Iso-Dis 80369-2 2015 (Connectors For Breathing Systems and Driving Gases Applications)

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
iTeh STANDARD PREVIEW

ICS 11.040.10; 11.040.20 (standards.iteh.ai)
ISO/DIS 80369-2
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6ea91a14e490/iso-dis-80369-2
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
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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.
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© International Organization for Standardization, 2015

ISO/DIS 80369-2

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ISO/DIS 80369-2
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© ISO 2015
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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
18
6.6
6.7
Resistance to separation from unscrewing ...................................................................................... 14
Resistance to overriding ..................................................................................................................... 14
19
20
6.8 (standards.iteh.ai)
Disconnection by unscrewing............................................................................................................ 14
Annex A (informative) Rationale and guidance ............................................................................................ 15
ISO/DIS 80369-2
21 Annex B (normative) SMALL-BORE CONNECTORS for BREATHING SYSTEMS and driving gases for
22 respiratory use ............................................................................................................................................................
6ea91a14e490/iso-dis-80369-2 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)
38

(standards.iteh.ai)
ISO/DIS 80369-2
6ea91a14e490/iso-dis-80369-2
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. (standards.iteh.ai)
57 For an explanation on the meaning of ISO specific
ISO/DIS terms and expressions related to conformity
80369-2
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
6ea91a14e490/iso-dis-80369-2
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 applications1
71  Part 5: Connectors for limb cuff inflation applications
1 Planned but not yet begun as of the date of publication.
© ISO 2015 – All rights reserved 5

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
(standards.iteh.ai)
for compliance with this standard;
88  “may” is used to describe a permissible way ISO/DIS 80369-2compliance with a requirement or test.
to achieve
89 An asterisk (*) as the first character of 6ea91a14e490/iso-dis-80369-2
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.

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
Normative references as listed Equivalent dated standard

in Clause 2 EN ISO/IEC
ISO 5356-1:2004 EN 5356-1:2004 ISO 5356-1:2004
ISO 5356-1:2015 iTeh STANDARD

EN 5356-1:— PREVIEW 2
ISO 5356-1:2015
ISO 5356-2:2006 (standards.iteh.ai)

EN 5356-2:2007 ISO 5356-2:2006
ISO 5356-2:2012 ISO/DIS 80369-2

EN 5356-2:2012 ISO 5356-2:2012
ISO 8185:2007 6ea91a14e490/iso-dis-80369-2
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
ISO 80369-3:2015 2 EN 80369-3:— 2 ISO 80369-3:2015 2
ISO 80369-20:2015 EN 80369-20:— 2 ISO 80369-20:2015
ASTM D638-10 — —
ASTM D790-10 — —
110
2 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 (standards.iteh.ai)
been assessed. Other parts of ISO 80369 include requirements for SMALL-BORE CONNECTORS used in
128 different APPLICATION categories.
ISO/DIS 80369-2
129 https://standards.iteh.ai/catalog/standards/sist/0ad90563-a425-4fc2-a16d-
CONNECTORS manufactured to the dimensions set out within this International Standard are dimensionally
6ea91a14e490/iso-dis-80369-2
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.
135

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
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. ISO/DIS 80369-2
154 NOTE 2 ISO 80369-1:2010, 5.8, specifies6ea91a14e490/iso-dis-80369-2
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 5356-1:20153, 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
3 Both the current and previous versions of this standard are normatively referenced.

ISO 80369-2:2015(E)
169 ISO 5356-2:20124, 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 1:20095
176 ISO 80369-1:2010, Small-bore connectors for liquids and gases in healthcare applications — Part 1: General
177 requirements
178 ISO 80369-3:2015 6), Small-bore connectors for liquids and gases in healthcare applications — Part 3:
179 Connectors for enteral applications
180 ISO 80369-6:2015 7), 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:
Common test methods
183
ASTM D638-10, Standard test method for tensile properties of plastics
185 ASTM D790-10, Standard test methods for flexural ISO/DISproperties

80369-2 of unreinforced and reinforced plastics and
186 electrical insulating materials
6ea91a14e490/iso-dis-80369-2
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]
6) To be published.
7) To be published.

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 <value> 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.
[SOURCE: IEC 62366-1:2015, definition 3.24]
214 3.5 ISO/DIS 80369-2

215 USER PROFILE https://standards.iteh.ai/catalog/standards/sist/0ad90563-a425-4fc2-a16d-
216 summary of the mental, physical and demographic traits of an intended USER group, as well as any special
6ea91a14e490/iso-dis-80369-2
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 iTeh STANDARD PREVIEW

The summary of criteria and requirements for CONNECTORS for this APPLICATION is provided in informative
250 Annex F.
(standards.iteh.ai)
251 NOTE 5 The summary of assessment of the design of CONNECTORS for this APPLICATION according to ISO 80369-
ISO/DIS 80369-2
252 1:2010, Clause 7, is contained in informative Annex G.
6ea91a14e490/iso-dis-80369-2
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.

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•m3/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•m3/s while being subjected to an
applied pressure of between 1 000 kPa and 1 050 kPa.
283 MANUFACTURERS may use a greater applied pressure ISO/DIS or a longer hold period.
80369-2
284 Check for compliance by applying the 6ea91a14e490/iso-dis-80369-2
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·m3/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
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
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

(standards.iteh.ai)
ISO/DIS 80369-2
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
6ea91a14e490/iso-dis-80369-2
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.
334

ISO 80369-2:2015(E)
335 Annex A
336 (informative)
337
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
(standards.iteh.ai)
351 In 2000, a Task Group of the European standards organisation CEN proposed a strategy to reduce
352 incidents of accidental misconnection of ISO/DIS PATIENT80369-2
therapy lines by the use of a series of NON-
353 INTERCONNECTABLE CONNECTORS, differentiated by design, for use in different medical APPLICATIONS. The
6ea91a14e490/iso-dis-80369-2
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] 8 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.
365
366
8 Figures in square brackets refer to the Bibliography.

Iso-Dis 80369-2 2015 (Connectors For Breathing Systems and Driving Gases Applications)

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DRAFT INTERNATIONAL STANDARD ISO/DIS 80369-2

ISO/TC 210 Secretariat: ANSI

Small bore connectors for liquids and gases in healthcare

iTeh STANDARD PREVIEW

ISO/CEN PARALLEL PROCESSING

To expedite distribution, this document is circulated as received from the committee

© International Organization for Standardization, 2015

iTeh STANDARD PREVIEW

COPYRIGHT PROTECTED DOCUMENT

ii © ISO 2015 – All rights reserved

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

9 5.1 RESP-125 (R1) SMALL-BORE CONNECTORS............................................................................................ 12

12 6.1 General performance requirements................................................................................................... 13

29 Annex F (informative) Summary of SMALL-BORE CONNECTOR criteria and requirements for

33 Annex H (informative) Reference to the Essential Principles .................................................................. 52

35 Annex I (informative) Terminology — alphabetized index of defined terms ...................................... 54

iTeh STANDARD PREVIEW

4 © ISO 2015 – All rights reserved

64 This is the first edition of ISO 80369-2.

67  Part 1: General requirements

69  Part 3: Connectors for enteral applications

70  Part 4: Connectors for urethral and urinary applications1

71  Part 5: Connectors for limb cuff inflation applications

1 Planned but not yet begun as of the date of publication.

© ISO 2015 – All rights reserved 5

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.

79  TERMS DEFINED IN CLAUSE 3 OF THIS STANDARD OR AS NOTED: SMALL CAPITALS.

6 © ISO 2015 – All rights reserved

Normative references as listed Equivalent dated standard

ISO 5356-1:2015 iTeh STANDARD

ISO 5356-2:2006 (standards.iteh.ai)

ISO 5356-2:2012 ISO/DIS 80369-2

ISO 80369-1:2010 EN 80369-1:2010 ISO 80369-1:2010

ISO 80369-3:2015 2 EN 80369-3:— 2 ISO 80369-3:2015 2

ISO 80369-20:2015 EN 80369-20:— 2 ISO 80369-20:2015

© ISO 2015 – All rights reserved 7

120 a) they do not misconnect with other SMALL-BORE CONNECTORS; and

8 © ISO 2015 – All rights reserved

136 Small-bore connectors for liquids and gases in healthcare

157 2 Normative references

© ISO 2015 – All rights reserved 9

185 ASTM D790-10, Standard test methods for flexural ISO/DISproperties

195 [SOURCE: ISO 7396-1:2007, definition 3.29]

10 © ISO 2015 – All rights reserved

207 [SOURCE: IEC 60601-1:2005, definition 3.97]

214 3.5 ISO/DIS 80369-2

219 [SOURCE: IEC 62366-1:2015, definition 3.29]

220 4 General requirements

229  the nipples of EN 13544-2:2002 and EN 13544-2:2002+A1:2009.

© ISO 2015 – All rights reserved 11

249 NOTE 4 iTeh STANDARD PREVIEW

258 4.3 TYPE TESTS

260 5 SMALL-BORE CONNECTORS for the respiratory APPLICATION

12 © ISO 2015 – All rights reserved

267 5.2 Dimensional requirements for RESP-6000 SMALL-BORE CONNECTORS (R2)

274 6 Performance requirements