SIST EN ISO 5359:2015

SLOVENSKI STANDARD
SIST EN ISO 5359:2015
01-januar-2015
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SIST EN ISO 5359:2008
SIST EN ISO 5359:2008/A1:2012
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Anaesthetic and respiratory equipment - Low-pressure hose assemblies for use with
medical gases (ISO 5359:2014)
Anästhesie- und Beatmungsgeräte - Niederdruck-Schlauchleitungssysteme zur
Verwendung mit medizinischen Gasen (ISO 5359:2014)
Matériel d'anesthésie et de réanimation respiratoire - Flexibles de raccordement à basse
pression pour utilisation avec les gaz médicaux (ISO 5359:2014)
Ta slovenski standard je istoveten z: EN ISO 5359:2014
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
83.140.40 Gumene cevi Hoses
SIST EN ISO 5359:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 5359:2015

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SIST EN ISO 5359:2015

EUROPEAN STANDARD
EN ISO 5359

NORME EUROPÉENNE

EUROPÄISCHE NORM
October 2014
ICS 11.040.10; 83.140.40 Supersedes EN ISO 5359:2008
English Version
Anaesthetic and respiratory equipment - Low-pressure hose
assemblies for use with medical gases (ISO 5359:2014)
Matériel d'anesthésie et de réanimation respiratoire - Anästhesie- und Beatmungsgeräte - Niederdruck-
Flexibles de raccordement à basse pression pour utilisation Schlauchleitungssysteme zur Verwendung mit
avec les gaz médicaux (ISO 5359:2014) medizinischen Gasen (ISO 5359:2014)
This European Standard was approved by CEN on 24 August 2014.

CEN 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 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 member into its own language and notified to the CEN-CENELEC Management Centre has the same
status as the official versions.

CEN members are the national standards bodies 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
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 5359:2014 E
worldwide for CEN national Members.

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SIST EN ISO 5359:2015
EN ISO 5359:2014 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4

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SIST EN ISO 5359:2015
EN ISO 5359:2014 (E)
Foreword
This document (EN ISO 5359:2014) has been prepared by Technical Committee ISO/TC 121 "Anaesthetic
and respiratory equipment" in collaboration with Technical Committee CEN/TC 215 “Respiratory and
anaesthetic equipment” the secretariat of which is held by BSI.
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 April 2015, and conflicting national standards shall be withdrawn at the
latest by October 2017.
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 ISO 5359:2008.
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(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 5359:2014 has been approved by CEN as EN ISO 5359:2014 without any modification.
3

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SIST EN ISO 5359:2015
EN ISO 5359:2014 (E)
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 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 standard 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 standard given in Table ZA.1
confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential
Requirements of that Directive and associated EFTA regulations.
Table ZA.1 — Correspondence between this International Standard and Directive 93/42/EEC
Clause(s)/subclause(s) of this Corresponding essential Qualifying remarks/notes
International Standard requirements of
Directive 93/42/EEC
4.5.3, 4.7.1, 6.3.1 7.2
4.5.1, 4.7.2 7.3
4.5.2, 6.1.6, 7.3, 2nd dash 7.5 partially covered for phthalates;
provision of rationale for using
phthalates with the information to be
provided not required
6.3.1 7.6
4.6.2.1, 4.6.7, 4.6.8, 4.6.9, 4.6.10, 9.1
4.6.11
4.5.2, 4.5.4, 4.6.2, 4.6.3, 4.6.5 9.2, first and second second indent covered for temperature
indents only and pressure
4.5.1, 4.7.1, 4.7.2 9.3 and via normative reference to
ISO 15001
4.6.2, 4.6.3, 4.6.4, 4.6.5 12.7.1
4.6.7, 4.6.8, 4.6.9 12.7.4
4.6.4 12.8.1
6.1, 6.2, 7 13.1
6.2 13.2 only gas-specific colour coding is
addressed.
6.1.2, 6.1.3, 7.2, 2nd dash 13.3 a) only covered if the name and address
of the authorized representative is
placed on the label, if applicable
6.3.2 13.3 b)
6.1.5 13.3 e)
7.3 first dash, 7.4 13.6 d) installation is not applicable
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SIST EN ISO 5359:2015
EN ISO 5359:2014 (E)
7.3 first dash 13.6 i)
7.3, last dash 13.6 q)
NOTE   Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance to the Medical Devices Directive 93/42/EEC. This means
that risks have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’ or
‘removed’, according to the wording of the corresponding essential requirement.
WARNING: Other requirements and other EU Directives may be applicable to the products falling within the scope of this
International Standard.
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SIST EN ISO 5359:2015

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SIST EN ISO 5359:2015
INTERNATIONAL ISO
STANDARD 5359
Fourth edition
2014-10-01
Anaesthetic and respiratory
equipment — Low-pressure hose
assemblies for use with medical gases
Matériel d’anesthésie et de réanimation respiratoire — Flexibles de
raccordement à basse pression pour utilisation avec les gaz médicaux
Reference number
ISO 5359:2014(E)
©
ISO 2014

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SIST EN ISO 5359:2015
ISO 5359:2014(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2014
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
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Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2014 – All rights reserved

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SIST EN ISO 5359:2015
ISO 5359:2014(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 General requirements . 6
4.1 Risk management . 6
4.2 Usability . 6
4.3 Clinical investigation . 6
4.4 Safety . 6
4.5 Materials . 7
4.6 Design requirements . 7
4.7 Constructional requirements .10
5 Test methods .11
5.1 General .11
5.2 Test method for pressure drop .11
5.3 Test method for leakage .11
5.4 Test method for gas specificity .11
5.5 Test method for mechanical strength .11
5.6 Test method for deformation under pressure .12
5.7 Test method for resistance to occlusion .12
5.8 Test method for durability of markings and colour coding .13
6 Marking, colour coding and packaging .13
6.1 Marking .13
6.2 Colour coding .14
6.3 Packaging .15
7 Information to be supplied by the manufacturer .15
Annex A (informative) Rationale .17
Annex B (informative) Environmental aspects .18
Annex C (informative) Reported regional and national deviations of colour coding and
nomenclature for medical gases .19
Bibliography .21
© ISO 2014 – All rights reserved iii

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SIST EN ISO 5359:2015
ISO 5359:2014(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. 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. 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 121, Anaesthetic and respiratory equipment,
Subcommittee SC 1, Breathing attachments and anaesthetic machines.
This fourth edition cancels and replaces the third edition (ISO 5359:2008) and the Amendment
ISO 5359:2008/Amd 1:2011, which has been technically revised as follows:
— deletion of the requirements on the dimensions and allocation of connectors (see ISO 18082);
— addition of definitions of terms;
— addition of requirements on risk management, usability, clinical investigation and leaching of substances;
— amendment of the marking requirements and requirements for information to be provided by the
manufacturer.
iv © ISO 2014 – All rights reserved

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SIST EN ISO 5359:2015
ISO 5359:2014(E)

Introduction
This International Standard has been prepared in response to the need for a safe method of connecting
medical equipment to a fixed medical gas pipeline system or other medical gas supply system such that
hose assemblies carrying different gases, or the same gas at different pressures, cannot be interchanged.
Fixed medical gas pipelines, once installed, are rarely disturbed and are subjected to commissioning
procedures to avoid the possibility of cross-connections or contamination of the medical gas conveyed.
However, hose assemblies are subjected to wear and tear, misuse and abuse throughout their relatively
short service life and are frequently connected to, and disconnected from, the medical equipment and
the fixed pipeline.
While recognizing that no system is absolutely safe, this International Standard includes those
requirements considered necessary to prevent foreseeable hazards arising from the use of hose
assemblies. Operators should be continually alert to the possibility of damage being caused by external
factors. Therefore regular inspection and repair should be undertaken to ensure that hose assemblies
continue to meet the requirements of this International Standard.
This International Standard pays particular attention to
— suitability of materials,
— gas specificity,
— prevention of cross-connections,
— cleanliness,
— testing,
— identification, and
— information supplied.
Requirements on respiratory therapy tubing are covered by ISO 17256, which refers to ISO 80369-2 on
small bore connectors for breathing systems and driving gases.
While the desirability of achieving agreement on a single International Standard for screw-threaded
connectors has never been in doubt, the present pattern of usage has made such agreement impossible.
Nevertheless, fears that proliferation of individual national standards or practices will eventually result
in potentially dangerous cross-connection between components for different gases have led to the
choice of three screw-threaded connector systems, and one gas-specific quick connector system for use
on low pressure hose assemblies. The three systems of non-interchangeable screw-threaded connectors
are the diameter index safety system (DISS), the non-interchangeable screw-threaded (NIST) system
and the sleeve indexed system (SIS). Dimensions and allocation of these connectors to medical gases are
not specified in this International Standard.
Rationales for some of the requirements of this International Standard are given in Annex A. Such
requirements are indicated by the asterisk (*) after the clause number in the main text.
© ISO 2014 – All rights reserved v

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SIST EN ISO 5359:2015

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SIST EN ISO 5359:2015
INTERNATIONAL STANDARD ISO 5359:2014(E)
Anaesthetic and respiratory equipment — Low-pressure
hose assemblies for use with medical gases
1 Scope
1.1 This International Standard specifies requirements for low-pressure hose assemblies intended for
use with the following medical gases:
— oxygen,
— nitrous oxide,
— medical air,
— helium,
— carbon dioxide,
— xenon,
— specified mixtures of the gases listed above,
— oxygen-enriched air,
— air for driving surgical tools,
— nitrogen for driving surgical tools,
and for use with vacuum.
1.2 *It applies to hose assemblies operating at pressures up to 1 400 kPa and for vacuum systems at
pressures not greater than 60 kPa absolute.
1.3 This International Standard does not specify the dimensions and allocation of the gas-specific inlet
and outlet connectors for the hose assemblies.
NOTE 1 Specifications for the dimensions and allocation of diameter index safety system (DISS) connectors
[28]
are specified in CGA V-5 .
NOTE 2 Specifications for the dimensions and allocation of sleeve indexed system (SIS) connectors are specified
[23]
in AS 2896 .
NOTE 3 Dimensions and allocation of non-interchangeable screw-threaded (NIST) connectors are specified in
[11]
ISO 18082 .
NOTE 4 Terminal units designed for quick connectors are specified in ISO 9170-1.
1.4 This International Standard does not specify requirements for coaxial hoses used for the supply
and removal of air for driving surgical tools.
1.5 This International Standard does not specify the intended uses of hose assemblies.
NOTE Environmental aspects are dealt with in Annex B.
© ISO 2014 – All rights reserved 1

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SIST EN ISO 5359:2015
ISO 5359:2014(E)

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.
ISO 1307:2006, Rubber and plastics hoses — Hose sizes, minimum and maximum inside diameters, and
tolerances on cut-to-length hoses
ISO 1402:2009, Rubber and plastics hoses and hose assemblies — Hydrostatic testing
ISO 8033:2006, Rubber and plastics hoses — Determination of adhesion between components
ISO 9170-1:2008, Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with
compressed medical gases and vacuum
ISO 14155:2011, Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 14971:2007, Medical devices — Application of risk management to medical devices
ISO 15001:2010, Anaesthetic and respiratory equipment — Compatibility with oxygen
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
accessory
additional component for use with equipment in order
— to perform its intended use,
— to adapt the equipment to some special use,
— to facilitate the use of the equipment,
— to enhance the performance of the equipment,
— to enable the functions of the equipment to be integrated with those of other equipment
[SOURCE: IEC 60788:2004, 3.6]
3.2
accompanying document
document accompanying a medical device or an accessory (3.1) and containing information for the
responsible organization (3.22) or operator, particularly regarding basic safety (3.3)
[SOURCE: IEC 60601-1:2005, 3.4, modified — by replacing medical electrical equipment, medical electrical
system by medical device and by deleting essential performance at the end of the definition.]
3.3
basic safety
freedom from unacceptable risk directly caused by physical hazards (3.7) when a medical device is used
under normal condition and single fault condition (3.24)
[SOURCE: IEC 60601-1:2005, 3.10, modified — by replacing medical electrical equipment, medical electrical
system by medical device.]
2 © ISO 2014 – All rights reserved

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SIST EN ISO 5359:2015
ISO 5359:2014(E)

3.4
connector
any of a range of male and female components intended to maintain gas specificity by the allocation of a
set of different diameters to the mating connectors for each particular gas
EXAMPLE Non-interchangeable screw-threaded connector (3.16) (NIST connector), diameter-index safety
system connector (DISS connector), sleeve index system connector (SIS connector).
3.5
gas-specific
having characteristics which prevent connections between different gas services
[SOURCE: ISO 7396-1:2007, 3.14]
3.6
harm
physical injury or damage to the health of people or animals, or damage to property or the environment
[SOURCE: ISO 14971:2007, 2.2, modified — by adding “or animals”.]
3.7
hazard
potential source of harm (3.6)
[SOURCE: ISO 14971:2007, 2.3]
3.8
hose assembly check valve
valve which is normally closed, and which allows flow in either direction when opened by the insertion
of an appropriate gas-specific (3.5) connector (3.4)
[SOURCE: ISO 4135:2001, 1.4.9]
3.9
hose insert
portion of a connector (3.4) which is pushed into, and secured within, the bore (lumen) of the hose
[SOURCE: ISO 4135:2001, 1.4.7]
3.10
inlet connector
gas-specific (3.5) part of a hose assembly which is connected to a medical gas supply system
3.11
low-pressure hose assembly
assembly that consists of a flexible hose with permanently attached gas-specific (3.5) inlet connectors (3.10)
and outlet connectors (3.18) and which is designed to conduct a medical gas at pressures less than 1 400 kPa
[SOURCE: ISO 9170-1:2008, 3.5]
3.12
manufacturer
natural or legal person with responsibility for the design, manufacture, packaging, or labelling of a
medical device, assembling a system, or adapting a medical device before it is placed on the market
or put into service, regardless of whether these operations are carried out by that person or on that
person’s behalf by a third party
Note 1 to entry: Attention is drawn to the fact that the provisions of national or regional regulations can apply to
the definition of manufacturer.
[9]
Note 2 to entry: ISO 13485 defines “labelling” as written, printed or graphic matter
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SIST EN ISO 5359:2015
ISO 5359:2014(E)

—  affixed to a medical device or any of its containers or wrappers, or
—  accompanying a medical device, related to identification, technical description, and use of the medical device,
but excluding shipping documents. In this standard, that material is described as markings and accompanying
documents (3.2).
Note 3 to entry: “Adapting” includes making substantial modifications to a medical device already in use.
Note 4 to entry: In some jurisdictions, the responsible organization (3.22) can be considered a manufacturer when
involved in the activities described.
[SOURCE: ISO 14971:2007, 2.8, modified — by replacing Note 2 and adding Notes 3 and 4.]
3.13
maximum operating pressure
maximum pressure for which the hose assembly is intended to be used
3.14
medical gas
any gas or mixture of gases intended for administration to patients for anaesthetic, therapeutic,
diagnostic or prophylactic purposes, or for surgical tool applications
[SOURCE: ISO 4135:2001, 1.1.1]
3.15
medical gas pipeline system
complete system which comprises a supply system, a monitoring and alarm system and a distribution
system with terminal units (3.26) at the points where medical gases (3.14) or vacuum are required
[SOURCE: ISO 7396-1:2007, 3.29]
3.16
non-interchangeable screw-threaded connector
NIST connector
range of male and female components intended to maintain gas specificity by the allocation of a set of
different diameters and a left- or right-hand screw thread to the mating components for each particular gas
[SOURCE: ISO 9170-1:2008, 3.10]
3.17
normal use
operation, including routine inspection and adjustments by any operator, and standby, according to the
instructions for use
Note 1 to entry: Normal use should not be confused with intended use. While both include the concept of use as
intended by the manufacturer (3.12), intended use focuses on the medical purpose while normal use incorporates
not only the medical purpose, but maintenance, service, transport, etc. as well.
[SOURCE: IEC 60601-1:2005, 3.71]
3.18
outlet connector
gas-specific (3.5) pa
...