prEN ISO 7396-1

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