Small-bore connectors for liquids and gases in healthcare applications — Part 2: Connectors for respiratory applications

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.

Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé — Partie 2: Raccords destinés à des applications respiratoires

General Information

Status
Published
Publication Date
01-Jul-2024
Current Stage
6060 - International Standard published
Start Date
02-Jul-2024
Due Date
15-Jan-2023
Completion Date
02-Jul-2024
Ref Project

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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 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
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
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
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

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 803
...


FINAL DRAFT
International
Standard
IEC/FDIS 80369-2
ISO/TC 210
Small-bore connectors for
Secretariat: ANSI
liquids and gases in healthcare
Voting begins on:
applications —
2024-03-08
Part 2:
Voting terminates on:
2024-05-31
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
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
This draft is submitted to a parallel vote in ISO and in IEC.
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/CEN PARALLEL PROCESSING LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
IEC/FDIS 80369-2:2024(en) © IEC 2024

FINAL DRAFT
IEC/FDIS 80369-2:2024(en)
International
Standard
ISO/FDIS 80369-2
ISO/TC 210
Small-bore connectors for
Secretariat: ANSI
liquids and gases in healthcare
Voting begins on:
applications —
2024-03-08
Part 2:
Voting terminates on:
2024-05-31
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
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
This draft is submitted to a parallel vote in ISO and in IEC.
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
© ISO 2024
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/CEN PARALLEL PROCESSING
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ISO/FDIS 80369-2:2024(en) © ISO 2024

© IEC 2024 – All rights reserved
ii
ISO/FDIS 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
Annex ZA (informative) Relationship between this European standard and the General Safety
and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered .50
Bibliography .54

iii
ISO/FDIS 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 medical devices, and IEC/TC 62, Electrical equipment, Subcommittee SC 62D, Electrical
equipment in medical practice, in collaboration 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/FDIS 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
FINAL DRAFT International Standard ISO/FDIS 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.
NOT
...


ISO/FDIS 80369-2:2023(E)
ISO TC 210/JWG 4
2023-04-1112
Secretariat: ANSI
Small-bore connectors for 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

FDIS Stage
ISO/FDIS 80369-2:2023(E)
All rights reserved. Unless otherwise specified, 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
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland.
ii © ISO 2023 – All rights reserved

ISO/FDIS 80369-2:2023(E)
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 drawnISO draws attention to the possibility that some of the elementsimplementation of this
document may beinvolve the subjectuse 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. 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 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.htmlwww.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 210, Quality management and
corresponding general aspects for medical devices, and IEC/TC 62, Electrical equipment, Subcommittee SC
62D, Electrical equipment in medical practice, in collaboration with the European Committee for
Standardization (CEN) Technical Committee, CEN/CENELEC JTC3/WG2, Small-bore connectorsCLC 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.htmlwww.iso.org/members.html.
ISO/FDIS 80369-2:2023(E)
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.
iv © ISO 2023 – All rights reserved

FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 80369-2:2023(E)

Small-bore connectors for liquids and gases in healthcare
applications — Part 2: Connectors for respiratory applications
1 Scope
NOTE There is guidance or rationale for this Clause contained in Annex A.
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 such as(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 such as(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 34 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 178:2019, 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 D638-14, Standard Test Method for Tensile Properties of Plastics
ISO/FDIS 80369-2:2023(E)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 14971:2019, ISO 80369-1:2018,
ISO 80369-7:2021, ISO 80369-20:2015 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 usedthat 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 10209:2012, 3.3.2, modified — Note 1 to entry has been removed.]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 4135:20212022, 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+AMD1:2017, 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+AMD1:2012+AMD2:2020, 3.71, modified — replaced ‘operator’ with ‘user’.]
3.6
socket
with internal sealing surface
2 © ISO 2023 – All rights reserved

ISO/FDIS 80369-2:2023(E)
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.
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 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
[168]
of 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 D638-14, 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
ISO/FDIS 80369-2:2023(E)
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
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 There isAnnex A contains guidance or rationale for this subclause contained in Annex A.
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 0,00025000 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 conn
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