1 Scope This European Standard defines and specifies the relevant characteristics and requirements of flat surface wood flooring products and parquets as well as the appropriate test met
Trang 1BSI Standards Publication
Wood flooring and parquet — Characteristics, evaluation of conformity and marking
Trang 2© The British Standards Institution 2015 Published by BSI StandardsLimited 2015
ISBN 978 0 580 92368 5ICS 79.080; 97.150
Compliance with a British Standard cannot confer immunity from legal obligations.
This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 July 2013
Amendments/corrigenda issued since publication
30 November 2015 Implementation of CEN correction notice 7
August 2015: Standard title corrected
Trang 3NORME EUROPÉENNE
English Version Wood flooring and parquet - Characteristics, evaluation of
conformity and marking
Planchers et parquet en bois - Caractéristiques, évaluation
de conformité et marquage
Holzfußböden und Parkett - Eigenschaften, Bewertung der
Konformität und Kennzeichnung
This European Standard was approved by CEN on 8 May 2013
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
C O M I T É E U R O P É E N D E N O R M A L I S A T I O N
E U R O P Ä I S C H E S K O M I T E E FÜ R N O R M U N G
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
Trang 4Contents Page
1 Scope 4
2 Normative references 5
3 Terms and definitions 6
4 Requirement for wood flooring products and parquets 6
4.1 Dimensional characteristics 6
4.2 Reaction to fire 6
4.3 Release of dangerous substances 8
4.3.1 Release of Formaldehyde 8
4.3.2 Content of pentachlorophenol 8
4.4 Release of other dangerous substances 8
4.5 Breaking strength 8
4.6 Slip resistance 8
4.7 Thermal properties 9
4.8 Biological durability 10
4.8.1 General 10
4.8.2 Recommended use class 10
4.8.3 Wood treated against biological attack 10
5 Evaluation of conformity 11
5.1 General 11
5.2 Initial Type Testing – Type Testing 11
5.2.1 General 11
5.2.2 Test reports 12
5.3 Factory production control (FPC) 12
5.3.1 General 12
5.3.2 Requirements 12
5.3.3 Product specific requirements 15
5.3.4 Initial inspection of factory and of FPC 16
5.3.5 Continuous surveillance of FPC [only for products covered by attestation of conformity system 1 ] 16
5.3.6 Procedure for modifications 17
6 Marking, labelling and packaging 17
Annex A (normative) Formaldehyde classes 18
Annex B (normative) Simplified encoding system for wood flooring 20
Annex ZA (informative) Clauses of this European Standard addressing the provisions of the EU Construction Products Directive 21
ZA.1 Scope and relevant characteristics 21
ZA.2 Procedure for attestation of conformity of wood and parquet flooring products 23
ZA.2.1 Systems of attestation of conformity 23
ZA.2.2 EC Certificate of Conformity and EC Declaration of Conformity 25
ZA.3 CE marking and labelling 27
ZA.3.1 General 27
ZA.3.2 CE marking 27
ZA.3.3 CE marking - simplified labelling 30
Bibliography 32
Trang 5Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights This document supersedes EN 14342:2005+A1:2008
In comparison with the previous edition, the entire document has been revised
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 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
Trang 61 Scope
This European Standard defines and specifies the relevant characteristics and requirements of flat surface wood flooring products and parquets as well as the appropriate test methods for determination of their suitability for use as internal flooring, including fully enclosed public transport premises
The European Standards for specific wood flooring products and parquets to which this European Standard relates, and which provide product definitions and requirements for dimensional tolerances, include the following:
solid parquet elements with tongues and grooves (EN 13226);
solid lamparquet products (EN 13227);
solid wood overlay elements including blocks with an interlocking system (EN 13228);
mosaic parquet elements (EN 13488);
multi-layer parquet elements (EN 13489);
solid pre-assembled hardwood board (EN 13629);
solid softwood floor boards (EN 13990);
wood veneer floor coverings (EN 14354);
solid wood parquet — vertical finger, wide finger and module brick (EN 14761)
This European Standard may also apply to other wood flooring products and parquets than those standards above However, it does not specify any requirements for dimensional limits of tolerances of such products This European Standard provides also for the evaluation of conformity and the requirements for marking the wood flooring products and parquets
This European Standard covers wood flooring products and parquets which may or may not be treated to improve their reaction to fire performance or their durability against biological agents
This European Standard does not apply to:
wood flooring products and parquets specifically manufactured for enhanced tactile and recognition;
bamboo flooring products;
laminate flooring products;
product made with plants such as aloe or cork or coconut
This European Standard covers wood flooring products and parquets with or without paint, varnish, lacquer, wax or oil
Trang 72 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 335, Durability of wood and wood-based products — Use classes: definitions, application to solid wood
and wood-based products
EN 350-1, Durability of wood and wood-based products — Natural durability of solid wood — Part 1: Guide to
the principles of testing and the classification of the natural durability of wood
EN 350-2, Durability of wood and wood-based products — Natural durability of solid wood — Part 2: Guide to
natural durability and treatability of selected wood species of importance in Europe
EN 351-1, Durability of wood and wood-based products — Preservative-treated solid wood — Classification of
preservative penetration and retention
EN 599-2, Durability of wood and wood-based products — Performance of preventive wood preservatives as
determined by biological tests — Part 2: Classification and labelling
EN 717-1, Wood based panels— Determination of formaldehyde release — Part 1: Formaldehyde emission
by the chamber method
EN 717-2, Wood based panels — Determination of formaldehyde release — Part 2: Formaldehyde release by
the gas analysis method
EN 844-9:1997, Round and sawn timber — Terminology — Part 9: Terms relating to features of sawn timber
EN 1533, Wood flooring — Determination of bending strength under static load — Test methods
EN 12664, Thermal performance of building materials and products — Determination of thermal resistance by
means of guarded hot plate and heat flow meter methods — Dry and moist products of medium and low thermal resistance
EN 13226, Wood flooring — Solid parquet elements with grooves and/or tongues
EN 13227, Wood flooring — Solid lamparquet products
EN 13228, Wood flooring — Solid wood overlay flooring elements including blocks with an interlocking system
EN 13488, Wood flooring — Mosaic parquet elements
EN 13489, Wood flooring — Multi-layer parquet elements
EN 13501-1, Fire classification of construction products and building elements — Part 1: Classification using
data from reaction to fire tests
EN 13629, Wood flooring — Solid individual and pre-assembled hardwood boards
EN 13756, Wood flooring — Terminology
EN 13986, Wood-based panels for use in construction — Characteristics, evaluation of conformity and
marking
EN 13990, Wood flooring — Solid softwood floor boards
Trang 8EN 14354, Wood-based panels — Wood veneer floor covering
EN 14761, Wood flooring — Solid wood parquet — Vertical finger, wide finger and module brick
CEN/TR 14823, Durability of wood and wood-based products — Quantitative determination of
pentachloro-phenol in wood — Gas chromatographic method
CEN/TS 15676, Wood flooring — Slip resistance — Pendulum test
EN ISO 9239-1, Reaction to fire tests for floorings — Part 1: Determination of the burning behaviour using a
radiant heat source (ISO 9239-1)
EN ISO 10456, Building materials and products — Hygrothermal properties — Tabulated design values and
procedures for determining declared and design thermal values (ISO 10456)
3 Terms and definitions
For the purpose of this document the terms and definitions given in EN 13756, EN 844-9 and those in the specific product standards (i.e EN 13226, EN 13227, EN 13228, EN 13488, EN 13489, EN 13990, EN 13629,
4.2 Reaction to fire
The reaction to fire performance of a wood flooring product and parquet, whether treated or not, shall be classified in accordance with EN 13501-1, after being tested in accordance with the test standards given therein and the relevant reaction to fire class declared
When tested, the product shall be mounted and fixed in accordance with the same mounting and fixing conditions used for obtaining the classification of products without the need of testing (i.e in accordance with
EN ISO 9239-1, on a substrate of at least Class D –s2, d0 (or Class A2 –s1, d0 when glued to substrate) and with minimum density of 400 kg/m3 or with an air gap underneath For parquet products with 14 mm thickness
or more and for veneered floor coverings in applications without air gap, an interlayer of at least class E and with minimum thickness of 3 mm may be included)
In case the product meets the requirements given in Table 11) it may be classified without the need for further testing (CWFT) in one of the appropriate classes shown therein In this case, the relevant reaction to fire class shall be declared (together with the corresponding mean density of the product, the overall thickness of the product as well as the end-use conditions)
1) This table is the same as Table 1 in Commission Decision 2006/213/EC of 2006-03-06 (see OJEU L79 of 2006-03-16).
Trang 9Table 1 —Classes of reaction to fire performance for wood flooring
Product a,g Product detail d Minimum
mean density e
(kg/m3)
Minimum overall thickness
not specified above i 400 6 All Efl
Wood parquet Multilayer parquet with a top
layer of oak of at least 5 mm thickness and with surface coating
650 (top layer) 10 Glued to substrate
f Cfl - s1
14b With or without air
gap underneath Multilayer parquet with surface
coating and not specified above 500 8 Glued to substrate Dfl - s1
10 Without air gap
underneath
14 b With or without air
gap underneath Solid wood (one layer) parquet
of walnut i 650 8 Glued to substrate j Dfl-s1 Solid (one layer) parquet of oak,
maple and ash i
Ash:650 Maple:
650 Oak: 720 8 Glued to substrate
spruce i
Pine: 480 Spruce: 400 14 Without air gap underneath Dfl-s1
Solid flooring of beech, oak, pine or spruce i
Beech: 700 Oak: 700 Pine: 430 Spruce: 400
20 With or without air gap underneath Dfl-s1
Veneered floor
covering Veneered floor covering with surface coating 800 6
b Without air gap
Trang 10d Type and quantity of surface coatings included are acrylic, polyurethane or soap, 50-100 g/m 2 , and oil, 20-60 g/m 2
e Conditioned according to EN 13238 (50 % RH 23 o C)
f Substrate at least Class A2 - s1, d0
g Applies also to steps of stairs
h An interlayer of at least Class Efl and with maximum thickness 3 mm and minimum density of 280 kg/m3 may be included
i Without surface coatings
j Substrate at least Class D-s2,d0
4.3 Release of dangerous substances
4.3.1 Release of Formaldehyde 2)
When required, formaldehyde release of wood flooring product and parquet shall be determined and declared
as a class E1 or E2 according to Annex A
Solid wood as such, used for the wood flooring products and parquets, without chemical treatment, adhesive, coating, or finishing, has release of formaldehyde values which are far below the upper limit for class E1 products
4.3.2 Content of pentachlorophenol
Wood flooring products and parquets naturally contain no pentachlorophenol (PCP) If the product contains raw materials that may include PCP (e.g softwood treated against blue stain) or when required, then the product shall be tested in accordance with CEN/TR 14823 In case the value of 5 ppm is exceeded, the indication “PCP > 5 ppm" shall be declared In the other case, it is necessary to declare PCP ≤ ppm
4.4 Release of other dangerous substances
National regulations on dangerous substances may require verification and declaration on release, and sometimes content, of other dangerous substances, in addition to those dealt with in other clauses, when construction products covered by this standard are placed on those markets
In the absence of European harmonised 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/enterprise/construction/cpd-ds/
4.5 Breaking strength
If breaking strength of the wood flooring product and parquet is required, it shall be tested for the installation required according to EN 1533 depending on the risk, if any The result shall be expressed and declared in terms of maximum load characteristic value, determined by using a static point load The span of the product,
as given in EN 1533 and associated with breaking strength value, shall be declared
NOTE This characteristic is only relevant for the self-supporting floorings
Trang 114.7 Thermal properties
Where subject to thermal insulation regulatory requirements the thermal conductivity of the wood flooring product and parquet shall be either determined and the value declared according to EN 12664 or given by using tabulated values related to density, as shown in Table 2, in line with EN ISO 10456
For multi-layer wood flooring product and parquet, the summation of the values of thermal resistance (i.e reciprocal property of the thermal conductivity) for each layer shall be taken into account
The thermal resistance R (in m2K/W) of a solid wood flooring product and parquet shall be determined by the following formula:
where t is the thickness of the wood flooring product and parquet (in m) and λ is the thermal conductivity (in W/m K)
The thermal resistance R (in m2K/W) ofa multi-layer wood flooring product and parquet shall be determined
by the following formula:
where each layer is characterised by its thickness t and its thermal conductivityλ
Table 2 —Thermal conductivity values for solid wood, some of wood-based panels used for the wood
flooring products and parquets
Solid wood and some
600
900
0,10 0,14 0,18
600
800
0,10 0,14 0,18
a For densities not given in this table, λ may be found by interpolation
b These values are in line with the values from EN ISO 10456
∑
= λ
t R
λ t R=
Trang 124.8.2 Recommended use class
The biological durability of the wood species used shall be classified using EN 335
Where several layers are used, the class for the weakest layer is declared
NOTE For construction precautions regarding durability of wood flooring products and parquets, see EN 335
If the species is listed in EN 350-2, the natural durability of the wood flooring product and parquet shall be given therein Otherwise, it shall be assessed in accordance with EN 350-1
4.8.3 Wood treated against biological attack
4.8.3.1 General
Preservative treated products shall be defined by:
use class in accordance with EN 335;
wood preservative in accordance with EN 599-2;
penetration class in accordance with EN 351-1;
retention of preservative in accordance with EN 351-1
Trang 135 Evaluation of conformity
5.1 General
The compliance of Wood flooring with the requirements of this standard and with the declared values (including classes) shall be demonstrated by:
Initial Type Testing;
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 product
5.2 Initial Type Testing – Type Testing
Tests 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 system of attestation of conformity, on the same product or products of similar design, construction and functionality, such that the results are applicable to the product in question
NOTE 1 Same system of attestation of conformity means testing by an independent third party [only for products covered by attestation of conformity system 1 and 3], under the responsibility of a product certification body [only for products covered by attestation of conformity system 1]
For the purposes of testing, 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 the same characteristics for all products within that same family (a product may be in different families for different characteristics)
NOTE 2 Reference to the test method standards can be made to allow the selection of a suitable representative sample
In addition, Type Tests or Initial Type Testing shall be performed for all characteristics included in the standard for which the manufacturer declares performances:
at the beginning of the production of a new or modified wood flooring (unless a member of the same family); 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 wood flooring design, in the raw material or in the supplier of the components, or in the production process (subject to the definition of a family), which would affect significantly one or more of the characteristics
Trang 14Where components are used whose characteristics have already been determined, by the component manufacturer, on the basis of compliance with other product standards, these characteristics need not be reassessed The specifications of these components shall be documented, as shall be included in the inspection scheme for ensuring their compliance
Products marked in accordance with appropriate harmonised European specifications may be presumed to have the performances stated with that marking, although this does not replace the responsibility on the wood flooring designer to ensure that the wood flooring as a whole is correctly designed and its component products have the necessary performance values to meet the design
5.2.2 Test reports
All Type Tests and/or Initial Type Tests and their results 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 wood flooring
to which they relate
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 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 production control system documentation shall ensure a common understanding of conformity evaluation and enable the achievement of the required product characteristics 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 this European standard
5.3.2 Requirements
5.3.2.1 General
The manufacturer is responsible for organising the effective implementation of the FPC system Tasks and responsibilities in the production control organisation 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 conformity, shall be defined This applies in particular to personnel that needs to initiate actions preventing product non-conformities from occurring, actions in case of non-conformities and to identify and register product conformity problems Personnel performing work affecting product conformity 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 conformity of the product at appropriate stages;
identify and record any instance of non-conformity;
identify procedures to correct instances of non-conformity
Trang 15The 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 conformity 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-conformity 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 these responsibilities on
to a subcontractor
NOTE Manufacturers having an FPC system, which complies with EN ISO 9001 standard and which addresses the requirements of this European Standard are recognised as satisfying the FPC requirements of the Council Directive 89/106/EEC
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 attestation of conformity level of the component shall be that given in the appropriate harmonised technical specification for that component
5.3.2.4 Design process
The factory production control system shall document the various stages in the design of products, identify the checking procedure and those individuals responsible for all stages of design During the design process itself, a record shall be kept of all checks, their results, and any corrective actions taken
Trang 16This record shall be sufficiently detailed and accurate to demonstrate that all stages of the design phase, and all checks, have been carried out satisfactorily
5.3.2.5 Traceability and marking
Individual product batches or packages shall be identifiable and traceable with regard to their production origin The manufacturer shall have written procedures ensuring that processes related to affixing traceability codes and/or markings are inspected regularly
5.3.2.6 Controls during manufacturing process
The manufacturer shall plan and carry out production under controlled conditions
5.3.2.7 Product testing and evaluation
The manufacturer shall establish procedures to ensure that the stated values of the characteristics he declares, are maintained The characteristics, and the means of control, are:
Reaction to fire: shall be subject to the tests indicated in 4.2;
The composition of the product shall be regularly controlled at a sufficient frequency to ensure that, for the CWFT product, the requirements of Table 1 are satisfied and, for the tested product, to ensure that the product remains in the same class as that obtained in the initial type testing If a fire retardant treated product (e.g some surface coated products) is used, the indications given by the manufacturer to maintain the characteristics shall be observed
Formaldehyde content shall be subject to the tests indicated in 4.3;
Where no formaldehyde containing materials are used for the product, this shall be regularly checked with
a frequency defined in the FPC manual
NOTE 1 When Class E2 product is declared there is no need to perform the corresponding part of the FPC testing, unless the upgraded class E1 of the same product is sought
Pentachlorophenol content: shall be subject to the tests indicated in 4.4;
Where no pentachlorophenol containing materials are used for the product, this shall be regularly checked with a frequency defined in the FPC manual
NOTE 2 When a product with the indication “PCP > 5 ppm " is declared, there is no need to perform the corresponding part of the FPC testing, unless for the same product an upgraded declaration for this characteristic (i.e without this indication) is sought
Breaking strength (only apply to self supporting floorings): shall be subject to the tests indicated in 5.5;
It shall be ensured that the species used for the product remain the same, and the product has the same composition and class (e.g strength class, given by visual classification) on a continuous basis, so that
no defects likely to reduce the breaking strength are present
Resistance to slip : shall be subject to the tests indicated in 4.6;
If a change in the product is made, such that it would significantly affect the slipperiness performance of the product, the initial type testing shall be repeated
Thermal conductivity: shall be subject to the tests indicated in 4.7;
Where a thermal conductivity value is declared, it shall be ensured that the continuous mean density of the material used for the product does not change by more than ± 10 % from that of the product used in the initial type testing (whether tested or using reference data)
Biological durability: shall be subject to the tests indicated in 4.8
For biological durability, it shall be ensured that the timber species used in the finished flooring product remain the same or do not change to an extent, which would change the declared use class
Trang 17For natural durability, the classification is given for species in EN 350-2 For a composite element and if a value has to be declared, it depends on the composition of the product For conferred durability classes, no FPC testing is necessary, as long as the wood used does not change and the preservative characteristics and the application method are maintained For preservative use, the parquet manufacturer shall follow indications
of internal control expressed by the preservative supplier
non-5.3.2.10 Handling, storage and packaging
The manufacturer shall have procedures providing methods of product handling and shall provide suitable storage areas preventing damage or deterioration
5.3.3 Product specific requirements
The FPC system shall:
address this European Standard,
and
ensure that the products placed on the market comply with the declared performance characteristics The FPC system shall include a product specific FPC, which identifies procedures to demonstrate compliance
of the product at appropriate stages, i.e.:
a) the controls and tests to be carried out prior to and/or during manufacture according to a frequency laid down in the FPC test plan,
In any case the operation shall lead to an equivalent level of compliance of the product as if FPC had been carried out during the production
NOTE Depending on the specific case, it can be necessary to carry out the operations referred to under a) and b), only the operations under a) or only those under b)
The operations under a) refer to the intermediate states of the product as on manufacturing machines and
Trang 18based on product type and composition, the manufacturing process and its complexity, the sensitivity of product features to variations in manufacturing parameters, etc
The manufacturer shall establish and maintain records that provide evidence that the production has been sampled and tested These records shall show clearly whether the production has satisfied the defined acceptance criteria and shall be available for at least three years
These records shall be available for inspection [only for products covered by attestation of conformity system 1]
Where the product fails to satisfy the acceptance measures, the provisions for non-complying products shall apply, the necessary corrective action shall immediately be taken and the products or batches not complying shall be isolated and properly identified
Once the fault has been corrected, the test or verification in question shall be repeated
The results of controls and tests shall be properly recorded The product description, date of manufacture, test method adopted, test results and acceptance criteria shall be entered in the records under the signature of the person responsible for the control/test
With regard to any control result not meeting the requirements of this European Standard, the corrective measures taken to rectify the situation (e.g a further test carried out, modification of manufacturing process, throwing away or putting right of product) shall be indicated in the records
Individual products or batches of products and the related manufacturing documentation shall be completely identifiable and retraceable
5.3.4 Initial inspection of factory and of FPC
Initial inspection of FPC [only for products covered by attestation of conformity system 1] shall be carried out when the production process has been finalised and in operation The factory and FPC documentation shall
be assessed to verify that the requirements of 5.3.2 and 5.3.3 are fulfilled
During the inspection it shall be verified:
a) that all resources necessary for the achievement of the product characteristics required by this European Standard are in place and correctly implemented, and
b) that the FPC-procedures in accordance with the FPC documentation are followed in practice, and
c) that the product complies with the Initial Type Testing/Type Testing samples, for which compliance with this European Standard 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
5.3.5 Continuous surveillance of FPC [only for products covered by attestation of conformity system
1 ]
Surveillance of the FPC shall be undertaken 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