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: 14-Feb-2026

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
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
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CH-1214 Vernier, Geneva
Phone: [phone]
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Email: [e-mail]
Website: www.iso.org
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
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
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
constitute an endorsement.
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
principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword — Supplementary
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
...

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
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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
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
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
constitute an endorsement.
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
principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword — Supplementary
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
...

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healthcare applications —
Part 3: Enteral applications
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ة�ت اوذاا تاقصاولاا ذاذعإا مت�ي ام ا�نااعو ،(وم�ي�الا ى�ق ءاضع�الا) ة�تنظواا س�ت�تقتاا تاه�حا ىلااع ذاحيا ىه (س�ت�تقتلا ة�تاوذاا ةلطنلاا) وم�ي�الا
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ة ا نوك�ي ن�ا ى�ق قحاا وضعاا اذها نإا�ق ، ة�تن�ق ةن�حا ةا تلكس ذ�ق عوصول�ن مالتهإا اها وضعاا ةه�حاا تناك اذإاو ، وم�ي�الا ة�تنقاا نا�حلاا لالر نم
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نواعتي و .وم�ي�الا ةلطنم عم لصاوي اها ىتاا ة�تموكحاا م�تعو اهنم ة�تموكحاا ة�تاوذاا تالطنلااا �كاذك للعاا ى�ق �كراس�يو .ةن�حلاا �كلي ى�ق لتلم
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.ىنقيومهكاا لا�حلاا ى�ق س�ت�تقتاا مهي ىتاا روم�الا ع�تلجر ى�ق (IEC) ة�تاوذاا ة�تنقيومهكاا ةن�حلاا عم ق�تيو لكس�ن وم�ي�الا ةلطنم
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ةقلتح لاا تاذذــحلاا هاــعامم �ت�ح�ي.لو�الا ءم�حاا ISO/IEC تاه�تجروتاا ىق ةحصوم اهيال�يذعيو ةق�تيواا هذه م�يوطتا ةع�نتلاا تاءامجرإالا نإا
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مــطنا) ISO/IEC تاه�تجروتاا ىق ةــ�يم�يمحتاا ذــعاوقلا ًاققو ةــق�تيواا هذه م�يوطي متصار لكس�ن وم�ي�الا قنايو نم هذذعتلاا عاون�الا ةمرالاا
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(www.iso.org/directives
ســ�ت�تقت لا ة�تاوذاا ةــلطنلاا للحتي ناو.ة�يمكقاا ة�تكللاا قوقحا ةعصار ةق�تيواا هذه مصانع صع�ن نوكي ن�ا ة�تاالترا ىاإا ها�نتنالا تقا ذونو
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اهجرارذإا مت�تس ةقصاولاا �ى�ق اهمكذ مي ة�يمكقاا ة�تكللاا قوقح�ن ةصار ل�تصاقي �ي�ا نإا اهع�تلجر و�ا قوقحاا هذه نم �ي�ا ذ�يذحي ة�تاووسم (وم�ي�الا)
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( www.iso.org/patents مطنا)ةللتسلاا ة�يمكقاا ة�تكللاا قوقر تاق�يمعي ةلنا�ق �ى�ق و�ا/و ةمذقلاا �ى�ق
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اها ىن�ني ي�ا لكس�ي الو ن�تمذحتسلاا ىلع مم�الا ل�تهستا ةمذقم تامولعم ىه ةق�تيواا هذه ى�ق ةمذحتسم ة�يرا�حي ةمالع ي�ا نإا
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ل ور تاــــمولعلاا �تناجر ىاإا ةق�ناطلاا م�يوقت�ن ةصاحاا تام�ت�نعتااو تاحلطضلاا ىنعمو ة�يرا�تترالا تاقصاولاا لور خ�تصوي ىلع لوضحلا
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تا مولعم - ةمذقم :ىااتاا ط�ناماا مطنا ،(TBT) هرا�حتلا ة�تنقاا قناوعاا ىق ة�تلااعاا هرا�حتاا ةلطنم يذا�نل�ن مامتاا لور س�ت�تقتلا ة�تاوذاا ةلطنلاا
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.ة�تل�تلكي
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.ة�ت�نطاا همهجر�الا�ن ةلضاا تاذ ةماعاا �تناو�حااو هذو�حاا هراذإا ,ISO/TC 210 ة�تاوذاا ةن�حلاا ل�ن�ق نم ة�تاوذاا ةقصاولاا هذه م�يوطي مي
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وم�ي�الا عقوم لالر نم اها لوصواا نكل�ي ISO 18250 series ة�تاوذاا ةقصاولاا�ن ةصاحاا ءامجر�الا ةلناق ىاإا لوصواا نكل�ي
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:ة�تااتاا ة�يم�يمحتاا م�ت�ياعلاا ماذحتسا مي ةق�تيواا هذه نلص
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.ة�تناموماا رومماا :ف�يراعتااو تا�نلطتلاا —
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ة�تح�تصوت اا تامولعلاا �كاذكو معص�ا طوطح�ن :ة�تعجرملاا تاراسإالاو ةلتم�الاو تاطراللاا لتم لواذ�حاا ججرار ة�تح�تصوتاا تامولعلاا —
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.لواذ�حاا نلص
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م�تع ص طح�ن :تاطراللك و�ا ةقصاولاا ىق هذراواا ف�يراعتاا —
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خ�تحص اهنم ءمجر �ي�ا لار �ى�ق ةح�تحص م�نتعي هرا�نعاا نإا�ق �كاذاو ن�تلضي �فمحك (و�ا) فطعاا �فمر مذحتس�ي ةق�تيواا هذه �ى�ق
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Annex A ذن�ناا �كاذ ىاإا هراسإا و�ا ل�تاذ ذوجرو ىاإا م�تسي لوذ�حاا و�ا صناا ة�ياذ�ن ىق و�ا ناونعاا ة�ياذ�ن ىق مممك (*) ةمالع نإا
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ISO 2018 — All rights reserved  ©
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م�تدقت
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ن�ت�ني ISO 80369-3:2016 فــ�يو�حتاا هم�تعص ة�يوعلاا تالصوللا ة�تسا�تقاا ةقصاولاا م�يوطي ءاني�ا يوعمـ�ن ةصاحاا ةقصاولاا م�يوطي ءاني�ا
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لالترا ةعجرامم تلي ذ�قو .ةللك�ا�ن يوعلاا ماطناا ى�ق مطناا �ت�ح�ي ةن�او ص�يملاا لوصو تالصوم ىلع مضتقي ما لاضيالا عاطقنا مظاحم ن�ا
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ف�يو�حت اا تاذ تالصولاا ف�يمعي نلص ط�نضاا�ن تس�تا يوعلاا نامحاا تالصوم نكا .م�تماسلااو يوعلاا نامحاا تالصوم ن�ت�ن لاضيالا مذع
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لراذ سا�تك�ا لتم يمر�الا ة�ت�نطاا همهجر�الا عم لاضيالا ءوس مظاحم هاعامم عم ، تالصواا هذها لضقنلاا را�تعلاا اذه م�يوطي رمقي ذق�ق ، م�تعضاا
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” IV“ مسا�ن اًض�ي�ا اه�تاإا راس�ي ىتاا ,ة�يومذاا ة�تعو�الا
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.ىااحاا ماذحتسالا ىق ة�يذعتاا تانامحا ةقلتحلاا عاون�الا سكعا تالصوللا ن�تقلتحم ن�تل�تلضي ن�تلضي مي
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ISO 2018 — All rights reserved  ©
ه
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ة�يخصلا ة�تاعزلا تاق�ي�بطيل نازخلا ل�يصوت ةمطنا تالصوم — ة�ي�بطلا ةزهجخ�ألا
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:3 ءمجر
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ة�يلخادلا تاق�ي�بطيلا
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لا�خملا * 1
.ة�يوعلاا تانامحاا ىق ماذحتسالا ةضضحلاا تالصوللا ىق�تظواا ءاذ�الاو م�تلضتاا تا�نلطتمو ذاع�ن�ا ذذح�ي ذنتسلاا اذه
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ذ�يذحتاا�ن تاــ�نلطتلاا هذه ءاطعإا مت�ي .تالــصولاا هذه مذحتــسي ىتاا اــهياقحلم و�ا ة�ت�نطاا همهجر�الا تا�نلطتمو ذاع�ن�ا ذنتسلاا اذه ذذح�ي ال
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.اهياقحلم و�ا ة�ت�نطاا همهجر�الا هذذحلاا ة�تاوذاا تاقصاولاا
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و ا ىتــر ، ة�ت�نطاا تاقحللاا و�ا ةّ�يوعلاا ة�ت�نطاا همهجر�الا ى�ق ذنتسلاا اذه ى�ق هذذحلاا تالصولاا جخمذ ىلع ةعّنضلاا تاكمساا ع�ت�حسي مت�ي 1 ةطراللاا
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نامــح اا تا�نلطتم ن�تلضي مت�تس، ن�تعم ى�نظ راهجر تاقصاوم ةعجرامم ذنع ةن�ا ع�قوتلاا نم .هذذحلاا ة�ت�نطاا همهجر�الا تاقصاولا اًق�قو ا�تاار ة�نولطم نكي ما
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.ISO 18250 ى�ق ذذحم وه الك ،تالصولاا
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ف�تلعي لاــ�حم ىاإا نوــلتن�ي ل�ن .ة�ت�نطاا همهجر�الا ةصار تالــصوم تس�تا اهن�ا ت�تر ججاتااو ن�تلقاا قانع�او ة�تطع�ا ىلع ةق�تيواا هذه ق�نطني ال
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.لاضيالا ة�نولطم ة�يوعلاا تاعول�حلاا نوكي ام ا�نااع ةن�ا نم معماا ىلع ,تا�نومسلااو ةلعظ�الا
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)2001 �ى�ق ة�تلع ةق�قاولاا تلي(DIN 55525: 1988 ، ASTM D2911‑94 �ى�ق هذذحم �تاولاا قانع�او ة�تطع�ا ىلع ةلتم�ا 2 ةطراللاا
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ى�ق ىجراتاا ن�تلقاا قانع�او ة�تطع�ال ةلتم�ا ذ�يذحي مت�ي .DIN 6063‑1: 2004 ، DIN 6063‑2: 2004 ، DIN 168‑1: 1998
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.DIN 6094‑1: 1998 ، ISO 12821: 2013 ، EN 14635: 2010
ة�يعجخزملا تاقصاوملا 2
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ا وذوع ،ةــرّروم عجرامم ىلع لوــضحلا .ةق�تيواا هذه تا�نلطتم لّكسي اهيا�يوتحم لك و�ا صع�ن ن�ا ةق�يمط�ن صناا ى�ق ة�تااتاا قنايواا ىاإا راس�ي
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ي�ا �كــاذ ى�ق ال�ن) ة�تعجرملاا ةــق�تيواا نم ةع�نظ تذر�ا ى�ق اهنوذــ�حت�ق ، ةــررولاا م�تع عــجرامللا ة�نــسناا�ن ام�ا .طق�ق اهمكذ مي ىتاا تاــع�نطلا
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.(تال�يذعي
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ةعناساا را�نترالا قمظو ةّماعاا تا�نلطتلاا :1 ءم�حاا - ة�تحضاا ة�ياعماا تاق�ت�نطتا تانامحاا ل�تصوي مطن تالصوم ،ISO 18250‑1
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ةعناساا را�نترالا قمظ :20 ءم�حاا - ة�تحضاا ة�ياعماا تاق�ت�نطي �ى�ق تاراعااو لناوسلا ف�يو�حتاا هم�تعص تالصوم ،ISO 80369‑20: 2015
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�ك�تتسال�نلا ذساا صناضحا ة�تسا�تقاا را�نترالا ةق�يمظ ،ASTM D638‑10
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ة�تنا�نمهك ةاراع ذاومو يوقلاا م�تعو يّوقلاا �ك�تتسال�نلا ءانحنالا صناضحا ة�تسا�تقاا را�نترالا قمظ ، ASTM D790‑10
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اهق�تزعتو تاخلطصملا 3
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تانا�ت�ن ذعاوق�ن IEC و ISO طقتحي .ىل�تس امو ISO 18250‑1 ى�ق هروكذلاا تاق�يمعتااو تاحلطضلاا ق�نطني ، ذنتسلاا ى�ق ةّصار ضامع�ال
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:ة�تااتاا ن�يوانعاا ى�ق س�ت�ياقلاا عصو ى�ق اهماذحتسال تاحلطضلاا�ن ةّصار
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ISO: Online Browsing Platform (OBP) (iso.org) �ت ةّصاحاا تنمتنإالا خقضي ةضنم -
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/ http://www.electropedia.org :�ى�ق م�قوتم IEC Electropedia -
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3.1
يوعم
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ىلضهاا راه�حاا ىاإاو نم (راعاا و�ا لناساا) لناوساا ةاارإا و�ا هراذإال مذحتس�ي
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[ISO 80369-3:2016, 3.1 :رذضم]
ISO 2018 — All rights reserved  ©
3.2
يع�ي�بظ مادخيسا
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ماذحتسالا تال�تلعتـا اًققو ، ذاذعتسالاو ، مذحتسم ي�ا ل�نق نم تال�يذعتااو ىن�تيوماا صحقاا �كاذ ىق ال�ن ، ل�تعستاا
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ةكمــس اا ل�ن�ق نم ذوــضقلااك ماذحتــسالا موهقم الهالك نلضت�ي الن�ت�ن .ذوضقلاا ماذحتــسالاو �يذاعاا ماذحتسالا ن�ت�ن طلحاا مذع �ت�ح�ي :لورذاا ةطرالم
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لــقن ااو ةمذحااو ةنا�تــضاا اًض�ي�ا نكاو ، �ى�نطاا ضمعلا طق�ق �كاذ �يذاعاا ماذحتسالا للس�ي ال الن�ت�ن �ى�نطاا ضمعاا ىلع ذوضقلاا ماذحتسالا مكم�ي ، ةعنضلاا
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.�كاذ ىاإا امو
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[(”للعتسلاا”�ت ”لماع“ ةللك لاذ�نتسا مي -ل�يذعي ,IEC 60601‑1:2005+A1:2012, 3.71 :رذضلاا) :رذضم]
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3.3
ةم�يف
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هذذحم ل�تعسي فومطا ةعنضلاا ةكمساا ل�نق نم ةن�تعم ةل�تق ىاإا م�تس�ي خلطضم
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[(IEC 60601‑1:2005+A1:2012, 3.97 :رذضلاا) :رذضم]
3.4
ة�بلص ةدام
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(لاكسا�ن ا�ح�تم 3433) 2 مس / م�حك 35000 نم م�نك�ا نوكي ميوتاا و�ا ىنتاا ى�ق امإا ةنومم لماعم تاذ هذام
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3.5
ة�بلص ة�بس ةدام
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و لاكــسا�ن اــ�ح�تم 700) عّ�نمم مس / مــ�حك 35000 و عّ�نمم مس / م�حك 138 7 ن�ت�ن ، ميوتاا و�ا ءانتنالا ةاار ىق امإا ةنومم لماعم تاذ هذام
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)لاكسا�ن ا�ح�تم 3433
ةّماع تا�بّلطيم 4
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ةط�نامتلاا م�تع صناضحاا 1.4
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ةكمس اا ىلع �ت�ح�ي ، ل�تصوتلا ةل�ناق م�تع صناضر نالضا قحلم و�ا ى�نطاا راه�حاا تالس و�ا ذاع�ن�ا ىلع ةق�تيواا هذه ط�نار م�تلضي ذلتع�ي ت�تر
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صناضح اا عم ققاوتاا راهظإال قحلم و�ا ى�نظ راهجر ىلع لصولاا ت�ت�نتي مت�ي ذق ، هرومضاا ذنع .ةط�نامتلاا م�تع صناضحاا نم ققحتاا ةعنضلاا
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.ىن�ت�ناا ل�تصوتلا ةل�ناقاا م�تع
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ذ قحللاا �ى�ق ذوجروم ق�ت�نطتاا اذه لراذ تالاضيالا عم اهضناضرو ة�ت�نطاا همهجر�الا صّحلم 1 ةطراللاا
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ـه قحللاا ىق ذوجروم يوعلاا نامحاا تالصوا ماذحتسالا ة�تل�ناق تا�نّلطتم صّحلم 2 ةطراللاا
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و قحللاا �ى�ق ذوجروم �يوعلاا ناّمحاا تالصوم تا�نلطتمو تاقصاوم صّحلم 3 ةطراللاا
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ر قحللاا ى�ق ذوجروم يوعلاا نامحاا تالصو م�تلضي م�ت�تقي صّحلم 4 ةطراللاا
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ذاولاا* 2.4
و ه يذاا ميوتاا ىق و�ا ىنتاا ىق امإا ةنومم لماعم تاذ ذاوم نم ةعونضم اهياقحلم و�ا ة�ت�نطاا همهجر�الا يوعلاا نامحاا تالصو نوكي ن�ا �ت�ح�ي
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.لاكسا�ن ا�ح�تم 700 نم م�نك�ا
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ASTM D790‑10
.نامحاا لصولا ىن�ت�ناا ل�تعستاا ة�تل�ناقو ىن�ت�ناا ل�تصوتاا ة�تل�ناق مذع ىلع ميوي ال�ا طمس�ن متحاا ضامع�ال ةنو�تا متك�ا ذاوم ماذحتسا�ن خلس�ي
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داع�ن�ألا تا�بّلطيم* 5
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:ى�ق ذراواا وحناا ىلع ةلضاا تاذ تايواقتااو ذاع�ن�الا عم ىلراذاا نامحاا تالصوم ق�قاوتي ن�ا �ت�ح�ي
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(E1R) ةعظاقتلاا تالصولاا ع�تل�حتا B.1 لوذ�حااو B.1 لكساا -
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(E1R) عظاقتلاا لصولاا ذولعا B.2 لوذ�حااو B.2 لكساا -
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(E1R) ذ�قانلاا م�نع نامر لصولاB.3 لوذ�حااو B.3 لكساا -
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(E2R) مكذ لصولا B.5 لوذ�حااو B.5 لكساا -
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ISO 2018 — All rights reserved  ©
.(E2R) يوتن�الا لصوللا B.6 لوذ�حااو B.6 لكساا -
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هذ ه مذحتــسي ISO 3826‑1. و ISO 1135‑4�ى�ق هذذــحلاا ذــ�قانلاا�ن لضتي ال ذنتسلاا اذه تا�نلطتم منالتا ةللضلاا تالصولاا 1 ةطراللاا
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خلــس�ي .ججوامتاا تالصوم ذاع�ن�ا نم ذ�يذعاا لو�نقا عسوتي ن�ا نكل�ي �ىتاا (IV) ة�يذ�يرواا سا�تك�الا ذ�قانم �ى�ق مذحتسلاا وحناا ىلع ةنمم هذام ذ�قانلاا
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.لناوساا ق�قذي ءاسنإا نوذ نكاو نملاا IV س�تكاا ذقنم قامترال لصوم ذاذتما�ن ذنتسلاا اذه �ى�ق تالصولاا م�تلضي
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.ذ�قانلاا م�نع نامحاا همناذ ةلصوو عظاقتلاا لصولاا ن�ت�ن لاضيالا B.4 لكساا مهطُ�ي 2 ةطراللاا
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(E2R) �ةّ�يوتن�الا تالصولااو مك�ذاا �ةق�ت�ظوو ذذحلاا �ىسذنهاا ط�تطحتاا�ن قلعتي تامولعم ىلع لوضحلا لو�الا قحللاا عجرار 3 �ة�طراللاا
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.مم�الا �ىضتق�ي امذنع ، �ت قحللاا �ى�ق هذّذحلاا تايواقتااو ذاع�ن�الا نم قّقحتاا ق�يمظ نع لاتتمالا نم قّقحي
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ءاد�ألا تا�بّلطيم 6
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ماعاا ءاذ�الا تا�نّلطتم 1.6
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.عون تارا�نترا �ىه ذنتسلاا اذه �ى�ق ة�قوصولاا تارا�نترالا
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ى�نا�ح�يإالا طعضاا لناس �تّمسي 2.6
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ي�ا مــهطي ال�ا �ت�ح�يو ى�نا�ح�يإالا طعضاا�ن لناساا �تمسي را�نترا ةق�يمظ ماذحتسا�ن ىلناساا �تمستاا ءاذ�ال يوعلاا نامحاا تالصوم م�ت�تقي �ت�ح�ي
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نــ�ت�ن جوامت�ي ق�نطم طعضا اهصمعي ءاني�ا ة�تناي 35 ىاإا ة�تناي 30 نم فقوي همتق يذم ىلع ، ءالاا نم طو�نه ل�تكستا ة�تقاك �تمستلا تامالع
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.لوظ�ا ق�تلعي همتق و�ا اًق�نطم م�نك�ا اًطعص نوعنضلاا مذحتس�ي ذق .لاكسا�ن ول�تك 60 و لاكسا�ن ول�تك 40
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مت م نيو�تن 0،08 ن�ت�ن ناروذاا ممع ق�ت�نطي عم ، جج قحللاا ، ISO 80369‑20: 2015 تارا�نترا ق�ت�نطي لالر نم ةق�ناطلاا نم ققحتاا �ت�ح�ي
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.ـه قحللاا �ى�ق ةجررذلاا تا�قامحنالا ىاإا مطناا�نو ، جج قحللاا �ى�ق ذذحلاا �تّمستلا �ىعجرملاا لصولاا ماذحتسا ءاني�ا ,متم نيو�تن 0،10 و
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يو�حاا طعضاا تحي ءاوهاا �تمسي 3.6
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م · لاكــسا�ن 0.005 نم متك�ا�ن �تمــست�ي ال ن�ا �ت�ح�يو ، يو�حاا طعضاا تحي ءاوهاا �تمسي نع فسكلا ىلراذاا نامحاا تالصوم م�ت�تقي �ت�ح�ي
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ن�ت�ن جوامتي را�حترا همتق لالر لاكسا�ن ول�تك 4،8 و لاكسا�ن ول�تك 4،0 ن�ت�ن ق�نطلاا يو�حاا فالعاا تحي طعضا اهصمعي ءاني�ا ة�تناي ىق �تّعكم
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.يو�حاا فالعاا تحي م�نك�ا يوجر طعص ةعنضلاا تاكمساا مذحتسي ذق .ة�تناي 20 و ة�تناي 15
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ذذح لاا �تّمستلا ىعجرملاا لصولاا ماذحتسا ءاني�ا ،ذ قحللاا ،ISO 80369‑20: 2015 تارا�نترا ق�ت�نطي لالر نم ةق�ناطلاا نم ققحتاا �ت�ح�ي
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.ج قحللاا ى�ق ةجررذلاا تا�قامحنالا هاعامم عم ، جج قحللاا ى�ق
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ذاهجرإالا م�تسكي 4.6
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طوعــض ا اهــصمعي ذع�ن 6.2 تاــ�نلطتل�ن ىقي ن�ا �ت�ح�ي يوعلاا نامحاا تالــصوم .يذاــهجرإالا ققستلا يوعلاا نامحاا تالــصوم م�ت�تقي �ت�ح�ي
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.ـه قحللاا ، ISO 80369‑20: 2015
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ى عجرملاا ذاهجرإالا م�تسكي لصوم ماذحتسا ءاني�ا ، ـه قحللاا ، ISO 80369‑20: 2015 تارا�نترا ق�ت�نطي لالر نم لاتتمالا نم ققحتاا �ت�ح�ي
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.ج قحللاا ى�ق ةجررذلاا تا�قامحنالا هاعامم عم ، جج قحللاا ى�ق ذّذحلاا
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يروحلاا للحاا نم لضقاا ةمواقم 5.6
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لالر ىــعجرملاا لــصولاا نع لضقني ال�ا �ت�ح�ي يوعلاا نامحاا تالصوم .يروحلاا للحاا نع لضقلا ىلراذاا نامحاا تالصو م�ت�تقي �ت�ح�ي
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نوع نــضلاا ع�تطتس�ي .نيو�تن 35 و نيو�تن 32 ن�ت�ن ةق�نطلاا ة�يروحلاا هوقاا لضقا اهصمعي ءاني�ا ة�تناي 15 و ناوي 10 ن�ت�ن جوامتي ق�تلعي همتق
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.لوظ�ا ق�تلعي همتق و�ا لاضّيالا لضقا م�نك�ا ة�يروحم هوق ماذحتسا
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ى عجرملاا لــصولاا نم لضقاا ماذحتسا ءاني�ا ،و قحللاا ، ISO 80369‑20: 2015 تارا�نترا ق�ت�نطي لالر نم لاتتمالا نم ققحتاا �ت�ح�ي
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.ج قحللاا ى�ق ةجررذلاا تا�قامحنالا هاعامم عم ، جج قحللاا ى�ق ذّذحلاا يروحلاا للحلا
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ىعام�ناا �كق نع لاضقنالا ةمواقم 6.6
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ق�تلعي همتقا �ىــعجرملاا لصولاا نع �يوعلاا نامحاا تالصوم لضقني ال�ا �ت�ح�ي .�تاولاا �ك�ق نع لضقلا �ىلراذاا نامحاا تالصو م�ت�تقي �ت�ح�ي
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ماذح تــسا ن�تعّنضللا رو�ح�ي. متم نيو�تن 0،02 ىاإا متم نيو�تن 0,0198 ن�ت�ن �ىعام�ناا �ك�ق ممعا اهصّمعي ءاني�ا ة�تناي 15 و ناوي 10 ن�ت�ن جوامتي
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.لوظ�ا ق�تلعي همت�ق و�ا ق�نطلاا �كقلا م�نك�ا ناروذ ممع
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.تا�نّلطتلاا هذه نم نا�تنتتسم اله B.6 لكساا ى�ق (E2R) يوتن�الا لصولااو B.5 لكساا ى�ق (E2R) يمكذاا لصولاا
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ى عجرملاا ط�ناماا �كق نع لضقاا ماذحتسا ءاني�ا ،جج قحللاا، ISO 80369‑20: 2015 تارا�نترا ق�ت�نطي لالر نم لاتتمالا نم ققحتاا �ت�ح�ي
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.و قحللاا ىق ةجررذلاا تاقامحنالا هاعامم عم ، جج قحللاا ىق ذذحلاا
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ISO 2018 — All rights reserved  ©
روا�حتاا ةمواقم 7.6
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�ى عجرملاا لــصوللا تاومعاا و�ا طو�تحاا روا�حتي ال�ا �ت�ح�ي �يوعلاا نامحاا تالصوم .روا�حتاا ةمواقلا �ىلراذاا نامحاا تالصوم م�ت�تقي �ت�ح�ي
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نوعّن ضلاا مذحتس�ي ذ�ق .ناوي 10 و ناوي 5 ن�ت�ن ق�تلعي همت�ق لالر متم نيو�تن 0.17 ىاإا متم نيو�تن 0.15 ن�ت�ن جوامت�ي ق�نطم ٍممع اهصمعي ءاني�ا
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.لوظ�ا ق�تلعي همت�ق و�ا م�نك�ا ناروذ ممع
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ى عجرملاا لصولاا روا�حي ةمواقم ماذحتسا ءاني�ا ،ه قحللاا، ISO 80369‑20: 2015 تارا�نترا ق�ت�نطي لالر نم لاتتمالا نم قّقحتاا �ت�ح�ي
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.ه قحللاا ى�ق ةجررذلاا تا�قامحنالا هاعامم عم ، جج قحللاا ى�ق ذذحلاا
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�كق ق�يمظ نع لضقاا 8.6
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نار وذ ممع�ن �ىعجرملاا لصولاا نع �يوعلاا نامحاا تالصوم لض�ق �ت�ح�ي .�ىعام�ناا �ك�ق ق�يمظ نع لضقلا �ىلراذاا نامحاا تالصو م�ت�تقي �ت�ح�ي
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.متم نيو�تن 0،26 ىاإا لض�ي �تاولاا �كقا
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.ىعمقاا ذن�ناا اذه تا�نّلطتم نم ىنتتسُم يوعلاا نامحاا تالصولا يذمقاا ماذحتسالا
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.ىعمقاا ذن�ناا اذه تا�نّلطتم نم ىنتتسُم B.6 لكساا ىق (E2R) يوتن�الا لصولااو B.5 لكساا ىق (E2R) روكذاا لصوم
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ط�نام اا �ك�ق ق�يمظ نع لضقاا ماذحتسا ءاني�ا ، ط قحللاا ، ISO 80369‑20: 2015 تارا�نترا ق�ت�نطي لالر نم لاتتمالا نم ققحتاا �ت�ح�ي
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.ه قحللاا �ى�ق ةجررذلاا تا�قامحنالا هاعامم عم ، جج قحللاا �ى�ق ذذحلاا �ىعجرملاا
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ISO 2018 — All rights reserved  ©
�ا قخلملا
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(يمالعإا)
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ة�يجخوي لاو يزهو�خلا �ب�بسلا
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ماع A.1
م ا مــهنكاو ةق�تيواا هذه عوصول�ن ة�يارذ ىلع ن�يذاا �كناو�ال صضحم وهو ، ةق�تيواا هذه تا�نّلطتم صع�نا �ىقطنلاا ساس�الا قحللاا اذه مّ�قو�ي
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م�تعي عم ، �كاذ ىلع هوالع .م�تلساا ق�ت�نطتاا لجر�الا نم اً�يرومص تا�نلطتلاا هذه ءارو نماكاا �ىقطنلاا ساس�الا مه�ق م�نتع�يُ .اهم�يوطي �ى�ق اوكراس�ي
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.تاروطتاا �كلي اه�نّلطتي ةق�تيواا هذها ةعجرامم �ي�ا لّهس�تس ًا�تقطنم ًاساس�ا ن�ا ذقتعُ�ي ، ا�تجرواونكتااو ة�ت�نطاا ةسراللاا
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ة�يعزقلا دوب�بلاو دوب�بلا صع�بل يقطبملا ساس�ألا A.2
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م�تقمت اا نإاق ، ىااتاا�نو .اه�تاإا م�تسي ىتاا ةق�تيواا هذه نم ة�تعمقاا ذون�نااو ذون�ناا م�تقمي عم ققاوتتا قحللاا اذه ىق تامققااو ذون�ناا م�تقمي مي
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.ا�تااتتم س�تا
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ةخمل 1 دب�بلا
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ن�تلق اا ة�تطع�او رالسلاا .ة�ت�نطاا همهجر�الا�ن ةصار تالصوم تس�تا اهن�ال ةق�تيواا هذه ق�ت�نطي نم ججاتااو ى�ناولاا ن�تلقاا قانع�او ة�تطع�ا ىنتتسُي
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ةقطن م نم فلتحي ال�نرو تا�نومسلااو ةلعظ�الا ف�تلعي ةعانص ى�ق عناس لكس�ن مذحتسُي ة�ت�ناولاا ة�تسذنهاا لاكس�الاو راطق�الا ةقلتحم قانع�او
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هذ ــه عا�نيا مذــع نم معماا ىلع اًق�نسم هذوــجرولاا ماعطاا تا�يواح�ن لاضيالا ةّ�يوعلاا ءاطعاا تاعول�حم نم �تلطُ�ي ام ا�نااع .يمر�ال ة�ت�قامعجر
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ن ع فلتح�ي لــصوم نامحا ةجراحاا، �كاذا .ة�ت�نطاا همهجر�الا�ن ةصاحاا خناولااو تاقصاولاا - �كاذ اهنم اً�نولطم س�تاو -تقواا مطعم تا�يواحاا
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قانع�ا لاو ة�تطع�الا هذه ةق�ناطم مذع�ن ءاعذا ي�ا �تن�حي لجر�ا نم .تاذاعااو ىلحلاا قوساا ىلع اًذالتعا انه �اسني ذق هذذحلاا ة�ت�نطاا تالصولاا
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اذ ــه قاطن نم نوذع�نتــسم ةــ�نقمااو ن�تلقاا ججايو رالسلاا. طق�ق ضار لكس�ن ةللضلاا ة�ت�نطاا تالصولاا عم لماعت�ي يذاا ، ذنتسلاا اذه عم
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.ذنتسلاا
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ة�تداملا تا�بلطيملا 4.2 يعزقلا دب�بلا
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.�تسانم م�تع هرا�نتعا مي �ىنولاا م�تممتاا ذ�يذحي نإا�ق ,�ى�نطاا راه�حلا اًرا�تعم س�تا ذنتسلاا اذه ن�ال اًمطن
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يوعملا نازخلا تالصول داع�ن�ألا تا�بلطيم 5 يعزقلا دب�بلا
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نكل�ي �كاذا .ة�يذ�يرواا سا�تك�الا لتم يمر�الا تانامحاا�ن لاضيالا مذع مظاحم هاعامم عم ذنتسلاا اذه ىق ةهجراواا تا�نلطتمو ذاع�ن�ا م�يوطي مي
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نامــح اا تالصوم عم لاــضّيالا خ�تت�ي نلق ، ذنتــسلاا اذه ىق هذوجرولاا ذاع�ن�الا اًققو يوعلاا نامحاا لصوم ع�تنضي مت�ي ناك اذإا ةن�ا ضامتقا
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.لناساا قّقذي لتم يمر�الا تاق�ت�نطتلا يمر�الا
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ISO 2018 — All rights reserved  ©
�ت قخلملا
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يوعملا نازخلا تالصوم(يرا�يعم)
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ىق متحاا لجر�ا نم ةنو�تا متك�ا ذاوم ماذحتسا .(ةنملاا نناذلاا نم نوك�ي ن�ا لاتلاا ل�ت�نس ىلع) 4.2 عم ققاوتاا ىاإا متحاا خطس ججاتح�ي ال a
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.ة�ن جولسم ىن�ت�ناا ل�تعستااو ط�نامتاا مذع ىلع ميوي ال اهن�ا ن�تر
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ً.الماك ط�تحلا ىصمعاا عطقلاا عم لّو�الا مسقاا ىاإا AG ذع�ناا م�تس�ي .ةعّنضلاا ةكمساا�ن ضار �تاولاا ءذ�ن خنامس لكس b
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(E1R) ةعظاقيملا تالصوملا ةعوم�خم - — B.1 لكسلا
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B.1 لكساا ذاع�ن�ا ىلع B.1 لوذ�حاا يوتح�ي
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راودلا لققلاو دومعلا ع�يم�خت داع�ن�ا :(E1R) عظاقيم لصوم - — B.1 لود�خلا
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�كلد �فالخ زكد�ت مل ام زيم�يلملا�ن داع�ن�ألا
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( E1R)عظاقتلاا لصولااو مناذاا لققاا ةعول�حم
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ذع�ناا
هراسإالا             ن�ت�تعتاا
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ىنذ�الا ذحاا            �ىلسالا             ىلع�الا ذحاا
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ØA             مطقاا ججرار راّوذ لق�ق س�ار             16,00             —             —
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ØB            �تاولاا رذ�حا ىلراذاا مطقاا             12,30             12,40             12,65
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ØC            �ىلراذاا �تاولاا ةّل�ق مط�ق             11,10             11,20             11,45
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D            �تاولاا لوظ             10,80             11,15             11,50
ة�تسحاا خطسو راوذاا لققاا س�ار نم ة�قاسلاا
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E             ذولعاا ساس�او راوذاا لققاا س�ار نم ة�قاسلاا و�ا 8,55             10,15             11,75
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ة�تسحاا ماذحتسا مت�ي ما اذإا همناطاا
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H             راوذاا لققاا نم �فمطاا ة�نذر             18,70b             19,10             23,05c
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ISO 2018 — All rights reserved  ©
راودلا لققلاو دومعلا ع�يم�خت داع�ن�ا :(E1R) عظاقيم لصوم - — B.1 لود�خلا
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(ةلتي) �كلد �فالخ زكد�ت مل ام زيم�يلملا�ن داع�ن�ألا
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( E1R)عظاقتلاا لصولااو مناذاا لققاا ةعول�حم
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K             (تاجررذاا�ن) �تاولاا فللا ة�تمام�الا ة�يواماا             30°             40°             50°
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(تاجررذاا�ن) �تاولاا فللا ة�تقلحاا ة�يواماا
J             10°             15°             20°            �������
تا لسامم ىق ةساقلاا �تاولاا مسق هذعاق لوظ
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L             مطقاا ةلق —             —             1,70
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ØCd ىلراذاا
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M             ة�قامحنا/ �تاولاا رامتها             —             2,00             —
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تالساملـ�ن ةساقم �تاولاا مسق هذعاق لوظ
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ØB رذ�حلا ىلراذاا مطقاا
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AG            �تاولاا ة�ياذ�نو راوذاا لققاا س�ار ن�ت�ن ة�قاسلاا      —             —             1,50
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(a) ةك�تلس تا�تسر ماذحتسا�ن خلس�ي ذذحلاا ذع�ناا قاطن .ةعنضلاا ةكمساا�ن ةصار ة�تسحاا تام�تم
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(b)طق�ق ة�تسحاا ماذحتسا�ن ةل�تقاا نم ىنذ�الا ذحلا لوصواا نكل�ي
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(c).ة�يذالاا تالاحاا مطعم ى�ق ذولعو ةّ�يذام ةاار لق�ا ى�ق راوذ لقق عم ، ة�تسر نوذ�ن الإا يوضقاا ةل�تقاا ىاإا لوصواا نكل�ي ال
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(d).ىاالجرإالا ىضحساا فللاا ىاإا L ذع�ناا م�تس�ي .ØC مطقاا ققحت�ي ن�ا ةط�يمس راط�ق�ا �فاضن�ا �تاولاا ةّل�ق نوكي ذ�ق
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ISO 2018 — All rights reserved  ©
(E1R) عظاقيملا لصوملا دومع - — B.2 لكسلا
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.B.2 لكساا ذاع�ن�ا ىلع B.2 لوذ�حاا نّلضت�ي
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دومعلا ل�يصاقت داع�ن�ا :(E1R) عظاقيم لصوم - — B.2 لود�خلا
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ذولعاا ل�تصاقي :(E1R) عظاقتم لصوم
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ذع�ناا
هراسإالا             ن�ت�تعتاا
����ىنذ�الا ذحاا             ىلسالا             ىلع�الا ذحاا
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A              ة�قاحاا ىاإا هذعاقاا نم ذولعاا لوظ             31,00             31,30             31,60
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عم ذماعتم يوتسم ىلع جان�حاا ذاذتما ضمع
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b             �فمطاا�ن مل�يو خمماا روحم
ةعلجر ل�نق ذولعاا هذعاق ذنع جان�حاا ذاذتما
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c              هذعاقاا�ن
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d              ىلع�الا �ى�ق جان�حاا ضمع             0,80             0,90             1,00
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e              هذعاقاا�ن ةعلجر ل�ن�ق لقس�الا �ى�ق جان�حاا ضمع      1,00             1,10             1,20
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ISO 2018 — All rights reserved  ©
(ةلتي) دومعلا ل�يصاقت داع�ن�ا :(E1R) عظاقيم لصوم - — B.2 لود�خلا
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ذولعاا ل�تصاقي :(E1R) عظاقتم لصوم
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ذع�ناا
هراسإالا             ن�ت�تعتاا
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ىنذ�الا ذحاا            �ىلسالا             ىلع�الا ذحاا
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Øf              ىلع�الا ىق ىلراذاا مطقاا             2,10             2,20             2,30
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مل�ي �يذاا عطقلاا ىلع لقس�الا �ى�ق �ىلراذاا مطقاا
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Øg              خمماا ىلع خنامساا ة�ياذ�ن م�نع
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h              قساا ضمع             0,90             1,00             1,25
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i              ة�قاحاا نم قساا قلع             6,15             6,40             6,65
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m              ة�قاحاا نم �ىلقساا جان�حاا ة�ياذ�ن             5,35             5,60             5,85
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n              (تاجررذاا�ن) �ىلقساا جان�حاا س�ار �ة�يوار             70°             80°             85°
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p              (تاجررذاا�ن) هانقاا س�ار ىلع �تطساا ة�يوار             —             —             90°
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ةحنجر�الا �يولعاا لضناا ىلع �تطساا ة�يوار
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q              (تاجررذاا�ن)
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r              هذعاقااو ذولعاا ن�ت�ن ىسحم مطق فضن             —             —             0,5
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ذولعاا روحمو جان�حاا همقس ن�ت�ن ة�يواماا
�������65°             85°             105°
s              (تاجررذاا�ن)
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Øt              ىلع�الا �ى�ق ساس�الا رالسلاا مط�ق             —             —             3,5
Øu              لقس�الا ىق ساس�الا رالسلاا مطق             —             —             3,6
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Øv              ساس�الا مط�ق             10,00             10,50             11,05
.�يمناذ فضن قساا لكس نوك�ي ذ�ق
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�كاذ �فالر مكذ�ي ما ام متل�تللاا�ن ذاع�ن�الا
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ISO 2018 — All rights reserved  ©
ةعنضلاا ةكمساا�ن ضار وهو (ةنملاا نناذلاا نم نوك�ي ن�ا لاتلاا ل�ت�نس ىلع) 4.2 عم ققاوتاا ىاإا متحاا ءاسع ججاتح�ي ال a
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(E1R) د�فابملا ز�بع نازخلا لصوم- — B.3 لكسلا
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B.3 لكساا ذاع�ن�ا ىلع B.3 لوذ�حاا يوتح�ي
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(E1R) دفابملا ز�بع نازخلا لصوم داع�ن�ا - — B.3 لود�خلا
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�كاذ �فالر مكذ�ي ما ام متل�تللاا�ن ذاع�ن�الا
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( E1R)عظاقتلاا لصولااو مناذاا لققاا ةعول�حم
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ذع�ناا
هراسإالا             ن�ت�تعتاا
����ىنذ�الا ذحاا             ىلسالا             ىلع�الا ذحاا
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P             (a)�تاولاا ة�ياذ�ن ىاإا س�اماا نم ة�قاسلاا             1,90             —             6,85
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Q            �تاولاا لوظ             4,00             —             —
ØS             (b,c) تاومعاا هذعاق ذنع ىجرراحاا مطقاا             9,90             10,60             11,00
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ØT            �ىجرراحاا �تاولاا مط�ق             11,75             12,00             12,30
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U             (d)مس�حاا لوظ             5,50             —             —
(لصاوي) (E1R) �د�فابملا ز�بع نازخلا لصومو عظاقيملا لصوملا ل�يصوت — B.4 لكسلا
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ISO 2018 — All rights reserved  ©
( E1R)عظاقتلاا لصولااو مناذاا لققاا ةعول�حم
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ذع�ناا
هراسإالا             ن�ت�تعتاا
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ىنذ�الا ذحاا             ىلسالا             ىلع�الا ذحاا
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ل�تطت سم) عظاقتلاا ف�يو�حتاا �ى�ق جان�حاا ذاذتما
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V             ساو�ق�ا نم ةعونضم جان�حاا �فامظ�ا تناك اذإا سوقنم 6,80             6,90             7,50
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(ة�يمناذ
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W             عظاقتلاا ف�يو�حتاا ىق جان�حاا ضمع             1,10             1,20             1,50
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ØX             ة�تساس�الا �ت�تلضاا ف�يو�حي مط�ق             3,60             3,70             3,80
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س�ام اا ىلع ة�تظومحلاا ة�ياوماا ة�يوار
������Y             —             —             22°
(تاجررذاا�ن)
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ـ�ن ساقي ىتاا �تاولاا مسق ةلق لوظ
�������Z             —             —             0,50
ØT مطقاا تالسامم
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AA             (تاجررذاا�ن) �تاولاا فللا ة�تقلحاا ة�يواماا             —             —             25°
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AB             (تاجررذاا�ن) �تاولاا فللا ة�تمام�الا ة�يواماا             30°             40°             47°
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AC              ىنل�تاا ذ�تاا�ن ، هذراو ة�ياذ�ن ، �تاولاا هوطر             2,00
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AD            �ىلراذاا اهمط�قو اه�ترانجر ن�ت�ن ةحسقاا             0,0             —             —
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R1             س�امااو مس�حاا ن�ت�ن ة�تل�تق مطق فضن             —             —             1,50
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�تجروتس�ي ىتاا قنا�قمااو س�اماا ن�ت�ن ة�قاسلاا
������AE            �—             —             23,75
اه�نقي
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ØAF             س�اماا ىلع ة�تظومحلاا ة�ياوماا هذعا�ق مط�ق             —             —             8,75
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ةاذ�ا نوعنــضلاا مذق�ي ن�ا �ت�ح�ي .ا�تاار هذــلتعلاا متحاا ةلطن�او تا�تنقتاا ن�تلضي لجر�ا نم اه�ن جولسم ةقلتحلاا �تاولاا تا�تعصو(a)
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.ISO 18250‑1 ى�قو ذنتسلاا اذه ى�ق هذذحلاا ة�تق�تظواا تا�نلطتللا اًق�قو ىق�تظواا خ�تحضتلا ة�ت�ن�يم�حي
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ىتن�ا س�نقم عم لاضيالا ءوس عنم لجر�ا نم .متحاا ةل�طن�او ة�تااحاا تا�تنقتاا ن�تلضي لجر�ا نم R1 و ØS نم تاعول�حم هذع�ن خلسُ�ي(b)
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ةن�يا�نت لاا ةاذاعلاا عم ذاع�ن�الا هذه ققاوتي ن�ا �ت�ح�ي ، ة�تسحاا ذص ٍفاك لكس�ن �تمستلا عنام خطس م�تقوي لجر�ا نمو متل�تللم ISO 5356‑1 8.5
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.مم ØS - 2 × R1 8.5 :ة�تااتاا
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ةعون ضم لاتلاا ل�ت�نس ىلع) س�اماا ىلع هوستلا ةل�نا�ق �تمستلا ةعنام ة�قا�قر ذالتعا .طق�ق �تلضاا ذقنلاا مسجر ىاإا ØS ذع�ناا م�تس�ي(c)
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.لاضيالا ءوس �ى�ق ة�ت�قاصإا ةلكسم �ي�ا �ى�ق �ت�نستي ال ØT تس�تا نكاو ØS روا�حتي �ىتاا (تاق�نطاا ذذعتم �تكملاا و�ا مو�تنموا�الا نم
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رذ ضم خطس ىلع مس�حاا لوظ ىهتن�ي .متحاا ةلطن�او ة�تااحاا هذلتعلاا تا�تنقتاا ن�تلضي لجر�ا نم ذ�قانللا ةقلتحم لاوظ�ا�ن خلسُ�ي(d)
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.اه�تلع عصوي ىتاا ة�ت�نطاا همهجر�الا فلم س�تاو تالصولاا تا�نلطتم ذنتسلاا اذه ذذح�ي .ة�يذعتاا
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راطق�ا لا نم جخ�يمم ىلع Z ةل�تق ذلتعي .الها ةل�تق ىنذ�ا ىلع AB و AA ن�تت�يواماا ط�نص ذنع متل�تللم 0.50 ىه Zل يوضقاا ةل�تقاا(e)
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.AB و AA نات�يوامااو ، ØT و ØS
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ءان�ت لاا لوــظ ىلع �ىصمعاا فــ�يو�حتاا عاط�ق مضر ق�يمظ نع لارذإالا ءاني�ا ذولعلا محاا قالمنالا �ىلراذاا مطقاا نلض�ي ن�ا �ت�ح�ي(f)
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.قلعاا لراذ
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.ىاالجرإالا ىضحساا فللاا ىاإا Z ذع�ناا م�تس�ي .ØT مطق ق�تقحي ةط�يمس خنامس مطق فضن ىلع �تاولاا ةلق يوتحي ذق(g)
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(لصاوي) (E1R) دفابملا ز�بع نازخلا لصومو عظاقيملا لصوملا ل�يصوت — B.4 لكسلا
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ISO 2018 — All rights reserved  ©
(E1R) �د�فابملا ز�بع نازخلا لصومو عظاقيملا لصوملا ل�يصوت — B.4 لكسلا
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.ذقنلاا م�نع نامحاا لصومو عظاقتلاا لصولاا ن�ت�ن خ�تحضاا لاضيالا �تناجر راهظإا لجر�ا نم طق�ق �ىمالعإا ضمعا B.4 لكساا ضمع مي ةطرالم
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ISO 2018 — All rights reserved  ©
.قالعإالا �تقي راه�ح�ن لاضيالا عنلا لك�ته a
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.Øb قاطن �ى�ق النالم نوك�ي ن�ا �ت�ح�ي نكاو ، اسو�ق نوك�ي ن�ال ةجرار ال b
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(E2R) زكد لصوم - — B.5 لكسلا
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.B.5 لكساا ذاع�ن�ا ىلع B.5 لوذ�حاا يوتح�ي
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(E2R) روكدلا لصوم داع�ن�ا - — B.5 لود�خلا
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�كاذ �فالر مكذ�ي ما ام متل�تللاا�ن ذاع�ن�الا
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ISO 2018 — All rights reserved  ©
( E2R) مكذ لصوم
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ذع�ناا
هراسإالا             ن�ت�تعتاا
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ىنذ�الا ذحاا             ىلسالا             ىلع�الا ذحاا
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Øa             لققاا هومعا �ىجررار مط�ق ىض�ق�ا             21,10             21,20             21,30
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Øb             هذعاقلا ىجررار مطق ىضق�ا             —             —             18,10
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Øc             مكذاا ةهوّقا ىجررار مطق ىضق�ا             9,30             9,35             9,40
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Ød             رذ�حاا ذنع مكذاا ةهوقا �ىجرراحاا مطقاا             9,04             9,09             9,14
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ىاإا رذ�حاا نم مكذاا ةهوق لوظ
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e            �1,45             1,50             1,55
(Øc) ىجررار مطق ىضق�ا
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f             مكذاا ةهو�ق لوظ             2,40             2,50             2,60
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g             لققاا ص�نقم ة�ياذ�ن ىاإا روحلاا نم لوطاا             5,95             6,00             6,05
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h             لققاا ص�نقم لّو�ا ذنع عاقيرالا             0,45             0,50             0,55
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i            �تاذر�الا نم يولعاا ءم�حاا ى�ق عاقيرالا             1,52             1,57             1,62
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k             لققاا ص�نقم لّو�ا ىاإا �تاذر�الا لقس�ا نم لوطاا      5,05             5,10             5,15
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m             لققاا ص�نقم ذنع ضمعاا             9,60             —             —
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n            �تاذر�الا نم ىلقساا ءم�حاا ى�ق عاقيرالا             1,25             1,30             1,35
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o             لققاا ص�نقم ة�يوار             15,00°             16,00°             17,00°
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q             هذعاقاا لوظ             4,00             —             —
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Øu             مكذاا ةهو�ق �فمظ ذنع �ىلراذاا مطقاا             7,15             7,35             7,55
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(لصاوي) (E2R) يين�ا لصوم - — B.6 لكسلا
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ISO 2018 — All rights reserved  ©
(E2R) يين�ا لصوم - — B.6 لكسلا
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.B.6 لكساا ذاع�ن�ا ىلع B.6 لوذ�حاا يوتح�ي
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(E2R) يي�ن�ا لصوم - — B.6 لود�خلا
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�كاذ فالر مكذ�ي ما ام متل�تللاا�ن ذاع�ن�الا
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( E2R) ىتن�ا لصوم
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ذع�ناا
هراسإالا             ن�ت�تعتاا
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ىنذ�الا ذحاا            �ىلسالا             ىلع�الا ذحاا
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ØA             معتاا ل�تاذ نوذ�ن لققاا ءم�حا ىلراذاا مطقاا             21,50             21,60             21,70
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ØB             معتاا ل�تاذ عم لققاا ءم�حا ىلراذاا مطقاا             18,20             18,30             18,40
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ISO 2018 — All rights reserved  ©
( E2R) ىتن�ا لصوم
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ذع�ناا
هراسإالا             ن�ت�تعتاا
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ىنذ�الا ذحاا             ىلسالا             ىلع�الا ذحاا
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ØC            �يوتن�الا ف�يو�حتلا معص�الا ة�ياهنلا �ىلراذاا مطقاا      8,85             8,90             8,95
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ف�يو�حت لا جوتقلاا فمطاا ذنع ىلراذاا مطقاا
���������ØD             9,10             9,15             9,20
يوتن�الا
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F             يوتن�الا ف�يو�حتاا قلع             3,45             3,50             3,55
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G             رذحنلاا ة�ياذ�ن ىاإا روحلاا نم لوطاا             5,95             6,00             6,05
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H             ة�تجروتاا ف�يو�حتا هو�حق ىنذ�ا             0,45             0,50             0,55
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ىاإا �تاذر�الا نم ىلقساا ءم�حاا ن�ت�ن هو�حقاا
�����I            ��1,62             1,67             1,72
ةروتقلاا ة�ياهناا وذ خطساا
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K             رذحنلاا ة�ياذ�ن ىاإا �تاذر�الا ىلع�ا نم لوطاا             5,05             5,10             5,15
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ىاإا �تاذر�الا نم يولعاا ءم�حاا ن�ت�ن هو�حقاا
������N             1,15             1,20             1,25
ةروتقلاا ة�ياهناا وذ خطساا
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O             ة�تجروتاا ف�يو�حي ة�يوار             15,00°             16,00°             17,00°
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ة�ياذ�ن ىاإا ة�تجروتاا ف�يو�حي ة�ياهن نم لوطاا
������P            �0,15             0,20             0,25
رذحنلاا
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Q             ف�يو�حتاا ل�تاذ عم لققاا ءم�حا ىض�ق�الا عاقيرالا      —             —             3,00
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ØR             لناساا ف�يو�حتا �ىلراذاا مطقاا             3,30             3,55             3,80
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ØS             ف�يو�حتاا ل�تاذ عم لققاا ءم�حا ىجرراحاا مطقاا      23,50             24,00             24,50
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ØT             يوتن�الا ف�يو�حتلا ىجرراحاا مطقاا             11,10             11,25             11,40
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ISO 2018 — All rights reserved  ©
جج قخلملا
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ة�يعجخزم تالصوم
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ة�يعجخزملا تالصوملل ةّماعلا تا�بّلطيملا 1.جج
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خطــــس�ا لا ىلع متــمومك�تم 0،8 رواــ�حتي ال Ra ةل�تق�ن خطس ةنوــسر عم لك�اتلا ةمواقم ة�نلص ذاوم نم عّنضتي ن�ا ة�تعجرملاا تالصولاا ىلع
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ة�يعجخزملا تالصوملا 2.جج
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�تزست ، ي�نا�خ�تإألا طعصلا لناس �تزست ـل (E1R) عظاقيملا لصوملا را�بيخا لجخ�ا نم �د�فابملا ز�بع يعجخزملا نازخلا لصوم جج — 1 لكسلا
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�كقلا نع لصقلاو ، �كقلا ق�تزظ نع لصقلا ، داهجخإألا ز�يسكت ، يو�خلا طعصلا بخت ءاوهلا
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ISO 2018 — All rights reserved  ©
�كاذ فالر مكذ�ي ما ام متل�تللاا�ن ذاع�ن�ا
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يروخملا لمخلا نع لصقلل صصخملا (E1R) عظاقيملا لصوملا را�بيخا لجخ�ا نم د�فابملا ز�بع نازخلل يعجخزم لصوم جج — 2 لكسلا
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بخت ءاوهلا �تزست ، ي�نا�خ�تإألا طعصلا لناس �تزست ـل (E1R) دفابملا ز�بع نازخلا لصوم را�بيخا لجخ�ا نم عظاقيم لصوم جج — 3 لكسلا
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(لصاوي) �كقلا نع لصقلاو ، �كقلا ق�تزظ نع لصقلا ، داهجخإألا ز�يسكت ، يو�خلا طعصلا
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ISO 2018 — All rights reserved  ©
بخت ءاوهلا �تزست ، ي�نا�خ�تإألا طعصلا لناس �تزست ـل (E1R) دفابملا ز�بع نازخلا لصوم را�بيخا لجخ�ا نم عظاقيم لصوم جج — 3 لكسلا
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�كقلا نع لصقلاو ، �كقلا ق�تزظ نع لصقلا ، داهجخإألا ز�يسكت ، يو�خلا طعصلا
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روا�خيلا �ةمواقمو �يروخملا لمخلا نع لصقلل (E1R) �د�فابملا ز�بع نازخلا لصوم را�بيخا لجخ�ا نم عظاقيم لصوم جج — 4لكسلا
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�كاذ �فالر مكذ�ي ما ام متل�تللاا�ن ذاع�ن�الا
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ISO 2018 — All rights reserved  ©
بخت ءاوهلا �تزست ، �ي�نا�خ�تإألا ط�عصلا لناس �تزست ـل (E2R) �يوي�ن�ألا �يوعملا نازخلا لصوم را�بيخأل زك�د �يعجخزم لصوم جج — 5 لكسلا
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روا�خيلا �ةمواقم ,�يروخملا لمخلا نع لاص�ق�نألا �ةمواقم ، داهجخإألا ز�يسكت ، �يو�خلا ط�عصلا
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�كاذ فالر مكذ�ي ما ام متل�تللاا�ن ذاع�ن�الا
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ISO 2018 — All rights reserved  ©
بخت ءاوهلا �تزست ، ي�نا�خ�تإألا طعصلا لناس �تزست ـل (E2R) زكدلا يوعملا نازخلا لصوم را�بيخأل يين�ا يعجخزم لصوم جج — 6 لكسلا
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روا�خيلا ةمواقم ,يروخملا لمخلا نع لاصقنألا ةمواقم ، داهجخإألا ز�يسكت ، يو�خلا طعصلا
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ISO 2018 — All rights reserved  ©
د قخلملا
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ق�ي�بطيلا اده لخاد تألاصتا عم اهصناصخو ة�ي�بطلا ةزهجخ�ألا م�ي�يقت
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ل لعاا ةــــعول�حم ل�نق نم م�ت�تقي ىلع اض�ي�ا يوــتح�يو .ة�يوعلاا تاق�ت�نطتاا لراذ اهياقحلمو ة�ت�نطاا همهجر�الا ةلتم�ا ىلع D.1 لوذ�حاا يوتح�ي
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.ذوضقلاا لاضيالا�ن قّلعتي اهن�ا ال�ن تاقحللااو ة�ت�نطاا همهجر�الا ةماهاا تالسلا
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اهتاقصو ق�ي�بطيلا اده لخاد تالصو اهل ييلا ة�ي�بطلا ةزهجخ�ألا يلع ةليم�ا - — D.1 لود�خلا
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ISO 2018 — All rights reserved  ©
ـه قخلملا
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ة�توعملا تاق�ي�بطيلل نازخلا تالصول مادخيسألا تا�بلطيم صخلم
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مدخيسملل يق�تزعت فلم 1.ـه
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�ي�ا ىاإا ة�قاصإالا�ن ،ن�تمذحتسلاا ةعول�حلا ذوضقلاا مذحتسللا ة�ت�قامعول�يذااو ة�يذس�حااو ة�تلقعاا تالسلا صّحلم وه مذحتسلاا ف�يمعي فلم
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.ةق�تظواا تا�نلطتمو ة�تنهلاا تاراهلاا لتم ،م�تلضتاا تارام�ق ىلع م�تي�اي اها نوك�ي ن�ا نكل�ي ةصار صناضر
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ن�ت�ت�ن ــطاا م�تع ضاحــس�الا و�ا ةّ�يم�نتحلاا و�ا ةّ�يذا�تعاا�ن ن�تّضتحلاا ضاحس�الا نم ة�يوعلاا تاق�ت�نطتلا نامحاا تالصوم ىمذح
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