oSIST prEN ISO 5359:2026

• Abstract:

  ISO 5359:2014 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. 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. It does not specify the dimensions and allocation of the gas-specific inlet and outlet connectors for the hose assemblies.It does not specify requirements for coaxial hoses used for the supply and removal of air for driving surgical tools.Nor does it specify the intended uses of hose assemblies.

• Status: Not Published
• Public Enquiry End Date: 29-Nov-2026
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• ICS: 83.140.40 - Hoses
• Technical Committee: VAZ - Healthcare
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 06-Oct-2026
• Due Date: 23-Feb-2027
• Ref Project: prEN ISO 5359 - Anaesthetic and respiratory equipment - Low-pressure hose assemblies for use with medical gases (ISO/DIS 5359:2026)

• Revises: SIST EN ISO 5359:2015/A1:2018 - Anaesthetic and respiratory equipment - Low-pressure hose assemblies for use with medical gases - Amendment 1 (ISO 5359:2014/Amd 1:2017)
• Effective Date: 08-Oct-2025
• Revises: SIST EN ISO 5359:2015 - Anaesthetic and respiratory equipment - Low-pressure hose assemblies for use with medical gases (ISO 5359:2014)
• Effective Date: 08-Oct-2025

oSIST prEN ISO 5359:2026 is a draft standard for anaesthetic and respiratory equipment - low-pressure hose assemblies for use with medical gases. It specifies how these hose assemblies are designed, tested, marked, packaged and documented so they can be used with the intended medical gases, with gases for driving surgical tools, with anaesthetic gas scavenging systems (AGSS) and with vacuum. For manufacturers, test laboratories, hospitals and buyers, it gives a common way to check gas specificity, safety and performance.

What does oSIST prEN ISO 5359:2026 specify?

oSIST prEN ISO 5359:2026 covers low-pressure hose assemblies used for medical gases, driving gases, excess gas for AGSS and vacuum. It sets the framework for the hose assembly itself, while connector dimensions and allocation are handled elsewhere.

The scope applies to assemblies for the document’s stated pressure ranges, including vacuum and AGSS service. It also leaves out coaxial hoses for the supply and removal of air for driving surgical tools, and it does not define the intended clinical use of the hose assembly.

The document is organized into these main parts:

Part	What it covers
Clause 1	Scope
Clause 2	Normative references
Clause 3	Terms and definitions
Clause 4	General requirements
Clause 5	Test methods
Clause 6	Marking, colour coding and packaging
Clause 7	Information to be supplied by the manufacturer
Annex A	Rationale
Annex B	Environmental aspects
Annex C	Reported regional and national deviations of colour coding and nomenclature

What are the key requirements of oSIST prEN ISO 5359:2026?

oSIST prEN ISO 5359:2026 focuses on risk control, gas specificity, mechanical integrity, leakage, flow performance and clear identification. In practice, the standard is meant to keep different gas services from being connected incorrectly and to make sure the hose assembly remains safe through use, handling and maintenance.

Safety and risk control

Clause 4 requires the manufacturer to follow a risk management process in accordance with ISO 14971:2019. Unacceptable risks are to be controlled by design features, protective means, monitoring or alarm systems, or by warnings and handling advice in marking or labelling.

Clause 4 also requires the hose assembly to remain safe in normal use and in single-fault condition during transport, storage, installation, operation and maintenance. For a buyer or user, this means the supplier has to show how foreseeable hazards were identified and reduced, not just how the hose was built.

Materials, cleanliness and temperature performance

Clause 4 requires materials in contact with the gas to be compatible with oxygen, the other gases and their mixtures over the expected service life. It also requires the design to reduce risks from substances leaching from the materials, and hoses for breathable gas to meet ISO 18562-1:2024.

If phthalates are present in parts that contact the patient directly or indirectly, the hose assembly must be labelled and the instructions for use must describe the residual risk and any precautions. Clause 4 also ties performance to the permitted temperature range after storage and shipping, so the hose still has to meet the design requirements after the environmental conditions stated by the manufacturer.

Construction and gas-specific design

Clause 4 requires hose assemblies to have gas-specific connectors so hoses for different gases, or the same gas at different operating pressures, cannot be interchanged. The ends must be arranged as an inlet connector and an outlet connector, with permitted connector forms linked to ISO 9170-1:2017, ISO 9170-2 and national or regional screw-threaded connector systems.

The clause also controls how the hose is joined to the hose insert. It allows secure methods such as swaging or crimped ferrules, but it rejects detachable clips and similar arrangements that could loosen in service. This matters because the hose connection itself is part of the safety barrier.

Mechanical performance and leakage

Clause 4 sets requirements for burst resistance, tensile strength, deformation under pressure, resistance to occlusion, adhesion strength, flexibility, leakage and pressure drop. In practice, the manufacturer has to prove the hose can withstand handling loads, pressure changes and temporary squeezing without losing function.

Leakage testing applies to the hose assembly as a whole, and a separate limit applies if a hose assembly check valve is fitted at the outlet end. Pressure drop is also limited for compressed gases, driving gases and vacuum, so the assembly has to deliver enough flow for the application without excessive loss.

Marking, colour coding and packaging

Clause 6 requires clear, durable marking, including the manufacturer’s name or identification and traceability information such as type, batch or serial number or year of manufacture. Where phthalates are used, the marking must also show that fact.

If colour coding is used, it must follow the document’s table or regional and national standards, and the colouring must remain durable. Packaging must protect the hose assembly from particulate contamination and physical damage, and it must allow the contents to be identified without opening the package.

What terms does oSIST prEN ISO 5359:2026 define?

• Low-pressure hose assembly - A flexible hose with permanently attached gas-specific inlet and outlet connectors, designed for medical gas and vacuum service.
• Anaesthetic gas scavenging system (AGSS) - A system connected to breathing-system exhaust ports to convey excess gases to a discharge point.
• Gas-specific - Designed so that different gas services or vacuum services cannot be connected to each other.
• Hose assembly check valve - A normally closed valve that opens only when the correct gas-specific connector is inserted.
• Connector - A male or female component set that maintains gas specificity through matching dimensions.
• Responsible organization - The entity accountable for use and maintenance of the medical device.
• Terminal unit - The outlet or vacuum inlet point in a medical gas pipeline system where the operator connects and disconnects equipment.

Who uses oSIST prEN ISO 5359:2026?

oSIST prEN ISO 5359:2026 is used by manufacturers of medical gas hose assemblies, test laboratories and quality teams that verify performance and conformity. It is also relevant to hospital engineering, biomedical maintenance, procurement and service organizations that install, inspect and replace hose assemblies.

In practice, these users apply it when selecting connector types, checking gas-specific identification, planning maintenance, writing instructions for use, and confirming that a hose assembly is suitable for its intended gas service and pressure conditions.

What changed in oSIST prEN ISO 5359:2026 from the previous edition?

The foreword says this fourth edition cancels and replaces ISO 5359:2008 and ISO 5359:2008/Amd 1:2011. The revision deletes the requirements on the dimensions and allocation of connectors, adds definitions of terms, adds requirements on risk management, usability, clinical investigation and leaching of substances, and updates the marking requirements and the information to be supplied by the manufacturer.

Which standards are used with oSIST prEN ISO 5359:2026?

• ISO 14971:2019 - Provides the risk management process that Clause 4 requires the manufacturer to follow.
• ISO 15001 - Gives compatibility guidance for oxygen-related use and cleaning requirements for certain hose assemblies.
• ISO 18562-1:2024 - Sets the biocompatibility evaluation approach for breathing gas pathways when breathable gas is conveyed.
• ISO 1307 - Provides hose size and tolerance information for internal diameters.
• ISO 1402 - Supports hydrostatic testing used in mechanical strength and deformation-related testing.
• ISO 8033 - Provides the adhesion test method for hoses with concentric layers.
• ISO 9170-1:2017 and ISO 9170-2 - Define terminal units, probes and related gas-specific connection points used for the hose ends.
• ISO 18082 - Gives the dimensions of NIST low-pressure connectors, which the scope points to for connector allocation.
• ISO 7396-1:2016+Amd1:2017 - Provides the medical gas pipeline system context used in the introduction and definitions.
• ISO 80601-2-13:2022 - Is referenced where AGSS pressure-drop performance is discussed in the notes.

What does the oSIST prEN ISO 5359:2026 document contain?

oSIST prEN ISO 5359:2026 contains test methods for pressure drop, leakage, gas specificity, mechanical strength, deformation under pressure, resistance to occlusion, and durability of markings and colour coding. It also includes the design and construction rules that support those tests, so the document can be used for product development, type testing and conformity checking.

The document gives a dedicated occlusion test rig in Figures 1 and 2, and it uses Table 1 for marking and colour coding. Annex B maps the environmental aspects addressed across the product life cycle, and Annex C summarizes reported regional and national differences in colour coding and gas nomenclature.

SLOVENSKI STANDARD
01-november-2026
Anestezijska in dihalna oprema - Nizkotlačne povezovalne cevi za uporabo z
medicinskimi plini (ISO/DIS 5359:2026)
Anaesthetic and respiratory equipment - Low-pressure hose assemblies for use with
medical gases (ISO/DIS 5359:2026)
Anästhesie- und Beatmungsgeräte - Niederdruck-Schlauchleitungssysteme zur
Verwendung mit medizinischen Gasen (ISO/DIS 5359:2026)
Matériel d'anesthésie et de réanimation respiratoire - Flexibles de raccordement à basse
pression pour utilisation avec les gaz médicaux (ISO/DIS 5359:2026)
Ta slovenski standard je istoveten z: prEN ISO 5359
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
83.140.40 Gumene cevi Hoses
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT
International
Standard
ISO/DIS 5359
ISO/TC 121/SC 1
Anaesthetic and respiratory
Secretariat: DIN
equipment — Low-pressure hose
Voting begins on:
assemblies for use with medical
2026-09-25
gases
Voting terminates on:
2026-12-18
Matériel d'anesthésie et de réanimation respiratoire — Flexibles
de raccordement à basse pression pour utilisation avec les gaz
médicaux
ICS: 11.040.10
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document has not been edited by the ISO Central Secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Reference number
ISO/DIS 5359:2026(en)
DRAFT
ISO/DIS 5359:2026(en)
International
Standard
ISO/DIS 5359
ISO/TC 121/SC 1
Anaesthetic and respiratory
Secretariat: DIN
equipment — Low-pressure hose
Voting begins on:
assemblies for use with medical
gases
Voting terminates on:
Matériel d'anesthésie et de réanimation respiratoire — Flexibles
de raccordement à basse pression pour utilisation avec les gaz
médicaux
ICS: 11.040.10
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document has not been edited by the ISO Central Secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2026
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
ISO copyright office
RECIPIENTS OF THIS DRAFT ARE INVITED
CP 401 • Ch. de Blandonnet 8
TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
Phone: [phone]
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: [e-mail]
Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 5359:2026(en)
ii
ISO/DIS 5359:2026(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General requirements . 6
4.1 Risk management .6
4.2 Safety.6
4.3 Materials .7
4.4 Design requirements .8
4.4.1 Hose internal diameter .8
4.4.2 Mechanical strength .8
4.4.3 Deformation under pressure .8
4.4.4 Resistance to occlusion .8
4.4.5 Adhesion strength .9
4.4.6 Flexibility .9
4.4.7 Gas specificity .9
4.4.8 End connectors .9
4.4.9 Joining hoses to hose inserts .10
4.4.10 Leakage .10
4.4.11 *Pressure drop .11
4.5 Constructional requirements .11
4.5.1 Cleaning .11
4.5.2 Lubricants .11
5 Test methods .11
5.1 General .11
5.1.1 Ambient conditions .11
5.1.2 Test gas . .11
5.1.3 Reference conditions . 12
5.2 Test method for pressure drop . 12
5.3 Test method for leakage . 12
5.3.1 For all hose assemblies . 12
5.3.2 For hose assemblies fitted with a hose assembly check valve . 12
5.4 Test method for gas specificity . 12
5.5 Test method for mechanical strength . 12
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 .14
6 Marking, colour coding and packaging. 14
6.1 Marking .14
6.2 Colour coding . 15
6.3 Packaging .16
7 Information to be supplied by the manufacturer .16
Annex A (informative) Rationale .18
Annex B (informative) Environmental aspects . 19
Annex C (informative) Reported regional and national deviations of colour coding and
nomenclature for medical gases .20
Bibliography .22

iii
ISO/DIS 5359:2026(en)
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/DIS 5359:2026(en)
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.

v
DRAFT International Standard ISO/DIS 5359:2026(en)
Anaesthetic and respiratory equipment — Low-pressure hose
assemblies for use with medical gases
1 Scope
1.1 This document specifies requirements for low-pressure hose assemblies intended for the following:
— gases and gas mixtures intended for medical use,
— gases for driving surgicial tools,
— excess gas for AGSS,
— vacuum.
NOTE AGSS removes excess gases from an anaesthetic workstation.
1.2 *It applies to hose assemblies operating at pressures up to 1 400 kPa, for vacuum systems at pressures
not greater than 60 kPa absolute and for AGSS from -30 kPa to 10 kPa relative to ambient pressure.
1.3 This document does not specify the dimensions and allocation of the gas-specific inlet and
[1]
outlet connectors for the hose assemblies, which can be found in national standards or in ISO 18082 ,
ISO 9170-1:2017 and ISO 9170-2 .
NOTE 1 Specifications for the dimensions and allocation of diameter index safety system (DISS) connectors are
[2]
specified in CGA C-9 .
NOTE 2 Specifications for the dimensions and allocation of sleeve indexed system (SIS) connectors are specified in
[3] [4]
AS 2902:2005 and NEN 8877:2024 .
NOTE 3 Dimensions and allocation of non-interchangeable screw-threaded (NIST) connectors are specified in
[1]
ISO 18082 .
NOTE 4 Terminal units designed for quick connectors are specified in ISO 9170-1:2017.
NOTE 5 Terminal units for anaesthetic gas scavenging systems are specified in ISO 9170-2.
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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements 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/DIS 5359:2026(en)
ISO 8033, Rubber and plastics hoses — Determination of adhesion between components
ISO 9170-1:2017, Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with
compressed medical gases and vacuum
ISO 9170-2, Terminal units for medical gas pipeline systems — Part 2: Terminal units for anaesthetic gas
scavenging systems
ISO 14971:2019, Medical devices - Application of risk management to medical devices
ISO 15001, Anaesthetic and respiratory equipment — Compatibility with oxygen
ISO 18562-1:2024, Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1:
Evaluation and testing within a risk management process
ISO 9170-1:2017, Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with
compressed medical gases and vacuum
ISO 14971:2019, Medical devices — Application of risk management to medical devices
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
accessory, noun
additional component for use with equipment 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 equipment
[5]
[SOURCE: I EC 6 06 01-1:20 05+A M D1: 2012+ A M D2: 2020 C S V , 3.3]
3.2
accompanying document, noun
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)
[5]
[SOURCE: I EC 6 06 01-1:20 05+A M D1: 2012+ A M D2: 2020 C S V , 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
anaesthetic gas scavenging system, noun
AGSS, noun
system which is connected to the exhaust ports of a breathing system or of other equipment for the purpose
of conveying excess gases to an appropriate point of discharge
Note 1 to entry: Functionally, an AGSS comprises three parts: a transfer system, a receiving system and an AGSS
disposal system. These three functionally discrete parts may be either separate or sequentially combined in part or
in total. One or more parts of an AGSS may be combined with an anaesthetic breathing system component or other
equipment.
Note 2 to entry: The excess gases can contain anaesthetic gases and vapours.

ISO/DIS 5359:2026(en)
[6]
[SOURCE: ISO 4135:2022 , 3.9.1.1, modified by replacing "excess anaesthtetic gases and vapours" by "excess
gases" and by adding note 2 to entry.]
3.4
basic safety, noun
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)
[5]
[SOURCE: I EC 6 06 01-1:20 05+A M D1: 2012+ A M D2: 2020 C S V , 3.10, modified by replacing "medical electrical
equipment, medical electrical system" by "medical device".]
3.5
connector, noun
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).
3.6
gas-specific, noun
having characteristics which prevent connections between different gas services or vacuum services
[7]
[SOURCE: ISO 7396-1:2016+Amd1:2 017 , 3.17]
3.7
harm, noun
physical injury or damage to the health of people or animals, or damage to property or the environment
[SOURCE: ISO 14971:2019, 3.3, modified by adding “physical” and "or animals".]
3.8
hazard, noun
potential source of harm (3.6)
[SOURCE: ISO 14971:2019, 3.4]
3.9
hose assembly check valve, noun
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)
[6]
[SOURCE: ISO 4135:2022 , 3.2.3.6]
3.10
hose insert, noun
portion of a connector (3.4) which is pushed into and secured within the bore (lumen) of the hose
[6]
[SOURCE: ISO 4135:2022 , 3.1.4.25]
3.11
inlet connector, noun
gas-specific (3.5) part of a hose assembly which is connected to a medical gas supply system
3.12
low-pressure hose assembly, noun
assembly consisting of a flexible hose with permanently attached gas-specific (3.5)inlet (3.10) and outlet
connectors (3.18) and designed to conduct a medical gas at pressures less than 1 400 kPa and vacuum
[SOURCE: ISO 9170-1:2017, 3.5]

ISO/DIS 5359:2026(en)
3.13
manufacturer, noun
natural or legal person with responsibility for the design and/or manufacture of a medical device with the
intention of making the medical device available for use, under his name, whether or not such a medical
device is designed and/or manufactured by that third person himself or on his behalf by another person(s)
Note 1 to entry: The natural or legal person has ultimate legal responsibility for ensuring compliance with all
applicable regulatory requirements for the medical device in the countries or jurisdictions where it is intended to
be made available or sold, unless this responsibility is specifically imposed on another person by the Regulatory
Authority (RA) within that jurisdiction.
Note 2 to entry: The manufacturer's responsibilities are described in other GHTF guidance documents. These
responsibilities include meeting both pre-market requirements and post-market requirements, such as adverse event
reporting and notification of corrective actions.
Note 3 to entry: "Design and/or manufacture" can include specification development, production, fabrication,
assembly, processing, packaging, repackaging, labelling, relabelling, sterilization, installation, or remanufacturing of
a medical device; or putting a collection of devices, and possibly other products, together for a medical purpose.
Note 4 to entry: Any person who assembles or adapts a medical device that has already been supplied by another
person for an individual patient, in accordance with the instructions for use, is not the manufacturer, provided the
assembly or adaptation does not change the intended use of the medical device.
Note 5 to entry: Any person who changes the intended use of, or modifies, a medical device without acting on behalf
of the original manufacturer and who makes it available for use under his own name, should be considered the
manufacturer of the modified medical device.
Note 6 to entry: An authorised representative, distributor or importer who only adds its own address and contact
details to the medical device or the packaging, without covering or changing the existing labelling, is not considered a
manufacturer.
Note 7 to entry: To the extent that an accessory is subject to the regulatory requirements of a medical device, the
person responsible for the design and/or manufacture of that accessory is considered to be a manufacturer.
[SOURCE: ISO 14971:2019, 3.9]
3.14
maximum operating pressure, noun
〈hose assembly〉 maximum pressure for which the hose assembly is intended to be used
3.15
medical gas, noun
any gas or mixture of gases intended for administration to patients for anaesthetic, therapeutic, diagnostic
or prophylactic purposes, or as a source of pneumatic power for medical or surgical tools
[6]
[SOURCE: ISO 4135:2022 , 3.1.1.20]
3.16
medical gas pipeline system, noun
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
[7]
[SOURCE: ISO 7396-1:2016+Amd1:2 017 , 3.36]
3.17
non-interchangeable screw-threaded connector, noun
NIST connector, noun
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 9170-1:2017, 3.11]

ISO/DIS 5359:2026(en)
3.18
normal use, noun
operation, including routine inspection and adjustments by any operator, and stand-by, according to the
instructions for use
[5]
[SOURCE: I EC 6 06 01-1:20 05+A M D1: 2012+ A M D2: 2020 C S V , 3.71]
3.19
outlet connector, noun
gas-specific (3.5) part of a hose assembly which is connected to the point where gas is delivered
3.20
oxygen 90+ (O 90+), noun
a gas mixture that meets the following criteria for composition;
— oxygen (O ): volume fraction of no less than 90 %, potentially varying in this range over time;
— argon (Ar), volume fraction of no more than 5 %;
— nitrogen (N ), volume fraction of no more than 10 %;
— carbon dioxide (CO ), volume fraction of of no more than 300 ppm;
— carbon monoxide (CO), volume fraction of of no more than 10 ppm;
— nitrogen oxides (NOx), volume fraction of of no more than 2 ppm;
— sulfur dioxide (SO ), volume fraction of of no more than 1 ppm;
— oils: no more than 0,1 mg/m
Note 1 to entry: The definiton of oxygen 90+ will be removed when the according definition is published by ISO 4135.
[8]
[SOURCE: ISO 4135:2022/DAmd 1.2 , 3.1.1.22.1.]
3.21
probe, noun
gas-specific (3.5) male component designed for acceptance by, and retention in, the socket (3.25)
[SOURCE: ISO 9170-1:2017, 3.13]
3.22
quick connector, noun
pair of non-threaded gas-specific (3.5) components which can be easily and rapidly joined together by a
single action of one or both hands without the use of tools
[SOURCE: ISO 9170-1:2017, 3.14]
3.23
responsible organization, noun
entity accountable for the use and maintenance of a medical device
Note 1 to entry: The accountable entity can be, for example, a hospital, an individual clinician or a layperson. In home
use applications, the patient, operator and responsible organization can be one and the same person.
Note 2 to entry: Education and training is included in “use.”
[5]
[SOURCE: I EC 6 06 01-1:20 05+A M D1: 2012+ A M D2: 2020 C S V , 3.101, modified by replacing "medical
electrical equipment" and "medical electrical system" by "medical device".]
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