BSI 22/30455929 DC 2022

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BS EN ISO 80369-20. Small-bore connectors for liquids and gases in healthcare applications – Part 20. Common test methods

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4	ISO TC 210/ N1321 Date: 2022-04-15 ISO 80369-20(Ed 2) ISO TC 210/JWG 4 Secretariat: ANSI 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 courantes — Partie 20: Méthodes d’essai courantes CD stage Warning for WDs and CDs This document is not an ISO International Standard. It is distributed for review and comment. It is subject to change without notice and may not be referred to as an International Standard. 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.
5	© ISO 2021 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. ISO copyright office Case postale 56 • CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail [email protected] Web www.iso.org Published in Switzerland.
6	Contents Page Foreword 7 Introduction 9 1 Scope 1 2 Normative references 1 3 Terms and definitions 1 4 Test methods for small-bore connectors 2 Annex A (informative) Rationale and guidance 3 A.1 General guidance 3 A.2 Rationale for particular clauses and subclauses 3 Annex B (normative) Leakage by pressure decay test method 7 B.1 Principle 7 B.2 Test conditions 7 B.2.1 Test sample preconditioning 7 B.2.2 Environmental test conditions 7 B.3 Apparatus 7 B.4 Procedure 8 B.5 Test report 9 Annex C (normative) Falling drop positive-pressure liquid leakage test method 10 C.1 Principle 10 C.2 Test conditions 10 C.2.1 Test sample preconditioning 10 C.2.2 Environmental test conditions 10 C.3 Apparatus 10 C.4 Procedure 10 C.5 Test report 11 Annex D (normative) Subatmospheric-pressure air leakage test method 12 D.1 Principle 12 D.2 Test conditions 12 D.2.1 Test sample preconditioning 12 D.2.2 Environmental test conditions 12 D.3 Apparatus 12 D.4 Procedure 13
7	D.5 Test report 14 Annex E (normative) Stress cracking test method 15 E.1 Principle 15 E.2 Test conditions 15 E.2.1 Test sample preconditioning 15 E.2.2 Environmental test conditions 15 E.3 Apparatus 15 E.4 Procedure 15 E.5 Test report 16 Annex F (normative) Resistance to separation from axial load test method 17 F.1 Principle 17 F.2 Test conditions 17 F.2.1 Test sample preconditioning 17 F.2.2 Environmental test conditions 17 F.3 Apparatus 17 F.4 Procedure 17 F.5 Test report 18 Annex G (normative) Resistance to separation from unscrewing test method 19 G.1 Principle 19 G.2 Test conditions 19 G.2.1 Test sample preconditioning 19 G.2.2 Environmental test conditions 19 G.3 Apparatus 19 G.4 Procedure 19 G.5 Test report 20 Annex H (normative) Resistance to overriding test method 21 H.1 Principle 21 H.2 Test conditions 21 H.2.1 Test sample preconditioning 21 H.2.2 Environmental test conditions 21 H.3 Apparatus 21 H.4 Procedure 21 H.5 Test report 22 Annex I (normative) Disconnection by unscrewing test method 23 I.1 Principle 23 I.2 Test conditions 23 I.2.1 Test sample preconditioning 23
8	I.2.2 Environmental test conditions 23 I.3 Apparatus 23 I.4 Procedure 23 I.5 Test report 24 Annex J (informative) Modification of the test methods to generate variable data for statistical analysis 25 J.1 Principle 25 J.2 Test method variations 25 J.2.1 Fluid leakage test by pressure decay test method 25 J.2.2 Falling drop positive pressure liquid leakage test method 25 J.2.3 Subatmospheric-pressure air leakage test method 25 J.2.4 Resistance to separation from axial load test method 25 J.2.5 Resistance to separation from unscrewing test method 26 J.2.6 Resistance to overriding test method 26 J.2.7 Disconnection by unscrewing test method 26 J.3 Statistical analysis of variable data 26 J.3.1 Test for normality 26 J.3.2 Tolerance limit calculation 26 Annex K (normative) Aspiration of air leakage test method 28 K.1 Principle 28 K.2 Test conditions 28 K.2.1 Test sample preconditioning 28 K.2.2 Environmental test conditions 28 K.3 Apparatus 28 Figure 1 — Example aspiration air leakage test apparatus 29 K.4 Procedure 29 K.5 Test report 30 Bibliography 32 Terminology — Alphabetized index of defined terms 33
9	Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives). Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents). Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement. For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISO’s adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www.iso.org/iso/foreword.html. This document was prepared by Technical Committee ISO/TC 210, Quality management and corresponding general aspects for medical devices, and IEC/SC62D, Electromedical equipment in collaboration with the European Committee for Standardization (CEN/CLC) Technical Committee CEN/ CLC JTC 3, Quality management and corresponding general aspects for medical devices, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement). This second edition cancels and replaces the first edition (ISO 80369-20:2015), which has been technically revised. The main changes compared to the previous edition are as follows: — Major technical revision of the test methods described in annex B “Leakage by pressure decay test method” and annex D “Subatmospheric-pressure air leakage test method.” As acceptance criterion the leakage rate is replaced by the pressure change. Three defined mandatory test conditions were defined. More information about this change is included in Annex A. — -Introduction of a new attributive test method “Aspiration of air leakage test method” as annex K. — Editorial revision of the assembling procedures of a connector under test. All annexes with test methods are affected. — Editorial update of the introduction due to the latest ISO formatting standards. — Replacing the terms “male” by “cone” and “female” by “socket” in the description of a connector half. — Update of dated normative references
10	Any feedback or questions on this document should be directed to the user’s national standards body. A complete listing of these bodies can be found at www.iso.org/members.html.
11	Introduction In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the conditions is true. In this document, the following verbal forms are used: — “shall” indicates a requirement; — “should” indicates a recommendation; — “may” indicates a permission; — “can” is used to describe a possibility or capability. This document describes the common test methods for evaluating the performance requirements of the small-bore connectors specified in this series. It is recognized that not all connectors can be evaluated using each test method in this document. The test methods applicable to each connector are specified in the respective part of the ISO 80369 series.
13	Small-bore connectors for liquids and gases in healthcare applications — Part 20: Common test methods 1 Scope This document specifies the common test methods to evaluate the performance requirements for small-bore connectors specified in the ISO 80369 series. NOTE There is guidance or rationale for this Clause contained in Clause A.2. 2 Normative references The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. NOTE Informative references are listed in the bibliography. ISO 14971:2019, Medical devices — Application of risk management to medical devices ISO 803691:2018, Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 803691:2018, ISO 14971:2019, and the following apply. ISO and IEC maintain terminological databases for use in standardization at the following addresses: — ISO Online browsing platform: available at https://www.iso.org/obp — IEC Electropedia: available at http://www.electropedia.org/ NOTE An alphabetized index of defined terms is found following the bibliography. 3.1 type test test on a representative sample of the equipment with the objective of determining if the equipment, as designed and manufactured, can meet the requirements of this standard [SOURCE: IEC 60601-1:2005, definition 3.135] 4 Test methods for small-bore connectors Table 1 contains the list of test methods and their corresponding Annex included in this document. Manufacturers may use the modified test methods of Annex J.
14	NOTE The application standards specify which tests given in Table 1 are required as well as their acceptance criterion. 455BTable 1 — Test methods and corresponding Annex of this document Table 1 — Test methods and corresponding Annex of this document Annex Test method Annex B Leakage by pressure decay Annex C Positive pressure liquid leakage Annex D Subatmospheric-pressure air leakage Annex E Stress cracking Annex F Resistance to separation from axial load Annex G Resistance to separation from unscrewing Annex H Resistance to overriding Annex I Disconnection by unscrewing Annex J Modification of the test methods to generate variable data for statistical analysis
15	Annex A (informative) Rationale and guidance A.1 General guidance This Annex provides a rationale for some requirements of this document and is intended for those who are familiar with the subject of this document, but who have not participated in its development. An understanding of the rationales underlying these requirements is considered to be essential for their proper application. Furthermore, as clinical practice and technology change, it is believed that a rationale for the present requirements will facilitate any revision of this document necessitated by those developments. The committee attempted to harmonize the functional test methods for the connectors of each application in this document. The test method Annexes in this document describe a specific test procedure for a type test but allow for modification to specific test conditions or acceptance criteria as necessary for each application. Many of the test methods in this document were extracted from the ISO 594 series of standards (now withdrawn). The committee attempted to minimize changes to these test methods. However, changes were made to test methods which contained subjective acceptance criteria. The assembly procedure in each Annex mimics the assembly procedure that was extracted from ISO 594. An additional clarification was made for connectors with a floating or rotatable locking collar. Test sample preconditioning and environmental test condition requirements were added to each Annex. Manufacturers should also consider performing functional performance testing using a representative sample of the small-bore connector being evaluated with a representative sample of appropriate mating connectors. A.2 Rationale for particular clauses and subclauses The numbering of the following rationales corresponds to the numbering of the clauses and subclauses of this document. The numbering is, therefore, not consecutive. — Clause 1 Scope The ease of assembly test method that was part of the ISO 594 series has been removed as a requirement from the application parts of ISO 80369 and is not present in this document. The acceptance criterion of the ISO 594 series for ease of assembly was subjective. It was underdefined for a standardized test method, i.e. “a satisfactory fit” is not repeatable. Furthermore, the intent of the ease of assembly test was to ensure that the user can complete the connection using the mating halves of the connector. This requirement is satisfied by the requirement for usability validation for all new connectors being added to ISO 80369. Therefore, the ease of assembly test method has been omitted from the ISO 80369 series of standards. — Subclause B.2, C.2, D.2, E.2, F.2, G.2, H.2, I.2 Test conditions Subclause 2 in each test method includes preconditioning and environmental test requirements. Temperature and humidity preconditioning requirements from ISO 5941 and ISO 5942 also have been added in the test methods for hygroscopic materials, as these materials are known to absorb moisture from surrounding gases and liquids, which can alter physical characteristics, dimensions, and performance of connectors. The impact of humidity and temperature for materials can be evaluated by using manufacturing data, material technical data or comparative study.
16	The temperature range specified for testing is identical to that specified in ISO 5941 and ISO 5942. However, it is permitted to utilize different ranges if specified in the relevant application part of these series of standards, to evaluate the performance of connectors exposed to heated solutions and outdoor conditions. — Annex B Leakage by pressure decay test method This pressure decay test method is based upon the informative liquid leakage test method of ISO 594-1:1986, Annex A. The test method of ISO 594-1:1986, Annex A used an applied pressure on the inside of the connection and the change of this pressure over time to describe a leak. To describe the size of a leak, the leakage rate was calculated by the leakage rate formula. In the development of this present document, it was seen that the leakage rate formula is only applicable under very specific test conditions. Some of the factors are the geometrical shape of the leak which is unknown and the type of gas flow which can change during the test. In order to overcome the difficulty related to the test conditions the evaluation within the test method was modified. The leakage rate and the calculation of the leakage rate were taken out of the test method and the pressure change itself is used as the acceptance criterion. This modification allows to use the test method in a wider range of test conditions. Mandatory test conditions are – start pressure, – test period and – test volume. Values for these test conditions are not specified in Annex B. These values are individual for each connector depending on their use case and the pressure change threshold. A document referencing the test method of annex B need to state the values for theses test conditions for each pressure change threshold specified by that reverencing standard. In this test method the use of a compressible fluid, usually air or other gases, is preferable to liquids because the test, when performed with fluids that are considered incompressible, is strongly biased by the artifact of the elastic compliance of the components of the connector under test. In this case, the true effect of the leaking orifice cannot be detected. — Annex C Falling drop positive-pressure liquid leakage test method This liquid leakage test method is performed in the same manner as in the ISO 594 series. — Annex D Subatmospheric-pressure air leakage test method This subatmospheric-pressure air leakage test method is a new test method that was not part of the former ISO 594 series. The ISO 594 series test method for subatmospheric-pressure (ISO 5941, 5.3 and ISO 5942, 5.3) creates an unspecified subatmospheric test pressure and asks the observer to look for continued formation of bubbles of an unspecified size. The test method included in this document was developed during the committee drafts of ISO 803692 and ISO 803696.
17	This test method is similar to the test method of Annex B. The difference is that the test method of Annex D applies a subatmospheric pressure inside the connector while the test method of annex B pressurizes the inside of the connector. Allowing for this difference, the rationale for Annex B is also applicable for Annex D. — Annex E Stress cracking test method This stress cracking test method is performed in the same manner as in the ISO 594 series. The acceptance criteria have been changed to require passing a functional leak test after the stress cracking test has been performed. — Annex F Resistance to separation from axial load test method This resistance to separation from axial load test method is performed in the same manner as in the ISO 594 series. The title and principle have been elaborated to describe the intent of the test. — Annex G Resistance to separation from unscrewing test method This resistance to separation from unscrewing test method is performed in the same manner as the ISO 594 series. The title and principle have been elaborated to describe the intent of the test. — Annex H Resistance to overriding test method This resistance to overriding test method is performed in the same manner as the ISO 594 series. — Annex I Disconnection by unscrewing test method This disconnection by unscrewing test method replaces the test method described in the ISO 594 series to account for locking, non-locking (slip) and rotating-collar connectors. It is intended to ensure that connectors, which can be connected and disconnected multiple times per day, can be successfully disconnected by the user. — Annex J Alternate test methods to generate variable data for statistical analysis Multiple test methods in this document are written as attribute data test methods that can be modified to become variable data test methods. Attribute data tests are more commonly known as pass/fail tests. Attribute data tests can only determine if the specification is met. They provide no indication of how the connector fails and typically require a large sample size to have the same statistical power as an equivalent variable data test. Variable data tests are those tests that produce a quantifiable result such as the force required to separate the connectors or the actual leak rate. Variable data test results determine the value at which the connector fails, provide a numerical result that can be statistically analysed, and typically require a smaller sample size to have the same statistical power as equivalent attribute data test results. — Annex K Aspiration air leakage test method This aspiration air leakage test method is based on a test method in the former ISO 594 series. It is based on visually detecting bubbles of leaking air passing through water. This test method was refined to overcome some shortcomings of the test method in the ISO 594 series. The test methods of Annex D are not suitable to cover the requirements for all connector use cases. When the intent of the connection is to convey liquids, the test method of Annex K could be a better and more suitable test method than the subatmospheric pressure air leakage test methods. In such cases, a pressure decay threshold corresponding to the use requirement must be determined and confirmed first before requiring the test method according to Annex D.
19	Annex B (normative) Leakage by pressure decay test method B.1 Principle NOTE There is guidance or rationale for this Clause contained in Clause A.2. The connector under test is assembled to an appropriate reference connector. Air is introduced into the connection and pressurized to the specified pressure. The relevant application part of ISO 80369 or ISO 18250 specifies the test conditions, i.e., the test volume, the test period, the start pressure, and the acceptance criterion, i.e., the maximum pressure change. B.2 Test conditions NOTE There is guidance or rationale for this Clause contained in Clause A.2. B.2.1 Test sample preconditioning Prior to testing, precondition the connector under test at 20 °C ± 5 °C and 50 % ± 10 % relative humidity for not less than 24 h. Preconditioning need not be performed for a connector made from non-hygroscopic materials. B.2.2 Environmental test conditions Perform tests at a temperature within the range of 15 °C to 30 °C and at a relative humidity between 10 % and 70 %, unless other ranges are specified in the relevant application part of ISO 80369. B.3 Apparatus a) the cone or socket connector under test; b) the appropriate reference connector, as specified in the relevant application part of ISO 80369 for the leakage test method, to be assembled to the connector under test; c) a means to apply an axial force of 27,5 N and torque of 0,12 N·m, or more if required by the relevant application part of ISO 80369; d) a means to contain and pressurize air to the specified test pressure. Pressures specified in the application parts of part of ISO 80369 are gauge pressures. Rigid fixtures and apparatus materials (such as metal) should be used to avoid inaccurate test results; e) a means of measuring and displaying the elapsed time with an accuracy of ± 1 s; f) a means of measuring the applied gauge pressure with a accuracy of ± 0,3 % of the applied pressure; g) a means to achieve the test volume specified in the relevant application part of ISO 80369; NOTE: The test volume is the total volume of the connected system under pressure or vacuum, including small-bore connector and measuring equipment. Potential methods to determine the test volume can be based on e.g., a dimensional calculation or a measurement of the amount of water that the connected system can hold or a combination of these.
20	h) a stop valve; i) a means to seal the connector under test at its open end. An automated pressure decay leak test system may be substituted for any or all items d), e), f), g) and h). / Key 1 a means to seal the connector under test 2 connector under test 3 appropriate reference connector 4 stop-valve 5 pressure source 6 pressure-measuring device, e.g. a manometer 7 test volume 8 means to achieve the test volume Figure B.1 — Example leakage by pressure decay test apparatus B.4 Procedure a) Seal the outlet bore of the connector under test. b) Assemble the connector under test to the appropriate cone or socket reference connector, both connectors being dry. i) For a non-locking (slip) connector, assemble by applying an axial force of between 26,5 N and 27,5 N. Then whilst continuing to apply the axial force, rotate the connector under test to either a torque of between 0,08 N·m and 0,10 N·m or a rotation not exceeding 90° and hold for 5 s to 6 s. Then release.
21	ii) For a locking connector with fixed threads, assemble by rotating the connector under test to a torque of between 0,08 N·m and 0,12 N·m whilst applying an axial force of between 26,5 N and 27,5 N. Hold the force and torque for 5 s to 6 s and then release. iii) For a connector with a floating or rotatable collar, assemble by introducing the mating features (i.e. connector taper) together with an axial force of between 26,5 N and 27,5 N whilst rotating the collar of the connector under test to a torque of between 0,08 N·m and 0,12 N·m. Hold the force and torque for 5 s to 6 s and then release. c) Apply the pressure specified in the relevant application part of ISO 80369 and close the valve. d) Record the starting pressure and start the timing device. e) After the test period specified in the relevant application part of ISO 80369, record the end pressure and the elapsed time. f) Calculate the difference between end pressure and start pressure. g) Determine whether the change in pressure exceeds the value specified in the relevant application part of ISO 80369. B.5 Test report Prepare a test report that — specifies testing was performed according to ISO 8036920, Annex B, — identifies the connectors under test, — identifies the number of connectors tested, — identifies the preconditioning and environmental test conditions, — identifies the reference connector used, — identifies the applied pressure used, — identifies the acceptance criterion, — identifies the test volume as defined in Figure B.1, — discloses the test period, — discloses the pressure change during the test period, and — discloses whether the acceptance criterion is met.
22	Annex C (normative) Falling drop positive-pressure liquid leakage test method C.1 Principle A connector is assembled to a reference connector. Water is introduced into the connection and pressurized for the hold period. C.2 Test conditions NOTE There is guidance or rationale for this Clause contained in Clause A.2. C.2.1 Test sample preconditioning Prior to testing, precondition the connectors under test at 20 °C ± 5 °C and 50 % ± 10 % relative humidity for not less than 24 h. Preconditioning need not be performed for a connector made from non-hygroscopic materials. C.2.2 Environmental test conditions Perform tests at a temperature within the range of 15 °C to 30 °C and at a relative humidity between 10 % and 70 %, unless other ranges are specified in the relevant application part of ISO 80369. C.3 Apparatus a) the cone or socket connector under test; b) the appropriate reference connector, as specified in the relevant application part of ISO 80369 for the leakage test method, to be assembled to the connector under test; c) a means to simultaneously apply an axial force of 27,5 N and torque of 0,12 N·m, or more if required by the relevant application part of ISO 80369; d) a means to contain and pressurize water to the specified test pressure. Rigid fixtures and apparatus materials (such as metal) should be used to avoid inaccurate test results; e) a means of measuring the applied pressure with a minimum accuracy of 0,3 % of the applied pressure; f) a means of measuring and displaying the elapsed time with an accuracy of ± 1 s; g) distilled or potable water. The water may be dyed with methylene blue. C.4 Procedure a) Assemble the connector under test to the appropriate cone or socket reference connector, both connectors being dry.
23	i) For a non-locking (slip) connector, assemble by applying an axial force of between 26,5 N and 27,5 N. Then whilst continuing to apply the axial force, rotat the connector under test to either a torque of between 0,08 N·m and 0,10 N·m or a rotation not exceeding 90° and hold for 5 s to 6 s. Than release. ii) For a locking connector with fixed threads, assemble by rotating the connector under test to a torque of between 0,08 N·m and 0,12 N·m whilst applying an axial force of between 26,5 N and 27,5 N. Hold for 5 s to 6 s and than release. iii) For a connector with a floating or rotatable collar, assemble by introducing the mating features (i.e. connector taper) together with an axial force of between 26,5 N and 27,5 N whilst rotating collar of the connector under test to a torque of between 0,08 N·m and 0,12 N·m. Hold the force and torque for 5 s to 6 s and than release. b) Introduce water into the assembly to expel the air. c) Ensure that the outside of the connector assembly is dry. d) With the axis of assembled connectors horizontal, seal the assembly outlet and increase the internal water pressure to the applied pressure specified in the relevant application part of ISO 80369. e) Maintain the pressure for the hold period specified in the relevant application part of ISO 80369 while maintaining the assembled connectors in the horizontal orientation. f) Visually inspect for a falling drop of water from the connection during the specified hold period. C.5 Test report Prepare a test report that — specifies testing was performed according to ISO 8036920, Annex C, — identifies the connectors under test, — identifies the number of connectors tested, — identifies the preconditioning and environmental test conditions, — identifies the reference connector used, — identifies the applied pressure used, — identifies the acceptance criterion, — discloses the measured test pressure, — discloses the hold period of the test, — discloses the presence or absence of a falling drop of water within the specified hold period, and — discloses reference connector figure number used for testing.
24	Annex D (normative) Subatmospheric-pressure air leakage test method D.1 Principle NOTE There is guidance or rationale for this Clause contained in Clause A.2. Air leakage during aspiration in a connector assembly is tested by measuring the change in subatmospheric pressure over time after the vacuum pressure is applied to the bore of the connector. The relevant application part of ISO 80369 specifies the test conditions, i.e. the test volume, the test period, the start pressure, and the acceptance criterion, i.e. the maximum pressure change. D.2 Test conditions D.2.1 Test sample preconditioning Prior to testing, precondition the connector under test at 20 °C ± 5 °C and 50 % ± 10 % relative humidity for not less than 24 h. Preconditioning need not be performed for a connector made from non-hygroscopic materials. D.2.2 Environmental test conditions Perform tests at a temperature within the range of 15 °C to 30 °C and at a relative humidity between 10 % and 70 %, unless other ranges are specified in the relevant application part of ISO 80369. D.3 Apparatus a) the cone or socket connector under test; b) the appropriate reference connector, as specified in the relevant application part of ISO 80369 for the leakage test method, to be assembled to the connector under test; c) a means to apply an axial force of 27,5 N and torque of 0,12 N·m, or more if required by the relevant application part of ISO 80369; d) a vacuum source. Pressures specified in the application parts of part of ISO 80369 are gauge pressures. Rigid fixtures and apparatus materials (such as metal) should be used to avoid inaccurate test results; NOTE: At high altitudes the specified subatmospheric pressure might not be achievable. In this case measures need to be taken to increase the ambient pressure around the connector under test. e) a means of measuring and displaying the elapsed time with an accuracy of ± 1 s; f) a means of measuring the applied subatmospheric pressure with a accuracy of ± 0,3 % of the applied pressure; g) a means to achieve the test volume specified in the relevant application part of ISO 80369;
25	NOTE: The test volume is the total volume of the connected system under pressure or vacuum, including small-bore connector and measuring equipment. Potential methods to determine the test volume can be based on e.g. a dimensional calculation or a measurement of the amount of water that the connected system can hold or a combination of these. h) a stop valve; i) a means to seal the connector under test at its open end. An automated pressure decay leak test system may be substituted for any or all items d), e), f), g) and h). / Key a means to seal the connector under test 1 connector under test 2 appropriate reference connector 3 stop-valve 4 vacuum source 5 pressure-measuring device, e.g. a manometer 6 test volume 7 means to achieve the test volume 8 Figure D.1 — Example subatmospheric-pressure air leakage test apparatus D.4 Procedure a) Seal the outlet bore of the connector under test.
26	b) Assemble the connector under test to the appropriate cone or socket reference connector, both connectors being dry. i) For a non-locking (slip) connector, assemble by applying an axial force of between 26,5 N and 27,5 N. Then whilst continuing to apply the axial force, rotate the connector under test to either a torque of between 0,08 N·m and 0,10 N·m or a rotation not exceeding 90° and hold for 5 s to 6 s. Then release. ii) For a locking connector with fixed threads, assemble by rotating the connector under test to a torque of between 0,08 N·m and 0,12 N·m whilst applying an axial force of between 26,5 N and 27,5 N. Hold the force and torque for 5 s to 6 s and then release. iii) For a connector with a floating or rotatable collar, assemble by introducing the mating features (i.e. connector taper) together with an axial force of between 26,5 N and 27,5 N whilst rotating the collar of the connector under test to a torque of between 0,08 N·m and 0,12 N·m. Hold the force and torque for 5 s to 6 s and then release. c) Apply the subatmospheric pressure specified in the relevant application part of ISO 80369 and close the valve. d) Record the starting pressure and start the timing device. e) After the test period specified in the relevant application part of ISO 80369, record the end pressure and the elapsed time. f) Calculate the difference between end pressure and start pressure. g) Determine whether the change in pressure exceeds the value specified in the relevant application part of ISO 80369. D.5 Test report Prepare a test report that — specifies testing was performed according to ISO 8036920, Annex D, — identifies the connectors under test, — identifies the number of connectors tested, — identifies the preconditioning and environmental test conditions, — identifies the reference connector used, — identifies the applied pressure used, — identifies the acceptance criterion, — identifies the test volume as defined in Figure D.1, — discloses the test period, — discloses the pressure change during the test period, and
27	— discloses whether the acceptance criterion is met.
28	Annex E (normative) Stress cracking test method E.1 Principle A connector is securely assembled to an appropriate reference connector and the connection is evaluated for stress cracking by demonstrating that it properly seals utilizing the leak test. E.2 Test conditions NOTE There is guidance or rationale for this Clause contained in Clause A.2. E.2.1 Test sample preconditioning Prior to testing, precondition the connector under test at 20 °C ± 5 °C and 50 % ± 10 % relative humidity for not less than 24 h. Preconditioning need not be performed for a connector made from non-hygroscopic materials. E.2.2 Environmental test conditions Perform tests at a temperature within the range of 15 °C to 30 °C and at a relative humidity between 10 % and 70 %, unless other ranges are specified in the relevant application part of ISO 80369. E.3 Apparatus a) the cone or socket connector under test; b) the appropriate reference connector, as specified in the relevant application part of ISO 80369 for the stress cracking test method, to be assembled to the connector under test; c) a means to simultaneously apply an axial force of 27,5 N and torque of 0,12 N·m, or more if required by the relevant application part of ISO 80369; d) a means of measuring and displaying the elapsed time with an accuracy of ± 10 min for at least 48 h. E.4 Procedure a) Assemble the connector under test to the appropriate cone or socket reference connector, both connectors being dry. i) For a non-locking (slip) connector, assemble by applying an axial force of between 26,5 N and 27,5 N. Then whilst continuing to apply the axial force, rotate the connector under test to either a torque of between 0,08 N·m and 0,10 N·m or a rotation not exceeding 90° and hold for 5 s to 6 s. Then release. ii) For a locking connector with fixed threads, assemble by rotating the connector under test to a torque of between 0,08 N·m and 0,12 N·m whilst applying an axial force of between 26,5 N and 27,5 N. Hold the force and torque for 5 s to 6 s and then release.
29	iii) For a connector with a floating or rotatable collar, assemble by introducing the mating features (i.e. connector taper) together with an axial force of between 26,5 N and 27,5 N whilst rotating the collar of the connector under test to a torque of between 0,08 N·m and 0,12 N·m. Hold the force and torque for 5 s to 6 s and then release. b) Leave the connector under test and reference connector assembled for not less than 48 h unless otherwise specified in the relevant application part of ISO 80369. c) Confirm that the connector under test properly seals by performing a leakage test as specified in the relevant application part of ISO 80369. The preconditioning process of the leakage test need not be performed. E.5 Test report Prepare a test report that — specifies testing was performed according to ISO 8036920, Annex E, — identifies the connectors under test, — identifies the number of connectors tested, — identifies the preconditioning and environmental test conditions, — identifies the reference connector used, — discloses duration of the test, and — discloses the results of the leakage test performed.
30	Annex F (normative) Resistance to separation from axial load test method F.1 Principle The security of the connection to an axial pull is determined by applying an axial separation force between the assembled connector under test and the appropriate reference connector. The connection is expected to be maintained. F.2 Test conditions NOTE There is guidance or rationale for this Clause contained in Clause A.2. F.2.1 Test sample preconditioning Prior to testing, precondition the connector under test at 20 °C ± 5 °C and 50 % ± 10 % relative humidity for not less than 24 h. Preconditioning need not be performed for a connector made from non-hygroscopic materials. F.2.2 Environmental test conditions Perform tests at a temperature within the range of 15 °C to 30 °C and at a relative humidity between 10 % and 70 %, unless other ranges are specified in the relevant application part of ISO 80369. F.3 Apparatus a) the cone or socket connector under test; b) the appropriate reference connector, as specified in the relevant application part of ISO 80369 for the resistance to separation from axial load test method, to be assembled to the connector under test; c) a means to simultaneously apply an axial force of 35 N and torque of 0,12 N·m, or more if required by the relevant application part of ISO 80369; d) a means of measuring and displaying the elapsed time with an accuracy of ± 1 s; e) a means of measuring the specified axial separation force. F.4 Procedure a) Assemble the connector under test to the appropriate cone or socket reference connector, both connectors being dry. i) For a non-locking (slip) connector, assemble by applying an axial force of between 26,5 N and 27,5 N. Then whilst continuing to apply the axial force, rotate the connector under test to either a torque of between 0,08 N·m and 0,10 N·m or a rotation not exceeding 90° and hold for 5 s to 6 s. Then release.
31	ii) For a locking connector with fixed threads, assemble by rotating the connector under test to a torque of between 0,08 N·m and 0,12 N·m whilst applying an axial force of between 26,5 N and 27,5 N. Hold the force and torque for 5 s to 6 s and then release. iii) For a connector with a floating or rotatable collar, assemble by introducing the mating features (i.e. connector taper) together with an axial force of between 26,5 N and 27,5 N whilst rotating the collar of the connector under test to a torque of between 0,08 N·m and 0,12 N·m. Hold the force and torque for 5 s to 6 s and then release. b) Apply the specified axial force from the relevant application part of ISO 80369 in a direction away from the test fixture at a rate of approximately 10 N/s until the minimum specified force is reached. Hold the axial force for the hold period from the relevant application part of ISO 80369. Do not apply any force in other directions. For connectors with floating collar apply the axial force to the body that includes the mating surfaces. c) Confirm that the connectors have not completely detached at the interface between the connectors. F.5 Test report Prepare a test report that — specifies testing was performed according to ISO 8036920, Annex F, — identifies the connectors under test, — identifies the number of connectors tested, — identifies the preconditioning and environmental test conditions, — identifies the reference connector used, — identifies the applied axial force, — discloses the duration of the test, and — discloses the presence or absence of the complete detachment of the connectors.
32	Annex G (normative) Resistance to separation from unscrewing test method G.1 Principle The security of connection between cone and socket locking connectors is determined by inspecting the connection after applying specified unscrewing torque. The connection is expected to be maintained. G.2 Test conditions NOTE There is guidance or rationale for this Clause contained in Clause A.2. G.2.1 Test sample preconditioning Prior to testing, precondition the connector under test at 20 °C ± 5 °C and 50 % ± 10 % relative humidity for not less than 24 h. Preconditioning need not be performed for a connector made from non-hygroscopic materials. G.2.2 Environmental test conditions Perform tests at a temperature within the range of 15 °C to 30 °C and at a relative humidity between 10 % and 70 %, unless other ranges are specified in the relevant application part of ISO 80369. G.3 Apparatus a) the cone or socket connector under test; b) the appropriate reference connector, as specified in the relevant application part of ISO 80369 for the resistance to separation from unscrewing test method, to be assembled to the connector under test; c) a means to simultaneously apply an axial force of 27,5 N and torque of 0,12 N·m, or more if required by the relevant application part of ISO 80369; d) a means of measuring and displaying the elapsed time with an accuracy of ± 1 s; e) a means of measuring the specified unscrewing torque. G.4 Procedure a) Assemble the connector under test to the appropriate cone or socket reference connector, both components being dry. i) For a locking connector with fixed threads, assemble by rotating the connector under test to a torque of between 0,08 N·m and 0,12 N·m whilst applying an axial force of between 26,5 N and 27,5 N. Hold the force and torque for 5 s to 6 s and then release.
33	ii) For a connector with a floating or rotatable collar, assemble by introducing the mating features (i.e. connector taper) together with an axial force of between 26,5 N and 27,5 N whilst rotating the collar of the connector under test to a torque of between 0,08 N·m and 0,12 N·m. Hold the force and torque for 5 s to 6 s and then release. iii) For connectors with floating collar, apply an unscrewing torque to the collar as specified in the relevant application part of ISO 80369. b) Hold the torque at this value for the hold period specified in the relevant application part of ISO 80369. Do not apply any supplementary force in other directions. c) Confirm that the connectors have not completely separated. G.5 Test report Prepare a test report that — specifies testing was performed according to ISO 8036920, Annex G, — identifies the connectors under test, — identifies the number of connectors tested, — identifies the preconditioning and environmental test conditions, — identifies the reference connector used, — identifies the applied unscrewing torque, — discloses the duration of the test, and — discloses the presence or absence of the complete detachment of the connectors.
34	Annex H (normative) Resistance to overriding test method H.1 Principle The resistance to overriding of cone and socket locking connectors is determined by observing the thread or lugs of the connector under test after applying the specified torque. H.2 Test conditions NOTE There is guidance or rationale for this Clause contained in Clause A.2. H.2.1 Test sample preconditioning Prior to testing, precondition the connector under test at 20 °C ± 5 °C and 50 % ± 10 % relative humidity for not less than 24 h. Preconditioning need not be performed for a connector made from non-hygroscopic materials. H.2.2 Environmental test conditions Perform tests at a temperature within the range of 15 °C to 30 °C and at a relative humidity between 10 % and 70 %, unless other ranges are specified in the relevant application part of ISO 80369. H.3 Apparatus a) the cone or socket connector under test; b) the appropriate reference connector, as specified in the relevant application part of ISO 80369 for the resistance to overriding test method, to be assembled to the connector under test; c) a means to simultaneously apply an axial force of 27,5 N and torque of 0,12 N·m, or more if required by the relevant application part of ISO 80369; d) a means of measuring and displaying the elapsed time with an accuracy of ± 1 s; e) a means of measuring the specified overriding torque. H.4 Procedure a) Assemble the connector under test to the appropriate cone or socket reference connector, both connectors being dry. i) For a locking connector with fixed threads, assemble by rotating the connector under test to a torque of between 0,08 N·m and 0,12 N·m whilst applying an axial force of between 26,5 N and 27,5 N. Hold the force and torque for 5 s to 6 s and then release.
35	ii) For a connector with a floating or rotatable collar, assemble by introducing the mating features (i.e. connector taper) together with an axial force of between 26,5 N and 27,5 N whilst rotating the collar of the connector under test to a torque of between 0,08 N·m and 0,12 N·m. Hold the force and torque for 5 s to 6 s and then release. iii) Apply the torque specified in the relevant application part of ISO 80369 to the connector under test. b) Hold the torque at this value for the hold period specified in the relevant application part of ISO 80369. Do not apply any supplementary force or torque in other directions. c) Confirm that the threads or lugs of the reference connector have not completely extended past the threads or lugs of the connector under test and that there is no cocking of the connectors such that they are not axially aligned. H.5 Test report Prepare a test report that — specifies testing was performed according to ISO 8036920, Annex H, — identifies the connectors under test, — identifies the number of connectors tested, — identifies the preconditioning and environmental test conditions, — identifies the reference connector used, — identifies the applied torque, — discloses the hold period of the test, — discloses the presence or absence of the threads or lugs of the reference connector completely overriding the threads or lugs of the connector under test, and — discloses the presence or absence of cocking of the connectors such that they are not axially aligned.
36	Annex I (normative) Disconnection by unscrewing test method I.1 Principle The ability to disconnect the connection using a twist of cone and socket connectors is determined by inspecting the connection after applying the specified torque. The connection is expected to disconnect. I.2 Test conditions NOTE There is guidance or rationale for this Clause contained in Clause A.2. I.2.1 Test sample preconditioning Prior to testing, precondition the connector under test at 20 °C ± 5 °C and 50 % ± 10 % relative humidity for not less than 24 h. Preconditioning need not be performed for a connector made from non-hygroscopic materials. I.2.2 Environmental test conditions Perform tests at a temperature within the range of 15 °C to 30 °C and at a relative humidity between 10 % and 70 %, unless other ranges are otherwise specified in the relevant application part of ISO 80369. I.3 Apparatus a) the cone or socket connector under test; b) the appropriate reference connector, as specified in the relevant application part of ISO 80369 for the disconnection test method, to be assembled to the connector under test; c) a means to simultaneously apply an axial force of 27,5 N and torque of 0,12 N·m, or more if required by the relevant application part of ISO 80369; d) a means to measure an unscrewing torque of at least 0,24 N·m, or more if required by the relevant application part of ISO 80369; e) a means of measuring and displaying the elapsed time with an accuracy of ± 1 s. I.4 Procedure a) Assemble the connector under test to the appropriate cone or socket reference connector, both connectors being dry. i) For non-locking (slip) connectors, assemble by applying an axial force of between 26,5 N and 27,5 N. Then whilst continuing to apply the axial force, rotate the connector under test to either a torque of between 0,08 N·m and 0,10 N·m or a rotation not exceeding 90° and hold for 5 s to 6 s. Then release.
37	ii) For a locking connector with fixed threads, assemble by rotating the connector under test to a torque of between 0,08 N·m and 0,12 N·m whilst applying an axial force of between 26,5 N and 27,5 N. for 5 s to 6 s while rotating the connector under test to a torque of between 0,08 N·m and 0,12 N·m. Hold the force and torque for 5 s to 6 s and then release. iii) For a connector with a floating or rotatable collar, assemble by introducing the mating features (i.e. connector taper) together with an axial force of between 26,5 N and 27,5 N whilst rotating the collar of the connector under test to a torque of between 0,08 N·m and 0,12 N·m. Hold the force and torque for 5 s to 6 s and then release. b) Let the assembled connectors sit for 10 min and 15 min. c) Apply an unscrewing torque to the connector under test at a rate of approximately 2 r/min until the connection separates. Do not apply any supplementary force in other directions. d) Record the torque at which the connector under test completely detaches from the reference connector and confirm that the torque does not exceed the value specified in the relevant application part of ISO 80369. NOTE The sampling frequency of the means to measure the unscrewing torque needs to be appropriate in order to capture peak torque value caused by static friction. I.5 Test report Prepare a test report that — specifies testing was performed according to ISO 8036920, Annex I, — identifies the connectors under test, — identifies the number of connectors tested, — identifies the preconditioning and environmental test conditions, — identifies the reference connector used, and — identifies the applied unscrewing torque.
38	Annex J (informative) Modification of the test methods to generate variable data for statistical analysis J.1 Principle This Annex provides variations to test methods of this international standard that create variable test data for those manufacturers who wish to perform variable testing. Statistical methods for the analysis of the variable test data are also provided. J.2 Test method variations J.2.1 Fluid leakage test by pressure decay test method Use the test method for pressure decay described in Annex B. Determine the upper tolerance limit of the leakage rate from the test results and confirm that it does not exceed the value specified in the relevant application part of ISO 80369. J.2.2 Falling drop positive pressure liquid leakage test method The test method for liquid leakage in Annex C specifies pressurizing the connection with liquid for a minimum of 30 s at a specific minimum pressure and inspecting for a falling drop. Then the test is stopped. To acquire variable data, do not stop the test after 30 s. After 30 s, gradually increase the pressure until a drop forms and falls or the test sample bursts. Record the pressure at which the drop falls or the sample fails. Determine the lower tolerance limit from the test results and confirm that it exceeds the specification limit. J.2.3 Subatmospheric-pressure air leakage test method Use the test method for pressure decay described in Annex D. Determine the upper tolerance limit of the leakage rate from the test results and confirm that it does not exceed the value specified in the relevant application part of ISO 80369. J.2.4 Resistance to separation from axial load test method The test method for separation force described in Annex F specifies that the load on the samples is increased at a rate of approximately 10 N/s for the hold period specified in the relevant application part of ISO 80369, limiting the axial load to the specification limit. Then the test is stopped. To acquire variable data, do not stop the test after the hold period specified in the relevant application part of ISO 80369. After the hold period, continue increasing the load at approximately 10 N/s until the connectors separate. Determine the lower tolerance limit for the separation force from the test results and confirm that it exceeds the specification limit specified in the relevant application part of ISO 80369.
39	NOTE Testing to failure of connectors manufactured from certain materials such as metal is not recommended due to possible damage the reference connector. J.2.5 Resistance to separation from unscrewing test method The test method for unscrewing torque of Annex G specifies that the unscrewing torque as specified in the relevant application part of ISO 80369 is applied for the hold period specified in the relevant application part of ISO 80369, limiting the torque to the specification limit. Then the test is stopped. To acquire variable data, do not stop the test after the hold period specified in the relevant application part of ISO 80369. After the hold period, gradually increase the unscrewing torque until the connectors separate. Determine the lower tolerance limit for unscrewing torque from the test results and confirm that it exceeds the limit specified in the relevant application part of ISO 80369. J.2.6 Resistance to overriding test method The test method for resistance to overriding of Annex H specifies that the unscrewing torque is applied for hold period specified in the relevant application part of ISO 80369. Then the test is stopped. To acquire variable data, do not stop the test after the hold period specified in the relevant application part of ISO 80369. After the hold period, gradually increase the torque and hold for the specified hold period, repeating until the connectors override. Determine the lower tolerance limit from the test results and confirm that it exceeds the limit specified in the relevant application part of ISO 80369. J.2.7 Disconnection by unscrewing test method Use the test method for disconnection by unscrewing in Annex I. Determine the upper tolerance limit of the torque from the test results and confirm that it does not exceed the value specified in the relevant application part of ISO 80369. J.3 Statistical analysis of variable data J.3.1 Test for normality The test data should be analysed for normality per ISO 5479. If the data departs from the normal distribution, then the data should be transformed if possible using one of many available transforms such as a logarithmic, exponential, Box-Cox, or Johnson transform. If transformation does not produce normally distributed data, then distribution-free methods should be used to determine the tolerance limits. NOTE Most modern statistical software packages have incorporated tests for normality as well as multiple transformations for normalizing non-normal data. The use of one of these software packages for analysis of the test results is recommended. J.3.2 Tolerance limit calculation Calculate the one-sided upper or lower tolerance limit (UTL or LTL) per the methods detailed in ISO 162696. A brief summary of the method is described here. A statistical lower tolerance limit is in the form (μ – kσ), where we are (1-α) confident that at least (p) of the distribution is above μ – kσ. If this lower tolerance interval limit is above the lower specification limit then the specification passes. The same logic holds for the upper specification criterion as well as for a two-sided specification, simply changing the “-” to “+” or “±”.
40	The confidence level (1-α) and proportion (p) of the population used to calculate the tolerance limits should be determined per the manufacturer’s standard operating procedures. (1-α) and (p) are typically determined by the risk associated with failure of the connector in the intended application. Using the appropriate table in ISO 162696, determine k from the sample size (n), (1-α), and (p). Separate k factors are presented depending on the characteristic having a one or two-sided specification. Calculate the sample mean (x̄) and sample standard deviation (s). The upper or lower tolerance limit is determined from the formula x̄ ± k·s. NOTE 1 Most modern statistical software packages have incorporated the calculation of tolerance limits. The use of one of these software packages for analysis of the test results is recommended. NOTE 2 Tabled k factors are calculated using the inverse cumulative distribution function for the non-central t distribution and therefore assume that the data are normally distributed. Violations of this assumption can give biased results.
41	Annex K (normative) Aspiration of air leakage test method K.1 Principle NOTE There is guidance or rationale for this Clause contained in Clause A.2. Air leakage during aspiration in a connector assembly is tested by checking for the continued formation of air bubbles into a water vessel after applying negative pressure to the connector. K.2 Test conditions K.2.1 Test sample preconditioning Prior to testing, precondition the connector under test at 20 °C ± 5 °C and 50 % ± 10 % relative humidity for not less than 24 h. Preconditioning need not be performed for a connector made from non-hygroscopic materials. K.2.2 Environmental test conditions Perform tests at a temperature within the range of 15 °C to 30 °C and at a relative humidity between 10 % and 70 %, unless other ranges are specified in the relevant application part of ISO 80369. K.3 Apparatus a) the connector under test; b) the appropriate reference connector, as specified in the relevant application part of ISO 80369 for the leakage test method, to be assembled to the connector under test; c) a means to apply an axial force of 27,5 N and a torque of 0,12 N·m, or more if required by the relevant application part of ISO 80369; d) a vacuum source capable of producing and holding subatmospheric pressure as specified in the relevant application part of ISO 80369; NOTE At high altitudes the specified subatmospheric pressure might not be achievable. In this case measures need to be taken to increase the ambient pressure around the connector under test. e) a means of measuring and displaying the elapsed time with an accuracy of ± 1 s; f) a means of measuring the applied negative pressure with a accuracy of ± 1 % of the applied pressure; g) a transparent cylindrical vessel big enough to see bubbles and prevent water to be sucked into the vacuum source. The vessel shall be filled about one third of its capacity with distilled or potable water;
42	h) a means to seal the connector under test at its open end. / Key 1 a means to seal the connector under test 2 connector under test filled with water 3 reference connector filled with water 4 cylindrical vessel filled about one thired capacity with water 5 pressure-measuring device, e.g. a manometer 6 stop valve NOTE: The stop valve enables rapid application of the applied vacuum to the connector under test. 7 vacuum source, e.g., a vacuum pump Figure 1 — Example aspiration air leakage test apparatus K.4 Procedure a) Seal the open end of the connector under test so that it is airtight. b) Assemble the connector under test to the appropriate reference connector, both connectors being dry.
43	i) For a non-locking (slip) connector, assemble by applying an axial force of between 26,5 N and 27,5 N. Then whilst continuing to apply the axial force, rotate the connector under test to either a torque of between 0,08 N·m and 0,10 N·m or a rotation not exceeding 90° and hold for 5 s to 6 s. Then release. ii) For a locking connector with fixed threads, assemble by rotating the connector under test to a torque of between 0,08 N·m and 0,12 N·m whilst applying an axial force of between 26,5 N and 27,5 N. Hold the force and torque for 5 s to 6 s and then release. iii) For a connector with a floating or rotatable collar, assemble by introducing the mating features (i.e. connector taper) together with an axial force of between 26,5 N and 27,5 N whilst rotating the collar of the connector under test to a torque of between 0,08 N·m and 0,12 N·m. Hold the force and torque for 5 s to 6 s and then release. c) Add water into the assembled reference connector and the connector under test. Connect the open end of the reference connector to the test apparatus as shown in Figure #.1. d) Apply the negative pressure specified in the relevant application part of ISO 80369. NOTE If the pressure is not reached, there may be a leak in the connector under test. e) Once the required negative pressure is reached, record the pressure. f) Wait for up to 20 seconds for any initial bubble stream to stop than start the timing device. During the test period specified in the relevant application part of ISO 80369, visually inspect the water vessel for a continual formation of bubbles. The presence of a continuous stream of bubbles during the hold period or if the initial bubble stream does not stop indicates a leak from the connector under test. g) Release the test pressure at the end of the test period. h) Record the results. K.5 Test report Prepare a test report that — specifies testing was performed according to ISO 80369-20, Annex #, — identifies the connectors under test, — identifies the number of connectors tested, — identifies the preconditioning and environmental test conditions, — identifies the reference connector used, — identifies the applied pressure used, — identifies the acceptance criterion, — discloses the test period, — discloses the pressure range during the test,
44	— discloses whether the acceptance criterion is met.
45	Bibliography [1] ISO 594 (series)0F, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment [2] ISO 5479, Statistical interpretation of data — Tests for departure from the normal distribution [3] ISO 162696, Statistical interpretation of data — Part 6: Determination of statistical tolerance intervals [4] IEC 60601-1:2005+AMD1:2012+AMD2:2020, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance
46	Terminology — Alphabetized index of defined terms accessory………………………………………………………………………….……………ISO 803691:2018, definition 3.1 application……………………………………………………………………….……………ISO 803691:2018, definition 3.2 connection……………………………………………………………………….…………….ISO 803691:2018, definition 3.3 connector………………………….…………….…………………………………………….ISO 803691:2018, definition 3.4 manufacturer……………………………………………………………….….…………….ISO 14971:2019, definition 2.9 medical device………………………………..……………………………….……..……….ISO 14971:2019, definition 2.10 procedure……………….……………………..………………………………………………..ISO 14971:2019, definition 2.13 risk……………………………………………….………..……………………………………….ISO 14971:2019, definition 2.18 small-bore………………………………….……….……………………….……………….ISO 803691:2018, definition 3.13 test method………………………………………………………………………………… ISO 803691:2018, definition 3.15 type test………………………………………………………………………………………..……………………………………………3.1

Additional information

Status	Definitive
Pages	46
Publication Date	2022-05-26
Standard Number	22/30455929 DC
Title	BS EN ISO 80369-20. Small-bore connectors for liquids and gases in healthcare applications – Part 20. Common test methods
Descriptors	Blood transfusion equipment, Conical fittings (syringes), Pipe connections, Drug administration, Small, Medical equipment, Fluids handling equipment (medical), Catheters, Safety measures, Risk assessment, Gases, Medical breathing apparatus, Liquids, Parenteral infusion equipment
Publisher	BSI
Committee	CH/210
ICS Codes	11.040.25 - Syringes, needles and catheters

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