EN ISO 7396-1 Medical Gas Pipeline Systems - Test for Compressed Medical Gases and Vacuum

EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of EN ISO 7396-1 test. This standard specifies requirements for the design, installation, function, performance, testing, commissioning and documentation of pipeline systems used in healthcare facilities.

Specifies requirements for:

• Oxygen;
• nitrous oxide;
• medical air;
• carbon dioxide;
• Oxygen/nitrogen oxide mixtures;
• Helium/oxygen mixtures;
• Oxygen 93;
• Gases and gas mixtures classified as medical devices, gases supplied to medical devices or intended for medical purposes, or gases and gas mixtures not specified above for medical use;
• Air to drive surgical instruments;
• nitrogen to drive surgical instruments;
• Vacuum.

Regional or national regulations may prohibit the distribution of oxygen/nitrous oxide mixtures in medical gas pipeline systems. Anesthetic gas scavenging disposal systems are covered by ISO 7396‑2. This part of EN ISO 7396 contains requirements for supply systems, pipeline distribution systems, control systems, monitoring and alarm systems, and interchangeability between components of different gas/vacuum systems.

This part of EN ISO 7396 specifies safety requirements for pipeline systems used in both public and private healthcare facilities.

It applies to all healthcare facilities, regardless of type, size, location or range of services, including but not limited to:

• acute care healthcare facilities;
• Internal patient continuing care healthcare facilities;
• long-term care facilities;
• community-based providers;
• Outpatient and outpatient clinics (eg, day surgery, endoscopy clinics, and doctor's offices).

This part of EN ISO 7396 can also be used as a reference for pipeline systems for medical gases and vacuum intended to be installed outside healthcare facilities.

EN ISO 7396-1 applies to the following different oxygen supply systems:

• Supply systems where all supply sources provide oxygen; then the oxygen concentration will be more than 99%;
• Supply systems where all supply sources provide oxygen 93; in this case the oxygen concentration can range from 90% to 96%;

A mixture of oxygen 93 and oxygen can be delivered through a medical gas supply system. In this case, the concentration of the gas can vary between 90% and >99%.

EN ISO 7396-1 also applies to:

• Extensions of existing pipeline distribution systems;
• Modifications of existing pipeline distribution systems;
• Modifications or alteration of supply systems or sources of supply.

EUROLAB assists manufacturers with EN ISO 7396-1 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.