EN 16821-2017 en Rubber and plastics hoses and hose assemblies for use in the pharmaceutical and biotechnological industry - Silicone rubber hoses.pdf

1、Rubber and plastics hoses and hose assemblies for use in the pharmaceutical and biotechnological industry - Silicone rubber hosesBS EN 16821:2017BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 16821 June 2017 ICS 2

2、3.040.70 English Version Rubber and plastics hoses and hose assemblies for use in the pharmaceutical and biotechnological industry - Silicone rubber hoses Tuyaux et flexibles en caoutchouc et en plastique pour utilisation dans les industries pharmaceutique et biotechnologique - Tuyaux en silicone Gu

3、mmi- und Kunststoffschluche und -schlauchleitungen fr den Einsatz in der pharmazeutischen und biotechnischen Industrie - Schluche aus Siliconkautschuk This European Standard was approved by CEN on 20 February 2017. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipu

4、late 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 S

5、tandard 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

6、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,

7、 Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2017 CEN All rights of exploitation in any form an

8、d by any means reserved worldwide for CEN national Members. Ref. No. EN 16821:2017 ENational forewordThis British Standard is the UK implementation of EN 16821:2017.The UK participation in its preparation was entrusted to Technical Committee PRI/66, Rubber and plastics tubing, hoses and hose assembl

9、ies.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2017 Published by BSI St

10、andards Limited 2017ISBN 978 0 580 88450 4ICS 23.040.70Compliance with a British Standard cannot confer immunity from legal obligations. This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 August 2017.Amendments/corrigenda issued since publica

11、tionDate Text affectedBRITISH STANDARDBS EN 16821:2017EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 16821 June 2017 ICS 23.040.70 English Version Rubber and plastics hoses and hose assemblies for use in the pharmaceutical and biotechnological industry - Silicone rubber hoses Tuyaux et flexibl

12、es en caoutchouc et en plastique pour utilisation dans les industries pharmaceutique et biotechnologique - Tuyaux en silicone Gummi- und Kunststoffschluche und -schlauchleitungen fr den Einsatz in der pharmazeutischen und biotechnischen Industrie - Schluche aus Siliconkautschuk This European Standar

13、d was approved by CEN on 20 February 2017. 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 s

14、uch 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 o

15、wn 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,

16、 Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITE

17、E FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2017 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 16821:2017 EBS EN 16821:2017EN 16821:2017 (E) 2 Contents Page European foreword . 3 1 Scope 4 2 Norm

18、ative references 4 3 Classifications and conditions of use . 5 3.1 Hose types 5 3.2 Hose designs . 6 3.3 Hose assembly designs 6 4 Dimensions 7 4.1 Inside diameter, wall thickness of the hoses 7 4.2 Length and tolerances for the hose assemblies . 7 4.3 Minimum bend radius . 7 5 Materials . 8 6 Requi

19、rements and tests Physical properties . 9 7 Designs/types of connection 10 8 Manufacturing of the hose assembly . 11 9 Frequency of testing 11 10 Marking 12 10.1 Marking of the hoses . 12 10.2 Marking of the fittings 12 10.3 Marking of the hose assemblies 13 11 Installation and user instructions 13

20、12 Storage and permissible storage time 13 Annex A (normative) Surface roughness and design of hose couplings 14 Annex B (normative) Test frequencies for type tests and routine tests 15 Annex C (informative) Production acceptance tests 16 Bibliography . 17 BS EN 16821:2017EN 16821:2017 (E) 3 Europea

21、n foreword This document (EN 16821:2017) has been prepared by Technical Committee CEN/TC 218 “Rubber and plastic hoses and hose assemblies”, the secretariat of which is held by BSI. This European Standard shall be given the status of a national standard, either by publication of an identical text or

22、 by endorsement, at the latest by December 2017, and conflicting national standards shall be withdrawn at the latest by December 2017. 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 identifyi

23、ng any or all such patent rights. 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

24、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. BS EN 16821:2017EN 16821:2017 (E) 4 1 Scope T

25、his European Standard applies to type 1 to type 3 hose assemblies with hoses made of silicone rubber for the transport of liquid or powdery substances in the pharmaceutical and the biotechnological industries. It specifies the classification, manufacturing and testing of as well as the materials, re

26、quirements and quality surveillance for hose assemblies. These hose assemblies are intended to be used with the relevant substances at temperatures in the range from 40 C1)to +150 C and at operating pressures from 0,9 bar (vacuum) to 10 bar (see Table 1). These hose assemblies are not electrically c

27、onductive. The danger of static charging shall be considered on a case-by-case basis. Hose assemblies in accordance with this standard are classified into two designs, A and B (see 3.2). Attention is called to the fact that for certain applications the relevant legal regulations such as the Pressure

28、 Equipment Directive 2014/68/EU (PED) need to be complied with. 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, th

29、e latest edition of the referenced document (including any amendments) applies. EN 100882:2014, Stainless steels - Part 2: Technical delivery conditions for sheet/plate and strip of corrosion resisting steels for general purposes EN 10204, Metallic products - Types of inspection documents EN 12351,

30、Industrial valves - Protective caps for valves with flanged connections EN ISO 1043-1, Plastics - Symbols and abbreviated terms - Part 1: Basic polymers and their special characteristics (ISO 1043-1) EN ISO 1402, Rubber and plastics hoses and hose assemblies - Hydrostatic testing (ISO 1402) EN ISO 2

31、078, Textile glass - Yarns - Designation (ISO 2078) EN ISO 5817, Welding - Fusion-welded joints in steel, nickel, titanium and their alloys (beam welding excluded) - Quality levels for imperfections (ISO 5817) EN ISO 7233, Rubber and plastics hoses and hose assemblies - Determination of resistance t

32、o vacuum (ISO 7233) EN ISO 7326, Rubber and plastics hoses - Assessment of ozone resistance under static conditions (ISO 7326) EN ISO 10619-1, Rubber and plastics hoses and tubing - Measurement of flexibility and stiffness - Part 1: Bending tests at ambient temperature (ISO 10619-1) 1) Individual te

33、sts in the form of bending tests under very low temperatures are currently being performed by, for example, Department WTD 51 of the Bundesamt fr Wehrtechnik und Beschaffung (BWB, German Federal Office of Military Engineering and Procurement), Universittsstrae 5, 56070 Koblenz. BS EN 16821:2017EN 16

34、821:2017 (E) 5 EN ISO 10619-2, Rubber and plastics hoses and tubing - Measurement of flexibility and stiffness - Part 2: Bending tests at sub-ambient temperatures (ISO 10619-2) ISO 1629, Rubber and latices Nomenclature ISO 7619-1, Rubber, vulcanized or thermoplastic Determination of indentation hard

35、ness Part 1: Durometer method (Shore hardness) ISO 7619-2, Rubber, vulcanized or thermoplastic Determination of indentation hardness Part 2: IRHD pocket meter method 3 Classifications and conditions of use 3.1 Hose types Due to the operational requirements and the manufacturing conditions, the struc

36、tural design of hose assemblies in accordance with this standard can vary considerably. A selection of possible hose types/designs is given in Table 1. Other designs are permissible, provided they are at least technically equivalent and conform to the requirements of Clause 6. Table 1 Hose types Typ

37、e Structure Inside diameter Minimum working pressure aMaximum working pressure mm bar bar 1 hose made of silicone without reinforcing member (only silicone lining) 6 0,7 0,8 8 0,7 0,7 10 0,7 0,6 13 0,7 0,5 15 0,7 0,4 16 0,7 0,3 19 0,5 0,2 25 0,5 0,1 32 0,5 0,07 38 0,4 0,05 50 0,2 0,05 2 hose made of

38、 silicone lining with textile reinforcing member and silicone cover 6 0,85 8,0 8 0,85 7,0 10 0,85 6,0 13 0,8 6,0 15 0,8 5,0 16 0,8 5,0 BS EN 16821:2017EN 16821:2017 (E) 6 Type Structure Inside diameter Minimum working pressure aMaximum working pressure 19 0,8 5,0 25 0,75 3,0 32 0,7 2,0 38 0,6 2,0 50

39、 0,4 1,0 3 hose made of silicone lining with textile reinforcing members, incorporated high-grade steel helix and silicone cover 13 0,9 10 19 0,9 10 25 0,9 10 38 0,9 10 50 0,9 8,5 aPressure 0 bar (vacuum). Hose assemblies of types 1 to 3 in accordance with this standard shall have a Shore hardness o

40、f between 50 Shore A and 70 Shore A, determined in accordance with ISO 7619-1 or ISO 76192. Hose assemblies in accordance with this standard shall be autoclavable (vapour sterilization) for at least 30 min at 140 C. Each vapour application accelerates the natural ageing process of the silicone. Pres

41、sures and temperatures other than those given in the scope can be agreed upon between the manufacturer and the user. 3.2 Hose designs Hoses in accordance with this standard are classified into two designs: design A: FDA conformity of all hose materials; design B: FDA conformity of all parts of the h

42、ose lining in contact with the product. 3.3 Hose assembly designs Hose assemblies in accordance with this standard are classified into two designs: design A: FDA conformity of all hose materials and end fittings; design B: FDA conformity of all parts of the hose lining in contact with the product an

43、d end fittings. BS EN 16821:2017EN 16821:2017 (E) 7 4 Dimensions 4.1 Inside diameter, wall thickness of the hoses In Table 2, the usual inside diameters and the corresponding typical wall thicknesses for the different hose types are given. Table 2 Dimensions2)Inside diameter Type 1 Type 2 Type 3 Wal

44、l thickness Wall thickness Wall thickness Nominal size Tolerances mm Dimensions mm Tolerances mm Dimensions mm Tolerances mm Dimensions mm Tolerances mm 6 0,3 2 0,2 3,2 0,3 8 0,3 2 3,2 10 0,4 3 3,5 13 0,4 3 4,0 5,2 0,5 15 0,5 3 4,5 16 0,5 3 4,8 19 0,7 3 4,8 5,2 0,5 25 0,8 4 0,3 6,0 5,2 0,5 32 1,0 4

45、6,0 38 1,5 4 7,0 5,2 0,5 50 2,0 5 7,0 5,2 0,5 4.2 Length and tolerances for the hose assemblies The length of the hose assembly is considered to be the installation length measured between the sealing surfaces of the end fittings. The tolerance for hose assemblies shall be+3020,% . Narrower toleranc

46、es shall be agreed upon with the manufacturer of the hose assembly. 4.3 Minimum bend radius The information given in Table 3 applies to the minimum bend radius of type 1 to type 3 hose assemblies. 2) Other dimensions can be agreed upon between the user and the manufacturer. BS EN 16821:2017EN 16821:

47、2017 (E) 8 Table 3 Minimum bending radius Inside diameter mm Minimum bending radius r mm minimum Type 1 Type 2 Type 3 6 80 50 8 100 60 10 120 70 13 150 80 50 15 170 90 16 180 100 19 200 150 65 25 230 185 90 32 260 220 38 300 260 100 50 450 350 155 5 Materials Table 4 lists the commonly used material

48、s. Table 4 Materials Component Material In accordance with Silicone hose (Types 1 to 3) silicone rubber group ISO 1629 Textile reinforcing member (types 2 and 3) e.g. expanded glass (E-glass), polyamide or polyester (yarn or monofilament) or aramid EN ISO 2078 EN ISO 1043-1 Round wire helix (type 3)

49、 CrNi steel a Ferrule CrNi steel a, e.g. X5CrNi18-10 Threaded nipple, Screw connection with internal thread, Coupling nut X2CrNiMo18-10 X2CrNiMo18-14-3 X2CrNiMo17-13-5 NiCr21Mo14W Ti-II Aseptic couplings bX2CrNiMo18-10 X2CrNiMo18-14-3 X2CrNiMo17-13-5 NiCr21Mo14W Ti-II BS EN 16821:2017EN 16821:2017 (E) 9 Component Material In accordance with Clamp couplings bX2CrNiMo18-10 X2CrNiMo18-14-3 X2CrNiMo17-13-5 NiCr21Mo14W Ti-II aTo be agreed upon ordering. bPa