SIST EN 13249:2016

SLOVENSKI STANDARD
01-december-2016
Nadomešča:
SIST EN 13249:2014+A1:2015
Geotekstilije in geotekstilijam sorodni izdelki – Značilnosti, ki se zahtevajo pri
gradnji cest in drugih prometnih površin (izključuje železnice in asfalt (ali vgradnjo
v asfalt))
Geotextiles and geotextile-related products - Characteristics required for use in the
construction of roads and other trafficked areas (excluding railways and asphalt
inclusion)
Geotextilien und geotextilverwandte Produkte - Geforderte Eigenschaften für die
Anwendung beim Bau von Straßen und sonstigen Verkehrsflächen (mit Ausnahme von
Eisenbahnbau und Asphaltoberbau)
Géotextiles et produits apparentés - Caractéristiques requises pour l'utilisation dans la
construction de routes et autres zones de circulation (à l'exclusion des voies ferrées et
des couches de roulement)
Ta slovenski standard je istoveten z: EN 13249:2016
ICS:
59.080.70 Geotekstilije Geotextiles
93.080.20 Materiali za gradnjo cest Road construction materials
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN 13249
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2016
EUROPÄISCHE NORM
ICS 59.080.70 Supersedes EN 13249:2014+A1:2015
English Version
Geotextiles and geotextile-related products -
Characteristics required for use in the construction of
roads and other trafficked areas (excluding railways and
asphalt inclusion)
Géotextiles et produits apparentés - Caractéristiques Geotextilien und geotextilverwandte Produkte -
requises pour l'utilisation dans la construction de Geforderte Eigenschaften für die Anwendung beim Bau
routes et autres zones de circulation (à l'exclusion des von Straßen und sonstigen Verkehrsflächen (mit
voies ferrées et des couches de roulement) Ausnahme von Eisenbahnbau und Asphaltoberbau)
This European Standard was approved by CEN on 4 June 2016.

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
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 13249:2016 E
worldwide for CEN national Members.

Contents Page
European foreword . 4
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms, definitions and abbreviations . 7
3.1 Terms and definitions . 7
3.2 Abbreviations . 8
4 Required characteristics and corresponding methods of test. 8
4.1 General . 8
4.2 Selection of the appropriate standard in a specific application . 8
4.3 Characteristics relevant to specific conditions of use . 11
4.3.1 Stiffness at 2 %, 5 % and 10 % . 11
4.3.2 Tensile strength of seams and joints . 11
4.3.3 Static puncture . 11
4.3.4 Friction characteristics . 11
4.3.5 Tensile creep . 11
4.3.6 Resistance to damage during installation . 11
4.3.7 Water permeability normal to the plane . 11
4.4 Release of dangerous substances . 11
5 Assessment and verification of constancy of performance (AVCP) . 12
5.1 General . 12
5.2 Presentation of characteristics . 12
5.3 Product type determination (PTD) . 12
5.4 Factory production control (FPC) . 13
5.5 Verification of values . 13
5.6 Initial inspection of factory and of FPC . 14
5.7 Continuous surveillance of FPC . 14
6 Marking . 14
Annex A (normative) Factory production control . 15
A.1 Factory production control scheme . 15
A.1.1 General . 15
A.1.2 Product design . 15
A.1.3 Production . 15
A.1.4 Finished products . 15
A.1.5 Provisions applicable to A.1.2, A.1.3 and A.1.4 (to be used where appropriate) . 16
A.2 Assessment of a factory production control (FPC) system. 17
A.2.1 General . 17
A.2.2 Checklist . 17
A.2.3 Test frequency . 21
Annex B (normative) Durability aspects . 22
B.1 General . 22
B.1.1 Service life . 22
B.1.2 Initial and repeat testing of durability. 22
B.1.3 Use of rework material . 23
B.2 Weathering (all products) . 23
B.3 Products used in non-reinforcing applications and with service lives up to 5 years . 23
B.4 Other applications and service lives up to 25 years, 50 years and 100 years . 24
B.4.1 General . 24
B.4.2 Tests for specific materials . 24
Annex C (informative) Guidelines for the selection of the appropriate standard in a specific
application . 28
Annex D (informative) Significant technical changes to superseded versions of this standard . 30
Annex ZA (informative) Clauses of this European Standard addressing the provisions of the
EU Construction Products Regulation . 31
ZA.1 Scope and relevant characteristics . 31
ZA.2 Procedure for AVCP of Geotextiles and geotextiles-related products for the use in the
construction of roads and other trafficked areas . 36
ZA.2.1 Systems of AVCP . 36
ZA.2.2 Declaration of performance (DoP) . 39
ZA.3 CE marking and labelling . 44
Bibliography . 45

European foreword
This document (EN 13249:2016) has been prepared by Technical Committee CEN/TC 189
“Geosynthetics”, the secretariat of which is held by NBN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by April 2017, and conflicting national standards shall be
withdrawn at the latest by July 2018.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 13249:2014+A1:2015.
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 Regulation No 305/2011.
For relationship with Regulation (EU) Nr. 305/2011, see informative Annex ZA, which is an integral
part of this document.
Annex D provides details of significant technical changes between this European Standard and the
previous edition.
According to the CEN-CENELEC Internal Regulations, the national standards organisations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, 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 the United Kingdom.
Introduction
This European Standard allows manufacturers to describe geotextiles and geotextile-related products
on the basis of declared values for characteristics relevant to the intended use and if tested to the
specified method. It also includes procedures for the assessment and verification of constancy of
performance and factory production control.
This European Standard may also be used by designers, end-users and other interested parties to define
which functions and conditions of use are relevant.
The term “product” used in this European Standard refers to a geotextile or geotextile-related product.
This European Standard is part of a series of standards, addressing the requirements for geotextiles and
geotextile-related products when used in a specific application. Annex C provides guidance on how to
select the appropriate standard.
1 Scope
This European Standard specifies the relevant characteristics of geotextiles and geotextile-related
products used in the construction of roads and other trafficked areas (excluding railways and asphaltic
inclusion), and the appropriate test methods to determine these characteristics.
The intended use of these geotextiles or geotextile-related products is to fulfil one or more of the
following functions: filtration, separation and reinforcement. The separation function will always occur
in conjunction with filtration or reinforcement, and hence will not be specified alone.
This European Standard is not applicable to geosynthetic barriers, as defined in EN ISO 10318-1.
This European Standard provides for the assessment and verification of constancy of performance of
the product to this European Standard and for factory production control procedures.
Particular application cases may contain requirements regarding additional properties and – preferably
standardized – test methods, if they are technically relevant.
This European Standard may be used to derive design values by taking into account factors within the
context of the definitions given in EN 1997-1 (Eurocode 7), e.g. factors of safety. The design life of the
product should be determined, since its function may be temporary, as a construction expediency, or
permanent, for the lifetime of the structure.
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 12224, Geotextiles and geotextile-related products - Determination of the resistance to weathering
EN 12226, Geosynthetics - General tests for evaluation following durability testing
EN 12447, Geotextiles and geotextile-related products - Screening test method for determining the
resistance to hydrolysis in water
EN ISO 1043-1, Plastics - Symbols and abbreviated terms - Part 1: Basic polymers and their special
characteristics (ISO 1043-1)
EN ISO 3696, Water for analytical laboratory use - Specification and test methods (ISO 3696)
EN ISO 9862, Geosynthetics - Sampling and preparation of test specimens (ISO 9862)
EN ISO 10318-1, Geosynthetics - Part 1: Terms and definitions (ISO 10318-1)
EN ISO 10319, Geosynthetics - Wide-width tensile test (ISO 10319)
EN ISO 10320, Geotextiles and geotextile-related products - Identification on site (ISO 10320)
EN ISO 10321, Geosynthetics - Tensile test for joints/seams by wide-width strip method (ISO 10321)
EN ISO 10722, Geosynthetics - Index test procedure for the evaluation of mechanical damage under
repeated loading - Damage caused by granular material (ISO 10722)
EN ISO 11058, Geotextiles and geotextile-related products - Determination of water permeability
characteristics normal to the plane, without load (ISO 11058)
EN ISO 12236, Geosynthetics - Static puncture test (CBR test) (ISO 12236)
EN ISO 12956, Geotextiles and geotextile-related products - Determination of the characteristic opening
size (ISO 12956)
EN ISO 12957-1, Geosynthetics - Determination of friction characteristics - Part 1: Direct shear test (ISO
12957-1)
EN ISO 12957-2, Geosynthetics - Determination of friction characteristics - Part 2: Inclined plane test (ISO
12957-2)
EN ISO 13426-1, Geotextiles and geotextile-related products - Strength of internal structural junctions -
Part 1: Geocells (ISO 13426-1)
EN ISO 13426-2, Geotextiles and geotextile-related products - Strength of internal structural junctions -
Part 2: Geocomposites (ISO 13426-2)
EN ISO 13431, Geotextiles and geotextile-related products - Determination of tensile creep and creep
rupture behaviour (ISO 13431)
EN ISO 13433, Geosynthetics - Dynamic perforation test (cone drop test) (ISO 13433)
EN ISO 13438, Geotextiles and geotextile-related products - Screening test method for determining the
resistance to oxidation (ISO 13438)
ISO 10390, Soil quality — Determination of pH
ASTM D7409 — 15, Standard Test Method for Carboxyl End Group Content of Polyethylene Terephthalate
(PET) Yarns
ASTM D4603 — 03(2011) e1, Standard Test Method for Determining Inherent Viscosity of Poly(Ethylene
Terephthalate) (PET) by Glass Capillary Viscometer
3 Terms, definitions and abbreviations
3.1 Terms and definitions
For the purposes of this document, the terms and definitions given in EN ISO 10318-1 and the following
apply.
3.1.1
product
geotextile or geotextile-related product
3.1.2
specification
document in which the work, functions and specific conditions of use of the product are described
3.1.3
rework material
RWM
material that is generated in a process and capable of being reclaimed within the same process that
generated it
3.1.4
post-consumer material
PCM
material generated by households or by commercial, industrial and institutional facilities in their role as
end-users of the product which can no longer be used for its intended purpose
Note 1 to entry: This includes returns of material from the distribution chain.
3.1.5
post-industrial material
PIM
material diverted from the waste stream during a manufacturing process
3.2 Abbreviations
For the purposes of this document, the abbreviations given in EN ISO 1043-1 and EN ISO 10318-1 and
the following apply.
— AR: aramid
— GCO-R: geocomposite reinforcement
4 Required characteristics and corresponding methods of test
4.1 General
The main functions of geotextiles and geotextile-related products used in the construction of roads and
other trafficked areas are filtration, separation and reinforcement.
If a drainage or erosion control system is integrated in the construction, the requirements of the
appropriate standards shall also be fulfilled. As the separation function is always used in conjunction
with another function, the separation function shall never be specified alone.
The specification shall define which functions and conditions of use are relevant (see Table 1). The
producer shall provide the necessary data based on the requirements and test methods specified in this
European Standard, as described in 5.1.
The characteristics, their relevance to the conditions of use, and the test methods to be used, are
specified in Table 1. The list of characteristics in Table 1 includes characteristics relevant to all
conditions of use (A), and characteristics relevant to specific conditions of use (S). The indication “–”
means that the characteristic is not relevant for that function.
Where, for the same property, data for more than one function shall be provided, the following ranking
order shall be observed: A overrules S, and S overrules “–”.
The functions and conditions of use, corresponding with the S-coded characteristics in Table 1, are
specified in 4.3.
Durability shall be assessed in accordance with the requirements of Annex B.
4.2 Selection of the appropriate standard in a specific application
Guidelines for the selection of the appropriate standard in a specific application are given in Annex C.
Table 1 — Geotextiles and geotextile-related products used in the construction of roads and other trafficked areas – Functions,
function-related characteristics and test methods to be used
Functions
Characteristic Test method
Reinforcemen
Filtration Separation
t
b
(1) Tensile strength EN ISO 10319 A A A
(2) Elongation at maximum load EN ISO 10319 A A A
(3) Stiffness at 2 %, 5 % and 10 % EN ISO 10319 – – S
c d
(4) Tensile strength of seams and joints EN ISO 10321 S S S

a b
(5) Static puncture resistance (CBR test) EN ISO 12236 S A A
a
(6) Dynamic perforation resistance (cone drop test) EN ISO 13433 A A A
EN ISO 12957-1;
(7) Friction S S S
EN ISO 12957-2
(8) Tensile creep EN ISO 13431 – – S
(9) Resistance to damage during installation under repeated loading EN ISO 10722 S S S
(10) Characteristic opening size EN ISO 12956 A A –
(11) Water permeability normal to the plane (velocity index) EN ISO 11058 A A S
According to
(12) Durability A A A
Annex B
Relevance of codes:
A: relevant to all conditions of use
S: relevant to specific conditions of use
“–”: not relevant for that function.
Functions
Characteristic Test method
Reinforcemen
Filtration Separation
t
a
Static puncture resistance may not be relevant for some types of products, e.g. GGR, GCO-R or GST.
b
If the mechanical properties (tensile strength and static puncture) are coded “A” in this Table, the use of only one, either tensile strength or static puncture,
is usually sufficient in a project specification.
c
The strength of internal structural junctions of geocells shall be tested in accordance with EN ISO 13426-1.
d
The strength of internal structural junctions of geocomposites shall be tested in accordance with EN ISO 13426-2.
4.3 Characteristics relevant to specific conditions of use
4.3.1 Stiffness at 2 %, 5 % and 10 %
Data on stiffness are necessary for the reinforcement function if the deformation of the structure needs
to be evaluated.
4.3.2 Tensile strength of seams and joints
Data on tensile strength of seams and joints are necessary for all functions if the product is to be
mechanically jointed and if load is transferred across the seams and joints.
4.3.3 Static puncture
Data on static puncture or - as an alternative - on tensile strength, are necessary for the filtration
function if required by the specification, i.e. when the site loading conditions are such that there is a
potential risk of static puncture of the filter layer.
4.3.4 Friction characteristics
Data on friction characteristics are necessary for the functions separation and filtration when the
product is used in a situation where a differential movement can take place between the product and
adjacent material that may endanger the stability of the works. The friction characteristics can be
measured, using site specific materials, by a direct shear test according to EN ISO 12957-1 or, in the
case of loads up to 5 kPa, by an inclined plane test according to EN ISO 12957-2.
Friction behaviour with the adjacent construction materials, e.g. the soil or the geosynthetic barrier,
should also be considered.
4.3.5 Tensile creep
Data on tensile creep can be used to give an indication of the resistance to sustained loading, when the
product fulfils a reinforcement function.
4.3.6 Resistance to damage during installation
EN ISO 10722 can be used as an index test giving the relative performance of the product. Testing with
site specific soil and conditions may give more relevant results for specific design.
4.3.7 Water permeability normal to the plane
Data on water permeability are necessary when the reinforced structure is subject to water flow.
4.4 Release of dangerous substances
National regulations on dangerous substances may require verification and declaration on release, and
sometimes content, when construction products covered by this European Standard are placed on those
markets.
In the absence of European harmonized test methods, verification and declaration on release/content
should be done taking into account national provisions in the place of use.
NOTE An informative database covering European and national provisions on dangerous substances is
available at: http://ec.europa.eu/growth/tools-databases/cp-ds/index_en.htm.
5 Assessment and verification of constancy of performance (AVCP)
5.1 General
The compliance of geotextiles and geotextile-related products with the requirements of this European
Standard and with the declared values shall be demonstrated by:
— Product type determination (PTD);
— Factory production control (FPC) by the manufacturer, including product assessment.
The manufacturer shall always retain the overall control and shall have the necessary means to take
responsibility for the product.
5.2 Presentation of characteristics
The characteristics specified in Table 2, except for durability, shall be expressed as mean values and
tolerance value(s) corresponding to the 95 % confidence level. The values expressed may be verified
using the procedure referred to in 5.5.
NOTE The 95 % confidence level corresponds to the mean value minus (and/or plus) a tolerance value (see
Annex ZA, table ZA1.X column Notes). Both the mean value and the tolerance value are defined by the
manufacturer to be representative of the performance of the product for the corresponding characteristic (these
two values are not necessarily based on a statistical calculation).
Information on durability shall be expressed in accordance with Annex B.
5.3 Product type determination (PTD)
PTD tests shall be carried out by the manufacturer to define the values of the properties to be declared
for the product to satisfy the requirements of this European Standard.
PTD tests shall also be carried out on existing products when a change in the basic materials or
manufacturing procedures affects the declared properties or the use of a product. In these cases, the
PTD tests are those for the properties which are affected or shall be confirmed and new properties
introduced by a change of use.
The tests to be conducted shall be reference tests as specified in this standard and shall be selected
from the characteristics specified in Table 2, consistent with the product’s intended use:
Table 2 — Characteristics required for PTD and AVCP
Characteristic Functions
Tensile strength Filtration, separation, reinforcement
Elongation at maximum load Filtration, separation, reinforcement
Static puncture resistance (CBR test) Separation, reinforcement
Dynamic perforation resistance (cone drop
Separation, filtration, reinforcement
test)
Characteristic opening size Filtration, separation
Water permeability normal to the plane Filtration, separation
a
Durability Filtration, separation, reinforcement
a
For the durability aspects, see Table 1 and Annex B.
The results of PTD tests shall be recorded and be available for inspection.
The sample for the PTD tests shall be drawn according to EN ISO 9862 from a normal production run
using the same materials and forming processes as used for the full production process. The size of the
sample shall be big enough to allow the determination of the characteristics specified in Table 2.
Handmade samples, short trial batches and other development prototypes may be tested by the same
methods, but shall not be used for establishing characteristic values in PTD tests.
5.4 Factory production control (FPC)
A FPC scheme shall be established and documented in a manual prior to a product type being placed on
the market. Subsequently, any fundamental changes in raw materials and additives, manufacturing
procedures or the control scheme that affect the properties or use of a product shall be recorded in the
manual.
The manual shall include the FPC procedures relevant to the declared properties, as confirmed by the
product type determination.
The FPC procedures shall consist of a permanent internal production control system to ensure that such
products comply with this European Standard and that the measured values conform to the declared
values.
Annex A (normative) lists all the items that shall be considered to determine the appropriate control
measures for a product. The manufacturer shall establish control measures for the relevant items and
record them in his FPC manual. These measures shall be described in detail, include the type of tests to
be performed and the frequency of these tests (see also A.2).
When relevant, the procedure given in A.2.3 shall be used to check the conformity of the product for one
or more characteristics.
5.5 Verification of values
If verification of values is required, the compliance of characteristics with the values defined in 5.2 shall
be based on measurements made on two representative samples (A and B), taken from two different
rolls. Sampling shall be made in accordance with EN ISO 9862.
For on-site quality control purposes CEN/TR 15019 may also be considered.
The characteristics given in Table 2 shall be measured in accordance with the corresponding European
standards on specimens prepared from sample A.
If the test result(s) for a particular characteristic is (are) within the tolerance value(s) given by the
manufacturer, the product is accepted as complying with respect to this characteristic.
If the test result(s) for a particular characteristic is (are) outside 1,5 times the tolerance value(s), the
product does not comply with respect to that characteristic. If the test result(s) for a particular
characteristic is (are) within 1 and 1,5 times the tolerance value(s), specimens prepared from sample B
shall be tested.
If the test result(s) of the sample B specimens for the same characteristic is (are) within the given
tolerance value(s), the product is accepted as complying with respect to that characteristic. If the test
result(s) is (are) outside the tolerance value(s), the product is not accepted.
5.6 Initial inspection of factory and of FPC
Initial inspection of the factory and of FPC shall be carried out when the production process has been
finalized and in operation. The factory and FPC documentation shall be assessed to verify that the
requirements of 5.4 and Annex A are fulfilled.
During the inspection, it shall be verified that:
a) all resources necessary for the achievement of the product characteristics included in this
European Standard are in place and correctly implemented, and
b) the FPC-procedures in accordance with the FPC documentation are followed in practice, and
c) the product complies with the product type samples, for which compliance of the product
performance to the DoP has been verified.
All locations where final assembly or at least final testing of the relevant product is performed shall be
assessed to verify that the above conditions a) to c) are in place and implemented.
If the FPC system covers more than one product, production line or production process, and it is
verified that the general requirements are fulfilled when assessing one product, production line or
production process, then the assessment of the general requirements does not need to be repeated
when assessing the FPC for another product, production line or production process.
All assessments and their results shall be documented in the initial inspection report.
The single steps of this inspection are specified in A.2.
5.7 Continuous surveillance of FPC
Surveillance of the FPC shall be undertaken at least once per year. The surveillance of the FPC shall
include a review of the FPC test plan(s) and production processes(s) for each product to determine if
any changes have been made since the last assessment or surveillance. The significance of any changes
shall be assessed.
Checks shall be made to ensure that the test plans are still correctly implemented and that the
production equipment is still correctly maintained and calibrated at appropriate time intervals.
The records of tests and measurement made during the production process and to finished products
shall be reviewed to ensure that the values obtained still correspond with those values for the samples
submitted to the determination of the product type and that the corrective actions have been taken for
non-compliant products.
6 Marking
The manufacturer shall clearly and indelibly mark the product with the information specified in
EN ISO 10320.
NOTE For CE-marking see ZA.3.
Annex A
(normative)
Factory production control
A.1 Factory production control scheme
A.1.1 General
The items to be addressed in the factory production control manual relating to the system of control,
determined from 5.4, are given in A.1.
The single steps of factory production control are addressed in the check-list (A.2).
NOTE Manufacturers operating an FPC system, which complies with EN ISO 9001 and which addresses the
provisions of this European Standard, are considered to be able to satisfy the FPC requirements of this European
standard.
A.1.2 Product design
The manufacturer shall describe how product design requirements and criteria are identified, checked,
controlled and updated to be unambiguous and relevant to the use of the product and its specification.
The manufacturer shall describe the communication of the product design to the internal production
departments or to external subcontractors.
A.1.3 Production
A.1.3.1 Raw or incoming materials
The manufacturer shall define the acceptance criteria of raw or incoming materials and the procedures
that he operates to ensure that these are met.
The manufacturer shall document by analyses and/or certificates from his suppliers that all raw or
incoming materials meet the declared performance, including durability performance.
A.1.3.2 Production process
The relevant features of the plant and production process shall be defined giving the frequency of the
inspections, checks and tests, together with the values or criteria required on equipment and on work in
process. The actions to be taken when control values or criteria are not obtained shall be recorded.
These records shall be available for inspection.
A.1.4 Finished products
A.1.4.1 Tests on the finished product
The size of the samples and the frequency of sampling, together with the results obtained, shall be
recorded. These records shall be available for inspection.
A.1.4.2 Alternative tests
Where alternative tests to the reference tests are used, details of the alternative tests and procedures
together with their correlation with the reference tests shall be recorded and shall be made available
for inspection.
A.1.4.3 Equipment
Test equipment having an influence on test results shall be calibrated to traceable national or
international standards.
The manufacturer shall have or have available the installations, equipment and personnel which enable
him to carry out the necessary verifications and tests. He may meet this requirement by concluding a
subcontracting agreement with one or more organizations or persons having the necessary skills and
equipment.
The manufacturer shall calibrate or verify measuring or test equipment and maintain it in good
operating condition, whether or not it belongs to him.
The appropriate calibrations shall be carried out with defined measuring and test instruments
according to standards or manufacturer’s test procedures.
The equipment shall be used in conformity with the specification or the test reference system to which
the specification refers.
A.1.5 Provisions applicable to A.1.2, A.1.3 and A.1.4 (to be used where appropriate)
A.1.5.1 Records
The dates, together with details and results of inspections, checks and tests carried out during the
factory production control shall be properly recorded. These records shall be maintained for 10 years.
The product description, the date of manufacture, test method adopted, test results and acceptance or
rejection criteria shall be entered under the signature of the person responsible for control who carried
out the verification.
A.1.5.2 Assessment of results
Where possible and applicable, the results of inspections, checks and tests shall be interpreted
statistically by attributes or by variables to determine whether the corresponding production conforms
to the requirements and the declared values for the products.
A.1.5.3 Traceability
Systems of traceability and control of designs, incoming materials, and the use of materials shall be
given in the manual. The stock control system of manufactured products shall be given in the manual.
A.1.5.4 Corrective action for non-conforming materials and products
The immediate actions to be taken when incoming materials or finished products do not conform to the
requirements of this European Standard shall be described and recorded. These actions shall include
the steps necessary to rectify the deficiency, modify the manual if required, identify and isolate the
deficient raw or incoming materials and finished products and determine whether they shall be
discarded or re-specified.
A.1.5.5 Personnel
The manufacturer shall ensure that the personnel involved in the process are suitably trained. The job
description and responsibility of the operatives shall be given in the manual.
A.1.5.6 Quality management
The activities to ensure that all of the above requirements operate shall be described in the manual.
A.2 Assessment of a factory production control (FPC) system
A.2.1 General
A factory production control system is only applicable to one production site. In case of several
production lines at the same site, all of them shall be checked.
The FPC shall cover specified products produced on the same production site. Each product covered by
the FPC shall be clearly identified. To add a new product to the covered range, the producer shall submit
the results of the PTD of the new product for an extension of the FPC system. This shall be taken into
account at the next follow-up inspection. In case of a new production process the manufacturer shall
apply for a new inspection visit.
Follow-up inspections shall take place not less than once a year for each production line at each
production site.
All the questions in this checklist shall be checked at the first inspection visit and at each follow-up
inspection
A.2.2 Checklist
An example of a FPC checklist is given in Table A.1.
The items marked with “E” are considered to be of essential importance, i.e. immediate corrective
actions are needed if the requirement is not fulfilled.
The assessment can lead to A-, B- or C-type remarks:
— A: an immediate corrective action is needed;
— B: corrective action shall be taken within 3 months;
— C: corrective action shall be taken before the next inspection visit.
If a B-type remark is not corrected in due time, it becomes an A-type remark and if a C-type remark is
not corrected in due time, it becomes a B-type remark.
Table A.1 — Checklist for FPC
Question Relevance Comment
1 Design
1.1 – Has the manufacturer a description how To be assessed Refer to the manufacturer's
design requirements and criteria are identified, only if claimed by documentation.
checked, controlled and updated to be the
unambiguous and relevant to the use of the product manufacturer
and its specification?
1.2 – Has the manufacturer a description of the To be assessed Refer to the manufacturer's
communication of the design to the internal only if claimed by documentation.
production departments or to external the
subcontractors? manufacturer.
2 Product identification and traceability
2.1 – What are the means used for the unique E Refer to the manufacturer's
identification of any individual finished product? documentation.
Question Relevance Comment
2.2 – Is it possible to identify and check date, place E Refer to the manufacturer's
and general manufacturing conditions (including documentation.
raw material used) through the identifications on
the final product?
2.3 – Does the marking on the final product comply E
with EN ISO 10320?
3 Production process control
3.1 – Are there documents which define the E Refer to the manufacturer's
production process parameters which could affect documentation.
quality?
3.2 – Are the standards and procedures E
implemented?
3.3 – Are the specified requirements concerning E Refer to the manufacturer's
process validation, including the associated documentation.
personnel and equipment, documented?
4 Inspection and testing on receipt of raw materials
4.1 – Are there specification sheets concerning E Refer to the manufacturer's
incoming raw materials? documentation.
4.2 – Are there documents which define what shall E Refer to the manufacturer's
be done in case of non-conformance of raw documentation.
materials?
4.3 – A
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