Rubber and plastics hoses and hose assemblies for use in the pharmaceutical and biotechnological industry - Silicone rubber hoses

This final draft 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, 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 −40 °C ) to +150 °C and at operating pressures from −0,9 bar (vacuum) to 10 bar (see Table 1). These hose assemblies are not electrically conductive. 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 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 - Schläuche aus Siliconkautschuk

Dieser Europäische Norm-Entwurf gilt für Schlauchleitungen vom Typ 1 bis 3 mit Schläuchen aus Siliconkautschuk für die Förderung von 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 −40 °C ) bis +150 °C und bei einem Betriebsdruck von −0,9 bar (Vakuum) bis 10 bar (siehe Tabelle 1) vorgesehen. Diese Schlauchleitungen sind nicht elektrisch leitfähig. Die Gefahr der statischen Aufladung ist im Einzelfall zu betrachten.
Schlauchleitungen nach dieser Norm werden in zwei Ausführungen A und B eingeteilt (siehe 3.2).
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 les industries pharmaceutique et biotechnologique - Tuyaux en silicone

Le projet final de Norme européenne s’applique aux flexibles de type 1 au type 3 avec des tuyaux en silicone pour le transport de substances liquides ou en 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 −40 °C ) à +150 °C, et à des pressions de service de −0,9 bar (vide) à 10 bar (voir Tableau 1). Ces flexibles ne sont pas électriquement conducteurs. Le risque d’une charge statique doit être considéré au cas par cas.
Les flexibles conformes à la présente norme sont classés en deux conceptions, A et B (voir 3.2).
L'attention est attirée sur le fait que pour certaines applications des dispositions légales pertinentes telles que la Directive Equipements sous pression 2014/68/UE (DESP) sont à respecter.

Cevni priključki s cevmi iz nekovinskih materialov za uporabo v farmacevtski in biotehnološki industriji - Silikonske gumijaste cevi

Ta osnutek evropskega standarda se uporablja za tip 1 in tip 3 cevnih priključkov s cevmi iz silikona in gume za transport tekočih snovi in snovi v prahu v farmacevtski ter 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 −40 °C do +150 °C in pri delovnem tlaku od −0,9 bara (vakuum) do 10 barov (glej preglednico 1). Ti cevni priključki niso električno prevodni. Nevarnost statičnega naboja se določi za vsak posamezen primer.
Cevni priključki v skladu s tem standardom so razvrščeni v dve obliki: A in B (glej 3.2).
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

Status
Published
Publication Date
13-Jun-2017
Current Stage
9020 - Submission to 2 Year Review Enquiry - Review Enquiry
Due Date
15-Jul-2022
Completion Date
15-Jul-2022

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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Schlauchleitungen für den Einsatz in der pharmazeutischen und biotechnischen Industrie mit Schläuchen aus nichtmetallischen Werkstoffen - Schläuche aus SiliconkautschukFlexibles pour utilisation dans les industries pharmaceutique et biotechnologique avec tuyaux sans matériaux métalliques - Tuyaux en siliconeHose assemblies for use in the pharmaceutical and biotechnological industry with hoses of non-metallic materials - Silicone rubber hoses83.140.40Gumene ceviHoses11.120.99Drugi standardi v zvezi s farmacijoOther standards related to pharmaceuticsICS:Ta slovenski standard je istoveten z:EN 16821:2017SIST EN 16821:2017en,fr,de01-september-2017SIST EN 16821:2017SLOVENSKI

STANDARD
SIST EN 16821:2017
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 16821
June
t r s y ICS
t uä r v rä y r English Version

Rubber and plastics hoses and hose assemblies for use in the pharmaceutical and biotechnological industry æ Silicone rubber hoses Tuyaux et flexibles en caoutchouc et en plastique pour utilisation dans les industries pharmaceutique et biotechnologique æ Tuyaux en silicone

Gummiæ und Kunststoffschläuche und æschlauchleitungen für den Einsatz in der pharmazeutischen und biotechnischen Industrie æ Schläuche aus Siliconkautschuk This European Standard was approved by CEN on

t r February
t r s yä

egulations which stipulate the conditions for giving this European Standard the status of a national standard without any alterationä Upætoædate lists and bibliographical references concerning such national standards may be obtained on application to the CENæCENELEC Management Centre or to any CEN memberä

translation under the responsibility of a CEN member into its own language and notified to the CENæCENELEC Management Centre has the same status as the official versionsä

CEN members are the national standards bodies of Austriaá Belgiumá Bulgariaá Croatiaá Cyprusá Czech Republicá Denmarká Estoniaá Finlandá Former Yugoslav Republic of Macedoniaá Franceá Germanyá Greeceá Hungaryá Icelandá Irelandá Italyá Latviaá Lithuaniaá Luxembourgá Maltaá Netherlandsá Norwayá Polandá Portugalá Romaniaá Serbiaá Slovakiaá Sloveniaá Spainá Swedená Switzerlandá Turkey and United Kingdomä

EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre:
Avenue Marnix 17,
B-1000 Brussels

t r s y CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Membersä Refä Noä EN

s x z t sã t r s y ESIST EN 16821:2017

EN 16821:2017 (E) 2 Contents Page European foreword ....................................................................................................................................................... 3 1 Scope .................................................................................................................................................................... 4 2 Normative 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 Requirements 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 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

SIST EN 16821:2017

EN 16821:2017 (E) 3 European 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 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. SIST EN 16821:2017

EN 16821:2017 (E) 4 1 Scope This 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, 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

« v r °C1) to +150
¹C and at operating pressures from

« rá { bar (vacuum) to 10 bar (see Table 1). These hose assemblies are not electrically conductive. 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 Equipment Directive

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 10088–2: t r s v, Stainless steels - Part 2: Technical delivery conditions for sheet/plate and strip of corrosion resisting steels for general purposes EN

s r t r v, Metallic products - Types of inspection documents EN 12351, Industrial valves - Protective caps for valves with flanged connections EN ISO

s r v u-1, Plastics - Symbols and abbreviated terms - Part 1: Basic polymers and their special characteristics (ISO 1043-1) EN ISO

s v r t, Rubber and plastics hoses and hose assemblies - Hydrostatic testing (ISO 1402) EN ISO 2078, 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 to vacuum (ISO 7233) EN ISO 7326, Rubber and plastics hoses - Assessment of ozone resistance under static conditions (ISO 7326) EN ISO

s r x s {-1, Rubber and plastics hoses and tubing - Measurement of flexibility and stiffness - Part 1: Bending tests at ambient temperature (ISO 10619-1)

1) Individual tests in the form of bending tests under very low temperatures are currently being performed by, for example, Department WTD 51 of the Bundesamt für Wehrtechnik und Beschaffung (BWB, German Federal Office of Military Engineering and Procurement), Universitätsstraße 5, 56070 Koblenz. SIST EN 16821:2017

EN 16821:2017 (E) 5 EN ISO

s r x s {-2, Rubber and plastics hoses and tubing - Measurement of flexibility and stiffness - Part 2: Bending tests at sub-ambient temperatures (ISO 10619-2) ISO

s x t {, Rubber and latices — Nomenclature ISO

y x s {-1, Rubber, vulcanized or thermoplastic — Determination of indentation hardness — Part 1: Durometer method (Shore hardness) ISO

y x s {-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 structural 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 Type Structure Inside diameter Minimum working pressure a Maximum 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
rá v 16
«0,7 0,3
s {
«0,5 0,2 25
«0,5 0,1 32
«0,5 0,07 38
« rá v 0,05 50

«0,2 0,05 2 hose made of 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 SIST EN 16821:2017

EN 16821:2017 (E) 6 Type Structure Inside diameter Minimum working pressure a Maximum working pressure

s {
«0,8 5,0 25
«0,75 3,0 32
«0,7 2,0 38
«0,6 2,0 50

« rá v 1,0 3 hose made of silicone lining with textile reinforcing members, incorporated high-grade steel helix and silicone cover 13

« rá { 10
s {
« rá { 10 25
« rá { 10 38
« rá { 10 50

« rá { 8,5 a Pressure < 0 bar (vacuum). Hose assemblies of types 1 to 3 in accordance with this standard shall have a Shore hardness of between 50 Shore A and 70 Shore A, determined in accordance with ISO

y x s {-1 or ISO

y x s { «2. Hose assemblies in accordance with this standard shall be autoclavable (vapour sterilization) for at least 30 min at

s v r °C. Each vapour application accelerates the natural ageing process of the silicone. Pressures 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 hose 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 and end fittings. SIST EN 16821:2017

EN 16821:2017 (E) 7 4 Dim
...

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