Concrete paving blocks - Requirements and test methods

This European Standard specifies materials, properties, requirements and test methods for unreinforced cement bound concrete paving blocks and complementary fittings. It is applicable to precast concrete paving blocks and complementary fittings for pedestrian use, vehicular use and roof coverings, e.g. footpaths, precincts, cycle tracks, car parks, roads, highways, industrial areas (including docks and harbours), aircraft pavements, bus stations, petrol filling stations.
This standard does not deal with the tactility or visibility of blocks
Blocks with side features to provide wider joints for permeable pavements are included.
Permable blocks with large holes or voids or with an interconnected pore structure to allow water to pass through the block to provide a porous pavement are not included.  
In case of regular use of studded tyres additional requirements are sometimes needed.
This standard provides for the product marking and the evaluation of conformity of the product to this European Standard.

Pflastersteine aus Beton - Anforderungen und Prüfverfahren

Diese Europäische Norm beschreibt Materialien, Eigenschaften, Anforderungen und Prüfverfahren für unbewehrte Pflastersteine und Ergänzungssteine aus zementgebundenem Beton. Sie gilt für vorgefertigte Pflastersteine und Ergänzungssteine aus Beton im Fußgänger- und Verkehrsbereich und auf Dächern, z. B. Fußwege, Fußgängerzonen, Radwege, Parkplätze, Straßen, Autobahnen, Industriebereiche (einschließlich Docks und Häfen), Flugzeugrollbahnen, Busbahnhöfe und Tankstellen.
Diese Norm befasst sich nicht mit der Tastbarkeit und der visuellen Wahrnehmbarkeit von Pflastersteinen.
Es sind Pflastersteine für den Einsatz bei wasserdurchlässigen Pflastern einbezogen, die seitliche Verbund- oder Verlegemerkmale zur Bildung weiterer Fugen aufweisen.
Wasserdurchlässige Pflastersteine mit großen Hohlräumen oder einer vernetzten Porenstruktur zur Schaffung eines porösen Pflasters, das Wasserdurchlässigkeit ermöglicht, sind nicht einbezogen.
Bei regelmäßiger Verwendung von Spikereifen sind manchmal zusätzliche Anforderungen notwendig.
Diese Norm regelt die Produktkennzeichnung und die Beurteilung der Übereinstimmung des Produkts mit dieser Europäischen Norm.

Pavés en béton - Prescriptions et méthodes d'essai

La présente Norme européenne spécifie les matériaux, les propriétés, les prescriptions et les méthodes
d'essai relatifs aux pavés en béton à liant ciment non armé et à leurs pièces complémentaires. Elle s'applique
aux pavés préfabriqués en béton et à leurs pièces complémentaires à l'usage des piétons et des véhicules
ainsi que des toitures, par exemple pour chemins piétonniers, zones piétonnes, pistes cyclables, parkings,
routes, autoroutes, aires industrielles (y compris docks et ports), pavages d'aéroports, arrêts de bus, stations
services.
La présente norme ne traite pas de la perception visuelle ou tactile des pavés.
Les pavés avec des caractéristiques latérales qui assurent des joints plus larges pour des pavages
perméables sont inclus.
Les pavés perméables avec de larges trous ou vides, ou dotés d’une structure de pores interconnectés
permettant à l’eau de traverser le pavé pour fournir une chaussée poreuse, ne sont pas inclus.
En cas d'utilisation régulière de pneus cloutés, des prescriptions supplémentaires sont parfois nécessaires.
La présente norme définit le marquage du produit et l'évaluation de sa conformité à la présente Norme
européenne.

Betonski tlakovci - Zahteve in preskusne metode

General Information

Status
Not Published
Public Enquiry End Date
30-Oct-2010
Current Stage
98 - Abandoned project (Adopted Project)
Start Date
07-Oct-2013
Due Date
12-Oct-2013
Completion Date
07-Oct-2013

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SLOVENSKI STANDARD
oSIST prEN 1338:2010
01-oktober-2010
Betonski tlakovci - Zahteve in preskusne metode
Concrete paving blocks - Requirements and test methods
Pflastersteine aus Beton - Anforderungen und Prüfverfahren
Pavés en béton - Prescriptions et méthodes d'essai
Ta slovenski standard je istoveten z: prEN 1338
ICS:
91.100.30 Beton in betonski izdelki Concrete and concrete
products
93.080.20 Materiali za gradnjo cest Road construction materials
oSIST prEN 1338:2010 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN 1338:2010

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oSIST prEN 1338:2010


EUROPEAN STANDARD
DRAFT
prEN 1338
NORME EUROPÉENNE

EUROPÄISCHE NORM

July 2010
ICS 93.080.20 Will supersede EN 1338:2003
English Version
Concrete paving blocks - Requirements and test methods
Pavés en béton - Prescriptions et méthodes d'essai Pflastersteine aus Beton - Anforderungen und
Prüfverfahren
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee CEN/TC 178.

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 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland 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

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2010 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 1338:2010: E
worldwide for CEN national Members.

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oSIST prEN 1338:2010
prEN 1338:2010 (E)
Contents Page
Foreword . 3
1 Scope . 3
2 Normative references . 3
3 Terms and definitions . 4
4 Requirements for materials . 6
5 Requirements for products. 7
6 Evaluation of conformity criteria . 12
7 Marking. 17
8 Test report . 17
Annex A (informative)  Inspection schemes . 19
Annex B (normative)  Procedure for acceptance testing of a consignment at delivery . 23
Annex C (normative)  Measurement of the dimensions of a single block . 25
Annex D (normative)  Determination of freeze/thaw resistance with de-icing salt . 29
Annex E (normative)  Determination of total water absorption. 35
Annex F (normative)  Measurement of strength . 37
Annex G (normative)  Measurement of abrasion resistance . 41
Annex H (normative)  Measuring of abrasion according to the Böhme test . 48
Annex I (normative)  Method for the determination of unpolished slip resistance value (USRV) . 52
Annex J (normative)  Verification of visual aspects . 59
Annex K (informative)  Example of the application of the method for checking conformity of
tensile splitting strength by variables (6.3.8.3.B) . 60
Annex ZA (informative)  Clauses of this European Standard addressing the provisions of the
EU Construction Products Directive (89/106/EEC) . 63

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Foreword
This document (prEN 1338:2010) has been prepared by Technical Committee CEN/TC 178 “Paving units
and kerbs”, the secretariat of which is held by BSI.
This document is currently submitted to the CEN Enquiry.
This document will supersede EN 1338:2003.
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.

1 Scope
This European Standard specifies materials, properties, requirements and test methods for unreinforced
cement bound concrete paving blocks and complementary fittings. It is applicable to precast concrete paving
blocks and complementary fittings for pedestrian use, vehicular use and roof coverings, e.g. footpaths,
precincts, cycle tracks, car parks, roads, highways, industrial areas (including docks and harbours), aircraft
pavements, bus stations, petrol filling stations.
This standard does not deal with the tactility or visibility of blocks
Blocks with side features to provide wider joints for permeable pavements are included.
Permable blocks with large holes or voids or with an interconnected pore structure to allow water to pass
through the block to provide a porous pavement are not included.
In case of regular use of studded tyres additional requirements are sometimes needed.
This standard provides for the product marking and the evaluation of conformity of the product to this
European Standard.
2 Normative references
This European Standard incorporates by dated and undated references, 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 10083-2, Quenched and tempered steels — Part 2: Technical delivery conditions for unalloyed quality
steels.
EN 13369, Common rules for precast concrete products.
EN ISO 4288, Geometric product specification (GPS) - Surface texture: Profile method - Rules and
procedures for the assessment of surface texture (ISO 4288:1996).
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EN ISO 6506-1, Metallic materials - Brinell hardness test - Part 1: Test method (ISO 6506-1:1999).
EN ISO 6506-2, Metallic materials - Brinell hardness test - Part 2: Verification and calibration of testing
machines (ISO 6506-2:1999).
EN ISO 6506-3, Metallic materials - Brinell hardness test - Part 3: Calibration of reference blocks
(ISO 6506-3:1999).
ISO 48, Rubber, vulcanized or thermoplastic — Determination of hardness (hardness between 10 IRHD and
100 IRHD).
ISO 4662, Rubber — Determination of rebound resilience of vulcanizates.
ISO 7619, Rubber — Determination of indentation hardness by means of pocket hardness meters.
ISO 7873, Control charts for arithmetic average with warning limits.
ISO 7966, Acceptance control charts.
ISO 8486-1, Bond abrasives — Determination and designation of grain size distribution — Macrogrits F4 to
F220.
3 Terms and definitions
For the purposes of this European Standard, the following terms and definitions apply.
3.1
arris
part of a block where two faces meet. It can be bevelled, rounded, chamfered, radiussed or splayed
3.2
concrete paving block
precast concrete unit used as a surfacing material that satisfies the following conditions:
 at a distance of 50 mm from any edge, any cross-section does not show a horizontal dimension less
than 50 mm;
 its overall length divided by its thickness is less than or equal to four.
NOTE These two conditions are not applicable to complementary fittings.
3.3
complementary fitting
unit, sometimes a part of a block, which is used to infill and enable an area to be completely surfaced
3.4
Permeable paving block
block complying with this standard with side features to provide wider joints for use in permeable pavements
3.5
overall length
longer side of the rectangle with the smallest area able to enclose the block excluding any spacer nibs
3.6
overall width
shorter side of the rectangle with the smallest area able to enclose the block excluding any spacer nibs
4

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3.7
thickness
distance between the upper face and the bed face of the block
3.8
spacer nibs
small protruding profiles on a side face of a block
3.9
upper face
surface intended to be seen when in use
3.10
bed face
surface generally parallel to the upper face and in contact with the bedding after laying
3.11
facing layer
layer of concrete on the upper face of a block of different material and/or properties to the main body or
backing layer
NOTE To be distinguished from wipe, being a fine cement mortar or slurry applied to the surface of the block.
3.12
draw
intended angle of the side face from the vertical plane over the full height of a block as shown in Figure 1
1
1
2
α


Key
1  Chamfer 2  Thickness
α  Draw
Figure 1 — Example of chamfer and draw

3.13
chamfer
bevelled arris, as shown in Figure 1
5

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3.14
work dimension
any dimension of a block specified for its manufacture to which the actual dimension should conform within
specified permissible deviations
3.15
secondary processing
manufacturing process to texture the whole block or any surface, carried out after basic manufacture before
or after hardening
3.16
actual dimension
dimension of a block as measured
3.17
chased side face
side face of a concrete paving block, having a recessed profile
3.18
skid resistance
ability to resist relative movement between a vehicle tyre and the trafficked concrete paving block surface
3.19
slip resistance
ability to resist relative movement between a pedestrian foot and the trafficked concrete paving block surface
3.20
format
work dimensions of a block, specified in order of overall length, overall width and thickness
3.21
wipe
fine cement mortar or slurry applied to the surface of the units prior to curing
3.22
permeable block
block intended by its structure to allow the passage of water through the block. A permeable block may have
large voids intended to be filled with a drainage material of small interconnecting voids that allow water to
pass through.
4 Requirements for materials
4.1 General
Only materials with suitability established in terms of their properties and performance shall be used in the
manufacture of concrete paving blocks.
The suitability requirements of the materials used shall be given in the manufacturer’s production control
documentation.
Where, by conformity with relevant specifications, the properties and performance of materials have been
demonstrated, further testing need not be performed.
A reference scheme for materials inspection is given in annex A.
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4.2 Asbestos
Asbestos, or materials containing asbestos, shall not be used.
5 Requirements for products
5.1 General
The performance requirements of concrete paving blocks are defined by classes which have associated
marking designations.
Blocks may be produced with a single concrete throughout or with different facing and backing layers.
When blocks are produced with a facing layer this shall have a minimum thickness of 4 mm over the area
declared by the manufacturer, when measured in accordance with Annex C. Isolated particles of aggregate
protruding into the facing layer shall be ignored. The facing layer shall be an integral part of the block.
A wipe shall only be carried out on a unit prior to curing, the constituents used shall be the same as in the
body of the block.
An arris described as square may be bevelled or rounded, its horizontal or vertical dimensions shall not
exceed 2,0 mm.
An arris with horizontal or vertical dimensions exceeding 2,0 mm shall be described as chamfered. Its
dimensions and tolerances shall be declared by the manufacturer.
Blocks may be produced with functional and/or decorative profiles, which shall not be included in the work
dimensions of a block.
The surface of blocks may be textured, secondary processed or treated chemically; these finishes or
treatments shall be described and declared by the manufacturer.
5.2 Shape and dimensions
5.2.1 General
All references to dimensions in this sub clause are to work dimensions.
The conformity criteria corresponding to each requirement taken separately are given in 6.3.8.1. The
dimensions and deviations shall be measured according to annex C.
5.2.2 Work dimensions
The work dimensions shall be stated by the manufacturer.
5.2.3 Spacer nibs, draw or chased and profiled side faces
Blocks may be produced with spacer nibs, a draw or chased and profiled side faces. When these are
provided, the manufacturer shall declare their work dimensions. They are not included in the stated length or
width of a block.
NOTE The size of the space allocated to the block should include an allowance for joints and deviations.
5.2.4 Permissible deviations
The permissible deviations on the manufacturers declared work dimensions are given in Tables 1, 2 and 3.
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Table 1 — Permissible deviations
Block thickness Length Width Thickness
mm mm mm mm
< 100 ± 2.0 ± 2.0 ± 3.0
≥ 100 ± 3.0 ± 3.0 ± 4.0
The difference between any two measurements of the thickness of a single block shall
be ≤ 3.0 mm.

For non-rectangular blocks the deviations of the other dimensions shall be declared by the manufacturer.
When the length of the diagonals exceeds 300 mm, the maximum permissible differences between the
measurement of the two diagonals of a rectangular block are given in Table 2.
Table 2 — Maximum differences
Class Marking Maximum difference
 mm
1 J 5.0
2 K 3.0
3 L 2.0

When the maximum dimension of a block exceeds 300 mm, the deviations for flatness and bow given in
Table 3 shall apply to an upper face intended to be plane. When the upper face is not intended to be plane,
the manufacturer shall supply the information on deviations.

Table 3 — Deviations of flatness and bow
Length of gauge Maximum convex Maximum concave
mm mm mm
300 1,5 1,0
400 2,0 1,5

NOTE For special fields of application such as airports, other deviations can be required.
5.3 Physical and mechanical properties
5.3.1 General
The blocks shall conform to the following requirements at the time they are declared suitable for use by the
manufacturer.
When complementary fittings cannot be tested according to this standard, they are considered to conform to
this standard, provided they have at least the same concrete quality and manufacturing process as blocks
complying with this standard.
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5.3.2 Weathering resistance
5.3.2.1 Test method
The weathering resistance is determined by tests according to annex D for freeze-thaw resistance or
annex E for water absorption and to the conformity criteria of 6.3.8.2.
5.3.2.2 Performance and classes
The blocks shall conform to the requirements in Table 4.1 or Table 4.2.
Recommendations as to the class(es) of weathering resistance required to ensure durability for that country,
for the uses for which the product is put on the market, may be made at a national level.

Table 4.1 — Water absorption
Class Marking Water absorption
 % by mass
1 A no performance measured
2 B
≤ 6.5

Where specific conditions exist such as frequent contact of surfaces with de-icing salts under frost
conditions, the requirements defined in Table 4.2 may have to be fulfilled.

Table 4.2 — Resistance to freeze-thaw with de-icing salts
Class Marking Mass loss after freeze/thaw test
2
kg/m
3 D ≤ 1,0as a mean
with no individual value > 1,5


5.3.3 Tensile splitting strength
5.3.3.1 Test method
The characteristic tensile splitting strength T shall be determined by testing according to annex F and to the
conformity criteria given in 6.3.8.3.
5.3.3.2 Performance
The characteristic tensile splitting strength T shall not be less than 3.6MPa. None of the individual results
shall be less than 2.9MPa nor have a failure load less than 250N/mm of splitting length
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5.3.3.3 Durability of strength
Under normal exposure conditions of use precast concrete blocks will continue to provide satisfactory
strength, provided they conform to 5.3.3.2 and are subject to normal maintenance.
5.3.4 Abrasion resistance
5.3.4.1 Test method
Abrasion resistance is determined by the Wide Wheel Abrasion test (see annex G), or as an alternative by
the Böhme test (see annex H). The Wide Wheel Abrasion test is the reference test.
5.3.4.2 Performance and classes
Requirements for abrasion resistance are given in Table 5.1
No individual result shall be greater than the required value.
Table 5.1 — Abrasion resistance classes
Alternatively measured in
Measured in accordance accordance with test method Annex
Class Marking with test method Annex G H

1 F No performance measured No performance measured
3 2
3 H < 23,0 mm < 20 000 mm /5 000 mm
3 2
4 I < 20,0 mm < 18 000 mm /5 000 mm

5.3.5 Slip/skid resistance
5.3.5.1 Test Method
Slip /skid resistance is determined by testing in accordance with the test method as described in ENV 12633
NB If ENV 12633  is published separately as a CEN TS, the reference will need to be changed editorially
before final publication
5.3.5.2 Performance and classes
Requirements for slip/skid resistance are given in Table 5.3. Both the unpolished and polished values shall,
satisfy the requirements for the class
Table 5.3 — Skid Resistance classes

Class Marking Slip/skid resistance values



1 P No performance measured
2 Q > 35

3 R > 45
4 S > 55


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NOTE If the surface of a block contains ridges, grooves or other surface features which prevent testing by the
pendulum friction equipment, the product is deemed to satisfy the requirements of this standard without testing. Where
the block is too small to provide a test area, the manufacturer shall test a larger block having the same surface finish as
the block in question.
5.3.6 Fire performance
5.3.6.1 Reaction to fire
1)
Concrete paving blocks are Class A1 reaction to fire without testing.
5.3.6.2 External fire performance
Concrete paving blocks used as roof covering are deemed to satisfy the requirements for external fire
2)
performance without the need for testing.
5.3.7 Thermal conductivity
If concrete blocks are intended to contribute to the thermal performance of an element, then the
manufacturer shall declare the thermal conductivity using design data from EN 13369.
5.4 Visual aspects
5.4.1 Appearance
The upper faces of the concrete paving blocks shall not exhibit defects such as cracking or flaking when
examined in accordance with annex J.
In the case of two-layer blocks and when examined in accordance with annex J there shall be no
delamination (i.e. separation) between the layers.
NOTE When efflorescence occurs it is not deleterious to the performance of the blocks in use
5.4.2 Texture
In the case of blocks produced with special surface textures, the texture shall be described by the
manufacturer.
If examined in accordance with annex J, conformity shall be established if there are no significant differences
in texture to any samples supplied by the manufacturer and approved by the purchaser.
NOTE Variations in the texture consistency of the blocks can be caused by unavoidable variations in the properties
of the raw materials and by variations in curing and are not considered significant.
5.4.3 Colour
Colours may be provided in a facing layer or throughout the block at the manufacturer's discretion.

1)

Reference is made to the Commission Decision 96/603/EC, as amended.
2)

See Commission Decision 2000/553/EC.
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If examined in accordance with annex J, conformity shall be established if there are no significant differences
in colour to any samples supplied by the manufacturer and approved by the purchaser.
NOTE Variations in the colour consistency of the blocks can be caused by unavoidable variations in the shade and
properties of the raw materials and by variations in curing and are not considered significant.
6 Evaluation of conformity criteria
6.1 General
For the purpose of testing, the manufacturer may group products into families, where it is considered that the
value of a selected property is common to all products within that family. Such families are:
1) strength family: blocks manufactured using the same mix design and production methods,
irrespective of dimensions and colours;
NOTE Failure load is dependent upon block thickness
2) surface family: blocks with face mixes having the same main aggregate used in the mix
(e.g. natural river gravel, crushed granite, porphyr, basalt or limestone) and the same surface
treatment of the finished product, irrespective of dimensions and pigmentation.
6.1.1 Demonstration of conformity
The manufacturer shall demonstrate conformity of his product with the requirements of this standard and with
the declared values (levels or classes) for the product properties by carrying out both:
type testing of the product (see 6.2);
factory production control (see 6.3), including product testing.
6.1.2 Assessment of conformity
In addition, conformity of the product with this standard may be assessed:
 either by a third party inspecting the manufacturer’s type testing and factory production control
procedures;
 or by acceptance testing of a consignment at delivery (e.g. in the case of dispute, see annex B).
6.2 Type testing of the product
6.2.1 Initial type testing
Initial type testing shall be performed to demonstrate conformity with this standard at the beginning of the
manufacture of a new product type or a family of product types, or setting up a new production line, to
confirm that the achieved properties of the product meet the requirements of this standard and the values
declared for it by the manufacturer.
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6.2.2 Further type testing
Whenever a change occurs in the raw materials, the proportions used or the production equipment or
process, which would change significantly some or all of the properties of the finished product, the type tests
shall be repeated for the selected property or properties.
NOTE Examples of major changes:
1) change from natural river gravel to crushed rock aggregates or change of cement type or class;
2) partial substitution of cement by additions.
For abrasion and weathering resistance, type testing shall be repeated periodically with the frequency given
in Table 6 even when no change occurs.
Table 6 — Periodically repeated type testing
Property Frequency
Abrasion (only classes 3 and 4) Once per year per surface family
1)
Weathering resistance (only class 3) Once per year per surface family
1)
If for a surface family the result of a type test (mass loss) is lower than 50 % of the required value

the test frequency may be reduced to once per two years.
If for a surface family, routine water absorption testing at the frequency for class 2 products
(see 6.3.8.2.) is carried out to demonstrate consistency with blocks submitted to freeze/thaw testing,
the required test frequency may be reduced to once per two years.


6.2.3 Sampling, testing and conformity criteria
The number of blocks to be tested shall be in accordance with Table 7 for the selected property.

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Table 7 — Sampling plan and conformity criteria for initial and further type testing
Property Requirements Testing Number Conformity criteria
method of blocks
1)
Appearance 5.4 Annex J 20 No block shall show cracking, flaking or
2)
delamination
2)
Thickness of facing layer 5.1 C.6 8 Each block shall meet the
requirements
2) 1)
Shape and dimensions 5.2 Annex C 8 Each block shall meet the
requirements for the declared class
Tensile splitting strength 5.3.3 Annex F 8 Each block shall meet the
and failure load requirements for the declared class
Abrasion resistance 5.3.4 Annex G or H 3 Each block shall meet the
(only classes 3 and 4) requirements for the declared class
Slip/skid resistance 5.3.5 Annex I 4 The mean value shall meet the
requirements for the declared class
Weathering resistance
- class 2 5.3.2 Annex E 3 No block shall have a water absorption
greater than 6,0 % by mass
- class 3 5.3.2 Annex D 3 Each block shall meet the
requirements for the declared class
1)
These blocks may be used for subsequent tests.
2)
C.6 only applies for blocks with a facing layer.

The type tests shall be carried out in accordance with the reference test methods called up in this standard.
Type testing is normally carried out with the manufacturer's test equipment.
The test results shall be recorded.
6.3 Factory production control
6.3.1 General
The manufacturer shall establish, document and maintain a factory production control system to ensure that
the products placed on the market will conform with the specified or declared values.
The factory production control system shall consist of procedures, regular inspection and tests and the
utilisation of the results to control raw and other incoming materials, equipment, the production process and
the product.
An example of a suitable inspection scheme for factory production control is given in annex A.
The results of inspections requiring action and the results of tests shall be recorded.
The action to be taken when control values or criteria are not met shall be given.
6.3.2 Equipment
All weighing, measuring and testing equipment shall be calibrated and regularly inspected according to the
documented procedures, frequencies and criteria.
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An inspection scheme for equipment is given in A.1.
6.3.3 Raw and other incoming materials
The specifications of all incoming materials shall be documented.
An inspection scheme for raw materials is given in A.2.
6.3.4 Production process
The relevant features of the plant and production process shall be defined giving the frequency of the
inspection checks and tests, together with the criteria required both on equipment and on work in progress.
An inspection scheme for the production process is given in A.3.
6.3.5 Product testing
A sampling and testing plan of products shall be prepared and implemented.
The sample shall be representative of production.
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