prEN ISO 7396-1

• Abstract:

  ISO 7396-1:2016 specifies requirements for design, installation, function, performance, testing, commissioning and documentation of pipeline systems used in healthcare facilities for the following:; - oxygen;; - nitrous oxide;; - medical air;; - carbon dioxide;; - oxygen/nitrous oxide mixtures (see Note 1);; - helium/oxygen mixtures;; - (*) oxygen 93;; - gases and gas mixtures classified as medical device, gases delivered to medical devices or intended for medical purposes or gases and gas mixtures for medicinal use not specified above;; - air for driving surgical tools;; - nitrogen for driving surgical tools;; - vacuum.; NOTE 1 Regional or national regulations may prohibit the distribution of oxygen/nitrous oxide mixtures in medical gas pipeline systems.; NOTE 2 Anaesthetic gas scavenging disposal systems are covered in ISO 7396‑2.; This part of ISO 7396 includes requirements for supply systems, pipeline distribution systems, control systems, monitoring and alarm systems and non-interchangeability between components of different gas/vacuum systems.; This part of ISO 7396 specifies safety requirements for pipeline systems used in healthcare facilities, both public and private. It applies to all facilities providing healthcare services regardless of type, size, location or range of services, including, but not limited to:; a) acute care healthcare facilities;; b) internal patient continuing care healthcare facilities;; c) long-term care facilities;; d) community-based providers;; e) ambulatory and external patient care clinics (e.g. day surgery, endoscopy clinics and doctors' offices).; NOTE 3 This part of ISO 7396 may also be used as reference for pipeline systems for medical gases and vacuum intended to be installed in places other than healthcare facilities.; ISO 7396-1:2016 applies to the following different types of oxygen supply systems:; - supply systems in which all sources of supply deliver oxygen; in this case the concentration of the oxygen will be greater than 99%;; - supply systems in which all sources of supply deliver oxygen 93; in this case the concentration of the oxygen may vary between 90% and 96%;; NOTE 4 A mixture of oxygen 93 and oxygen may be delivered by a medical gas supply system. In this case the concentration of the gas can vary between 90% and >99%.; ISO 7396-1:2016 also applies to:; - extensions of existing pipeline distribution systems;; - modifications of existing pipeline distribution systems;; - modifications or replacement of supply systems or sources of supply.; Oxygen concentrators for domiciliary use are excluded from the scope of this part of ISO 7396.; NOTE 5 Requirements for oxygen concentrators for domiciliary use are specified in ISO 80601‑2-69.; (*) EN 14931 defines additional requirements for hyperbaric application, in particular for flows and pressures of compressed air required to pressurize the hyperbaric chamber and to drive other connected services. Also included are requirements for oxygen and other treatment gases administered to patients.; ISO 7396-1:2016 does not apply to vacuum systems intended to be used in dentistry.; ISO 7396-1:2016 does not apply to filling systems for transportable cylinders and transportable cylinder bundle systems.

• Status: Not Published
• Publication Date: 24-Jan-2028
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Drafting Committee: CEN/TC 215/WG 3 - Medical gas supply systems
• Current Stage: 4020 - Submission to enquiry - Enquiry
• Start Date: 30-Jul-2026
• Completion Date: 30-Jul-2026
• Directive: Harmonized Standard2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Directive:

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  Not Harmonized93/42/EEC - Medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Mandate: M/575 Amd 2 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medicial devices in support of Regulation (EU) 2017746
• Ref Project: oSIST prEN ISO 7396-1:2026 - Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO/FDIS 7396-1:2026)

• Consolidated By: ISO/FDIS 7396-1 - Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum
• Effective Date: 12-Feb-2026
• Revises: EN ISO 7396-1:2016 - Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2016)
• Effective Date: 14-Jun-2023
• Revises: EN ISO 7396-1:2016/A1:2019 - Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum - Amendment 1 (ISO 7396-1:2016/Amd 1:2017)
• Effective Date: 14-Jun-2023

Overview

prEN ISO 7396-1:2026 (Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum) defines the essential requirements for the safe design, installation, operation, and documentation of medical gas and vacuum pipeline systems in healthcare environments. Published by CEN and aligning with ISO/FDIS 7396-1:2026, this standard is critical for ensuring the consistent delivery of vital medical gases and vacuum services in hospitals, clinics, and care facilities worldwide.

Medical gas pipeline systems are pivotal for delivering gases such as oxygen, nitrous oxide, medical air, carbon dioxide, helium and oxygen mixtures, as well as vacuum and air/nitrogen for surgical tools. prEN ISO 7396-1 offers an internationally recognized framework for quality, reliability, and safety throughout the lifecycle of these installations.

Key Topics

prEN ISO 7396-1 covers a comprehensive range of topics that are crucial for medical gas pipeline systems, including:

• System Design: Specifies how to design pipeline systems for different gases, ensuring non-interchangeability and safe operation.
• Supply and Distribution: Requirements for supply sources, pipeline distribution systems, and integration with central control, monitoring, and alarm systems.
• Performance and Safety: Guidelines for maintaining quality, flow, pressure, and reliability, including risk management and material specifications.
• Installation and Commissioning: Instructions for setting up, inspecting, and verifying pipeline networks and associated equipment before usage.
• Monitoring and Alarms: Mandates for continuous system monitoring, alarm signals, and redundancy to prevent outages and ensure immediate response to faults.
• Extension and Modification: Provisions for safely modifying or expanding existing systems without disrupting essential healthcare services.
• Documentation: Detailed guidance on documentation, operational instructions, and conformance records to maintain compliance and traceability.
• Exclusions: Clear boundaries, such as the exclusion of oxygen concentrators for home use and vacuum systems for dental applications.

Applications

This standard applies broadly across the healthcare sector, including:

• Acute care facilities: Hospitals and emergency care centers where continuous reliable delivery of medical gases is vital for surgeries, intensive care, and emergency treatment.
• Long-term and continuing care: Facilities supporting ongoing patient care, rehabilitation, or chronic treatment requiring medical gases.
• Ambulatory and outpatient clinics: Day surgery centers, endoscopy clinics, and specialized outpatient settings.
• Community-based providers: Any healthcare setting outside traditional hospitals that relies on medical gas or vacuum pipelines.
• Modifications and upgrades: Ensures safety, compatibility, and integrity when making extensions to or upgrading existing medical gas systems.

Additionally, prEN ISO 7396-1 can serve as a reference for installations outside conventional healthcare environments where medical gas pipelines are needed.

Related Standards

Several international standards complement the guidance outlined in prEN ISO 7396-1:

• ISO 7396-2: Covers specific requirements for anaesthetic gas scavenging disposal systems.
• ISO 80601-2-69: Specifies requirements for oxygen concentrators intended for domiciliary (home) use.
• EN 14931: Addresses hyperbaric applications, including additional demands for flows, pressures, and connected services.
• ISO 7396 Series: Other parts provide further detail on related systems and requirements.

For compliance and optimal safety, prEN ISO 7396-1 should be used alongside these and other relevant medical device and healthcare facility standards.

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Keywords: medical gas pipeline systems, ISO 7396-1, healthcare facility standard, compressed medical gases, vacuum systems, pipeline system installation, medical oxygen, gas supply, CEN, medical gas safety, standardization, hospital infrastructure, medical air, nitrous oxide systems, pipeline monitoring, alarm systems, medical vacuum.

SLOVENSKI STANDARD
01-oktober-2026
Sistemi napeljav za medicinske pline - 1. del: Sistemi napeljav za stisnjene
medicinske pline in podtlak (ISO/FDIS 7396-1:2026)
Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases
and vacuum (ISO/FDIS 7396-1:2026)
Rohrleitungssysteme für medizinische Gase - Teil 1: Rohrleitungssysteme für
medizinische Druckgase und Vakuum (ISO/FDIS 7396-1:2026)
Systèmes de distribution de gaz médicaux - Partie 1: Systèmes de distribution de gaz
médicaux comprimés et de vide (ISO/FDIS 7396-1:2026)
Ta slovenski standard je istoveten z: prEN ISO 7396-1
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

FINAL DRAFT
International
Standard
ISO/FDIS 7396-1
ISO/TC 121/SC 6
Medical gas pipeline systems —
Secretariat: ANSI
Part 1:
Voting begins on:
2026-07-28
Pipeline systems for compressed
medical gases and vacuum
Voting terminates on:
2026-09-22
Systèmes de distribution de gaz médicaux —
Partie 1: Systèmes de distribution de gaz médicaux comprimés et
de vide
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 SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/CEN PARALLEL PROCESSING LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
ISO/FDIS 7396-1:2026(en) © ISO 2026

FINAL DRAFT
ISO/FDIS 7396-1:2026(en)
International
Standard
ISO/FDIS 7396-1
ISO/TC 121/SC 6
Medical gas pipeline systems —
Secretariat: ANSI
Part 1:
Voting begins on:
Pipeline systems for compressed
medical gases and vacuum
Voting terminates on:
Systèmes de distribution de gaz médicaux —
Partie 1: Systèmes de distribution de gaz médicaux comprimés et
de vide
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 SUPPOR TING DOCUMENTATION.
© ISO 2026
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/CEN PARALLEL PROCESSING
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
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Phone: [phone]
Email: [e-mail]
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Published in Switzerland Reference number
ISO/FDIS 7396-1:2026(en) © ISO 2026

ii
ISO/FDIS 7396-1:2026(en)
Contents Page
Foreword .vi
Introduction .viii
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 3
4 General requirements . 9
4.1 General .9
4.2 Safety and risk management .9
4.3 Gases for medical use .10
4.4 Materials .10
4.5 System design . 12
4.5.1 Requirements in the design . 12
4.5.2 Extensions and modifications of existing medical gas pipeline systems .14
4.5.3 Provision for Electrical Supply . 15
4.5.4 Biological risk . 15
4.5.5 Software . 15
4.5.6 Damage . 15
5 Supply systems .15
5.1 Supply system components . 15
5.2 General Requirements for supply systems .17
5.2.1 Capacity and storage.17
5.2.2 Continuity of supply .17
5.2.3 Primary source of supply .17
5.2.4 Secondary source of supply .17
5.2.5 Reserve source(s) of supply .17
5.2.6 Requirements for outlet pressure .18
5.2.7 Means of pressure relief .18
5.2.8 Maintenance supply assembly .19
5.2.9 Line pressure regulators .19
5.2.10 Ozone sterilizers .19
5.3 Supply systems with cylinders, cylinder bundles or high pressure reservoir(s).19
5.4 Supply systems with cryogenic or non cryogenic vessels . 20
5.5 Supply systems for air .21
5.6 Supply systems with oxygen concentrator unit(s) .27
5.6.1 General requirements .27
5.6.2 Primary source of supply .27
5.6.3 Secondary source of supply .27
5.6.4 Reserve source of supply .27
5.6.5 Specifications for pharmacopeial oxygen .27
5.6.6 Sources of supply with oxygen concentrator unit(s) . 28
5.6.7 Local filling of permanently attached high-pressure reservoir(s), acting as reserve
source of supply .32
5.7 Supply systems for vacuum . 33
5.8 Location of supply systems and sources of supply . 34
5.9 Sources of supply and supply systems assembled at site . 35
5.10 Sources of supply and supply systems preassembled in a factory . . 36
5.10.1 Leakage . 36
5.10.2 Marking . . 36
5.10.3 Packaging . 36
5.10.4 Information for installation .37
5.10.5 Information for use .37
5.10.6 Information for maintenance .37
6 Monitoring and alarms . .38

iii
ISO/FDIS 7396-1:2026(en)
6.1 General . 38
6.2 Installation requirements . 38
6.3 Monitoring and alarm signals . 39
6.3.1 General . 39
6.3.2 Auditory signals . 39
6.3.3 Visual signals . 39
6.3.4 Emergency and operating alarm characteristics . 39
6.3.5 Information signals . 40
6.3.6 Remote alarm extensions . 40
6.4 Provision of operating alarms . 40
6.5 Provision of emergency clinical alarms .41
6.6 Provision of emergency operating alarms .41
7 Pipeline distribution systems . 41
7.1 Mechanical resistance in single fault condition .41
7.2 Distribution pressure .41
7.3 Low-pressure hose assemblies and low-pressure flexible connections .43
7.4 Double-stage pipeline distribution systems.43
8 Shut-off valves and non-return valves .44
8.1 General . 44
8.2 Source shut-off valve . 44
8.3 Main shut-off valve . 44
8.4 Service shut-off valves .45
8.5 Riser shut-off valves .45
8.6 Pipeline branch shut-off valves .45
8.7 Area shut-off valves .45
8.8 Non-return valves . 46
9 Terminal units, pressure regulators and pressure gauges .46
10 Marking and colour coding .47
10.1 Marking .47
10.2 Colour coding .47
11 Pipeline Installation. 47
11.1 General .47
11.2 Pipeline supports . 48
11.3 Pipeline joints . 49
11.4 Extensions and modifications of existing medical gas pipeline systems . 49
12 Testing and commissioning .50
12.1 General . 50
12.2 General requirements for tests . 50
12.3 Inspections and tests for sources of supply and supply systems . 50
12.3.1 Tests of all sources of supply . 50
12.3.2 Tests for sources of supply with air compressor unit(s) .52
12.3.3 Tests for supply systems with oxygen concentrator unit(s) .52
12.3.4 Tests of the quality of air for driving surgical tools . . 54
12.3.5 Tests of the quality of medical air produced by supply systems with
proportioning unit(s). 54
12.3.6 Tests of the supply systems for vacuum . 54
12.3.7 Verification of restart after power supply failure . 54
12.4 Pipeline Tests . 54
12.4.1 Tests, checks and procedures before use of the pipeline distribution system . 54
12.4.2 Requirements for inspections and checks before concealment . 55
12.4.3 Requirements for tests, checks and procedures before use of the system . 55
12.4.4 Tests for leakage and mechanical integrity . 55
12.4.5 Tests of area shut-off valves for leakage and closure and checks for correct
zoning and correct identification .57
12.4.6 Test for cross-connection .57
12.4.7 Test for obstruction and flow rate . 58

iv
ISO/FDIS 7396-1:2026(en)
12.4.8 Checks of terminal units and NIST, DISS or SIS connectors for mechanical
function, gas-specificity and identification . 58
12.4.9 Tests or checks of system performance .59
12.4.10 Tests of pressure relief valves.59
12.4.11 Test for particulate contamination of pipeline distribution systems .59
12.4.12 Filling with specific gas . 60
12.4.13 Tests of gas identity . 60
12.5 Tests of monitoring and alarm systems . 60
12.6 Statement of conformance to this document . 60
13 Documentation requirements . 61
13.1 Instructions for installation .61
13.2 Instructions for use .61
13.3 Operational management information .62
13.4 “As-installed” drawings .62
13.5 Test reports . 63
Annex A (informative) Schematic representations of typical supply systems and area
distribution systems .64
Annex B (informative) Guidelines for location of cylinder manifolds, cylinder storage areas and
stationary vessels for cryogenic or non-cryogenic liquids .96
Annex C (informative) Example of procedure for testing and commissioning .97
Annex D (informative) Typical forms for documenting conformance of the medical gas pipeline
systems . .110
Annex E (informative) Temperature and pressure relationships .135
Annex F (informative) Rationale for air compressor unit hazards .137
Annex G (informative) Operational management .139
Annex H (informative) Risk management checklist . 158
Annex I (informative) Rationale .169
Annex J (informative) Considerations for implementation and use of oxygen following alternate
pharmacopeial specifications . .173
Annex K (informative) Manufacture of medical gases on site and responsibility for medical gas
quality .175
Annex L (informative) Roles and responsibilities .178
Annex M (Informative) Examples of pharmacopeial requirements for on-site production .180
Annex N (Informative) Application of this document together with other requirements .182
Annex ZA (informative) Relationship between this European standard and the General Safety
and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered .183
Bibliography .193

v
ISO/FDIS 7396-1:2026(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 document should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 6, Medical gas supply systems, in collaboration the European Committee for Standardization
(CEN) Technical Committee CEN/TC 215, Respiratory and anaesthetic equipment, in accordance with the
Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
This fourth edition cancels and replaces the third edition (ISO 7396-1:2016), which has been technically
revised. It also incorporates the Amendment ISO 7396-1:2016/Amd 1:2017.
The main changes are as follows:
— Compared to previous editions, there are few major changes to the pipeline system. Most updates are
improvements and clarifications based on practical experience, such as better drawings.
— Compressors have now been added as an integrated part of the standard, and oxygen concentrators have
been added as a subsystem. When reading this standard, it is important to note which section you are
in: the pipeline, packaged gases (manifolds and cryogenic supply), compressor section, or the oxygen
concentrator section.
— The number of annexes with additional information has increased. However, Annex D with typical forms
for test results is now available separately for download from the ISO portal (add link!).
— Annex G, which covered operations, has been removed. Such management topics are now included in
quality management standards. Annex G will become the foundation of a new document for operational
management.
— The revision of this standard was delayed by the COVID pandemic. During the pandemic, many healthcare
facilities discovered problems because the medical gas pipeline system had been designed with too little
capacity, was not well maintained, or had been expanded until the design limits were fully reached. For
this reason, the role of hospital management in the design, planning, construction, and future strategy
of the medical gas pipeline systems has been made more explicit.
— Clause 12 still covers the testing and commissioning of the installation, which should make becoming
familiar with this standard easier.

vi
ISO/FDIS 7396-1:2026(en)
A list of all parts in the ISO 7396 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

vii
ISO/FDIS 7396-1:2026(en)
Introduction
Many healthcare facilities use medical gas pipeline systems to deliver medical gases and to provide vacuum
to areas where they are used in patient care or to power equipment such as ventilators and surgical tools.
This document specifies requirements for medical gas pipeline systems for gases for medicinal use, medical
device gases, gases for driving surgical tools and vacuum. It is intended for use by those persons involved
in the design, construction, inspection, and operation of healthcare facilities treating human beings. Those
persons involved in the design, manufacture and testing of equipment intended to be connected to these
medical gas pipeline systems should also be aware of the contents of this document.
This document seeks to ensure that medical gas pipelines contain only the specific gas (or vacuum) intended
to be supplied. For this reason, gas-specific components are used for terminal units and for other connectors
which are intended to be used by the operator. In addition, each system is tested and certified to contain
only the specific gas (or vacuum).
The objectives of this document are to ensure the following:
a) non-interchangeability between different medical gas pipeline systems by design, installation and
testing;
b) continuous supply of gases and vacuum at specified quality, pressures and design flow rates by providing
appropriate sources;
c) use of suitable materials;
d) cleanliness of components;
e) correct installation;
f) provision of monitoring and alarm systems;
g) correct marking of the pipeline system;
h) testing and commissioning;
i) quality of the gases delivered by the pipeline system;
j) correct operational management;
k) safety features of the sources to ensure the quality and pressure of the gases delivered to the terminals
according to specification.
It is normal practice to assign responsibility for the quality of the medical gas supplied to a nominated person
within the healthcare facility such as the head pharmacist. Where the healthcare facility manufactures the
medical gas on site the healthcare facility is responsible for all aspects of the medical gas quality.
Vacuum for medical suction is also the responsibility of the healthcare facility.
[37]
EN 14931:2006 defines additional requirements for hyperbaric application, in particular for flow rates
and pressures of compressed air required to pressurize hyperbaric chambers and to drive other connected
services. Also included are requirements for oxygen and other treatment gases administered to patients
during hyperbaric therapies. Annex G, J and K provides guidance for the assignment of responsibility for
production and quality control of the gases and vacuum.
Annexes G and H provide some guidance as to how the quality of the gas should be managed to maintain
patient safety at the highest level.
Annex I contains rationale statements for some of the requirements of this document. It is included to
provide additional insight into the reasoning that led to the requirements and recommendations that have
been incorporated into this document.

viii
FINAL DRAFT International Standard ISO/FDIS 7396-1:2026(en)
Medical gas pipeline systems —
Part 1:
Pipeline systems for compressed medical gases and vacuum
1 Scope
This document specifies requirements for design, installation, function, performance, testing, commissioning
and documentation of medical gas pipeline systems used in healthcare facilities for the following:
— argon;
— pharmacopeial oxygen;
— nitrous oxide;
— medical air;
— carbon dioxide;
— oxygen/nitrous oxide mixtures;
— helium/oxygen mixtures;
— gases and gas mixtures classified as medical device, gases delivered to medical devices or intended for
medical purposes or gases and gas mixtures for medicinal use not specified above;
— air for driving surgical tools;
— nitrogen;
— vacuum.
NOTE 1 A rationale for this is contained in Annex I.2
[6]
NOTE 2 Anaesthetic gas scavenging disposal systems are covered in ISO 7396-2 .
This document includes requirements for supply systems, medical gas pipeline distribution systems, control
system(s), monitoring and alarm systems and non-interchangeability between different gas/vacuum
systems.
This document specifies safety requirements for medical gas pipeline systems used in healthcare facilities.
It applies to all facilities providing healthcare services regardless of type, size, location or range of services,
including, but not limited to:
a) acute care healthcare facilities;
b) internal patient continuing care healthcare facilities;
c) long-term care facilities;
d) community-based providers;
e) ambulatory and external patient care clinics (e.g. day surgery, endoscopy clinics and doctors’ offices).
This document may also be used as reference for medical gas pipeline systems intended to be installed
in places other than healthcare facilities.

ISO/FDIS 7396-1:2026(en)
This document applies to the following different types of oxygen supply systems:
— supply systems in which all sources of supply deliver oxygen produced off-site;
— supply systems in which some or all sources of supply deliver oxygen produced on-site; in this case the
concentration of the oxygen may vary, depending on the pharmacopeial specification selected by the
healthcare facility
Oxygen concentrators for domiciliary use are excluded from the scope of this document. This document also
applies to:
— extensions of existing pipeline distribution systems;
— modifications of existing pipeline distribution systems;
— modifications or replacement of supply systems or sources of supply.
This document does not apply to vacuum systems intended to be used in dentistry (A rationale is discussed
in Annex I.2)
This document does not apply to filling systems for transportable cylinders and transportable cylinder
bundle systems.
This document does not apply to cryogenic pipeline systems conveying liquified gases.
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 3746, Acoustics — Determination of sound power levels and sound energy levels of noise sources using sound
pressure — Survey method using an enveloping measurement surface over a reflecting plane
ISO 4126-1, Safety devices for protection against excessive pressure — Part 1: Safety valves
ISO 5011, Inlet air cleaning equipment for internal combustion engines and compressors — Performance testing
ISO 5359, Anaesthetic and respiratory equipment — Low-pressure hose assemblies for use with medical gases
ISO 8573-1, Compressed air — Part 1: Contaminants and purity classes
ISO 9170-1, Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with compressed
medical gases and vacuum
ISO 10524-2, Pressure regulators for use with medical gases — Part 2: Manifold and line pressure regulators
ISO 11197, Medical supply units
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 15001:2010, Anaesthetic and respiratory equipment — Compatibility with oxygen
ISO 17672, Brazing — Filler metals
ISO 20417, Medical devices — Information to be supplied by the manufacturer
ISO 21969, High-pressure flexible connections for use with medical gas systems
ISO 29463-1, High efficiency filters and filter media for removing particles in air — Part 1: Classification,
performance, testing and marking
ISO 18562-2, Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 2: Tests
for emissions of particulate matter

ISO/FDIS 7396-1:2026(en)
IEC 60529, Degrees of protection provided by enclosures (IP Code)
IEC 60601-1-8, Medical electrical equipment — Part 1-8: General requirements for basic safety and essential
performance — Collateral standard: General requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems
IEC 62304, Medical device software — Software life cycle processes
EN 286-1, Simple unfired pressure vessels designed to contain air or nitrogen — Part 1: Pressure vessels for
general purposes
EN 837-1, Pressure gauges, Bourdon tube pressure gauges, Dimensions, metrology, requirements and testing
EN 1254-1, Copper and copper alloys - Plumbing fittings - Fittings with ends for capillary soldering or capillary
brazing to copper tubes
EN 1012-1, Compressors and vacuum pumps - Safety requirements - Part 1: Air Compressors
EN 1012-2, Compressors and vacuum pumps - Safety requirements - Part 2: Vacuum Pumps
EN 13348, Copper and copper alloys — Seamless, round copper tubes for medical gases or vacuum
EN 13445-1, Unfired pressure vessels - Part 1: General
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
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