SIST EN 16820:2017

SLOVENSKI STANDARD
SIST EN 16820:2017
01-september-2017
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ELRWHKQRORãNLLQGXVWULML9H]DQHHODVWRPHUQHFHYLVSRGORJRDOLEUH]QMH
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
SIST EN 16820:2017 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 16820:2017

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SIST EN 16820:2017


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.

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SIST EN 16820:2017
EN 16820:2017 (E)
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
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SIST EN 16820:2017
EN 16820:2017 (E)
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

3

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SIST EN 16820:2017
EN 16820:2017 (E)
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.
4

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SIST EN 16820:2017
EN 16820:2017 (E)
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)
5

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SIST EN 16820:2017
EN 16820:2017 (E)
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 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 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
BS 3592-1:1986, Steel wire for hose reinforcement — Specification for coated round and flat steel wire for
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 standard can vary considerably. A selection of possible hose
types/designs is given in Table 1.
Table 1 — Hose types
Application limits/
Type Structure
operational data
rubber hose with or without a plastics
a
lining and with one or several
D
reinforcement(s) (pressure carrier)
rubber hose with or without a plastics
see Tables 2 and 3
lining and with one or several
reinforcement(s) (pressure carrier)
b
SD
offering sufficient form stability for suction
application or with one or several
integrated helix(es), respectively
a
D is a pressure hose.
b
SD is a suction and discharge hose.
Hose assemblies in accordance 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.
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SIST EN 16820:2017
EN 16820:2017 (E)
3.2 Hose grades
Hoses and hose assemblies 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 Ω: electrically conductive;
— grade M/T: electrically bonded and with an electrical volume resistance through the hose wall not
9
exceeding 10 Ω;
— grade Ω/T: electrically conductive and with an electrical volume resistance through the hose wall
9
not exceeding 10 Ω.
3.3 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.
3.4 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 conformity 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 thickness of the lining;
— the minimum bending radius.
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SIST EN 16820:2017
EN 16820:2017 (E)
Table 2 — Dimensions and bending radii for hose type D
Nominal Minimum
Minimum
Inside diameter Outside diameter
Vacuum
size thickness
bending
stability
b
radius
mm mm mm
Hose
a
Dimensions Tolerances Dimensions Tolerances mm bar
Lining
cover
13 13,0 23,0 90
16 16 26,0 100 −0,5
19 19,0 31,0 125
±0,5 ±1,0 2,0 1,6
25 25,0 37,0 150
32 32,0 44,0 175 −0,4
38 38,0 51,0 225
50 50,0 66,0 275
±0,7 −0,3
51 51,0 67,0 275
63 63,0 79,0 300
±1,2
c
75 75,0 91,0
350
2,0 2,0
c
76 76,0 92,0
±0,8 350 —
c
100 100,0 116,0
450
±1,6
c
101,5 101,5 118,0
450
a
The 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.
b
The bending radii given are not applicable for hoses made of PE-X/UPE and fluoro-plastics; in these cases they shall
be 1,5 times as large.
c
Only applicable for operation at minimum 1 bar, otherwise the hose will kink.
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SIST EN 16820:2017
EN 16820:2017 (E)
Table 3 — Dimensions and bending radii for hose type SD
Nominal Minimum
Minimum
Inside diameter Outside diameter
Vacuum
size thickness
bending
stability
radius
mm mm mm
Lining Hose
b
Dimensions Tolerances Dimensions Tolerances bar
mm
a
cover

19 19,0 31,0 125
25 25,0 37,0 150
±0,5 ±1,0 1,6 1,6
32 32,0 44,0 175
38 38,0 51,0 225
50 50,0 66,0 275
±0,7 ±1,2 1,7 1,7
51 51,0 67,0 275 −0,8
63 63,0 79,0 300
75 75,0 91,0 ±1,2 1,7 350
76 76,0 ±0,8 92,0 1,8 350
100 100,0 116,0 450
±1,6 2,0
101,5 101,5 118,0 450
a
The 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.
b
The bending radii given are not applicable for hoses made of PE-X/UPE and fluoro-plastics; in these cases they shall
be 1,5 times as large.
4.2 Concentricity
When determined in accordance with EN ISO 4671, on the basis of all readings of the dial gauge
between the inside diameter and the surface of the cover, the concentricity shall be ≤ 1,0 mm for hoses
with a nominal size ≤ 50 and ≤ 1,5 mm for hoses with a nominal size > 50.
4.3 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.
+15
The permissible tolerance is for hose assemblies with a length of up to and including 1 000 mm.
mm
−10
+1,5
The permissible tolerance is % for hose assemblies with a length of more than 1 000 mm.
−1,0
4.4 Minimum bending radius
The dimensions given in Tables 2 and 3 apply to the minimum bending radius of type D and type SD
hose assemblies.
Other dimensions will be agreed upon between the user and the manufacturer.
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SIST EN 16820:2017
EN 16820:2017 (E)
5 Materials
Table 4 lists the commonly used materials.
Table 4 — Materials
Component Material In accordance with
EPDM, IIR, UPE, fluoro-plastics (e.g. PTFE,
Hose lining —
b
PFA, FEP…)
galvanized hard or mild steel wire.
Alternatively, the helix or helixes may,
EN 10270–1 or
when required, consist of
EN 10270–2
X2CrNi19-11
Helix (galvanized to
X5CrNiMo17-12-2
EN 10244–2), or
X2CrNiMo17-12-2
BS 3592–1:1986
X3CrNiMo17-13-3
in accordance with EN 10088-3
X2CrNiMo18-10
a
Threaded nipple ,
X2CrNiMo18-14-3
Screw connection with internal
X2CrNiMo17-13-5 —
a
thread ,
NiCr21Mo14W
a
Coupling nut
Ti-II
X2CrNiMo18-10
X2CrNiMo18-14-3
X2CrNiMo17-13-5
Hose socket with weld-neck collar
NiCr21Mo14W
EN 1092–1
Ti-II
Loose flange
X2CrNiMo18-10
X6CrNiTi18-10
X6CrNiTi17-12-2
X2CrNiMo18-10
X2CrNiMo18-14-3
a
X2CrNiMo17-13-5 —
Aseptic couplings
NiCr21Mo14W
Ti-II
X2CrNiMo18-10
X2CrNiMo18-14-3
a
X2CrNiMo17-13-5 —
Clamp couplings
NiCr21Mo14W
Ti-II
a
Parts in contact with the product shall not be made of cast material. Parts made of X5CrNi18-10 as well as
X5CrNiMo17-12-2 not in contact with the product are permissible.
b
Other materials are permissible, provided they are at least of an equivalent quality.
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SIST EN 16820:2017
EN 16820:2017 (E)
Verification of the fitting materials used for parts in contact with the product shall be by inspection
documents, e.g. inspection certificate 3.1, in accordance with EN 10204.
The materials need to meet at least the requirements of the Regulation (EC) No 1935/2004 of the
European Parliament and of the Council of 27 October 2004 on materials and articles intended to come
into contact with food and repealing Directives 80/590/EEC and 89/109/EEC. The relevant certificates
1)
shall be presented upon request (of the customer). Further requirements, e.g. in accordance with USP
Class VI, or EN ISO 10993-5, may be agreed upon. Further requirements such as freedom of silicone and
of substances of animal origin as well as TSE Compliance (TSE: Transmissible Spongiform
Encephalopathies) shall be agreed upon separately.
6 Requirements and tests
6.1 Physical properties
The physical requirements for the lining and the cover are specified in Table 5 and the physical
requirements for the hose assemblies and the associated test methods are specified in Table 6.
Table 5 — Physical properties of the lining and the cover
Requirement
Properties Unit Test method
Lining Cover
ISO 37
Tensile strength min. MPa 8,0 8,0
(dumb bell)
Elongation at break  %
ISO 37
(dumb bell)
Materials, see Table 4 min.  250 250
Ageing  %
ISO 188 (air
Change in tensile strength max. — 15
oven method)
of the
7 days at
initial
Change in elongation at break max. — 20 (70 ± 1) °C
value

1)
United States Pharmacopeia, USP.
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SIST EN 16820:2017
EN 16820:2017 (E)
Table 6 — Physical properties of the hose assemblies
Properties Unit Requirements Test method
Proof pressure
no leakage or visible structural
of 1,5 times the maximum working  EN ISO 1402
damage
pressure (MWP) of 10 bar
Change in length, maximum type D: 0 to +8
type SD: 0 to +10
a) at proof pressure
% EN ISO 1402
type SD: −2
b) at –0,9 bar or –0,8 bar, respectively
(vacuum)
Change in twist, maximum
°/m 8 EN ISO 1402
at proof pressure
Resistance to vacuum
no damage,
Vacuum in accordance with Table 3, — EN ISO 7233
no collapse
for 10 min
Vacuum stability
no change in the diameter
Vacuum in accordance with Table 2, % EN ISO 7233
and/or the length
for 10 min
4 times the maximum working
Burst pressure, minimum  EN ISO 1402
pressure (MWP)
Adhesion between components, dry,
N/mm 2,4 EN ISO 8033
minimum
Pressure recovery (testing of crushing
strength) % 3 Annex B
– only type SD, maximum
EN ISO 7326,
relative humidity of
Ozone resistance, maximum no visible cracks at twofold (55 ± 10) %, ozone
—
72 h at 40 °C magnification concentration of
(50 ± 5) pphm, 20 %
elongation
no burning after 20 s,
Behaviour to fire exposure — no glowing combustion after Annex C
2 min, no leakage
2
Ω type M: R ≤ 10 /hose assembly
Electrical properties EN ISO 8031
6
type Ω: R ≤ 10 /hose assembly
Electrical volume resistance Ω
9
Annex A
≤ 10
(see 6.2)
Bending test, maximum deformation of %
the hose outside diameter at minimum
10 EN ISO 10619-1
bending radius and an internal
pressure of 0,7 bar (only type D)
— no permanent deformation or EN ISO 10619-2,
Flexibility at –20 °C
visible structural damage method B
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SIST EN 16820:2017
EN 16820:2017 (E)
6.2 Electrical properties
As a rule, a differentiation shall be made between electrically conductive and electrically non-
conductive or insulating hose assemblies.
For certain applications, insulating hose assemblies are explicitly required. In such cases the electrical
resistance, measured between the two hose fittings in accordance with EN ISO 8031, shall not fall below
9
10 Ω. Such hose assemblies shall be marked with the symbol “I”.
If electrical conductivity of the hose assemblies is required, this can be achieved by two methods:
1) Unless the hoses have a metallic supporting helix and/or (a) pressure carrier(s) designed as
metallic braid in accordance with Table 1, two electrically bonding wires of low resistance shall be
integrated into the hose design. The wires shall be mounted helically and guided such that they
cross each other in regular intervals.
If fittings are mounted onto this hose, the connecting wires, helixes or braids shall be safely
connected to the fittings.
2
Ω over the whole
When tested in accordance with EN ISO 8031, the resistance shall not exceed 10
length; the resistance being the one along the connecting wires, helixes or braids for hoses and the
one between the fittings for hose assemblies. If electrical conductivity is achieved by this method,
the hose shall be marked with the symbol “M”.
2) Integration of electrically dissipative materials into the hose design. If fittings are mounted onto
this hose, a connection between the end fittings and the dissipative layer shall be provided for.
6
When tested in accordance with EN ISO 8031, the resistance shall not exceed 10 Ω over the
whole length; the resistance being the one along the dissipative layer for hoses and the one
between the fittings for hose assemblies. If electrical conductivity is achieved by this method, the
hose shall be marked with the symbol “Ω”.
If hose assemblies in accordance with 1) or 2) are used in potentially explosive atmospheres, the
9
volume resistance through the whole hose wall shall not exceed 10 Ω. Further information is to be
found in IEC/TS 60079-32-1. In such cases, the hose shall additionally be marked with the symbol “T”,
i.e. either “M/T” or “Ω/T”. Exceptions from the requirement for a limitation of the volume resistance
valid for small outside hose diameters are listed in EN 12115.
The test method for the determination of the electrical volume resistance through the hose wall is given
in Annex A (normative).
Both during and following the hydrostatic test in accordance with EN ISO 1402, the electrical resistance
from one end to the other shall be complied with for every hose and the electrical resistance from one
end fitting to the next, for every hose assembly.
Electrical conductivity in Type SD shall not be obtained by only connecting the fittings to the helixes.
7 Designs/types of connection
The following designs/types of connection are specified in this standard:
— aseptic couplings;
— clamp couplings.
Other end fittings/couplings, such as flanges, shall be agreed upon between the user and the
manufacturer.
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SIST EN 16820:2017
EN 16820:2017 (E)
The surface roughness and design of hose couplings for contact with the medium shall be specified in
accordance with the hygiene classes given in Annex D.
Mounting shall be performed by means of, e.g. high-grade steel ferrules. Other types of assembly shall
be agreed upon between the manufacturer and the user.
Hose side fitting transitions shall be designed with as small a gap as possible. The transitions between
hose and fitting shall be conical and without beads (see Key 7 in Figure 1).
Any welds shall be made in accordance with EN ISO 5817, quality level B (high), e.g. free of temper
colours as well as free of burrs and gaps. Connection side fitting transitions shall be agreed upon
between the manufacturer and the user. An example is given i
...