ISO 80369-2:2024
(Main)Small-bore connectors for liquids and gases in healthcare applications - Part 2: Connectors for respiratory applications
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
ISO 80369-2:2024 Le présent document spécifie la conception et les dimensions de deux raccords de petite taille destinés à être utilisés pour des raccordements de dispositifs médicaux et d'accessoires dans le cadre d'applications respiratoires. Le premier raccord (R1) est destiné à être utilisé sur des dispositifs médicaux et des accessoires soumis à des pressions allant jusqu'à 15 kPa (par exemple, système respiratoire). Le second raccord (R2) est destiné à être utilisé sur des dispositifs médicaux et des accessoires soumis à des pressions plus élevées comprises entre 15 kPa et 600 kPa (par exemple, des tuyaux d'oxygénothérapie).
NOTE 1 La pression est fonction de la pression disponible au niveau de la source à laquelle le dispositif médical est raccordé.
NOTE 2 L'application prévue n'exclut pas l'utilisation d'autres raccords sur les dispositifs médicaux ou les accessoires relevant de cette application.
NOTE 3 Les exigences relatives aux raccords alternatifs pour cette application prévue sont spécifiées dans l'ISO 80369-1.
Le présent document ne spécifie pas d'exigences quant aux dispositifs médicaux ou aux accessoires sur lesquels ces raccords sont utilisés. Ces exigences sont précisées dans les normes spécifiques aux dispositifs.
NOTE 4 S'il n'existe pas de norme spécifique au dispositif, les exigences relatives aux performances et aux matériaux spécifiées dans l'ISO 80369-1 peuvent être utilisées à titre de recommandations.
General Information
Standards Content (Sample)
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
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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 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.
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
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.
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).
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
calculation methods were used.
Annex B
(normative)
Small-bore connectors for respiratory applications
Table B.1 contains the dimensions for Figure B.1.
The cone connector shows a permanently connected internally threaded lock fitting. A rotatable internally
threaded lock fitting may be used.
Figure B.1 — R1 cone small-bore connector
Table B.1 — R1 cone small-bore connector dimensions
Dimensions in millimetres unless otherwise indicated
R1 cone connector
Dimension
Reference Designation
Minimum Nominal Maximum
a1 Angle of the sealing cone, in degrees 58,0° — 62,0°
a2 Angle of the draft allowance, in degrees — — 1,00°
Angle of internal thread profile on the bearing surface against
b2 26,5° — 28,5°
separation, in degrees
Protrusion of the cone post geometry face from the face of
a
c 0 635 — 0 889
grip
Ød Outside diameter at the tip of the cone post geometry 3 600 — 3 700
e Depth of the cone post geometry 5 715 — —
Øf Inside diameter at the entrance face of the fluid lumen — — 2 850
Major inside thread diameter of the cone lock connector (diam-
Øh 9 267 — 9 521
eter at thread root)
Minor inside thread diameter of the cone lock connector, (di-
Øj 7 747 — 8001
ameter at thread crest)
m Width of the thread form at the crest of a cone lock connector 0 229 — 0 381
n Width of the thread form at the root of cone lock connector 0 873 — 1 083
Nominal pitch of double-start, right-hand thread of cone lock
p 1 508 — 1668
connector
s2 Thread length from open end of the grip 5 080 — —
Øu Inner diameter of the fluid lumen — — 2 850
Outside diameter of the smallest cylinder that encompasses
Øw 11 811 — 12 319
the outside surfaces of the external features of the collar
Øx2 Diameter at the base of the sealing cone 4 851 — 4 953
a
This dimension is when the floating or rotatable collar is positioned fully toward tip of the connector.
Table B.2 contains the dimensions for Figure B.2.
Figure B.2 — R1 socket small-bore connector
Table B.2 — R1 socket small-bore connector dimensions
Dimensions in millimetres unless otherwise indicated
R1 socket connector
Dimension
Reference Designation
Minimum Nominal Maximum
A1 Angle of the sealing cone, in degrees 58,0° — 62,0°
A2 Angle of the draft allowance, in degrees — — 1,00°
Angle of external thread profile on the bearing surface
B2 26,5° — 28,5°
against separation, in degrees
ØD Inside diameter at the open end of the socket geometry 5 060 — 5 150
E Depth of the socket geometry 5 207 — 5 461
E2 Depth to the base of the sealing cone 3 446 3766
ØF Inside diameter at the entrance face of the fluid lumen — — 2 850
TTabablele B B.22 ((ccoonnttiinnueuedd))
R1 socket connector
Dimension
Reference Designation
Minimum Nominal Maximum
Major outside thread diameter of the socket lock connector,
ØH 8 887 — 9 141
(diameter at thread crest)
Minor outside thread diameter of the socket lock connector,
ØJ 7 137 — 7 391
(diameter at thread root)
M Width of the thread form at the crest of a socket lock connector 0 384 — 0 444
N Thread width of socket lock connector at root 1 177 — 1 237
Nominal pitch of double-start, right-hand thread of the socket
P 1 461 — 1 715
lock connector
R Radius or chamfer at the entrance of the socket taper — — 0,25
S2 Thread length from open end of the socket taper 2 670 — —
Distance from the connector face to the beginning of the grip
T 5 207 — —
geometry
ØU Inner diameter of the fluid lumen (auxiliary dimension) — (1,950) —
Diameter of the smallest cylinder that encompasses the out-
ØW 11 811 — 12 319
side surfaces of the external features of the collar
Table B.3 contains the dimensions for Figure B.3.
The cone connector shows a permanently connected internally threaded lock fitting. A rotatable internally
threaded lock fitting may be used.
Figure B.3 — R2 cone small-bore connector
Table B.3 — R2 cone small-bore connector dimensions
Dimensions in millimetres unless otherwise indicated
R2 cone connector
Dimension
Reference Designation
Minimum Nominal Maximum
Angle of taper, (6 % taper nominal) degrees, (auxiliary dimen-
a — (3,44°) —
sion)
Angle of taper inside tip of cone taper (not yet shown on fig-
a2 0° — 1,0°
ure)
Angle of internal thread profile on the bearing surface against
b2 24,0° — 26,0°
separation, in degrees
Outside diameter at the tip of the cone taper at 0 500 (basic
Ød 8 164 — 8 266
dimension) from the tip (small end) of the cone taper
e Length of cone taper and length of inside diameter to Øu 7 366 — 7 620
Øf Inside diameter at the tip of the cone taper 5 300 — 5 609
Outside diameter of the larger end of the cone taper at 7 000
Øg 8554 — 8 656
(basic dimension) from the tip (small end) of the cone taper
a
g2 Front of grip to interior base of thread/cone taper 7 493 — 7 747
Major inside thread diameter of the cone lock connector (diam-
Øh 11 927 — 12 181
eter at thread root)
Minor inside thread diameter of the cone lock connector, (diam-
Øj 10 657 — 10 881
eter at thread crest)
m Width of the thread form at the crest of a cone lock connector 0 554 — 0 614
n Thread width of cone lock connector at root 1 161 — 1 221
Nominal pitch of double-start, right-hand thread of cone lock
p 2 413 — 2 667
connector – 5 mm lead
r Radius or chamfer at the tip of the cone taper 0 000 — 0 250
s2 Thread length from taper base of cone lock connector 7 493 — 7 747
Øu Inner diameter of the fluid lumen 3 375 — 3 629
Diameter of the smallest cylinder that encompasses the out-
Øw 18 340 — 18 872
b
side surfaces of the external features of the collar
a
This dimension is when the floating or rotatable collar is positioned fully toward tip of the connector.
b
The minimum value of w shall be maintained for the length of 1,00 mm and the maximum value shall be maintained for the
length of e.
Table B.4 contains the dimensions for Figure B.4.
Figure B.4 — R2 socket small-bore connectors
Table B.4 — R2 socket small-bore connector dimensions
Dimensions in millimetres unless otherwise indicated
R2 socket connector
Dimension
Reference Designation
Minimum Nominal Maximum
Angle of taper, degrees (6 % taper nominal) (auxiliary dimen-
A — (3,437°) —
sion)
Angle of external thread profile on the bearing surface
B2 27,5° — 30,0°
against separation, in degrees
Inside diameter at the open end of the socket taper at
ØD 0,500 (basic dimension) from the opening (large end) of the 8 385 — 8 487
socket taper
E Depth of socket taper 7 874 — 8 128
Inside diameter of the smaller end of the socket taper at 7,000
ØG (basic dimension) from the opening (large end) of the socket 7 995 8 097
taper
Outside major thread diameter of the socket lock connector,
ØH 11 543 — 11 797
(diameter at thread crest)
Minor inside thread diameter of the socket lock connector,
ØJ 10 301 — 10 555
(diameter at thread root)
M Width of the thread form at the crest of a socket lock connector 1 082 — 1 142
N Thread width of socket lock connector at root 1 799 — 1 859
Nominal pitch of double-start, right-hand thread of the socket
P 2 460 2620
lock connector
R Radius or chamfer at the entrance of the socket taper 0 000 — 0 250
S2 Thread length from open end of the socket taper 2 565 — 3 250
Distance from the connector face to the beginning of the grip — —
T 7 569
geometry
ØU Inner diameter of the fluid lumen 3 375 — 3 629
Diameter of the smallest cylinder that encompasses the out-
Øw 18 340 — 18 872
a
side surfaces of the external features of the collar
a
The minimum value of w shall be maintained for the length of 1,00 mm and the maximum value shall be maintained for the
length of E.
Figure B.5 — R1 small-bore connector assembly
Table B.5 contains the dimensions for Figure B.6.
Figure B.6 — R2 small-bore connector assembly
Table B.5 — R2 small-bore connector assembly
Dimensions in millimetres unless otherwise indicated
R2 connector assembly
Dimension
Reference Designation
Minimum Nominal Maximum
Length of engagement (auxiliary dimensions) (4 188)
L — —
(see Figure B.5) (4 683)
Annex C
(normative)
Reference connectors for testing small-bore connectors for respiratory
applications
C.1 General requirements for reference connectors
The reference connectors shall be manufactured from corrosion-resistant rigid materials with a modulus
of elasticity either in flexure or in tension greater than 35 000 kg/cm (3 433 MPa) and with a surface
roughness value, R , not exceeding 0,8 μm on critical surfaces. See Figures C.1 to C.14.
a
C.2 Reference connectors for R1 small-bore connectors
Dimensions in millimetres
Key
P thread pitch
V thread lead for a double start thread
All sharp edges and corners shall have a radius no greater than 0,15 mm (unless otherwise specified) for manufacturing
purposes.
Figure C.1 — Socket reference connector for testing R1 cone connectors for leakage, separation from
unscrewing, stress cracking and non-interconnectable characteristics
Dimensions in millimetres
Key
P thread pitch
V thread lead for a double start thread
All sharp edges and corners of lug shall have a radius no greater than 0,15 mm (unless otherwise specified) for
manufacturing purposes.
Figure C.2 — Socket reference connector for testing R1 cone connectors for separation from axial
load and resistance to overriding
Dimensions in millimetres
Key
1 R1 cone taper insert
2 R1 cone reference connector
Create this cone reference connector assembly by attaching the cone taper insert (Figure C.5) to the reference connector
(Figure C.6).
Figure C.3 — Cone reference connector for testing R1 socket connectors for leakage, separation from
unscrewing, stress cracking and non-interconnectable characteristics
Key
1 R1 cone taper insert
2 R1 cone reference connector
Create this cone reference connector assembly by attaching the cone taper insert (Figure C.5) to the reference connector
(Figure C.7).
Figure C.4 — Cone reference connector for testing R1 socket connectors from separation from axial
load and resistance to overriding
C.3 Reference connector components for R1 small-bore connectors
Dimensions in millimetres
Figure C.5 — Cone reference connector cone taper insert for testing R1 socket connectors for leakage,
separation from unscrewing, separation from axial load and resistance to overriding, stress
cracking and non-interconnectable characteristics
Dimensions in millimetres
Key
P thread pitch
V thread lead for a double start thread
Figure C.6 — Cone reference connector for testing R1 socket connectors for leakage, separation from
unscrewing, stress cracking and non-interconnectable characteristics
Dimensions in millimetres
Key
P thread pitch
V thread lead for a double start thread
Figure C.7 — Cone reference connector for testing R1 socket connectors separation from axial load
and resistance to overriding
C.4 Reference connectors for R2 small-bore connectors
Dimensions in millimetres
Key
P thread pitch
V thread lead for a double start thread
All sharp edges and corners of thread form shall have a radius no greater than 0,15 mm (unless otherwise specified) for
manufacturing purposes.
Figure C.8 — Socket reference lock connector for testing R2 cone connectors for leakage, separation
from unscrewing, stress cracking and non-interconnectable characteristics
Dimensions in millimetres
Key
P thread pitch
V thread lead for a double start thread
All sharp edges and corners of lug shall have a radius of greater than 0,15 mm (unless otherwise specified) for
manufacturing purposes.
Figure C.9 — Socket reference connector for testing R2 cone connectors for separation from axial
load and resistance to overriding
Dimensions in millimetres
Key
1 R2 cone taper insert
2 R2 cone reference connector
Create this cone reference connector assembly by attaching the cone taper insert (Figure C.12) to the reference connector
(Figure C.13).
Figure C.10 — Cone reference lock connector for testing R2 socket connectors for leakage, separation
from unscrewing, stress cracking and non-interconnectable characteristics
Dimensions in millimetres
Key
1 R2 cone taper insert
2 R2 cone reference connector
Create this cone reference connector assembly by attaching the cone taper insert (Figure C.12) to the reference connector
(Figure C.14).
Figure C.11 — Cone reference connector for testing R2 socket connectors separation from axial load
and resistance to overriding
C.5 Reference connector components for R2 small-bore connectors
Dimensions in millimetres
Figure C.12 — Cone reference connector cone taper insert for testing R2 socket connectors for
leakage, separation from unscrewing, stress cracking and separation from axial load and resistance
to overriding
Dimensions in millimetres
Key
P thread pitch
V thread lead for a double start thread
Figure C.13 — Cone reference connector for testing R2 socket connectors for leakage, separation
from unscrewing, stress cracking and non-interconnectable characteristics
Dimensions in millimetres
Key
P thread pitch
V thread lead for a double start thread
Figure C.14 — Cone reference connector for testing R2 socket connectors separation from axial load
and resistance to overriding
Annex D
(informative)
Assessment of medical devices and their attributeswith connections
within this application
Table D.1 contains examples of medical devices and accessories with connections to the ancillary port
connection of a breathing system or to be used with a respirable gas. The table contains an assessment of
the important attributes of medical devices and accessories as they relate to the intended connection. Each
connection is assessed according to the following index or subgroups:
a) breathing system connections;
b) diverting gas monitor connections;
c) oxygen source connections;
d) oxygen saving systems connections;
e) humidifier system connections;
f) sub-atmospheric connections;
g) connections for the delivery of liquids or drugs.
Table D.1 — Examples of medical devices with connections within this application
and their attributes
Part /component
to which the connector
is applied
Outlet port on a breath-
ing system to connect a 1.1.1 A — yes yes gas < 125 < 0,05 yes yes no
breathing pressure sensor
Inlet port of a breathing
pressure measuring line
1.1.2 A — yes yes gas < 125 < 0,05 yes yes no
to connect to the breathing
system
Outlet port of a breathing
pressure measuring line
1.1.3 A — yes yes gas < 125 < 0,05 yes yes no
to connect to the pressure
sensor
Inlet port on the pressure
sensor (e.g. ventilator) to
connect the outlet port 1.1.4 A — yes yes gas < 125 < 0,05 yes yes no
of a breathing pressure
measuring line
Key
Port is intended to mean any opening in the part of the medical device or the accessory concerned, including those with a connector
as well as those without a connector.
a
Connections for this use are typ
...
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