ISO 10524 Pressure Regulators for Use with Medical Gases

ISO 10524 Pressure Regulators for Use with Medical Gases

The ISO 10524 standard, developed by the International Organization for Standardization (ISO), describes the requirements and defines test methods for pressure regulators intended for use with medical gases. A pressure regulator is a device that reduces the inlet pressure and maintains the set outlet pressure within specified limits.

ISO 10524 Pressure Regulators for Use with Medical Gases

This standard consists of the following sections under the heading "Pressure regulators for use with medical gases":

  • ISO 10524-1 Part 1: Pressure regulators and pressure regulators with flow meters
  • ISO 10524-2 Part 2: Manifold and line pressure regulators
  • ISO 10524-3 Part 3: Pressure regulators integrated with cylinder valves (VIPRs)
  • ISO 10524-4 Part 4: Low pressure regulators

The ISO 10524-1 standard describes the design, construction, type testing and marking requirements for pressure regulators for the management of medical gases and their mixtures used in the treatment, management, diagnostic evaluation and care of patients or used gases. Gas examples include oxygen, medical air, and oxygen/nitrous oxide mixtures. This standard applies to the following types of pressure regulators:

  • Devices intended to be connected to cylinders by the operator
  • Integrated flow measuring devices intended to be connected to cylinders by the operator
  • An integral part of medical equipment (for example, anesthesia workstations, lung ventilators and resuscitators)

A pressure regulator with either a pressure outlet or flow outlet can be supplied and may be adjustable or pre-set. Pressure regulators are designed to be fitted to refillable cylinders with operating pressures up to 30,000 kPa (300 bar) and may be equipped with devices that control and measure the flow of the supplied medical gas.

For the purposes of this standard, pressure regulators are devices that reduce the inlet pressure and maintain the set outlet pressure within specified limits. The operating pressure is the constant pressure of compressed gas in a filled gas cylinder at a uniform reference temperature of 15 degrees.

ISO 10524-2 standard describes the design, construction, type testing, and marking requirements for manifold pressure regulators and line pressure regulators intended for use in medical gas pipeline systems. Gas examples include oxygen, medical air, and oxygen/nitrous oxide mixtures. This standard applies to manifold pressure regulators and line pressure regulators supplied as separate units or to associated components included in an assembly. Manifold pressure regulators are designed to be connected to a manifold system with a nominal inlet pressure of up to 30,000 kPa (300 bar). Line pressure regulators are designed to be connected downstream of the manifold pressure regulator with a supply pressure of up to 3,000 kPa (30 bar). This standard does not apply to pressure regulators for use with vacuum pipeline systems. Requirements for pressure regulators for use with vacuum pipeline systems are covered by ISO 10079-3 standard.

For the purposes of this standard , a manifold is a device used to connect the outlets of one or more cylinders or bundles of cylinders of the same medical gas to a medical gas pipeline system.

The ISO 10524-3 standard describes the design, type testing and marking requirements for cylinder valves with integrated pressure regulators for the application of medical gases or gases used to operate surgical instruments in the treatment, management, diagnostic evaluation and care of patients. This standard applies to valves with integrated pressure regulating installed in refillable cylinders with a working pressure of up to 30 000 kPa (300 bar), intended for filling in cylinder filling plants, or self-filling systems used in home care applications. Valves with integrated pressure regulating covered by this standard are preset pressures and are supplied with a pressure outlet or preset flow outlets. Gas examples include oxygen, medical air, and oxygen/nitrous oxide mixtures.

For the purposes of this standard, valves with integrated pressure regulators are a combination of a pressure regulator and a cylinder valve intended to be fitted to a medical gas cylinder.

The ISO 10524-3 standard covers the low pressure regulator types listed below intended for use with the following medical gases in the treatment, management, diagnostic evaluation and care of patients:

  • Oxygen
  • nitrous oxide
  • medical air
  • Helium
  • carbon dioxide
  • Xenon
  • Certain mixtures of these gases
  • Air for driving surgical instruments
  • nitrogen to drive surgical instruments
  • Oxygen-enriched air

The types of low pressure regulators covered by this standard are:

  • Low pressure regulators intended for connection to terminal units of medical gas pipeline systems complying with the ISO 7396-1 standard.
  • Low pressure regulators with integrated flow meters intended for connection to terminal units of medical gas pipeline systems conforming to the ISO 7396-1 standard.
  • Low pressure regulators intended to be connected to terminal units connected to pressure regulators conforming to ISO 10524-1 or ISO 10524-3 standards.
  • Operator adjustable low pressure regulators for air or nitrogen to drive surgical instruments that are an integral part of a medical gas pipeline system compliant with the ISO 7396-1 standard.

Among the numerous tests, measurements, analyses, and evaluations our organization provides for businesses in various sectors, we also offer testing services for pressure regulators intended for use with medical gases, in accordance with the ISO 10524 standard, thanks to our trained and expert staff and advanced technological equipment.

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