oSIST prEN ISO 80369-2:2015

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

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 respiratorische Anwendungen

Joints de petite dimension pour liquides et gaz pour des applications en santé - Partie 2 : Joints pour systèmes respiratoires et applications au gaz propulseur

Priključki z majhnim premerom za tekočine in pline za uporabo v zdravstvu - 2. del: Priključki za respiratorno uporabo

General Information

• Status: Not Published
• Public Enquiry End Date: 24-Oct-2015
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 98 - Abandoned project (Adopted Project)
• Start Date: 20-Nov-2019
• Due Date: 25-Nov-2019
• Completion Date: 20-Nov-2019
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: prEN ISO 80369-2 - Small bore connectors for liquids and gases in healthcare applications - Part 2 - Connectors for respiratory applications

Overview

The oSIST prEN ISO 80369-2:2015 standard, developed by the European Committee for Standardization (CEN) and coordinated with ISO, focuses on small-bore connectors for liquids and gases specifically designed for use in healthcare respiratory applications. This standard defines the design, dimensions, and performance requirements for connectors used in breathing systems and driving gases for medical devices and accessories conveying liquids or gases to or from patients.

The objective of ISO 80369-2 is to enhance patient safety by minimizing risks of misconnection errors, such as accidental intravenous administration of air or liquids intended for respiratory use. It sets specific parameters to ensure connectors used in respiratory applications are dimensionally incompatible with connectors in other medical fields, thereby preventing erroneous connections.

Key Topics

• Scope: Specifies small-bore connectors for ancillary port connections in breathing systems and respirable driving gases applications. It excludes requirements for the medical devices themselves, which are governed by other specific international standards.
• Connector Design and Dimensions: Detailed dimensional requirements for two types of connectors:
  • RESP-125 (R1) small-bore connectors
  • RESP-6000 (R2) small-bore connectors
• Material Requirements: Connectors must be made from medically compatible materials ensuring safety and durability.
• Performance and Testing:
  • Leakage testing via pressure decay and subatmospheric-pressure air leakage to ensure airtight connections
  • Stress cracking resistance to guarantee long-term durability
  • Resistance to separation from axial load, unscrewing, and overriding to avoid accidental disconnection during clinical use
• Risk Reduction: Designed incompatibilities prevent misconnections with connectors from other medical applications (e.g., intravenous, neuraxial).
• Supplementary Annexes: Provide rationale, usability requirements, design assessments, and correlation with essential principles and EU medical device directives.

Applications

This standard applies to small-bore connectors used in respiratory healthcare settings including:

• Breathing circuits for anesthesia and intensive care
• Ventilators and respiratory support devices
• Delivery systems providing driving gases for medical devices
• Ancillary port connections on respiratory medical accessories

By adopting ISO 80369-2 compliant connectors, manufacturers and healthcare providers can:

• Enhance patient safety by preventing accidental misconnections
• Improve interoperability and compatibility of respiratory devices and accessories
• Maintain compliance with international safety regulations and directives, such as the EU Medical Devices Directive (93/42/EEC)
• Facilitate standardization of respiratory medical equipment and components worldwide

Related Standards

ISO 80369-2 is part of the broader ISO 80369 series, which addresses small-bore connectors in various healthcare applications to reduce medical errors caused by misconnection. Related parts include:

• ISO 80369-1: General requirements for small-bore connectors
• ISO 80369-3: Connectors for enteral feeding
• ISO 80369-6: Connectors for neuraxial applications
• ISO 80369-20: Common test methods for small-bore connectors

Its normative references include other important medical connector and breathing system standards, such as:

• ISO 5356 (Connectors for anesthesia and respiratory use)
• ISO 8185 (Respiratory tract connectors)
• Related ASTM standards for material testing

Summary

Adhering to oSIST prEN ISO 80369-2:2015 is crucial for manufacturers aiming to produce safe, reliable respiratory connectors that comply with international healthcare safety mandates. It ensures standardized design and testing methods that directly contribute to reducing the risk of medical complications due to misconnections of respiratory devices. Healthcare providers benefit from enhanced clinical safety and improved device compatibility, making this standard a key reference in respiratory care equipment manufacturing and quality management.

Standards Content (Sample)

SLOVENSKI STANDARD
01-oktober-2015
3ULNOMXþNL]PDMKQLPSUHPHURP]DWHNRþLQHLQSOLQH]DXSRUDERY]GUDYVWYXGHO
3ULNOMXþNL]DUHVSLUDWRUQRXSRUDER
Small bore connectors for liquids and gases in healthcare applications - Part 2 -
Connectors for respiratory applications
Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in
medizinischen Anwendungen - Teil 2: Verbindungsstücke für respiratorische
Anwendungen
Joints de petite dimension pour liquides et gaz pour des applications en santé - Partie 2 :
Joints pour systèmes respiratoires et applications au gaz propulseur
Ta slovenski standard je istoveten z: prEN ISO 80369-2
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT INTERNATIONAL STANDARD ISO/DIS 80369-2
ISO/TC 210 Secretariat: ANSI
Voting begins on Voting terminates on
2015-07-30 2015-10-30
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION  МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ  ORGANISATION INTERNATIONALE DE NORMALISATION
INTERNATIONAL ELECTROTECHNICAL COMMISSION   МЕЖДУНАРОДНАЯ ЭЛЕКТРОТЕХНИЧЕСКАЯ КОММИСИЯ   COMMISSION ÉLECTROTECHNIQUE
INTERNATIONALE
Small bore connectors for liquids and gases in healthcare
applications —
Part 2:
Connectors for breathing systems and driving gases applications
Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé —
Partie 2: Raccords destinés à des systèmes respiratoires et applications au gaz propulseur

ICS 11.040.10; 11.040.20
This draft is submitted to a parallel enquiry in ISO and a CDV vote in the IEC.

ISO/CEN PARALLEL PROCESSING
This final draft has been developed within the European Committee for Standardization (CEN), and
processed under the CEN-lead mode of collaboration as defined in the Vienna Agreement. The final draft
was established on the basis of comments received during a parallel enquiry on the draft.
This final draft is hereby submitted to the ISO member bodies and to the CEN member bodies for a parallel
two-month approval vote in ISO and two-month formal vote in CEN.
Positive votes shall not be accompanied by comments.
Negative votes shall be accompanied by the relevant technical reasons.

To expedite distribution, this document is circulated as received from the committee
secretariat. ISO Central Secretariat work of editing and text composition will be undertaken at
publication stage.
Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du
secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au
Secrétariat central de l'ISO au stade de publication.

THIS DOCUMENT IS A DRAFT CIRCULATED 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 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 NATIONAL REGULATIONS.
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.
©  International Organization for Standardization, 2015

ISO/DIS 80369-2
©  ISO 2015
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.
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ii © ISO 2015 – All rights reserved

1 Contents
2 1 Scope . 9
3 2 Normative references . 9
4 3 Terms and definitions. 10
5 4 General requirements . 11
6 4.1 General requirements for the respiratory APPLICATION . 11
7 4.2 Material used for SMALL-BORE CONNECTORS . 12
8 5 Dimensional requirements for SMALL-BORE CONNECTORS for the respiratory APPLICATION . 12
9 5.1 RESP-125 (R1) SMALL-BORE CONNECTORS . 12
10 5.2 RESP-6000 (R2) SMALL-BORE CONNECTORS . 13
11 6 Performance requirements . 13
12 6.1 General performance requirements . 13
13 6.2 Leakage by pressure decay . 13
14 6.3 Subatmospheric-pressure air leakage . 13
15 6.4 Stress cracking . 13
16 6.5 Resistance to separation from axial load . 14
17 6.6 Resistance to separation from unscrewing . 14
18 6.7 Resistance to overriding . 14
19 6.8 Disconnection by unscrewing . 14
20 Annex A (informative) Rationale and guidance . 15
21 Annex B (normative) SMALL-BORE CONNECTORS for BREATHING SYSTEMS and driving gases for
22 respiratory use . 16
23 ANNEX C (normative) Reference CONNECTORS for testing SMALL-BORE CONNECTORS for neuraxial
24 APPLICATIONS . 24
25 Annex D (informative) Assessment of MEDICAL DEVICES and their attributes with CONNECTIONS within
26 this APPLICATION . 38
27 ANNEX E (informative) Summary of the usability requirements for SMALL-BORE CONNECTORS for
28 BREATHING SYSTEMS and driving gases for respiratory use . 42
29 Annex F (informative) Summary of SMALL-BORE CONNECTOR criteria and requirements for
30 BREATHING SYSTEMS and driving gases for respiratory use APPLICATIONS . 44
31 Annex G (informative) Summary of assessment of the design of the SMALL-BORE CONNECTORS for
32 BREATHING SYSTEMS and driving gases for respiratory use . 49
33 Annex H (informative) Reference to the Essential Principles . 52
34 Table H.1 — Correspondence between this document and the essential principles (1 of 2) . 52
35 Annex I (informative) Terminology — alphabetized index of defined terms . 54
36 Annex ZA (informative) Relationship between this document and the Essential Requirements of
37 EU Directive 93/42/EEC . 56

ISO 80369-2:2015(E)
4 © ISO 2015 – All rights reserved

ISO 80369-2:2015(E)
39 Foreword
40 ISO (the International Organization for Standardization) is a worldwide federation of national standards
41 bodies (ISO member bodies). The work of preparing International Standards is normally carried out
42 through ISO technical committees. Each member body interested in a subject for which a technical
43 committee has been established has the right to be represented on that committee. International
44 organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO
45 collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
46 electrotechnical standardization.
47 The procedures used to develop this document and those intended for its further maintenance are
48 described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
49 different types of ISO documents should be noted. This document was drafted in accordance with the
50 editorial rules of the ISO/IEC Directives, Part 2. www.iso.org/directives
51 Attention is drawn to the possibility that some of the elements of this document may be the subject of
52 patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any
53 patent rights identified during the development of the document will be in the Introduction and/or on
54 the ISO list of patent declarations received. www.iso.org/patents
55 Any trade name used in this document is information given for the convenience of users and does not
56 constitute an endorsement.
57 For an explanation on the meaning of ISO specific terms and expressions related to conformity
58 assessment, as well as information about ISO's adherence to the WTO principles in the Technical Barriers
59 to Trade (TBT) see the following URL: Foreword - Supplementary information
60 ISO 80369-2 was prepared by a Joint Working Group of Technical Committee ISO/TC 210, Quality
61 management and corresponding general aspects for medical devices, IEC/TC 62, Electrical equipment,
62 Subcommittee SC 62D, Electrical equipment in medical practice and CEN/CENELEC TC3/WG 2, Small-bore
63 connectors.
64 This is the first edition of ISO 80369-2.
65 ISO 80369 consists of the following parts, under the general title Small-bore connectors for liquids and
66 gases in healthcare applications:
67  Part 1: General requirements
68  Part 2: Connectors for breathing systems and driving gases applications (this standard)
69  Part 3: Connectors for enteral applications
70  Part 4: Connectors for urethral and urinary applications
71  Part 5: Connectors for limb cuff inflation applications

Planned but not yet begun as of the date of publication.
ISO 80369-2:2015(E)
72  Part 6: Connectors for neuraxial applications
73  Part 7: Connectors with 6% (Luer) taper for intravascular or hypodermic applications
74  Part 20: Common test methods
75 In this standard, the following print types are used:
76  Requirements and definitions: roman type.
77  Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
78 Normative text of tables is also in a smaller type.
79  TERMS DEFINED IN CLAUSE 3 OF THIS STANDARD OR AS NOTED: SMALL CAPITALS.
80 In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination
81 of the conditions is true.
82 The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives,
83 Part 2. For the purposes of this standard, the auxiliary verb:
84  “shall” means that compliance with a requirement or a test is mandatory for compliance with this
85 standard;
86  “should” means that compliance with a requirement or a test is recommended but is not mandatory
87 for compliance with this standard;
88  “may” is used to describe a permissible way to achieve compliance with a requirement or test.
89 An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates
90 that there is guidance or rationale related to that item in Annex A.
91 The attention of Member Bodies and National Committees is drawn to the fact that equipment
92 manufacturers and testing organizations may need a transitional period following publication of a new,
93 amended or revised ISO or IEC publication in which to make products in accordance with the new
94 requirements and to equip themselves for conducting new or revised tests. It is the recommendation of
95 the committees that the content of this publication be adopted for implementation nationally not earlier
96 than 3 years from the date of publication for equipment newly designed and not earlier than 5 years from
97 the date of publication for equipment already in production.
6 © ISO 2015 – All rights reserved

ISO 80369-2:2015(E)
98 European Foreword
99 The following referenced documents are indispensable for the application of this document. For undated
100 references, the latest edition of the referenced document (including any amendments) applies. For dated
101 references, only the edition cited applies. However, for any use of this standard “within the meaning of
102 Annex ZA", the user should always check that any referenced document has not been superseded and that
103 its relevant contents can still be considered the generally acknowledged state-of-art.
104 When the ISO or IEC standard is referred to in the ISO text standard, this must be understood as a
105 normative reference to the parallel EN standard or dated ISO standard, as outlined below, including the
106 foreword and the Annexes ZZ.
107 NOTE The way in which these references documents are cited in normative requirements determines the extent (in whole or
108 in part) to which they apply.
109 Table – Correlations between normative references and dated EN and ISO/IEC standards
Equivalent dated standard
Normative references as listed
in Clause 2
EN ISO/IEC
ISO 5356-1:2004 EN 5356-1:2004 ISO 5356-1:2004
ISO 5356-1:2015 ISO 5356-1:2015
EN 5356-1:—
ISO 5356-2:2006 EN 5356-2:2007 ISO 5356-2:2006
ISO 5356-2:2012 EN 5356-2:2012 ISO 5356-2:2012
ISO 8185:2007 EN 8185:2009 ISO 8185:2007
EN 13544-2:2002 EN 13544-2:2002 —
EN 13544-2:2002+A1:2009 EN 13544-2:2002+A1:2009 —
ISO 80369-1:2010 EN 80369-1:2010 ISO 80369-1:2010
2 2 2
ISO 80369-3:2015 EN 80369-3:— ISO 80369-3:2015
ISO 80369-20:2015 ISO 80369-20:2015
EN 80369-20:—
ASTM D638-10 — —
ASTM D790-10 — —
To be published.
ISO 80369-2:2015(E)
111 Introduction
112 This International Standard was developed because of several incidents, with catastrophic consequences,
113 resultant from inappropriate medication, liquid nutritional formula or air being administered
114 intravenously. Many incidents have been reported leading to international recognition of the importance
115 of these issues, and a need has been identified to develop specific CONNECTORS for MEDICAL DEVICES and
116 their ACCESSORIES used to deliver fluids in other APPLICATIONS.
117 The ISO 80369 series was developed to prevent misconnection between SMALL-BORE CONNECTORS used in
118 different APPLICATIONS. Part 1 specifies the requirements necessary to verify the designs and dimensions
119 of SMALL-BORE CONNECTORS to ensure that:
120 a) they do not misconnect with other SMALL-BORE CONNECTORS; and
121 b) they safely and securely connect with their mating half.
122 Part 20 contains the common TEST METHODS to support the performance requirements for SMALL-BORE
123 CONNECTORS.
124 This part of ISO 80369 specifies the design, the dimensions and the drawings of SMALL-BORE CONNECTORS
125 intended for use as an ancillary port CONNECTION in a BREATHING SYSTEM and respirable driving gases
126 APPLICATIONS. The informative Annex D through Annex G describe the methods by which this design has
127 been assessed. Other parts of ISO 80369 include requirements for SMALL-BORE CONNECTORS used in
128 different APPLICATION categories.
129 CONNECTORS manufactured to the dimensions set out within this International Standard are dimensionally
130 incompatible with any of the other CONNECTORS for APPLICATIONS identified in the ISO 80369 series of
131 standards for SMALL-BORE CONNECTORS, except as indicated in Annex G. If fitted to the relevant MEDICAL
132 DEVICES and ACCESSORIES, these CONNECTORS should reduce the RISK of air, non-vascular medication and
133 liquid nutritional formula being delivered via an alternative route, such as intravenously or via an airway
134 device.
8 © ISO 2015 – All rights reserved

ISO 80369-2:2015(E)
136 Small-bore connectors for liquids and gases in healthcare
137 applications — Part 2: Connectors for breathing systems and
138 driving gases applications
139 1 * Scope
140 This part of ISO 80369 specifies dimensions and requirements for the design and functional performance
141 of SMALL-BORE CONNECTORS intended to be used for CONNECTIONS either as an ancillary port CONNECTION in
142 the BREATHING SYSTEM or in the respirable driving gas APPLICATIONS of MEDICAL DEVICES and ACCESSORIES.
143 This part of ISO 80369 does not specify requirements for the MEDICAL DEVICES or ACCESSORIES that use these
144 CONNECTORS. Such requirements are given in particular International Standards for specific MEDICAL
145 DEVICES or ACCESSORIES.
146 This part of ISO 80369 does not specify requirements for pressurizing and depressurizing the retention
147 mechanism (e.g. balloon) used to hold invasive respiratory MEDICAL DEVICES in place.
148 NOTE 1 MANUFACTURERS are encouraged to incorporate the SMALL-BORE CONNECTORS specified in this part of
149 ISO 80369 into MEDICAL DEVICES, medical systems or ACCESSORIES, even if currently not required by the relevant
150 particular MEDICAL DEVICE standards. It is expected that when the relevant particular MEDICAL DEVICE standards are
151 revised, requirements for SMALL-BORE CONNECTORS, as specified in this part of ISO 80369, will be included.
152 Furthermore, it is recognised that standards need to be developed for many MEDICAL DEVICES used for the BREATHING
153 SYSTEM and respirable driving gas APPLICATIONS.
154 NOTE 2 ISO 80369-1:2010, 5.8, specifies alternative methods of compliance with ISO 80369-1:2010, for SMALL-
155 BORE CONNECTORS intended for use as an ancillary port CONNECTION in the BREATHING SYSTEM or in the respirable driving
156 gas APPLICATIONS of MEDICAL DEVICES or ACCESSORIES, which do not comply with this part of ISO 80369.
157 2 Normative references
158 The following documents, in whole or in part, are normatively referenced in this document and are
159 indispensable for the application of this document. For dated references, only the edition cited applies.
160 For undated references, the latest edition of the referenced document (including any amendments)
161 applies.
162 NOTE 1 The way in which these referenced documents are cited in normative requirements determines the
163 extent (in whole or in part) to which they apply.
164 NOTE 2 Informative references are listed in the bibliography on page 58.
165 ISO 5356-1:2004, Anaesthetic and respiratory equipment -- Conical connectors -- Part 1: Cones and socket
166 ISO 5356-1:2015 , Anaesthetic and respiratory equipment -- Conical connectors -- Part 1: Cones and socket
167 ISO 5356-2:2006, Anaesthetic and respiratory equipment -- Conical connectors -- Part 2: Screw-threaded
168 weight-bearing connectors
Both the current and previous versions of this standard are normatively referenced.
ISO 80369-2:2015(E)
169 ISO 5356-2:2012 , Anaesthetic and respiratory equipment -- Conical connectors -- Part 2: Screw-threaded
170 weight-bearing connectors
171 ISO 8185:2007, Respiratory tract humidifiers for medical use -- Particular requirements for respiratory
172 humidification systems
173 EN 13544-2:2002, Respiratory therapy equipment - Part 1: Nebulizing systems and their components
174 EN 13544-2:2002, Respiratory therapy equipment - Part 1: Nebulizing systems and their components
175 Amendment 1:2009
176 ISO 80369-1:2010, Small-bore connectors for liquids and gases in healthcare applications — Part 1: General
177 requirements
6)
178 ISO 80369-3:2015 , Small-bore connectors for liquids and gases in healthcare applications — Part 3:
179 Connectors for enteral applications
7)
180 ISO 80369-6:2015 , Small-bore connectors for liquids and gases in healthcare applications — Part 7:
181 Connectors for neuraxial applications
182 ISO 80369-20:2015, Small-bore connectors for liquids and gases in healthcare applications — Part 20:
183 Common test methods
184 ASTM D638-10, Standard test method for tensile properties of plastics
185 ASTM D790-10, Standard test methods for flexural properties of unreinforced and reinforced plastics and
186 electrical insulating materials
187 3 Terms and definitions
188 For the purposes of this document, the terms and definitions specified in ISO 80369-1:2010,
189 ISO 80369-7:2015, ISO 80369-20:2015, ISO 14971:2007 and the following apply. For convenience, the
190 sources of all defined terms used in this document are given in Annex I.
191 3.1
192 MEDICAL GAS PIPELINE SYSTEM
193 complete system which comprises a supply system, a monitoring and alarm system and a distribution
194 system with terminal units at the points where medical gases or vacuum are required
195 [SOURCE: ISO 7396-1:2007, definition 3.29]

Both the current and previous versions of this standard are normatively referenced.
Both the current and previous versions of this standard are normatively referenced.
6)
To be published.
7)
To be published.
10 © ISO 2015 – All rights reserved

ISO 80369-2:2015(E)
196 3.2
197 NORMAL USE
198 operation, including routine inspection and adjustments by any USER, and stand-by, according to the
199 instructions for use
200 NOTE 1 to entry: NORMAL USE should not be confused with INTENDED USE. While both include the concept of use as
201 intended by the MANUFACTURER, INTENDED USE focuses on the medical purpose while NORMAL USE incorporates not only
202 the medical purpose, but maintenance, service, transport, etc. as well.
203 [SOURCE: IEC 60601-1:2005+A1:2012, definition 3.97, modified, replaced ‘OPERATOR’ with ‘USER’.]
204 3.3
205 RATED
206 term referring to a value assigned by the MANUFACTURER for a specified operating condition
207 [SOURCE: IEC 60601-1:2005, definition 3.97]
208 3.4
209 USER
210 person interacting with (i.e. operating or handling) the MEDICAL DEVICE
211 Note 1 to entry: There can be more than one USER of a MEDICAL DEVICE.
212 Note 2 to entry: Common USERS include clinicians, PATIENTS, cleaners, maintenance and service personnel.
213 [SOURCE: IEC 62366-1:2015, definition 3.24]
214 3.5
215 USER PROFILE
216 summary of the mental, physical and demographic traits of an intended USER group, as well as any special
217 characteristics, such as occupational skills, job requirements and working conditions, which can have a
218 bearing on design decisions
219 [SOURCE: IEC 62366-1:2015, definition 3.29]
220 4 General requirements
221 4.1 General requirements for the respiratory APPLICATION
222 SMALL-BORE CONNECTORS made in compliance with this standard comply with the general requirements of
223 ISO 80369-1:2010 unless otherwise indicated in this standard.
224 Because the following CONNECTORS are inadequately specified, RESP-125 and RESP-6000 SMALL-BORE
225 CONNECTORS should not, but may connect with:
226  the cones and sockets of ISO 5356-1:2004, ISO 5356-1:2015, ISO 5356-2:2006 and ISO 5356-2:2012;
227  the temperature sensor CONNECTOR and mating ports made in compliance with Annex DD of
228 ISO 8185:2007; and
229  the nipples of EN 13544-2:2002 and EN 13544-2:2002+A1:2009.
230 The reference CONNECTORS for evaluation of the NON-INTERCONNECTABLE characteristics are described in
231 Annex C.
ISO 80369-2:2015(E)
232 Where the design of a CONNECTOR of this standard relies on dimensions or features of the MEDICAL DEVICE
233 or ACCESSORY to ensure NON-INTERCONNECTABLE characteristics, the NON-INTERCONNECTABLE characteristics
234 of the CONNECTOR shall be VERIFIED.
235 Check compliance by applying the tests of ISO 80369-1:2010, 5.1, and ISO 80369-1:2010, Annex B.
236 Compliance also may be shown by applying a computer aided design (CAD) analysis of the dimensions of
237 all of the ISO 80369 series SMALL BORE CONNECTORS and the SMALL BORE CONNECTOR under test, in
238 conjunction with physical testing of the SMALL BORE CONNECTOR per Annex B where the CAD analysis does
239 not demonstrate the NON-INTERCONNECTABLE characteristics. When necessary, the SMALL-BORE CONNECTOR
240 may be installed on the MEDICAL DEVICE or ACCESSORY to demonstrate compliance with the NON-
241 INTERCONNECTABLE characteristics test requirements of ISO 80369-1:2010, Annex B.
242 NOTE 1 MEDICAL DEVICES using the SMALL-BORE CONNECTORS of this standard that do not rely on the dimensions or
243 features of the MEDICAL DEVICE or ACCESSORY to ensure NON-INTERCONNECTABLE characteristics are presumed to comply
244 with the NON-INTERCONNECTABLE characteristics test requirements of this standard.
245 NOTE 2 The summary of MEDICAL DEVICES and their attributes with CONNECTIONS within this APPLICATION is
246 provided in informative Annex D.
247 NOTE 3 The summary of the usability requirements for CONNECTORS for this APPLICATION is provided in
248 informative Annex E.
249 NOTE 4 The summary of criteria and requirements for CONNECTORS for this APPLICATION is provided in informative
250 Annex F.
251 NOTE 5 The summary of assessment of the design of CONNECTORS for this APPLICATION according to ISO 80369-
252 1:2010, Clause 7, is contained in informative Annex G.
253 4.2 Material used for SMALL-BORE CONNECTORS
254 In addition to the requirements of ISO 80369-1:2010, Clause 4, RESP-125 and RESP-6000 SMALL-BORE
255 CONNECTORS shall be made of materials with a nominal modulus of elasticity either in flexure or in tension
256 greater than 700 MPa.
257 Check compliance by application of the tests of ASTM D638-10 or ASTM D790-10.
258 4.3 TYPE TESTS
259 Compliance with the requirements of this International Standard shall be determined by TYPE TESTS.
260 5 SMALL-BORE CONNECTORS for the respiratory APPLICATION
261 5.1 Dimensional requirements for RESP-125 SMALL-BORE CONNECTORS (R1)
262 SMALL-BORE CONNECTORS intended for use in this APPLICATION at pressures less than 150 hPa (15 kPa) above
263 ambient shall comply with the relevant dimensions and tolerances as given in
264  Figure B.1 and Table B.1 for the male RESP-125 CONNECTOR (R1).
265  Figure B.2 and Table B.2 for the female -125 CONNECTOR (R1).
266 Check compliance by confirming the relevant dimensions and tolerances specified in Annex B.
12 © ISO 2015 – All rights reserved

ISO 80369-2:2015(E)
267 5.2 Dimensional requirements for RESP-6000 SMALL-BORE CONNECTORS (R2)
268 SMALL-BORE CONNECTORS intended to be used to convey air or oxygen from one MEDICAL DEVICE or ACCESSORY
269 to another in driving gas APPLICATIONS for respiratory use at pressures between 15 kPa and 600 kPa above
270 ambient shall comply with the relevant dimensions and tolerances given in
271  Figure B.3 and Table B.3 for a male RESP-6000 CONNECTOR (R2).
272  Figure B.4 and Table B.4 for a female RESP-6000 CONNECTOR (R2).
273 Check compliance by confirming the relevant dimensions and tolerances specified in Annex B.
274 6 Performance requirements
275 6.1 * Leakage by pressure decay
276 RESP-125 and RESP-6000 SMALL-BORE CONNECTORS shall be evaluated for fluid leakage using the leakage
277 by pressure decay TEST METHOD. When tested over a hold period between 30 s and 35 s using air as the
278 medium, the leakage flowrate of
279  a RESP-125 (R1) SMALL-BORE CONNECTOR shall not exceed 0,005 Pa•m /s while being subjected to an
280 applied pressure of between 12.5 kPa and 15,0 kPa.
281  a RESP-6000 (R2) SMALL-BORE CONNECTOR shall not exceed 0,005 Pa•m /s while being subjected to an
282 applied pressure of between 1 000 kPa and 1 050 kPa.
283 MANUFACTURERS may use a greater applied pressure or a longer hold period.
284 Check for compliance by applying the tests of ISO 80369-20:2015, Annex B, while using the leakage
285 reference CONNECTOR specified in Annex C.
286 6.2 Subatmospheric pressure air leakage
287 RESP-125 and RESP-6000 SMALL-BORE CONNECTORS shall be evaluated for subatmospheric pressure air
288 leakage. These SMALL-BORE CONNECTORS shall not leak by more than 0,005 Pa·m /s while being subjected
289 to an applied subatmospheric pressure of
290  between 3,0 kPa and 5,0 kPa over a hold period of between 25 s and 35 s for a RESP-125 (R1)
291 CONNECTOR.
292  between 35,0 kPa and 45,0 kPa over a hold period of between 20 s and 30 s for a RESP-6000 (R2)
293 CONNECTOR.
294 MANUFACTURERS may use a greater applied subatmospheric pressure.
295 Check compliance by applying the tests of ISO 80369-20:2015, Annex D, while using the stress cracking
296 reference CONNECTOR specified in Annex C.
297 6.3 Stress cracking
298 RESP-125 and RESP-6000 SMALL-BORE CONNECTORS shall be evaluated for stress cracking. These SMALL-
299 BORE CONNECTORS shall meet the requirements of 6.1 after being subjected to stresses of ISO 80369-
300 20:2015, Annex E.
ISO 80369-2:2015(E)
301 Check compliance by applying the tests of ISO 80369-20: 2015, Annex E, while using the stress cracking
302 reference CONNECTOR specified in Annex C.
303 6.4 Resistance to separation from axial load
304 RESP-125 and RESP-6000 SMALL-BORE CONNECTORS shall be evaluated for separation from axial load. These
305 SMALL-BORE CONNECTORS shall not separate from the reference CONNECTOR over a hold period between 10 s
306 and 15 s while being subjected to a disconnection applied axial force between 32 N and 35 N.
307 MANUFACTURERS may use a greater disconnection applied axial force or a longer hold period.
308 Check compliance by applying the tests of ISO 80369-20:2015, Annex F, while using the separation from
309 axial load reference CONNECTOR specified in Annex C.
310 6.5 Resistance to separation from unscrewing
311 RESP-125 and RESP-6000 SMALL-BORE CONNECTORS shall be evaluated for separation from unscrewing.
312 These CONNECTORS shall not separate from the reference CONNECTOR for a hold period between 10 s and
313 15 s while being subjected to an unscrewing torque of between 0,0198 N･m to 0,02 N･m. MANUFACTURERS
314 may use a greater applied unscrewing torque or a longer hold period.
315 Check compliance by applying the tests of ISO 80369-20:2015, Annex G, while using the separation from
316 axial load reference CONNECTOR specified in Annex C.
317 6.6 Resistance to overriding
318 RESP-125 and RESP-6000 SMALL-BORE CONNECTORS shall be evaluated for resistance to overriding. These
319 SMALL-BORE CONNECTORS shall not override the threads or lugs of the reference CONNECTOR while being
320 subjected to an applied torque of
321  between 0,15 N･m to 0,17 N･m over a hold period between 5 s and 10 s for a RESP-125 (R1)
322 CONNECTOR.
323  between 0,22 N･m to 0,25 N･m over a hold period between 5 s and 10 s for a RESP-6000 (R2)
324 CONNECTOR.
325 MANUFACTURERS may use a greater applied torque or a longer hold period.
326 Check compliance by applying the tests of ISO 80369-20:2015, Annex H, while using the separation from
327 axial load reference CONNECTOR specified in Annex C.
328 6.7 Disconnection by unscrewing
329 RESP-125 and RESP-6000 SMALL-BORE CONNECTORS shall be evaluated for disconnection by unscrewing.
330 These SMALL-BORE CONNECTOR shall separate from the reference CONNECTOR with an applied unscrewing
331 torque of no greater than 0,35 N･m.
332 Check compliance by applying the tests of ISO 80369-20:2015, Annex I, while using the disconnection by
333 unscrewing reference CONNECTOR specified in Annex C.
14 © ISO 2015 – All rights reserved

ISO 80369-2:2015(E)
335 Annex A
336 (informative)
338 Rationale and guidance
339 A.1 General guidance
340 This Annex provides a rationale for some requirements of ISO 80369-2, and is intended for those who are
341 familiar with the subject of ISO 80369-2 but who have not participated in its development. An
342 understanding of the rationale underlying these requirements is considered to be essential for their
343 proper application. Furthermore, as clinical practice and technology change, it is believed that a rationale
344 for the present requirements will facilitate any revision of this document necessitated by those
345 developments.
346 A.2 Rationale for particular clauses and subclauses
347 The clauses and subclauses in this Annex have been numbered to correspond to the numbering of the
348 clauses and subclauses of this document to which they refer. The numbering is, therefore, not
349 consecutive.
350 Clause 1 Scope
351 In 2000, a Task Group of the European standards organisation CEN proposed a strategy to reduce
352 incidents of accidental misconnection of PATIENT therapy lines by the use of a series of NON-
353 INTERCONNECTABLE CONNECTORS, differentiated by design, for use in different medical APPLICATIONS. The
354 strategy reserves the use of LUER CONNECTORS solely for use in MEDICAL DEVICES used to access the vascular
355 system or for hypodermic syringes so that they can achieve their intended function. [7]  The CONNECTORS
356 of this standard are reserved for use as an ancillary port CONNECTION in the BREATHING SYSTEM or to be used
357 for a respirable gas of MEDICAL DEVICES and ACCESSORIES intended for use with a PATIENT.
358 MANUFACTURERS and RESPONSIBLE ORGANIZATIONS are encouraged to report their experience with the SMALL-
359 BORE CONNECTORS specified in this part of ISO 80369 to the Secretariat of ISO/TC 210, so that it can
360 consider this feedback during the revision of the relevant part of this series of International Standards.
361 Subclause 6.1 Air leakage
362 The test pressures chosen are the worst-case pressures that could be generated under a SINGLE FAULT
363 CONDITION for a BREATHING SYSTEM for the RESP-125 (R1) CONNECTOR and for a MEDICAL GAS PIPELINE SYSTEM
364 for the RESP-6000 (R2) CONNECTOR.
Figures in square brackets refer to the Bibliography.
ISO 80369-2:2015(E)
367 Annex B
368 (normative)
370 SMALL-BORE CONNECTORS for BREATHING SYSTEMS and gases for respiratory use
372 Table B.1 contains the dimensions for this figure. The male CONNECTOR shows a permanently connected
373 internally threaded lock fitting. A rotatable internally threaded lock fitting may be used.
374 Figure B.1 — Male RESP-125 SMALL-BORE CONNECTOR (R1)
16 © ISO 2015 – All rights reserved

ISO 80369-2:2015(E)
375 Table B.1 — Male RESP-125 SMALL-BORE CONNECTOR dimensions (R1)
376 Dimensions in mm unless otherwise indicated
RESP-125 Male CONNECTOR (R1)
Dimension
Reference Designation
Minimum Nominal Maximum
a1 Angle of the sealing cone, degrees 58,0° 60,0° 62,0°
a2 Angle of the draft allowance, degrees — 0,50° 1,00°
b2 Thread angle, degrees 26,5° 27,5° 28,5°
c Protrusion of the male post geometry face from the face of grip 0,635 0,762 0,889
Ød Outside diameter at the tip of the male post geometry 3,505 3,556 3,607
e Depth of the male post geometry 5,715 5,842 —
Øf Inside diameter at the entrance face of the fluid lumen — 1,950 2,900
g Depth to base of the sealing cone 1,120 1,166 1,214
Major inside thread diameter of the male lock CONNECTOR
9,039 9,166 9,293
Øh
(diameter at thread crest)
Minor inside thread diameter of the male lock CONNECTOR,
Øj 7,747 7,874 8,001
(diameter at thread root)
m Width of the thread form at the crest of a male lock CONNECTOR 0,229 0,305 0,381
n Width of the thread form at the root of male lock CONNECTOR 0,873 0,977 1,083
Nominal pitch of double-start, right-hand thread of male lock
p 1,461 1,588 1,715
CONNECTOR
Thread length from open end of the grip 5,080 — —
s2
Inner diameter of the fluid lumen — 1,950 —
Øu
Thread lead, mm per 360° revolution; (right-hand trapezoidal
v2 2,973 3,176 3,379
thread is double start)
Outside diameter of the smallest cylinder that encompasses the
Øw 11,811 12,065 12,319
outside surfaces of the external features of the collar
Øx2 Diameter at the base of the sealing cone at g 4,851 4,902 4,953
ISO 80369-2:2015(E)
378 Table B.2 contains the dimensions for this figure.
379 Figure B.2 — Female RESP-125 SMALL-BORE CONNECTOR (R1)
18 © ISO 2015 – All rights reserved

ISO 80369-2:2015(E)
380 Table B.2 — Female RESP-125 SMALL-BORE CONNECTOR dimensions (R1)
381 Dimensions in mm unless otherwise indicated
RESP-125 Female CONNECTOR (R1)
Dimension
Reference Designation
Minimum Nominal Maximum
A1 Angle of the sealing cone, degrees 58,0° 60,0° 62,0°
A2 Angle of the draft allowance, degrees — 0,50° 1,00°
B2 Thread angle, degrees 26,5° 27,5° 28,5°
ØD Inside diameter at the open end of the female socket geometry 5,060 5,105 5,150
E Depth of the female socket geometry 5,207 5,334 5,461
ØF Inside diameter at the entrance face of the fluid lumen — 1,950 2,900
G Depth to the base of the sealing cone 3,446 3,607 3,766
Major outside thread diameter of the female lock CONNECTOR,
8,659 8,786 8,913
ØH
(diameter at thread root)
Minor outside thread diameter of the female lock CONNECTOR,
ØJ 7,137 7,264 7,391
(diameter at thread crest)
Width between the open thread form at the crest of the female
K2 1,063 1,173 1,283
lock CONNECTOR
Nominal pitch of double-start, right-hand thread of the female
P 1,461 1,588 1,715
lock CONNECTOR
Width between the open thread form at the root of the female
Q2 0,305 0,381 0,457
lock CONNECTOR
S2 Thread length from open end of the female taper 2,670 — —
Distance from the CONNECTOR face to the beginning of the grip
2,413 2,540 2,667
T
geometry
ØU Inner diameter of the fluid lumen — 1,950 —
Thread lead, mm per 360° revolution; (right-hand trapezoidal
V2 2,973 3,176 3,379
thread is double start)
Diameter of the smallest cylinder that encompasses the outside
ØW 11,811 12,065 12,319
surfaces of the external features of the collar
ISO 80369-2:2015(E)
384 Table B.3 contains the dimensions for this figure. The male CONNECTOR shows a permanently connected
385 internally threaded lock fitting. A rotatable internally threaded lock fitting may be used.
386 Figure B.3 — Male RESP-6000 SMALL-BORE CONNECTOR (R2)
20 © ISO 2015 – All rights reserved

ISO 80369-2:2015(E)
388 Table B.3 — Male RESP-6000 SMALL-BORE CONNECTOR dimensions (R2)
389 Dimensions in mm unless otherwise indicated
RESP-6000 Male CONNECTOR (R2)
Dimension
Reference Designation
Minimum Nominal Maximum
a Angle of taper, (6% taper nominal) (degrees, reference) 3,35° 3,44° 3,52°
Angle of internal thread non-bearing surface against separation
b2 with the plane perpendicular to the axis of a male lock 24,0° 25,0° 26,0°
CONNECTOR, (degrees)
Ød Outside diameter at the tip of the male taper 7,764 7,815 7,866
e Length of male taper 7,366 7,493 7,620
Øf Inside diameter at the tip of the male taper 5,000 5,155 5,309
Front of grip to interior base of thread/male taper 7,493 7,620 7,747
g2
Major inside thread diameter of the male lock CONNECTOR
11,557 11,684 11,811
Øh
(diameter at thread root)
Minor inside thread diameter of the male lock CONNECTOR,
Øj 10,257 10,384 10,511
(diameter at thread crest)
Width of the thread form at the root of a male lock CONNECTOR
(k2) 1,926 1,956 1,986
(reference)
Length of engagement (reference) 2,916 4,188 5,459
(L)
m Width of the thread form at the crest of a male lock CONNECTOR 0,554 0,584 0,614
n Thread width of male lock CONNECTOR at root 1,161 1,191 1,221
Nominal pitch of double-start, right-hand thread of MALE LOCK
2,413 2,540 2,667
p
CONNECTOR – 5 mm lead
Width between thread flanks at crest (reference) 1,319 1,349 1,379
(q2)
Radius or chamfer at the tip of the male taper 0,077 0,127 0,177
r
s2 Thread length from taper base of male lock CONNECTOR 7,493 7,620 7,747
Øu Inner diameter of the fluid lumen 3,411 3,538 3,665
Thread lead (mm per 360° revolution; right-hand trapezoidal
v2 4,953 5,080 5,207
thread is double start)
Diameter of the smallest cylinder that encompasses the outside
18,340 18,606 18,872
Øw
a
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.
ISO 80369-2:2015(E)
393 Table B.4 contains the dimensions for this figure.
394 Figure B.4 — Female RESP-6000 SMALL-BORE CONNECTORS (R2)
22 © ISO 2015 – All rights reserved
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