oSIST prEN ISO 7396-1:2026

• 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
• Public Enquiry End Date: 21-Oct-2026
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 14-Aug-2026
• Due Date: 01-Jan-2027
• Directive: 2017/745 - 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:

  ---

  93/42/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: prEN ISO 7396-1 - Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO/FDIS 7396-1:2026)

• Revises: SIST 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: SIST 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

oSIST prEN ISO 7396-1:2026 is the Slovenian adoption of the ISO draft standard for medical gas pipeline systems. It specifies requirements for the design, installation, function, performance, testing, commissioning and documentation of pipeline systems for compressed medical gases and vacuum in healthcare facilities. It is aimed at manufacturers, installers, healthcare facility managers and the technical and quality staff who specify, build, operate and verify these systems.

What does oSIST prEN ISO 7396-1:2026 specify?

oSIST prEN ISO 7396-1:2026 specifies safety and performance requirements for medical gas pipeline systems in healthcare facilities, both public and private. It covers supply systems, pipeline distribution systems, control systems, monitoring and alarm systems, and the non-interchangeability of components between different gas and vacuum systems.

The scope includes systems for argon, pharmacopeial oxygen, nitrous oxide, medical air, carbon dioxide, oxygen/nitrous oxide mixtures, helium/oxygen mixtures, oxygen 93, nitrogen, vacuum, and other gases or gas mixtures used for medical purposes. It also covers air and nitrogen used for driving surgical tools. Exclusions include anaesthetic gas scavenging disposal systems, oxygen concentrators for domiciliary use, vacuum systems for dentistry, and filling systems for transportable cylinders and transportable cylinder bundle systems.

This document applies to healthcare facilities of any type, size, location or service range, including acute care, continuing care, long-term care, community-based providers, and ambulatory or external patient care clinics. It may also be used as a reference for similar installations outside healthcare facilities.

Annex	What it covers
A	Schematic representations of typical supply systems and area distribution systems
B	Location guidance for cylinder manifolds, cylinder storage areas and stationary cryogenic vessels
C	Example procedure for testing and commissioning
D	Forms for documenting conformity and test results
E	Pressure-temperature correction and a worked example
F	Rationale for air compressor unit hazards
G	Operational guidance for management, responsibilities and procedures
H	Risk management procedure and checklist
I	Rationale for selected requirements
K	Responsibilities for medical gas quality and on-site manufacture
L	Role separation for design, installation, verification and operation
M	Examples of pharmacopeial requirements for on-site production

What are the key requirements of oSIST prEN ISO 7396-1:2026?

oSIST prEN ISO 7396-1:2026 requires the whole system to be designed so the correct gas or vacuum reaches the correct terminal point, with risks assessed and controlled across the complete lifecycle. It then sets out the supply redundancy, pressure control, monitoring, installation and testing needed to keep the system safe in use.

Safety, risk management and materials

Clause 4 makes risk management central to the standard. The system has to be assessed as a whole, risks to patients and staff have first priority, and the risk assessment must be documented. In practice, this means design decisions, changes and maintenance work all need a traceable safety rationale, not just a technical layout.

Clause 4 also requires suitable materials for gas-contacting parts, resistance to corrosion, oxygen compatibility where relevant, and compatible lubricants if lubricants are used. This matters because contamination, ignition, corrosion and material incompatibility can affect gas quality and patient safety.

Supply systems and continuity of supply

Clause 5 sets the basic supply architecture. Supply systems for compressed medicinal gases and vacuum are built around multiple sources so the system can keep running during failure or maintenance, and vacuum systems use multiple pumps. Air or nitrogen for driving surgical tools has its own supply arrangements, because those services are operationally important but not the same as medicinal gas supply.

Clause 5 also covers primary, secondary and reserve sources, outlet pressure, pressure relief, maintenance supply assemblies, and line pressure regulators. It means the facility must plan for normal demand, peak demand, and source changeover without interrupting service.

Clause 5 includes several source types: cylinders and cylinder bundles, cryogenic or non-cryogenic vessels, air compressor unit(s), oxygen concentrator unit(s), proportioning unit(s), and systems assembled at site or preassembled in a factory. For buyers and engineers, this is the part that drives selection of the supply concept and the equipment package.

Monitoring and alarms

Clause 6 divides alarm functions into operating alarms, emergency operating alarms, emergency clinical alarms and information signals. The difference matters in practice because each type has a different urgency and different users: technical staff, clinical staff, or both.

Clause 6 also requires visual and auditory signals, alarm initiation on communication failure, and remote alarm extensions where required. Specific alarm conditions include source changeover, low supply, external power failure, gas quality out of range, and unsafe pressure conditions. This helps staff detect loss of supply, contamination or pressure faults early enough to respond.

Distribution pressure, valves and terminal points

Clause 7 requires pipeline distribution systems to withstand 1.2 times the maximum pressure that can occur under single fault condition. It also limits distribution pressure and terminal-unit pressure, including a specific absolute limit for vacuum. In practice, this is what keeps the network from being overstressed and from delivering unsafe pressure to patients or tools.

Clauses 8 to 10 cover shut-off valves, non-return valves, terminal units, pressure regulators, pressure gauges, marking and colour coding. Valves must be identifiable, secure from unauthorized operation, and placed so sections or areas can be isolated for maintenance or emergencies. Terminal units must be gas-specific, and colour coding follows ISO 5359 when used.

Installation, testing and documentation

Clause 11 sets installation rules for routing, supports, joints, protection from damage, and extensions or modifications to existing systems. Metallic joints are brazed except where specific mechanical joints are allowed, and the pipeline is purged during brazing or welding. That reduces leak risk, contamination and installation defects.

Clause 12 requires testing and commissioning before use, with calibrated measuring devices and documented results. It includes tests for leakage, mechanical integrity, cross-connection, obstruction and flow, particulate contamination, gas identity, source performance and monitoring and alarm performance. The standard also requires a written statement of conformance and permanent records for the healthcare facility.

Clause 13 requires documentation for installation, use, operation and maintenance, plus as-installed drawings and test reports. In practice, the facility needs the information needed to run the system safely long after the installer has left.

What terms does oSIST prEN ISO 7396-1:2026 define?

• Medical gas pipeline system (MGPS) - The installed pipeline system that supplies medical gases and vacuum to terminal units in a healthcare facility.
• Applicable policy - The set of requirements that apply to a medical device or accessory, including form, fit, function, process or manufacturer information.
• Air compressor unit - The part of a supply source that compresses or moves ambient air, together with the drive system and required operating components.
• Air for driving surgical tools - A gas mixture mainly of oxygen and nitrogen, supplied for powering surgical tools.
• Audio off - A temporary state in which part or all of an alarm system does not produce an audible alarm signal.
• Booster compressor unit - A compressor unit used to raise an already elevated pressure to a higher pressure.
• Authorized person (AP) - The person appointed to manage the day-to-day operation of a designated MGPS or section of it.
• Quality controller (QC) - The person responsible for quality control of the medical gas supply and related verification activities.

Who uses oSIST prEN ISO 7396-1:2026?

oSIST prEN ISO 7396-1:2026 is used by hospitals, long-term care facilities, clinics and other healthcare providers that install or operate medical gas pipeline systems. It is also used by manufacturers, system designers, installers, maintenance contractors and testing personnel who need to build or verify the system against a common technical basis.

In practice, it is used by executive managers, facilities engineering managers, authorized persons, competent persons, quality controllers, designated medical officers and designated nursing officers to assign responsibilities and control changes, maintenance, repairs and emergency actions. Buyers and project teams use it to specify the right supply concept, terminal equipment and documentation package.

What changed in oSIST prEN ISO 7396-1:2026 from the previous edition?

oSIST prEN ISO 7396-1:2026 updates ISO 7396-1:2016.

Which standards are used with oSIST prEN ISO 7396-1:2026?

Standard	What it contributes
ISO 14971	Risk management principles for medical devices
ISO 20417	Information to be supplied by the manufacturer
ISO 9170-1	Requirements for terminal units for compressed medical gases and vacuum
ISO 10524-2	Requirements for manifold and line pressure regulators
ISO 11197	Requirements for medical supply units
ISO 5359	Low-pressure hose assemblies and colour coding for medical gases
ISO 8573-1	Compressed air contaminants and purity classes
ISO 15001:2010	Oxygen compatibility of anaesthetic and respiratory equipment
ISO 17672	Brazing filler metals
ISO 21969	High-pressure flexible connections for medical gas systems
ISO 29463-1	High efficiency filter classification, testing and marking
ISO 18562-2	Particulate emissions from breathing gas pathways
ISO 3746	Sound power and noise measurement method
ISO 4126-1	Safety valves for overpressure protection
ISO 5011	Performance testing of inlet air cleaning equipment
IEC 60529	Degrees of protection provided by enclosures
ISO 7396-2	Anaesthetic gas scavenging disposal systems
ISO 80601-2-69	Oxygen concentrators for domiciliary use
EN 14931	Additional requirements for hyperbaric application

What does the oSIST prEN ISO 7396-1:2026 document contain?

The document contains clauses for scope, normative references, terms, general requirements, supply systems, alarms, distribution systems, valves, terminal units, marking, installation, testing, commissioning and documentation. It also contains tables for pressure limits, alarm conditions and other technical details, plus figures for typical system arrangements.

Annex C provides a worked example of testing and commissioning, including checks before concealment and before use. Annex D gives forms for records, Annex E gives pressure-temperature correction guidance, and Figure 1 in Clause 12 illustrates the particulate contamination test device.

The annexes also include operational guidance, role assignments, risk management checklists and rationale statements. That makes the standard useful not only for design and installation, but also for audits, maintenance planning, training and long-term operation.

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.
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BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
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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
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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

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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.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .
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