SIST EN 15814:2011+A1:2012
(Main)Polymer modified bituminous thick coatings for waterproofing - Definitions and requirements
Polymer modified bituminous thick coatings for waterproofing - Definitions and requirements
This European Standard specifies the definitions and requirements of prefabricated polymer modified bituminous thick coatings used for the waterproofing of below ground structures. It applies to both one-component and two-component products. These products can be used with or without inlay. This European Standard does not apply to products that are to be used for roof waterproofing.
Kunststoffmodifizierte Bitumendickbeschichtungen zur Bauwerksabdichtung - Begriffe und Anforderungen
Diese Europäische Norm legt die Begriffe und Anforderungen für vorgefertigte kunststoffmodifizierte Bitumendickbeschichtungen zur Abdichtung von erdberührten Bauteilen fest. Sie gilt sowohl für Einkomponenten- als auch für Zweikomponentenprodukte. Diese Produkte können mit oder ohne Einlage verwendet werden. Diese Europäische Norm gilt nicht für Produkte, die zur Dachabdichtung verwendet werden.
Revêtements bitumineux épais modifiés aux polymères pour imperméabilisation - Définitions et exigences
La présente Norme européenne donne les définitions et les exigences relatives aux revêtements bitumineux épais
modifiés aux polymères utilisés pour l'imperméabilisation des structures enterrées. Elle s'applique aux produits à un
composant et à deux composants. Ces produits peuvent être utilisés avec ou sans renfort.
La présente Norme européenne ne s'applique pas aux produits utilisés pour l’étanchéité des toitures.
Bitumenske debeloslojne prevleke, modificirane s polimeri - Definicije in zahteve
Ta evropski standard določa definicije in zahteve za montažne bitumenske debeloslojne prevleke, modificirane s polimeri, ki se uporabljajo za hidroizolacijo spodaj ležečih talnih struktur. Velja za eno- in dvokomponentne proizvode. Ti proizvodi se lahko uporabljajo z vložki ali brez njih. Ta evropski standard ne velja za proizvode, ki se uporabljajo za hidroizolacije strehe.
General Information
Relations
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Bitumenske debeloslojne prevleke, modificirane s polimeri - Definicije in zahteveKunststoffmodifizierte Bitumendickbeschichtungen zur Bauwerksabdichtung - Begriffe und AnforderungenRevêtements bitumineux épais modifiés aux polymères pour imperméabilisation - Définitions et exigencesPolymer modified bituminous thick coatings for waterproofing - Definitions and requirements91.100.50Veziva. Tesnilni materialiBinders. Sealing materialsICS:Ta slovenski standard je istoveten z:EN 15814:2011+A1:2012SIST EN 15814:2011+A1:2012en,fr,de01-december-2012SIST EN 15814:2011+A1:2012SLOVENSKI
STANDARD
SIST EN 15814:2011+A1:2012
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 15814:2011+A1
October 2012 ICS 91.100.50 Supersedes EN 15814:2011English Version
Polymer modified bituminous thick coatings for waterproofing - Definitions and requirements
Revêtements bitumineux épais modifiés aux polymères pour imperméabilisation - Définitions et exigences
Kunststoffmodifizierte Bitumendickbeschichtungen zur Bauwerksabdichtung - Begriffe und Anforderungen This European Standard was approved by CEN on 14 July 2011 and includes Amendment 1 approved by CEN on 20 August 2012.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2012 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 15814:2011+A1:2012: ESIST EN 15814:2011+A1:2012
EN 15814:2011+A1:2012 (E) 2 Contents Page Foreword .31Scope .42Normative references .43Terms and definitions .54Requirements .65Evaluation of conformity .86Marking, labelling and packaging . 14Annex A (normative)
Reaction to fire — Specifications for mounting specimens in the test rigs . 15Annex ZA (informative)
!!!!Clauses of this European Standard addressing the provisions of the EU Construction Products Directive"""" . 16 SIST EN 15814:2011+A1:2012
EN 15814:2011+A1:2012 (E) 3 Foreword This document (EN 15814:2011+A1:2012) has been prepared by Technical Committee CEN/TC 361 “Project Committee - Thick synthetic modified bitumous coating masses - Definitions and requirements/Test methods”, the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by April 2013, and conflicting national standards shall be withdrawn at the latest by April 2013. Attention 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 includes Amendment 1, approved by CEN on 2012-08-20. This document supersedes EN 15814:2011. The start and finish of text introduced or altered by amendment is indicated in the text by tags!". !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, see informative Annex ZA, which is an integral part of this document." According to the CEN/CENELEC Internal Regulations, the national standards organizations 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. SIST EN 15814:2011+A1:2012
EN 15814:2011+A1:2012 (E) 4 1 Scope This European Standard specifies the definitions and requirements of prefabricated polymer modified bituminous thick coatings used for the waterproofing of below ground structures. It applies to both one-component and two-component products. These products can be used with or without inlay. This European Standard does not apply to products that are to be used for roof waterproofing. 2 Normative references The following referenced documents are indispensable for the application 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 459-2:2010, Building lime - Part 2: Test methods EN 1931, Flexible sheets for waterproofing — Bitumen, plastic and rubber sheets for roof waterproofing — Determination of water vapour transmission properties EN 13238, Reaction to fire tests for building products — Conditioning procedures and general rules for selection of substrates EN 13501-1, Fire classification of construction products and building elements — Part 1: Classification using data from reaction to fire tests EN 13823, Reaction to fire tests for building products - Building products excluding floorings exposed to the thermal attack by a single burning item EN 15812, Polymer modified bituminous thick coatings for waterproofing — Determination of crack bridging ability EN 15813, Polymer modified bituminous thick coatings for waterproofing — Determination of flexibility at low temperatures EN 15815, Polymer modified
bituminous thick coatings for waterproofing — Resistance to compression EN 15816, Polymer modified bituminous thick coatings for waterproofing — Resistance to rain EN 15817, Polymer modified bituminous thick coatings for waterproofing — Water resistance EN 15818, Polymer modified bituminous thick coatings for water proofing — Determination of dimensional stability at high temperature EN 15819, Polymer modified bituminous thick coatings for waterproofing — Reduction of the thickness of the layer when fully dried
EN 15820, Polymer modified bituminous thick coatings for waterproofing — Determination of watertightness ISO 1183-1: 2004, Plastics - Methods for determining the density of non-cellular plastics - Part_1: Immersion method, liquid pyknometer method and titration method EN ISO 2811-1:2011, Paints and varnishes — Determination of density — Part 1: Pyknometer method (ISO 2811-1:1997) EN ISO 2811-2, Paints and varnishes — Determination of density — Part 2: Immersed body (plummet) method (ISO 2811-2:1997) SIST EN 15814:2011+A1:2012
EN 15814:2011+A1:2012 (E) 5 EN ISO 3251, Paints, varnishes and plastics — Determination of non-volatile-matter content (ISO 3251:2008)
EN ISO 3451-1, Plastics — Determination of ash — Part 1: General methods (ISO 3451-1:2008) EN ISO 3923-1, Metallic powders — Determination of apparent density — Part 1: Funnel method (ISO 3923-1:2008) EN ISO 11925-2, Reaction to fire tests — Ignitability of products subjected to direct impingement of flame — Part 2: Single-flame source test (ISO/FDIS 11925-2:2010) 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 crack bridging ability ability of a product to bridge a crack that originates below ground under specified conditions and without damage 3.2 free film cured polymer modified bituminous coating emulsion based, which is tested without being applied to a substrate 3.3 inlay industrially produced material, which is incorporated as an intermediate layer when applying the coating
3.4 PMBC !Polymer Modified Bituminous thick Coating emulsion based, with or without admixtures, such as additives and mineral aggregates, comprising of one or two components" 3.5 pressure water water in ground with hydrostatic pressure
SIST EN 15814:2011+A1:2012
EN 15814:2011+A1:2012 (E) 6 4 Requirements All PMBC according to this European Standard have to fulfil the general requirements of Table 1. Table 1 — General requirements Column 1 2 3 Line Characteristic Requirement Test method1 Crack bridging ability Class CB 0 No requirement Class CB 1 No damage
Crack width ≥ 1 mm dry layer thickness
≥ 3 mm (MLV) Class CB 2 No damage
Crack width ≥ 2 mm dry layer thickness
≥ 3 mm (MLV) EN 15812 Method A or BNOTE The test method has to be declared with the classification.
2 Resistance to rain Class R0 No require-ment
Class R1 ≤ 24 h
wet layer thickness ≥ 3 mm (MLV) Class R2
≤ 8 h
wet layer thickness ≥ 3 mm (MLV) Class R3 ≤ 4 h
wet layer
thickness ≥ 3 mm (MLV) EN 15816 3 Water resistance 1.No colouration of the water 2.No debonding from inlay, if used dry layer ≥ 4 mm No changes to the material according to EN 15817,
EN 15817 4 Flexibility at low temperature !deleted text" No cracks
EN 15813 5 Dimensional stability at high temperature !deleted text" No sliding or draining down
EN 15818 SIST EN 15814:2011+A1:2012
EN 15814:2011+A1:2012 (E) 7 Table 1 (continued) Column 1 2 3 Line Characteristic Requirement Test method6 Reduction of layer thickness when fully dried ≤ 50 % (MLV) EN 15819 7 Reaction to fire Class to be declared according to EN 13501-1
Testing in accordance with the specifications in the classification standard EN 13501-1and Annex A.
8 Watertightness a Class W1 ≥ 24 h at 0,0075 N/mm2dry layer
thickness without inlay ≥ 3 mm (MLV) Class W2A ≥ 72 h at 0,075 N/mm2 dry layer thickness with inlay ≥ 4 mm with inlay (MLV) Class W2B ≥ 72 h at
0,075 N/mm2 dry layer thickness without inlay ≥ 4 mm without inlay (MLV) EN 15820 9 Resistance to compression a Class C0 No requirement Class C1 Stabilization at ≤ 50 % (change maximum 3 % within 3 subse-quent days) 0,06 MN/m2dry layer thickness
≥ 3 mm (MLV) Class C2A Stabilization at ≤ 50 % (change maximum 3 % within 3 subse-quent days) 0,30 MN/m2dry layer thickness
≥ 4 mm with inlay (MLV) Class C2B Stabilization at ≤ 50 % (change maximum 3 % within 3 subse-quent days) 0,30 MN/m2 dry layer thickness
≥ 4 mm without inlay (MLV) EN 15815 !a The testing procedure of characteristics are also related to durability aspects." manufacturer's limiting value (MLV) value stated by the manufacturer to be met during testing. The manufacturer's limiting value can be a minimum or a maximum value according to statements made under product characteristics of this document
When required, the water vapour diffusion resistance shall be tested in accordance with EN 1931. SIST EN 15814:2011+A1:2012
EN 15814:2011+A1:2012 (E) 8 ! 5 Evaluation of conformity 5.1 General The compliance of PMBC 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 5.2.1 General Initial Type Testing and Type Testing shall be performed to demonstrate compliance with this European standard. All essential characteristics for which the manufacturer declares performances, are subject to Initial Type Testing. In addition, the need to perform Type Tests applies to all other characteristics included in a standard when the manufacturer claims compliance, unless the standard gives provisions (e.g. use of previously existing data, CWFT and conventionally accepted performance) for declaring performances without performing tests. 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). See Annex ZA. 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 that same characteristics for all products within that same family (a product may be in different families for different characteristics). NOTE 2 Products may be in different families for different characteristics. NOTE 3 Reference to the test method standards should 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 PMBC (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 PMBC 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. SIST EN 15814:2011+A1:2012
EN 15814:2011+A1:2012 (E) 9 Where 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 re-assessed. 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 the marking, although this does not replace the responsibility on the PMBC designer to ensure that the PMBC 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 PMBC 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 organizing the effective implementation of the FPC system. 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 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. 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 conformity of the product.
SIST EN 15814:2011+A1:2012
EN 15814:2011+A1:2012 (E) 10 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 fulfill his responsibilities according to this European Standard. If the manufacturer has part of the product designed, manufactured, assembled, packed, processed and/or labeled 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 9000 series standard and which addresses the requirements of this European Standard are recognized as satisfying the FPC requirements of the Council Directive 89/106/EEC. 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 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. This record shall be sufficiently detailed and accurate to demonstrate that all stages of the design phase, and all checks, have been carried out satisfactorily. SIST EN 15814:2011+A1:2012
EN 15814:2011+A1:2012 (E) 11
5.3.2.5
Controls during manufacturing process The manufacturer shall plan and carry out production under controlled conditions. 5.3.2.6 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 given in Table 2. Table 2 — Factory Production Control
Characteristic Test method Production control frequency Tolerances Flexibility at low temperature EN 15813 Weekly or per batch According to EN 15813 Dimensional stability at high temperature EN 15818 Weekly or per batch According to EN 15818 For the A-component
— Solids content EN ISO 3251 Weekly or per batch ± 4 % absolute — Ash content (only for products with ash content ≥ 5 mass %) EN ISO 3451-1 with testing at a temperature of (75 ± 25) °C Weekly or per batch ± 2 % absolute For the B-component (only for two component PMBC)
— Bulk density (for powder
component) EN ISO 3923-1 Weekly or per batch ± 0,1 g/cm3 — Density (for liquid
component) EN ISO 2811-1 Weekly or per batch ± 0,1 g/cm3 For the cured PMBC
— Density
EN ISO 2811-2
Weekly or per batch
± 0,1 g/cm3 Identification for inlays:
— Type — Mass per unit area — Strength and elongation at break To be stated. Depending on the type of inlay, a suitable test has to be applied at incoming products. At incoming products
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For the purpose of the Factory Production Control alternative tests to those given in Table 2 may be used, provided that a correlation of the results between both tests, for the product in question, is established. The use of alternative tests shall be recorded and maintained.
5.3.2.7 Non-complying products The manufacturer shall have written procedures which specify how non-complying products shall be dealt with. Any such events shall be recorded as they occur and these records shall be kept for the period defined in the manufacturer’s written procedures. SIST EN 15814:2011+A1:2012
EN 15814:2011+A1:2012 (E) 12
5.3.2.8 Corrective action The manufacturer shall have documented procedures that instigate action to eliminate the cause of non-conformities in order to prevent recurrence. 5.3.2.9 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 v address this European Standard and v 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, and/or b) the verifications and tests to be carried out on finished products according to a frequency laid down in the FPC test plan on basis of Table 2. If the manufacturer uses only finished products, the operations under b) shall lead to an equivalent level of compliance of the product as if FPC had been carried out during the production. If the manufacturer carries out parts of the production himself, the operations under b) may be reduced and partly replaced by operations under a). Generally, the more parts of the production that are carried out by the manufacturer, the more operations under b) may be replaced by operations under a). 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 their adjustment, and measuring equipment etc. These controls and tests and their frequency shall be chosen based 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. 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. SIST EN 15814:2011+A1:2012
EN 15814:2011+A1:2012 (E) 13 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 shall be carried out when the production process has been finalized and in operation. The factory and FPC documentation shall be assessed to verify that the requirements of clause 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
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. Checks shall be made to ensure that the test plans are still correctly implemented and that the production equipment is still correctly maintained and calibrated. The records of tests and measurement made during the production process and to finished products shall be reviewed to ensure that the values obtained still correspond with those values for the samples submitted to Initial Type Testing/Type Testing and that the correct actions have been taken for non-compliant devices. 5.3.6 Procedure for modifications If modifications are made to the product, production process or FPC system that could affect any of the product characteristics required by this standard, then all the characteristics
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