EN ISO 80369-1:2010

SLOVENSKI STANDARD
01-marec-2011
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SIST EN 15546-1:2008
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6SORãQH]DKWHYH,62
Small bore connectors for liquids and gases in healthcare applications - Part 1: General
requirements (ISO 80369-1:2010)
Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in
medizinischen Anwendungen - Teil 1: Allgemeine Anforderungen (ISO 80369-1:2010)
Joints de petite dimension pour liquides et gaz pour des applications en santé - Partie 1:
Exigences générales (ISO 80369-1:2010)
Ta slovenski standard je istoveten z: EN ISO 80369-1:2010
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 80369-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2010
ICS 11.040.10; 11.040.20 Supersedes EN 15546-1:2008
English version
Small bore connectors for liquids and gases in healthcare
applications - Part 1: General requirements (ISO 80369-1:2010)
Raccords de petite taille pour liquides et gaz utilisés dans Verbindungsstücke mit kleinem Durchmesser für
le domaine de la santé - Partie 1: Exigences générales Flüssigkeiten und Gase in medizinischen Anwendungen -
(ISO 80369-1:2010) Teil 1: Allgemeine Anforderungen (ISO 80369-1:2010)
This European Standard was approved by CEN on 14 December 2010.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United
Kingdom.
CEN Management Centre: CENELEC Central Secretariat:
Avenue Marnix 17, B-1000 Brussels Avenue Marnix 17, B-1000 Brussels
© 2010 CEN/CENELEC All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 80369-1:2010 E
worldwide for CEN national Members and for CENELEC
Members.
Contents Page
Foreword .3
Annex ZA .5

Foreword
This document (EN ISO 80369-1:2010) 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 June 2011, and conflicting national standards shall be withdrawn at
the latest by June 2011.
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 supersedes EN 15546-1:2008.
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.
For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document.
Compared to EN 15546-1:2008 the following changes were implemented:
a) Clause 3 "Terms and definitions" has been editorially revised and amended by the terms "accessory",
"breathing system", "non-interconnectable", "patient" and "responsible organization". The terms "risk" and
"safety" have been cancelled and replaced by a general reference to the appropriate terms given in EN
ISO 14971 and IEC 62366;
b) Clause 4 on materials has been amended by a reference to two ASTM standards for tests on conformity;
c) Clause 5 on the requirements has been completely revised and amended by a sub-section on
incompatibility;
d) A new Clause 6 on additional applications has been added;
e) Clause 7 (respectively Clause 6 in EN 15546-1) on the assessment of new designs (validation) has been
completely revised, more detailed in the structure and amended. Especially the sections on the proposal
initiation (7.2) and on the procedure to assess acceptability and non-interconnectable characteristics (7.3)
have been stated more detailed;
f) Annex A "Rationale" has been completely revised by providing the reasons for this standard by clauses.
In addition the Table A.1 on risk analysis of possible misconnections has been cancelled;
g) A new Annex B "Mechanical tests for verifying non-interconnectable characteristics" has been added;
h) Annex C "Applications" (respectively Clause B in EN 15546-1) has been editorially revised;
i) Annex C "Small bore connectors for vascular systems applications" of EN 15546-1 has been cancelled;
j) A new Annex D "Reference to the Essential Principles" according ISO/TR 16142 has been added;
k) Annex ZA on the relationship to the Medical Device Directive (93/42/EWG) has been aligned;
l) The Bibliography has been updated and amended;
m) A new clause Terminology has been added at the end of the standard;
n) Editorial revision in alignment with the overtaking of the original European Standard into an International
Standard.
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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 80369-1:2010 has been approved by CEN as a EN ISO 80369-1:2010 without any
modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC
This European Standard has been prepared under a mandate given to CEN by the European Union and the
European Free Trade Association to provide a means to conforming to Essential Requirements of the New
576 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 document 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, within the limits of the scope of this document, a presumption of conformity
with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC
Corresponding Essential
Clause/subclause
Requirement Qualifying remarks/notes
of this Document
of Directive 93/42/EEC
all 1, 2
4, 5 7.5, 7.6, 9.1, 12.7.4
6 6 a, 7.5, 7.6, 9.1, 12.7.4
WARNING: Other requirements and other EU Directives may be applicable to the products falling within the
585 scope of this International Standard.
INTERNATIONAL ISO
STANDARD 80369-1
First edition
2010-12-15
Small-bore connectors for liquids and
gases in healthcare applications —
Part 1:
General requirements
Raccords de petite taille pour liquides et gaz utilisés dans le domaine
de la santé —
Partie 1: Exigences générales
Reference number
ISO 80369-1:2010(E)
©
ISO 2010
ISO 80369-1:2010(E)
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ii © ISO 2010 – All rights reserved

ISO 80369-1:2010(E)
Contents Page
Foreword .iv
Introduction.v
1 Scope.1
2 Normative references.2
3 Terms and definitions .2
4 Materials used for SMALL-BORE CONNECTORS.3
5 Requirements for SMALL-BORE CONNECTORS for specific APPLICATIONS.4
5.1 SMALL-BORE CONNECTOR incompatibility.4
5.2 BREATHING SYSTEMS and driving gases APPLICATIONS.4
5.3 Enteral and gastric APPLICATIONS.4
5.4 Urethral and urinary APPLICATIONS.4
5.5 Limb cuff inflation APPLICATIONS.4
5.6 Neuraxial APPLICATIONS.5
5.7 Intravascular or hypodermic APPLICATIONS .5
5.8 Alternative SMALL-BORE CONNECTORS .5
6 Additional SMALL-BORE CONNECTOR APPLICATIONS.5
7 PROCEDURE to assess a proposed new design of SMALL-BORE CONNECTOR for inclusion in
this series of standards .6
7.1 General .6
7.2 Proposal initiation .6
7.3 PROCEDURE to assess acceptability and NON-INTERCONNECTABLE characteristics.6
7.3.1 Design.6
7.3.2 Design realization.6
7.3.3 Design VERIFICATION .7
7.3.4 Design validation.7
7.4 Design review .7
7.5 Subsequent parts of this series of standards .7
Annex A (informative) Rationale.8
Annex B (normative) Mechanical tests for verifying NON-INTERCONNECTABLE characteristics.11
Annex C (informative) APPLICATIONS of SMALL-BORE CONNECTORS .12
Annex D (informative) Reference to the Essential Principles .14
Bibliography.16
Terminology – Alphabetized index of defined terms.17

ISO 80369-1:2010(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 80369-1 was prepared by a Joint Working Group of Technical Committee ISO/TC 210, Quality
management and corresponding general aspects for medical devices, IEC/TC 62, Electrical equipment,
Subcommittee SC D, Electrical equipment in medical practice and CEN/CENELEC TC 3/WG 2, Small-bore
connectors.
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
The following parts are under preparation:
⎯ Part 2: Connectors for breathing systems and driving gases applications
⎯ Part 3: Connectors for enteral applications
⎯ Part 4: Connectors for urethral and urinary applications
⎯ Part 5: Connectors for limb cuff inflation applications
⎯ Part 6: Connectors for neuraxial applications
⎯ Part 7: Connectors for intravascular or hypodermic applications
iv © ISO 2010 – All rights reserved

ISO 80369-1:2010(E)
Introduction
In the 1990s concern grew regarding the proliferation of MEDICAL DEVICES fitted with Luer CONNECTORS and the
reports of PATIENT death or injury arising from misconnections that resulted in the inappropriate delivery of
enteral solutions, intrathecal medication or compressed gases.
Concerns regarding the use of Luer CONNECTORS with enteral feeding tubes and gas sampling and gas
delivery systems were raised with CEN/BT and the European Commission. In November 1997 the newly
created CHeF steering group set up a Forum Task Group (FTG) to consider the problem.
The FTG produced CEN Report CR 13825, in which they concluded that there is a problem arising from the
use of a single CONNECTOR design to a number of incompatible APPLICATIONS. In a coronary care unit there are
as many as 40 Luer CONNECTORS on the MEDICAL DEVICES used with a single PATIENT. Therefore it is not
surprising that misconnections are made.
MEDICAL DEVICES have for many years followed the established principle of “safety under single fault
conditions”. Simply stated this means that a single fault should not result in an unacceptable RISK. This
principle is embodied in the requirements of numerous MEDICAL DEVICE standards. Extending this principle to
the application of Luer CONNECTORS, i.e. that misconnection should not result in an unacceptable RISK to a
PATIENT, the FTG recommended that the Luer CONNECTOR should be restricted to MEDICAL DEVICES intended to
be connected to the vascular system or a hypodermic syringe. In addition, new designs of SMALL-BORE
CONNECTORS should be developed for other APPLICATIONS, and these should be NON-INTERCONNECTABLE with
Luer CONNECTORS and each other.
ISO/TR 16142:2006 addresses this type of problem in Essential Principle A.1.2:
The solutions adopted by the manufacturer for the design and construction of the devices should
conform to safety principles, taking into account the generally acknowledged state of the art.
In selecting the most appropriate solutions, the manufacturer should apply the following principles
in the following order:
— identify hazards and the associated risks arising from the intended use and foreseeable
misuse;
— eliminate or reduce risks as far as possible (inherently safe design and construction);
It is understood that SMALL-BORE CONNECTOR systems cannot be designed to overcome all chances of
misconnection or to eliminate deliberate misuse. However, a number of steps that would improve the current
situation and lead to greater PATIENT safety can be taken. This will only be achieved through a long-term
commitment involving industry, healthcare professionals, MEDICAL DEVICE purchasers and MEDICAL DEVICE
regulatory authorities.
This is the first edition of ISO 80369-1 and it cancels and replaces EN 15546-1:2008 which has been
editorially revised.
Part 1 of this International Standard and its parts are intended to be the reference documents in which the
necessary measures and PROCEDURES to prevent misconnection between SMALL-BORE CONNECTORS used in
different APPLICATIONS and designs of SMALL-BORE CONNECTORS for APPLICATIONS are listed. The JWG of
ISO/TC 210 – IEC 62D and CEN/CENELEC TC 3/WG 2 is developing this series of standards in such a way
that ISO 80369-1 includes general requirements to prevent misconnections between SMALL-BORE CONNECTORS
used in different APPLICATIONS.
ISO 80369-1:2010(E)
This part 1 of this International Standard contains general requirements to ensure the prevention of
misconnection between SMALL-BORE CONNECTORS used in different APPLICATIONS. Subsequent parts of this
series of standards are expected to include requirements with regard to the CONNECTORS used in different
APPLICATION categories.
In this standard, 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 CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL
CAPITALS TYPE.
In this standard, 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 standard conform to usage described in Annex H of the ISO/IEC Directives,
Part 2. For the purposes of this standard, the auxiliary verb:
⎯ “shall” means that compliance with a requirement or a test is mandatory for compliance with this
standard;
⎯ “should” means that compliance with a requirement or a test is recommended but is not mandatory for
compliance with this standard;
⎯ “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 attention of Member Bodies and National Committees is drawn to the fact that equipment
MANUFACTURERS and testing organizations may 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 3 years
from the date of publication for equipment newly designed and not earlier than 5 years from the date of
publication for equipment already in production.
vi © ISO 2010 – All rights reserved

INTERNATIONAL STANDARD ISO 80369-1:2010(E)

Small-bore connectors for liquids and gases in healthcare
applications —
Part 1:
General requirements
1 Scope
This part of ISO 80369 specifies general requirements for SMALL-BORE CONNECTORS, which convey liquids or
gases in healthcare APPLICATIONS. These SMALL-BORE CONNECTORS are used in MEDICAL DEVICES or
ACCESSORIES intended for use with a PATIENT.
This International Standard also specifies the healthcare fields in which these SMALL-BORE CONNECTORS are
intended to be used.
These healthcare fields of use include, but are not limited to, APPLICATIONS for:
⎯ BREATHING SYSTEMS and driving gases,
⎯ enteral and gastric,
⎯ urethral and urinary,
⎯ limb cuff inflation,
⎯ neuraxial devices, and
⎯ intravascular or hypodermic.
SMALL-BORE CONNECTORS as specified in this International Standard are NON-INTERCONNECTABLE with:
⎯ the cones and sockets of ISO 5356-1:2004 and ISO 5356-2:2006;
⎯ the temperature sensor CONNECTOR and mating ports specified in Annex DD of ISO 8185:2007; and
⎯ the nipples of EN 13544-2:2002.
This International Standard provides the methodology to assess NON-INTERCONNECTABLE characteristics of
SMALL-BORE CONNECTORS based on their inherent design and dimensions in order to reduce the RISK of
misconnections between MEDICAL DEVICES or between ACCESSORIES for different APPLICATIONS and to reduce
the RISK of misconnections between MEDICAL DEVICES with 6 % Luer CONNECTORS, and all other non-Luer
CONNECTORS that will be developed under future parts of this series of standards.
It does not specify requirements for the MEDICAL DEVICES or ACCESSORIES that use these SMALL-BORE
CONNECTORS. Such requirements are given in particular International Standards for specific MEDICAL DEVICES
or ACCESSORIES.
NOTE 1 It is intended that new designs of SMALL-BORE CONNECTORS will be included in this series of standards after
they have been assessed according to the PROCEDURE given in Clause 6.
ISO 80369-1:2010(E)
NOTE 2 MANUFACTURERS are encouraged to incorporate the SMALL-BORE CONNECTORS specified in this series of
standards into MEDICAL DEVICES, medical systems or ACCESSORIES, even if currently not required by the relevant particular
MEDICAL DEVICE standards. It is expected that when the relevant particular MEDICAL DEVICE standards are revised,
requirements for SMALL-BORE CONNECTORS as specified in the series of standards will be included.
NOTE 3 MANUFACTURERS and RESPONSIBLE ORGANIZATIONS are encouraged to report their experience with the SMALL-
BORE CONNECTORS specified in this series of standards to the Secretariat of ISO/TC 210 to consider this feedback during
the revision of the relevant part of this series of standards.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 5356-1:2004, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets
ISO 5356-2:2006, Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded
weight-bearing connectors
ISO 14971:2007, Medical devices — Application of risk management to medical devices
EN 13544-2:2002, Respiratory therapy equipment — Part 2: Tubing and connectors
IEC 62366:2007, Medical devices — Application of usability engineering to medical devices
3 Terms and definitions
For the purposes of this document, the terms and definitions specified in ISO 14971:2007, IEC 62366:2007
and the following apply. For convenience, the sources of all defined terms used in this document are given in
an index on page 17.
3.1
ACCESSORY
additional part(s) for use with MEDICAL DEVICE in order to:
⎯ achieve the INTENDED USE,
⎯ adapt it to some special use,
⎯ facilitate its use,
⎯ enhance its performance, or
⎯ enable its functions to be integrated with those of other MEDICAL DEVICES
[Modified from IEC 60601-1:2005, definition 3.3]
3.2
APPLICATION
specific healthcare field in which a SMALL-BORE CONNECTOR is intended to be used
NOTE Annex C lists SMALL-BORE CONNECTOR APPLICATIONS.
3.3
BREATHING SYSTEM
inspiratory and expiratory pathways through which gas flows at respiratory pressures and bounded by the port
through which fresh gas enters, the PATIENT CONNECTION port and the exhaust port
2 © ISO 2010 – All rights reserved

ISO 80369-1:2010(E)
3.4
CONNECTION
union or joining of mating halves of a CONNECTOR
3.5
CONNECTOR
mechanical device, consisting of one of two mating halves and designed to join a conduit to convey liquids or
gases
3.6
NON-INTERCONNECTABLE
having characteristics which incorporate geometries or other characteristics that prevent different
CONNECTORS from being connected
3.7
PATIENT
person undergoing a medical, surgical or dental PROCEDURE
[Modified from IEC 60601-1:2005, definition 3.76]
3.8
RESPONSIBLE ORGANIZATION
entity accountable for the use and maintenance of a MEDICAL DEVICE
NOTE 1 The accountable entity can be, for example, a hospital, an individual clinician or a layperson. In home use
applications, the PATIENT, USER and RESPONSIBLE ORGANIZATION can be one and the same person.
NOTE 2 Education and training is included in “use.”
[Modified from IEC 60601-1:2005, definition 3.101]
3.9
RIGID MATERIAL
material with a modulus of elasticity either in flexure or in tension greater than 35 000 kg/cm (3 433 MPa)
3.10
SEMI-RIGID MATERIAL
2 2
material with a modulus of elasticity either in flexure or in tension, between 700 kg/cm and 35 000 kg/cm
(69 MPa and 3 433 MPa)
3.11
SMALL-BORE
inner-fluid pathway of a CONNECTION with a diameter less than 8,5 mm
NOTE For the purposes of this standard, the 8,5 mm cone and socket of ISO 5356-1 is not considered a SMALL-BORE
CONNECTOR.
4 Materials used for SMALL-BORE CONNECTORS
A SMALL-BORE CONNECTOR shall be made of RIGID MATERIAL or SEMI-RIGID MATERIAL.
Check compliance by application of the tests of ASTM D747 or ASTM D790 at (23 ± 2) °C and (50 ± 5) %
relative humidity.
ISO 80369-1:2010(E)
5 Requirements for SMALL-BORE CONNECTORS for specific APPLICATIONS
5.1 SMALL-BORE CONNECTOR incompatibility
SMALL-BORE CONNECTORS of each APPLICATION category specified in this International Standard shall be NON-
INTERCONNECTABLE with any of the SMALL-BORE CONNECTORS of every other APPLICATION category for RISKS to
be acceptable, unless otherwise indicated.
SMALL-BORE CONNECTORS for APPLICATION categories specified in this International Standard shall be NON-
INTERCONNECTABLE with:
⎯ the cones and sockets of ISO 5356-1:2004 and ISO 5356-2:2006; and
⎯ the nipples of EN 13544-2:2002;
⎯ the temperature sensor CONNECTOR and mating ports specified in Annex DD of ISO 8185:2007;
unless otherwise indicated.
Check compliance by confirming that OBJECTIVE EVIDENCE verifies that RISKS have been reduced to acceptable
levels for the acceptability criteria specified in Annex B and other acceptability criteria established by the
MANUFACTURER for NON-INTERCONNECTABLE characteristics. Verify that the SMALL-BORE CONNECTOR is NON-
INTERCONNECTABLE.
5.2 BREATHING SYSTEMS and driving gases APPLICATIONS
SMALL-BORE CONNECTORS intended to be used either as an ancillary port CONNECTION in a BREATHING SYSTEM
or a respirable driving gas APPLICATION of MEDICAL DEVICES and ACCESSORIES shall comply with
ISO 80369-2:—, unless the use of these CONNECTORS creates an unacceptable RISK for a specific MEDICAL
DEVICE, or shall comply with 5.8.
Check compliance by inspection of the RISK MANAGEMENT FILE for a specific MEDICAL DEVICE or application of
the tests of ISO 80369-2:—. See also 5.8 for alternative methods of compliance.
5.3 Enteral and gastric APPLICATIONS
SMALL-BORE CONNECTORS intended to be used for CONNECTIONS in enteral and gastric APPLICATIONS shall
comply with ISO 80369-3:—, unless the use of these CONNECTORS creates an unacceptable RISK for a specific
MEDICAL DEVICE or shall comply with 5.8.
Check compliance by inspection of the RISK MANAGEMENT FILE for a specific MEDICAL DEVICE or application of
the tests of ISO 80369-3:—. See also 5.8 for alternative methods of compliance.
5.4 Urethral and urinary APPLICATIONS
SMALL-BORE CONNECTORS intended to be used for CONNECTIONS in urethral and urinary APPLICATIONS shall
comply with ISO 80369-4:— or 5.8, unless the use of these CONNECTORS creates an unacceptable RISK for a
specific MEDICAL DEVICE or shall comply with 5.8.
Check compliance by inspection of the RISK MANAGEMENT FILE for a specific MEDICAL DEVICE or application of
the tests of ISO 80369-4:—. See also 5.8 for alternative methods of compliance.
5.5 Limb cuff inflation APPLICATIONS
SMALL-BORE CONNECTORS intended to be used for CONNECTIONS in limb cuff inflation APPLICATIONS shall comply
with ISO 80369-5:—, unless the use of these CONNECTORS creates an unacceptable RISK for a specific
MEDICAL DEVICE or shall comply with 5.8.
4 © ISO 2010 – All rights reserved

ISO 80369-1:2010(E)
Check compliance by inspection of the RISK MANAGEMENT FILE for a specific MEDICAL DEVICE or application of
the tests of ISO 80369-5:—. See also 5.8 for alternative methods of compliance.
5.6 Neuraxial APPLICATIONS
SMALL-BORE CONNECTORS intended to be used for CONNECTIONS in neuraxial APPLICATIONS shall comply with
ISO 80369-6:—, unless the use of these CONNECTORS creates an unacceptable RISK for a specific MEDICAL
DEVICE or shall comply with 5.8.
Check compliance by inspection of the RISK MANAGEMENT FILE for a specific MEDICAL DEVICE or application of
the tests of ISO 80369-6:—. See also 5.8 for alternative methods of compliance.
5.7 Intravascular or hypodermic APPLICATIONS
SMALL-BORE CONNECTORS intended to be used for CONNECTIONS in intravascular or hypodermic APPLICATIONS
shall comply with ISO 80369-7:—, unless the use of these CONNECTORS creates an unacceptable RISK for a
specific MEDICAL DEVICE or shall comply with 5.8.
NOTE Upon its publication, ISO 80369-7:— will replace ISO 594-1:1986 and ISO 594-2:1998.
Check compliance by inspection of the RISK MANAGEMENT FILE for a specific MEDICAL DEVICE or application of
the tests of ISO 80369-7:—. See also 5.8 for alternative methods of compliance.
5.8 Alternative SMALL-BORE CONNECTORS
Alternative designs of SMALL-BORE CONNECTORS to those specified in 5.2 to 5.7 may be used in a MEDICAL
DEVICE or ACCESSORY, and if used, they shall:
a) be NON-INTERCONNECTABLE with the CONNECTORS specified in 5.2 through 5.7, inclusive;
b) not create an unacceptable RISK for a specific MEDICAL DEVICE or ACCESSORY;
c) be evaluated according to Annex B; and
d) comply with Clause 4.
Check compliance by confirming that OBJECTIVE EVIDENCE verifies that RISKS have been reduced to acceptable
levels for the acceptability criteria specified in Annex B and other acceptability criteria established by the
MANUFACTURER for NON-INTERCONNECTABLE characteristics for the MEDICAL DEVICE or ACCESSORY.
6 Additional SMALL-BORE CONNECTOR APPLICATIONS
Alternative designs of SMALL-BORE CONNECTORS to those specified in 5.2 to 5.7, which convey liquids or gases,
and which are used in MEDICAL DEVICES and ACCESSORIES intended for use with a PATIENT for other
APPLICATIONS, may be used, and if used, they shall:
a) be NON-INTERCONNECTABLE with the CONNECTORS specified in 5.2 through 5.7, inclusive;
b) not create an unacceptable RISK for a specific MEDICAL DEVICE or ACCESSORY; and
c) be evaluated according to Annex B.
Check compliance by confirming that OBJECTIVE EVIDENCE verifies that RISKS have been reduced to acceptable
levels for the acceptability criteria specified in Annex B and other acceptability criteria established by the
MANUFACTURER for NON-INTERCONNECTABLE characteristics.
ISO 80369-1:2010(E)
7 PROCEDURE to assess a proposed new design of SMALL-BORE CONNECTOR for
inclusion in this series of standards
7.1 General
Working groups or individuals, including MANUFACTURERS, wishing to include a new design of a SMALL-BORE
CONNECTOR into this family of International Standards, should make this request to ISO/TC 210 according to
the PROCEDURE set out in this clause. ISO/TC 210 shall consider this request and shall determine which
relevant part of this series of standards should be amended or revised, in accordance with ISO and IEC
PROCEDURES.
Groups or individuals submitting a design shall verify that there are no outstanding intellectual property right
issues or, as appropriate, shall declare that they are prepared to license relevant patents, both granted and
pending, which are necessary to manufacture and sell MEDICAL DEVICES that include the submitted design.
Groups or individuals holding patents hereby shall also declare that they are aware of the rules governing
inclusion of patented items in International Standards as described in the appropriate ISO PROCEDURES and
that they are willing to negotiate licenses with an unlimited number of applicants throughout the world under
reasonable and non-discriminatory terms and conditions that are demonstrably free of any unfair competition.
7.2 Proposal initiation
Groups or individuals submitting a new SMALL-BORE CONNECTOR design shall submit to ISO/TC 210 a concept
proposal identifying the targeted APPLICATION category. ISO/TC 210, or a designated working group, shall
evaluate the submitted proposal.
The submitter shall develop the design proposal and shall maintain and supply RECORDS for the evaluation.
The design proposal shall include:
a) a justification for the proposal that includes a description of any CONNECTIONS of concern, which need to
become NON-INTERCONNECTABLE, literature reviews, adverse event information and/or complaint analysis;
b) design requirements that include USER PROFILES, according to IEC 62366:2007, use environments,
USABILITY goals, according to IEC 62366:2007, functional requirements suitable to maintain clinical
performance necessary to achieve freedom from unacceptable RISK, requirements suitable to maintain
NON-INTERCONNECTABLE characteristics, RISK ANALYSIS and results, according to ISO 14971:2007, if any,
from previous similar designs;
c) design specifications, including a USABILITY specification, according to IEC 62366:2007, which satisfy all
aspects of design requirements; it shall include objective evidence that risks have been reduced to
acceptable levels, according to ISO 14971:2007, for the acceptability criteria specified in Annex B; and
d) a completed summary of SMALL-BORE CONNECTOR criteria and requirements for the proposed SMALL-BORE
CONNECTOR design.
7.3 PROCEDURE to assess acceptability and NON-INTERCONNECTABLE characteristics
7.3.1 Design
The submitter shall conduct an engineering analysis of the design of the proposed SMALL-BORE CONNECTOR
using the design details in this series of standards. This evaluation can include, but is not limited to, minimum
and maximum tolerance stack up assessments that compare the proposed design with other existing or
proposed designs of SMALL-BORE CONNECTORS in this series. Computer-assisted design (CAD) drawing
evaluations or other appropriate design feasibility assessment tools may be utilized.
7.3.2 Design realization
The submitter shall produce test samples and carry out testing, as described in 7.3.3 and 7.3.4, to verify that
design requirements and design specifications are met. This PROCESS may be iterative.
6 © ISO 2010 – All rights reserved

ISO 80369-1:2010(E)
7.3.3 Design VERIFICATION
The submitter shall verify the design as follows:
a) Select an independent party to carry out design review and VERIFICATION testing.
b) Conduct dimensional analyses, physical testing and MEDICAL DEVICE category-specific performance
testing on sample sizes sufficient to allow statistical analysis of test results. The tests shall verify that
dimensions meet specification and NON-INTERCONNECTABLE characteristics with other SMALL-BORE
CONNECTORS in this series, and that physical performance properties and MEDICAL DEVICE performance
requirements are met. It shall include OBJECTIVE EVIDENCE that RISKS have been reduced to acceptable
levels, according to ISO 14971:2007, for the acceptability criteria specified in Annex B and other
acceptability criteria established for NON-INTERCONNECTABLE characteristics.
c) The potential for misuse, aging and disinfection/sterilization shall be considered.
d) Evidence of design acceptance by clinical USERS of a potential target MEDICAL DEVICE shall be provided.
VERIFICATION reports summarizing the above testing shall be prepared and submitted for consideration to the
technical committee or a designated working group. These reports shall include VERIFICATION results for each
identified design requirement and each element of the design specification.
7.3.4 Design validation
After design VERIFICATION, the submitter shall conduct a design validation assessment. Validation shall assess
the acceptability of production quality SMALL-BORE CONNECTORS in the intended APPLICATION and MEDICAL
DEVICE with a population of USERS in the clinical or simulated environment. The validation shall assess the
NON-INTERCONNECTABLE characteristics of the SMALL-BORE CONNECTOR with the SMALL-BORE CONNECTORS of the
other APPLICATIONS as specified in Clause 5. Conclusions shall be statistically based and demonstrate that
performance objectives have been met.
The design validation shall also include a USABILITY validation according to IEC 62366:2007, 5.9.
7.4 Design review
ISO/TC 210, or a designated working group, shall assign a group with specific technical expertise in the
targeted APPLICATION and MEDICAL DEVICE(S) that are affected, to assess the design and submitted information
resulting from 7.3, and prepare a report to ISO/TC 210 giving its conclusions.
ISO/TC 210 shall decide on the suitability of the proposed SMALL-BORE CONNECTOR for inclusion in this series
of standards for the intended APPLICATION.
7.5 Subsequent parts of this series of standards
If the proposed SMALL-BORE CONNECTOR is suitable for inclusion in this series of standards, ISO/TC 210, or a
designated working group, shall assign the proposal to the relevant working group, which shall initiate the
appropriate steps to include the new design by amendment, revision or creation of the relevant part of this
series of standards.
A summary of the data and reports (see 7.3) shall be prepared as an informative annex to be included as a
rationale in the preparation of the subsequent Standard.
ISO 80369-1:2010(E)
Annex A
(informative)
Rationale
This Annex provides rationale for the important requirements of this document and is intended for those who
are familiar with the subject of this document but who have not participated in its development. An
understanding of the reasons for the main requirements is considered to be essential for its proper application.
Furthermore, as clinical practice and technology change, it is believed that rationale for the present
requirements will facilitate any revision of this document necessitated by those developments.
The clauses in this annex have been so numbered to correspond to the clauses in this International Standard
to which they refer. The numbering is, therefore, not consecutive.
Clause 1 Scope
Advances in modern medicine have led to a significant rise in the number of MEDICAL DEVICES attached to
PATIENTS. Many of these devices fall into the categories of monitoring devices, diagnostic devices and drug
delivery devices.
Such MEDICAL DEVICES perform a variety of similar, but not interchangeable, functions
...