EN 13212-2011 en Road marking materials - Requirements for factory production control《眼科光学 接触镜片护理品 储藏寿命的测定指南》.pdf

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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN 13212:2011Road marking materials Requirements for factoryproduction controlBS EN 13212:2011 BRITISH STANDARDNational forewordThis British Standard is the UK implementation

2、of EN 13212:2011. Itsupersedes BS EN 13212:2001 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee B/509/2, Horizontal road markings and road studs.A list of organizations represented on this committee can beobtained on request to its secretary.This public

3、ation does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. BSI 2011ISBN 978 0 580 72624 8ICS 93.080.20Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the auth

4、ority of theStandards Policy and Strategy Committee on 30 June 2011.Amendments issued since publicationDate Text affectedBS EN 13212:2011EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 13212 June 2011 ICS 93.080.20 Supersedes EN 13212:2001English Version Road marking materials - Requirements fo

5、r factory production control Produits de marquage routier - Exigences pour le contrle de la production en usine Straenmarkierungsmaterialien - Anforderungen an die werkseigene Produktionskontrolle This European Standard was approved by CEN on 22 April 2011. CEN members are bound to comply with the C

6、EN/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 C

7、entre 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

8、the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Roma

9、nia, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2011 CEN All rights of exploitation in any form and by any means reserved

10、worldwide for CEN national Members. Ref. No. EN 13212:2011: EBS EN 13212:2011EN 13212:2011 (E) 2 Contents Foreword . 31 Scope . 42 Normative references . 43 Terms and definitions 44 General requirements for factory production control (FPC) 5Annex A (normative) Preformed self-adhesive road marking Te

11、st method for determination of mass per unit area of the adhesive. . 13BS EN 13212:2011EN 13212:2011 (E) 3 Foreword This document (EN 13212:2011) has been prepared by Technical Committee CEN/TC 226 “Road equipment”, the secretariat of which is held by AFNOR. This European Standard shall be given the

12、 status of a national standard, either by publication of an identical text or by endorsement, at the latest by December 2011, and conflicting national standards shall be withdrawn at the latest by December 2011. Attention is drawn to the possibility that some of the elements of this document may be

13、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 13212:2001. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implem

14、ent this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Swit

15、zerland and the United Kingdom. The Annex A of this European Standard is normative. This European Standard is one of a package of inter-related European Standards with a common date of withdrawal (dow) fixed on December 2011 (including the request of an extension for the co-existence period): EN 179

16、0, Road marking materials Preformed road markings, EN 1824, Road marking materials Road trials, EN 1871, Road marking materials Paint, thermoplastic and cold plastic materials - Specifications, EN 12802, Road marking materials Laboratory methods for identification, EN 13197, Road marking materials W

17、ear simulator Turntable, EN 13212, Road marking materials Requirements for factory production control, EN 13459, Road marking materials Sampling and testing. BS EN 13212:2011EN 13212:2011 (E) 4 1 Scope This document gives the requirements for factory production control (FPC) for the manufacturer of

18、road marking materials This document specifies which types of test have to be taken into consideration within the FPC but it leaves the precise methods to be applied to be dependent on the characteristics of the manufacturers installation and production methods. The precise parameters and methods wi

19、ll be found in the written procedures agreed between the manufacturer and the third party responsible for the initial assessment of the FPC. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited

20、applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN 1423, Road marking materials Drop on materials Glass beads, antiskid aggregates and mixtures of the two EN 1424, Road marking materials Premix glass beads EN 1463 (all parts), Road m

21、arking materials Retroreflecting road studs EN 1790, Road marking materials Preformed road markings EN 1871, Road marking materials Paint, thermoplastic and cold plastic materials Specifications EN 12802, Road marking materials Laboratory methods for identification EN ISO 9001:2008, Quality manageme

22、nt systems Requirements (ISO 9001:2008) ISO 5725-2, Accuracy (trueness and precision) of measurement methods and results Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method 3 Terms and definitions For the purpose of this document, the foll

23、owing terms and definitions apply. 3.1 retained sample sample, labelled and stored for some period of time, to be used in case additional testing or verification is needed 3.2 batch amount of product produced as one complete operation not being part of a continuous process 3.3 factory production con

24、trol (FPC) permanent internal control of production exercised by the product manufacturer 3.4. factory single site of production consisting of one or more production lines where raw materials are converted into final products BS EN 13212:2011EN 13212:2011 (E) 5 4 General requirements for factory pro

25、duction control (FPC) 4.1 General The manufacturer shall establish, document and maintain an FPC system to ensure that the products placed on the market conform to the declared performance characteristics. The FPC system shall consist of written procedures (works manual), regular inspections and tes

26、ts 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. Records shall remain legible, readily identifiable and retrievable for the period defined in the manufacturers written procedures. The manufa

27、cturer shall be responsible for organizing the effective implementation of the FPC system. Tasks and responsibilities shall be documented and this documentation shall be kept up-to-date. In each factory, the manufacturer may delegate the action to a person who shall have the necessary authority to:

28、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 establish procedures to ensure that the production tolerances allow for the produ

29、ct performances to be in conformity with the declared values, derived from initial type testing. The procedures shall be chosen in the interests of ensuring that the level of confidence obtained by the production control is effectively the same for all conceivable situations of manufacture. All thes

30、e procedures, elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic manner in the form of written policies and procedures. The manufacturer shall implement these procedures and instructions and record the operations and results. The results shall be us

31、ed to correct the effects of any deviations and, where necessary, treat any resulting non-conformity and, if required, to revise the FPC system to rectify the cause of non-conformity. The results of inspections, tests or assessments requiring action shall be recorded, as shall any action taken. The

32、action to be taken when control values or criteria are not met shall be recorded and retained for the period specified in the manufacturers FPC procedures. A complaint register shall contain a short chronological view of the received complaints concerning the products covered by this FPC, identifyin

33、g the source of complaint, its content and its follow-up. The complaint register shall contain the additional documents relating to the treatment of the complaint. The FPC system shall at least include the necessary procedures for: records and treatment of non-conformity; personnel; installations an

34、d equipment; raw materials; manufacturing process; conformity control; BS EN 13212:2011EN 13212:2011 (E) 6 packaging, labelling, handling and storage; final testing. An FPC system conforming to the requirements of EN ISO 9001, and made specific to the requirements of the specific product standard an

35、d this document shall be considered to satisfy the above requirements. 4.2 System requirements 4.2.1 Personnel 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 pe

36、rsonnel that need 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 (e.g. operator, sample taking, lab-assistant, warehouse manag

37、er.) shall be competent on the basis of appropriate education, training, skills and experience for which records shall be maintained. 4.2.2 Installations and equipment All weighting, measuring and testing equipment necessary to achieve, or produce evidence of conformity shall be calibrated or verifi

38、ed and regularly inspected according to documented procedures, frequencies and criteria. Control of monitoring and measuring devices shall comply with the appropriate clause of EN ISO 9001. All equipment used in the manufacturing process shall be regularly inspected and maintained to ensure use, wea

39、r or failure does not cause inconsistency in the manufacturing process. Inspections and maintenance shall be carried out and recorded in accordance with the manufacturers written procedures and the records retained for the period defined in the manufacturers FPC procedures. The manufacturer shall ha

40、ve a scheme or a flow sheet of the plant equipment, resuming the whole production process, from the incoming of the raw material to the storage of the products. This document is the basis for the documentation of the manufacturing processes (see 4.2.4). 4.2.3 Raw materials The specifications of all

41、incoming raw materials and components shall be documented, as shall the inspection scheme for ensuring their conformity. The verification of conformity of the raw material with the specification shall be in accordance with EN ISO 9001:2008, 7.4.3. The manufacturer shall prepare and keep up-to-date d

42、ocumented procedures and instructions for: the use of the relevant materials from “approved suppliers“; the conformity control and testing of raw materials: cullets (glass composition), binder, pigment, fillers, solvent, additive, premix glass beads; drop-on antiskid aggregates (also used in mixture

43、s with glass beads) may be either CE-marked products or they shall be tested by the manufacturer as in 4.3.2.4 (acting as a user). 4.2.4 Design process The FPC system shall document the various stages in the design of products; identify the checking procedure and those individuals responsible for al

44、l stages of design. BS EN 13212:2011EN 13212:2011 (E) 7 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,

45、 have been carried out satisfactorily. Compliance with EN ISO 9001:2008, 7.3 shall be deemed to satisfy the requirements of this sub-clause. The manufacturing process shall be documented. Processes may also be shown by flowcharts indicating related documents and responsibilities (see also 4.2.3). Pr

46、ocesses which are covered by this document and undertaken by subcontractors shall be documented by the manufacturer or the subcontractor as if done on the site of the manufacturer. 4.2.5 Production control The manufacturer shall plan and carry out production under controlled conditions. Compliance w

47、ith EN ISO 9001:2008, 7.5.1 and 7.5.2 shall be deemed to satisfy the requirements of this subclause. The manufacturer shall have a FPC system in order to ensure that all manufactured products fulfil the relevant requirements of the concerned product standard. The test methods to be applied and the t

48、olerances for the results of all the tests used shall be specified in the FPC system of the manufacturer. The minimum frequency of final testing for each product shall be as in 4.3.2. The laboratory for internal control shall have the measuring and test equipments necessary to carry out the tests re

49、quired by this document and the product standard. The manufacturer may call upon measuring and test equipment from an external laboratory. The mutual obligations of the manufacturer and the external laboratory for the internal control shall be defined in a written agreement. The appropriate calibrations shall be carried out on defined measuring and testing equipment. If products have been delivered before all the results of testing are available, a procedure and records shall