EN ISO 7396 Medical Gas Pipeline Systems

The "EN ISO 7396 Medical gas pipeline systems" standard, which is based on a European standard and later published by the International Organization for Standardization (ISO), consists of the following subsections published under the same title:

• The standard “EN ISO 7396-1 Part 1: Pipeline systems for compressed medical gases and vacuum” describes the following requirements for the design, installation, function, performance, testing, commissioning and documentation of pipeline systems used in healthcare facilities:
  • Oxygen
  • Nitrous oxide
  • medical air
  • Carbon dioxide
  • Oxygen/nitrous oxide mixtures
  • Helium/oxygen mixtures
  • Oxygen 93
  • Gases and gas mixtures classified as medical devices, gases delivered to medical devices or designed for medical purposes, or gases and gas mixtures for medical use not specified above
  • Air to operate surgical instruments
  • Nitrogen to power surgical instruments
  • Vacuum

Regional or national regulations may prohibit the distribution of oxygen/nitrous oxide mixtures in medical gas pipeline systems. Anesthetic gas cleaning and disposal systems are covered by ISO 7396-2.

This standard includes requirements for interchangeability between components of supply systems, pipeline distribution systems, control systems, monitoring and alarm systems, and different gas/vacuum systems. This standard specifies safety requirements for pipeline systems used in both public and private healthcare facilities.

This standard applies to all healthcare facilities, regardless of type, size, location, or range of services. These include, but are not limited to:

• Acute care healthcare facilities
• Internal patient continuing care healthcare facilities
• Long-term care facilities
• Community-based providers
• Outpatient and outpatient clinics (e.g., day surgery, endoscopy clinics, and physician offices)

This standard can also be used as a reference for pipeline systems for medical gases and vacuum intended for installation in locations other than healthcare facilities.

This standard applies to the following different oxygen supply systems:

• Feeding systems in which all feed sources provide oxygen (in this case, the oxygen concentration is greater than 99 percent).
• Feeding systems in which all feed sources provide oxygen 93 (in this case, the oxygen concentration can vary between 90 and 96 percent).

A mixture of oxygen 93 and oxygen may be provided by a medical gas supply system. In this case, the gas concentration may vary from 90 percent to more than 99 percent.

This standard also applies to:

• Expansion of existing pipeline distribution systems
• Replacing existing pipeline distribution systems
• Modification or replacement of supply systems or supply sources.

Oxygen concentrators used in homes are outside the scope of this standard.

• The standard “EN ISO 7396-2 Part 2: Anaesthetic gas cleaning and disposal systems” describes the requirements for the design, installation, function, performance, documentation, testing and commissioning of anaesthetic gas cleaning waste systems to ensure patient safety and minimise exposure of the operator and other persons to anaesthetic gases and vapours.

This standard includes requirements for the power device, pipeline system, performance, non-interchangeability between essential components, and prevention of cross-connections between anesthetic gas purge scavenging systems and medical gas and vacuum pipeline systems.

In this standard, the term "pipeline" refers only to pipelines that are part of a dedicated anesthetic gas scavenging system. This standard applies only to scavenging systems intended to be connected via anesthetic gas scavenging system terminal units complying with ISO 9170-2 and to anesthetic gas scavenging receiver systems complying with ISO 8835-3.

This standard also applies to:

• Expansion of existing anesthetic gas cleaning disposal systems
• Replacement of existing anesthetic gas purge disposal systems
• Replacement or replacement of power devices

This standard applies to proportioning units intended to be components of a medical gas supply system for medical air feeding a medical gas pipeline distribution system complying with ISO 7396-1.

The number of proportioning units in a medical air supply system and their combination with other supply sources (e.g. cylinder manifolds) to ensure that the supply system consists of at least three supply sources are outside the scope of this standard.

Requirements for medical air supply systems are included in the ISO 7396-1 standard.

• The standard "EN ISO 7396-4 Part 4: Air compressor units" applies to air compressor units designed to produce medical air from ambient air. This standard applies to air compressor units designed as components of a medical gas supply system for medical air supplying a medical gas pipeline distribution system in accordance with ISO 7396-1. This standard is currently in a draft version under evaluation. It is not yet an official standard, but has been proposed and published by the European Standards Organization.

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