ISO 18250-3:2018

Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 3: Enteral applications

This document specifies dimensions and requirements for the design and functional performance of connectors intended to be used on enteral reservoirs. This document does not specify the dimensions and requirements for the medical devices or accessories that use these connectors. Such requirements are given in particular International Standards for specific medical devices or accessories. NOTE 1 Manufacturers are encouraged to incorporate the connectors specified in this document into enteral medical devices or accessories, even if not currently required by the particular medical device Standards. It is expected that when the particular medical device Standards are revised, requirements for reservoir connectors, as specified in ISO 18250, will be included. This document does not apply to screw and crown cork caps and necks as they are not connectors specific for medical devices. They rather belong to the food and beverage packaging domain despite often enteral giving sets are required to connect with them. NOTE 2 Examples of screw caps and necks are defined in DIN 55525:1988, ASTM D2911-94 (reapproved 2001), DIN 6063-1:2004, DIN 6063-2:2004, DIN 168-1:1998. Examples of crown cork caps and necks are defined in DIN 6094-1:1998, ISO 12821:2013, EN 14635:2010.

Dispositifs médicaux — Connecteurs pour systèmes de livraison de réservoir pour des applications de soins de santé — Partie 3: Applications entérales

General Information

• Status: Published
• Publication Date: 25-Jun-2018
• ICS: 11.040.25 - Syringes, needles an catheters
• Technical Committee: ISO/TC 210 - Quality management and corresponding general aspects for medical devices
• Drafting Committee: ISO/TC 210/WG 5 - Connectors for reservoir delivery systems
• Current Stage: 9093 - International Standard confirmed
• Start Date: 19-Dec-2025
• Completion Date: 27-Dec-2025

Relations

• Consolidated By: ISO 12957-1:2018 - Geosynthetics - Determination of friction characteristics - Part 1: Direct shear test
• Effective Date: 06-Jun-2022

Overview

ISO 18250-3:2018 - Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 3: Enteral applications specifies dimensional and functional requirements for enteral reservoir connectors. The standard defines two connector designs (E1R and E2R), material stiffness requirements, dimensional tolerances, and type-test performance criteria to reduce the risk of misconnections (for example with intravenous systems). It applies to connectors intended for enteral reservoirs and complements device-specific standards rather than replacing them.

Key topics and requirements

• Scope and purpose: Defines connector geometry and performance for enteral reservoirs; encourages manufacturers to adopt these connectors to improve safety and interoperability.
• Connector types: Two designs covered - cross-type connectors (E1R) and male/female types (E2R) with dimensional details in Annex B (figures and tables).
• Materials: Reservoir connector materials shall have a modulus of elasticity > 700 MPa (rigid/semi-rigid); softer sealing materials are allowed if they do not compromise non-interconnectability.
• Non-interconnectability: Design and verification requirements to prevent unintended mating with other medical device ports (e.g., IV bag ports).
• Dimensional verification: Compliance checked against specified figures/tables for each connector design (Annex B) and reference connectors (Annex C).
• Performance (type) tests - referenced methods and example requirements:
  • Positive pressure liquid leakage: no visible leakage at 40–60 kPa over ~30–35 s (torque 0.08–0.10 N·m per ISO 80369-20 Annex C).
  • Subatmospheric air leakage: maximum leakage limit specified (test at ~4.0–4.8 kPa, hold 15–20 s; see ISO 80369-20 Annex D).
  • Stress cracking, axial separation, unscrewing and override resistance: test procedures referenced to ISO 80369-20 (Annexes E–F); axial disconnection load example 32–35 N (hold 10–15 s).
• Guidance and usability: Informative annexes provide rationale, usability summaries and assessment guidance (Annexes A, D–G).
• Exclusions: Screw and crown cork caps/necks (food/beverage packaging standards) are outside this standard’s scope.

Applications and who uses it

• Medical device manufacturers designing enteral reservoirs, feeding bags and connectors should use ISO 18250-3 to ensure safe, non-interconnectable interfaces.
• Product designers and R&D teams for tubing, pumps and enteral accessories seeking dimensional and performance compatibility.
• Regulatory and quality engineers for product compliance, risk mitigation and design verification.
• Test laboratories performing type tests referenced to ISO 80369-20 and ASTM/ISO material tests.
• Procurement and healthcare providers evaluating device interoperability and safety.

Related standards

• ISO 18250-1 (general requirements)
• ISO 80369-20 (common test methods)
• ISO 80369-3 (small-bore enteral connectors)
• ASTM D638-10, ASTM D790-10 (material test methods)
• Relevant DIN / ISO / EN standards for caps and necks (listed in the standard)

Keywords: ISO 18250-3:2018, enteral connectors, reservoir connectors, medical device connectors, non-interconnectable, leakage test, dimensional requirements, ISO 80369-20.

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 18250-3
First edition
2018-06
Medical devices — Connectors
for reservoir delivery systems for
healthcare applications —
Part 3:
Enteral applications
Dispositifs médicaux — Connecteurs pour systèmes de livraison de
réservoir pour des applications de soins de santé —
Partie 3: Applications entérales
Reference number
©
ISO 2018
© ISO 2018
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
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below or ISO’s member body in the country of the requester.
ISO copyright office
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Published in Switzerland
ii © ISO 2018 – All rights reserved

Contents Page
Foreword .iv
Introduction .v
1 *Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 2
4.1 non-interconnectable characteristics . 2
4.2 *Materials . 2
5 *Dimensional requirements . 3
6 Performance requirements . 3
6.1 General performance requirements . 3
6.2 Positive pressure liquid leakage . 3
6.3 Subatmospheric-pressure air leakage . 3
6.4 Stress cracking . 4
6.5 Resistance to separation from axial load. 4
6.6 Resistance to separation from unscrewing . 4
6.7 Resistance to overriding . 4
6.8 Disconnection by unscrewing . 4
Annex A (informative) Rationale and guidance . 5
Annex B (normative) enteral reservoir connectors . 6
Annex C (normative) Reference connectors .17
Annex D (informative) Assessment of medical devices and their attributes with
connections within this application .23
Annex E (informative) Summary of the usability requirements for reservoir connectors
for enteral applications .24
Annex F (informative) Summary of reservoir connector criteria and requirements for
enteral applications .28
Annex G (informative) Summary of assessment of the design of the reservoir connectors
for enteral applications .31
Annex H (informative) Deviations from ISO 80369-20 .36
Annex I (informative) Twist-lock connector geometric layout and functioning .37
Bibliography .39
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
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committee has been established has the right to be represented on that committee. International
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electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/patents).
Any trade name used in this document is information given for the convenience of users and does not
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For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the WTO
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information.
This document was prepared by Technical Committee ISO/TC 210, Quality management and
corresponding general aspects for medical devices.
A list of all parts in the ISO 18250 series can be found on the ISO website.
In this document, the following print types are used:
— Requirements and definitions: roman type.
— Informative material appearing outside of tables, such as notes, examples and references: in smaller
type. Normative text of tables is also in a smaller type.
— Terms defined in this standard or as noted: small capitals.
In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates
that there is guidance or rationale related to that item in Annex A.
iv © ISO 2018 – All rights reserved

Introduction
During the development of the Standard for enteral small-bore connectors (ISO 80369-3:2016)
it became clear that the risk of misconnections was not limited to the patient access connectors
and that the whole enteral system needed to be considered. The possible misconnection between
enteral reservoir connectors and spikes was also reviewed. However as enteral reservoir
connectors are not exactly within the definition of small-bore connectors it was decided to develop
this separate Standard for these connectors, taking into account the risks of misconnection with
other medical devices such as intravascular (also referred as "IV") bags.
Two different designs of connectors have been included to reflect the varying types of feed reservoirs
in current use.
INTERNATIONAL STANDARD ISO 18250-3:2018(E)
Medical devices — Connectors for reservoir delivery
systems for healthcare applications —
Part 3:
Enteral applications
1 *Scope
This document specifies dimensions and requirements for the design and functional performance of
connectors intended to be used on enteral reservoirs.
This document does not specify the dimensions and requirements for the medical devices or
accessories that use these connectors. Such requirements are given in particular International
Standards for specific medical devices or accessories.
NOTE 1 Manufacturers are encouraged to incorporate the connectors specified in this document into
enteral medical devices or accessories, even if not currently required by the particular medical device
Standards. It is expected that when the particular medical device Standards are revised, requirements for
reservoir connectors, as specified in ISO 18250, will be included.
This document does not apply to screw and crown cork caps and necks as they are not connectors
specific for medical devices. They rather belong to the food and beverage packaging domain despite
often enteral giving sets are required to connect with them.
NOTE 2 Examples of screw caps and necks are defined in DIN 55525:1988, ASTM D2911-94 (reapproved 2001),
DIN 6063-1:2004, DIN 6063-2:2004, DIN 168-1:1998. Examples of crown cork caps and necks are defined in DIN
6094-1:1998, ISO 12821:2013, EN 14635:2010.
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.
ISO 18250-1, Connectors for reservoir delivery systems for healthcare applications — Part 1: General
requirements and common test methods
ISO 80369-20:2015, Small-bore connectors for liquids and gases in healthcare applications — Part 20:
Common test methods
ASTM D638-10, Standard test method for tensile properties of plastics
ASTM D790-10, Standard test methods for flexural properties of unreinforced and reinforced plastics and
electrical insulating materials
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 18250-1 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https: //www .iso .org/obp
— IEC Electropedia: available at http: //www .electropedia .org/
3.1
enteral
used for administration or removal of fluid (liquid or gas) to or from the gastrointestinal tract
[SOURCE: ISO 80369-3:2016, 3.1]
3.2
normal use
operation, including routine inspection and adjustments by any user, and stand-by, according to the
instructions for use
Note 1 to entry: Normal use should not be confused with intended use. While both include the concept of use as
intended by the manufacturer, intended use focuses on the medical purpose while normal use incorporates
not only the medical purpose, but maintenance, service, transport, etc. as well.
[SOURCE: IEC 60601-1:2005+A1: 2012, 3.71, modified – The word ‘operator’ has been replaced with
‘user’.]
3.3
rated (value)
term referring to a value assigned by the manufacturer for a specified operating condition
[SOURCE: IEC 60601-1:2005+A1: 2012, 3.97]
3.4
rigid material
material with a modulus of elasticity either in flexure or in tension greater than 35 000 kg/cm
(3 433 MPa)
3.5
semi-rigid material
material with a modulus of elastic either in flexure or in tension, between 7 138 kg/cm and 35 000 kg/
cm (700 MPa and 3 433 MPa)
4 General requirements
4.1 non-interconnectable characteristics
Where the design of the connector of this document relies on dimensions or features of the medical
device or accessory to ensure non-interconnectable characteristics, the manufacturer shall
verify the non-interconnectable characteristics. When necessary, the connector may be installed
on the medical device or accessory to demonstrate compliance with non-interconnectable
characteristics.
NOTE 1 The summary of medical devices and their attributes with connections within this application is
provided in Annex D.
NOTE 2 The summary of the usability requirements for enteral reservoir connectors is provided in
Annex E.
NOTE 3 The summary of enteral reservoir connectors criteria and requirements is provided in Annex F.
NOTE 4 The summary of assessment of the design of enteral reservoir connectors is contained in Annex G.
4.2 *Materials
Enteral reservoir connectors of medical devices or accessories shall be made of materials with a
modulus of elasticity either in flexure or in tension greater than 700 MPa.
2 © ISO 2018 – All rights reserved

Compliance shall be checked by applying the tests of the relevant parts of ISO 527/ASTM D638-10 or
ISO 178/ASTM D790-10.
The use of softer materials for sealing purposes is permitted provided that they do not affect the non-
interconnectability and interoperability of the reservoir connector.
5 *Dimensional requirements
Enteral reservoir connectors shall comply with the relevant dimensions and tolerances as given in:
— Figure B.1 and Table B.1 for cross connector assembly (E1R);
— Figure B.2 and table B.2 for cross connector shaft (E1R);
— Figure B.3 and Table B.3 for a cross port reservoir connector (E1R);
— Figure B.5 and Table B.5 for a male connector (E2R);
— Figure B.6 and Table B.6 for a female connector (E2R).
NOTE 1 Connectors designed to fit the requirements of this document do not connect with the ports defined
in ISO 1135-4 and ISO 3826-1. These ports utilize flexible material as used on intravenous (IV) bag ports that
can expand to accept many dimensions of mating connectors. The design of the connectors in this document
allows the connector to penetrate the elastic IV bag port but without establishing a fluid flow.
NOTE 2 Figure B.4 shows the connection between the cross connector and the cross port reservoir
connector.
NOTE 3 Refer to Annex I for information relative to the specific geometric layout and functionality of the male
and female connectors (E2R).
Check compliance by verifying the dimensions and tolerances specified in Annex B, as appropriate.
6 Performance requirements
6.1 General performance requirements
The tests described in this document are type tests.
6.2 Positive pressure liquid leakage
Enteral reservoir connectors shall be evaluated for fluid leakage performance with the positive
pressure liquid leakage test method and shall show no signs of leakage, sufficient to form a falling
drop of water, over a hold period of 30 s to 35 s while being subjected to an applied pressure of between
40 kPa and 60 kPa. Manufacturers may use a greater applied pressure or a longer hold period.
Compliance shall be checked by applying the tests of ISO 80369-20:2015, Annex C, applying a torque of
between 0,08 N·m and 0,10 N·m while using the leakage reference connector specified in Annex C, and
considering the deviations listed in Annex H.
6.3 Subatmospheric-pressure air leakage
Enteral reservoir connectors shall be evaluated for subatmospheric pressure air leakage, and shall
not leak by more than 0,005 Pa·m /s while being subjected to an applied subatmospheric pressure of
between 4,0 kPa and 4,8 kPa over a hold period of between 15 s and 20 s. Manufacturers may use a
greater applied subatmospheric pressure.
Compliance shall be checked by applying the tests of ISO 80369-20:2015, Annex D, while using the
leakage reference connector specified in Annex C, and considering the deviations listed in Annex H.
6.4 Stress cracking
Enteral reservoir connectors shall be evaluated for stress cracking. enteral reservoir
connectors shall meet the requirements of 6.2 after being subjected to stresses of ISO 80369-20:2015,
Annex E.
Compliance shall be checked by applying the tests of ISO 80369-20:2015, Annex E, while using the stress
cracking reference connector specified in Annex C, and considering the deviations listed in Annex H.
6.5 Resistance to separation from axial load
Enteral reservoir connectors shall be evaluated for separation from axial load. enteral reservoir
connectors shall not separate from the reference connector over a hold period between 10 s and 15 s
while being subjected to a disconnection applied axial force between 32 N and 35 N. Manufacturers
may use a greater disconnection applied axial force or a longer hold period.
Compliance shall be checked by applying the tests of ISO 80369-20:2015, Annex F, while using the
separation from axial load reference connector specified in Annex C, and considering the deviations
listed in Annex H.
6.6 Resistance to separation from unscrewing
Enteral reservoir connectors shall be evaluated for separation from unscrewing. Enteral
reservoir connectors shall not separate from the reference connector for a hold period between
10 s and 15 s while being subjected to an unscrewing torque of between 0,019 8 N·m to 0,02 N·m.
Manufacturers may use a greater applied unscrewing torque or a longer hold period.
Male connector (E2R) in Figure B.5 and female connector (E2R) in Figure B.6 are exempted from this
requirement.
Compliance shall be checked by applying the tests of ISO 80369-20:2015, Annex G, while using the
separation from unscrewing reference connector specified in Annex C, and considering the deviations
listed in Annex H.
6.7 Resistance to overriding
Enteral reservoir connectors shall be evaluated for resistance to overriding. enteral reservoir
connectors shall not override the threads or lugs of the reference connector while being subjected
to an applied torque of between 0,15 N·m to 0,17 N·m over a hold period between 5 s and 10 s.
Manufacturers may use a greater applied torque or a longer hold period.
Compliance shall be checked by applying the tests of ISO 80369-20:2015, Annex H, while using the
resistance to overriding reference connector specified in Annex C, and considering the deviations
listed in Annex H.
6.8 Disconnection by unscrewing
Enteral reservoir connectors shall be evaluated for disconnection by unscrewing. enteral
reservoir connectors shall separate from the reference connector with an applied unscrewing
torque up to 0,26 N·m.
Single use enteral reservoir connectors are exempted from the requirement of this subclause.
Male connector (E2R) in Figure B.5 and female connector (E2R) in Figure B.6 are exempted from the
requirement of this subclause.
Compliance shall be checked by applying the tests of ISO 80369-20:2015, Annex I, while using the
disconnection by unscrewing reference connector specified in Annex C, and considering the deviations
listed in Annex H.
4 © ISO 2018 – All rights reserved

Annex A
(informative)
Rationale and guidance
A.1 General
This annex provides a rationale for some requirements of this document, and is intended for those who
are familiar with the subject of this document but who have not participated in its development. An
understanding of the rationale underlying these requirements is considered to be essential for their
proper application. Furthermore, as clinical practice and technology change, it is believed that a
rationale will facilitate any revision of this document necessitated by those developments.
A.2 Rationale for particular clauses and subclauses
The clauses and subclauses in this annex have been numbered to correspond to the numbering of
the clauses and subclauses of this document to which they refer. The numbering is, therefore, not
consecutive.
Clause 1 Scope
Screw and crown cork caps and necks are excluded from the application of this document because
they are not connectors specific for medical devices. Screw and crown cork caps and necks of various
diameters and thread geometries are commonly used in food and beverage packaging industry and may
vary from one geographical region to another. Enteral giving sets are often asked to connect to pre-
existing food containers despite such containers almost always do not follow — and are not required
to follow — the standards and regulations for medical devices. Therefore, the need for a reservoir
connector different from the specifically medical connectors herein defined may arise depending
on the local market and customs. In order to avoid any claim of non-conformity of such caps and necks
with this document, that deals with specifically designed medical connectors only, the screw and
crown cork caps and necks are clearly excluded from the scope of this document.
Subclause 4.2 Material requirements
As this document is not a medical device standard specifying colour coding was considered
inappropriate.
Subclause 5 Dimensional requirements for enteral reservoir connectors
The interface dimensions and requirements in this document have been developed taking into account
the risks of misconnecting with other reservoirs such as IV bags. It can therefore be assumed that if
an enteral reservoir connector is manufactured to the dimensions in this document then it will not
provide a connection with other reservoir connectors of other applications such that liquid will flow.
Annex B
(normative)
enteral reservoir connectors
a
The sealing surface does not need to comply with 4.2 (e.g. be elastomeric). The use of softer materials for
sealing purposes whereas they do not affect non-interconnectability and interoperability is permissible.
b
The thread start fillet shape is manufacturer-specific. Dimension AG refers to the first section with complete
thread cross-section.
Figure B.1 — Cross connector assembly (E1R)
Table B.1 contains the dimensions for Figure B.1.
6 © ISO 2018 – All rights reserved

Table B.1 — Cross connector (E1R): Dimensions of the assembly of shaft and revolving lock
Dimensions in millimetres unless otherwise indicated
Revolving lock and cross connector assembly (E1R)
Dimension
Reference Designation
Minimum Nominal Maximum
ØA Revolving lock head outside diameter 16,00 — —
ØB Thread root internal diameter 12,30 12,40 12,65
ØC Thread crest internal diameter 11,10 11,20 11,45
D Thread length 10,80 11,15 11,50
Distance from revolving lock head and gasket sur-
E face or distance from revolving lock head and shaft 8,55 10,15 11,75
a
basis plane if gasket is not used
b c
H Tip protrusion from revolving lock 18,70 19,10 23,05
K Front angle of thread profile (degrees) 30° 40° 50°
J Rear angle of thread profile (degrees) 10° 15° 20°
Base length of thread section measured in corre-
L — — 1,70
d
spondence of crest internal diameter ØC
M Thread pitch — 2,00 —
Base length of thread section measured in corre-
N 0,65 — —
spondence of root internal diameter ØB
Distance between revolving lock head and
AG — — 1,50
thread start
a
Gasket features are manufacturer-specific. The specified dimension range permits the use of very thick and soft
gaskets.
b
Minimum value can be reached with gasket only.
c
Maximum value can be reached only without gasket, with revolving lock in least material condition and shaft in most
material condition.
d
Thread crest may have fillet radii provided that diameter ØC is achieved. Dimension L refers to the gross profile.
Figure B.2 — Cross connector shaft (E1R)
Table B.2 contains the dimensions for Figure B.2.
8 © ISO 2018 – All rights reserved

Table B.2 — Cross connector (E1R): Dimensions of the details of the shaft
Dimensions in millimetres unless otherwise indicated
Cross connector (E1R): details of the shaft
Dimension
Reference Designation
Minimum Nominal Maximum
a Shaft length from base to tip 31,00 31,30 31,60
Wing span projected on a plane orthogonal to
b 6,50 6,60 6,70
shaft axis and that passes on tip
c Wing span at shaft basis before fillet with base 6,70 6,80 6,90
d Wing width at top 0,80 0,90 1,00
e Wing width at bottom before fillet with base 1,00 1,10 1,20
Øf Inner diameter at top 2,10 2,20 2,30
Inner diameter at bottom on a section that passes
Øg 2,10 — —
through the fillet start on shaft
h Slit width 0,90 1,00 1,25
a
i Slit depth from tip 6,15 6,40 6,65
m Lower wing start from tip 5,35 5,60 5,85
n Lower wing head nook angle (degrees) 70° 80° 85°
p Chamfer angle on channel head (degrees) — — 90°
q Chamfer angle on upper wings blade (degrees) — — 60°
r Fillet radius between shaft and basis — — 0,5
s angle between wing blade and shaft axis (degrees) 65° 85° 105°
Øt Spike core diameter at top — — 3,5
Øu Spike core diameter at bottom — — 3,6
Øv Diameter of the basis 10,00 10,50 11,05
a
Slit shape may be semi-circular.
a
The sealing membrane does not need to comply with 4.2 (e.g. be elastomeric) and is manufacturer-specific.
Figure B.3 — Cross port reservoir connector (E1R)
Table B.3 contains the dimensions for Figure B.3.
10 © ISO 2018 – All rights reserved

Table B.3 — Cross port reservoir connector (E1R) dimensions
Dimensions in millimetres unless otherwise indicated
Cross port reservoir connector (E1R)
Dimension
Reference Designation
Minimum Nominal Maximum
a
P Distance from head to thread start 1,90 — 6,85
Q Thread length 4,00 — —
b,c
ØS Outside diameter at base of lugs 9,90 10,60 11,00
ØT Thread external diameter 11,75 12,00 12,30
d
U Body length 5,50 — —
Wing span in cross bore (inscribed rectangle if
V 6,80 6,90 7,50
wing tips are made of circular arches)
W Wing width in cross bore 1,10 1,20 1,50
ØX Diameter of cross bore core 3,60 3,70 3,80
Y Angle of conical nook on head (degrees) — — 22°
Crest length of thread section measured in corre-
Z — — 0,50
e,g
spondence of diameter ØT
AA Rear angle of thread profile (degrees) — — 25°
AB Front angle of thread profile (degrees) 30° 40° 47°
AC Thread pitch, single-start, right-handed 2,00
AD Clearance between wingspan and internal diameter 0,0 — —
R1 Fillet radius between body and head — — 1,50
AE Distance between head and foil to be pierced — — 23,75
ØAF Base diameter of conical nook on head — — 8,75
a
Different thread positions are allowed in order to include current adopted technologies and sealing systems.
Manufacturers shall provide experimental evidence for correct functionally according to functional requirements
specified in this document and in ISO 18250-1.
b
Several combinations of ØS and R1 are allowed in order to include current technologies and sealing systems. To prevent
misconnection with the ISO 5356-1 8,5 mm female socket and to provide enough sealing surface against the gasket, these
dimensions shall comply with the following inequality: ØS − 2 × R1 ≥ 8,5 mm.
c
Dimension ØS refers to port rigid body only. The adoption of a deformable sealing foil on head (e.g. made of aluminium
or multilayer composite) that exceeds ØS but not ØT does not create any additional misconnection issue.
d
Different port lengths are allowed in order to include current adopted technologies and sealing systems. The body
length ends on the nutrition source surface. This document specifies requirements for the connectors and not the medical
devices upon which they are placed.
e
0,50 mm is the maximum value of Z when angles AA and AB are set at their minimum values. The Z value depends from
combination of diameters ØS and ØT, angles AA and AB.
f
Internal diameter shall ensure free sliding of the shaft during insertion by circumscribing the cross bore profile along
the port inside depth.
g
Thread crest may have fillet radii provided that diameter ØT is achieved. Dimension Z refers to the gross profile.
Figure B.4 — Connection of cross connector and cross port reservoir connector (E1R)
NOTE Figure B.4 is provided for informative purpose only in order to show the aspect of the correct
connection between cross connector and cross port reservoir connector.
12 © ISO 2018 – All rights reserved

a
Structure to prevent connection with closure piercing device.
b
No need to be an arc, but be satisfied in Øb range.
Figure B.5 — Male connector (E2R)
Table B.5 contains the dimensions for Figure B.5.
Table B.5 — Male connector dimensions (E2R)
Dimensions in millimetres unless otherwise indicated
Male connector (E2R)
Dimension
Reference Designation
Minimum Nominal Maximum
Øa Maximum outside diameter of the lock lug 21,10 21,20 21,30
Øb Maximum outside diameter of the base — — 18,10
Øc Maximum outside diameter of the male nozzle 9,30 9,35 9,40
Ød Outside diameter of the male nozzle at the root 9,04 9,09 9,14
Length of the male nozzle from the root to the
e 1,45 1,50 1,55
maximum outside diameter (Øc)
f Length of th
...