SIST EN ISO 80369-2:2024

SLOVENSKI STANDARD
01-oktober-2024
Priključki z majhnim premerom za tekočine in pline za uporabo v zdravstvu - 2. del:
Priključki za respiratorno uporabo (ISO 80369-2:2024)
Small-bore connectors for liquids and gases in healthcare applications - Part 2:
Connectors for respiratory applications (ISO 80369-2:2024)
Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in
medizinischen Anwendungen - Teil 2: Verbindungsstücke für Atemsysteme und
Antriebsgasanwendungen (ISO 80369-2:2024)
Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé - Partie
2: Raccords destinés à des applications respiratoires (ISO 80369-2:2024)
Ta slovenski standard je istoveten z: EN ISO 80369-2:2024
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN ISO 80369-2

NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2024
ICS 11.040.20; 11.040.10
English version
Small-bore connectors for liquids and gases in healthcare
applications - Part 2: Connectors for respiratory
applications (ISO 80369-2:2024)
Raccords de petite taille pour liquides et gaz utilisés Verbindungsstücke mit kleinem Durchmesser für
dans le domaine de la santé - Partie 2: Raccords Flüssigkeiten und Gase in medizinischen
destinés à des applications respiratoires (ISO 80369- Anwendungen - Teil 2: Verbindungsstücke für
2:2024) respiratorische Anwendungen (ISO 80369-2:2024)
This European Standard was approved by CEN on 3 July 2024.

CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for
giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical
references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to
any CEN and CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN and CENELEC member into its own language and notified to the CEN-CENELEC
Management Centre has the same status as the official versions.

CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium,
Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia,
Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and United Kingdom.

CEN-CENELEC Management Centre:
Rue de la Science 23, B-1040 Brussels
© 2024 CEN/CENELEC All rights of exploitation in any form and by any means
Ref. No. EN ISO 80369-2:2024 E
reserved worldwide for CEN national Members and for
CENELEC Members.
Contents Page
European foreword . 3
Annex ZA (informative)  Relationship between this European standard and the
General Safety and Performance Requirements of Regulation (EU) 2017/745
aimed to be covered . 4

European foreword
This document (EN ISO 80369-2:2024) has been prepared by Technical Committee ISO/TC 210
"Quality management and corresponding general aspects for products with a health purpose
including medical devices" in collaboration with Technical Committee CEN-CENELEC/ JTC 3
“Quality management and corresponding general aspects for medical devices” the secretariat of
which is held by NEN.
This European Standard shall be given the status of a national standard, either by publication of
an identical text or by endorsement, at the latest by February 2025, and conflicting national
standards shall be withdrawn at the latest by February 2025.
Attention is drawn to the possibility that some of the elements of this document may be the
subject of patent rights. CEN-CENELEC shall not be held responsible for identifying any or all
such patent rights.
This document has been prepared under a standardization request addressed to CEN and
CENELEC by the European Commission. The Standing Committee of the EFTA States
subsequently approves these requests for its Member States.
For the relationship with EU Legislation, see informative Annex ZA, which is an integral part of
this document.
Any feedback and questions on this document should be directed to the users’ national
standards body/national committee. A complete listing of these bodies can be found on the CEN
and CENELEC websites.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary,
Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden,
Switzerland, Türkiye and the United Kingdom.
Endorsement notice
The text of ISO 80369-2:2024 has been approved by CEN-CENELEC as EN ISO 80369-2:2024
without any modification.
Annex ZA
(informative)
Relationship between this European standard and the General Safety
and Performance Requirements of Regulation (EU) 2017/745 aimed
to be covered
This European standard has been prepared under M/575 to provide one voluntary means of
conforming to the General Safety and Performance Requirements of Regulation (EU) 2017/745
of 5 April 2017 concerning medical devices [OJ L 117] and to system or process requirements
including those relating to quality management systems, risk management, post-market
surveillance systems, clinical investigations, clinical evaluation or post-market clinical follow-up.
Once this standard is cited in the Official Journal of the European Union under that Regulation,
compliance with the normative clauses of this standard given in Table ZA.1 confers, within the
limits of the scope of this standard, a presumption of conformity with the corresponding
General Safety and Performance Requirements of that Regulation, and associated EFTA
Regulations.
Where a definition in this standard differs from a definition of the same term set out in
Regulation (EU) 2017/745, the differences shall be indicated in this Annex Z. For the purpose of
using this standard in support of the requirements set out in Regulation (EU) 2017/745, the
definitions set out in this Regulation prevail.
Where the European standard is an adoption of an International Standard, the scope of this
standard can differ from the scope of the European Regulation that it supports. As the scope of
the applicable regulatory requirements differ from nation to nation and region to region, the
standard can only support European regulatory requirements to the extent of the scope of
the European regulation for medical devices (EU) 2017/745.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Regulation (EU) 2017/745. This means that risks
have to be ‘reduced as far as possible’, ‘reduced to the lowest possible level’, ‘reduced as far as possible
and appropriate’, ‘removed or reduced as far as possible’, ‘eliminated or reduced as far as possible’,
’removed or minimized as far as possible’, or ‘minimized’, according to the wording of the corresponding
General Safety and Performance Requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with General
Safety and Performance Requirements 1, 2, 3, 4, 5, 8, 9, 10, 11, 14, 16, 17, 18, 19, 20, 21 and 22 of the
Regulation.
, it means
NOTE 3 When a General Safety and Performance Requirement does not appear in Table ZA.1
that it is not addressed by this European Standard.
Table ZA.1 — Correspondence between this European standard and Annex I of Regulation
(EU) 2017/745 [OJ L 117] and to system or process requirements including those relating
to quality management systems, risk management, post-market surveillance systems,
clinical investigations, clinical evaluation or post-market clinical follow-up

General Safety and Perfor- Clause(s) /
mance Requirements of subclause(s) of this EN
Remarks / Notes
Regu- lation (EU)
2017/745
14.1 4, 5, 6, 7 This requirement is partially covered in
that intended connections do not leak
and can only be connected to intended
medical devices or accessories.
Misconnections between small-bore
connectors of this series of standards,
which could result in an unacceptable
risk, are made impossible by design.
14.5 4, 5, 6, 7 This requirement is partially covered in
that by ensuring that the intended
connections do not leak and can only be
connected to intended medical devices or
accessories.
20.4 4, 5, 6, 7 This requirement is partially covered in
that intended connections do not leak
and can only be connected to intended
medical devices or accessories.
Misconnections between small-bore
connectors of this series of standards,
which could result in an unacceptable
risk, are made impossible by design.
20.5 4, 5, 6, 7 This requirement is partially covered in
that intended connections can only be
connected to intended medical devices or
accessories. Misconnections between
small-bore connectors of this series of
standards, which could result in an
unacceptable risk, are made impossible
by design.
21.1 4, 5, 6, 7 This requirement is partially covered in
that by ensuring that the intended
connections do not leak and can only be
connected to intended medical devices or
accessories. Such connections permit a
medical device to be capable of
controlling the flowrate.
WARNING 1 Presumption of conformity stays valid only as long as a reference to this European
standard is maintained in the list published in the Official Journal of the European Union. Users
of this standard should consult frequently the latest list published in the Official Journal of the
European Union.
WARNING 2 Other Union legislation may be applicable to the product(s) falling within the scope
of this standard.
For devices which are also machinery within the meaning of Article 2(a) of Directive
2006/42/EC on Machinery, in accordance with Article 1(12) of Regulation (EU) 2017/745, the
following Table ZA.2 details the relevant Essential Health and Safety Requirements of Directive
2006/42/EC on Machinery to the extent to which they are more specific than the General Safety
and Performance Requirements set out in Chapter II of Annex I of Regulation (EU) 2017/745
along with the corresponding clauses of this European Standard. Table ZA.2, however, does not
imply any citation in the OJEU under the machinery directive and thus does not provide
presumption of conformity for the machinery directive.
Where a definition in this standard differs from a definition of the same term set out in
Regulation (EU) 2017/745, the differences shall be indicated in the Annex Z. For the purpose of
using this standard in support of the requirements set out in Regulation (EU) 2017/745, the
definitions set out in this Regulation prevail.
Where the European standard is an adoption of an International Standard, the scope of this
standard can differ from the scope of the European Regulation that it supports. As the scope of
the applicable regulatory requirements differ from nation to nation and region to region, the
standard can only support European regulatory requirements to the extent of the scope of the
European Regulation for medical devices (EU) 2017/745.
For the case that small-bore connectors are attached to medical devices or accessories which are
also machinery as defined in the Machinery Directive 2006/42/EC, the relevant Essential Health
and Safety Requirements from Directive 2006/42/EC on machinery are also addressed by this
Document (according to article 1, item 12, of Regulation (EU) 2017/745).

Table ZA.2 — Relevant Essential Health and Safety Requirements from Directive
2006/42/EC on machinery that are addressed by this Document (according to article 1,
item 12, of Regulation (EU) 2017/745)
Essential Health and Clause(s) / sub- Remarks / Notes
Safety Require- ments of clause(s) of this EN
Directive 2006/42/EC
1.5.4 4, 5, 6, 7 This requirement is partially covered in
that misconnections between small-
bore connectors of this series of
standards, which could result in an
unacceptable risk, are made impossible
by design.
Table ZA.3 — Applicable Standards to confer presumption of conformity as described in
this Annex ZA
Column 1 Column 2 Inter- Column 3 Title Column 4
Reference in Clause national Standard Corresponding
2 Edition European
Standard Edition
ISO 80369-1:2018 ISO 80369-1:2018 Small-bore connectors for EN ISO 80369-1:2018
liquids and gases in
healthcare applica- tions —
Part 1: General require-
ments
ISO 80369-20:2015 ISO 80369-20:2015 Small-bore connectors for EN ISO 80369-
liquids and gases in 20:2015
healthcare applica- tions —
Part 20: Common test
methods
ISO 527-1:2019 ed.3 ISO 527-1:2019 ed.3 Determination of tensile EN ISO 527-1:2019
proper- ties — Part 1: ed.3
General principles
ISO 178:2019 ed.6 ISO 178:2019 ed.6 Determination of flexural EN ISO 178:2019
proper- ties
ISO 6892-1:2019 ed.3 ISO 6892-1:2019 ed.3 Metallic materials — EN ISO 6892-1:2019
Tensile testing — Part 1:
Method of test at room
temperature
ISO 291:2008 ed.4 ISO 291:2008 ed.4 Plastics — Standard EN ISO 291:2008
atmospheres for
conditioning and testing
ASTM D638-22 ISO 527-1:2019 ed.3 Standard Test Method for ----------------------------
Tensile Properties of ------
See NOTE 1 below
Plastics
ASTM D790-17 ISO 178:2019 ed.6 Standard Test Methods for ----------------------------
Flexur- al Properties of ------
See NOTE 2 below
Unreinforced and
Reinforced Plastics and
Electrical Insulating
Materials
NOTE 1 Both ISO 527-1 and ASTM D638 specify test methods for the tensile test. Both standards are
technically equivalent, but do not provide fully comparable results, since specimen shapes, test speeds
and the method of determining results differ in some respects. The results of both standards are
sufficiently compatible to differentiate the modulus of elasticity. See also References (15) and (19).
NOTE 2 ISO 178 is very similar to ASTM D790, with some differences:
ISO 178 requires the use of either a deflectometer or a conformity adjustment to determine
modulus. For ASTM D790, modulus can be calculated by crosshead displacement alone.
Preferred specimen sizes vary, and since the test speed depends on the specimen depth, the test
speeds of the standards may differ. The recommended depth of ISO 178 specimens is 4 mm,
while the recommended depth of ASTM D790 specimens is 3,2 mm.
For ASTM D790, only one test speed is allowed, while ISO 178 allows a second (faster) test speed
after measuring the module. The results of both standards are sufficiently compatible to
differentiate the modulus of elasticity. See also References (15) and (19).
The documents listed in the Column 1 of Table ZA.3, in whole or in part, are normatively
referenced in this document, i.e. are indispensable for its application. The achievement of the
presumption of conformity is subject to the application of the edition of Standards as listed in
Column 4 or, if no European Standard Edition exists, the International Standard Edition given in
Column 2 of Table ZA.3.
International
Standard
ISO 80369-2
First edition
Small-bore connectors for
2024-07
liquids and gases in healthcare
applications —
Part 2:
Connectors for respiratory
applications
Raccords de petite taille pour liquides et gaz utilisés dans le
domaine de la santé —
Partie 2: Raccords destinés à des applications respiratoires
Reference number
ISO 80369-2:2024(en) © ISO 2024

ISO 80369-2:2024(en)
© ISO 2024
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: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 80369-2:2024(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Non-interconnectability requirements . 3
5 Material requirements . 3
6 Dimensions and tolerances . 3
6.1 R1 small-bore connectors .3
6.2 R2 small-bore connectors.3
7 Performance requirements . . 4
7.1 Leakage by pressure decay .4
7.2 Sub-atmospheric pressure air leakage.4
7.3 Stress cracking .4
7.4 Resistance to separation from axial load .4
7.5 Resistance to separation from unscrewing .4
7.6 Resistance to overriding .5
7.7 Disconnection by unscrewing . .5
Annex A (informative) Rationale and guidance . 6
Annex B (normative) Small-bore connectors for respiratory applications . 7
Annex C (normative) Reference connectors for testing small-bore connectors for respiratory
applications .16
Annex D (informative) Assessment of medical devices and their attributeswith connections
within this application .31
Annex E (informative) Summary of the usability requirements for small-bore connectors for
respiratory applications.37
Annex F (informative) Summary of small-bore connector design requirementsfor respiratory
applications .39
Annex G (informative) Summary of assessment of the design of the small-bore connectorsfor
respiratory applications.45
Annex H (informative) Reference to the IMDRF essential principles .48
Annex I (informative) Terminology — Alphabetized index of defined terms .49
Bibliography .50

iii
ISO 80369-2:2024(en)
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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of 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 World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 210, Quality management and corresponding
general aspects for products with a health purpose including medical devices, in collaboration with Technical
Committee IEC/SC 62D, Particular medical equipment, software, and systems, and with the European
Committee for Standardization (CEN) Technical Committee CEN/CLC/JTC 3, Quality management and
corresponding general aspects for medical devices, in accordance with the Agreement on technical cooperation
between ISO and CEN (Vienna Agreement).
A list of all parts in the ISO 80369 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

iv
ISO 80369-2:2024(en)
Introduction
The small-bore connectors specified in this document conform with the requirements for non-interconnectable
characteristics of ISO 80369-1.
This document includes design and performance requirements for small-bore connectors for the respiratory
application.
It is recognised that the small-bore connectors specified in this document might not be suitable for some
medical devices or accessories within this application.
Annex A contains guidance or rationale on the requirements in this document.
This document has been prepared to support the essential principles for medical device or accessories
incorporating respiratory application small-bore connectors according to the International Medical Device
Regulators Forum (IMDRF). See Annex H.
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.
In this document, the following verbal forms are used:
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “may” indicates a permission;
— “can” indicates a possibility or capability; and
— "must" is used to express an external constraint.
NOTE This document uses italic type to distinguish defined terms from the rest of the text. It is important for the
correct understanding of this document that those defined terms are identifiable throughout the text of this document.
A list of the terms in italics is given in Annex I.

v
International Standard ISO 80369-2:2024(en)
Small-bore connectors for liquids and gases in healthcare
applications —
Part 2:
Connectors for respiratory applications
1 Scope
This document specifies the design and dimensions for two small-bore connectors intended to be used for
connections in respiratory applications of medical devices and accessories. One connector (R1) is intended for
use on medical devices and accessories subjected to pressures up to 15 kPa (e.g. a breathing system). The
other connector (R2) is intended for use on medical devices and accessories subjected to higher pressures
between 15 kPa and 600 kPa (e.g. oxygen therapy tubing).
NOTE 1 The pressure is related to pressure available at the source to which the medical device is connected.
NOTE 2 The intended application does not preclude the use of other connectors on medical devices or accessories
within this application.
NOTE 3 Requirements for alternative connectors for this intended application are specified in ISO 80369-1.
This document does not specify requirements for the medical devices or accessories that use these connectors.
Such requirements are given in device-specific standards.
NOTE 4 If a device-specific standard does not exist, the performance and material requirements specified in
ISO 80369-1 can be used as guidance.
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 178, Plastics — Determination of flexural properties
ISO 527 (all parts), Determination of tensile properties
ISO 6892-1:2019, Metallic materials — Tensile testing — Part 1: Method of test at room temperature
ISO 14971:2019, Medical devices — Application of risk management to medical devices
ISO 80369-1:2018, Small-bore connectors for liquids and gases in healthcare applications — Part 1: General
requirements
ISO 80369-7:2021, Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors
for intravascular or hypodermic applications
ISO 80369-20:2015, Small-bore connectors for liquids and gases in healthcare applications — Part 20: Common
test methods
ASTM D638-22, Standard Test Method for Tensile Properties of Plastics
ASTM D790-17, Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and
Electrical Insulating Materials

ISO 80369-2:2024(en)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 14971, ISO 80369-1, ISO 80369-7,
ISO 80369-20 and the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org
NOTE For convenience, the sources of all defined terms that appear in italics in this document are given in Annex I.
3.1
auxiliary dimension
dimensions derived from other dimensions given for information purposes only
[SOURCE: ISO 10209:2022, 3.3.2]
3.2
breathing system
pathways through which gas flows to or from the patient at respiratory pressures and continuously or
intermittently in fluid communication with the patient’s respiratory tract during any form of artificial
ventilation or respiratory therapy
[SOURCE: ISO 4135:2022, 3.6.1.1, modified — Notes 1 to 5 to entry have been removed.]
3.3
cone
with external sealing surface
Note 1 to entry: The sealing surface need not be conical.
Note 2 to entry: This type of connector was previously referred to as male.
3.4
medical gas pipeline system
complete system which comprises a supply system, a monitoring and alarm system and a distribution
system with terminal units at the points where medical gases or vacuum are required
[SOURCE: ISO 7396-1:2016, 3.36]
3.5
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, 3.71, modified — replaced ‘operator’ with ‘user’.]
3.6
socket
with internal sealing surface
Note 1 to entry: This type of connector was previously referred to as female.
3.7
user
person interacting with (i.e. operating or handling) the medical device
Note 1 to entry: There can be more than one user of a medical device.

ISO 80369-2:2024(en)
Note 2 to entry: Common users include clinicians, patients, cleaners, maintenance and service personnel.
[SOURCE: IEC 62366-1:2015, 3.24]
4 Non-interconnectability requirements
Small-bore connectors made in conformance with this document conform with the requirements of
ISO 80369-1.
NOTE 1 The reference connectors for evaluation of the non-interconnectable characteristics are described in
Annex C.
NOTE 2 The summary of medical devices and their attributes with connections within this application is provided in
informative Annex D.
NOTE 3 The summary of the usability requirements for connectors for this application is provided in informative
Annex E.
NOTE 4 The summary of criteria and requirements for connectors for this application is provided in informative
Annex F.
NOTE 5 The summary of assessment of the design of connectors for this application according to ISO 80369-1:2018,
6.1, is contained in informative Annex G.
NOTE 6 This document has been prepared to address the relevant general safety and performance requirements of
[8]
European regulation (EU) 2017/745 .
5 Material requirements
NOTE There is rationale for the option to apply either the ISO or the ASTM standards to confirm the modulus of
elasticity contained in Annex A.
a) R1 and R2 small-bore connectors shall be made of materials with a nominal modulus of elasticity either
in flexure or in tension greater than 700 MPa.
b) Surfaces, other than those necessary to ensure non-interconnectable characteristics, need not comply
with the modulus of elasticity requirement.
Check conformity by applying the tests of ASTM D638-22, the ISO 527 series, ASTM D790-17 or ISO 178 or
for metallic materials, the tests of ISO 6892-1.
6 Dimensions and tolerances
6.1 R1 small-bore connectors
Small-bore connectors intended for use on respiratory medical devices and accessories at pressures less than
150 hPa (15 kPa) above ambient shall conform with the dimensions and tolerances as given in
a) Figure B.1 and Table B.1 for a R1 cone connector, and
b) Figure B.2 and Table B.2 for a R1 socket connector.
Check conformity by confirming the relevant dimensions and tolerances specified in Annex B.
6.2 R2 small-bore connectors
Small-bore connectors intended to be used on respiratory medical devices and accessories at pressures
between 15 kPa and 600 kPa above ambient shall conform with the dimensions and tolerances given in
a) Figure B.3 and Table B.3 for a R2 cone connector, and

ISO 80369-2:2024(en)
b) Figure B.4 and Table B.4 for a R2 socket connector.
Check conformity by confirming the relevant dimensions and tolerances specified in Annex B.
7 Performance requirements
7.1 Leakage by pressure decay
NOTE Annex A contains guidance or rationale for this subclause.
a) R1 and R2 small-bore connectors shall be evaluated for fluid leakage using the leakage by pressure decay
test method.
b) When tested over a hold period between 30 s and 35 s using air as the medium,
1) a R1 small-bore connector shall not exceed a leakage rate of 0,000 25 Pa∙m /s while being subjected
to an applied pressure of between 12,5 kPa and 15,0 kPa, and
2) a R2 small-bore connector shall not exceed 0,005 Pa∙m /s while being subjected to an applied
pressure of between 600 kPa and 640 kPa.
Check conformity by applying the tests of ISO 80369-20:2015, Annex B, while using the leakage reference
connector specified in Annex C (Figures C.1, C.3, C.8, and C.10, as appropriate). A greater applied pressure or
a longer hold period may be used.
7.2 Sub-atmospheric pressure air leakage
a) A R1 connector shall not exceed a leakage flowrate of 0,000 05 Pa·m /s while being subjected to an
applied sub atmospheric pressure of between 3,0 kPa and 5,0 kPa over a hold period of between 25 s
and 35 s.
b) A R2 connector shall not exceed a leakage flowrate of 0,005 Pa·m /s while being subjected to an applied
sub atmospheric pressure of between 35,0 kPa and 45,0 kPa over a hold period of between 20 s and 30 s.
Check conformity by applying the tests of ISO 80369-20:2015, Annex D, while using the leakage reference
connector specified in Annex C (Figures C.1, C.3, C.8, and C.10, as appropriate). A greater applied sub-
atmospheric pressure may be used.
7.3 Stress cracking
R1 and R2 small-bore connectors shall meet the requirements of 7.1 and 7.2 after being subjected to the
stresses specified in ISO 80369-20:2015, Annex E.
Check conformity by applying the tests of ISO 80369-20:2015, Annex E, while using the stress cracking
reference connector specified in Annex C (Figures C.1, C.3, C.8, and C.10, as appropriate).
7.4 Resistance to separation from axial load
R1 and R2 small-bore 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.
Check conformity by applying the tests of ISO 80369-20:2015, Annex F, while using the separation from
axial load reference connector specified in Annex C (Figures C.2, C.4, C.9, and C.11, as appropriate). A greater
disconnection applied axial force or a longer hold period may be used.
7.5 Resistance to separation from unscrewing
R1 and R2 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 0,018 N∙m to 0,020 N∙m.

ISO 80369-2:2024(en)
Check conformity by applying the tests of ISO 80369-20:2015, Annex G, while using the separation from
unscrewing reference connector specified in Annex C (Figures C.1, C.3, C.8, and C.10, as appropriate). A
greater applied unscrewing torque or a longer hold period may be used.
7.6 Resistance to overriding
R1 and R2 small-bore connectors shall not override the threads or lugs of the reference connector while being
subjected to an applied torque of
a) between 0,15 N∙m to 0,17 N∙m over a hold period between 5 s and 10 s for a R1 connector, and
b) between 0,22 N∙m to 0,25 N∙m over a hold period between 5 s and 10 s for a R2 connector.
Check conformity by applying the tests of ISO 80369-20:2015, Annex H, while using the resistance to
overriding reference connector specified in Annex C (Figures C.2, C.4, C.9, and C.11, as appropriate). A greater
applied torque or a longer hold period may be used.
7.7 Disconnection by unscrewing
R1 and R2 small-bore connectors shall separate from the reference connector with an applied unscrewing
torque of no greater than 0,35 N∙m.
Check conformity by applying the tests of ISO 80369-20:2015, Annex I, while using the disconnection by
unscrewing the reference connector specified in Annex C (Figures C.1, C.3, C.8, and C.10, as appropriate).

ISO 80369-2:2024(en)
Annex A
(informative)
Rationale and guidance
A.1 General guidance
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 for the
present requirements 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
In 2000, a Task Group of the European standards organization, CEN, proposed a strategy to reduce incidents
of accidental misconnection of patient therapy lines by the use of a series of non-interconnectable connectors,
differentiated by design, for use in different medical applications. The strategy reserves the use of Luer
connectors solely for use in medical devices used to access the vascular system or for hypodermic syringes so
[7]
that they can achieve their intended function. The connectors specified in this document are intended to
be used on respiratory medical devices.
Manufacturers and responsible organizations are encouraged to report their experience with the small-
bore connectors specified in this document to their national standards body (see the last paragraph of the
Foreword), so that it can consider this feedback during the revision of the relevant part of the ISO 80369 series.
Subclause 6.1  Leakage by pressure decay
The test pressures chosen are the worst-case pressures that can be generated under a single fault condition
for a breathing system for the R1 connector and for a medical gas pipeline system for the R2 connector.
Clause 5  Material requirements
It was determined although several fundamental differences exist between ASTM D 638 Standard Test
Method of Tensile Properties of Plastics and ISO 527 Plastics - Determination of Tensile Properties, the actual
test results can be quite similar. Test data for both test methods have been gathered by an interlaboratory
testing provider and the summary statistics of the two groups were compared. The thermoplastic resins
tested in this study included polycarbonate (PC), polybutylene terephthalate (PBT), acrylonitrilebutadiene-
styrene (ABS) and high impact polystyrene (HIPS). All resins were unfilled, unreinforced, and uncoloured.
The following properties were analysed: Tensile Stress at Yield, Tensile Stress at Break, Elongation at Yield,
and Modulus of Elasticity. After removing outliers, the data from the remaining labs were analysed. The
strength of agreement between ISO data and ASTM data varied depending on the property and material
used. There were surprising similarities for modulus of elasticity since different speeds of testing and
calcu
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