sheet of paper, carton board, plastic film, metal foil or flexible laminate wound on a cylindrical
core
3.1.9
film web
continuous sheet of paper, plastic film, metal foil or laminate
3.1.10
fixed guard
guard affixed in such a manner (for example, by screws, nuts, and welding) that it can only be opened or
removed by the use of tools or by destruction of the means by which the guard is affixed
Note 1 to entry: A fixed guard does not comply with this definition unless it complies with subclause 4.1.2.2 of
this document.
3.1.11
hot melt adhesive
adhesive that is solid at room temperature and which is melted and applied at elevated temperature
3.1.12
interlocking guard
guard associated with an interlocking device so that, together with the control system of the machine, the
following functions are performed:
— the hazardous machine functions “covered” by the guard cannot operate until the guard is closed;
— if the guard is opened while hazardous machine functions are operating, a stop command is given;
— when the guard is closed, the hazardous machine functions “covered” by the guard can operate (the
closure of the guard does not, by itself, start the hazardous machine functions)
10
---------------------- Page: 12 ----------------------
SIST EN 415-3:2021
EN 415-3:2021 (E)
Note 1 to entry: An interlocking guard does not comply with this definition unless it complies with subclause
4.1.2.2 of this document.
3.1.13
longitudinal seal
seal made on a package in line with the direction of material travel in the machine
3.1.14
magazine
mechanical assembly designed to hold stacks of cartons, carton blanks, pre-made bags, pre-made sacks,
leaflets, labels, lids or stackable containers
3.1.15
mandrel
mechanical assembly around which a flexible package or carton is formed
3.1.16
manually adjustable guard
adjustable guard where the adjustment is made manually and the adjustment remains fixed during a
particular operation
Note 1 to entry: A manually adjustable guard does not comply with this definition unless it complies with
subclause 4.1.2.2 of this document.
3.1.17
modified atmosphere
atmosphere where the normal atmosphere within a package is completely or partially replaced by one or
more selected gases
Note 1 to entry: Usually the objective is to extend shelf or storage life of the packaged products.
3.1.18
pack
package
assembly of product and packaging materials produced by a packaging machine
3.1.19
packaging material
material used to make a package
EXAMPLEs Film laminate, carton board, paper.
3.1.20
packaging material transport mechanism
mechanical assembly which transports packaging material through the packaging machine
3.1.21
pre-made bag
pre-formed flat or gusseted flexible package longitudinally seamed and closed at one end made from
paper, plastic film, foil, laminate or a woven material
11
---------------------- Page: 13 ----------------------
SIST EN 415-3:2021
EN 415-3:2021 (E)
3.1.22
pre-made sack
pre-formed flat or gusseted sack longitudinally seamed and closed at one or both ends made from paper,
plastic film, laminate, or a woven material
3.1.23
product
substance, article pack or package that is handled in the packaging machine
3.1.24
reclosing feature applicator
mechanism which applies a zip or self-adhesive packaging component to a package on a packaging
machine
3.1.25
sachet
flat package which when formed from two webs of flexible material is sealed on four sides and when
formed from one web is sealed on three or four sides
3.1.26
sack placer
mechanism which places an empty pre-made sack onto a filling spout
3.1.27
sack transfer mechanism
mechanism which takes empty sacks from a sack magazine and transfers them to a sack placer
3.1.28
soil
any unwanted matter, including product residues, micro-organisms, residual detergent or disinfecting
agents
3.1.29
transverse seal
seal made on a package at right angles to the direction of material travel in the machine
3.1.30
trip guard
interlocking guard which is designed to move easily when touched by someone and which stops the
machine before a hazard zone can be reached
3.1.31
tubular bag
flexible package closed at both ends and made from a flat film tube
12
---------------------- Page: 14 ----------------------
SIST EN 415-3:2021
EN 415-3:2021 (E)
3.2 Definitions of machines covered by this document
3.2.1 Form, fill and seal machines
3.2.1.1
flow-wrapping machine
horizontally operating form, fill and seal machine with material reel mounted above the operating level,
the product loaded horizontally and a longitudinal seal formed below the pack
Figure 1 — Principle of operation of a typical flow-wrapping machine
13
---------------------- Page: 15 ----------------------
SIST EN 415-3:2021
EN 415-3:2021 (E)
3.2.1.2
vertical form, fill and seal machine
machine which uses flexible packaging material to form a tube, which is then filled vertically with product
and sealed in a sequence of operations whilst the packaging material is transported vertically downwards
Note 1 to entry: There are several variants of this typical design, including one where the bag is formed vertically
and then transferred to a horizontal mechanism for filling and sealing.
Figure 2 — Principle of operation of a typical vertical form, fill and seal machine
14
---------------------- Page: 16 ----------------------
SIST EN 415-3:2021
EN 415-3:2021 (E)
3.2.1.3
horizontal sachet form, fill and seal machine
horizontally operating form, fill and seal machine in which packs are formed, sealed on 2 or 3 sides, filled
vertically with product and sealed on the remaining side whilst the film web is moved horizontally with
the pack vertical
Figure 3 — Principle of operation of a typical horizontal sachet form, fill and seal machine
3.2.1.4
thermoform, fill and seal machine
machine in which a web of thermoformable material is heated and formed with pressure and/or vacuum,
before being filled vertically with product, sealed with a top film or pre-formed lid and fin
...
SLOVENSKI STANDARD
oSIST prEN 415-3:2018
01-november-2018
Varnost pakirnih naprav - 3. del: Oblikovalne, polnilne in zapiralne naprave;
polnilne in zapiralne naprave
Safety of packaging machines - Part 3: Form, fill and seal machines; fill and seal
machines
Sicherheit von Verpackungsmaschinen - Teil 3: Form-, Füll- und Verschließmaschinen;
Füll- und Verschließmaschinen
Sécurité des machines d'emballage - Partie 3 : Machines d'emballage à former, remplir
et sceller ; machines d'emballage à remplir et sceller
Ta slovenski standard je istoveten z: prEN 415-3
ICS:
55.200 Pakirni stroji Packaging machinery
oSIST prEN 415-3:2018 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
oSIST prEN 415-3:2018
---------------------- Page: 2 ----------------------
oSIST prEN 415-3:2018
DRAFT
EUROPEAN STANDARD
prEN 415-3
NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2018
ICS 55.200 Will supersede EN 415-3:1999+A1:2009
English Version
Safety of packaging machines - Part 3: Form, fill and seal
machines; fill and seal machines
Sécurité des machines d'emballage - Partie 3 : Sicherheit von Verpackungsmaschinen - Teil 3: Form-,
Machines d'emballage à former, remplir et sceller ; Füll- und Verschließmaschinen; Füll- und
machines d'emballage à remplir et sceller Verschließmaschinen
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee
CEN/TC 146.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 415-3:2018 E
worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
oSIST prEN 415-3:2018
prEN 415-3:2018 (E)
Contents Page
European foreword . 7
Introduction . 8
1 Scope . 9
2 Normative references . 10
3 Terms and definitions . 12
3.1 Definition of terms . 12
3.2 Definitions of machines covered by this standard . 15
3.2.1 Form, fill and seal machines . 15
3.2.2 Fill and seal machines . 20
3.2.3 Filling machines . 22
3.3 Definition of machines which have similar hazards to those machines covered by
this standard . 22
4 Hazards . 27
4.1 Hazards which occur on all machines in the scope of this standard . 27
4.2 Hazards on a flow wrapping machine . 30
4.3 Hazards on a vertical form, fill and seal machine . 33
4.4 Hazards on typical horizontal sachet form, fill and seal machines . 36
4.5 Hazards on a thermoform, fill and seal machine . 38
4.6 Hazards on a tubular bag form, fill and seal machine . 40
4.7 Hazards on a mandrel form, fill and seal machine . 43
4.8 Hazards on a pre-made bag erect, fill and seal machine . 45
4.9 Hazards on a cup or tub fill and seal machine . 47
4.10 Hazards on a sack fill and seal machine . 49
4.10.1 Hazards on an in-line sack fill and seal machine . 49
4.10.2 Hazards on a typical rotary sack fill and seal machine . 51
4.11 Hazards on an auger filler . 52
4.12 Hazards on a volumetric cup filler . 53
4.13 Hazards on a nett weigher . 55
4.14 Hazards on a multi-head weigher . 56
5 Safety requirements . 57
5.1 General requirements . 57
5.1.1 Requirements to minimize mechanical risks . 58
5.1.2 Electrical equipment . 60
5.1.3 Thermal hazards . 60
5.1.4 Noise reduction . 60
5.1.5 Vibrating mechanisms . 61
5.1.6 Radiation . 61
5.1.7 Products and substances used on machines which pose a risk. 61
5.1.8 Ergonomic design . 64
5.1.9 Hygienic design requirements . 65
5.2 Safety requirements for a flow-wrapping machine . 65
5.2.1 General . 65
5.2.2 Product feed . 66
5.2.3 Film reel unwind mechanism . 70
5.2.4 Longitudinal sealing mechanism . 72
2
---------------------- Page: 4 ----------------------
oSIST prEN 415-3:2018
prEN 415-3:2018 (E)
5.2.5 Transverse sealing and cutting mechanisms . 74
5.2.6 Discharge mechanism . 74
5.2.7 Integrity of safety related control systems . 74
5.3 Safety requirements for a vertical form, fill and seal machine . 75
5.3.1 General . 75
5.3.2 Product feeding devices . 76
5.3.3 Packing material reel unwind mechanism . 76
5.3.4 Longitudinal sealing mechanism . 76
5.3.5 Packaging material transport mechanism . 76
5.3.6 Transverse sealing and associated mechanisms. 76
5.3.7 Cutting and perforating mechanisms . 77
5.3.8 Product discharge opening . 77
5.3.9 Discharge conveyor. 77
5.3.10 Discharge into bins . 77
5.3.11 Provision for changing the forming tube . 77
5.3.12 Integrity of safety related control systems . 78
5.4 Safety requirements for a horizontal sachet form, fill and seal machine . 79
5.4.1 General . 79
5.4.2 Film reel unwind mechanism . 79
5.4.3 Vertical seal mechanism . 79
5.4.4 Transport mechanism . 79
5.4.5 Product feeding devices . 80
5.4.6 Product settling mechanism . 80
5.4.7 Top sealing mechanism . 80
5.4.8 Cutting mechanism. 80
5.4.9 Discharge chute or conveyor . 80
5.4.10 Integrity of safety related control systems . 80
5.5 Safety requirements for a thermoform, fill and seal machine . 80
5.5.1 General . 80
5.5.2 Lower web reel unwind mechanism . 81
5.5.3 Transport mechanism . 81
5.5.4 Heating chamber . 81
5.5.5 Forming die . 82
5.5.6 Packaging material apertures . 82
5.5.7 Automatic product feeding devices . 87
5.5.8 Upper film reel unwind mechanism . 87
5.5.9 Sealing die . 87
5.5.10 Cutting devices . 87
5.5.11 Scrap reel . 87
5.5.12 Discharge mechanism . 88
5.5.13 Pad or leaflet inserters . 88
5.5.14 Integrity of safety related control systems . 88
5.6 Safety requirements for a tubular bag form, fill and seal machine . 88
5.6.1 General . 88
5.6.2 Film reel unwind mechanism . 89
5.6.3 Transverse or corner sealing and cutting mechanism . 89
5.6.4 Openings in guards . 90
5.6.5 Cutting and perforating mechanisms . 90
5.6.6 Film draw and compensator . 90
5.6.7 Cooling mechanism . 90
5.6.8 Filling station . 90
5.6.9 Bag opening mechanism . 90
5.6.10 Product settling mechanism . 90
3
---------------------- Page: 5 ----------------------
oSIST prEN 415-3:2018
prEN 415-3:2018 (E)
5.6.11 Bag sealing mechanism . 90
5.6.12 Discharge conveyor . 90
5.6.13 Conveyor height adjustment . 90
5.6.14 Bag transport mechanism . 91
5.6.15 Integrity of safety related control systems . 91
5.7 Safety requirements for a mandrel form, fill and seal machine . 91
5.7.1 General . 91
5.7.2 Packaging material reel unwind mechanism . 92
5.7.3 Cutting mechanism . 92
5.7.4 Sealing mechanisms . 92
5.7.5 Carton blank magazine . 92
5.7.6 Mandrel former . 93
5.7.7 Compression mechanism . 94
5.7.8 Transfer mechanisms . 94
5.7.9 Transport section . 94
5.7.10 Product feed . 94
5.7.11 Product settling devices . 94
5.7.12 Sterilization section . 94
5.7.13 Auxiliary media injection . 94
5.7.14 Package closing mechanism . 94
5.7.15 Vacuum sealing mechanism . 94
5.7.16 Discharge or compression conveyor . 94
5.7.17 Pak reject mechanism . 95
5.7.18 Integrity of safety related control systems . 95
5.8 Safety requirements for a pre-made bag, erect, fill and close machine . 95
5.8.1 General . 95
5.8.2 Bag magazine . 96
5.8.3 Bag erecting mechanism . 96
5.8.4 Transport mechanism . 96
5.8.5 Product feed . 96
5.8.6 Product settling devices . 96
5.8.7 Bag closing mechanism . 97
5.8.8 Discharge or compression conveyor . 97
5.8.9 Integrity of safety related control systems . 97
5.9 Safety requirements for a cup or tub fill and seal machine . 97
5.9.1 General . 97
5.9.2 Cup magazine . 98
5.9.3 Cup dispensing mechanism . 99
5.9.4 Transport mechanism . 100
5.9.5 Product feed devices . 100
5.9.6 Manual product loading . 100
5.9.7 Foil and lid magazines . 100
5.9.8 Reel unwind mechanisms . 100
5.9.9 Foil sealing mechanisms . 100
5.9.10 Scrap reels . 100
5.9.11 Lid placing mechanism . 100
5.9.12 Discharge mechanism and conveyor . 100
5.9.13 Integrity of safety related control systems . 100
5.10 Safety requirements for a sack fill and seal machine. 101
5.10.1 Safety requirements for an in-line sack fill and seal machine . 101
5.10.2 Safety requirements for a rotary sack fill and seal machine . 103
5.11 Safety requirements for an auger filler . 106
5.11.1 General . 106
4
---------------------- Page: 6 ----------------------
oSIST prEN 415-3:2018
prEN 415-3:2018 (E)
5.11.2 Auger, stirrers and hopper . 107
5.11.3 Screw feeder . 107
5.11.4 Auger discharge and cut off devices . 107
5.11.5 Power supplies . 107
5.11.6 Ergonomic design requirements . 108
5.11.7 High level access . 108
5.11.8 Dusty products . 108
5.11.9 Integrity of safety related control systems . 108
5.12 Safety requirements for a volumetric cup filler . 108
5.12.1 General . 108
5.12.2 Hopper . 109
5.12.3 Cup plates . 109
5.12.4 Discharge hopper. 109
5.12.5 Ergonomic design requirements . 110
5.12.6 High level access . 110
5.12.7 Dusty products . 110
5.12.8 Integrity of safety related control systems . 110
5.13 Safety requirements for a nett weigher . 110
5.13.1 General . 110
5.13.2 Product feed .
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.