oSIST prEN ISO 80369-2:2021

Small-bore connectors for liquids and gases in healthcare applications - Part 2: Connectors for respiratory applications (ISO/DIS 80369-2:2021)

This part of ISO 80369 specifies requirements for small-bore connectors intended to be used for connections in breathing systems applications and driving gases applications of medical devices and accessories that contain or directly or indirectly convey liquids or gases to or from a patient or to provide driving power to medical devices or accessories.
This part of ISO 80369 does not specify 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 Manufacturers are encouraged to incorporate the small-bore connectors specified in this part of ISO 80369 into medical devices, medical systems or accessories, even if currently not required by the relevant particular device standards. It is expected that when the relevant particular device standards are revised, requirements for small-bore connectors, as specified in this part of ISO 80369, will be included.

Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in medizinischen Anwendungen - Teil 2: Verbindungsstücke für Atemsysteme und Antriebsgasanwendungen (ISO/DIS 80369-2:2021)

Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé - Partie 2: Raccords destinés à des applications respiratoires (ISO/DIS 80369-2:2021)

Priključki z majhnim premerom za tekočine in pline za uporabo v zdravstvu - 2. del: Priključki za respiratorno uporabo (ISO/DIS 80369-2:2021)

General Information

• Status: Not Published
• Public Enquiry End Date: 14-Jul-2021
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 12-May-2021
• Due Date: 29-Sep-2021
• Completion Date: 04-Jun-2021
• Ref Project: prEN ISO 80369-2 - Small bore connectors for liquids and gases in healthcare applications - Part 2 - Connectors for respiratory applications

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN ISO 80369-2:2021
01-julij-2021
Priključki z majhnim premerom za tekočine in pline za uporabo v zdravstvu - 2. del:
Priključki za respiratorno uporabo (ISO/DIS 80369-2:2021)
Small-bore connectors for liquids and gases in healthcare applications - Part 2:
Connectors for respiratory applications (ISO/DIS 80369-2:2021)
Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in
medizinischen Anwendungen - Teil 2: Verbindungsstücke für Atemsysteme und
Antriebsgasanwendungen (ISO/DIS 80369-2:2021)
Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé - Partie
2: Raccords destinés à des applications respiratoires (ISO/DIS 80369-2:2021)
Ta slovenski standard je istoveten z: prEN ISO 80369-2
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
oSIST prEN ISO 80369-2:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 80369-2:2021

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oSIST prEN ISO 80369-2:2021
DRAFT INTERNATIONAL STANDARD
ISO/DIS 80369-2
ISO/TC 210 Secretariat: ANSI
Voting begins on: Voting terminates on:
2021-05-03 2021-07-26
Small-bore connectors for liquids and gases in healthcare
applications —
Part 2:
Connectors for respiratory applications
ICS: 11.040.20; 11.040.10
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 80369-2:2021(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2021

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oSIST prEN ISO 80369-2:2021
ISO/DIS 80369-2:2021(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2021
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: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved

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oSIST prEN ISO 80369-2:2021
ISO/DIS 80369-2:2021(E)

Contents Page
Foreword .iv
Introduction .v
1 * Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General requirements . 3
4.1 General requirements for the respiratory application . 3
4.2 Material used for small-bore connectors . 3
4.3 Type tests . 3
5 Dimensional requirements . 3
5.1 R1 small-bore connectors . 3
5.2 R2 small-bore connectors . 4
6 Performance requirements . 4
6.1 * Leakage by pressure decay . 4
6.2 Subatmospheric pressure air leakage . 4
6.3 Stress cracking . 4
6.4 Resistance to separation from axial load. 5
6.5 Resistance to separation from unscrewing . 5
6.6 Resistance to overriding . 5
6.7 Disconnection by unscrewing . 5
Annex A (informative) Rationale and guidance . 6
Annex B (normative) Small-bore connectors for breathing systems and driving gases .7
Annex C (normative) Reference connectors for testing small-bore connectors for breathing
systems and driving gases .16
Annex D (informative) Assessment of medical devices and their attributeswith connections
within this application .30
Annex E (informative) Summary of the usability requirements for small-bore connectors for
breathing systems and gases for respiratory use .35
Annex F (informative) Summary of small-bore connector design requirementsfor breathing
systems and gases for respiratory use applications .37
Annex G (informative) Summary of assessment of the design of the small-bore
connectorsfor breathing systems and gases for respiratory use .42
Annex H (informative) Reference to the Essential Principles .45
Annex I (informative) Terminology — Alphabetized index of defined terms .46
Bibliography .47
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oSIST prEN ISO 80369-2:2021
ISO/DIS 80369-2:2021(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. 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. 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 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
ISO 80369-2 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/WG 2, Small-bore connectors, in accordance with the
Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
This is the first edition of ISO 80369-2.
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oSIST prEN ISO 80369-2:2021
ISO/DIS 80369-2:2021(E)

Introduction
This International Standard was developed because of several incidents, with catastrophic
consequences, resultant from inappropriate medication, liquid nutritional formula or gas being
administered via the incorrect route. Many incidents have been reported leading to international
recognition of the importance of these issues, and a need has been identified to develop specific
connectors for medical devices and their accessories used to deliver fluids in other applications.
The ISO 80369 series was developed to prevent misconnection between small-bore connectors used in
different applications. Part 1 specifies the requirements necessary to verify the designs and dimensions
of small-bore connectors to ensure that:
a) they do not misconnect with other small-bore connectors; and
b) they safely and securely connect with their mating half.
Part 20 contains the common test methods to support the performance requirements for small-bore
connectors.
This part of ISO 80369 specifies the design, the dimensions and the drawings as well as performance
of small-bore connectors intended for use as an ancillary port connection in a breathing system and
respirable driving gases applications. The informative Annex D through Annex G describe the methods
by which these designs have been assessed. Other parts of ISO 80369 include requirements for small-
bore connectors used in different application categories.
Connectors manufactured to the dimensions set out within this International Standard are dimensionally
incompatible with any of the other connectors for applications identified in the ISO 80369 series of
documents for small-bore connectors, except as indicated in Annex G. If fitted to the relevant medical
devices and accessories, these connectors should reduce the risk of gas, medication and liquid nutritional
formula being delivered via an alternative route.
By conforming with the requirements of this document manufacturers of medical devices incorporating
these respiratory small-bore connectors can presume conformance with the requirements of
ISO 80369-1.
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 Clause 3 of this document or as noted: italics.
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.
The verbal forms used in this document conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this document, the auxiliary verb:
— “shall” means that conformance with a requirement or a test is mandatory for conformance with
this document;
— “should” means that conformance with a requirement or a test is recommended but is not mandatory
for conformance with this document;
— “may” is used to describe a permission (e.g. a permissible way to achieve conformance with a
requirement or test);
— “can” is used to describe a possibility or capability; and
— “must” is used to express an external constraint.
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oSIST prEN ISO 80369-2:2021
DRAFT INTERNATIONAL STANDARD ISO/DIS 80369-2:2021(E)
Small-bore connectors for liquids and gases in healthcare
applications —
Part 2:
Connectors for respiratory applications
1 * Scope
This document specifies dimensions for two respiratory small-bore connectors. One (R1) for use on medical
devices subjected to pressures up to 15 kPa such as a breathing system, the other (R2) for use on medical
devices subjected to higher pressures between 15 kPa and 600 kPa such as oxygen therapy tubing.
This document also specifies the performance requirements used to verify the dimensions.
This document does not specify 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.
This document does not specify requirements for connectors for pressurizing and depressurizing the
retention mechanism (e.g. balloon) used to hold invasive respiratory medical devices in place.
NOTE 1 Manufacturers are encouraged to incorporate the small-bore connectors specified in this part of
ISO 80369 into medical devices, medical systems or accessories of breathing systems or respirable driving gas
applications even if currently not required by the relevant particular medical device standards. It is expected that
when the relevant particular medical device standards are revised, requirements for small-bore connectors, as
specified in this part of ISO 80369, will be included.
NOTE 2 ISO 80369-1:2018, Clause 7, specifies alternative methods of conformance with ISO 80369-1:2018, for
small-bore connectors intended for use as an ancillary port connection in the breathing system or in the respirable
driving gas applications of medical devices or accessories, which do not conform with this part of ISO 80369.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for the application 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.
NOTE 1 The way in which these referenced documents are cited in normative requirements determines the
extent (in whole or in part) to which they apply.
NOTE 2 Informative references are listed in the Bibliography.
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 80369-3:2016, Small-bore connectors for liquids and gases in healthcare applications — Part 3:
Connectors for enteral applications
ISO 80369-7:2016, Small-bore connectors for liquids and gases in healthcare applications — Part 7:
Connectors for intravascular or hypodermic applications
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oSIST prEN ISO 80369-2:2021
ISO/DIS 80369-2:2021(E)

ISO 80369-20:2015, Small-bore connectors for liquids and gases in healthcare applications — Part 20:
Common test methods
3 Terms and definitions
For the purposes of this document, the terms and definitions specified in ISO 80369-1:2018,
ISO 80369-7:2015, ISO 80369-20:2015, ISO 14971:2019 and the following apply. For convenience, the
sources of all defined terms used in this document are given in Annex I.
3.1
auxiliary dimension
dimensions derived from other dimensions given for information purposes only
[5]
[SOURCE: ISO 10209:2012 , 4.2]
3.2
breathing system
inspiratory and expiratory pathways through which gas flows at respiratory pressures and bounded by
the port through which fresh gas enters, the patient connection port and the exhaust port
3.3
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
[3] 1)
[SOURCE: ISO 7396-1:2007 , definition 3.36]
3.4
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
[6]
[SOURCE: IEC 60601-1:2005+A1: 2012 , definition 3.97, modified, replaced ‘operator’ with ‘user’.]
3.5
rated
term referring to a value assigned by the manufacturer for a specified operating condition
[6]
[SOURCE: IEC 60601-1:2005 , definition 3.97]
3.6
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.
[9]
[SOURCE: IEC 62366-1:2015 , definition 3.24]
1) Figures in square brackets refer to the Bibliography
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3.7
user profile
summary of the mental, physical and demographic traits of an intended user group, as well as any
special characteristics, such as occupational skills, job requirements and working conditions, which
can have a bearing on design decisions
[9]
[SOURCE: IEC 62366-1:2015 , definition 3.29]
4 General requirements
4.1 General requirements for the respiratory application
Small-bore connectors made in conformance with this document conform with the requirements of
ISO 80369-1:2018 unless otherwise indicated in this document.
The reference connectors for evaluation of the non-interconnectable characteristics are described in
Annex C (Figures C.1, C.3, C.8, and C.10, as appropriate).
Where a medical device or accessory is designed to provide features of the respiratory small-bore
connector of this document, those features shall be included in the verification to this document.
When necessary, install the small-bore connector on the medical device or accessory to demonstrate
conformance with this document.
NOTE 1 The summary of medical devices and their attributes with connections within this application is
provided in informative Annex D.
NOTE 2 The summary of the usability requirements for connectors for this application is provided in
informative Annex E.
NOTE 3 The summary of criteria and requirements for connectors for this application is provided in
informative Annex F.
NOTE 4 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 5 This document has been prepared to address the relevant essential principles of safety and
[6]
performance of ISO 16142-1:2016 as indicated in Annex H.
NOTE 6 This document has been prepared to address the relevant general safety and performance
[13]
requirements of European regulation (EU) 2017/745 as indicated in Annex I.
4.2 Material used for small-bore connectors
R1 and R2 small-bore connectors shall be made of materials that conform with ISO 80369-1:2018,
Clause 4.
4.3 Type tests
Conformance with the requirements of this document shall be determined by type tests.
5 Dimensional requirements
5.1 R1 small-bore connectors
Small-bore connectors intended for use in the respiratory application at pressures less than 150 hPa
(15 kPa) above ambient shall conform with the dimensions and tolerances as given in
— Figure B.1 and Table B.1 for the male R1 connector.
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oSIST prEN ISO 80369-2:2021
ISO/DIS 80369-2:2021(E)

— Figure B.2 and Table B.2 for the female R2 connector.
Check conformance by confirming the relevant dimensions and tolerances specified in Annex B.
5.2 R2 small-bore connectors
Small-bore connectors intended to be used to convey air, oxygen or oxygen mixtures from one medical
device or accessory to another in driving gas applications for respiratory use at pressures between
15 kPa and 600 kPa above ambient shall conform with the dimensions and tolerances given in
— Figure B.3 and Table B.3 for a male R2 connector.
— Figure B.4 and Table B.4 for a female R2 connector.
Check conformance by confirming the relevant dimensions and tolerances specified in Annex B.
6 Performance requirements
6.1 * Leakage by pressure decay
R1 and R2 small-bore connectors shall be evaluated for fluid leakage using the leakage by pressure
decay test method. When tested over a hold period between 30 s and 35 s using air as the medium, the
leakage flowrate of
3
— a R1 small-bore connector shall not exceed a leakage rate of 0,00025 Pa·m /s while being subjected
to an applied pressure of between 12,5 kPa and 15,0 kPa.
3
— a R2 small-bore connector shall not exceed 0,005 Pa•m /s while being subjected to an applied
pressure of between 1 000 kPa and 1 050 kPa.
Check for conformance 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.
6.2 Subatmospheric pressure air leakage
R1 and R2 small-bore connectors shall be evaluated for subatmospheric pressure air leakage. These
small-bore connectors shall not exceed a leakage flowrate of more than
3
— 0,00005 Pa·m /s while being subjected to an applied subatmospheric pressure of between 3,0 kPa
and 5,0 kPa over a hold period of between 25 s and 35 s for an R1 connector.
3
— 0,005 Pa·m /s while being subjected to an applied subatmospheric pressure of between 35,0 kPa
and 45,0 kPa over a hold period of between 20 s and 30 s for a R2 connector.
Check conformance 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 subatmospheric pressure may be used.
6.3 Stress cracking
R1 and R2 small-bore connectors shall be evaluated for stress cracking. These small-bore connectors shall
meet the requirements of 6.1 and 6.2 after being subjected to stresses of ISO 80369-20:2015, Annex E.
Check conformance 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).
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6.4 Resistance to separation from axial load
R1 and R2 small-bore connectors shall be evaluated for separation from axial load. These 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 conformance 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.
6.5 Resistance to separation from unscrewing
R1 and R2 small-bore connectors shall be evaluated for separation from unscrewing. These 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 0,0198 N･m to 0,02 N･m.
Check conformance 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.
6.6 Resistance to overriding
R1 and R2 small-bore connectors shall be evaluated for resistance to overriding. These small-bore
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 for a R1 connector.
— 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 conformance 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.
6.7 Disconnection by unscrewing
R1 and R2 small-bore connectors shall be evaluated for disconnection by unscrewing. These small-bore
connector shall separate from the reference connector with an applied unscrewing torque of no greater
than 0,35 N･m.
Check conformance by applying the tests of ISO 80369-20:2015, Annex I, while using the disconnection
by unscrewing reference connector specified in Annex C (Figures C.1, C.3, C.8, and C.10, as appropriate).
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ISO/DIS 80369-2:2021(E)

Annex A
(informative)

Rationale and guidance
A.1 General guidance
This Annex provides a rationale for some requirements of ISO 80369-2, and is intended for those
who are familiar with the subject of ISO 80369-2 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
[10]
system or for hypodermic syringes so that they can achieve their intended function . The connectors
specified in t
...