prEN ISO 80369-2
(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 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
Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN ISO 80369-2:2015
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
oSIST prEN ISO 80369-2:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 80369-2:2015
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oSIST prEN ISO 80369-2:2015
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
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oSIST prEN ISO 80369-2:2015
ISO/DIS 80369-2
COPYRIGHT PROTECTED DOCUMENT
© 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
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Published in Switzerland
ii © ISO 2015 – All rights reserved
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oSIST prEN ISO 80369-2:2015
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
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38
4 © ISO 2015 – All rights reserved
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oSIST prEN ISO 80369-2:2015
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
1
70 Part 4: Connectors for urethral and urinary applications
71 Part 5: Connectors for limb cuff inflation applications
1
Planned but not yet begun as of the date of publication.
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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.
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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
2
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
2
ISO 80369-20:2015 ISO 80369-20:2015
EN 80369-20:—
ASTM D638-10 — —
ASTM D790-10 — —
110
2
To be published.
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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.
135
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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
3
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
3
Both the current and previous versions of this standard are normatively referenced.
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4
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
5
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]
4
Both the current and previous versions of this standard are normatively referenced.
5
Both the current and previous versions of this standard are normatively referenced.
6)
To be published.
7)
To be published.
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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.
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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.
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267 5.2 Dimensional req
...
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