EN 16820-2017 en Rubber and plastics hoses and hose assemblies for use in the pharmaceutical and biotechnological industry - Bonded elastomeric hoses with or without a lining.pdf

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1、Rubber and plastics hoses and hose assemblies for use in the pharmaceutical and biotechnological industry - Bonded elastomeric hoses with or without a liningBS EN 16820:2017BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE N

2、ORM EN 16820 June 2017 ICS 23.040.70 English Version Rubber and plastics hoses and hose assemblies for use in the pharmaceutical and biotechnological industry - Bonded elastomeric hoses with or without a lining Tuyaux et flexibles en caoutchouc et en plastique pour utilisation dans lindustrie pharma

3、ceutique et biotechnologique - Tuyaux lis en lastomre avec ou sans tube intrieur Gummi- und Kunststoffschluche und -schlauchleitungen fr den Einsatz in der pharmazeutischen und biotechnischen Industrie - Verbundene Schluche aus Elastomeren mit oder ohne Innenschicht This European Standard was approv

4、ed 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 such national

5、 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

6、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, Hun

7、gary, 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 KOMITEE FR NORMUNG

8、 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 16820:2017 ENational forewordThis British Standard is the UK implementation of EN 16820:2017.The UK participatio

9、n in its preparation was entrusted to Technical Committee PRI/66, Rubber and plastics tubing, hoses and hose assemblies.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 con

10、tract. Users are responsible for its correct application. The British Standards Institution 2017 Published by BSI Standards Limited 2017ISBN 978 0 580 88449 8ICS 23.040.70Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the au

11、thority of the Standards Policy and Strategy Committee on 31 August 2017.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN 16820:2017EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 16820 June 2017 ICS 23.040.70 English Version Rubber and plastics hoses and ho

12、se assemblies for use in the pharmaceutical and biotechnological industry - Bonded elastomeric hoses with or without a lining Tuyaux et flexibles en caoutchouc et en plastique pour utilisation dans lindustrie pharmaceutique et biotechnologique - Tuyaux lis en lastomre avec ou sans tube intrieur Gumm

13、i- und Kunststoffschluche und -schlauchleitungen fr den Einsatz in der pharmazeutischen und biotechnischen Industrie - Verbundene Schluche aus Elastomeren mit oder ohne Innenschicht This European Standard was approved by CEN on 20 February 2017. CEN members are bound to comply with the CEN/CENELEC I

14、nternal 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

15、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

16、 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, Nor

17、way, Poland, Portugal, Romania, 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

18、 of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 16820:2017 EBS EN 16820:2017EN 16820:2017 (E) 2 Contents Page European foreword . 4 1 Scope 5 2 Normative references 5 3 Classifications and conditions of use . 6 3.1 Hose types 6 3.2 Hose grades .

19、 7 3.3 Hose designs . 7 3.4 Hose assembly designs 7 4 Dimensions 7 4.1 Inside diameter, minimum thickness of the lining, bending radii 7 4.2 Concentricity . 9 4.3 Length and tolerances for the hose assemblies . 9 4.4 Minimum bending radius . 9 5 Materials 10 6 Requirements and tests . 11 6.1 Physica

20、l properties 11 6.2 Electrical properties . 13 7 Designs/types of connection 13 8 Manufacturing of the hose assembly . 14 9 Frequency of testing 15 10 Marking 15 10.1 Marking of the hoses . 15 10.2 Marking of the fittings 16 10.3 Marking of the hose assemblies 16 11 Installation and user instruction

21、s 16 12 Storage and permissible storage time 17 Annex A (normative) Test procedure to determine the electrical resistance through the wall of hoses . 18 A.1 General . 18 A.2 Test procedure for hoses (without end fittings) . 18 A.2.1 Preparation for the test . 18 A.2.2 Electrodes and contacts . 18 A.

22、2.3 Preparation and cleaning for test 18 A.2.4 Conditioning . 18 A.2.5 Test procedure 19 Annex B (normative) Testing of crushing strength (only for hose type SD) 20 Annex C (normative) Behaviour to fire exposure 22 BS EN 16820:2017EN 16820:2017 (E) 3 C.1 Test specimen 22 C.2 Test equipment 22 C.3 Te

23、st procedure 22 Annex D (normative) Surface roughness and design of hose couplings 24 Annex E (normative) Test frequencies for type tests and routine tests 25 Annex F (informative) Production acceptance tests . 26 Bibliography . 27 BS EN 16820:2017EN 16820:2017 (E) 4 European foreword This document

24、(EN 16820:2017) 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 by endorsement, at the l

25、atest 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 identifying any or all such patent

26、 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 Republic of Macedonia, Fr

27、ance, 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 16820:2017EN 16820:2017 (E) 5 1 Scope This European Standard app

28、lies to type D and type SD hose assemblies with hoses made of elastomers and bonded plastics for the transport of gaseous, vaporous, liquid or powdery substances in the pharmaceutical and the biotechnological industries. It specifies the classification, manufacturing and testing of as well as the ma

29、terials, requirements and quality surveillance for hose assemblies. These hose assemblies are intended to be used with the relevant substances at temperatures in the range from 30 C to +100 C, depending on the medium, and at operating pressures from 0,9 bar (vacuum) to 10 bar (see Tables 2 and 3). F

30、or hoses with a lining made of PTFE and derivatives, temperatures from 30 C to +140 C are permissible. Hose assemblies in accordance with this standard are classified into two designs, A and B (see 3.3). Attention is called to the fact that for certain applications the relevant legal regulations suc

31、h as the Pressure 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 undat

32、ed references, the latest edition of the referenced document (including any amendments) applies. EN 1092-1, Flanges and their joints Circular flanges for pipes, valves, fittings and accessories, PN designated Part 1: Steel flanges EN 10204, Metallic products - Types of inspection documents EN 10244-

33、2, Steel wire and wire products - Non-ferrous metallic coatings on steel wire - Part 2: Zinc or zinc alloy coatings EN 10270-1, Steel wire for mechanical springs - Part 1: Patented cold drawn unalloyed spring steel wire EN 10270-2, Steel wire for mechanical springs - Part 2: Oil hardened and tempere

34、d spring steel wire EN 12115, Rubber and thermoplastics hoses and hose assemblies for liquid or gaseous chemicals - Specification EN 12351, Industrial valves - Protective caps for valves with flanged connections EN ISO 1402, Rubber and plastics hoses and hose assemblies - Hydrostatic testing (ISO 14

35、02) EN ISO 4671, Rubber and plastics hoses and hose assemblies - Methods of measurement of the dimensions of hoses and the lengths of hose assemblies (ISO 4671) EN ISO 5817, Welding - Fusion-welded joints in steel, nickel, titanium and their alloys (beam welding excluded) - Quality levels for imperf

36、ections (ISO 5817) EN ISO 7233, Rubber and plastics hoses and hose assemblies - Determination of resistance to vacuum (ISO 7233) EN ISO 7326, Rubber and plastics hoses - Assessment of ozone resistance under static conditions (ISO 7326) EN ISO 8031:2009, Rubber and plastics hoses and hose assemblies

37、- Determination of electrical resistance and conductivity (ISO 8031:2009) BS EN 16820:2017EN 16820:2017 (E) 6 EN ISO 8033, Rubber and plastics hoses - Determination of adhesion between components (ISO 8033) EN ISO 10619-1, Rubber and plastics hoses and tubing - Measurement of flexibility and stiffne

38、ss - Part 1: Bending tests at ambient temperature (ISO 10619-1) 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 37, Rubber, vulcanized or thermoplastic Determination of tensile stres

39、s-strain properties ISO 188, Rubber, vulcanized or thermoplastic Accelerated ageing and heat resistance tests ISO 1817, Rubber, vulcanized or thermoplastic Determination of the effect of liquids BS 3592-1:1986, Steel wire for hose reinforcement Specification for coated round and flat steel wire for

40、rubber hose reinforcement IEC/TS 60079-32-1, Explosive atmospheres Part 32-1: Electrostatic hazard Guidance 3 Classifications and conditions of use 3.1 Hose types Due to the operational requirements and the manufacturing conditions, the structural design of hose assemblies in accordance with this st

41、andard can vary considerably. A selection of possible hose types/designs is given in Table 1. Table 1 Hose types Type Structure Application limits/ operational data D arubber hose with or without a plastics lining and with one or several reinforcement(s) (pressure carrier) see Tables 2 and 3 SD brub

42、ber hose with or without a plastics lining and with one or several reinforcement(s) (pressure carrier) offering sufficient form stability for suction application or with one or several integrated helix(es), respectively aD is a pressure hose. bSD is a suction and discharge hose. Hose assemblies in a

43、ccordance with this standard shall be autoclavable (vapour sterilization) for at least 30 min at 130 C. Pressures and temperatures other than those given in the scope can be agreed upon between the manufacturer and the user. BS EN 16820:2017EN 16820:2017 (E) 7 3.2 Hose grades Hoses and hose assembli

44、es for this application shall be classified into five grades: grade I: electrically insulated (no electrical bonding AND no static-dissipative layers); grade M: electrically bonded without static-dissipative lining or cover; grade : electrically conductive; grade M/T: electrically bonded and with an

45、 electrical volume resistance through the hose wall not exceeding 109; grade /T: electrically conductive and with an electrical volume resistance through the hose wall not exceeding 109. 3.3 Hose designs Hoses in accordance with this standard are classified into two designs: design A: FDA conformity

46、 of all hose materials; design B: FDA conformity of all parts of the hose lining in contact with the product. 3.4 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 con

47、formity of all parts of the hose lining in contact with the product and end fittings. 4 Dimensions 4.1 Inside diameter, minimum thickness of the lining, bending radii Depending on the type, the following shall conform to the values in Tables 2 and 3: the inside diameter of hoses; the minimum thickne

48、ss of the lining; the minimum bending radius. BS EN 16820:2017EN 16820:2017 (E) 8 Table 2 Dimensions and bending radii for hose type D Nominal size Inside diameter Outside diameter Minimum thickness Minimum bending radiusbVacuum stability mm mm mm Dimensions Tolerances Dimensions Tolerances Lining a

49、Hose cover mm bar 13 13,0 0,5 23,0 1,0 2,0 1,6 90 0,5 16 16 26,0 100 19 19,0 31,0 125 25 25,0 37,0 150 0,4 32 32,0 44,0 175 38 38,0 51,0 225 50 50,0 0,7 66,0 1,2 2,0 2,0 275 0,3 51 51,0 67,0 275 63 63,0 0,8 79,0 300 75 75,0 91,0 350 c76 76,0 92,0 350 c100 100,0 116,0 1,6 450 c101,5 101,5 118,0 450 caThe dimensions for the minimum thickness of the lining are not applicable for hoses made of PE-X/UPE and fluoro-plastics. The thickness of these materials shall be at least 0,4 mm. bThe bending rad