oSIST prEN 14695:2018

SLOVENSKI STANDARD
01-januar-2018
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Flexible sheets for waterproofing - Reinforced bitumen sheets for waterproofing of
concrete bridge decks and other trafficked areas of concrete - Definitions and
characteristics
Abdichtungsbahnen - Bitumenbahnen mit Trägereinlage für die Abdichtung von
Betonbrücken und anderen Verkehrsflächen aus Beton - Definitionen und Eigenschaften
Feuilles souples d'étanchéité - Feuilles bitumineuses armées pour l'étanchéité des
tabliers de ponts en béton et autres surfaces en béton circulables par les véhicules -
Définitions et caractéristiques
Ta slovenski standard je istoveten z: prEN 14695
ICS:
91.100.30 Beton in betonski izdelki Concrete and concrete
products
91.100.50 Veziva. Tesnilni materiali Binders. Sealing materials
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT
EUROPEAN STANDARD
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2017
ICS 91.100.50 Will supersede EN 14695:2010
English Version
Flexible sheets for waterproofing - Reinforced bitumen
sheets for waterproofing of concrete bridge decks and
other trafficked areas of concrete - Definitions and
characteristics
Feuilles souples d'étanchéité - Feuilles bitumineuses Abdichtungsbahnen - Bitumenbahnen mit
armées pour l'étanchéité des tabliers de ponts en béton Trägereinlage für die Abdichtung von Betonbrücken
et autres surfaces en béton circulables par les véhicules und anderen Verkehrsflächen aus Beton - Definitionen
- Définitions et caractéristiques und Eigenschaften
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee
CEN/TC 254.
If this draft becomes a European Standard, CEN members are bound to comply with the CEN/CENELEC Internal Regulations
which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.

This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC
Management Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 14695:2017 E
worldwide for CEN national Members.

Contents Page
European foreword . 4
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 6
4 Product characteristics . 8
4.1 General . 8
4.2 Sheet characteristics . 8
4.2.1 Visible defects . 8
4.2.2 Dimensions, tolerances and mass per unit area . 8
4.2.3 Initial amount of mineral surface protection . 9
4.2.4 Tensile properties. 9
4.2.5 Water absorption . 9
4.2.6 Flexibility at low temperature. 9
4.2.7 Flow resistance at elevated temperature . 9
4.2.8 Dimensional stability at elevated temperatures . 9
4.2.9 Artificial ageing behaviour . 10
4.3 Performance related characteristics . 10
4.3.1 General . 10
4.3.2 Bond strength . 10
4.3.3 Shear strength . 10
4.3.4 Crack bridging ability . 10
4.3.5 Compatibility by heat conditioning . 10
4.3.6 Resistance to compaction of an asphalt layer . 10
4.3.7 Behaviour of bitumen sheets during application of mastic asphalt . 11
4.3.8 Watertightness . 11
4.4 Dangerous substances . 11
5 Assessment and verification of constancy of performance - AVCP . 11
5.1 General . 11
5.2 Type testing . 11
5.2.1 General . 11
5.2.2 Test samples, testing and compliance criteria . 12
5.2.3 Test reports . 14
5.2.4 Shared other party results . 14
5.3 Factory production control (FPC) . 14
5.3.1 General . 14
5.3.2 Requirements . 15
5.3.3 Product specific requirements . 18
5.3.4 Initial inspection of factory and of FPC . 19
5.3.5 Continuous surveillance of FPC . 19
5.3.6 Procedure for modifications . 19
5.3.7 One-off products, pre-production products (e.g. prototypes) . 20
6 Product data sheet . 20
7 Marking, labelling and packaging . 21
Annex A (normative) Determination of dimensional stability at 160 °C . 22
A.1 General . 22
A.2 Procedure . 22
A.3 Precision of test method . 22
A.4 Test report . 22
Annex B (informative) Example of a product data sheet . 23
Annex C (normative) Determination of the initial amount of mineral surface protection . 25
C.1 General . 25
C.2 Apparatus and materials . 25
C.3 Procedure . 25
C.4 Calculations and expression of results . 25
C.5 Precision of the test method . 25
C.6 Test report . 25
Annex ZA (informative) Clauses of this European Standard addressing provisions of the EU
Construction Products Regulation . 26
ZA.1 Scope and relevant characteristics . 26
ZA.2 System of Assessment and Verification of Constancy of Performance (AVCP) . 27
ZA.3 Assignment of AVCP tasks . 27
Bibliography . 29

European foreword
This document (prEN 14695:2017) has been prepared by Technical Committee CEN/TC 254 “Flexible
sheets of waterproofing”, the secretariat of which is held by NEN.
This document is currently submitted to the CEN Enquiry.
This document will supersede EN 14695:2010.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association,
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this
document.
1 Scope
This European Standard specifies characteristics and performance of reinforced bitumen sheets for
waterproofing of concrete bridge decks and other trafficked areas of concrete where the waterproofing
system is fully bonded to the concrete deck and fully bonded to the asphalt overlay.
This standard does not cover concrete surfaces trafficable by vehicles where the waterproofing is not
fully bonded to the concrete and/or not fully bonded to an overlay.
This European Standard also specifies the test methods used for verifying the characteristics and gives
rules for the assessment and verification of constancy of performance of the product.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
EN 1107-1, Flexible sheets for waterproofing — Part 1: Bitumen sheets for roof waterproofing —
Determination of dimensional stability
EN 1109, Flexible sheets for waterproofing — Bitumen sheets for roof waterproofing — Determination of
flexibility at low temperature
EN 1110, Flexible sheets for waterproofing — Bitumen sheets for roof waterproofing — Determination of
flow resistance at elevated temperature
EN 1296, Flexible sheets for waterproofing — Bitumen, plastic and rubber sheets for roofing — Method of
artificial ageing by long term exposure to elevated temperature
EN 1848-1, Flexible sheets for waterproofing — Determination of length, width and straightness — Part 1:
Bitumen sheets for roof waterproofing
EN 1849-1, Flexible sheets for waterproofing — Determination of thickness and mass per unit area — Part
1: Bitumen sheets for roof waterproofing
EN 1850-1, Flexible sheets for waterproofing — Determination of visible defects — Part 1: Bitumen sheets
for roof waterproofing
EN 12039:2016, Flexible sheets for waterproofing — Bitumen sheets for roof waterproofing —
Determination of adhesion of granules
EN 12311-1, Flexible sheets for waterproofing — Part 1: Bitumen sheets for roof waterproofing —
Determination of tensile properties
EN 13375, Flexible sheets for waterproofing — Waterproofing of concrete bridge decks and other concrete
surfaces trafficable by vehicles — Specimen preparation
EN 13416, Flexible sheets for waterproofing — Bitumen, plastic and rubber sheets for roof waterproofing
— Rules for sampling
EN 13596, Flexible sheets for waterproofing — Waterproofing of concrete bridge decks and other concrete
surfaces trafficable by vehicles — Determination of bond strength
EN 13653, Flexible sheets for waterproofing — Waterproofing of concrete bridge decks and other concrete
surfaces trafficable by vehicles — Determination of shear strength
EN 14223, Flexible sheets for waterproofing — Waterproofing of concrete bridge decks and other concrete
surfaces trafficable by vehicles — Determination of water absorption
EN 14224, Flexible sheets for waterproofing — Waterproofing of concrete bridge decks and other concrete
surfaces trafficable by vehicles — Determination of crack bridging ability
EN 14691, Flexible sheets for waterproofing — Waterproofing of concrete bridge decks and other concrete
surfaces trafficable by vehicles — Compatibility by heat conditioning
EN 14692, Flexible sheets for waterproofing — Waterproofing of concrete bridge decks and other concrete
surfaces trafficable by vehicles — Determination of the resistance to compaction of an asphalt layer
EN 14693, Flexible sheets for waterproofing — Waterproofing of concrete bridge decks and other concrete
surfaces trafficable by vehicles — Determination of the behaviour of waterproofing sheets during
application of mastic asphalt
EN 14694, Flexible sheets for waterproofing — Waterproofing of concrete bridge decks and other concrete
surfaces trafficable by vehicles — Determination of resistance to dynamic water pressure after damage by
pre-treatment
3 Terms and definitions
For the purposes of this document, the terms and definitions given in EN 13375, EN 13416 and the
following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
3.1
waterproofing
action to protect the structure and the construction against the ingress and the passage of water and or
moisture
3.2
waterproofing system
assembly of layers between a concrete bridge deck (or other trafficked areas of concrete) and an
overlay
Note 1 to entry: Generally comprises a primer, the reinforced bitumen sheet (or the assembly of several
reinforced bitumen sheets) and the protection layer if specified by the manufacturer, see Figure 1.
Key
1 concrete deck
2 primer
3 reinforced bitumen sheet(s)
4 protection layer
5 overlay (asphalt)
6 bridge waterproofing system (2 + 3 and 4 if specified)
Figure 1 — Example of schematic section of a waterproofing system for bridges and other
trafficked areas of concrete
3.3
carrier
material incorporated into or onto a factory-made reinforced bitumen sheet to ensure its stability
and/or mechanical resistance
3.4
backing
material incorporated onto a factory-made reinforced bitumen sheet without a permanent mechanical
function
3.5
surfacing
material applied on one or both sides of reinforced bitumen sheets, either as a permanent light surface
protection on the upper surface or as an anti-sticking substance of the reinforced bitumen sheets
3.6
batch
amount of product manufactured to the same specification without interruption and within a maximum
period of 24 h
3.7
manufacturer’s limiting value
MLV
value stated by the manufacturer to be met during testing
Note 1 to entry: The MLV can be a minimum or a maximum value according to statements made under product
characteristics of this European Standard.
3.8
manufacturer’s declared value
MDV
value declared by the manufacturer accompanied by a declared tolerance
3.9
primer
first layer of the system applied directly to the prepared concrete deck to achieve adhesion to the
concrete surface; the primer can be made by one or more layers of bituminous products or resin based
products
3.10
reinforced bitumen sheet
factory made flexible layer of bitumen with internal or external incorporation of one or more carriers,
supplied in roll form ready to use
3.11
protection layer
layer above the reinforced bitumen sheet, the aim of which being to protect the sheet from mechanical
damage
Note 1 to entry: Depending on the waterproofing system, this layer can have an additional waterproofing
function.
3.12
overlay
asphalt layer immediately above the waterproofing system
Note 1 to entry: Typically, the overlay can be made up of asphalt concrete, sand asphalt or coarse aggregate
mastic asphalt.
4 Product characteristics
4.1 General
Where a tolerance is defined by this European Standard it does not have to be declared by the
manufacturer.
When tested for purposes other than type testing or factory production control (see 5.1), that are for
example market surveillance, the tests to determine product characteristics indicated in this European
Standard shall be started within one month of delivery from the manufacturer.
4.2 Sheet characteristics
4.2.1 Visible defects
The product shall be free of visible defects, as determined in accordance with EN 1850-1.
4.2.2 Dimensions, tolerances and mass per unit area
The length, width and straightness shall be determined in accordance with EN 1848-1. The length and
width shall not be shorter than the manufacturer's limiting value. The maximum deviation from
straightness shall not exceed 20 mm per 10 m length, or in proportion for other lengths (e.g. 10 mm per
5 m length).
Where a product is specified by mass per unit area, it shall be measured in accordance with EN 1849-1,
and the results shall lie within the declared tolerance of the manufacturer's declared value.
Where a product is specified by thickness, it shall be measured in accordance with EN 1849-1 and the
results shall lie within the declared tolerance of the manufacturer's declared value.
Where sheets with incorporated mineral protection are specified by thickness, the measurement of
thickness may additionally be carried out on the granule-free selvedge. This shall be declared in the
report.
4.2.3 Initial amount of mineral surface protection
The initial amount of mineral surface protection shall be determined in accordance with EN
12039:2016, Annex B, except that a 125 μm sieve shall be used. If a distinction is to be made between
the different sides of the sheet the initial amount of mineral surface protection shall be determined in
accordance with Annex C. The results for the test used shall lie within the declared tolerance of the
manufacturer's declared value.
4.2.4 Tensile properties
The tensile properties shall be determined in accordance with EN 12311-1 and the results (for the
longitudinal and transverse directions) shall lie within the declared tolerance of the manufacturer's
declared value.
4.2.5 Water absorption
The content of water absorbed shall be determined in accordance with EN 14223. The water absorption
shall be less than or equal to the manufacturer's limiting value.
4.2.6 Flexibility at low temperature
The flexibility at low temperature shall be determined in accordance with EN 1109 and shall be less
than or equal to the manufacturer's limiting value.
This test does not give results directly corresponding to the application conditions in practice. Results
should only be used to compare products of similar thickness and construction.
In the case of sheets with the same bituminous compound on both sides and where the reinforcement is
placed in the cross section visually closer to the upper surface, the test shall be performed on the
bottom face only.
If the upper surface is covered with a non- woven (e.g. tissue, fleece, etc.) or metal facing the test shall
be performed on the bottom side only.
If the sheet on the upper surface is covered with permanent light surface protection and where the
reinforcement is placed in the cross section visually closer to the upper surface the test shall be
performed on the bottom side only.
4.2.7 Flow resistance at elevated temperature
The flow resistance at elevated temperature shall be determined in accordance with EN 1110. The
result shall be greater than or equal to the manufacturer's limiting value.
4.2.8 Dimensional stability at elevated temperatures
The dimensional stability at elevated temperature shall be determined in accordance with EN 1107-1
(24 h at 80 °C). The result shall be less than or equal to the manufacturer's limiting value.
For reinforced bitumen sheets to be used with a layer of coarse aggregate mastic asphalt directly on the
reinforced bitumen sheet, the dimensional stability at elevated temperatures (1 h at 160 °C) shall be
evaluated in accordance with Annex A .The test result shall be less than or equal to the manufacturer's
limiting value.
NOTE The test at 80 °C is intended to determine the dimensional changes as a result of production-induced
internal stresses under the effect of heat. When combined with a coarse aggregate mastic asphalt layer, the effect
of heat is much larger and can cause severe shrinkage to the reinforced bitumen sheet. This effect is therefore
declared as well for sheets intended for use in combination with a coarse aggregate mastic asphalt layer.
4.2.9 Artificial ageing behaviour
In order to verify the artificial ageing behaviour of the product, characteristics shall be determined
before and after exposure in accordance with EN 1296 for a period of 12 weeks at 70 °C. The relevant
characteristics are the flexibility at low temperature and the flow resistance at elevated temperature.
The flexibility at low temperature shall be determined in accordance with EN 1109 (see 4.2.6) and the
results shall lie within the declared tolerance of the manufacturer's declared value. The flow resistance
at elevated temperature shall be determined in accordance with EN 1110 (see 4.2.7) and the results
shall lie within the declared tolerance of the manufacturer’s declared value.
The purpose of testing in accordance with EN 1296 is to characterize the long-term stability of
elastomeric or plastomeric bitumen sheets. The test does not give results corresponding to the service
conditions in practice. Results should only be used to compare products of similar thickness,
construction and composition, and they cannot be used for general durability classification. The chosen
exposure duration for artificial ageing in accordance to EN 1296 has no relevance to a real product
lifetime.
4.3 Performance related characteristics
4.3.1 General
Test specimens for performance-related testing shall be prepared in accordance with EN 13375. Where
a sheet can be used in different waterproofing systems, some of the following tests shall require
repeating.
4.3.2 Bond strength
The bond strength shall be determined in accordance with EN 13596, and shall be greater than or equal
to the manufacturer's limiting value.
4.3.3 Shear strength
The shear strength shall be determined in accordance with EN 13653, and shall be greater than or equal
to the manufacturer's limiting value.
4.3.4 Crack bridging ability
Where required the crack bridging ability of fully bonded reinforced bitumen sheets shall be
determined in accordance with EN 14224 and the temperature shall be lower than or equal to the
manufacturer's limiting value. Testing on type 3 specimens covers also type 1 specimens.
4.3.5 Compatibility by heat conditioning
The compatibility by heat conditioning shall be determined in accordance with EN 14691. The test
result shall be greater than or equal to the manufacturer's limiting value.
4.3.6 Resistance to compaction of an asphalt layer
For reinforced bitumen sheets to be used with a compacted asphalt layer directly on the reinforced
bitumen sheet, the resistance of the reinforced bitumen sheet to compaction of an asphalt layer shall be
determined in accordance with EN 14692, method 1 or method 2, and a resistant result is required to
demonstrate product compliance with this European Standard.
4.3.7 Behaviour of bitumen sheets during application of mastic asphalt
Only a bitumen sheet intended for use with a protection layer of coarse aggregate mastic asphalt shall
be tested to determine its behaviour during application of mastic asphalt in accordance with EN 14693.
The test results shall be less than or equal to the manufacturer's limiting value.
4.3.8 Watertightness
The watertightness of the reinforced bitumen sheet (or double sheet system) shall be determined in
accordance with EN 14694 without pretreatment. The conformity of watertightness shall be
demonstrated.
4.4 Dangerous substances
National regulations on dangerous substances may require verification and declaration on release, and
sometimes content, when construction products covered by this 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 the Construction web site on EUROPA accessed through: http://ec.europa.eu/growth/tools-
databases/cp-ds_en
5 Assessment and verification of constancy of performance - AVCP
5.1 General
The compliance of the reinforced bitumen sheets for waterproofing of concrete bridge decks and other
trafficked areas of concrete with the requirements of this standard and with the performances declared
by the manufacturer in the DoP (Declaration of Performance) shall be demonstrated by:
— determination of the product type;
— factory production control 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 conformity of the product with its declared performance(s).
NOTE The assignment of tasks to the notified body(ies) and the manufacturer is shown in Annex ZA,
(Table ZA.3).
5.2 Type testing
5.2.1 General
All performances related to characteristics included in this standard shall be determined when the
manufacturer intends to declare the respective performances unless the standard gives provisions for
declaring them without performing tests (e.g. use of previously existing data, CWFT and conventionally
accepted performance).
Assessment previously performed in accordance with the provisions of this standard, may be taken into
account provided that they were made to the same or a more rigorous test method, under the same
AVCP system on the same product or products of similar design, construction and functionality, such
that the results are applicable to the product in question.
For the purposes of assessment, the manufacturer's products may be grouped into families, where it is
considered that the results for one or more characteristics from any one product within the family are
representative for that same characteristics for all products within that same family
NOTE 1 Products can be grouped in different families for different characteristics.
NOTE 2 It is advised to make reference to the assessment method standards to allow the selection of a suitable
representative sample.
In addition, the determination of the product type shall be performed for all characteristics included in
the standard for which the manufacturer declares the performance:
— at the beginning of the production of a new or modified reinforced bitumen sheet for waterproofing
of concrete bridge decks and other trafficked areas of concrete (unless a member of the same
product range), or
— at the beginning of a new or modified method of production (where this may affect the stated
properties); or
— they shall be repeated for the appropriate characteristic(s), whenever a change occurs in the
reinforced bitumen sheet for waterproofing of concrete bridge decks and other trafficked areas of
concrete design, in the raw material or in the supplier of the components, or in the method of
production (subject to the definition of a family), which would affect significantly one or more of
the characteristics.
Where components are used whose characteristics have already been determined, by the component
manufacturer, on the basis of assessment methods of other product standards, these characteristics
need not be re-assessed. The specifications of these components shall be documented.
Products bearing regulatory marking in accordance with appropriate harmonized European
specifications may be presumed to have the performances declared in the DoP, although this does not
replace the responsibility on the reinforced bitumen sheet for waterproofing of concrete bridge decks
and other trafficked areas of concrete manufacturer to ensure that the reinforced bitumen sheet for
waterproofing of concrete bridge decks and other trafficked areas of concrete as a whole is correctly
manufactured and its component products have the declared performance values.
5.2.2 Test samples, testing and compliance criteria
Samples shall be taken according to EN 13416 and specimens shall be prepared according to EN 13375.
The number of samples of reinforced bitumen sheet for waterproofing of concrete bridge decks and
other trafficked areas of concrete to be tested/assessed shall be at least one.
Table 1 — Compliance criteria for type testing
Sub-clause
Compliance criteria
Property Parameter Test method in this
(where required)
document
Visible
Visible defects EN 1850-1 4.2.1 No visible defects
defects
Within declared
Length and width MDV EN 1848-1 4.2.2
tolerance of MDV
Less than or
Straightness equal to 20 EN 1848-1 4.2.2 Conforming
mm/10 m
Mass per unit area Within declared
MDV EN 1849-1 4.2.2
or thickness tolerance of MDV
Initial amount of
Within declared
mineral surface MDV EN 12039:2016 4.2.3
tolerance of MDV
protection
Tensile properties
— tensile strength MDV EN 12311-1 4.2.3 > MDV
— elongation
Water absorption % EN 14223 4.2.5 < MLV
Flexibility at low
EN 1109 4.2.6 < MLV
temperature
Flow resistance at
elevated MLV EN 1110 4.2.7 > MLV
temperature
Dimensional
EN 1107-1 4.2.8 < MLV
stability
Artificial ageing by
long term
EN 1109 < MLV
exposure to
4.2.9
elevated
EN 1110 > MDV
temperature by EN
Bond strength MLV EN 13596 4.3.2 > MLV
Shear strength MLV EN 13653 4.3.3 > MLV
Crack bridging
MLV EN 14224 4.3.4 MLV
ability
Compatibility by
MLV EN 14691 4.3.5 MLV
heat conditioning
Resistance to
compaction of an  EN 14692 4.3.6 Conforming
asphalt layer
Behaviour of
bitumen sheets
EN 14693 4.3.7 Conforming
during application
of mastic asphalt
Water-
Watertightness EN 14694 4.3.8 Conforming
tightness
Dangerous
As relevant As relevant 4.4 As relevant
substances
5.2.3 Test reports
The results of the determination of the product type shall be documented in test reports. All test reports
shall be retained by the manufacturer for at least 10 years after the last date of production of the
reinforced bitumen sheet for waterproofing of concrete bridge decks and other trafficked areas of
concrete to which they relate.
5.2.4 Shared other party results
A manufacturer may use the results of the product type determination obtained by someone else (e.g.
by another manufacturer, as a common service to manufacturers, or by a product developer), to justify
his own declaration of performance regarding a product that is manufactured according to the same
design (e.g. dimensions) and with raw materials, constituents and manufacturing methods of the same
kind, provided that:
— the results are known to be valid for products with the same essential characteristics relevant for
the product performance;
— in addition to any information essential for confirming that the product has such same
performances related to specific essential characteristics, the other party who has carried out the
determination of the product type concerned or has had it carried out, has expressly accepted to
transmit to the manufacturer the results and the test report to be used for the latter’s product type
determination, as well as information regarding production facilities and the production control
process that can be taken into account for FPC;
— the manufacturer using other party results accepts to remain responsible for the product having
the declared performances and he also:
— ensures that the product has the same characteristics relevant for performance as the one that has
been subjected to the determination of the product type, and that there are no significant
differences with regard to production facilities and the production control process compared to
that used for the product that was subjected to the determination of the product type; and
— keeps available a copy of the determination of the product type report that also contains the
information needed for verifying that the product is manufactured according to the same design
and with raw materials, constituents and manufacturing methods of the same kind.
The formulation of such an agreement can be done by license, contract, or any other type of written
consent.
5.3 Factory production control (FPC)
5.3.1 General
The manufacturer shall establish, document and maintain an FPC system to ensure that the products
placed on the market comply with the declared performance of the essential characteristics.
The FPC system shall consist of procedures, regular inspections and tests and/or assessments and the
use of the results to control raw and other incoming materials or components, equipment, the
production process and the product.
All the elements, requirements and provisions adopted by the manufacturer shall be documented in a
systematic manner in the form of written policies and procedures. This factory production control
system documentation shall ensure a common understanding of the evaluation of the constancy of
performance and enable the achievement of the required product performances and the effective
operation of the production control system to be checked. Factory production control therefore brings
together operational techniques and all measures allowing maintenance and control of the compliance
of the product with the declared performances of the essential characteristics.
In case the manufacturer has used shared or cascading product type results, the FPC shall also include
the appropriate documentation as foreseen in 5.2.4.
5.3.2 Requirements
5.3.2.1 General
The manufacturer is responsible for organizing the effective implementation of the FPC system in line
with the content of this product standard. Tasks and responsibilities in the production control
organization shall be documented and this documentation shall be kept up-to-date.
The responsibility, authority and the relationship between personnel that manages, performs or verifies
work affecting product constancy, shall be defined. This applies in particular to personnel that need to
initiate actions preventing product non-constancies from occurring, actions in case of non-constancies
and to identify and register product constancy problems.
Personnel performing work affecting the constancy of performance of the product shall be competent
on the basis of appropriate education, training, skills and experience for which records shall be
maintained.
In each factory the manufacturer may delegate the action to a person having the necessary authority to:
— identify procedures to demonstrate constancy of performance of the product at appropriate stages;
— identify and record any instance of non-constancy;
— identify procedures to correct instances of non-constancy.
The manufacturer shall draw up and keep up-to-date documents defining the factory production
control. The manufacturer's documentation and procedures should be appropriate to the product and
manufacturing process. The FPC system should achieve an appropriate level of confidence in the
constancy of performance of the product.
This involves:
a) the preparation of documented procedures and instructions relating to factory production control
operations, in accordance with the requirements of the technical specification to which reference is
made;
b) the effective implementation of these procedures and instructions;
c) the recording of these operations and their results;
d) the use of these results to correct any deviations, repair the effects of such deviations, treat any
resulting instances of non-conformity and, if necessary, revise the FPC to rectify the cause of non-
constancy of performance.
Where subcontracting takes place, the manufacturer shall retain the overall control of the product and
ensure that he receives all the information that is necessary to fulfil his responsibilities according to this
European Standard.
If the manufacturer has part of the product designed, manufactured, assembled, packed, processed
and/or labelled by subcontracting, the FPC of the subcontractor may be taken into account, where
appropriate for the product in question.
The manufacturer who subcontracts all of his activities may in no circumstances pass the above
responsibilities on to a subcontractor.
NOTE Manufacturers having an FPC system, which complies with EN ISO 9001 standard and which addresses
the provisions of the present European Standard are considered as satisfying the FPC requirements of the
Regulation (EU) No 305/2011.
5.3.2.2 Equipment
5.3.2.2.1 Testing
All weighing, measuring and testing equipment shall be calibrated and regularly inspected according to
documented procedures, frequencies and criteria.
5.3.2.2.2 Manufacturing
All equipment used in the manufacturing process shall be regularly inspected and maintained to ensure
use, wear or failure does not cause inconsistency in the manufacturing process. Inspections and
maintenance shall be carried out and recorded in accordance with the manufacturer’s written
procedures and the records retained for the period defined in the manufacturer's FPC procedures.
5.3.2.3 Raw materials and components
The specifications of all incoming raw materials and components shall be documented, as shall the
inspection scheme for ensuring their compliance. In case supplied kit components are used, the
constancy of performance system of the component shall be that given in the appropriate harmoniz
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