SIST EN ISO 5359:2008

SLOVENSKI STANDARD
SIST EN ISO 5359:2008
01-september-2008
1DGRPHãþD
SIST EN 739:2000
SIST EN 739:2000/A1:2002
1L]NRWODþQHSRYH]RYDOQHFHYL]DGHOR]PHGLFLQVNLPLSOLQL,62
Low-pressure hose assemblies for use with medical gases (ISO 5359:2008)
Niederdruckschlauchleitungssysteme zur Verwendung mit medizinischen Gasen (ISO
5359:2008)
Flexibles basse pression utilisés dans les systemes de gaz médicaux (ISO 5359:2008)
Ta slovenski standard je istoveten z: EN ISO 5359:2008
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
83.140.40 Gumene cevi Hoses
SIST EN ISO 5359:2008 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 5359:2008

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SIST EN ISO 5359:2008
EUROPEAN STANDARD
EN ISO 5359
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2008
ICS 83.140.40; 11.040.10 Supersedes EN 739:1998
English Version
Low-pressure hose assemblies for use with medical gases (ISO
5359:2008)
Flexibles de raccordement à basse pression pour utilisation Niederdruck-Schlauchleitungssysteme zur Verwendung mit
avec les gaz médicaux (ISO 5359:2008) medizinischen Gasen (ISO 5359:2008)
This European Standard was approved by CEN on 29 May 2008.
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 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, 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.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2008 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 5359:2008: E
worldwide for CEN national Members.

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SIST EN ISO 5359:2008
EN ISO 5359:2008 (E)
Contents Page
Foreword.3
Annex ZA (informative) Relationship between this International Standard and the Essential
Requirements of EU Directive 93/42/EEC.4

2

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SIST EN ISO 5359:2008
EN ISO 5359:2008 (E)
Foreword
This document (EN ISO 5359:2008) 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 December 2008, and conflicting national standards shall be withdrawn
at the latest by June 2010.
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 739:1998.
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 EC Directive(s).
For relationship with EC Directive, 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, 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 5359:2008 has been approved by CEN as a EN ISO 5359:2008 without any modification.
3

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SIST EN ISO 5359:2008
EN ISO 5359:2008 (E)
Annex ZA
(informative)

Relationship between this International Standard and the Essential
Requirements of EU Directive 93/42/EEC
This International Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide one means of conforming to Essential Requirements of
the New Approach Directive 93/42/EEC Medical devices.

Once this standard is cited in the Official Journal of the European Communities under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the normative
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 Medical devices

Clause(s)/sub-clause(s) of this Essential Requirements (ERs) of Qualifying remarks/Notes
International Standard Directive 93/42/EEC
4 1
4.1 2.6
4.2 2
4.3.1 7.1, 7.3, 9.3
4.3.2 4, 7.1, 9.2
4.3.3 3, 5, 7.2
4.4.2 9.1, 9.2, 12.7.1
4.4.3 9.2
4.4.4 12.7.1, 12.8.1
4.4.7 9.1, 12.7.4
4.4.8 9.1, 12.7.4
4.4.9 9.1, 12.7.4
4.4.13 7.5
4.4.14 9.1
4.5.1 7.2, 9.3
4.5.2 9.3
5.2 9.1
5.3 7.5
5.4 9.1, 12.7.4
5.5 9.1, 9.2, 12.7.1
5.6 9.2
5.7 12.7.1, 12.8.1
5.8 13.2
6.1 13.2
6.1.3 13.1, 13.3 a), 13.3 d), 13.5
6.1.5 13.3 e)
6.2 13.2
6.3.1 5, 7.2, 7.6
6.3.2 13.1, 13.3 b)
7 2, 13.1, 13.3 a), 13.4, 13.6 d)

WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
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SIST EN ISO 5359:2008

INTERNATIONAL ISO
STANDARD 5359
Third edition
2008-06-15

Low-pressure hose assemblies for use
with medical gases
Flexibles de raccordement à basse pression pour utilisation avec les
gaz médicaux




Reference number
ISO 5359:2008(E)
©
ISO 2008

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SIST EN ISO 5359:2008
ISO 5359:2008(E)
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ii © ISO 2008 – All rights reserved

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SIST EN ISO 5359:2008
ISO 5359:2008(E)
Contents Page
Foreword. v
Introduction . vi
0.1 General. vi
0.2 Standardization of screw-threaded connectors for use in hose assemblies. vi
1 Scope. 1
2 Normative references. 2
3 Terms and definitions. 2
4 General requirements. 5
4.1 Safety. 5
4.2 * Alternative construction. 6
4.3 Materials. 6
4.4 Design requirements . 6
4.4.1 Hose internal diameter . 6
4.4.2 Mechanical strength. 6
4.4.3 Deformation under pressure . 7
4.4.4 Resistance to occlusion. 7
4.4.5 Adhesion strength . 7
4.4.6 Flexibility. 7
4.4.7 Gas-specificity. 7
4.4.8 End connectors. 8
4.4.9 Design of NIST connectors. 8
4.4.10 Design of DISS connectors. 8
4.4.11 Design of SIS connectors . 16
4.4.12 Joining hoses to hose inserts . 16
4.4.13 Leakage. 17
4.4.14 * Pressure drop . 17
4.4.15 Expulsion of nipple. 17
4.5 Constructional requirements. 17
4.5.1 * Cleaning . 17
4.5.2 * Lubricants . 18
5 Test methods. 18
5.1 General. 18
5.1.1 Ambient conditions . 18
5.1.2 Test gas. 18
5.1.3 Reference conditions . 18
5.2 Test method for pressure drop . 18
5.3 Test method for leakage . 18
5.3.1 For all hose assemblies . 18
5.3.2 For hose assemblies fitted with a hose assembly check valve. 18
5.4 Test method for gas-specificity. 18
5.5 Test method for mechanical strength. 19
5.6 Test method for deformation under pressure . 19
5.7 Test method for resistance to occlusion. 19
5.8 Test method for durability of markings and colour coding. 21
6 Marking, colour coding and packaging. 21
6.1 Marking. 21
6.2 Colour coding. 22
6.3 Packaging. 22
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SIST EN ISO 5359:2008
ISO 5359:2008(E)
7 Information to be supplied by the manufacturer . 22
Annex A (informative) Rationale . 24
Annex B (informative) Environmental aspects . 25
Annex C (informative) Reported regional and national deviations of colour coding and
nomenclature for medical gases . 26
Bibliography . 28

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SIST EN ISO 5359:2008
ISO 5359:2008(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 5359 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 1, Breathing attachments and anaesthetic machines.
This third edition cancels and replaces the second edition (ISO 5359:2000), which has been technically
revised.
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SIST EN ISO 5359:2008
ISO 5359:2008(E)
Introduction
0.1 General
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 physical 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 recognising 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, and 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;
⎯ cleanliness;
⎯ testing;
⎯ identification;
⎯ information supplied.
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.
0.2 Standardization of screw-threaded connectors for use in hose assemblies
Whilst 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 for inclusion in this International Standard.
The three systems of connectors, which are non-interchangeable, are diameter-index safety system (DISS),
non-interchangeable screw-threaded (NIST) and sleeve indexed system (SIS). Tables 1 and 5 detail those
gases and gas mixtures for which DISS, NIST and SIS connectors have been allocated. Dimensions of NIST
connectors are given in Tables 2, 3 and 4 and Figures 2, 3, 4 and 5. Dimensions of DISS connectors can be
obtained from the Compressed Gas Association Inc., 1725 Jefferson Davis Highway, Arlington, VA
22202, USA. Dimensions of SIS connectors can be obtained from Standards Australia, GPO Box 476 Sydney,
New South Wales, 2001, Australia.
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SIST EN ISO 5359:2008
ISO 5359:2008(E)
As an alternative to the screw-threaded connector, a “quick connector” which is gas-specific can be used at
the inlet (outlet for vacuum) of the hose assembly, i.e. to connect the hose assembly to the fixed pipeline.
Quick-connector systems of differing design should be non-interchangeable with each other in any one health-
care facility.

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SIST EN ISO 5359:2008

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SIST EN ISO 5359:2008
INTERNATIONAL STANDARD ISO 5359:2008(E)

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;
⎯ vacuum.
It is intended in particular to ensure gas-specificity and to prevent cross-connection between systems
conveying different gases. These hose assemblies are intended for use at maximum operating pressures of
less than 1 400 kPa.
1.2 This International Standard specifies the allocation of (NIST), (DISS), (SIS) connectors to medical
gases and specifies the dimensions of non-interchangeable screw-threaded (NIST) connectors.
1.3 This International Standard does not specify:
⎯ requirements for coaxial hoses used for the supply and disposal of air for driving surgical tools;
⎯ requirements for electrical conductivity.
1.4 This International Standard does not specify the intended uses of hose assemblies.
NOTE Some examples of intended use specified in other International Standards are as follows:
[7] [8]
a) between a terminal unit and medical equipment (ISO 9170-1, IEC 60601-2-12 , IEC 60601-2-13 );
[10] [13]
b) between the fixed pipeline system and a terminal unit of that system (ISO 7396-1 , ISO 11197 );
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SIST EN ISO 5359:2008
ISO 5359:2008(E)
c) between a terminal unit and a second terminal unit (ISO 7396-1);
[12]
d) between an emergency supply and an emergency and maintenance inlet point of a pipeline system (ISO 10524-1 ,
ISO 7396-1);
[16]
e) between an emergency supply and medical equipment (ISO 10524-1, ISO 10524-3 , IEC 60601-2-12,
IEC 60601-2-13).
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 1307, Rubber and plastics hoses — Hose sizes, minimum and maximum inside diameters, and
tolerances on cut-to-length hoses
ISO 1402, Rubber and plastics hoses and hose assemblies — Hydrostatic testing
ISO 8033, Rubber and plastics hoses — Determination of adhesion between components
ISO 9170-1, Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with
compressed medical gases and vacuum
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 15001, Anaesthetic and respiratory equipment — Compatibility with oxygen
EN 1089-3:2004, Transportable gas cylinders — Gas cylinder identification (excluding LPG) — Part 3: Colour
coding
AS 2896-1998, Medical gas systems — Installations and testing of non-flammable medical gas pipeline
systems
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
Examples of use of some of these terms to describe permitted inlet and outlet connectors for hose assemblies
are given in Figure 1.
3.1
DISS connector
diameter-index safety system 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
3.2
gas-specific
having characteristics which prevent interchangeability, thereby allowing assignment to only one gas service
or vacuum service
3.3
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 connector
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SIST EN ISO 5359:2008
ISO 5359:2008(E)
3.4
hose insert
that portion of a connector which is pushed into, and secured within, the bore (lumen) of the hose
3.5
inlet connector
that gas-specific part of a hose assembly which is connected to a medical gas supply system
3.6
low-pressure hose assembly
assembly that consists of a flexible hose with permanently attached gas-specific inlet and outlet connectors
and which is designed to conduct a medical gas at pressures less than 1 400 kPa
3.7
maximum operating pressure
maximum pressure for which the hose assembly is intended to be used
3.8
medical gas
any gas or mixture of gases intended to be administered to patients for therapeutic, diagnostic or prophylactic
purposes, or for surgical tool applications
NOTE For the purposes of this document, this term includes vacuum.
3.9
medical gas pipeline system
central supply system with control equipment, a pipeline distribution system and terminal units at the points
where medical gases or vacuum can be required or any other installation having no permanent pipeline
system but employing a medical gas source complete with pressure regulators
3.10
NIST connector
non-interchangeable screw-threaded connector
any of a 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
3.11
outlet connector
that gas-specific part of a hose assembly which is connected to the point where gas is delivered
3.12
oxygen-enriched air
gas produced by an oxygen concentrator
NOTE Regional or national regulations might specify the name, symbol and colour coding for oxygen-enriched air.
3.13
probe
non-interchangeable male component designed for acceptance by, and retention in, the socket
3.14
quick connector
pair of non-threaded gas-specific components that can be easily and rapidly joined together or separated by a
single action of one or both hands without the use of tools
3.15
single-fault condition
condition in which a single means for protection against a safety hazard in equipment is defective or a single
external abnormal condition is present
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SIST EN ISO 5359:2008
ISO 5359:2008(E)
3.16
SIS connector
sleeve-index system 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
3.17
socket
female part of a terminal unit which is either integral or attached to the base block by a gas-specific interface
and which contains the gas-specific connection point
3.18
terminal unit
outlet assembly (inlet for vacuum) in a medical gas supply system at which the operator makes connections
and disconnections
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SIST EN ISO 5359:2008
ISO 5359:2008(E)

Key
1 probe 4 NIST, DISS or SIS body
2 NIST, DISS or SIS nut and nipple 5 terminal unit or gas-specific connection
3 inlet connector 6 outlet connector
Figure 1 — Diagram of permitted end connectors
4 General requirements
4.1 Safety
Hose assemblies shall, when transported, stored, installed, operated in normal use and maintained according
to the instructions of the manufacturer, cause no safety hazard which could be foreseen using risk analysis
procedures in accordance w
...