oSIST prEN 16820:2025

Rubber and plastics hoses and hose assemblies for use in the pharmaceutical and biotechnological industry - Bonded elastomeric hoses with or without a lining

This document 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 Table 2 and Table 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 document are classified into four types, A - D, A - SD. B - D, B - SD.

Gummi- und Kunststoffschläuche und -schlauchleitungen für den Einsatz in der pharmazeutischen und biotechnischen Industrie - Verbundene Schläuche aus Elastomeren mit oder ohne Innenschicht

Dieses Dokument gilt für Schlauchleitungen der TypenD undSD mit Schläuchen aus Elastomeren und gebun
denen Kunststoffen für die Förderung von gasförmigen, dampfförmigen, flüssigen oder pulverförmigen Stoffen in der pharmazeutischen und biotechnischen Industrie. Sie legt die Klassifizierung, Werkstoffe, Herstellung, Anforderungen und 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 −0,9bar (Vakuum) bis 10bar (siehe Tabelle2 und Tabelle3) vorgesehen. Für Schläuche mit einer Innenschicht aus PTFE und PTFE-Derivaten sind Temperaturen von –30°C bis +140°C zulässig.
Schlauchleitungen nach diesem Dokument werden in vier Typen eingeteilt: A- D, A- SD, B- D, B- SD.

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 document 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 Tableau 2 et Tableau 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 au présent document sont classés en quatre types, A - D, A - SD. B - D, B - SD.

Gumene in polimerne cevi in cevni priključki za uporabo v farmacevtski in biotehnološki industriji - Vezane elastomerne cevi s podlogo ali brez nje

General Information

• Status: Not Published
• Public Enquiry End Date: 18-Feb-2025
• ICS: 11.120.99 - Other standards related to pharmaceutics
• ICS: 23.040.70 - Hoses and hose assemblies
• ICS: 83.140.40 - Hoses
• Technical Committee: IPMA - Polimer materials and products
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 18-Dec-2024
• Due Date: 07-May-2025
• Ref Project: prEN 16820 - Rubber and plastics hoses and hose assemblies for use in the pharmaceutical and biotechnological industry - Bonded elastomeric hoses with or without a lining

Relations

• Revises: SIST EN 16820:2017 - Rubber and plastics hoses and hose assemblies for use in the pharmaceutical and biotechnological industry - Bonded elastomeric hoses with or without a lining
• Effective Date: 04-Sep-2024

Standards Content (Sample)

SLOVENSKI STANDARD
01-februar-2025
Gumene in polimerne cevi in cevni priključki za uporabo v farmacevtski in
biotehnološki industriji - Vezane elastomerne cevi s podlogo ali brez nje
Rubber and plastics hoses and hose assemblies for use in the pharmaceutical and
biotechnological industry - Bonded elastomeric hoses with or without a lining
Gummi- und Kunststoffschläuche und -schlauchleitungen für den Einsatz in der
pharmazeutischen und biotechnischen Industrie - Verbundene Schläuche aus
Elastomeren mit oder ohne Innenschicht
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
Ta slovenski standard je istoveten z: prEN 16820
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.

DRAFT
EUROPEAN STANDARD
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2024
ICS 23.040.70 Will supersede EN 16820:2017
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 draft European Standard is submitted to CEN members for parallel enquiry. It has been drawn up by the Technical
Committee CEN/TC 218.
If this draft becomes a European Standard, 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.

This draft European Standard was established by CEN 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 16820:2024 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
1 Scope . 4
2 Normative references . 4
3 Terms and definitions . 5
4 Classifications and conditions of use . 5
4.1 Hose types . 5
4.2 Hose grades . 7
5 Dimensions. 8
5.1 Inside diameter, minimum thickness of the lining, bending radii . 8
5.2 Concentricity . 9
5.3 Length and tolerances for the hose assemblies . 9
5.4 Minimum bending radius . 9
6 Materials . 9
7 Requirements and tests . 11
7.1 Physical properties . 11
7.2 Electrical properties . 12
8 Designs/types of connection. 13
9 Manufacturing of the hose assembly . 14
10 Frequency of testing . 14
11 Marking . 15
11.1 Marking of the hoses . 15
11.2 Marking of the fittings . 15
11.3 Marking of the hose assemblies . 15
12 Installation and user instructions . 16
13 Storage and permissible storage time . 16
Annex A (normative) Test procedure to determine the electrical resistance through the wall of
hoses . 17
Annex B (normative) Testing of crushing strength (only for hose type SD) . 19
Annex C (normative) Behaviour to fire exposure . 21
Annex D (normative) Surface roughness and design of hose couplings . 23
Annex E (normative) Test frequencies for type tests and routine tests . 24
Bibliography . 25

European foreword
This document (prEN 16820:2024) has been prepared by Technical Committee CEN/TC 218 “Rubber
and plastics hoses and hose assemblies”, the secretariat of which is held by BSI.
This document is currently submitted to the CEN Enquiry.
This document will supersede EN 16820:2017.
This document includes the following significant technical changes with respect to EN 16820:2017:
— In 4.1, Table 1 the term “design” has been changed to “type”;
— In 4.2, an error in the value for electrical volume resistance has been corrected;
— In 4.3 and 4.4 the term “design” has been changed to “type”;
— In Clause 6 the reference to EU Regulation 1935/2004 has been removed;
— In Clause 8, Figure 1 has been corrected;
1 Scope
This document 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 Table 2 and Table 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 document are classified into four types, A – D, A – SD. B – D, B –
SD.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. 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 1402:2021, Rubber and plastics hoses and hose assemblies - Hydrostatic testing (ISO 1402:2021)
EN ISO 4671:2022, Rubber and plastics hoses and hose assemblies - Methods of measurement of the
dimensions of hoses and the lengths of hose assemblies (ISO 4671:2022)
EN ISO 5817:2023, Welding - Fusion-welded joints in steel, nickel, titanium and their alloys (beam welding
excluded) - Quality levels for imperfections (ISO 5817:2023)
EN ISO 7233:2021, Rubber and plastics hoses and hose assemblies - Determination of resistance to
vacuum (ISO 7233:2021)
EN ISO 7326:2016, Rubber and plastics hoses - Assessment of ozone resistance under static conditions (ISO
7326:2016)
EN ISO 8031:2020, Rubber and plastics hoses and hose assemblies - Determination of electrical resistance
and conductivity (ISO 8031:2020)
EN ISO 8033:2017, Rubber and plastics hoses - Determination of adhesion between components (ISO
8033:2016)
EN ISO 10619-1:2018, Rubber and plastics hoses and tubing - Measurement of flexibility and stiffness -
Part 1: Bending tests at ambient temperature (ISO 10619-1:2017)
EN ISO 10619-2:2021, Rubber and plastics hoses and tubing - Measurement of flexibility and stiffness -
Part 2: Bending tests at sub-ambient temperatures (ISO 10619-2:2021)
IEC/TS 60079-32-1:2018, Explosive atmospheres - Part 32-1: Electrostatic hazards, guidance
ISO 37, Rubber, vulcanized or thermoplastic — Determination of tensile stress-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
3 Terms and definitions
No terms and definitions are listed in this document.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp
— IEC Electropedia: available at https://www.electropedia.org/
4 Classifications and conditions of use
4.1 Hose types
Due to the operational requirements and the manufacturing conditions, the structural design of hose
assemblies in accordance with this document can vary considerably. A selection of possible hose/hose
assembly types is given in Table 1 and Table 2
d
Table 1 — Hose types
Type Conformity Structure Application
limits/operational
data
rubber hose with or without a
plastics lining and with one or
a
A – D
several reinforcement(s)
(pressure carrier)
Conformity of all components
of the hose with the
rubber hose with or without a
requirements of the
plastics lining and with one or
pharmaceutical and
several reinforcement(s)
c
b biotechnology industry
A – SD (pressure carrier) offering
sufficient form stability for suction
application or with one or several
integrated helix(es), respectively
see Table 3 and
Table 4
rubber hose with or without a
plastics lining and with one or
a
B – D
several reinforcement(s)
Conformity of all components
(pressure carrier)
of the lining of the hose, which
rubber hose with or without a
is in contact with the product,
plastics lining and with one or
with the requirements of the
several reinforcement(s
...