Standards
ISO 21969:2009: high-pressure flexible connections for medical gases
ISO 21969:2009 is the ISO standard for high-pressure flexible connections that link medical gas cylinders or cylinder bundles, at nominal filling pressures up to 25 000 kPa at 15 °C, to pipeline manifolds or to medical equipment; ISO lists edition 2 (November 2009) as current, last reviewed and confirmed in 2022.
Scope
According to the ISO abstract, the standard applies to high-pressure flexible connections intended to be connected to cylinders or cylinder bundles with nominal filling pressures up to 25 000 kPa at 15 °C. It covers two uses: connecting cylinders or bundles to manifolds within the sources of supply of medical gas pipeline systems complying with ISO 7396-1, and connecting a cylinder to an inlet port of medical equipment, such as an anaesthetic workstation or lung ventilator, fitted with an integral pressure regulator complying with ISO 10524-1.
The gases listed are oxygen, nitrous oxide, air for breathing, helium, carbon dioxide, xenon, mixtures of these gases, air and nitrogen for driving surgical tools, and oxygen-enriched air.
Edition and status
- Edition 2, published in November 2009, 13 pages, prepared by ISO/TC 121/SC 6. It replaced ISO 21969:2005, which ISO lists as withdrawn.
- On 23 October 2026 the ISO page showed stage 90.93 (International Standard confirmed): the publication was last reviewed and confirmed in 2022, so this version remains current. ISO reviews its standards every 5 years.
- NHS England's HTM 02-01 (2026) cites it as BS EN ISO 21969:2009.
How hospital guidance uses it
- HTM 02-01 Part B (2026), 4.18, describes the standard as applying to the flexible connections used to connect medical gas cylinders to manifolds, and says it states that non-metallic hoses should not be used, in addition to requirements for gas-specific connections and ignition and other safety-related items.
- SHTM 02-01 Part A (NHS Scotland, Version 2, August 2026) states that cylinder manifold tailpipes manufactured to ISO 21969 will provide a flow of 83 litres/min when the cylinders are nominally empty (20 bar(g)) (5.131), and that ISO 21969 specifies that the flexible hose for cylinder packs should be rated at 830 litres/min gas flow when the pack drops to nominally empty contents (5.136).
- The 2020 WHO interim specification for PSA oxygen plants, which WHO's December 2024 specifications supersede, listed ISO 21969 among its product performance standards.
Tailpipes in manifold design and maintenance
Under HTM 02-01 Part A (2026), 5.33, manifold headers should incorporate a replaceable check valve to prevent discharge of a complete cylinder bank in the event of tailpipe rupture. The maintenance tasks for automatic manifolds in Part B (11.170) include isolating one cylinder in turn and disconnecting the tailpipe to check its non-return valve: a minor weep is permissible and likely, but an obvious major leak denotes failure of the valve. The tasks for manual emergency reserve manifolds (11.168) include the same check.
Related standards
ISO 7396-1 covers the pipeline system and its sources of supply, and ISO 10524 covers pressure regulators. Low-pressure hose assemblies are a separate standard, ISO 5359, which HTM 02-01 Part B lists on its own (4.17).
More questions
Does ISO 21969 cover low-pressure hoses at the bedside?
No. Its abstract covers high-pressure connections to cylinders or cylinder bundles; low-pressure hose assemblies are covered by ISO 5359, which HTM 02-01 (2026) lists separately.
Is ISO 21969:2009 still current?
Yes. On 23 October 2026 ISO listed edition 2 (2009) at stage 90.93, last reviewed and confirmed in 2022.
Sources
- ISO 21969:2009, iso.org (read in a browser on 23 October 2026)
- NHS England, HTM 02-01 Part B (2026), paragraphs 4.17, 4.18, 11.168 and 11.170
- NHS England, HTM 02-01 Part A (2026), paragraph 5.33
- NHS Scotland, SHTM 02-01 Part A, Version 2 (August 2026), paragraphs 5.131 and 5.136
- WHO, Technical specifications for PSA oxygen plants, interim guidance (8 June 2020)
- WHO, Technical specifications for health facility based medical oxygen systems (31 December 2024), 1.1 note (supersedes the 2020 interim PSA specifications)
Ultra Controlo figures come from its technical datasheets. Third-party facts were read at the source on the date shown.