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CEN

prEN ISO 24158-1

(Main)

Packaging machinery - Part 1: General safety requirements (ISO/DIS 24158-1:2025)

Packaging machinery - Part 1: General safety requirements (ISO/DIS 24158-1:2025)

This document contains general requirements and measures for machinery that performs packaging functions for:
— Conditioning of products and packaging materials
— Primary (first) packaging, secondary (second) packaging and tertiary (third) packaging.

Verpackungsmaschinen - Teil 1: Allgemeine Sicherheitsanforderungen (ISO/DIS 24158-1:2025)

Machines d’emballage - Partie 1: Exigences générales de sécurité (ISO/DIS 24158-1:2025)

Pakirne naprave - 1. del: Splošne varnostne zahteve (ISO/DIS 24158-1:2025)

General Information

Status
Not Published
Publication Date
02-Apr-2023
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
4020 - Submission to enquiry - Enquiry
Start Date
25-Sep-2025
Due Date
09-Sep-2021
Completion Date
25-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)
2023/1230 - Regulation (EU) 2023/1230 of the European Parliament and of the Council of 14 June 2023 on machinery and repealing Directive 2006/42/EC of the European Parliament and of the Council and Council Directive 73/361/EEC (Text with EEA relevance)
Mandate
M/396 - Mandate to CEN and Cenelec for standardisation in the field of machinery
M/605 - COMMISSION IMPLEMENTING DECISION of 20.1.2025 on a standardisation request to the European Committee for Standardization and to the European Committee for Electrotechnical Standardization as regards machinery and related products in support of Regulation (EU) 2023/1230 of the European Parliament and of the Council
Ref Project
oSIST prEN ISO 24158-1:2025 - Packaging machinery - Part 1: General safety requirements (ISO/DIS 24158-1:2025)

Relations

Revises
EN 415-10:2014 - Safety of packaging machines - Part 10: General Requirements
Effective Date
01-Jul-2020
prEN ISO 24158-1:2025 - BARVEprEN ISO 24158-1:2025 - BARVE
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Draft
prEN ISO 24158-1:2025 - BARVE
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Standards Content (Sample)


SLOVENSKI STANDARD
01-november-2025
Pakirne naprave - 1. del: Splošne varnostne zahteve (ISO/DIS 24158-1:2025)
Packaging machinery - Part 1: General safety requirements (ISO/DIS 24158-1:2025)
Verpackungsmaschinen - Teil 1: Allgemeine Sicherheitsanforderungen (ISO/DIS 24158-
1:2025)
Machines d’emballage - Partie 1: Exigences générales de sécurité (ISO/DIS 24158-
1:2025)
Ta slovenski standard je istoveten z: prEN ISO 24158-1
ICS:
55.200 Pakirni stroji Packaging machinery
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT
International
Standard
ISO/DIS 24158-1
ISO/TC 313
Packaging machinery —
Secretariat: UNI
Part 1:
Voting begins on:
General safety requirements 2025-09-22
Voting terminates on:
ICS: 55.200
2025-12-15
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document has not been edited by the ISO Central Secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
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.
Reference number
ISO/DIS 24158-1:2025(en)
DRAFT
ISO/DIS 24158-1:2025(en)
International
Standard
ISO/DIS 24158-1
ISO/TC 313
Packaging machinery —
Secretariat: UNI
Part 1:
Voting begins on:
General safety requirements
Voting terminates on:
ICS: 55.200
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document has not been edited by the ISO Central Secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2025
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
ISO copyright office
RECIPIENTS OF THIS DRAFT ARE INVITED
CP 401 • Ch. de Blandonnet 8
TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
Phone: +41 22 749 01 11
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 24158-1:2025(en)
ii
ISO/DIS 24158-1:2025(en)
Contents Page
Foreword .vi
Introduction .vii
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 5
4 Risk assessment . 8
5 Safety requirements and risk reduction measures . 8
5.1 General .8
5.2 Inherently safe design .9
5.2.1 General .9
5.2.2 Physical aspects .9
5.2.3 Visibility and maintenance aspects .9
5.3 Safeguarding .10
5.3.1 General .10
5.3.2 Power and force limiting by safety functions .10
5.3.3 Guards .10
5.3.4 Interlocking guards . 12
5.3.5 Adjustable guards. 12
5.3.6 Change part guards. 12
5.3.7 ESPE . 12
5.3.8 Separation of hazard zones . 15
5.3.9 Openings in guards . 15
5.4 Release from trapping . . 35
5.5 Unexpected lowering of machine components . 36
5.5.1 General . 36
5.5.2 Strength of mechanical components that support a load . 36
5.5.3 Requirements for lifting mechanisms . 36
5.5.4 Methods to prevent unintended lowering of components .37
5.6 Ejected, tilting, or falling product . 39
5.6.1 Risks from falling product during operator interventions . 39
5.6.2 Risk reduction measures in case of failure of an energy supply . 40
5.7 Slip, trip and fall hazards . 40
5.7.1 Slip . 40
5.7.2 Trip. 40
5.7.3 Fall, means of access. 40
5.8 Stability .41
5.9 Reduction of electrical risks .41
5.9.1 General .41
5.9.2 Degree of protection .41
5.9.3 Electrostatic phenomena .41
5.10 Reduction of thermal risks .42
5.10.1 Hot surfaces .42
5.10.2 Cold surfaces .42
5.11 Reduction of noise risks .42
5.12 Reduction of vibration risks .43
5.13 Reduction of radiation risks .43
5.13.1 General .43
5.13.2 Laser equipment .43
5.13.3 Non-ionizing radiation (excluding laser) .43
5.13.4 Ionizing radiation . 44
5.14 Reduction of chemical risks . 44
5.14.1 General . 44
5.14.2 Substances used for sanitizing .45

iii
ISO/DIS 24158-1:2025(en)
5.14.3 Requirements for cleaning in place, strainers and drainage . 46
5.15 Risk reduction measures to control fire or explosion hazards . 46
5.16 Risk reduction measures to control biological hazards - hygienic design requirements .47
5.17 Ergonomic design principles .47
5.17.1 Operator interface and machine mounted contro
...

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EN 415-2:2025(Main)
Safety of packaging machines - Part 2: Packaging machines for pre-formed rigid containers
SIST EN 415-2:2025

This document applies to the following machines and to machines which incorporate more than one function as listed below. The document also applies to partly completed machinery as far as conformity is claimed for certain essential health and safety requirements.
This document deals with the following machines handling rigid containers including:
-   unscrambling machines;
-   cap removing machines;
-   cleaning machines;
-   sanitizing machines;
-   filling machines;
-   capping, closing and sealing machines;
-   closure securing machines;
-   inspection machines;
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-   decorating machines;
-   heating- and cooling machines for packed product, working at atmospheric pressure;
-   sterilizing machines (others than heat treatment)
with one or more of the following functions: cleaning, sanitizing, pasteurizing, filling, labelling, closing, sealing or inspecting and handling pre-formed rigid containers including their closures.
This document also deals with equipment when it is part of a machine listed above:
-   conveyors;
-   vacuum or magnetic transfer conveyors;
-   dispose or eject devices (pushers);
-   keg stopping devices;
-   keg lift and inverting machines;
-   extraction or ventilation system or blowers;
-   hoppers;
-   rotary mechanisms;
-   coding and marking equipment incorporated in a packaging machine;
-   hot foil coders;
-   laser coders;
-   ink jet coders;
-   emboss coders.
The individual machines are described in 3.2.
This document deals with safety requirements and their verification for machine design, construction and information applicable to installation, commissioning, operation, adjustment, maintenance, cleaning, dismantling of packaging machines for pre-formed rigid containers.
The extent to which hazards, hazardous situations and events are covered is indicated in Annex B.
NOTE   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 covered by this document or EN 415-10, the manufacturer can assess these hazards and take measures by using the principles detailed in EN ISO 12100:2010.
Exclusions
This document is not applicable to the following machines:
-   machines that were manufactured before the date of publication of this document by CEN;
-   machines for cups or trays or tubs made of a foil of plastic, aluminium or paper, which are the subject of EN 415-3;
-   aerosol filling and sealing machines;
-   filling machines for gas;
-   autoclaves;
-   conveyors which link packaging machines but are not integrated in packaging machines or part of packaging machines;
-   blow moulding machines;
NOTE   See EN 422:2009:
-   sleeve label removing machines.
This document does not consider the following hazards:
-   the use of packaging machines in potentially explosive atmospheres not generated by the machine itself;
-   hazards associated with packing explosives;
-   hazards arising from ancillary equipment, which is not part of the machine, e.g. equipment for evacuating gases, for cooling or refrigeration, for the supply of steam, energy or product.

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EN 415-8:2025(Main)
Safety of packaging machines - Part 8: Strapping machines
SIST EN 415-8:2025

This document is applicable to the following groups of machines:
-   powered hand strapping tools;
-   semi-automatic strapping machines;
-   automatic strapping machines.
This document does not apply to:
-   strapping tools, where the strap tension is only applied by manual effort;
-   machines, intended for use with paper strap;
-   hand-held motor-operated electric strapping tools.
NOTE   For hand-held motor-operated electric strapping tools see EN 60745-2-18:2009 and EN 62841-1:2015.
This document deals with safety requirements for machine design, transport, installation, commissioning, operation, adjustment, maintenance and cleaning. The extent to which hazards, hazardous situations and events are covered is indicated in Annex A.
This document does not consider the following hazards:
-   the use of strapping machines in potentially explosive atmosphere;
-   the 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 are associated with decommissioning strapping machines.
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EN 415-11:2021(Main)
Safety of packaging machines - Part 11: Determination of efficiency and availability
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This document is applicable to packaging machines falling within the scope of EN 415 1, referred to in the following as “machine systems”. This document can also be applied by analogy to other related processing machines. This document specifies
—   a time model,
—   an output model derived from this time model,
—   general key figures,
—   technical key figures, and
—   a methodology for system acceptance
for describing the operating behaviour of packaging machines and packaging lines.
This document does not contain safety requirements.

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EN 415-3:2021(Main)
Safety of packaging machines - Part 3: Form, fill and seal machines; fill and seal machines
SIST EN 415-3:2021

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.
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.

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EN 415-1:2014(Main)
Safety of packaging machines - Part 1: Terminology and classification of packaging machines and associated equipment
SIST EN 415-1:2014

This European Standard defines the field of packaging machines. The machines defined fall within the following general groups:
—   filling machines;
—   closing machines;
—   labelling, decorating and coding machines;
—   cleaning, sterilizing, cooling and drying machines;
—   fill and seal machines;
—   inspection machines;
—   container and packaging component handling machines;
—   form, fill and seal machines;
—   carton erecting, carton closing and cartoning machines;
—   wrapping machines;
—   group or secondary packaging machines;
—   palletizers, depalletizers and ancillary equipment;
—   pallet wrapping machines;
—   strapping machines.
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Safety of packaging machines - Part 10: General Requirements
SIST EN 415-10:2014

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;
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EN 415-6:2013(Main)
Safety of packaging machines - Part 6: Pallet wrapping machines
SIST EN 415-6:2013

This European Standard applies to the following groups of machines:
-   pallet banding machines;
-   stretch film pallet wrapping machines;
-   stretch film hood application machines;
-   mobile stretch film wrapping machines;
-   semi automatic self driving stretch film wrapping machines;
-   shrink film pallet wrapping machines;
-   shrink film hood application machines;
-   film removing machines;
-   shrinking systems;
-   sleeve wrapping machines for product greater than 400 mm in one direction;
-   product centralising machines.
The individual machines are described in 3.2.
This standard deals with safety requirements for machine design, construction, installation, commissioning, operation, adjustment, maintenance and cleaning of pallet wrapping machines.
The extents to which hazards, hazardous situations and events are covered are indicated in Clause 4.
Exclusions
This European Standard is not applicable to the following machines:
   machines that were manufactured before the date of publication of this document by CEN;
-   pallet strapping machines and destrapping machines. These machines are within the scope of
EN 415-8;
-   conveying systems that connect packaging machines with each other, but includes conveying systems that are part of the machines.
This standard does not consider the following hazards:
-   the use of pallet wrapping machines in potentially explosive atmospheres;
-   the 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 electromagnetic emissions from pallet wrapping machines;
-   hazards that may be associated with decommissioning pallet wrapping machines.

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EN 415-5:2006+A1:2009(Main)
Safety of packaging machines - Part 5: Wrapping machines
SIST EN 415-5:2006+A1:2010

This European Standard applies to the following groups of machines:
-   wrapping machines which partially wrap products (see Figures 1-4)
-   wrapping machines which form a complete wrap without sealing (see Figures 5-7)
-   wrapping machines which form a complete wrap with sealing (see Figures 8-14)
-   shrinking equipment which is connected to wrapping machines covered by this standard (see Figures 15-16)
The individual machines are described in 3.2 of this standard.
This European Standard deals with safety requirements for machine design, construction, installation, commissioning, operation, adjustment, maintenance and cleaning of wrapping machines.
The extent to which hazards, hazardous situations and events are covered are indicated in Clause 4 of this document.
Exclusions:
This standard is not applicable to larger examples of wrapping machines designed to handle products higher than 400 mm and wider than 400 mm. These machines are covered by EN 415-6.
This document is not applicable to wrapping machines which are manufactured before the date of publication of this document by CEN.
This standard does not consider the following hazards:
-   Use of wrapping machines in potentially explosive atmospheres;
-   Health, safety or hygiene hazards associated with the products that may be handled by the machines but does include general advice on this subject;
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EN 415-9:2009(Main)
Safety of packaging machines - Part 9: Noise measurement methods for packaging machines, packaging lines and associated equipment, grade of accuracy 2 and 3
SIST EN 415-9:2010

This standard specifies all the information necessary to carry out efficiently and under defined conditions the determination, information and verification of airborne noise emission from packaging machine covered by EN 415-1.
This measurement method specifies procedures for the determination of emission sound pressure levels at work station, at other specified positions and the sound power level on the basis of both the sound pressure level method and the sound intensity method. It also specifies installation and operating conditions.
This standard applies to machines covered by EN 415-1 as well as for any other packaging machine which are not covered by any other specific noise test code as well as for machines being part of packaging line. In such cases, all information relating to the assembly, installation and to the operating conditions as well as the arrangement of the work station shall be recorded and reported in the test report.
Noise emission characteristics include the following data:
- emission sound pressure level at work station  and at other specified positions;
- sound power emitted by machine.
Both can be used:
- to determine the noise emitted by machine;
- to inform on the noise emitted by the machine;
- to verify the noise emitted by the machine.
Noise emission values permit comparison of packaging machines on the market.
The use of this standard ensures the reproducibility of the determination of the characteristic noise emissions values within specific limits which will be determined by the grade of accuracy of the noise emission measuring method used.

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EN 415-7:2006+A1:2008(Main)
Safety of packaging machines - Part 7: Group and secondary packaging machines
SIST EN 415-7:2007+A1:2008

This European Standard applies to the following groups of machines:
Group and secondary packaging machines and the collating systems associated with them.
The individual machines are described in 3.2 of this European Standard.
This European Standard deals with safety requirements for machine design, construction, installation, commissioning, operation, adjustment, maintenance and cleaning of group and secondary packaging machines.
The extent to which hazards, hazardous situations and events are covered, are indicated in Clause 4.
Exclusions
This European Standard is not applicable to the following machines:
-   machines that were manufactured before the date of publication of this document by CEN;
-   strapping machines. These machines are covered by EN 415-8;
-   crate loaders and un-loaders for pre-formed rigid containers. These machines are covered by
EN 415-2;
-   cartoning machines. Cartoning machines are covered by EN 415-3.
This European Standard does not consider the following hazards:
-   use of group and secondary packaging machines in potentially explosive atmospheres;
-   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 electromagnetic emissions from group and secondary packaging machines;
-   hazards that may be associated with decommissioning group and secondary packaging machines.

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