EN 415-10:2014

Safety of packaging machines - Part 10: General Requirements

This European Standard gives general requirements for packaging machines which are defined in the scope of EN 415 1 or are in the scope of another relevant machine specific part of EN 415. When used together with a relevant machine specific part of EN 415, it gives the requirements for that specific type of machine.
This document deals with safety requirements and their verification for design, construction, installation, commissioning, operation, adjustment, maintenance and cleaning of packaging machines when used as intended and under the conditions of misuse foreseeable by a manufacturer.
The extent to which hazards, hazardous situations and events are covered is indicated in Clause 4.
The hazards on a specific machine can vary depending on its working principle; the type, size and mass of the product; the packaging material; auxiliary equipment attached to the machine and the environment in which the machine is used. If the machine presents hazards that are not dealt with in this standard, the manufacturer should assess these hazards by using the principles detailed in EN ISO 12100:2010. Such deviations or additions are outside the scope of this standard.
Exclusions
This European Standard is not applicable to the following:
-   machines that were manufactured before the date of publication of this document by CEN.
This standard does not consider the following:
-   the risk resulting from the use of machines in public accessed areas.
NOTE   For machines used in public accessed areas different or additional requirements can apply. It is the responsibility of the manufacturer to identify such additional risks, which are outside the scope of this standard or such deviating risks which arise from this specific use, and provide suitable protective measures in accordance with EN ISO 12100.
-   the use of packaging machines in potentially explosive atmospheres;
-   specific health, safety or hygiene hazards associated with the products that may be handled by the machines, but does include general advice on this subject;
-   hazards that may be associated with decommissioning packaging machines.

Sicherheit von Verpackungsmaschinen - Teil 10: Allgemeine Anforderungen

Diese Europäische Norm enthält allgemeine Anforderungen an Verpackungsmaschinen, die im Anwendungs-bereich von EN 415-1 oder im Anwendungsbereich eines anderen maschinenspezifischen Teils von EN 415 festgelegt sind. Bei der gemeinsamen Anwendung mit einem entsprechenden maschinenspezifischen Teil von EN 415 liefert sie Anforderungen für diese bestimmte Maschinenart.
Das vorliegende Dokument beschreibt Sicherheitsanforderungen und deren Nachweis hinsichtlich Gestaltung, Konstruktion, Installation, Inbetriebnahme, Betrieb, Einstellungen, Wartung und Reinigung von Verpackungs-maschinen, wenn sie bestimmungsgemäß und unter vom Hersteller vorhersehbaren Bedingungen der Fehl-anwendung verwendet werden.
Der Umfang, in dem Gefährdungen, Gefährdungssituationen und Gefährdungsereignisse behandelt werden, ist in Abschnitt 4 dargelegt.
Die Gefährdungen an einer spezifischen Maschine können in Abhängigkeit von ihrer Funktionsweise, von Typ, Größe und Masse des Produktes, vom Packstoff, von an der Maschine angebrachtem Zubehör sowie von der Umgebung, in der die Maschine verwendet wird, variieren. Weist die Maschine Gefährdungen auf, die in der vorliegenden Norm nicht behandelt werden, sollte der Hersteller diese Gefährdungen anhand der in EN ISO 12100:2010 beschriebenen Grundsätze beurteilen. Derartige Abweichungen und Ergänzungen fallen nicht in den Anwendungsbereich der vorliegenden Norm.
Ausnahmen
Diese Europäische Norm gilt nicht für Folgendes:
- Maschinen, die vor dem Datum der Veröffentlichung dieses Dokuments durch CEN hergestellt wurden.
Diese Norm behandelt nicht Folgendes:
- das Risiko, das sich durch die Verwendung der Maschinen in öffentlich zugänglichen Bereichen ergibt;
ANMERKUNG Für Maschinen, die in öffentlich zugänglichen Bereichen verwendet werden, können andere oder zusätzliche Anforderungen gelten. Es ist die Verantwortlichkeit des Herstellers, diese zusätzlichen Risiken, die nicht in den Anwendungsbereich dieser Norm fallen oder solche abweichenden Risiken, die sich aus spezifischen Anwendungen ergeben, zu ermitteln und geeignete Schutzmaßnahmen nach EN ISO 12100 zur Verfügung zu stellen.
- die Verwendung von Verpackungsmaschinen in explosionsfähigen Atmosphären;
- spezifische Gefährdungen für Gesundheit, Sicherheit oder Hygiene im Zusammenhang mit den Produkten, die möglicherweise auf den Maschinen verarbeitet werden, allerdings sind allgemeine Hinweise dazu angegeben;
- Gefährdungen, die mit der Außerbetriebnahme von Verpackungsmaschinen zusammenhängen können.

Sécurité des machines d'emballage - Partie 10: Prescriptions générales

La présente Norme européenne spécifie les exigences générales applicables aux machines d’emballage définies dans le cadre du domaine d’application de l’EN 415-1 ou relevant de parties spécifiques de l’EN 415 applicables à d’autres machines concernées. Lorsqu’elle est utilisée en association avec une autre partie spécifique de l’EN 415 applicable à une machine concernée, elle exprime les exigences applicables à ce type de machine spécifique.
Le présent document traite des exigences de sécurité, ainsi que des vérifications associées, s’appliquant à la conception, la construction, l’installation, la mise en service, le fonctionnement, le réglage, la maintenance et le nettoyage des machines d’emballage lorsqu'elles sont utilisées normalement ou dans les conditions de mauvaise utilisation prévisibles par un fabricant.
L’étendue des phénomènes, situations et événements dangereux couverts est indiquée à l’Article 4.
Les phénomènes dangereux d’une machine spécifique peuvent varier en fonction de son principe de fonctionnement, du type, des dimensions et de la masse du produit, du matériau d’emballage, des équipements auxiliaires fixés à la machine et de l’environnement dans lequel la machine est utilisée. Si la machine est le siège de phénomènes dangereux qui ne sont pas traités dans cette norme, il convient que le fabricant les évalue selon les principes détaillés dans l’EN ISO 12100:2010. De tels écarts ou ajouts ne font pas partie du domaine d'application de la présente norme.
Exclusions
La présente Norme européenne ne s’applique pas aux machines suivantes :
-   machines fabriquées avant la date de publication du présent document par le CEN.
La présente norme ne traite pas des risques suivants :
-   le risque issu de l’utilisation des machines dans les zones accessibles au public ;
NOTE   Des exigences différentes ou supplémentaires peuvent s’appliquer aux machines utilisées dans les zones accessibles au public. Le fabricant porte la responsabilité d’identifier les risques supplémentaires ne faisant pas partie du domaine d'application de la présente norme, ou les risques d’écarts dus à cette utilisation spécifique, et de prendre les mesures de protection adéquates conformément à l’EN ISO 12100.
-   l’utilisation de machines d’emballage dans des atmosphères explosibles ;
-   les phénomènes dangereux concernant la santé, la sécurité ou l’hygiène associés aux produits pouvant être manipulés par les machines ; toutefois, des conseils d’ordre général sont inclus à ce sujet ;
-   les phénomènes dangereux pouvant être associés à la mise hors service des machines d’emballage.

Pakirne naprave - Varnost pakirnih naprav - 10. del: Splošne zahteve

Standard EN 415-10 navaja splošne zahteve za pakirne naprave, določene v predmetu standarda EN 415-1 ali v predmetu drugega ustreznega dela standarda EN 415, ki velja za posamezno napravo. Kadar se ta standard uporablja skupaj z ustreznim delom standarda EN 415, ki velja za posamezno napravo, določa zahteve za posamezno vrsto naprave. Ta dokument obravnava varnostne zahteve in njihovo preverjanje za projektiranje, konstruiranje, nameščanje, začetek uporabe, delovanje, prilagajanje, vzdrževanje in čiščenje pakirnih naprav, kadar se uporabljajo v skladu z njihovim namenom in pod pogoji pričakovane nepravilne uporabe, ki jih določa proizvajalec. V točki 4 je naveden obseg, v okviru katerega so vključena tveganja, nevarne razmere in nevarni dogodki. Tveganja pri posamezni napravi se lahko razlikujejo glede na njene načine delovanja, vrsto, velikost in težo izdelka, embalažo, pomožno opremo, nameščeno na napravo, in okolje, v katerem se naprava uporablja. Če naprava predstavlja tveganja, ki niso obravnavana v tem standardu, je priporočljivo, da proizvajalec ta tveganja oceni na podlagi načel, podrobneje opisanih v standardu EN ISO 12100: 2010. Tovrstna odstopanja ali dodatki ne spadajo na področje uporabe tega standarda. Izvzetja Ta evropski standard se ne uporablja za: – naprave, ki so bile izdelane, preden je CEN izdal ta dokument. Ta evropski standard ne upošteva naslednjega: – tveganja, ki je posledica uporabe naprav na javno dostopnih krajih. OPOMBA: za naprave, uporabljene na javno dostopnih krajih, morda veljajo druge ali dodatne zahteve. Proizvajalec je dolžan opredeliti tovrstna dodatna tveganja, ki ne spadajo na področje uporabe tega standarda, ali tovrstna odstopajoča tveganja, ki so posledica tovrstne posebne uporabe, in je dolžan zagotoviti zaščitne ukrepe v skladu s standardom EN ISO 12100. – uporaba pakirnih naprav v potencialno eksplozivnih ozračjih, –posebna tveganja za zdravje, varnost ali higieno, povezana z izdelki, s katerimi naprave lahko ravnajo, vendar vsebuje tudi splošne nasvete o tej temi, – tveganja, ki so lahko povezana s prenehanjem uporabe pakirnih naprav.

General Information

• Status: Published
• Publication Date: 21-Jan-2014
• Withdrawal Date: 30-Jul-2014
• ICS: 55.200 - Packaging machinery
• Technical Committee: CEN/TC 146 - Packaging machines - Safety
• Drafting Committee: CEN/TC 146/WG 9 - Safety of packaging machines - Technical Report: General Requirements
• Current Stage: 9092 - Decision on results of review/2YR ENQ - revise - Review Enquiry
• Start Date: 24-Jun-2020
• Completion Date: 23-Sep-2025
• Directive: 2006/42/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)
• Mandate: M/396 - Mandate to CEN and Cenelec for standardisation in the field of machinery
• Ref Project: SIST EN 415-10:2014 - Safety of packaging machines - Part 10: General Requirements

Relations

• Revised: prEN ISO 24158-1 - Packaging machinery - Part 1: General safety requirements (ISO/DIS 24158-1:2025)
• Effective Date: 01-Jul-2020

Overview

EN 415-10:2014 - Safety of packaging machines: Part 10: General Requirements defines the general safety requirements and verification methods for packaging machines covered by EN 415‑1 or other machine‑specific parts of EN 415. It addresses safety throughout the machine lifecycle - design, construction, installation, commissioning, operation, adjustment, maintenance and cleaning - when used as intended and under reasonably foreseeable misuse. The standard helps manufacturers and designers reduce hazards associated with packaging machinery and specifies how to verify that safety measures are effective.

Key topics and technical requirements

This part of EN 415 focuses on broad, non‑machine‑specific safety measures and verification. Major topics include:

• List of significant hazards - mechanical hazards (moving parts, slips/trips, stability, guards), pneumatic/hydraulic risks, electrical hazards, electrostatic phenomena, thermal hazards, noise and radiation.
• Hazards from products and materials - risks generated by handled products and packaging materials and general guidance to control them.
• Ergonomic and hygienic design principles - requirements to support safe operation, maintenance and cleaning.
• Control and safety functions - normal stop, operational stop, emergency stop, prevention of unexpected start, safety‑related stops, stopping times and safety control behaviour.
• Stored energy and failure modes - measures for energy sources, failures of power supplies and safety‑related control parts, and remote diagnostics/control.
• Specific elements/processes - cutting and sealing devices, film reel unwind, conveyors, handles/hand‑wheels, size/product change-over, hot‑melt equipment, modified atmosphere packaging.
• Verification - visual inspections (machine stopped and running), measurements, electrical testing and guard checks to confirm compliance.

The standard highlights that hazards vary by machine type, packaging material, product characteristics and environment. Where hazards are not addressed, manufacturers must apply the principles in EN ISO 12100:2010 for risk assessment and mitigation.

Practical applications and who uses it

SIST EN 415‑10:2014 is used by:

• Machine manufacturers and designers to build compliant, safer packaging machinery.
• Safety engineers and compliance officers to prepare technical files and CE marking evidence.
• System integrators and machine builders for applying general safety measures alongside machine‑specific EN 415 parts.
• Test laboratories and inspectors for verification and conformity assessment.
• Maintenance teams and end‑users to understand safe operation, cleaning and maintenance requirements.

This standard is applied in sectors using packaging machinery (food, pharmaceuticals, consumer goods) to reduce workplace injuries and ensure regulatory compliance.

Related standards

• EN 415 series (machine‑specific parts) - used together with Part 10 for specific packaging machine types.
• EN ISO 12100:2010 - general principles for risk assessment and risk reduction; referenced where Part 10 does not cover specific hazards.

Note: SIST EN 415‑10:2014 excludes machines manufactured before its publication date and does not cover use in public access areas, explosive atmospheres, product‑specific health hazards or decommissioning hazards; manufacturers must identify and mitigate those separately.

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Pakirne naprave - Varnost pakirnih naprav - 10. del: Splošne zahteveSicherheit von Verpackungsmaschinen - Teil 10: Allgemeine AnforderungenSécurité des machines d'emballage - Partie 10: Exigences généralesSafety of packaging machines - Part 10: General Requirements55.200Pakirni strojiPackaging machineryICS:Ta slovenski standard je istoveten z:EN 415-10:2014SIST EN 415-10:2014en,fr,de01-julij-2014SIST EN 415-10:2014SLOVENSKI
STANDARD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 415-10
January 2014 ICS 55.200 English Version
Safety of packaging machines - Part 10: General Requirements Sécurité des machines d'emballage - Partie 10: Prescriptions générales
Sicherheit von Verpackungsmaschinen - Teil 10: Allgemeine Anforderungen This European Standard was approved by CEN on 12 October 2013.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, 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:
Avenue Marnix 17,
B-1000 Brussels © 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 415-10:2014 ESIST EN 415-10:2014

Page
Foreword .5 Introduction .6 1 Scope .7 2 Normative references .7 3 Terms and definitions . 10 4 List of significant hazards . 11 4.1 General . 11 4.2 Mechanical hazards . 12 4.2.1 Moving parts . 12 4.2.2 Slip, trip and fall hazards . 12 4.2.3 Loss of stability . 12 4.2.4 Hazards from guards . 12 4.3 Pneumatic and hydraulic equipment . 12 4.4 Hazards from electrical equipment . 13 4.5 Hazards from electrostatic phenomena . 13 4.6 Thermal hazards . 13 4.6.1 Hot Surfaces . 13 4.6.2 Cold surfaces . 13 4.7 Noise . 13 4.8 Radiation . 13 4.9 Hazards from products and materials . 14 4.9.1 Hazards generated by products . 14 4.9.2 Hazards generated by packaging materials . 14 4.10 Hazards due to neglecting ergonomic principles . 15 4.11 Hazards due to neglecting hygienic design principles. 15 4.12 Hazards caused by failures . 15 4.12.1 General . 15 4.12.2 Failure of power supplies . 15 4.12.3 Failure of safety related parts of control systems . 16 4.12.4 Failure of electronic drive systems. 16 4.13 Hazards caused by the presence of stored energy. 16 4.14 Hazards due to remote diagnostics or control . 16 4.15 Reasonably foreseeable misuse . 16 4.16 Hazards from specific elements or processes of packaging machines . 17 4.16.1 Cutting devices . 17 4.16.2 Sealing devices . 17 4.16.3 Film reel unwind mechanisms . 18 4.16.4 Conveyors . 18 4.16.5 Handles and hand-wheels . 20 4.16.6 Size or product changing . 20 4.16.7 Hot melt adhesive equipment . 21 4.16.8 Modified atmosphere packaging . 21 5 Safety requirements and/or protective measures . 21 5.1 General . 21 5.2 Requirements to minimize mechanical risks . 22 5.2.1 Protective measures against risks from moving parts . 22 5.2.2 Requirements to prevent slip, trip and fall hazards . 52 5.2.3 Stability of machines . 52 SIST EN 415-10:2014

Evaluation of energy or force . 87 Annex B (informative)
Maximum values for inherently safe design . 88 Annex ZA (informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 2006/42/EC . 89 Bibliography . 92
EN 415-10. The requirements of the machine specific parts of EN 415 may supplement or modify the corresponding clauses of EN 415-10. The machinery concerned and the extent to which hazards, hazardous situations and events are covered are indicated in the scope of this standard. 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. SIST EN 415-10:2014

1) This standard is impacted by the stand-alone amendment EN 60204-1:2006/A1:2009, Safety of machinery  Electrical equipment of machines  Part 1: General requirements (EN 60204-1:2005/A1:2008) 2) This standard is impacted by the stand-alone amendment EN 60529:1991/A1:2000, Degrees of protection provided by enclosures (IP Code) (IEC 60529:1989/A1:1999) and EN 60529:1991/A2:2013, Degrees of protection provided by enclosures (IP Code) (IEC 60529:1989/A2:2013). SIST EN 415-10:2014

EN 60204-1:2006, EN 415-1 and the following apply. 3.1 change parts machine parts designed to handle a specific product, packaging material or pack size that are changed when the machine is set up to handle a different product, packaging material or pack size 3.2 film compensator device which maintains a constant film tension 3.3 film reel mandrel device which may be fixed to the machine or which is loose and which supports a reel of film 3.4 hot melt adhesive adhesive that is solid at room temperature and which can be applied at elevated temperature 3.5 minimum distance calculated distance between the safeguard and the hazard zone necessary to prevent a person or part of a person reaching the hazard zone before the termination of the hazardous machine function
3) This standard is impacted by the stand-alone amendment EN ISO 14122-1:2001/A1:2010, Safety of machinery  Permanent means of access to machinery  Part 1: Choice of fixed means of access between two levels  Amendment 1 (ISO 14122-1:2001/Amd 1:2010). SIST EN 415-10:2014

The combined safety-related parts of a control system start at the point where the safety-related input signals are initiated (including, for example, the actuating cam and the roller of the position switch) and end at the output of the power control elements (including, for example, the main contacts of a contactor). Note 2 to entry:
If monitoring systems are used for diagnostics, they are also considered as SRP/CS. [SOURCE: EN ISO 13849-1:2008, 3.1.1] 3.11 strap band of material, usually made from mild steel, polypropylene or polyester, which is passed around a group of products, tensioned and then sealed to hold the products together 3.12 teleservice machine control mode where faults can be diagnosed, parameters changed and machine functions can be initiated from a remote location Note 1 to entry: Collecting data or monitoring machine parameters is not considered as teleservice. 4 List of significant hazards 4.1 General This clause lists all the significant hazards, hazardous situations and events that can be found on most packaging machines. SIST EN 415-10:2014
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