EN ISO 9170-1 Terminal Units for Medical Gas Pipeline Systems - Part 1: Terminal Units for Use with Compressed Medical Gases and Vacuum

The standard “EN ISO 9170-1 Terminal units for medical gas pipeline systems - Part 1: Terminal units for use with compressed medical gases and vacuum”, which is based on a European standard and published by the International Organization for Standardization (ISO), is specifically designed to ensure gas-specific installation of terminal units, mechanical resistance, flow, leakage and pressure drop, and to prevent transitions between different gases and services, and is applicable to the following terminal units:

• Designed for use in medical gas pipeline systems in accordance with ISO 7396-1 standard
• Used as pressure outlets in pressure regulators in accordance with ISO 10524-1 standard
• Used as pressure outlets in pressure regulators integrated with cylinder valves in accordance with ISO 10524-3 standard

This standard applies to terminal units (A) for use with the following types of gases for administration to patients or for medical purposes:

• Oxygen (A)
• Nitrous oxide (A)
• Medical air (A)
• Carbon dioxide (A)
• Oxygen/nitrous oxide mixture (A)
• Helium/oxygen mixtures (A)
• Oxygen 93 (A)
• Gases and gas mixtures classified as medical devices (A)
• Gases supplied to medical devices or designed for medical purposes (A)
• Gases and gas mixtures for medical purposes not specified above (A)

This standard applies to terminal units for use with the following types of gases (B):

• Air (B) for driving surgical instruments
• Nitrogen (B) for driving surgical instruments

This standard applies to terminal units for use with vacuum systems (C).

The requirements of this standard may be used as a guide for terminal units for other gases. These other gases are considered for inclusion in this standard when they come into general use.

This standard specifies requirements for terminal units for the supply and disposal of nitrogen and air to drive surgical instruments.

This standard specifies requirements for probes intended to be connected to a gas-specific junction.

This standard does not specify the dimensions of probes or gas-specific ports. Regional or national standards specifying the dimensions of probes and gas-specific ports are included in the bibliography.

Other connection systems in national use may be accepted within the scope of this document. Dimensioning for such connections is specified by the relevant national standards. This standard does not cover the requirements for terminal units for anaesthetic gas scavenging systems specified in ISO 9170-2.

For the purposes of this standard, the following definitions apply:

• Diameter-index safety system connector refers to any of a set of male and female components intended to maintain gas specificity by allocating a set of different diameters for each gas to mating connectors.
• Refers to having gas-specific properties that prevent connections between different gas services or vacuum services.
• The gas-specific port is the part of the socket that is the receiver for a gas-specific probe.
• A gas-specific connector is a connector with dimensional specifications that prevent connections between different gas services. Examples of gas-specific connectors include quick connectors, threaded connectors, diameter index safety system connectors, non-interchangeable threaded connectors, or sleeve index connectors.
• Low-pressure hose assembly refers to an assembly consisting of a flexible hose with permanently attached gas-specific inlet and outlet connectors and designed to deliver a medical gas at pressures less than 1 400 kPa and in vacuum.
• Medical device gas refers to any gas or gas mixture intended by the manufacturer for human use for:
  • Diagnosis, prevention, monitoring, treatment or alleviation of diseases
  • Investigation, modification, or alteration of an anatomy or physiological process
  • Control of pregnancy

Medical devices also refer to devices that do not achieve their intended effect in or on the human body by pharmacological, immunological or metabolic means, but whose function can be assisted by such means. In European Union countries, these gases are classified as medical devices in accordance with Directive 93/42/EC.

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