Liquid applied water impermeable products for use beneath ceramic tiling bonded with adhesives - Requirements, test methods, assessment and verification of constancy of performance, classification and marking

This European Standard applies to all liquid-applied water impermeable products, based on polymer modified cementitious mortars, dispersions and reaction resin coatings, used beneath ceramic tiling, for external tile installations on walls and floors and in swimming pools.
This European Standard gives the terminology concerning the products and specifies the test methods and the values of performance requirements for liquid-applied water impermeable products associated with tile adhesives.
This European Standard specifies the evaluation of conformity and the classification and designation of liquid-applied water impermeable products beneath ceramic tiling.
This European Standard does not contain recommendations for the design and installation of ceramic tiles and grouts in combination with water impermeable products.
NOTE 1   Liquid-applied water impermeable products may also be used beneath other types of tiles (natural and agglomerated stones, etc.), where they do not adversely affect these materials.
NOTE 2   The user of this European Standard should be familiar with normal laboratory practice. This European Standard does not purport to address all the safety problems associated with its use. It is the responsibility of the user to establish appropriate health and safety practices and to ensure compliance with any European and national regulatory conditions.

Flüssig zu verarbeitende wasserundurchlässige Produkte im Verbund mit keramischen Fliesen und Plattenbelägen - Anforderungen, Prüfverfahren, Bewertung und Überprüfung der Leistungsbeständigkeit, Klassifizierung und Bezeichnung

Produits d'imperméabilisation appliqués en phase liquide utilisés sous carrelage collé - Spécifications, méthodes d'essai, évaluation et vérification de la constance de performance, classification et marquage

La présente Norme européenne s’applique à tous les produits d’imperméabilisation à base de mortiers de ciment modifiés par des polymères, de résine réactive et de résine en dispersion appliqués en phase liquide et utilisés sous carrelage collé, pour la pose, en extérieur, des carreaux céramiques au sol et mur, et dans les piscines.
La présente Norme européenne donne la terminologie concernant les produits et prescrit les méthodes d’essai ainsi que les exigences de performance des produits d’imperméabilisation appliqués en phase liquide en association avec des colles à carrelage.
La présente Norme européenne spécifie l’évaluation et la vérification de la constance de performance, la classification le marquage des produits d’imperméabilisation appliqués en phase liquide destinés à être utilisés sous du carrelage céramique.
La présente Norme européenne ne contient pas de recommandations relatives à la conception et à la pose de carreaux céramiques ni à la réalisation de joints, en association avec les produits d’imperméabilisation.
NOTE Les produits d’imperméabilisation appliqués en phase liquide peuvent également être utilisés pour la pose d’autres types de carreaux (pierres naturelles ou agglomérées, etc.), s’ils sont compatibles avec ces matériaux.

Tekoče vgrajevani za vodo neprepustni izdelki za uporabo pod keramičnimi ploščicami, lepljenimi z lepili - Zahteve, preskusne metode, ocenjevanje in preverjanje nespremenljivosti lastnosti, razvrščanje in označevanje

Ta evropski standard se uporablja za vse tekoče vgrajevane za vodo neprepustne izdelke na osnovi polimer-cementnih malt, disperzij in malt na osnovi smol, ki se uporabljajo pod keramičnimi ploščicami za namestitev zunanjih ploščic na zidove in tla ter v bazene. Ta evropski standard podaja terminologijo na področju izdelkov in določa preskusne metode in vrednosti zahtev glede zmogljivosti tekoče vgrajevanih za vodo neprepustnih izdelkov, povezanih z lepili za ploščice. Ta evropski standard določa vrednotenje skladnosti ter klasifikacijo in označevanje tekoče vgrajevanih za vodo neprepustnih izdelkov pod keramičnimi ploščicami. Ta evropski standard ne vključuje priporočil za načrtovanje in vgradnjo keramičnih ploščic in lepil v kombinaciji z za vodo neprepustnimi izdelki. OPOMBA 1:   Tekoče vgrajevani za vodo neprepustni izdelki se lahko uporabljajo tudi pod ploščicami drugih vrst (iz naravnega in aglomeriranega kamna itd.), če ne vplivajo škodljivo na te materiale. OPOMBA 2:   Uporabniki tega evropskega standarda morajo biti seznanjeni z običajno laboratorijsko prakso. Ta evropski standard ne obravnava vseh varnostnih težav, ki se nanašajo na njegovo uporabo. Za vzpostavitev ustreznih varnostnih in zdravstvenih praks ter za zagotovitev skladnosti s katerimi koli evropskimi in nacionalnimi regulativnimi pogoji je odgovoren uporabnik.

General Information

Status
Published
Publication Date
14-Feb-2017
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
15-Feb-2017
Completion Date
15-Feb-2017

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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.PLþQLPLMHFlüssig zu verarbeitende wasserundurchlässige Produkte im Verbund mit keramischen Fliesen und Plattenbelägen - Anforderungen, Prüfverfahren, Bewertung und Überprüfung der Leistungsbeständigkeit, Klassifizierung und BezeichnungProduits d'imperméabilisation appliqués en phase liquide utilisés sous carrelage collé - Spécifications, méthodes d'essai, évaluation et vérification de la constance de performance, classification et marquageLiquid applied water impermeable products for use beneath ceramic tiling bonded with adhesives - Requirements, test methods, assessment and verification of constancy of performance, classification and marking91.100.50Veziva. Tesnilni materialiBinders. Sealing materials91.100.23Ceramic tilesICS:Ta slovenski standard je istoveten z:EN 14891:2017SIST EN 14891:2017en,fr,de01-maj-2017SIST EN 14891:2017SLOVENSKI

STANDARDSIST EN 14891:2012/AC:2013SIST EN 14891:20121DGRPHãþD
SIST EN 14891:2017
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 14891
February
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{ sä s r rä w r Supersedes EN
s v z { sã t r s tEnglish Version

Liquid applied water impermeable products for use beneath ceramic tiling bonded with adhesives æ Requirementsá test methodsá assessment and verification of constancy of performanceá classification and marking Produits d 5imperméabilisation appliqués en phase liquide utilisés sous carrelage collé æ Spécificationsá méthodes d 5essaiá évaluation et vérification de la constance de performanceá classification et marquage Flüssig zu verarbeitende wasserundurchlässige Produkte im Verbund mit keramischen Fliesen und Plattenbelägen æ Anforderungená Prüfverfahrená Bewertung und Überprüfung der Leistungsbeständigkeitá Klassifizierung und Bezeichnung This European Standard was approved by CEN on

y November
t r s xä

egulations which stipulate the conditions for giving this European Standard the status of a national standard without any alterationä Upætoædate lists and bibliographical references concerning such national standards may be obtained on application to the CENæCENELEC Management Centre or to any CEN memberä

translation under the responsibility of a CEN member into its own language and notified to the CENæCENELEC Management Centre has the same status as the official versionsä

CEN members are the national standards bodies of Austriaá Belgiumá Bulgariaá Croatiaá Cyprusá Czech Republicá Denmarká Estoniaá Finlandá Former Yugoslav Republic of Macedoniaá Franceá Germanyá Greeceá Hungaryá Icelandá Irelandá Italyá Latviaá Lithuaniaá Luxembourgá Maltaá Netherlandsá Norwayá Polandá Portugalá Romaniaá Serbiaá Slovakiaá Sloveniaá Spainá Swedená Switzerlandá Turkey and United Kingdomä

EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre:
Avenue Marnix 17,
B-1000 Brussels

t r s y CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Membersä Refä Noä EN

s v z { sã t r s y ESIST EN 14891:2017

EN 14891:2017 (E) 2 Contents Page European foreword ....................................................................................................................................................... 4 1 Scope .................................................................................................................................................................... 5 2 Normative references .................................................................................................................................... 5 3 Terms and definitions ................................................................................................................................... 6 4 Product characteristics ................................................................................................................................. 7 4.1 General ................................................................................................................................................................ 7 4.2 Release of dangerous substances .............................................................................................................. 7 5 Testing, assessment and sampling methods ......................................................................................... 8 6 Assessment and verification of constancy of performance (AVCP) .............................................. 8 6.1 General ................................................................................................................................................................ 8 6.2 Type testing ....................................................................................................................................................... 8 6.2.1 General ................................................................................................................................................................ 8 6.2.2 Test samples, testing and compliance criteria ..................................................................................... 9 6.2.3 Test reports ....................................................................................................................................................... 9 6.2.4 Shared other party results ........................................................................................................................... 9 6.3 Factory Production Control (FPC) .......................................................................................................... 10 6.3.1 General ............................................................................................................................................................. 10 6.3.2 Requirements ................................................................................................................................................ 10 6.3.3 Product specific requirements ................................................................................................................ 13 6.3.4 Procedure for modifications .................................................................................................................... 14 6.3.5 One-off products, pre-production products (e.g. prototypes) and products produced in very low quantity .................................................................................................................................... 14 7 Classification and designation ................................................................................................................. 15 8 Marking and labelling ................................................................................................................................. 16 Annex A (normative)

Testing, assessment and sampling methods......................................................... 18 A.1 Sampling .......................................................................................................................................................... 18 A.2 Test conditions .............................................................................................................................................. 18 A.3 Test materials ................................................................................................................................................ 18 A.3.1 General ............................................................................................................................................................. 18 A.3.2 Ceramic tiles ................................................................................................................................................... 18 A.3.3 Test substrate ................................................................................................................................................ 18 A.3.3.1 Concrete slab ................................................................................................................................................. 18 A.3.3.2 Other substrates (optional) ...................................................................................................................... 18 A.3.4 Ceramic tile adhesive .................................................................................................................................. 19 A.3.5 Sodium hypochlorite ................................................................................................................................... 19 A.4 Apparatus ........................................................................................................................................................ 19 A.4.1 Weight (Mass) ................................................................................................................................................ 19 SIST EN 14891:2017

EN 14891:2017 (E) 3 A.4.2 Pull head plates ............................................................................................................................................. 19 A.4.3 Machine for pull testing .............................................................................................................................. 19 A.4.4 Air-circulating oven ..................................................................................................................................... 19 A.4.5 Mould ................................................................................................................................................................ 19 A.4.6 Jig ........................................................................................................................................................................ 21 A.4.7 Equipment for permeability test ............................................................................................................. 22 A.4.8 Machine for tensile testing ........................................................................................................................ 23 A.5 Mixing of liquid-applied water impermeable products .................................................................. 23 A.6 Tensile adhesion tests ................................................................................................................................. 23 A.6.1 Preparation of test pieces .......................................................................................................................... 23 A.6.2 Initial tensile adhesion strength ............................................................................................................. 24 A.6.3 Tensile adhesion strength after water contact .................................................................................. 24 A.6.4 Alternative method for tensile adhesion strength after water contact .................................... 24 A.6.5 Tensile adhesion strength after heat ageing ...................................................................................... 25 A.6.6 Tensile adhesion strength after freeze–thaw cycle .......................................................................... 25 A.6.7 Tensile adhesion strength after contact with chlorinated water ................................................ 25 A.6.8 Alternative method for tensile adhesion strength after contact with chlorinated water ................................................................................................................................................................. 26 A.6.9 Tensile adhesion strength after contact with lime water .............................................................. 26 A.6.10 Evaluation and expression of the results ............................................................................................. 27 A.7 Water impermeability ................................................................................................................................ 27 A.8 Crack bridging ability .................................................................................................................................. 29 A.8.1 General ............................................................................................................................................................. 29 A.8.2 Crack bridging ability under standard conditions ........................................................................... 30 A.8.3 Crack bridging ability at low temperature .......................................................................................... 30 A.9 Test report ...................................................................................................................................................... 30 Annex ZA (informative)

Relationship of this European Standard with Regulation (EU) No.305/2011 .................................................................................................................................................. 32 ZA.1 Scope and relevant characteristics ........................................................................................................ 32 ZA.2 System of Assessment and Verification of Constancy of Performance (AVCP) ...................... 33 ZA.3 Assignment of AVCP tasks ......................................................................................................................... 33 Bibliography ................................................................................................................................................................. 35

SIST EN 14891:2017

EN 14891:2017 (E) 4 European foreword This document (EN 14891:2017) has been prepared by Technical Committee CEN/TC 67 “Ceramic tiles”, the secretariat of which is held by UNI. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by August 2017, and conflicting national standards shall be withdrawn at the latest by December 2018. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights. This document supersedes EN 14891:2012. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports basic requirements for construction works of Regulation No. 305/2011. For relationship with this Regulation, see informative Annex ZA, which is an integral part of this document. The significant technical changes between this European Standard and the previous edition are listed herewith: — Clause 3.7 replacement of the term “Fundamental” with “Basic”; — Clause 4, Tables 1; — New Clause 5; — New Clause 6 in accordance with CEN Guidance documents; — New Annex ZA (informative) in accordance with the CPR (Regulation (EU) No. 305/2011) and the Commission Delegated Regulations (EU) No. 568/2014 relative to the assessment and verification of constancy of performance. 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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. SIST EN 14891:2017

EN 14891:2017 (E) 5 1 Scope This European Standard applies to all liquid-applied water impermeable products, based on polymer modified cementitious mortars, dispersions and reaction resin coatings, used beneath ceramic tiling, for external tile installations on walls and floors and in swimming pools. This European Standard gives the terminology concerning the products and specifies the test methods and the values of performance requirements for liquid-applied water impermeable products associated with tile adhesives. This European Standard specifies the assessment and verification of constancy of performance, and the classification and marking of liquid-applied water impermeable products beneath ceramic tiling. This European Standard does not contain recommendations for the design and installation of ceramic tiles and grouts in combination with water impermeable products. NOTE Liquid-applied water impermeable products may also be used beneath other types of tiles (natural and agglomerated stones, etc.), where they do not adversely affect these materials. 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN 196-1:2016, Methods of testing cement - Part 1: Determination of strength EN 197-1:2011, Cement - Part 1: Composition, specifications and conformity criteria for common cements EN 480-1:2014, Admixtures for concrete, mortar and grout - Test methods - Part 1: Reference concrete and reference mortar for testing EN 1008, Mixing water for concrete - Specification for sampling, testing and assessing the suitability of water, including water recovered from processes in the concrete industry, as mixing water for concrete EN 1067, Adhesives - Examination and preparation of samples for testing prEN 12004-1:2014, Adhesives for tiles — Part 1: Requirements, evaluation of conformity, classification and designation EN 12004-2:2016, Adhesives for tiles — Part 2: Test methods EN 12390-2, Testing hardened concrete - Part 2: Making and curing specimens for strength tests EN 12620:2002+A1:2008, Aggregates for concrete EN 14411:2016, Ceramic tiles — Definitions, classification, characteristics, evaluation of conformity and marking EN ISO 15605, Adhesives - Sampling (ISO 15605) SIST EN 14891:2017

EN 14891:2017 (E) 6 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 liquid-applied water impermeable product single- or multicomponent waterproofing material applied in a uniform layer, beneath ceramic tiling Note 1 to entry: The water impermeable layer can include a reinforcing cloth or mesh. 3.2 polymer modified cementitious liquid-applied water impermeable product CM mixture of hydraulic binding agents, aggregates and organic additives that has only to be mixed with water or liquid admixture just before use 3.3 dispersion liquid-applied water impermeable product DM ready for use mixture of organic binding agent(s) in the form of an aqueous polymer dispersion, organic additives and mineral fillers 3.4 reaction resin liquid-applied water impermeable product RM one or more component mixture of synthetic resin, mineral fillers and organic additives in which hardening occurs by chemical reaction 3.5 crack bridging ability ability of the hardened waterproofing material to withstand propagation of the cracks without deterioration 3.6 primer liquid coating applied to the surface, prior to the application of a liquid product, to improve adhesion and durability of the bond 3.7 basic characteristics characteristics that a liquid-applied water impermeable product absolutely has to have 3.8 optional characteristics characteristics for specific service conditions where enhanced levels of performance are required or which provide further information about its general performance SIST EN 14891:2017

EN 14891:2017 (E) 7 4 Product characteristics 4.1 General Characteristics of the liquid-applied water impermeable products shall comply with the requirements specified in Table 1, Section 1.a. When needed for special service condition(s) of liquid-applied water impermeable products, its optional characteristics shall comply with the requirements specified in Table 1, Section 1.b. The amount of water and/or liquid admixture required for preparing the cementitious liquid-applied water impermeable products shall be the same for all tests. Table 1 — Product requirements 1 a BASIC CHARACTERISTICS (CM – DM – RM) Characteristic Requirement Test method Initial tensile adhesion strength

· 0,5 N/mm2 A.6.2 Tensile adhesion strength after water contact
· 0,5 N/mm2 A.6.3 or A.6.4 Tensile adhesion strength after heat ageing
· 0,5 N/mm2 A.6.5 Tensile adhesion strength after freeze–thaw cycles
· 0,5 N/mm2 A.6.6 Tensile adhesion strength after contact with lime water
· 0,5 N/mm2 A.6.9 Waterproofing No penetration and
¶ 20 g weight gain A.7 Crack bridging ability under standard conditions

· 0,75 mm A.8.2 1 b OPTIONAL CHARACTERISTICS Characteristic Requirement Test method Tensile adhesion strength after contact with chlorinated water (P)

· 0,5 N/mm2 A.6.7 or A.6.8 Crack bridging ability at low temperature (- 5°C) (O1)

· 0,75 mm A.8.3 Crack bridging ability at very low temperature (- 20°C) (O2)

· 0,75 mm A.8.3 4.2 Release of dangerous substances Materials used in products shall not release any dangerous substances in excess of the maximum permitted levels specified in a relevant European Standard for the material or permitted in the national regulations of the member state of destination. 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 website on EUROPA accessed through: http://ec.europa.eu/growth/tools-databases/cp-ds/

SIST EN 14891:2017

EN 14891:2017 (E) 8 5 Testing, assessment and sampling methods Testing and assessment methods and requirements for sampling shall be as set out in Annex A. 6 Assessment and verification of constancy of performance (AVCP) 6.1 General The compliance of liquid-applied water impermeable products with the requirements of this standard and with the performances declared by the manufacturer in the DoP shall be demonstrated by: — determination of the product type on the base of 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 conformity of the product with its declared performances. 6.2 Type testing 6.2.1 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 liquid applied water impermeable 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. NOTE 1 Products are grouped in different families for different characteristics. NOTE 2 The assessment method standards are chosen 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 liquid applied water impermeable product (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 product 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 (e.g. cement) are used whose characteristics have already been determined by the component supplier on the basis of conformity with other product standards, these characteristics need SIST EN 14891:2017

EN 14891:2017 (E) 9 not be re-assessed to demonstrate compliance with the European Standard. 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 liquid-applied water impermeable products manufacturer to ensure that liquid-applied water impermeable products as a whole is correctly manufactured and its component products have the declared performance values. 6.2.2 Test samples, testing and compliance criteria The number of samples of liquid-applied water impermeable product and the testing method to be tested/assessed shall be in accordance with Annex A (A.6, A.7 and A.8) and Table 2. Table 2 — Number of samples to be tested and compliance criteria Characteristic Requirement Assessment method No. of samples Compliance criteria Initial tensile adhesion strength Clause 4 A.6 1 Table 1.a of Clause 4 Tensile adhesion strength after water contact Clause 4 A.6 1 Table 1.a of Clause 4 Tensile adhesion strength after heat ageing Clause 4 A.6 1 Table 1.a of Clause 4 Tensile adhesion strength after freeze–thaw cycles Clause 4 A.6 1 Table 1.a of Clause 4 Tensile adhesion strength after contact with lime water Clause 4 A.6 1 Table 1.a of Clause 4 Waterproofing Clause 4 A.7 1 Table 1.a of Clause 4 Crack-bridging ability under standard conditions Clause 4 A.8 1 Table 1.a of Clause 4 Tensile adhesion strength after contact with chlorinated water Clause 4 A.6 1 Table 1.b of Clause 4 Crack-bridging ability at low temperature Clause 4 A.8 1 Table 1.b of Clause 4 6.2.3 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 liquid-applied water impermeable product to which they relate. 6.2.4 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: SIST EN 14891:2017

EN 14891:2017 (E) 10 — 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 (by licence, contract, or any other type of written consent) 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. 6.3 Factory Production Control (FPC) 6.3.1 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 o

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