ISO DIS 7396-1

Description / Abstract: This part of ISO 7396 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 can prohibit the distribution of oxygen/nitrous oxide mixtures in medical gas pipeline systems.

NOTE 2: Anesthetic 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 health care facilities, both public and private. It applies to all facilities providing health care 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: This part of ISO 7396 can also be used as reference for pipeline systems for medical gases and vacuum 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; in this case the concentration of the gas will be >99%;

- supply systems in which all sources of supply deliver oxygen 93; in this case the concentration of the gas may vary between 90% and 96%;

NOTE: In some countries, a mixture of oxygen 93 and oxygen can be delivered by a medical gas supply system. In this case the concentration of the gas can vary between 90% and >99%.

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 standard.

NOTE 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.

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 above 30 bar(g).