Food processing machinery - Pasteurizers, vats and cream cookers - Safety and hygiene requirements

This European Standard applies to machines of ice cream mixes, pasty liquid products for gelato, pastry, chocolate and food processing, as described in Clause 3.
The European Standard applies to fixed and movable artisan machinery (not designed to be moved during operation), with a rated capacity of not more than 600 l.
This European Standard deals with all significant hazards, hazardous situations and events relevant to the machinery, when they are used as intended and under conditions of misuse which are reasonably foreseeable by the manufacturer (see Clause 4).
This European Standard deals with the hazards which can arise during transport, assembly, commissioning, operation, cleaning, use, maintenance, decommissioning, dismantling, disabling and scrapping of the machine.
This European Standard covers the following types of machines:
-   pasteurizers;
-   ageing vats;
-   cream cookers.
This European Standard does not apply to equipment feeding and dosing, equipment, supply of inert gas and heating and cooling equipment and any extraction (container, extraction belt etc.).
This European Standard is not applicable to cream cookers without cooling systems
This European Standard is not applicable to machines which are manufactured before the date of publication of this European Standard by CEN.

Nahrungsmittelmaschinen - Pasteurisiergeräte, Bottiche und Eismaschinen - Sicherheits- und Hygieneanforderungen

Diese Europäische Norm gilt für Maschinen zur Verarbeitung von Eiskremmix, dickflüssigen Produkten für Eis, Teig und Schokolade sowie zur Lebensmittelverarbeitung, wie in Abschnitt 3 beschrieben.
Die Europäische Norm gilt für fest installierte und ortsveränderliche Handwerksmaschinen (die nicht dazu bestimmt sind, während des Betriebs bewegt zu werden), mit einem Nennfassungsvermögen von nicht mehr als 600 l.
Diese Europäische Norm behandelt alle signifikanten Gefährdungen, Gefährdungssituationen und Gefährdungsereignisse, die auf diese Maschinen zutreffen, wenn sie bestimmungsgemäß und unter Bedingungen von durch den Hersteller vernünftigerweise vorhersehbaren Fehlanwendungen verwendet werden (siehe Abschnitt 4).
Diese Europäische Norm behandelt die Gefährdungen, die während Transport, Montage, Inbetriebnahme, Betrieb, Reinigung, Verwendung, Instandhaltung, Außerbetriebnahme, Demontage, Außerbetriebsetzung und Verschrottung der Maschine auftreten können.
Diese Europäische Norm deckt die folgenden Arten von Maschinen ab:
-   Pasteurisiergeräte;
-   Reifebottiche;
-   Eismaschinen (Cremekocher).
Diese Europäische Norm gilt nicht für Vorrichtungen zur Beschickung und Dosierung, zur Versorgung mit Inertgas, für Heiz- und Kühlgeräte und für Vorrichtungen zur Entnahme (Behälter, Entnahmeband usw.).
Diese Europäische Norm gilt nicht für Eismaschinen ohne Kühlsystem.
Diese Europäische Norm gilt nicht für Maschinen, die vor deren Veröffentlichung durch CEN hergestellt wurden.

Machines pour les produits alimentaires - Pasteurisateurs, cuves et cuiseurs de crème - Prescriptions relatives à la sécurité et l'hygiène

La présente Norme européenne s'applique aux machines pour mélanges de crèmes glacées, aux produits liquides pâteux destinés à la fabrication de glaces artisanales, de pâtisseries, de chocolat et autres produits alimentaires, tel que décrit à l'Article 3.
La présente Norme européenne s'applique aux machines artisanales fixes et mobiles (non conçues pour être déplacées en cours de fonctionnement), d'une capacité nominale inférieure ou égale à 600 l.
La présente Norme européenne traite de tous les phénomènes, situations et événements dangereux significatifs applicables aux machines dans les conditions d'utilisation normales et inappropriées, dès lors que ces dernières sont raisonnablement prévisibles par le fabricant (voir Article 4).
La présente Norme européenne traite des phénomènes dangereux qui peuvent survenir pendant le transport, l'assemblage, la mise en service, le fonctionnement, le nettoyage, l'utilisation, la maintenance, la mise hors service, le démantèlement et la mise au rebut de la machine.
La présente Norme européenne couvre les types de machines suivants :
-   les pasteurisateurs ;
-   les cuves de maturation ;
-   les cuiseurs de crème.
La présente Norme européenne ne s'applique pas à l'alimentation et au dosage des équipements, aux équipements, à l'alimentation en gaz inerte, aux équipements de chauffage et de refroidissement et aux dispositifs d'extraction (conteneur, courroie d'extraction, etc.).
La présente Norme européenne ne s'applique pas aux cuiseurs de crème dépourvus de systèmes de refroidissement.
La présente Norme européenne ne s’applique pas aux machines fabriquées avant la date de publication de la présente Norme européenne par le CEN.

Stroji za predelavo hrane - Pasterizatorji, kadi in kuhalniki za pripravo kreme - Varnostne in higienske zahteve

General Information

Status
Not Published
Public Enquiry End Date
29-Sep-2015
Technical Committee
Current Stage
5020 - Formal vote (FV) (Adopted Project)
Start Date
22-May-2017
Due Date
10-Jul-2017
Completion Date
01-Sep-2017

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SLOVENSKI STANDARD
oSIST prEN 16881:2015
01-september-2015
Stroji za predelavo hrane - Pasterizatorji, kadi in kuhalniki za pripravo kreme -
Varnostne in higienske zahteve
Food processing machinery - Pasteurizers, vats and cream cookers - Safety and hygiene
requirements
Nahrungsmittelmaschinen - Pasteurisiergeräte, Bottiche und Eismaschinen - Sicherheits-
und Hygieneanforderungen
Machines pour les produits alimentaires - Pasteurisateurs, cuves et cuiseurs de crème -
Prescriptions relatives à la sécurité et l'hygiène
Ta slovenski standard je istoveten z: prEN 16881
ICS:
67.260 Tovarne in oprema za Plants and equipment for the
živilsko industrijo food industry
oSIST prEN 16881:2015 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN 16881:2015

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oSIST prEN 16881:2015

EUROPEAN STANDARD
DRAFT
prEN 16881
NORME EUROPÉENNE

EUROPÄISCHE NORM

June 2015
ICS 67.260
English Version
Food processing machinery - Pasteurizers, vats and cream
cookers - Safety and hygiene requirements
Machines pour les produits alimentaires - Pasteurisateurs, Nahrungsmittelmaschinen - Pasteurisiergeräte, Bottiche
cuves et cuiseurs de crème - Prescriptions relatives à la und Eismaschinen - Sicherheits- und
sécurité et l'hygiène Hygieneanforderungen
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee CEN/TC 153.

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, 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: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 16881:2015 E
worldwide for CEN national Members.

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Contents Page
Foreword .4
Introduction .5
1 Scope .6
2 Normative references .6
3 Terms and definitions and description of machines .7
3.1 Terms and definitions .7
3.2 Description of machines .8
3.2.1 Pasteurizers .8
3.2.2 Ageing Vats .9
3.2.3 Cream cookers .9
4 List of significant hazards . 10
4.1 General . 10
4.2 Mechanical hazards . 10
4.3 Electrical hazards . 11
4.4 Thermal hazards . 11
4.5 Hazards generated by noise . 12
4.6 Hazard generated by neglecting ergonomic principles . 12
4.7 Hazard generated by neglecting hygienic principles . 12
4.8 Hazards generated by loss of stability or tipping . 12
5 Safety and hygiene requirements and/or protective measures . 12
5.1 General . 12
5.2 Mechanical hazards . 12
5.2.1 Elimination of hazards by design . 12
5.2.2 Zone 1 – Access to trapping points between the lid and the hopper/tank . 13
5.2.3 Zone 2 – Access to the rotating devices through the feed opening . 13
5.2.4 Zone 3 – Loss of stability of machine/access to areas adjacent to the machine . 13
5.2.5 Zone 4 – Access to high temperature surfaces . 13
5.2.6 Zone 5 – Access to the rotating parts through the draw-off opening . 13
5.3 Electrical hazards . 13
5.3.1 General . 13
5.3.2 Safety requirements relating to electromagnetic phenomena . 13
5.3.3 Protection against electric shock . 13
5.3.4 Power circuits . 14
5.3.5 Earth faults . 14
5.3.6 Emergency stop . 14
5.3.7 Degrees of protection of external enclosures of electrical equipment (see EN 60529) . 14
5.3.8 Start function . 14
5.3.9 Unexpected start-up . 14
5.3.10 Motor enclosures . 14
5.3.11 Electrical requirements of controls . 14
5.4 Thermal hazards . 14
5.5 Noise control . 14
5.6 Ergonomic design principles . 15
5.7 Hygiene requirements . 15
5.7.1 General . 15
5.7.2 Heating . 15
5.7.3 Refrigeration . 16
5.8 Harmful substance. 18
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6 Verification of safety and hygiene requirements and/or protective measures . 18
7 Information of use . 18
7.1 General . 18
7.2 Instruction handbook . 18
7.3 Service manual . 20
7.4 Cleaning . 20
7.5 Marking . 20
Annex A (normative) Noise test code (Grade 2 of accuracy) . 21
A.1 Terms and definitions . 21
A.2 Installation and mounting conditions . 21
A.3 Operating conditions . 21
A.4 Emission sound pressure level determination . 21
A.5 Measurement uncertainties . 22
A.6 Information to be recorded . 22
A.7 Information to be reported . 22
A.8 Declaration and verification of noise emission values . 22
Annex B (normative) Principles of design to ensure the cleanability of the machinery . 23
B.1 Definitions . 23
B.2 Material of construction . 23
B.3 Design . 24
Annex C (normative) Testing Disinfection of Pasteurizers, Vats Machines . 41
C.1 Testing disinfection by cleaning . 41
C.2 Testing of the pasteurization process . 41
C.3 Testing during cream production . 42
Annex ZA (informative) Relationship between this European Standard and the Essential Requirements

of EU Directive 2006/42/EC . 43
Bibliography . 44

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Foreword
This document (prEN 16881:2015) 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 document is currently submitted to the CEN Enquiry.
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 Directive(s), see informative Annex ZA, which is an integral part of this document.
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Introduction
This European Standard is a type C standard as stated in EN ISO 12100:2010.
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.
Complementary to the hygiene requirements common to all food processing machines, specific requirements for
cleanability and sanitation of the machines in the scope are formulated.
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1 Scope
This European Standard applies to machines of ice cream mixes, pasty liquid products for gelato, pastry, chocolate
and food processing, as described in Clause 3.
The European Standard applies to fixed and movable artisan machinery (not designed to be moved during
operation), with a rated capacity of not more than 600 l.
This European Standard deals with all significant hazards, hazardous situations and events relevant to the
machinery, when they are used as intended and under conditions of misuse which are reasonably foreseeable by
the manufacturer (see Clause 4).
This European Standard deals with the hazards which can arise during transport, assembly, commissioning,
operation, cleaning, use, maintenance, decommissioning, dismantling, disabling and scrapping of the machine.
This European Standard covers the following types of machines:
— pasteurizers;
— ageing vats;
— cream cookers.
This European Standard does not apply to equipment feeding and dosing, equipment, supply of inert gas and
heating and cooling equipment and any extraction (container, extraction belt etc.).
This European Standard is not applicable to cream cookers without cooling systems
This European Standard is not applicable to machines which are manufactured before the date of publication of this
European Standard by CEN.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are indispensable for
its application. For dated references, only the edition cited applies. For undated references, the latest edition of the
referenced document (including any amendments) applies.
EN 349:1993+A1:2008, Safety of machinery - Minimum gaps to avoid crushing of parts of the human body
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, Safety of machinery – Guards – General requirements for the design and construction of fixed and movable
guards
EN 1672-2:2005+A1:2009, Food processing machinery - Basic concepts - Part 2: Hygiene requirements
EN 60204-1:2006, Safety of machinery - Electrical equipment of machines - Part 1: General requirements (IEC
60204:2005, modified)
EN 60529, Degrees of protection provided by enclosures (IP Code) (IEC 60529)
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)
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EN ISO 4287, Geometrical product specifications (GPS) - Surface texture: Profile method - Terms, definitions and
surface texture parameters (ISO 4287)
EN ISO 4871, Acoustics - Declaration and verification of noise emission values of machinery and equipment (ISO
4871)
EN ISO 11201, 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)
EN ISO 11688-1, Acoustics - Recommended practice for the design of low-noise machinery and equipment - Part 1:
Planning (ISO/TR 11688-1)
EN ISO 12100:2010, Safety of machinery - General principles for design - Risk assessment and risk reduction (ISO
12100:2010)
EN ISO 13732-1, Ergonomics of the thermal environment - Methods for the assessment of human responses to
contact with surfaces - Part 1: Hot surfaces (ISO 13732-1)
EN ISO 13732-3, Ergonomics of the thermal environment - Methods for the assessment of human responses to
contact with surfaces - Part 3: Cold surfaces (ISO 13732-3)
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 13850, Safety of machinery - Emergency stop - Principles for design (ISO 13850)
EN ISO 13857:2008, Safety of machinery - Safety distances to prevent hazard zones being reached by upper and
lower limbs (ISO 13857:2008)
EN ISO 14119:2013, Safety of machinery - Interlocking devices associated with guards - Principles for design and
selection (ISO 14119:2013)
3 Terms and definitions and description of machines
3.1 Terms and definitions
For the purposes of this document, the terms and definitions given in EN ISO 12100:2010 and the following apply.
3.1.1
hopper lid
mobile guard used to lock the hopper which contain the mixing device of the product
Note 1 to entry: The hopper lid is also used to restart the work cycle.
3.1.2
mixing device
suitable device to ensure mixing and circulation of the mixture
3.1.3
draw-off device
suitable device to allow the extraction of the finished product
3.1.4
hopper
part of the machinery suitable to store the mixture during the work cycle
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3.1.5
compression type machines
machines where the cooling is performed by means of a refrigerant liquid at low pressure in a heat exchanger
(evaporator), the steam thus formed becomes a liquid by a mechanical compression higher pressure and cooling in
another heat exchanger (condenser)
3.1.6
condenser
heat exchanger in which after compression, the vaporized refrigerant is liquefied, giving off heat to external cooling
system
3.1.7
evaporator
heat exchanger in which, after the reduction of pressure, the refrigerant is vaporized by absorbing heat from the
medium which shall be cooled
3.2 Description of machines
3.2.1 Pasteurizers
Machine used for mixing, heating, cooling ingredients in order to produce and store the mix for artisan gelato (see
Figure 1), operated step by step or fully automatically, whose hopper can be heated or cooled by air or water
condensing unit, internal or remote.

Key
1 hopper
2 hopper lid (cover)
3 mixing device
4 draw-off device
5 heated or cooled device
6 compressor
7 condensing unit
8 castors/pins
Figure 1 — Typical layout of pasteurizers
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3.2.2 Ageing Vats
Machine used for the storage and ageing the mix for artisan gelato (see Figure 2), operated step by step or fully
automatically, whose hopper can be heated or cooled by air or water condensing unit, internal or remote.

Key
1 hopper
2 hopper lid (cover)
3 mixing device
4 draw-off device
5 heated or cooled device
6 compressor
7 condensing unit
8 castors/pins
Figure 2 — Typical layout of vats
3.2.3 Cream cookers
Pasteurizer intended for use with liquid and thick mixes (see Figure 3), operated step by step or fully automatically,
whose hopper can be heated or cooled by air or water condensing unit, internal or remote.
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Key
1 hopper
2 hopper lid (cover)
3 mixing device
4 draw-off device
5 heated or cooled device
6 compressor
7 condensing unit
8 castors/pins
Figure 3 — Typical layout of cream cookers
4 List of significant hazards
4.1 General
This clause contains all the significant hazards, hazardous situations and events, as far as they are dealt with in this
European Standard, identified by risk assessment as significant for this type of machinery and which require action
to eliminate or reduce the risk.
4.2 Mechanical hazards
The example shown in Figure 4 illustrates danger zones associated with these hazards:
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Key
1 Zone 1
2 Zone 2
3 Zone 3
4 Zone 4
5 Zone 5
Figure 4 — Danger zones
Zone 1: Access to trapping points between the lid and the hopper/tank:
— crushing hazard of fingers and hands between the edge hopper and the lid;
Zone 2: Access to the rotating devices through the feed opening:
— hazards of trapping and shearing of arms between the blades of mixing device and the hopper/tank;
Zone 3: Loss of stability of machine - access to areas adjacent to the machine:
— hazard of trapping and crushing of whole or part of body if machine overturns;
Zone 4: Access to high temperature surfaces:
— hazard of scalds and burns, in case of accidental contact;
Zone 5: Access to the rotating parts through the draw-off opening:
— hazard of trapping and shearing of arms between the blades of rotating device.
4.3 Electrical hazards
Hazard of electric shock from direct or indirect contact with live components. Hazard of external influences on
electrical equipment (e.g. cleaning with water). If liquids such as spilled products or cleaning agents such as water
come into contact with the electrical conductors, there is a danger of electric shock.
4.4 Thermal hazards
High temperature of external parts and hand operated components creates a hazard of scalds and burns. This
hazard can be present also when the machinery is switched off.
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4.5 Hazards generated by noise
Machinery can generate an airborne noise being able to involve a deterioration of hearing or accidents due to the
interferences with the oral communication and the perception of the acoustical signals. The noise can produce:
— ringing in the ears;
— tiredness, stress, etc.;
— other effects as loss of balance, loss of perception;
— interference with speech communication;
— inability to hear acoustic warning signals.
4.6 Hazard generated by neglecting ergonomic principles
During operation, cleaning and maintenance, there could be the risk for safety and health resulting from awkward
body postures or from an excessive effort. Movement or filling of the bowl especially at heights can create a risk of
injury to the body from lifting, pushing and pulling of heavy loads.
4.7 Hazard generated by neglecting hygienic principles
The neglect of hygienic principles can create unacceptable contamination of foodstuff and therefore a risk to human
health of the operator and consumer, i.e. through physical, chemical or microbial pollution.
4.8 Hazards generated by loss of stability or tipping
Risk of impact or crushing the body, in particular resulting from machinery with castors.
5 Safety and hygiene requirements and/or protective measures
5.1 General
Machinery shall be designed according to the principles of EN ISO 12100:2010 for hazard relevant but not
significant, which are not dealt with by this standard (e.g. sharp edges). This specific risk assessment shall be part of
the general risk assessment of the machine. When fixed guard, or parts of the machine acting as such, are not
permanently fixed, e.g. by welding, their fixing systems shall remain attached to the guards or to the machinery when
the guards are removed.
5.2 Mechanical hazards
5.2.1 Elimination of hazards by design
Unless otherwise specified, interlocking guards shall be at least interlocking without guard blocking as defined in
EN ISO 14119:2013, 4.2, and they shall comply with EN ISO 14119:2013, Clause 5, 7 and 8. Access to dangerous
zones of drive shafts, coupling between the motor and the reduction gear and transmission belts shall be prevented
by fixed guards or movable interlocking guards in accordance with EN 953. Any gaps between moving parts and
fixed parts of the machinery shall be so arranged that either it is not possible for a finger to enter the gap (i.e. a gap
of 6 mm or less) or the gap shall be sufficiently large to prevent trapping and crushing in accordance with
EN 349:1993+A1:2008, Table 1. The safety related parts of the control system shall meet at least a performance
level “c” defined in accordance with EN ISO 13849-1:2008. Openings in guards shall comply with
EN ISO 13857:2008, Table 4.
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5.2.2 Zone 1 – Access to trapping points between the lid and the hopper/tank
Covers of hopper/tank when in opening position shall have a device keeping the covers in a stable position to
prevent unintentional closing (i.e. with balancing systems). The speed of closure of the lids, having a mass greater
than 2,8 kg, shall not be greater than 50 mm/s when the distance from the hopper/tank to the front edge of the lid is
less than 200 mm. Powered lid shall be operated by a hold-to-run control device in conformity to
EN 574:1996+A1:2008, 5.4.1, and shall remain in their position in case of power failure.
5.2.3 Zone 2 – Access to the rotating devices through the feed opening
Access to the zone in which it moves the rotary mixer shall be prevented by a lid/guard interlocked with guard
locking (see EN ISO 14119:2013, 4.3). Openings and/or slides in cover or in the hopper/tank shall be in accordance
with EN ISO 13857:2008, 4.5. For small openings shall be used EN ISO 13857:2008, Table 4. The interlocking
device of the lid shall operate at a maximum opening of the lid of 30 mm.
5.2.4 Zone 3 – Loss of stability of machine/access to areas adjacent to the machine
Machines shall be designed to be stable. For machines designed to be fixed to the floor, the instruction handbook
shall indicate the values of forces at the fixing points and the dimensions of the anchor points provided. Free
standing machines without castors shall not fall or tip over when tilted 10° from the horizontal plane in the most
unfavourable direction and containing the most unfavourable load. Free standing machines with castors shall have
at least two castors (or sets of castors) fitted with a locking device to prevent rolling or turni
...

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