EN 16820:2017
(Main)Rubber and plastics hoses and hose assemblies for use in the pharmaceutical and biotechnological industry - Bonded elastomeric hoses with or without a lining
Rubber and plastics hoses and hose assemblies for use in the pharmaceutical and biotechnological industry - Bonded elastomeric hoses with or without a lining
This final draft European Standard applies 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 materials, 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). For 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 such as the Pressure Equipment Directive 2014/68/EU (PED) need to be complied with.
Gummi- und Kunststoffschläuche und -schlauchleitungen für den Einsatz in der pharmazeutischen und biotechnischen Industrie - Verbundene Schläuche aus Elastomeren mit oder ohne Innenschicht
Dieser Europäische Norm-Entwurf gilt für Schlauchleitungen der Typen D und SD mit Schläuchen aus Elastomeren und gebundenen Kunststoffen für die Förderung von gasförmigen, dampfförmigen, flüssigen oder pulverförmigen Stoffen in der pharmazeutischen und biotechnischen Industrie. Er legt die Klassifizierung, Werkstoffe, Herstellung, Anforderungen und die Prüfung von Schlauchleitungen sowie deren Qualitätsüberwachung fest.
Die Schlauchleitungen sind für den Einsatz mit den Stoffen im Temperaturbereich von -30 °C bis +100 °C in Abhängigkeit vom Medium und bei einem Betriebsdruck von -0,9 bar (Vakuum) bis 10 bar (siehe Tabellen 2 und 3) vorgesehen. Für Schläuche mit einer Innenschicht aus PTFE und PTFE-Derivaten sind Temperaturen von -30 °C bis +140 °C zulässig.
Schlauchleitungen nach dieser Norm werden in zwei Ausführungen A und B eingeteilt (siehe 3.3).
Es wird darauf hingewiesen, dass bei bestimmten Einsatzfällen die zutreffenden gesetzlichen Regelungen, wie z. B. die Druckgeräterichtlinie 2014/68/EU (DGRL), einzuhalten sind.
Tuyaux et flexibles en caoutchouc et en plastique pour utilisation dans l'industrie pharmaceutique et biotechnologique - Tuyaux liés en élastomère avec ou sans tube intérieur
Le présent projet final de Norme européenne s’applique aux flexibles de type D et de type SD avec des tuyaux en élastomère et en plastique liés pour le transport de substances gazeuses, de vapeur, de liquides ou de poudre dans les industries pharmaceutique et biotechnologique. Il spécifie la classification, la fabrication et les essais, ainsi que les matériaux, les exigences et la surveillance de la qualité des flexibles.
Ces flexibles sont destinés à être utilisés avec les substances appropriées à des températures comprises dans la plage de −30 °C à +100 °C, selon le media, et à des pressions de service de −0,9 bar (vide) à 10 bar (voir Tableaux 2 et 3). Pour les tuyaux avec un tube intérieur en PTFE et dérivés, des températures de −30 °C à +140 °C sont admissibles.
Les flexibles conformes à la présente norme sont classés en deux conceptions, A et B (voir 3.3).
L'attention est attirée sur le fait que pour certaines applications les dispositions légales pertinentes telles que la Directive Equipements sous pression 2014/68/EU (DESP) sont à respecter.
Gumene in polimerne cevi in cevni priključki za uporabo v farmacevtski in biotehnološki industriji - Vezane elastomerne cevi s podlogo ali brez nje
Ta osnutek evropskega standarda se uporablja za tip D in tip SD cevnih priključkov s cevmi iz elastomerov in polimernih materialov za transport plinastih in tekočih snovi ter snovi v prahu v farmacevtski in biotehnološki industriji. Določa razvrščanje, izdelavo in preskušanje ter tudi materiale, zahteve in nadzor kakovosti cevnih priključkov.
Ti cevni priključki so namenjeni za ustrezne snovi pri temperaturah od −30 °C do +100 °C, odvisno od medija, in pri delovnem tlaku od −0,9 bara (vakuum) do 10 barov (glej preglednici 2 in 3). Pri ceveh s podlogami iz PTFE in derivatov so dovoljene temperature od −30 °C do +140 °C.
Cevni priključki v skladu s tem standardom so razvrščeni v dve obliki: A in B (glej 3.3).
Opozoriti je treba, da je pri nekaterih načinih uporabe treba upoštevati ustrezne pravne predpise, kot je direktiva 97/23/ES o tlačni opremi (PED).
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2017
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Rubber and plastics hoses and hose assemblies for use in the pharmaceutical and
biotechnological industry - Bonded elastomeric hoses with or without a lining
Schlauchleitungen für den Einsatz in der pharmazeutischen und biotechnischen Industrie
mit Schläuchen aus nichtmetallischen Werkstoffen - Schläuche aus Elastomeren mit und
ohne Liner
Flexibles pour utilisation dans les industries pharmaceutique et biotechnologique avec
tuyaux sans matériaux métalliques - Tuyaux en élastomère avec ou sans revêtement
Ta slovenski standard je istoveten z: EN 16820:2017
ICS:
11.120.99 Drugi standardi v zvezi s Other standards related to
farmacijo pharmaceutics
83.140.40 Gumene cevi Hoses
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN 16820
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2017
EUROPÄISCHE NORM
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 Gummi- und Kunststoffschläuche und -
utilisation dans l'industrie pharmaceutique et schlauchleitungen für den Einsatz in der
biotechnologique - Tuyaux liés en élastomère avec ou pharmazeutischen und biotechnischen Industrie -
sans tube intérieur Verbundene Schläuche 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 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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR 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 Ref. No. EN 16820:2017 E
worldwide for CEN national Members.
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 . 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 Physical 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 instructions . 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.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
C.1 Test specimen . 22
C.2 Test equipment . 22
C.3 Test 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
European foreword
This document (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 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 identifying 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 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.
1 Scope
This European Standard applies 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 materials, 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). For 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 such 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 undated
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 10244-2, 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 tempered 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 1402)
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 imperfections (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 - Determination of electrical resistance
and conductivity (ISO 8031:2009)
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 stiffness - Part 1:
Bending tests at ambient temperature (ISO 10619-1)
EN ISO 10619-2, Rubber and plastics hoses and tubin
...
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