This part of ISO 7396 specifies requirements for design, installation, function, performance, documentation,
testing and commissioning of pipeline systems for compressed medical gases, gases for driving surgical tools
and vacuum in healthcare facilities to ensure continuous delivery of the correct gas and the provision of
vacuum from the pipeline system. It includes requirements for supply systems, pipeline distribution systems,
control systems, monitoring and alarm systems and non-interchangeability between components of different
gas systems.
This part of ISO 7396 is applicable to:
a) pipeline systems for the following medical gases:
- oxygen;
- nitrous oxide;
- medical air;
- carbon dioxide;
- oxygen/nitrous oxide mixtures (see Note 1);
b) pipeline systems for the following gases:
- (*) oxygen-enriched air;
- air for driving surgical tools;
- nitrogen for driving surgical tools;
c) pipeline systems for vacuum.
This part of ISO 7396 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.
NOTE 1 Regional or national regulations can prohibit the distribution of oxygen/nitrous oxide mixtures in medical gas
pipeline systems.
(*) NOTE 2 EN 14931 [23] defines additional or alternative requirements for the specific application, in particular for flows
and pressures of compressed air required to pressurize the hyperbaric chambers and to drive other connected services
and of oxygen and other treatment gases administered to patients.
ISO 7396-1:2007 Referenced Document
EN 1041 Information supplied by the manufacturer of medical devices*, 2013-09-01 Update
EN 13348 Copper and copper alloys - Seamless@ round copper tubes for medical gases or vacuum*, 2016-06-01 Update
EN 286-1 Simple unfired pressure vessels designed to contain air or nitrogen - Part 1: Pressure vessels for general purposes
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 CO...*, 2020-07-01 Update
ISO 10083 Oxygen concentrator supply systems for use with medical gas pipeline systems
ISO 10524-2 Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators*, 2017-12-31 Update
ISO 11197 Medical supply units*, 2019-11-07 Update
ISO 14971 Medical devices - Application of risk management to medical devices*, 2019-12-01 Update
ISO 15001:2003 Anaesthetic and respiratory equipment - Compatibility with oxygen
ISO 21969 High-pressure flexible connections for use with medical gas systems*, 2009-10-01 Update
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*, 2010-12-01 Update
ISO 5359 Anaesthetic and respiratory equipment — Low-pressure hose assemblies for use with medical gases AMENDMENT 1*, 2014-01-01 Update
ISO 8573-1:2001 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*, 2017-07-01 Update
ISO 7396-1:2007 history
2017ISO 7396-1:2016/Amd 1:2017 Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum; Amendment 1
2016ISO 7396-1:2016 Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum
2013ISO 7396-1:2007/Amd 3:2013 Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum - Amendment 3: Terminology relating to alarm systems
2010ISO 7396-1:2007/Amd 2:2010 Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum; Amendment 2
2010ISO 7396-1:2007/Amd 1:2010 Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum - Amendment 1: Requirements for terminal units for vacuum fitted on medical supply units with operator-adjustable portions and connected to the pipeline throug
2007ISO 7396-1:2007 Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum
2002ISO 7396-1:2002 Medical gas pipeline systems - Part 1: Pipelines for compressed medical gases and vacuum