SIST EN 13951:2004
(Main)Liquid pumps - Safety requirements - Agrifoodstuffs equipment ; Design rules to ensure hygiene in use
Liquid pumps - Safety requirements - Agrifoodstuffs equipment ; Design rules to ensure hygiene in use
This standard specifies special technical safety requirements for liquid pumps and pump units operating with agrifoodstuffs
Flüssigkeitspumpen - Sicherheitsanforderungen - Nahrungsmittelausrüstungen; Konstruktionsregeln zur Sicherstellung der Hygiene bei der Verwendung
In dieser Europäischen Norm werden spezielle technische Sicherheitsanforderungen an Flüssigkeitspumpen und Pumpen-aggregate behandelt, die Lebensmittel fördern. Sie erweitert EN 809 und enthält eine Liste der zusätzlichen signifikanten Gefährdungen, die auftreten können, wenn Pumpen und Pumpenaggregate für Substanzen angewendet werden, die für den Verbrauch durch Menschen und Haustiere vorgesehen sind.
Bei Erstellung dieser Norm wurde davon ausgegangen, dass Pumpen, die in den Anwendungsbereich dieser Norm fallen, allen wesentlichen Anforderungen von EN 809 entsprechen.
In dieser Norm werden auch Anforderungen und/oder Maßnahmen festgelegt, die zur Verminderung der Risiken führen.
Diese Europäische Norm ist weder geeignet für die Anwendung von Pumpen und Pumpenaggregaten in allen Stufen der öffentlichen Wasserversorgung noch für Pumpen zur Förderung pharmazeutischer Produkte oder für andere Anwendungen, für die möglicherweise besser geeignete Normen existieren.
Die Übereinstimmung mit dieser Norm trägt zum sicheren Gebrauch der Pumpe bei, wenn vorausgesetzt wird, dass die Anwendung nach der Bedienungsanleitung erfolgt und die Pumpe so ausreichend gereinigt ist, dass sie keine Verunreinigung des Pumpen-Förderguts bewirkt. Obgleich der Hersteller dafür verantwortlich ist, dass die Pumpe bedingt durch den Einfluss des Förderguts, den angewendeten Prozess und das Reinigungsverfahren gereinigt werden kann, sollte letzen Endes der Endbetreiber die Verantwortung für die Hygiene der Pumpe tragen.
In den Anwendungsbereich dieser Norm fallen folgende Pumpen und Pumpenaggregate:
3 Kreiselpumpen;
3 rotierende Verdrängerpumpen;
3 oszillierende Verdrängerpumpen
Pumpen für die Förderung von Lebensmitteln, die nicht in den Anwendungsbereich dieser Norm fallen, sollten EN 1672-2 entsprechen.
Pompes pour liquides - Prescriptions de sécurité - Matériel agroalimentaire ; Regles de conception pour assurer l'hygiene a l'utilisation
Črpalke za tekočine - Varnostne zahteve - Oprema za kmetijska živila - Pravila pri načrtovanju za zagotavljanje higiene med uporabo
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 13951:2004
01-september-2004
ýUSDONH]DWHNRþLQH9DUQRVWQH]DKWHYH2SUHPD]DNPHWLMVNDåLYLOD3UDYLODSUL
QDþUWRYDQMX]D]DJRWDYOMDQMHKLJLHQHPHGXSRUDER
Liquid pumps - Safety requirements - Agrifoodstuffs equipment ; Design rules to ensure
hygiene in use
Flüssigkeitspumpen - Sicherheitsanforderungen - Nahrungsmittelausrüstungen;
Konstruktionsregeln zur Sicherstellung der Hygiene bei der Verwendung
Pompes pour liquides - Prescriptions de sécurité - Matériel agroalimentaire ; Regles de
conception pour assurer l'hygiene a l'utilisation
Ta slovenski standard je istoveten z: EN 13951:2003
ICS:
23.080 ýUSDONH Pumps
67.260 Tovarne in oprema za Plants and equipment for the
živilsko industrijo food industry
SIST EN 13951:2004 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 13951:2004
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SIST EN 13951:2004
EUROPEAN STANDARD
EN 13951
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2003
ICS 23.080; 67.260
English version
Liquid pumps - Safety requirements - Agrifoodstuffs equipment ;
Design rules to ensure hygiene in use
Pompes pour liquides - Prescriptions de sécurité - Matériel Flüssigkeitspumpen - Sicherheitsanforderungen -
agroalimentaire ; Règles de conception pour assurer Nahrungsmittelausrüstungen ; Konstruktionsregeln zur
l'hygiène à l'utilisation Sicherstellung der Hygiene bei der Verwendung
This European Standard was approved by CEN on 28 November 2002.
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 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 Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovak Republic, Spain, Sweden, Switzerland and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2003 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 13951:2003 E
worldwide for CEN national Members.
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SIST EN 13951:2004
EN 13951:2003 (E)
Contents
page
Foreword.3
Introduction .4
1 Scope .4
2 Normative references .5
3 Terms and definitions.5
4 List of hazards.8
5 Hygiene: safety requirements and/or measures.11
5.1 Materials.11
5.2 Design – Food areas.12
5.3 Design - Non-food areas .16
5.4 Auxiliary liquids, barriers and lubricants .16
5.5 Guards and shrouds.17
5.6 Legs.17
6 Verification of hygiene measures.17
6.1 Inspection of documentation.17
6.2 Inspection of the assembled pump or pump unit.17
6.3 Materials.17
6.4 Level of cleanability.17
6.5 Surface roughness test.18
7 Information for use .18
7.1 General.18
7.2 Instruction for use - Instruction handbook .18
Annex A (informative) Materials in contact with foodstuffs (EU regulations).20
A.1 Metallic materials in contact with foodstuffs.20
A.2 Elastomeric materials in contact with foodstuffs.20
A.3 Plastic materials in contact with foodstuffs.20
Annex B (informative) Surface roughness.21
Annex C (informative) Design practices .22
Annex D (informative) Hygienic risk associated with types of pump inlet and outlet connections .24
D.1 Hazards sources .24
D.2 Criteria to be taken into account.24
Annex E (informative) Hygienic risk linked to the choice of shaft sealing system and to the
characteristics of the pumped product .25
Annex ZA (informative) Relationship of this document with EC Directives.26
Bibliography .27
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Foreword
This document (EN 13951:2003) has been prepared by Technical Committee CEN/TC 197 "Pumps", the
secretariat of which is held by AFNOR.
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 September 2003, and conflicting national standards shall be withdrawn at the
latest by September 2003.
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.
This document deals with essential requirements 2.1 "Agrifoodstuffs machinery" of Machinery Directive.
The annexes A, B, C, D, E and F are informative.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal,
Slovak Republic, Spain, Sweden, Switzerland and the United Kingdom.
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Introduction
This document is a type C standard as stated in EN 1070.
The machinery concerned and the extent to which hazards, hazardous situations and 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.
1 Scope
This European Standard is concerned with the special technical safety requirements for liquid pumps and pump
units operating with agrifoodstuffs. It augments EN 809 and contains a list of the additional significant hazards
which can arise from the pump and pump units used with substances intended for human and domestic animal
consumption.
In drafting this standard it was assumed that the pumps falling within its scope will conform to all relevant
requirement of EN 809.
It also establishes requirements and/or measures which lead to a reduction of the risks.
This standard is not intended to be used for pumps and pump units at any stage in the public water supply, nor for
pumps handling pharmaceutical products, nor for any other application for which more appropriate standards can
exist.
Conformity to this standard aims to ensure that the pump, if used in accordance with the instruction handbook, will
remain safe and, provided it is adequately cleaned, will not cause contamination of the pumped product. Although it
is the responsibility of the manufacturer to ensure that the pump can be cleaned, due to the influence of the
product, the process and the cleaning regime adopted, the hygiene of the pump should ultimately be the
responsibility of the end-user.
The pumps and pump units which fall within the scope of this standard are described as:
rotodynamic pumps;
rotary positive displacement pumps;
reciprocating positive displacement pumps.
Pumps handling agrifoodstuffs which do not fall within this scope should comply with EN 1672-2.
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2 Normative references
This European Standard incorporates by dated or undated reference, provisions from other publications. These
normative references are cited at the appropriate places in the text, and the publications are listed hereafter. For
dated references, subsequent amendments to or revisions of any of these publications apply to this European
Standard only when incorporated in it by amendment or revision. For undated references the latest edition of the
publication referred to applies (including amendments).
EN 809, Pumps and pump units for liquids – Common safety requirements.
EN 1050, Safety of machinery – Principles for risk assessment.
EN 1070, Safety of machinery – Terminology.
EN 1672-2:1997, Food processing machinery – Basic concepts – Part 2: Hygiene requirements.
EN ISO 4287, Geometrical Product Specifications (GPS) – Surface texture : Profile method – Terms, definitions
and surface texture parameters (ISO 4287:1997).
3 Terms and definitions
For the purposes of this European Standard, the terms and definitions given in EN 1070 together with the following
apply.
3.1
food/agrifoodstuffs products
any product, ingredient or material intended to be orally consumed at any stage of its production process
3.2
food hygiene
taking of all measures during the preparation and processing of food to ensure that it is fit for human or animal
consumption
(Definition in accordance with EN 1672-2:1997)
3.3
adverse influence
reduction of the fitness for consumption of a food. A food can be adversely influenced in particular by microbial
pathogens or other unwanted micro-organisms, toxins, vermin, domestic animals and other contaminants
3.4
areas of equipment
NOTE These areas are not to be confused with any others amongst those defined in other standards (e.g. electro-technical
standards).
(Note in accordance with EN 1672-2:1997)
3.4.1
food area
area composed of surfaces in contact with food. The food area also includes the surfaces with which the product
may come into contact under intended conditions of use, after which it returns into the product
(Definition in accordance with EN 1672-2:1997)
3.4.2
non-food area
any area other than those specified above
(Definition in accordance with EN 1672-2:1997)
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3.5
product/pumped product
all products passing through the pumps as a result of process, testing, cleaning, rinsing, or disinfecting products
3.6
cleaning
operations which reduce the potential for contamination to an acceptable level
3.6.1
cleanable
design and construction which permits soils to be removed by appropriate cleaning methods
3.6.2
cleanability
ability of the pump to be cleaned by a defined procedure to defined conditions of cleanliness
3.6.2.1
cleaned in place or mechanical cleaning (CIP, NEP)
CIP or NEP means soil removal by impingement, circulation or flowing chemical detergent solutions and water
rinses into and on to the surfaces to be cleaned without dismantling
NOTE The term CIP corresponds to the abbreviation of the English wording "Cleaned In Place". In French language the
following term NEP is the abbreviation of the wording "Nettoyage En Place". In German language it is the term CIP which is
used.
3.6.2.2
cleaned out of place or manual cleaning (COP, NHP)
COP or NHP means soil removal when the equipment is partially or totally dismantled
NOTE The term COP corresponds to the abbreviation of the English wording "Cleaned Out of Place". In French language,
the following term NHP is the abbreviation of the wording "Nettoyage Hors Place". In German language it is the term CIP which
is used.
3.7
contamination
presence of soils
(Definition in accordance with EN 1672-2:1997)
3.8
corrosion resistant material
material resistant to normally occurring action of chemical or electrochemical nature at all stages of food
processing, cleaning and disinfection according to the instructions for use
3.9
crevice
surface defect e.g. crack, fissure, which has an adverse influense on cleanability
3.10
dead space
any space wherein a pumped product, or soils may be retained or not completely removed during the cleaning
operation
3.11
disinfection
process applied to a cleaned surface which is capable of reducing the numbers of viable micro-organisms, but not
necessarily their spores, to a level considered safe for product production
3.12
sterilization
validated process used to reach a state free from viable micro-organisms including all relevant bacterial spores
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NOTE In a sterilization process, the nature of microbial death or reduction is described by an exponential function.
Therefore, the number of micro-organisms that survive a sterilization process can be expressed in terms of probability. While the
probability can be reduced to a very low number, it can never be reduced to zero.
3.13
durable
ability of a surface to withstand the intended conditions of use, for example : to resist damage caused by the action
of the process, contact with the pumped product including thermal actions
3.14
joint
junction of two or more pieces of material
(Definition in accordance with EN 1672-2:1997)
3.15
non absorbent material
material which, under intended conditions of use, does not retain substances with which it comes into contact so
that it has no adverse influence on pumped products
3.16
non toxic material
material which does not produce or release substances injurious to health under intended conditions of use
(Definition in accordance with EN 1672-2:1997)
3.17
seal
component to prevent the unwanted entry or passage of any matter
3.18
self draining
design and construction of the shape and surface finish so as to ensure the evacuation by gravity of the pumped
products
3.19
smooth
condition of a surface (with reference to surface finish) which satisfies operational and hygienic requirements
3.20
soil
any unwanted matter, including product residues, micro-organisms, residual detergent or disinfecting agents
(Definition in accordance with EN 1672-2:1997)
3.21
vermin
animals (including mammals, birds, reptiles and insects) which may adversely influence the pumped products
3.22
toxic/toxicity
toxicity of a material is defined by EU or local regulations.
Toxicity depends on the quantity of material which can migrate either by wear or by diffusion in the pumped product
under intended use
3.23
compatibility (material)
compatibility means that the material is non absorbent and insoluble, and that the material surfaces do not
deteriorate due to chemical, microbiological, mechanical or thermal action, as a result of contact with the pumped
product
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3.24
compatible (liquid)
compatible means that the liquid identified does not create toxic conditions or any other adverse influence when
mixed with the pumped product
3.25
method of assembly
all steps to assemble components or parts when they are in a dismantled state
3.26
auxiliary liquid
auxiliary liquid is a liquid provided for flush, pressure balance, or other similar purposes
3.27
barrier liquid
barrier liquid is an appropriate (that is clean, compatible, etc….) liquid inserted between two seals or barriers
4 List of hazards
The potential hazards which can be associated with pumps and pump units used for pumping agrifoodstuffs
products can arise from:
micro-biological causes such as pathogens, spoilage, micro-organisms or toxins resulting from their
ingress to or retention by the product;
chemical causes resulting from contamination such as lubricating, cleaning, or disinfection substances;
foreign materials entering the product such as unwanted allergies, pests, metals, wear debris, etc.,
resulting from raw materials or other materials used in the construction of the equipment, or entry through
unprotected openings;
mechanical causes such as possible mis-assembly or mis-use resulting in opportunities for micro-
biological, chemical or foreign material hazards;
any deterioration resulting from thermal, chemical, or vibration effects on the pump or plant.
The micro-biological hazards which may arise in a pump or pump unit reflect the particular characteristics of the
installation in which it is installed such as whether the pumped product can develop micro-organisms, or whether
these are reduced to non-hazardous levels by subsequent stages of the process, or the operating pattern involving
a change in the product being pumped.
For these reasons it is only possible to fully assess the hazards only by considering the whole production line. It is
the responsibility of the user to consider the hazards and to carry out any tests deemed to be necessary to
demonstrate the reduction of risks.
The manufacturer of the pump or pump unit assists in the reduction of risks by designing the pump or pump unit to
avoid undesirable features known to create risks to hygiene, and to accommodate effective cleaning. The reduction
of other non-biological hazards should be considered also during the design of the pump or pump unit.
The hazards can be generated at any time during the stages of installation, commissioning, adjustment, operation,
maintenance, or disposal, from the normal usage or from foreseeable misuse of the pump or pump unit. The risks
of hazards shall be assessed using the procedure described in EN 1050 (see Figure 1) and steps taken to reduce
the risks to an acceptable level using the safety requirements or methods, and means of verification given in this
standard and shown also in Table 1.
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Figure 1 — The iterative process to achieve safety
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Table 1 — List of Hazards related to Hygiene which are addressed in this standard
EN 13951
Reference to sub-clause
Significant hazards to Hygiene Measures to Means of
reduce the hazard verification
Hazards arising from the ingress of foreign matter Clause Clause
- wear debris.……. 5.1.1, 5.1.2.1 6.3
- sealing of openings and joints.……. 5.2.6, 5.2.11, 6.2
5.2.12, 5.3.1
- sealing around shafts.……. 5.2.9 6.2
- spillage of product.……. 5.3.1 6.2
- vermin.…. 5.3.1, 5.6 6.2
Hazards arising from microbiological causes
- retention of product.
- general. 5.2.1, 5.2.2, 5.3.1 6.4
- cleaning. 5.2.2, 5.2.3 6.4
- draining.…. 5.2.2, 5.2.3.1, 6.2
5.2.11
- surface finish/texture.…. 5.2.5 6.5
- obstructions/protrusions.…. 5.2.2, 5.2.7 6.2
- bearings.……. 5.2.8, 5.3.2 6.1, 6.2
- shaft seals.……. 5.2.9 6.2
- fasteners.………. 5.2.10, 5.3.3 6.2
- sensors.……. 5.2.12 6.1, 6.2
- lubricants.……. 5.4 6.1, 6.2
Hazards arising from chemical causes
- material compatibility 5.1 6.3
- general. 5.1.1, 5.1.2.1,5.2.9 6.3
- metals. 5.1.2.2 6.1, 6.3
- non-metals. 5.1.2.3 6.1, 6.3
- non-food areas. 5.1.3 6.3
- soldering. 5.2.6 6.2
- cleaning fluids. 5.2.3.1 6.2, 6.4
- sensors. 5.2.12 6.2
- auxiliary liquids. 5.2.8, 5.4 6.1,6.3
- barrier liquids.
5.4 6.1, 6.2
Hazards arising from mechanical causes
- material finishes. 5.1 6.2,6.5
- joints.…. 5.2.6 6.1,6.2
- fasteners.……. 5.2.10 6.1,6.2
- mis-assembly. 5.3.3 6.1,6.2
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5 Hygiene: safety requirements and/or measures
The operating conditions and features required of every pump unit falling within the scope of this standard will be
either defined by the user in a specification or by the manufacturer description which includes limits of operation.
The manufacturer shall assess any foreseeable hazards of hygiene arising from operating conditions where
specified of the pump or pump unit. The pump or pump unit shall be designed in such a way as to reduce hazards
of this standard to an acceptable level. Specifications shall classify the pumps and units, including auxiliary
equipment, according to the levels of cleanability required. It is the purchaser's responsibility to select the levels of
cleanability appropriate to the application, taking into account the risks arising from the pumped product, the
placement of the pump in the process and the cleaning regime anticipated.
Where the means of reducing the risk is by a safe system of working the machinery, the manufacturer shall include
in the information for use details of the systems of the element of training required by the operating personnel.
5.1 Materials
5.1.1 Common requirements
Materials shall be suitable for intended use.
Surfaces of materials and coatings shall be durable, cleanable, without being damaged, and be without breaks,
resistant to chipping, flaking, erosion, corrosion and abrasion, and prevent penetration of unwanted matter during
intended use.
The pump components intended to be dismantled for cleaning shall not be painted.
5.1.2 Food areas
5.1.2.1 Additional requirements
In addition to the common requirements set out in 5.1.1, materials used in the food contact area shall be
compatible with the pumped product under all foreseeable conditions of use. The compatibility shall not be
compromised by the cleaning solutions nor by any disinfection and sterilization treatments specified by the
customer.
The materials shall be non-absorbant, except where this is technically or functionally unavoidable in which
circumstance it shall not reduce the level of safety intended.
Operation at intended pressures and product velocities shall not be detrimental to the performance of the materials
nor shall temperature give rise to risks from thermal expansion or contraction nor any other thermal degradation.
The materials shall be non-toxic and not deleterious to health, and incapable of being dissolved or broken down
into elements or compounds which are. Where coatings (metallic or non-metallic) and/or adhesives are used to
meet these requirements, the bond shall be and remain continuous.
The pumped product shall remain non toxic.
Where parts within the pump are subject to wear (for example, mechanical seal rings or close-fitting, rotating rubber
components), any wear debris shall be of a size and quantity which is not deleterious to health or to the quality of
the pumped product.
If abrasive (for example, crystalline or fibrous) foodstuffs will be pumped, the possibility of abrasive wear of the
surfaces should be considered and the choice of material subject to agreement between customer and supplier.
The manufacturer shall define the safe working value of NPSHR/NPIPR to avoid damage to the material surfaces
from cavitation erosion.
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Any specific hygienic hazards which can appear because of a mis-use e.g.: dry running, poor (NPSHA) (NPIPA)
shall be clearly specified in an instruction handbook.
5.1.2.2 Metals
Product contact surfaces shall be of stainless steel of a type appropriate to the application, or of other metals
(including solder) suitable for the conditions of intended use.
NOTE 1 General experience has shown that the varieties of austenitic stainless steel complying with the following
specifications is compatible with the majority of food stuff:
C £ 0,08 %
Cr ‡ 13 %
Ni ‡ 8%
Other stainless steels such as duplex stainless steels are often used in pumps.
A typical specification for duplex stainless steel is: Cr 22 % Ni 5 %.
NOTE 2 Consideration should be given to designating stainless steels in accordance with EN10088 –1.
5.1.2.3 Plastics and elastomers
All plastic materials used shall be produced only from monomers according to EU regulation (see annex A) and
shall conform to the general requirements of this standard.
All elastomeric materials used shall conform to the general requirements of this standard and take into account the
information provided in annex A.
5.1.3 Non-food areas
In addition to the common requirements set out in 5.1.1, materials used in the non-food contact areas shall not
react chemically with the product in its pumped condition nor any cleaning solutions nor by the disinfection and
sterilization treatments specified by the customer, in such a way as to reduce the suitability of the material for its
intended use in the non-food area.
Pump components in non-food areas shall be made from corrosion resistant materials or rendered corrosion
resistant by an appropriate treatment or coating. If a coating is used it shall be well bonded and act as part of the
component to which it is bonded. The materials shall be non-absorbe
...
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