oSIST prEN ISO 80369-20:2023
(Main)Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods (ISO/DIS 80369-20:2023)
Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods (ISO/DIS 80369-20:2023)
Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in medizinischen Anwendungen - Teil 20: Allgemeine Prüfverfahren (ISO/DIS 80369-20:2023)
Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé - Partie 20: Méthodes d'essai communes (ISO/DIS 80369-20:2023)
Priključki z majhnim premerom za tekočine in pline za uporabo v zdravstvu - 20. del: Splošne preskusne metode (ISO/DIS 80369-20:2023)
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Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN ISO 80369-20:2023
01-junij-2023
Nadomešča:
SIST EN ISO/IEC 80369-20:2015
Priključki z majhnim premerom za tekočine in pline za uporabo v zdravstvu - 20.
del: Splošne preskusne metode (ISO/DIS 80369-20:2023)
Small-bore connectors for liquids and gases in healthcare applications - Part 20:
Common test methods (ISO/DIS 80369-20:2023)
Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in
medizinischen Anwendungen - Teil 20: Allgemeine Prüfverfahren (ISO/DIS 80369-
20:2023)
Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé - Partie
20: Méthodes d'essai communes (ISO/DIS 80369-20:2023)
Ta slovenski standard je istoveten z: prEN ISO 80369-20
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
oSIST prEN ISO 80369-20:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 80369-20:2023
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oSIST prEN ISO 80369-20:2023
DRAFT INTERNATIONAL STANDARD
ISO/DIS 80369-20
ISO/TC 210 Secretariat: ANSI
Voting begins on: Voting terminates on:
2023-03-14 2023-06-06
Small-bore connectors for liquids and gases in healthcare
applications —
Part 20:
Common test methods
Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé —
Partie 20: Méthodes d'essai communes
ICS: 11.040.20; 11.040.10; 11.040.25
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
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oSIST prEN ISO 80369-20:2023
ISO/DIS 80369-20:2023(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 80369-20
ISO/TC 210 Secretariat: ANSI
Voting begins on: Voting terminates on:
Small-bore connectors for liquids and gases in healthcare
applications —
Part 20:
Common test methods
Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé —
Partie 20: Méthodes d'essai communes
ICS: 11.040.20; 11.040.10; 11.040.25
This document is circulated as received from the committee secretariat.
COPYRIGHT PROTECTED DOCUMENT
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2023
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All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
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ii
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PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023
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oSIST prEN ISO 80369-20:2023
ISO/DIS 80369-20:2023(E)
© ISO 2023
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
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iii
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oSIST prEN ISO 80369-20:2023
ISO/DIS 80369-20:2023(E)
1 Contents Page
2 Foreword . 5
3 Introduction . 7
4 1 Scope . 1
5 2 Normative references . 1
6 3 Terms and definitions . 1
7 4 Test methods for small-bore connectors . 1
8 Annex A (informative) Rationale and guidance . 3
9 Annex B (normative) Leakage by pressure decay test method . 6
10 Annex C (normative) Falling drop positive-pressure liquid leakage test method . 9
11 Annex D (normative) Subatmospheric-pressure air leakage test method .11
12 Annex E (normative) Stress cracking test method.14
13 Annex F (normative) Resistance to separation from axial load test method .16
14 Annex G (normative) Resistance to separation from unscrewing test method .18
15 Annex H (normative) Resistance to overriding test method .20
16 Annex I (normative) Disconnection by unscrewing test method .22
17 Annex J (informative) Modification of the test methods to generate variable data
18 for statistical analysis .24
19 Annex K (normative) Air leakage during aspiration test method .27
20 Bibliography .30
21 Terminology — Alphabetized index of defined terms .31
22
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23 Foreword
24 ISO (the International Organization for Standardization) is a worldwide federation of national standards
25 bodies (ISO member bodies). The work of preparing International Standards is normally carried out
26 through ISO technical committees. Each member body interested in a subject for which a technical
27 committee has been established has the right to be represented on that committee. International
28 organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO
29 collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
30 electrotechnical standardization.
31 The procedures used to develop this document and those intended for its further maintenance are
32 described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
33 different types of ISO documents should be noted. This document was drafted in accordance with the
34 editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
35 Attention is drawn to the possibility that some of the elements of this document may be the subject of
36 patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any
37 patent rights identified during the development of the document will be in the Introduction and/or on
38 the ISO list of patent declarations received (see www.iso.org/patents).
39 Any trade name used in this document is information given for the convenience of users and does not
40 constitute an endorsement.
41 For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
42 expressions related to conformity assessment, as well as information about ISO's adherence to the World
43 Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see
44 www.iso.org/iso/foreword.html.
45 This document was prepared by Technical Committee ISO/TC 210, Quality management and
46 corresponding general aspects for medical devices, and IEC/SC62D, Electromedical equipment in
47 collaboration with the European Committee for Standardization (CEN/CLC) Technical Committee CEN/
48 CLC JTC 3, Quality management and corresponding general aspects for medical devices, in accordance with
49 the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
50 This second edition cancels and replaces the first edition (ISO 80369-20:2015), which has been
51 technically revised. The main changes compared to the previous edition are as follows:
52 Major technical revision of the test methods described in annex B “Leakage by pressure decay test
53 method” and annex D “Subatmospheric-pressure air leakage test method.” As acceptance criterion the
54 leakage rate is replaced by the pressure change. Three defined mandatory test conditions were defined.
55 More information about this change is included in Annex A.
56 — Introduction of a new attributive test method “Air leakage during aspiration” as Annex K.
57 — Editorial revision of the assembling procedures of a connector under test. All annexes with test
58 methods are affected.
59 — Editorial update due to the latest ISO formatting standards.
60 — Replacing the terms “male” by “cone” and “female” by “socket” in the description of a connector half.
61 — Update of dated normative references.
62 — Technical revision of the test methods described in Annex B and Annex D. All test conditions have
63 been specified thereby the leakage rate calculation has become superfluous.
64 — Definition for type test is updated.
65 — The range of environmental test conditions for relative humidity has been expanded.
66 — The requirements for test reports have been extended.
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67 — Clarified that all tests are intended be type tests.
68 A list of all parts in the ISO and IEC 80369 series can be found on the ISO and IEC websites.
69 Any feedback or questions on this document should be directed to the user’s national standards
70 body. A complete listing of these bodies can be found at www.iso.org/members.html and
71 www.iec.ch/national-committees.
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oSIST prEN ISO 80369-20:2023
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72 Introduction
73 In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination
74 of the conditions is true.
75 In this document, the following verbal forms are used:
76 — “shall” indicates a requirement;
77 — “should” indicates a recommendation;
78 — “may” indicates a permission;
79 — "can" is used to describe a possibility or capability.
80 This document describes the common test methods for evaluating the performance requirements of the
81 small-bore connectors specified in this series.
82 It is recognized that not all connectors can be evaluated using each test method in this document. The test
83 methods applicable to each connector are specified in the respective part of the ISO and IEC 80369 series.
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oSIST prEN ISO 80369-20:2023
ISO/DIS 80369-20:2023(E)
84 Small-bore connectors for liquids and gases in healthcare
85 applications — Part 20: Common test methods
86 1 Scope
87 NOTE 1 There is guidance or rationale for this Clause contained in Clause A.2.
88 This document specifies the common test methods to evaluate the performance requirements for small-
89 bore connectors specified in the ISO and IEC 80369 series.
90 NOTE 2 The application parts of the ISO and IEC 80369 series specify which tests are required as well as their
91 acceptance criterion.
92 2 Normative references
93 The following documents are referred to in the text in such a way that some or all of their content
94 constitutes requirements of this document. For dated references, only the edition cited applies. For
95 undated references, the latest edition of the referenced document (including any amendments) applies.
96 NOTE Informative references are listed in the bibliography.
97 ISO 14971:2019, Medical devices — Application of risk management to medical devices
98 ISO 80369-1:2018, Small-bore connectors for liquids and gases in healthcare applications — Part 1:
99 General requirements
100 3 Terms and definitions
101 For the purposes of this document, the terms and definitions given in ISO 80369-1:2018, ISO 14971:2019,
102 and the following apply.
103 ISO and IEC maintain terminological databases for use in standardization at the following addresses:
104 — ISO Online browsing platform: available at https://www.iso.org/obp
105 — IEC Electropedia: available at http://www.electropedia.org/
106 NOTE An alphabetized index of defined terms is found following the bibliography.
107 3.1
108 type test
109 test on a representative sample of the equipment with the objective of determining if the equipment, as
110 designed and manufactured, can meet the requirements of this document
111 [SOURCE: IEC 60601-1:2005, 3.135, modified — replaced “standard” with ”document.”]
112 4 Test methods for small-bore connectors
113 Table 1 contains the list of test methods and their corresponding Annex included in this document.
114 Manufacturers may use the modified test methods of Annex J. The tests to evaluate the performance
115 requirements for small-bore connectors specified in the ISO and IEC 80369 series described in this
116 document are intended be performed as type tests.
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117 NOTE The application parts of the ISO and IEC 80369 series specify which tests given in Table 1 are required as
118 well as their acceptance criterion.
119 Table 1 — Test methods and corresponding Annex of this document
Test method Annex of this document
Leakage by pressure decay Annex B
Falling drop positive pressure liquid leakage Annex C
Subatmospheric-pressure air leakage Annex D
Stress cracking Annex E
Resistance to separation from axial load Annex F
Resistance to separation from unscrewing Annex G
Resistance to overriding Annex H
Disconnection by unscrewing Annex I
Modification of the test methods to generate variable data for Annex J
statistical analysis
Air leakage during aspiration Annex K
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120 Annex A
121 (informative)
122 Rationale and guidance
123 A.1 General guidance
124 This Annex provides a rationale for some requirements of this document and is intended for those who
125 are familiar with the subject of this document, but who have not participated in its development. An
126 understanding of the rationales underlying these requirements is considered to be essential for their
127 proper application. Furthermore, as clinical practice and technology change, it is believed that a rationale
128 for the present requirements will facilitate any revision of this document necessitated by those
129 developments.
130 The committee attempted to harmonize the functional test methods for the connectors of each application
131 in this document. The test method Annexes in this document describe a specific test procedure for a type
132 test but allow for modification to specific test conditions or acceptance criteria as necessary for each
133 application.
134 Many of the test methods in this document were extracted from the ISO 594 series of documents (now
135 withdrawn). The committee attempted to minimize changes to these test methods. However, changes
136 were made to test methods which contained subjective acceptance criteria.
137 The assembly procedure in each Annex mimics the assembly procedure that was extracted from ISO 594.
138 An additional clarification was made for connectors with a floating or rotatable locking collar. Test sample
139 preconditioning and environmental test condition requirements were added to each Annex.
140 A.2 Rationale for particular clauses and subclauses
141 The numbering of the following rationales corresponds to the numbering of the clauses and subclauses
142 of this document. The numbering is, therefore, not consecutive.
143 — Clause 1 Scope
144 The ease of assembly test method that was part of the ISO 594 series has been removed as a
145 requirement from the application parts of the ISO and IEC 80369 series and is not present in this
146 document. The acceptance criterion of the ISO 594 series for ease of assembly was subjective. It was
147 underdefined for a standardized test method, i.e. “a satisfactory fit” is not repeatable. Furthermore,
148 the intent of the ease of assembly test was to ensure that the user can complete the connection using
149 the mating halves of the connector. This requirement is satisfied by the requirement for usability
150 validation for all new connectors being added to the ISO and IEC 80369 series. Therefore, the ease of
151 assembly test method has been omitted from the ISO and IEC 80369 series.
152 — Clause B.2, C.2, D.2, E.2, F.2, G.2, H.2, I.2, K.2 Test conditions
153 Clause 2 in each test method includes preconditioning and environmental test requirements.
154 Temperature and humidity preconditioning requirements from ISO 594-1 and ISO 594-2 also have
155 been added in the test methods for hygroscopic materials, as these materials are known to absorb
156 moisture from surrounding gases and liquids, which can alter physical characteristics, dimensions,
157 and performance of connectors. The impact of humidity and temperature for materials can be
158 evaluated using manufacturing data, material technical data or comparative study.
159 The temperature range specified for testing is identical to that specified in ISO 594-1 and ISO 594-2.
160 However, it is permitted to utilize different ranges if specified in the relevant application part of these
161 series of the ISO and IEC 80369 series, to evaluate the performance of connectors exposed to heated
162 solutions and outdoor conditions.
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163 — Annex B Leakage by pressure decay test method
164 This pressure decay test method is based upon the informative liquid leakage test method of ISO 594-
165 1:1986, Annex A. The test method of ISO 594-1:1986, Annex A used an applied pressure on the inside
166 of the connection and the change of this pressure over time to describe a leak. To describe the size of
167 a leak, the leakage rate was calculated by the leakage rate formula. In the development of this present
168 document, it was seen that the leakage rate formula is only applicable under very specific test
169 conditions. Some of the factors are the geometrical shape of the leak which is unknown and the type
170 of gas flow which can change during the test. In order to overcome the difficulty related to the test
171 conditions the evaluation within the test method was modified. The leakage rate and the calculation
172 of the leakage rate were taken out of the test method and the pressure change itself is used as the
173 acceptance criterion. This modification allows to use the test method in a wider range of test
174 conditions.
175 Mandatory test conditions are
176 — start pressure,
177 — test period and
178 — test volume.
179 Values for these test conditions are not specified in Annex B. These values are individual for each
180 connector depending on their use case and the pressure change threshold. A document referencing
181 the test method of Annex B needs to state the values for these test conditions for each specified
182 pressure change threshold.
183 — Annex C Falling drop positive-pressure liquid leakage test method
184 This liquid leakage test method is performed in the same manner as in the now withdrawn
185 ISO 594-1:1986 and ISO 594-2:1998.
186 — Annex D Subatmospheric-pressure air leakage test method
187 This subatmospheric-pressure air leakage test method is a new test method that was not part of the
188 former ISO 594 series. The ISO 594 series test method for subatmospheric-pressure (ISO 594-1, 5.3
189 and ISO 594-2, 5.3) created an unspecified subatmospheric test pressure and asked the observer to
190 look for continued formation of bubbles of an unspecified size.
191 This test method is similar to the test method of Annex B. The difference is that the test method of
192 Annex D applies a subatmospheric pressure inside the connector while the test method of Annex B
193 pressurizes the inside of the connector. Allowing for this difference, the rationale for Annex B is also
194 applicable for Annex D.
195 — Annex E Stress cracking test method
196 This stress cracking test method is performed in the same manner as in the ISO 594 series. The
197 acceptance criteria have been changed to require passing a functional leak test after the stress
198 cracking test has been performed.
199 — Annex F Resistance to separation from axial load test method
200 This resistance to separation from axial load test method is performed in the same manner as in the
201 ISO 594 series. The title and principle have been elaborated to describe the intent of the test.
202 — Annex G Resistance to separation from unscrewing test method
203 This resistance to separation from unscrewing test method is performed in the same manner as the
204 ISO 594 series. The title and principle have been elaborated to describe the intent of the test.
205 — Annex H Resistance to overriding test method
206 This resistance to overriding test method is performed in the same manner as the ISO 594 series.
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207 — Annex I Disconnection by unscrewing test method
208 This test method is intended to ensure that connectors, which can be connected and disconnected
209 multiple times per day, can be successfully disconnected by the user.
210 — Annex J Alternate test methods to generate variable data for statistical analysis
211 Multiple test methods in this document are written as attribute data test methods that can be modified
212 to become variable data test methods.
213 Attribute data tests are more commonly known as pass/fail tests. Attribute data tests can only
214 determine if the specification is met. They provide no indication of how the connector fails and
215 typically require a large sample size to have the same statistical power as an equivalent variable data
216 test.
217 Variable data tests are those tests that produce a quantifiable result such as the force required to
218 separate the connectors or the actual change in pressure. Variable data test results determine the
219 value at which the connector fails, provide a numerical result that can be statistically analysed, and
220 typically require a smaller sample size to have the same statistical power as equivalent attribute data
221 test results.
222 — Annex K Air leakage during aspiration test method
223 This air leakage during aspiration test method is based on a test method in the former ISO 594 series.
224 It is based on visually detecting bubbles of leaking air passing through water. This test method was
225 refined to overcome some shortcomings of the test method in the ISO 594 series.
226 The test method of Annex D is not suitable to cover the requirements for all connector use cases. When
227 the intent of the connection is to convey liquids, the test method of Annex K can be a better and more
228 suitable test method than the subatmospheric pressure air leakage test method.
229
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230 Annex B
231 (normative)
232 Leakage by pressure decay test method
233 NOTE There is guidance or rationale for this Annex contained in Clause A.2.
234 B.1 Principle
235 The connector under test is assembled to an appropriate reference connector.
236 Air is introduced into the connection and pressurized to the specified pressure. The relevant application
237 part of the ISO and IEC 80369 series or the ISO 18250 series specifies the test conditions, i.e., the test
238 volume, the test period, the start pressure, and the acceptance criterion, i.e., the maximum pressure
239 change.
240 B.2 Test conditions
241 B.2.1 Test sample preconditioning
242 Prior to testing, precondition the connector under test at 20 °C ± 5 °C and 50 % ± 10 % relative humidity
243 for not less than 24 h. Preconditioning need not be performed for a connector made from non-hygroscopic
244 materials.
245 B.2.2 Environmental test conditions
246 Perform tests at a temperature within the range of 15 °C to 30 °C and at a relative humidity between 10 %
247 and 70 %, unless other ranges are specified in the relevant application part of the ISO and IEC 80369
248 series.
249 B.3 Apparatus
250 The following shall be used (see Figure B.1):
251 a) the cone or socket connector under test;
252 b) the appropriate reference connector, as specified in the relevant application part of the ISO and
253 IEC 80369 series for the leakage test method, to be assembled to the connector under test;
254 c) a means to simultaneously apply an axial force of 27,5 N and torque of 0,12 N·m, or more if required
255 by the relevant application part of the ISO and IEC 80369 series;
256 d) a means to contain and pressurize air to the specified test pressure. Pressures specified in the
257 application parts of the ISO and IEC 80369 series are gauge pressures. Rigid fixtures and apparatus
258 materials (such as metal) should be used to achieve accurate and repeatable test results;
259 e) a means of measuring and displaying the elapsed time with an accuracy of ± 1 s;
260 f) a means of measuring the applied gauge pressure with a accuracy of ± 0,3 % of the applied pressure;
261 g) a means to achieve the test volume specified in the relevant application part of the ISO and IEC 80369
262 series;
263 NOTE: The test volume is the total volume of the connected system under pressure or vacuum, including small-
264 bore connector and measuring equipment. Potential methods to determine the test volume can be based on e.g., a
265 dimensional calculation or a measurement of the amount of water that the connected system can hold or a
266 combination of these.
267 h) a stop valve; and
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268 i) a means to seal the connector under test at its open end.
269 An automated pressure decay leak test system may be substituted for any or all items d), e), f), g) and h).
270
271 Key
272 1 a means to seal the connector under test
273 2 connector under test
274 3 appropriate reference connector
275 4 stop-valve
276 5 pressure source
277 6 pressure-measuring device, e.g. a manometer
278 7 test volume
279 8 means to achieve the test volume
280 Figure B.1 — Example test apparatus for leakage by pressure decay
281 B.4 Procedure
282 a) Seal the outlet bore of the connector under test.
283 b) Assemble the connector under test to the app
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