Standards Development

Scope

This part of ISO 7396 specifies requirements for design, installation, function, performance, testing, commissioning and documentation of medical gas pipeline systems used in healthcare facilities for the following:

— argon;

— 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.

NOTE 2 Anesthetic gas scavenging disposal systems are covered in ISO 7396-2[6]

This part of ISO 7396 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 part of ISO 7396 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).

NOTE 3: This part of ISO 7396 may also be used as reference for medical gas pipeline systems intended to be installed in places other than healthcare facilities.

This part of ISO 7396 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

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.

Oxygen concentrators for domiciliary use are excluded from the scope of this part of ISO 7396.

EN 14931:2006[37] defines additional requirements for hyperbaric application, in particular for flow rates 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.

This part of ISO 7396 does not apply to vacuum systems intended to be used in dentistry.

This part of ISO 7396 does not apply to filling systems for transportable cylinders and transportable cylinder bundle systems.

This part of ISO 7396 does not apply to liquid nitrogen cryogenic piping for cryobanks.