SIST EN ISO/IEC 80369-20:2015
(Main)Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods (ISO 80369-20:2015)
Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods (ISO 80369-20:2015)
This part of ISO 80369 specifies the functional requirements for SMALL-BORE CONNECTORS intended to be used for CONNECTIONS of MEDICAL DEVICES and related ACCESSORIES. This part of ISO 80369 specifies functional requirements for the essential performance of SMALL-BORE CONNECTORS. This part of ISO 80369 does not specify the functional requirements for the MEDICAL DEVICES or ACCESSORIES that use these CONNECTORS. Such requirements are given in particular International Standards for specific MEDICAL DEVICES or ACCESSORIES.
Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in medizinischen Anwendungen - Teil 20: Allgemeine Prüfverfahren (ISO 80369-20:2015)
Der vorliegende Teil der ISO 80369 legt die PRÜFVERFAHREN zur Unterstützung der Funktionsanforderungen für VERBINDUNGSSTÜCKE mit KLEINEM DURCHMESSER zur Verwendung für VERBINDUNGEN von MEDIZIN¬PRODUKTEN und entsprechenden ZUBEHÖRTEILEN fest.
Der vorliegende Teil der ISO 80369 legt nicht die Funktionsanforderungen für die MEDIZINPRODUKTE oder ZUBEHÖRTEILE fest, mit denen diese VERBINDUNGSSTÜCKE verwendet werden. Derartige Anforderungen sind in den einzelnen Internationalen Normen für spezifische MEDIZINPRODUKTE oder ZUBEHÖRTEILE angegeben.
Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé - Partie 20: Méthodes d'essai courantes (ISO 80369-20:2015)
L'ISO 80369-20:2015 spécifie les méthodes d'essai qui permettent d'évaluer les exigences de performance relatives aux raccords de petite taille spécifiés dans la série de l'ISO 80369.
Priključki z majhnim premerom za tekočine in pline za uporabo v zdravstvu - 20. del: Splošne preskusne metode (ISO 80369-20:2015)
Ta del standarda ISO 80369 določa funkcionalne zahteve za PRIKLJUČKE Z MAJHNIM PREMEROM, namenjene uporabi za POVEZAVE MEDICINSKIH PRIPOMOČKOV in povezane DODATKE. Ta del standarda ISO 80369 določa funkcionalne zahteve za bistvene lastnosti PRIKLJUČKOV Z MAJHNIM PREMEROM. Ta del standarda ISO 80369 ne določa funkcionalnih zahtev za MEDICINSKE PRIPOMOČKE ali DODATKE, v katerih se uporabljajo ti PRIKLJUČKI. Takšne zahteve so podane v zadevnih mednarodnih standardih za posamezne MEDICINSKE PRIPOMOČKE ali DODATKE.
General Information
Relations
Related Packages
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO/IEC 80369-20:2015
01-september-2015
3ULNOMXþNL]PDMKQLPSUHPHURP]DWHNRþLQHLQSOLQH]DXSRUDERY]GUDYVWYX
GHO 6SORãQHSUHVNXVQHPHWRGH ,62
Small-bore connectors for liquids and gases in healthcare applications - Part 20:
Common test methods (ISO 80369-20:2015)
Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in
medizinischen Anwendungen - Teil 20: Allgemeine Prüfverfahren (ISO 80369-20:2015)
Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé - Partie
20: Méthodes d'essai courantes (ISO 80369-20:2015)
Ta slovenski standard je istoveten z: EN ISO 80369-20:2015
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO/IEC 80369-20:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO/IEC 80369-20:2015
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SIST EN ISO/IEC 80369-20:2015
EUROPEAN STANDARD
EN ISO/IEC 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/IEC 80369-20:2015 E
CEN/CENELE worldwide for CEN national Members and for CENELEC Members.
C
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SIST EN ISO/IEC 80369-20:2015
EN ISO/IEC 80369-20:2015 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this part of EN ISO/IEC 80369 and the essential
requirements of EU Directive 93/42/EEC .4
2
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SIST EN ISO/IEC 80369-20:2015
EN ISO/IEC 80369-20:2015 (E)
Foreword
This document (EN ISO/IEC 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/IEC 80369-20:2015 without any
modification.
3
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SIST EN ISO/IEC 80369-20:2015
EN ISO/IEC 80369-20:2015 (E)
Annex ZA
(informative)
Relationship between this part of EN ISO/IEC 80369 and the essential
requirements of EU Directive 93/42/EEC
This part of EN ISO/IEC 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/IEC 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/IEC 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/IEC 80369 and Directive 93/42/EEC
Clause(s)/sub-clause(s) of this Essential requirements (ERs) of
Qualifying remarks/notes
part of EN ISO/IEC 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/IEC 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/IEC 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/IEC 80369
4 1.5.4
4
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SIST EN ISO/IEC 80369-20:2015
INTERNATIONAL ISO
STANDARD 80369-20
First edition
2015-05-15
Small-bore connectors for liquids and
gases in healthcare applications —
Part 20:
Common test methods
Raccords de petite taille pour liquides et gaz utilisés dans le domaine
de la santé —
Partie 20: Méthodes d’essai communes
Reference number
ISO 80369-20:2015(E)
©
ISO 2015
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SIST EN ISO/IEC 80369-20:2015
ISO 80369-20:2015(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2015, Published in Switzerland
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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2015 – All rights reserved
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SIST EN ISO/IEC 80369-20:2015
ISO 80369-20:2015(E)
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
© ISO 2015 – All rights reserved iii
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SIST EN ISO/IEC 80369-20:2015
ISO 80369-20:2015(E)
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.
iv © ISO 2015 – All rights reserved
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SIST EN ISO/IEC 80369-20:2015
ISO 80369-20:2015(E)
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.
© ISO 2015 – All rights reserved v
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SIST EN ISO/IEC 80369-20:2015
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SIST EN ISO/IEC 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.
© ISO 2015 – All rights reserved 1
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SIST EN ISO/IEC 80369-20:2015
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.
2 © ISO 2015 – All rights reserved
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SIST EN ISO/IEC 80369-20:2015
ISO 80369-20:2015(E)
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.
© ISO 2015 – All rights reserved 3
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SIST EN ISO/IEC 80369-20:2015
ISO 80369-20:2015(E)
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/t ) which normalizes the results, making all results
p
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.
4 © ISO 2015 – All rights reserved
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SIST EN ISO/IEC 80369-20:2015
ISO 80369-20:2015(E)
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
...
SLOVENSKI STANDARD
oSIST prEN ISO/IEC 80369-20:2013
01-november-2013
3ULNOMXþNL]PDMKQLPSUHPHURP]DWHNRþLQHLQSOLQH]DXSRUDERY]GUDYVWYX
GHO 6SORãQHSUHVNXVQHPHWRGH ,62',6
Small-bore connectors for liquids and gases in healthcare applications - Part 20:
Common test methods (ISO/DIS 80369-20:2013)
Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in
medizinischen Anwendungen - Teil 20: Allgemeine Prüfverfahren (ISO/DIS 80369-
20:2013)
Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé - Partie
20: Méthodes d'essai courantes (ISO/DIS 80369-20:2013)
Ta slovenski standard je istoveten z: prEN ISO/IEC 80369-20
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
oSIST prEN ISO/IEC 80369-20:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO/IEC 80369-20:2013
---------------------- Page: 2 ----------------------
oSIST prEN ISO/IEC 80369-20:2013
DRAFT INTERNATIONAL STANDARD
ISO/IEC DIS 80369-20
ISO/TC 210 Secretariat: ANSI
Voting begins on: Voting terminates on:
2013-08-15 2014-01-15
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
ICS: 11.040.25
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ISO/IEC DIS 80369-20:2013(E)
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PROVIDE SUPPORTING DOCUMENTATION. ISO/IEC 2013
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ISO/IEC DIS 80369-20:2013(E)
Copyright notice
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oSIST prEN ISO/IEC 80369-20:2013
ISO/DIS 80369-20
1 Contents Page
2 Foreword . iv
3 Introduction . vi
4 1 Scope . 1
5 2 Normative references . 1
6 3 Terms and definitions . 1
7 4 TEST METHODS for SMALL-BORE CONNECTORS . 1
8 4.1 Fluid leakage TEST METHOD by pressure decay . 1
9 4.2 Falling drop positive pressure liquid leakage TEST METHOD . 2
10 4.3 Subatmospheric-pressure air leakage TEST METHOD . 2
11 4.4 Stress cracking TEST METHOD . 2
12 4.5 Resistance to separation from axial load TEST METHOD . 2
13 4.6 Resistance to separation from unscrewing TEST METHOD . 2
14 4.7 Resistance to overriding TEST METHOD . 2
15 4.8 Disconnection by unscrewing TEST METHOD . 2
16 4.9 Variable data TEST METHODS . 2
17 Annex A (informative) Rationale and Guidance . 3
18 Annex B (normative) Fluid leakage TEST METHOD by pressure decay . 6
19 Annex C (normative) Falling drop positive pressure liquid leakage TEST METHOD . 9
20 Annex D (normative) Subatmospheric-pressure air leakage TEST METHOD. 11
21 Annex E (normative) Stress cracking TEST METHOD . 15
22 Annex F (normative) Resistance to separation from axial load TEST METHOD . 17
23 Annex G (normative) Resistance to separation from unscrewing TEST METHOD . 19
24 Annex H (normative) Resistance to overriding TEST METHOD . 21
25 Annex I (normative) Disconnection by unscrewing TEST METHOD . 23
26 Annex J (normative) Alternate TEST METHODS to generate variable data for statistical analysis . 25
27 Bibliography . 28
28 Terminology - Alphabetized index of defined terms . 29
29
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30 Foreword
31 ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
32 (ISO member bodies). The work of preparing International Standards is normally carried out through ISO
33 technical committees. Each member body interested in a subject for which a technical committee has been
34 established has the right to be represented on that committee. International organizations, governmental and
35 non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
36 International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
37 International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
38 The main task of technical committees is to prepare International Standards. Draft International Standards
39 adopted by the technical committees are circulated to the member bodies for voting. Publication as an
40 International Standard requires approval by at least 75 % of the member bodies casting a vote.
41 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
42 rights. ISO shall not be held responsible for identifying any or all such patent rights.
43 ISO 80369-20 was prepared jointly by Technical Committees ISO/TC 210, Quality management and
44 corresponding general aspects for medical devices, and IEC/SC62D, Electromedical equipment used in
45 medical practice. The draft was circulated for voting to the national bodies of both ISO and IEC.
46 ISO consists of the following parts, under the general title Small-bore connectors for liquids and gases in
47 healthcare applications:
48 Part 1: General requirements
49 Part 2: Connectors for breathing systems and driving gases applications
50 Part 3: Connectors for enteral applications
51 Part 5: Connectors for limb cuff inflation applications
52 Part 6: Connectors for neuraxial applications
53 Part 7: Connectors for intravascular or hyopdermic applications
54 Part 20: Common test methods (this standard)
55 In this standard, the following print types are used:
56 Requirements and definitions: roman type.
57 Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative
58 text of tables is also in a smaller type.
59 TERMS DEFINED IN ISO 80369-1 AND CLAUSE 3 OF THIS STANDARD: SMALL CAPITALS.
60 In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of
61 the conditions is true.
62 The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives, Part
63 2. For the purposes of this standard, the auxiliary verb:
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64 “shall” means that compliance with a requirement or a test is mandatory for compliance with this
65 standard;
66 “should” means that compliance with a requirement or a test is recommended but is not mandatory for
67 compliance with this standard;
68 “may” is used to describe a permissible way to achieve compliance with a requirement or test.
69 An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that
70 there is guidance or rationale related to that item in Annex A.
71 The attention of Member Bodies and National Committees is drawn to the fact that equipment manufacturers
72 and testing organizations may need a transitional period following publication of a new, amended or revised
73 ISO or IEC publication in which to make products in accordance with the new requirements and to equip
74 themselves for conducting new or revised tests. It is the recommendation of the committee that the content of
75 this publication be adopted for implementation nationally not earlier than 3 years from the date of publication
76 for equipment newly designed and not earlier than 5 years from the date of publication for equipment already
77 in production.
78
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79 Introduction
80 This part of ISO 80369 includes common TEST METHODS for evaluating the functional performance of the
81 SMALL-BORE CONNECTORS of this series.
82 Many of the attribute TEST METHODS in this standard are extracted from the previous standards for Luer
83 CONNECTORS, ISO 594-1 and ISO 594-2. Modifications of the TEST METHODS were developed to permit testing
84 using variable data.
85 The TEST METHODS of this standard were developed based on the resolution of the comments generated
86 during the Committee Draft phase of the development of the ISO 80369 series. During the development of the
87 ISO 80369 series, the committee recognized that many of the performance requirements for the individual
88 CONNECTORS of the series were the same. This standard was developed to standardize the TEST METHODS of
89 this series. It is recognized that some CONNECTORS use TEST METHODS that are not common to other
90 CONNECTORS. In this case, TEST METHODS specific to the CONNECTOR can be found in the corresponding part of
91 this series. It is also recognized that not all CONNECTORS can be evaluated using each TEST METHOD in this part.
92 The TEST METHODS applicable to each CONNECTOR are specified in the respective part of the ISO 80369 series.
93
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DRAFT INTERNATIONAL STANDARD ISO/DIS 80369-20
94 Small-bore connectors for liquids and gases in healthcare
95 applications — Part 20: Common test methods
96 1 * Scope
97 This part of ISO 80369 specifies the TEST METHODS to support the functional requirements for SMALL-BORE
98 CONNECTORS intended to be used for CONNECTIONS of MEDICAL DEVICES and related ACCESSORIES.
99 This part of ISO 80369 does not specify the functional requirements for the MEDICAL DEVICES or ACCESSORIES
100 that use these CONNECTORS. Such requirements are given in particular International Standards for specific
101 MEDICAL DEVICES or ACCESSORIES.
102 2 Normative references
103 The following referenced documents are indispensable for the application of this document. For dated
104 references, only the edition cited applies. For undated references, the latest edition of the referenced
105 document (including any amendments) applies.
106 ISO 80369-1:2010, Small-bore connectors for liquids and gases in healthcare applications – Part 1: General
107 requirements
108 3 Terms and definitions
109 For the purposes of this document, the terms and definitions specified in ISO 80369-1:2010 and
110 ISO 14971:2007 and the following apply. For convenience, the sources of all defined terms used in this
111 document are given in the index at the end of this document.
112 3.1
113 TEST METHOD
114 definitive PROCEDURE for evaluating CONNECTORS that produces a test result
115 3.2
116 TYPE TEST
117 test on a representative sample with the objective of determining if the CONNECTOR, as designed and
118 manufactured, can meet the requirements of this standard
119 [SOURCE: IEC 60601-1:2005, definition 3.135 modified: deleted ‘of the equipment’ and replaced ‘equipment’
120 with ‘CONNECTOR’.]
121 4 TEST METHODS for SMALL-BORE CONNECTORS
122 4.1 Fluid leakage TEST METHOD by pressure decay
123 Annex B contains the TYPE TEST for fluid leakage by pressure decay.
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124 4.2 Falling drop positive pressure liquid leakage TEST METHOD
125 Annex C contains the TYPE TEST for liquid leakage.
126 4.3 Subatmospheric-pressure air leakage TEST METHOD
127 Annex D contains the TYPE TEST for subatmospheric-pressure air leakage.
128 4.4 Stress cracking TEST METHOD
129 Annex E contains the TYPE TEST for stress cracking.
130 4.5 Resistance to separation from axial load TEST METHOD
131 Annex F contains the TYPE TEST for resistance to separation from axial load.
132 4.6 Resistance to separation from unscrewing TEST METHOD
133 Annex G contains the TYPE TEST for resistance to separation from unscrewing.
134 4.7 Resistance to overriding TEST METHOD
135 Annex H contains the TYPE TEST for resistance to overriding.
136 4.8 Disconnection by unscrewing TEST METHOD
137 Annex I contains the TYPE TEST for disconnection by unscrewing.
138 4.9 Variable data TEST METHODS
139 Annex J contains the TYPE TEST modifications to the previous TEST METHODS utilizing variable test data.
140
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141 Annex A
142 (informative)
143
144 Rationale and Guidance
145 A.1 General guidance
146 This Annex provides a rationale for some requirements of ISO 80369-20 and is intended for those who are
147 familiar with the subject of ISO 80369-20 but who have not participated in its development. An understanding
148 of the rationale underlying these requirements is considered to be essential for their proper application.
149 Furthermore, as clinical practice and technology change, it is believed that a rationale for the present
150 requirements will facilitate any revision of this document necessitated by those developments.
151 The committee attempted to harmonize the functional TEST METHODS for the CONNECTORS of each APPLICATION
152 in this international standard. The TEST METHOD annexes in this standard describe a specific test PROCEDURE
153 for a TYPE TEST but allow for modification to specific test conditions or acceptance criteria as necessary for
154 each APPLICATION.
155 Many of the TEST METHODS in this standard were extracted from the ISO 594 series of standards. The
156 committee attempted to minimize changes to these TEST METHODS. However, changes were made to TEST
157 METHODS which contained subjective acceptance criteria.
158 The assembly PROCEDURE in each Annex mimics the assembly PROCEDURE that was extracted from ISO 594.
159 An additional clarification was made for CONNECTORS with a floating or rotatable locking collar. Test sample
160 preconditioning and environmental test condition requirements were added to each Annex.
161 A.2 Rationale for particular clauses and subclauses
162 The clauses and subclauses in this Annex have been numbered to correspond to the numbering of the
163 clauses and subclauses of this document to which they refer. The numbering is, therefore, not consecutive.
164 Clause 1 Scope
165 The ease of assembly TEST METHOD that was part of the ISO 594 series has been removed as a requirement
166 from the APPLICATION parts of this series of standards and is not present in this standard. The acceptance
167 criterion of the ISO 594 series for ease of assembly was subjective. It was underdefined for a standardized
168 TEST METHOD, i.e. “a satisfactory fit” is not repeatable. Furthermore, the intent of the ease of assembly test was
169 to ensure that the USER can complete the CONNECTION using the mating halves of the CONNECTOR. This
170 requirement is satisfied by the requirement for usability validation for all new connectors being added to this
171 series of standards. Therefore, the ease of assembly TEST METHOD has been omitted from the ISO 80369
172 series of standards.
173 Subclause B.2.1 Test sample preconditioning
174 Subclause C.2.1 Test sample preconditioning
175 Subclause D.2.1 Test sample preconditioning
176 Subclause E.2.1 Test sample preconditioning
177 Subclause F.2.1 Test sample preconditioning
178 Subclause G.2.1 Test sample preconditioning
179 Subclause H.2.1 Test sample preconditioning
180 Subclause I.2.1 Test sample preconditioning
181 Temperature range specified for testing is greater than that specified in ISO 594-1 and ISO 594-2 to evaluate
182 the performance of CONNECTORS exposed to heated solutions and outdoor conditions.
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183 Temperature and humidity preconditioning requirements have been added in TYPE TESTS for hygroscopic
184 materials. Hygroscopic materials are known to absorb moisture from surrounding gases and liquids, which can
185 alter physical characteristics, dimensions and performance of CONNECTORS.
186 Annex B Fluid leakage TEST METHOD by pressure decay
187 This pressure decay TEST METHOD is a new TEST METHOD that was not part of the former ISO 594 series.
188 However, it is based upon the informative liquid leakage TEST METHOD of ISO 594-1:1986, Annex A. The
189 acceptance criteria are the same.
190 Annex C Falling drop positive pressure liquid leakage TEST METHOD
191 TEST METHOD is performed in the same manner as in the ISO 594 series. The pressure that
This liquid leakage
192 the test is performed at is modified from "300 to 330 kPa" to "at least 300 kPa unless otherwise specified."
193 Annex D Subatmospheric-pressure air leakage TEST METHOD
194 This subatmospheric-pressure air leakage TEST METHOD is a new TEST METHOD that was not part of the former
195 ISO 594 series. The ISO 594 series TEST METHOD for subatmospheric-pressure (5.3 of both part 1 and part 2)
196 creates an unspecified subatmospheric test pressure and asks the observer to look for continued formation of
197 bubbles of an unspecified size. The TEST METHOD included in this standard was developed during the
198 committee drafts of ISO 80369-2 and ISO 80369-6 and specifies the subatmospheric-pressure and leakage
199 rate. The leakage rate from ISO 594-1:1986, Annex A, for positive pressure liquid leakage was used for the
200 acceptance criteria for this TEST METHOD.
201 Annex E Stress cracking TEST METHOD
202 This stress cracking TEST METHOD is performed in the same manner as in the ISO 594 series. The acceptance
203 criteria have been changed to require passing a functional leak test after the stress cracking test has been
204 performed.
205 Annex F Resistance to separation from axial load TEST METHOD
206 This resistance to separation from axial load TEST METHOD is performed in the same manner as in the ISO 594
207 series. The title and principle have been elaborated to describe the intent of the test.
208 Annex G Resistance to separation from unscrewing TEST METHOD
209 This resistance to separation from unscrewing TEST METHOD is performed in the same manner as the ISO 594
210 series. The title and principle have been elaborated to describe the intent of the test.
211 Annex H Resistance to overriding TEST METHOD
212 This resistance to overriding TEST METHOD is performed in the same manner as the ISO 594 series.
213 Annex I Disconnection by unscrewing TEST METHOD
214 This disconnection by unscrewing TEST METHOD supplements the TEST METHOD described in the ISO 594
215 series. It is intended to ensure that CONNECTORS, which can be connected and disconnected multiple times
216 per day, can be successfully disconnected by the USER.
217 Annex J Alternate TEST METHODS to generate variable data for statistical analysis
218 Multiple TEST METHODS in this standard are written as attribute data TEST METHODS that can be modified to
219 become variable data TEST METHODS.
220 Attribute data tests are more commonly known as pass/fail tests. Attribute data tests can only determine if the
221 specification is met. They provide no indication of how the CONNECTOR fails and typically require a large
222 sample size to have the same statistical power as an equivalent variable data test.
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223 Variable data tests are those tests that produce a quantifiable result such as the force required to separate the
224 CONNECTORS or the actual leak rate. Variable data test results determine the value at which the CONNECTOR
225 fails, provide a numerical result that can be statistically analyzed, and typically require a smaller sample size
226 to have the same statistical power as equivalent attribute data test results.
227
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228 Annex B
229 (normative)
230
231 * Fluid leakage TEST METHOD by pressure decay
232 B.1 Principle
233 The CONNECTOR under test is securely assembled to an appropriate reference CONNECTOR. The medium, as
234 specified in the relevant APPLICATION part of this series, is introduced into the CONNECTION and pressurized to
235 the specified pressure.
236 B.2 * Test conditions
237 B.2.1 Test sample preconditioning
238 Prior to testing, precondition the CONNECTOR under test at 20 °C ± 5 °C and 50 % ± 10 % relative humidity for
239 not less than 24 h. Preconditioning need not be performed for a CONNECTOR made from non-hygroscopic
240 materials.
241 B.2.2 Environmental test conditions
242 Perform tests at a temperature within the range of 15 °C to 30 °C and at a relative humidity between 25 % and
243 65 %, unless other ranges are specified in the relevant APPLICATION part of this series of standards.
244 B.3 Apparatus
245 The following items shall be utilized.
246 a) The male or female CONNECTOR under test.
247 b) The appropriate reference CONNECTOR, as specified in the relevant APPLICATION part of this series of
248 standards for the leakage TEST METHOD, to be assembled to the CONNECTOR under test.
249 c) An axial force meter and torque meter capable of measuring a simultaneous axial force of 27,5 N and
250 torque of 0,12 N･m.
251 d) Means to contain and pressurize fluid to the specified test pressure.
252 e) A timing device capable of displaying seconds.
253 f) A pressure gauge or meter, capable of displaying the specified test pressure.
254 g) A stop valve.
255 h) A leak-proof plug.
256 An automated pressure decay leak test system may be substituted for items d), e), f) and g).
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257 B.4 PROCEDURE
258 Check compliance with the following test.
259 a) Assemble the CONNECTOR under test to the appropriate male or female reference CONNECTOR, both
260 CONNECTORS being dry.
261 b) For a non-locking CONNECTOR, assemble by applying an axial force not exceeding 27,5 N for a minimum
262 of 5 s while rotating the CONNECTOR under test to a torque not exceeding 0,1 N･m and a rotation not
263 exceeding 90°.
264 c) For a locking CONNECTOR with fixed threads, assemble by applying an axial force not exceeding 27,5 N
265 for a minimum of 5 s while rotating the CONNECTOR under test to a torque not exceeding 0,12 N･m.
266 d) For a CONNECTOR with a floating or rotatable locking collar, assemble by applying an axial force not
267 exceeding 27,5 N for a minimum of 5 s while rotating the CONNECTOR under test to a torque not exceeding
268 0,1 N･m and a rotation not exceeding 90°. Then engage the collar and tighten to a torque not exceeding
269 0,12 N･m.
270 e) Seal the outlet bore of the CONNECTOR under test.
271 f) Apply the medium at the applied pressure specified in the relevant APPLICATION part of this series of
272 standards to the assembly through the bore and close the valve.
273 g) Record the pressure and start the timing device.
274 h) Wait the hold period specified in the relevant APPLICATION part of this series of standards and record the
275 pressure and time.
276 i) Calculate the change in pressure.
277 j) Calculate the leakage rate, L on the basis of the following Equation B.1.
sp p
278 L v (B.1)
tp t
279 where
280 L = the leakage rate,
281 sp = the specified nominal test pressure,
282 tp = the actual test pressure at the start of the test,
283 v = the volume from the valve to the test specimen,
284 Δp = the pressure change during the test period, and
285 = the test period.
Δt
286 EXAMPLE At a specified pressure of 300 kPa, a test pressure of 290 kPa and a total volume of 10 ml, a pressure
287 drop of 10 kPa is established within a period of 25 s.
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5 4
310 110
6 3
288 L 1010 0.0041Pa m / s
5
2.910 25
289 k) Verify that the leakage rate does not exceed the value specified in the relevant APPLICATION part of this
290 series of standards.
291 B.5 Test Report
292 Prepare a test report that:
293 specifies testing was performed according to ISO 80369-20:, Annex B, Fluid leakage by pressure
294 decay;
295 identifies the CONNECTORS under test;
296 identifies the type of fluid used;
297 identifies the applied pressure used;
298 identifies the acceptance criterion;
299 discloses the measured test pressure;
300 discloses the volume of the test apparatus;
301 discloses the pressure drop during the test period;
302 discloses the hold period of the test; and
303 discloses the calculated leakage rate.
304
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305 Annex C
306 (normative)
307
308 Falling drop positive pressure liquid leakage TEST METHOD
309 C.1 Principle
310 A CONNECTOR is securely assembled to a reference CONNECTOR. Water is introduced into the CONNECTION and
311 pressurized for the hold period.
312 C.2 * Test c
...
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