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 ...