1、STD=BSI BS EN L3312-4-ENCL 2OOL H Lb24bb9 0903588 TL2 BRITISH STANDARD Biotechnology - Performance criteria for piping and instrumentation - Part 4: Tubes and pipes The European Standard EN 13312-4:2001 has the status of a British Standard ICs 07.080; 07.100.01 m BS EN 13312-4:2001 NO COPYING WITHOU
2、T BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW STD-BSI BS EN 13312-4-ENGL 2001 1624669 0903587 959 BS EN 13312-4:2001 Amd. No. This British Standard, having been prepared under the direction of the Sector Committee for Materials and Chemicals, was published under the authority of the Standard
3、s Committee and comes into effect on 15 April 2001 Date Comments National foreword This British Standard is the official English language version of The UK participation in its preparation was entrusted to Technical Committee CIU58, Biotechnology, which has the responsibility to: EN 13312-42001. - -
4、 aid enquirers to understand the text; present to the responsible European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. - A list of organizations repr
5、esented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspond
6、ence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of
7、itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 9 and a back cover. The BSI copyright date displayed in this document indicates when the document was last issued. O BSI 04-2001 ISBN O 680 3746
8、9 9 STDmBSI BS EN 13312-4-ENGL 2001 = lb24bb7 0703590 670 EUROPEAN STANDARD EN 133124 NORME EUROPENNE EUROPISCHE NORM February 2001 ICs 07.080; 07.1 00.01 English version Biotechnology - Performance criteria for piping and instrumentation - Part 4: Tubes and pipes Biotechnologie - Critres de perform
9、ance pour tuyauteries et instrumentation - Partie 4 Tubes et tuyauterie Biotechnik - Leistungskfierien fr Leitungssysteme und Instrumentierung - Teil 4 Rohre und Rohrleitungen This European Standard was approved by CEN on 13 January 2001. CEN members are bound to comply with the CEWCENELEC Internal
10、Regulations which stipulate the conditions for giving this European Standard the staius 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 Management Centre or to any CEN member. This
11、 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 Management Centre has the same status as the official versions. CEN members are the n
12、ational standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Gemany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMlTEE FOR STANDARDIZATION EUROPISCHES KOMITEE FUR NORMUNG COMITE EURO
13、PEEN DE NORMALISATION Management Centre: rue de Stassart, 36 B-1050 Brussels 8 2001 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 13312-4:2001 E STD-BSI BS EN L33L2-4-ENGL 2OOL = Lb24bb9 0903591i 507 = Page 2 EN 1331 2-412001 Con
14、tents Page Foreword . 3 Introduction 4 1 Scope . 4 2 Normative references . 4 3 Terms and definitions . 4 4 Hazards 4 5 Performance classes 5 6 Classification and verification of performance . 5 7 Marking and packaging 6 8 Documentation 6 Annex A (informative) Guidance on test methods for determinin
15、g leaktightness. cleanability and sterilizability of tubes and pipes . 7 Annex B (informative) Guidance of design for tubes and pipes 8 Bibliography . 9 STD.BSI ES EN L3312-4-ENGL 2001 Lb24669 0903592 L143 Page 3 EN 1331 2-4:2001 Foreword This European Standard has been prepared by Technical Committ
16、ee CEN/TC 233 “Biotechnology“, the secretariat of which is held by AFNOR. 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 2001, and conflicting national standards shall be withdrawn at the
17、latest by August 2001. This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association. This standard is one of a series of European Standards concerned with performance criteria for piping and instrumentation. These standards
18、are: EN 1331 2-1, Biotechnology - Performance criteria for piping and instrumentation - Part 1 : General performance criteria. EN 1331 2-2, Biotechnology - Performance criteria for piping and instrumentation - Part 2 : Couplings. EN 1331 2-3, Biotechnology - Performance criteria for piping and instr
19、umentation - Part 3 : Sampling and inoculation devices. EN 1331 2-4, Biotechnology - Performance criteria for piping and instrumentation - Part 4 : Tubes and pipes. EN 13312-5, Biotechnology - Performance criteria for piping and instrumentation - Part 5 : Valves. EN 1331 2-6, Biotechnology - Perform
20、ance criteria for piping and instrumentation - Part 6 : Equipment probes. This standard includes a bibliography. According to the CENKENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Re
21、public, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. STD.BS1 BS EN 13312-4-ENGL 2001 Lb24bb9 0903593 387 Page 4 EN 1331 2-412001 Introduction Use of this European Standard will aid th
22、e equipment manufacturer in the classification of tubes and pipes with regard to safe performance in biotechnological processes. The classification is easily understandable and readily utilizable by the user and the regulatory authorities. 1 Scope This European Standard specifies performance criteri
23、a for tubes and pipes used in biotechnological processes with respect to the potential hazards to the worker and the environment from microorganisms in use. This European Standard applies where the intended use of the tubes and pipes includes hazardous or potentially hazardous microorganisms used in
24、 biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety. This European Standard is also applicable to flexible pipes and tubes. 2 Normative references This European Standard incorporates by dated or undated reference,
25、provisions from other publications. These normative references are cited at the appropriate places in the text and the publications are listed hereafter. For dated references, subsequent amendments to or revisions of any of these publications apply to this European Standard only when incorporated in
26、 it by amendment or revision. For undated references the latest edition of the publication referred to applies (including amendments). EN 1331 2-1 :2001, Biotechnology - Performance criteria for piping and instrumentation - Part 1: General performance criteria. 3 Terms and definitions For the purpos
27、es of this standard, the terms and definitions given in EN 13312-1:2001 apply- 4 Hazards The following hazards shall be taken into account. a) Release of microorganisms caused by incorrectly welded joints and seams. NOTE 1 Discontinuities in the internal surface like excessive penetration or undercu
28、t can harbour soil and can prevent drainage. Poor welding techniques such as misalignment, lack of adequate removal of oxygen to prevent oxidation during welding, uneven temperature and uneven speed can also result in a variety of surface imperfections and poor weld-penetration and possible leakages
29、. b) Release of microorganisms caused by mismatching of tubes and pipes resulting in inappropriate cleaning and therefore inappropriate sterilization. STD.BS1 BS EN 13312-4-ENGL 2001 W 1b24bb9 0903594 21h w Page 5 EN 1 331 2-4:2001 NOTE 2 Mismatching leads to incorrectly welded joints. This is very
30、likely to occur because there is a multiplicity of internal and external sizes and combinations hereof within existing standards (see l, 2, 3, 4, 5, SI, 7, 8, 9, lo and li). Furthermore, many of these sizes are very close to each other and cannot be differentiated in existing installation merely by
31、measuring their external diameters. NOTE 3 Distortion from the original dimensions of tubes and pipes during transport can cause mismatching. c) Poor installation design resulting in dead-spots and soil-traps, inadequate mechanical support, poor drainage and cold-spots. Poor installation design can
32、in itself reduce the performance classes for cleanability and sterilizability below that which is required. d) Inadequate materials used, even some types of stainless steel, leading to a variety of corrosion mechanisms, abrasion and chemical attack by process and cleaning materials. Use of these mat
33、erials can reduce the performance classes for cleanability, leaktightness and sterilizability below that which is required. e) Release of microorganisms caused by overpressurizing of especially flexible tubes and/or high temperature and/or aggressive media. f) Release of microorganisms caused by bre
34、akage resulting from fatigue and overlexing. 5 Performance classes The tubes and pipes shall be classified for leaktightness, cleanability and sterilizability in accordance with 5.1 to 5.4 of EN 13312-1:2001. The selection of the appropriate class for performance of tubes and pipes shall be made in
35、accordance with 5.5 of EN 13312-1 :2001. NOTE 1 Leaktightness of tubes and pipes can be obtained by a quality assurance approach to manufacture and installation. In particular, joints should be welded wherever possible and welding practice should be documented. Orbital welding should be used where p
36、ossible. NOTE 2 Inspection of welds by boroscopy and radiography can be carried out on a specific percentage of welds. In the event of failures on neighbouring seam welds, all welds in the same weldingrun (man, day) should be examined. Failure of seam welds can be avoided by quality assurance of the
37、 supplier, using a quality system in accordance with EN IS0 9001:1994 (see 12) or equivalent. 6 Classification and verification of performance Tubes and pipes shall conform to the general requirements given in clause 6 of EN 13312- 1 :2001. Tubes and pipes that are an integral part of a unit of equi
38、pment shall meet the performance requirements for that unit of equipment. Guidance on test methods for determining leaktightness of tubes and pipes is given in annex A. Guidance on design for tubes and pipes is given in annex B. STD.BSI BS EN 13312-4-ENGL 2001 m Lb24bh9 0903595 152 Page 6 EN 13312-4
39、2001 7 Marking and packaging Tubes and pipes shall conform to the requirements given in clause 7 of EN 1331 2-1 :2001. 8 Documentation Tubes and pipes shall conform to the requirements given in clause 8 of EN 1331 2-1 2001. Annex A (informative) Guidance on test methods for determining leaktightness
40、, cleanability and sterilizability of tubes and pipes A list of test methods for leaktightness is given in table A.l of EN 12298:1998 (see 13). From that list suitable test methods to the testing of tubes and pipes are given in table A.1. Table Al - Suitable alternative leaktightness test methods fo
41、r tubes and pipes a Freon is an example of a suitable product available commercially. This information is given for the convenience of the user of this Standard and does not constitute an endorsement of CEN of these products. STDOBSI BS EN 13312-4-ENGL 2001 W Zb24bb9 0903597 T25 Page 8 EN 1331 2-4:2
42、001 Annex B (informative) Guidance of design for tubes and pipes B.l Materials Stainless steel with an appropriate corrosion resistance should be used. It should be in accordance with EN 10088-1 :1995 (see 7) or similar. Optimal cleanability and improved corrosion resistance are given by electromech
43、anical polishing material. In case of higher requirements on corrosion-resistance, e.g. on chloride containing media, stainless steel 1.4539 (see SI) should be used. 8.2 Welding Orbital welding should be used wherever possible. Orbital Thungsten Inert Gas (TIG) welding with argon U gas protection sh
44、ould be used. All welding operators should produce sample welds which meet requirements. Welded joints are preferred to couplings unless a demountable facility is required. The number of welds should be minimised by careful design and by use of pipe-bending rather than use of prefabricated component
45、s such as elbows. Valves, couplings, tees and other components should as far as possible have extended weld-on stubs in order to permit use of closed-head orbital welders. Weld quality should be controlled by documentation of parameters used, time and day of weld, identity of operator and purge sect
46、ion and location of weld. Internal accessible seam welds can be subjected to boroscopic inspection and radiological inspection by an independent inspector. To avoid failure of seam welds or poor weld quality, the specification and approval of welding procedures for metallic materials should be in ac
47、cordance with EN 288-3:1992 (see 14). Information on possible failure of seam welds and poor weld quality is given in EN IS0 6520-1:1998 (see 15). 8.3 Dimensions Tubes and pipes with tightly controlled dimensions should be used to avoid mismatching in respect to internal diameter, external diameter
48、or ovality, for example metric tubing with ovality tolerances in accordance with IS0 1127 (see l), or equivalents with finer tolerances for internal diameter, external diameter or ovality (see 4). Quality assurance of this specification for the as delivered material should be documented under EN IS0
49、 9001 :1994 (see 12) or an equivalent quality management system. 8.4 Surface roughness Seam-welded and cold drawn tube is preferred to seam-welded bead-rolled tube because of the superior surface finish. In case or requirements of better roughness and corrosion resistance an electrochemical polishing of stainless steel pipes should be preferred where applicable. Page 9 EN 13312-412001 Bibliography IS0 1127:1992, Stainless steel tubes - Dimensions, tolerances and conventional masses per unit length. IS0 2037:1992, Stainless steel tubes for the f
