BS EN ISO 80369-20:2015

BSI Standards Publication

Small-bore connectors for

liquids and gases in healthcare
applications
Part 20: Common test methods
BS EN ISO 80369-20:2015 BRITISH STANDARD

National foreword
This British Standard is the UK implementation of EN ISO
80369-20:2015.
The UK participation in its preparation was entrusted to Technical
Committee CH/210/5, Small Bore Connectors for Medical Devices.
A list of organizations represented on this committee can be
obtained on request to its secretary.
This publication does not purport to include all the necessary
provisions of a contract. Users are responsible for its correct
application.
© The British Standards Institution 2015. Published by BSI Standards
Limited 2015
ISBN 978 0 580 82893 5
ICS 11.040.25
Compliance with a British Standard cannot confer immunity from
legal obligations.
This British Standard was published under the authority of the
Standards Policy and Strategy Committee on 30 June 2015.
Amendments issued since publication
Date Text affected
EUROPEAN STANDARD EN ISO 80369-20
NORME EUROPÉENNE
EUROPÄISCHE NORM May 2015

ICS 11.040.25

English Version

Small-bore connectors for liquids and gases in healthcare

applications - Part 20: Common test methods (ISO 80369-
20:2015)

Raccords de petite taille pour liquides et gaz utilisés dans le Verbindungsstücke mit kleinem Durchmesser für
domaine de la santé - Partie 20: Méthodes d'essai Flüssigkeiten und Gase in medizinischen Anwendungen -
communes (ISO 80369-20:2015) Teil 20: Allgemeine Prüfverfahren (ISO 80369-20:2015)

This European Standard was approved by CEN on 5 March 2015.

CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving
this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning
such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN and CENELEC
member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN and CENELEC member into its own language and notified to the CEN-CENELEC Management Centre
has the same status as the official versions.

CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia,
Spain, Sweden, Switzerland, Turkey and United Kingdom.

EUROPEAN COMMITTEE FOR STANDARDIZATION

COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels

© 2015 All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 80369-20:2015 E
CEN/CENELE worldwide for CEN national Members and for CENELEC Members.
C
BS EN ISO 80369-20:2015
EN ISO 80369-20:2015 (E)

Foreword

This document (EN ISO 80369-20:2015) has been prepared by Technical Committee ISO/TC 210 “Quality
management and corresponding general aspects for medical devices” in collaboration with Technical
Committee CEN/CLC/TC 3 “Quality management and corresponding general aspects for medical devices” the
secretariat of which is held by NEN.

This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by November 2015, and conflicting national standards shall be withdrawn
at the latest by November 2015.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.

This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).

For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document.

According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.

Endorsement notice

The text of ISO 80369-20:2015 has been approved by CEN as EN ISO 80369-20:2015 without any
modification.

3
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EN ISO 80369-20:2015 (E)

Annex ZA
(informative)

Relationship between this part of EN ISO 80369 and the essential

requirements of EU Directive 93/42/EEC

This part of EN ISO 80369 has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means to conforming to essential requirements of the
New Approach Directive 93/42/EEC, Council Directive of 14 June 1993 on the approximation of the laws of
the member states concerning medical devices” (Medical Device Directive).

Once this part of EN ISO 80369 is cited in the Official Journal of the European Union under that directive and
has been implemented as a national standard in at least one member state, compliance with the clauses of
this document given in Table ZA.1 confers, within the limits of the scope of this part of EN ISO 80369, a
presumption of conformity with the corresponding essential requirements of that directive and associated
EFTA regulations.

Table ZA.1 — Correspondence between this part of EN ISO 80369 and Directive 93/42/EEC

Clause(s)/sub-clause(s) of this Essential requirements (ERs) of

Qualifying remarks/notes
part of EN ISO 80369 EU Directive 93/42/EEC
4, Annex B, Annex C 7.5
4, Annex D 7.6
4, Annex F, Annex G, Annex H, 9.1
Annex I
4, Annex E 12.7.1
4 12.7.4

WARNING Other requirements and other EU Directives might be applicable to the products falling within the
scope of this part of EN ISO 80369.

For devices which are also machinery within the meaning of Directive 2006/42/EC on Machinery, Article 2(a),
in accordance with Directive 93/42/EEC, Article 3, the following Table ZA.2 details the relevant essential
health and safety requirements of Directive 2006/42/EC on Machinery to the extent to which they are more
specific than those of Directive 93/42/EEC along with the corresponding clauses of this part of EN ISO 80369.
Table ZA.2, however, does not imply any citation in the OJEU under the machinery directive and thus does
not provide presumption of conformity for the machinery directive.

Table ZA.2 — Relevant Essential Health and Safety Requirements (EHSRs) from Directive 2006/42/EC
on machinery that are addressed by this document

Clause(s)/sub-clause(s) of this EHSR of 2006/42/EC Qualifying remarks/notes

part of EN ISO 80369
4 1.5.4

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Contents Page

Foreword......................................................................................................................................................................................................................................... iv
Introduction...................................................................................................................................................................................................................................v
1 *Scope............................................................................................................................................................................................................................... 1
2 Normative references....................................................................................................................................................................................... 1
3 Terms and definitions...................................................................................................................................................................................... 1
4 Test methods for small-bore connectors............................................................................................................................. 1
Annex A (informative) Rationale and guidance......................................................................................................................................... 3
Annex B (normative) *Leakage by pressure decay test method............................................................................................ 6
Annex C (normative) Falling drop positive-pressure liquid leakage test method.............................................. 9
Annex D (normative) Subatmospheric-pressure air leakage test method.............................................................11
Annex E (normative) Stress cracking test method...........................................................................................................................15
Annex F (normative) Resistance to separation from axial load test method........................................................17
Annex G (normative) Resistance to separation from unscrewing test method..................................................19
Annex H (normative) Resistance to overriding test method..................................................................................................21
Annex I (normative) Disconnection by unscrewing test method......................................................................................23
Annex J (informative) Modification of the test methods to generate variable data for
statistical analysis.............................................................................................................................................................................................25
Annex K (informative) Terminology — alphabetized index of defined terms........................................................28
Bibliography.............................................................................................................................................................................................................................. 29

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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 on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT), see the following URL: Foreword — Supplementary information.
The committee responsible for this document is ISO/TC 210, Quality management and corresponding
general aspects for medical devices, and IEC/SC62D, Electromedical equipment. The draft was circulated
for voting to the national bodies of both ISO and IEC.
ISO 80369 consists of the following parts, under the general title Small-bore connectors for liquids and
gases in healthcare applications
— Part 1: General requirements
— Part 3: Connectors for enteral applications
— Part 5: Connectors for limb cuff inflation applications
— Part 6: Connectors for neuraxial applications
— Part 7: Connectors with 6% (Luer) taper for intravascular or hypodermic applications
— Part 20: Common test methods
The following parts are under preparation:
— Part 2: Connectors for breathing systems and driving gases applications
An additional part on Connectors for urethral and urinary applications is planned.

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Introduction
In this part of ISO 80369, the following print types are used:
— requirements and definitions: roman type;
— informative material appearing outside of tables, such as notes, examples, and references: in smaller
type. Normative text of tables is also in a smaller type;
— terms defined in ISO 80369-1 and Clause 3: small capitals.
In this part of ISO 80369, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
The verbal forms used in this International Standard conform to usage described in ISO/IEC Directives,
Part 2, Annex H. For the purposes of this part of ISO 80369, the auxiliary verb
— “shall” means that compliance with a requirement or a test is mandatory for compliance with this
part of ISO 80369,
— “should” means that compliance with a requirement or a test is recommended but is not mandatory
for compliance with this part of ISO 80369, and
— “may” is used to describe a permissible way to achieve compliance with a requirement or test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates
that there is guidance or rationale related to that item in Annex A.
The following paragraph is directed to authorities with jurisdiction and is not intended to address
clinical implementation.
The attention of Member Bodies and National Committees is drawn to the fact that equipment
manufacturers and testing organizations might need a transitional period following publication of a
new, amended or revised ISO or IEC publication in which to make products in accordance with the new
requirements and to equip themselves for conducting new or revised tests. It is the recommendation of
the committee that the content of this publication be adopted for implementation nationally not earlier
than three years from the date of publication for equipment newly designed and not earlier than five
years from the date of publication for equipment already in production.
This part of ISO 80369 describes the common test methods for evaluating the performance requirements
of the small-bore connectors specified in this series.
During the development of the ISO 80369- series, it became evident that many of the test methods were
very similar for each of the applications. It was therefore decided to standardize all the test methods
into a separate part of the series to prevent unnecessary duplication and minor differences. It is also
recognized that not all connectors can be evaluated using each test method in this part. The test
methods applicable to each connector are specified in the respective part of the ISO 80369- series.

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 BS EN ISO 80369-20:2015
INTERNATIONAL STANDARD ISO 80369-20:2015(E)

Small-bore connectors for liquids and gases in healthcare

applications —
Part 20:
Common test methods

1 *Scope
This part of ISO 80369 specifies the test methods to evaluate the performance requirements for small-
bore connectors specified in the ISO 80369- series.

2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
NOTE 1 The way in which these referenced documents are cited in normative requirements determines the
extent (in whole or in part) to which they apply.

NOTE 2 Informative references are listed in the bibliography.

ISO 14971:2007, Medical devices — Application of risk management to medical devices

ISO 80369-1:2010, 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 80369-1:2010, ISO 14971:2007,
and the following apply.
3.1
test method
definitive procedure for evaluating connectors that produces a test result
3.2
type test
test on a representative
[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 part of ISO 80369.

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ISO 80369-20:2015(E)


Table 1 — Test methods and corresponding Annex of this part of ISO 80369

Test method Annex

Leakage by pressure decay Annex B
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 statistical Annex J
analysis
NOTE Manufacturers can use the modified test methods of Annex J.

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Annex A
(informative)

Rationale and guidance

A.1 General guidance

This annex provides a rationale for some requirements of this part of ISO 80369 and is intended for
those who are familiar with the subject of this part of ISO  80369, but who have not participated in
its development. An understanding of the rationale 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 part of ISO 80369
necessitated by those developments.
The committee attempted to harmonize the functional test methods for the connectors of each
application in this part of ISO 80369. The test method annexes in this part of ISO 80369 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 part of ISO 80369 were extracted from the ISO 594- series of standards.
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.
NOTE Manufacturer 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 clauses and subclauses in this annex have been numbered to correspond to the numbering of the clauses
and subclauses of this part of ISO 80369 to which they refer. 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 part of ISO 80369. 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.
This part was given the −20 designation to leave space for connectors in new applications that might
be developed in the future using the numbers ISO 80369-8 through ISO 80369-19.
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.

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Temperature and humidity preconditioning requirements from ISO  594-1 and ISO  594-2 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 temperature range specified for testing is identical to that specified in ISO 594-1 and ISO 594-2.
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 a new test method that was not part of the former ISO 594- series.
However, it is based upon the informative liquid leakage test method of ISO 594-1:1986, Annex A.
Formula B.1
Formula B.1 utilized in this test method is derived from ISO 594-1:1986, Annex A. The following
paragraphs are a discussion of the derivation of Formula B.1 and practicalities of the usage of this formula.
Formula  B.1 yields a leakage index as opposed to a more traditional leak rate (mass or volume over
time). In a common leak test, the leak rate is proportional to the applied pressure, requiring the initial
applied pressure to be tightly specified in order to compare results from one test to another. To eliminate
this discrepancy, Formula B.1 includes a term (1/tp) which normalizes the results, making all results
comparable to the requirement regardless of different initial applied pressures.
The results from Formula B.1 are approximated from a linear pressure versus time law instead of the
exact exponential relationship that occurs for a compressible fluid and rigid container. Because of this
derivation, the error between the exact and approximated pressure versus time equations is less than
4 % when the recorded pressure decay does not exceed 22 % of the starting pressure.
Formula B.1 neglects a temperature correction. Within the specified range of test condition temperatures,
15°C to 25°C, the error is less than ± 1 %, which is noticeably less than the expected variability range for
a common product, as well as the effects of the linear approximation for pressure decay.
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 connection 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 594-1, 5.3
and ISO 594-2, 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 part of
ISO 80369 was developed during the committee drafts of ISO 80369-2 and ISO 80369-6.
Formula D.1
See also rationale for Formula B.1.
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.

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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 part of ISO 80369 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.

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Annex B
(normative)

*Leakage by pressure decay test method

B.1 Principle
The connector under test is assembled to an appropriate reference connector. The medium, as specified
in the relevant application part of this series, is introduced into the connection and pressurized to the
specified pressure.

B.2 *Test conditions

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
25 % and 65 %, unless other ranges are specified in the relevant application part of ISO 80369.

B.3 Apparatus
a) the male or female 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 the medium 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 and displaying the elapsed time with an accuracy of ± 1 s;
f) a means of measuring the applied pressure with a minimum accuracy of 0,3 %;
g) a stop valve;
h) a leak-proof plug.
An automated pressure decay leak test system may be substituted for any or all items d), e), f), and g).

B.4 Procedure
a) Assemble the connector under test to the appropriate male or female reference connector, both
connectors being dry.

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b) For a non-locking (slip) connector, assemble by 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
0,10 N·m and a rotation not exceeding 90°.
c) For a locking connector with fixed threads, assemble by 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.
d) 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 for 5 s to 6 s while
rotating the collar of the connector under test to a torque of between 0,08 N·m and 0,12 N·m.
e) Seal the outlet bore of the connector under test.
f) Apply the medium at the applied pressure specified in the relevant application part of ISO 80369
to the assembly through the bore and close the valve.
g) Record the test pressure and start the timing device.
h) After the hold period specified in the relevant application part of ISO 80369 and record the test
pressure and time.
i) Calculate the change in test pressure.
j) Calculate the leakage rate, L on the basis of Formula B.1.
sp ∆p
L= ×v× (*B.1)
tp ∆t
Where
  L is the the leakage rate, in Pa·m3/s;

  sp is the lower limit of test pressure as specified in the relevant application part of ISO 80369, in
Pa;

  tp is the test pressure at the start of the test, in Pa;

  v is the volume from the valve to the test specimen, in m3;

  Δp is the pressure change during the test period, in Pa;

  Δt is the test period, in s.

EXAMPLE At a specified pressure of 300 kPa, a test pressure of 310 kPa (gauge) and a total volume of 10 ml,
a pressure drop of 10 kPa (gauge) is established within a period of 25 s.

3 × 105 1 × 10 4
L= × 10 × 10 −6 × = 0, 0039 Pa×m 3 /s (B.2)
3, 1 × 105 25
k) Verify that the leakage rate does not exceed 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 80369-20, Annex B,
— identifies the connectors under test,

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— identifies the number of connectors tested,

— identifies the type of medium used,
— identifies the applied pressure used,
— identifies the acceptance criterion,
— discloses the measured test pressure,
— discloses the volume of the test apparatus,
— discloses the pressure drop during the test period,
— discloses the hold period of the test, and
— discloses the calculated leakage rate.

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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

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
25 % and 65 %, unless other ranges are specified in the relevant application part of ISO 80369.

C.3 Apparatus
a) the male or female 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 %;
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 male or female reference connector, both
connectors being dry.
b) For a non-locking (slip) connector, assemble by 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
0,10 N·m and a rotation not exceeding 90°.

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c) For a locking connector with fixed threads, assemble by 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.
d) 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 for 5 s to 6 s while
rotating collar of the connector under test to a torque of between 0,08 N·m and 0,12 N·m.
e) Introduce water into the assembly to expel the air.
f) Ensure that the outside of the connector assembly is dry.
g) 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.
h) 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.
i) 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 80369-20, Annex C,
— identifies the connectors under test,
— identifies the number of connectors tested,
— 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.

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ISO 80369-20:2015(E)


Annex D
(normative)

Subatmospheric-pressure air leakage test method

D.1 Principle
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.

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
25 % and 65 %, unless other ranges are specified in the relevant application part of ISO 80369.

D.3 Apparatus
a) the male or female 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 vacuum source;
EXAMPLE A syringe in accordance with ISO  7886-1 or a syringe capable of producing and holding
subatmospheric pressure as specified in the relevant application part of this series.

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 minimum accuracy of ± 0,3 %;
g) a stop valve;
h) a leak proof plug.
An automated pressure decay leak test system may be substituted for items d), e), f), and g).
If a digital pressure gauge is used with manual recording of data, the gauge may incorporate some form
of a data stabilization algorithm to facilitate easy reading of the digital display.

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D.4 Procedure
a) Assemble the connector under test to the appropriate male or female reference connector, both
connectors being dry.
b) For a non-locking (slip) connector, assemble by 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
0,10 N·m and a rotation not exceeding 90°.
c) For a locking connector with fixed threads, assemble by 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 0,12 N·m.
d) For a connector with a floating or rotatable collar, assemble by introducing the mating features
(i.e. connector taper) together with an axial force not exceeding 27,5 N for 5 s to 6 s while rotating
the collar of the connector under test to a torque of between 0,08 N·m and 0,12 N·m.
e) Assemble the subatmospheric-pressure air leak test apparatus as shown in Figure D.1.
f) The internal volume of the leak test apparatus on the test sample side of the stop valve (opposite the
vacuum source) shall not exceed 25 ml.
g) Seal the outlet bore of the connector under test so that it is airtight.
h) Apply the subatmospheric pressure specified in the relevant application part of ISO 80369 and
close the valve.
i) Record the pressure and start the stopwatch.
j) After the hold period specified in the relevant application part of ISO 80369 and record the
pressure and time.
k) Calculate the change in pressure.
l) Calculate the leakage rate, L, on the basis of Formula D.1.
sp ∆p
L= ×v× (*D.1)
tp ∆t
where
  L is the leakage rate;

  sp is the specified nominal subatmospheric test pressure;

  tp is the actual subatmospheric test pressure at the start of the test;

  v is the volume, in cubic meters, between the valve and the test specimen;

  Δp is the pressure change during the test period;

  Δt the test period.

EXAMPLE At a specified subatmospheric pressure of 40 kPa (gauge), a test subatmospheric pressure of 39 kPa
(gauge) and a total volume of 10 ml, a pressure change of 10 kPa (gauge) is established within a period of 25 s, or

−4 × 10 4 1 × 10 4
L= × 10 × 10−6 × (D.2)
−3,9 × 10 4 25

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L = 0, 0041 Pa ⋅ m 3 /s (D.3)

Where a range is specified in the relevant application part of this series, the nominal value is the mean
value between the range values. For example, 84 kPa.
m) Verify that the leakage rate does not exceed the value specified in the relevant application part
of ISO 80369.

Key
1 leak-proof plug
2 connector under test
3 reference connector
4 stop-valve
5 vacuum source, e.g. a syringe
6 pressure-measuring device, e.g. a manometer

Figure D.1 — Example subatmospheric-pressure air leakage test apparatus

D.5 Test report

Prepare a test report that
— specifies testing was performed according to ISO 80369-20, Annex D,
— identifies the connectors under test,
— identifies the number of connectors tested,
— identifies the applied pressure used,
— identifies the acceptance criterion,
— discloses the volume of the test apparatus,

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— discloses the hold period of the test,

— discloses the pressure at the start and end of the test, and
— discloses the calculated leak rate.

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ISO 80369-20:2015(E)


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

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
25 % and 65 %, unless other ranges are specified in the relevant application part of ISO 80369.

E.3 Apparatus
a) the male or female 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 male or female reference connector, both
connectors being dry.
b) For a non-locking (slip) connector, assemble by 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
0,10 N·m and a rotation not exceeding 90°.
c) For a locking connector with fixed threads, assemble by 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.
d) 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 for 5 s to 6 s while
rotating the collar of the connector under test to a torque of between 0,08 N·m and 0,12 N·m.

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e) 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.
f) Verify 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 80369-20, Annex E,
— identifies the connectors under test,
— identifies the number of connectors tested,
— discloses duration of the test, and
— discloses the results of the leakage test performed.

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ISO 80369-20:2015(E)


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

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
25 % and 65 %, unless other ranges are specified in the relevant application part of ISO 80369.

F.3 Apparatus
a) the male or female connector under test;
b) the appropriate reference connector, as specified in the relevant application part of ISO 80369
for the resistance to separation 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 male or female reference connector, both
connectors being dry.
b) For a non-locking (slip) connector, assemble by 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
0,1 N·m and a rotation not exceeding 90°.
c) For a locking connector with fixed threads, assemble by 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.

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d) 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 for 5 s to 6 s while
rotating the collar of the connector under test to a torque of between 0,08 N·m and 0,12 N·m.
e) 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.
f) Verify 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 80369-20, Annex F,
— identifies the connectors under test,
— identifies the number of connectors tested,
— identifies the applied axial force,
— discloses the duration of the test, and
— discloses the presence or absence of the separation of the connectors.

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ISO 80369-20:2015(E)


Annex G
(normative)

Resistance to separation from unscrewing test method

G.1 Principle
The security of connection between male and female locking connectors is determined by inspecting the
connection after applying specified unscrewing torque. The connection is expected to be maintained.

G.2 *Test conditions

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
25 % and 65 %, unless other ranges are specified in the relevant application part of ISO 80369.

G.3 Apparatus
a) the male or female connector under test;
b) the appropriate reference connector, as specified in the relevant application part of ISO 80369
for the resistance to separation 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 male or female reference connector, both
components being dry.
b) For a locking connector with fixed threads, assemble by 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.
c) 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 for 5 s to 6 s while
rotating the collar of the connector under test to a torque of between 0,08 N·m and 0,12 N·m.
d) For connectors with floating collar, apply an unscrewing torque to the collar as specified in the
relevant application part of ISO 80369.

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e) 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.
f) Verify that the connectors have not completely separated.

G.5 Test report

Prepare a test report that
— specifies testing was performed according to ISO 80369-20, Annex G,
— identifies the connectors under test,
— identifies the number of connectors tested,
— identifies the applied unscrewing torque,
— discloses the duration of the test, and
— discloses the presence or absence of the separation of the connectors.

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ISO 80369-20:2015(E)


Annex H
(normative)

Resistance to overriding test method

H.1 Principle
The resistance to overriding of male and female locking connectors is determined by observing the
thread or lugs of the connector under test after applying the specified torque.

H.2 *Test conditions

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
25 % and 65 %, unless other ranges are specified in the relevant application part of ISO 80369.

H.3 Apparatus
a) the male or female 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 male or female reference connector, both
connectors being dry.
b) For a locking connector with fixed threads, assemble by 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.
c) 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 for 5 s to 6 s while
rotating the collar of the connector under test to a torque of between 0,08 N·m and 0,12 N·m.
d) Apply the torque specified in the relevant application part of ISO 80369 to the connector under test.

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e) 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.
f) Verify 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 80369-20, Annex H,
— identifies the connectors under test,
— identifies the number of connectors tested,
— 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.

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ISO 80369-20:2015(E)


Annex I
(normative)

Disconnection by unscrewing test method

I.1 Principle
The ability to disconnect the connection using a twist of male and female connectors is determined by
inspecting the connection after applying the specified torque. The connection is expected to disconnect.

I.2 *Test conditions

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 25 %
and 65 %, unless other ranges are otherwise specified in the relevant application part of ISO 80369.

I.3 Apparatus
a) the male or female 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 male or female reference connector, both
connectors being dry.
b) For non-locking (slip) connectors, assemble by 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 0,10 N·m
and a rotation not exceeding 90°.
c) For a locking connector with fixed threads, assemble by 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.

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d) 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 for 5 s to 6 s while
rotating the collar of the connector under test to a torque of between 0,08 N·m and 0,12 N·m.
e) Let the assembled connectors sit for 10 min and 15 min.
f) 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.
g) Record the torque at which the connector under test completely detaches from the reference
connector and verify 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 80369-20, Annex I,
— identifies the connectors under test,
— identifies the number of connectors tested,
— identifies the applied unscrewing torque, and
— discloses the presence or absence of the separation of the connectors.

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ISO 80369-20:2015(E)


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 verify 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 verify 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 verify 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.

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Determine the lower tolerance limit for the separation force from the test results and verify that it
exceeds the specification limit specified in the relevant application part of ISO 80369.
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 verify 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 verify 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 verify 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 16269-6. A brief summary of the method is described here.

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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 “±”.
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 16269-6, 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.

© ISO 2015 – All rights reserved  27

BS EN ISO 80369-20:2015
ISO 80369-20:2015(E)


Annex K
(informative)

Terminology — alphabetized index of defined terms

accessory………………………………………………………………………….…………...ISO 80369-1:2010, definition 3.1

application……………………………………………………………………….……………ISO 80369-1:2010, definition 3.2
connection……………………………………………………………………….…………....ISO 80369-1:2010, definition 3.4
connector………………………….…………….…………………………………………….ISO 80369-1:2010, definition 3.5
manufacturer……………………………………………………………….….…………….ISO 14971:2007, definition 2.8
medical device………………………………..……………………………….……..……….ISO 14971:2007, definition 2.9
procedure……………….……………………..………………………………………………..ISO 14971:2007, definition 2.12
risk……………………………………………….………..……………………………………….ISO 14971:2007, definition 2.16
small-bore………………………………….……….……………………….……………….ISO 80369-1:2010, definition 3.11
test method……………………………………………………………………………..……...………………………………………….3.1
type test………………………………………………………………………………………..……………………………………………3.2

28  © ISO 2015 – All rights reserved

 BS EN ISO 80369-20:2015
ISO 80369-20:2015(E)


Bibliography

[1] ISO 5479, Statistical interpretation of data — Tests for departure from the normal distribution
[2] ISO/IEC/TR  10000-1, Information technology — Framework and taxonomy of International
Standardized Profiles — Part 1: General principles and documentation framework
[3] ISO 10241-1, Terminological entries in standards — Part 1: General requirements and examples
of presentation
[4] ISO 10241-2, Terminological entries in standards — Part 2: Adoption of standardized
terminological entries
[5] ISO 16269-6, Statistical interpretation of data — Part 6: Determination of statistical tolerance intervals
[6] IEC 60027 (all parts), Letter symbols to be used in electrical technology
[7] ISO 80000 (all parts), Quantities and units
[8] ISO 14971:2007, Medical devices — Application of risk management to medical devices

© ISO 2015 – All rights reserved  29

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