ISO 5359:2014

Overview

ISO 5359:2014 - "Anaesthetic and respiratory equipment - Low‑pressure hose assemblies for use with medical gases" specifies safety, design and test requirements for flexible low‑pressure hose assemblies used with medical gases. The standard covers hose assemblies for gases such as oxygen, nitrous oxide, medical air, helium, carbon dioxide, xenon, specified mixtures, oxygen‑enriched air, driving gases (air, nitrogen) and vacuum. It applies to assemblies for pressures up to 1 400 kPa and vacuum systems down to 60 kPa absolute.

Note: ISO 5359:2014 does not prescribe connector dimensions or allocations (those are covered by other standards), nor does it cover coaxial hoses for driving surgical tools or define intended clinical uses.

Key topics and technical requirements

ISO 5359:2014 focuses on practical safety and performance aspects, including:

• Risk management and usability - design driven by foreseeable use, misuse and maintenance considerations (links to ISO 14971).
• Materials and construction - suitability, compatibility (including oxygen compatibility) and cleanliness to minimise contamination and leaching.
• Gas specificity and prevention of cross‑connections - design and marking to avoid interchange between different gas services (references common connector systems such as DISS, NIST and SIS).
• Testing requirements - defined test methods for:
  • pressure drop,
  • leakage,
  • gas specificity,
  • mechanical strength,
  • deformation under pressure,
  • resistance to occlusion,
  • durability of markings and colour coding.
• Marking, colour coding and packaging - mandatory identification, labelling and user information to ensure safe connection and handling.
• Manufacturer information - documentation and instructions that must accompany the hose assembly.

The standard also includes informative annexes on rationale, environmental aspects and regional variations in colour coding.

Practical applications

ISO 5359:2014 is used to ensure that low‑pressure medical gas hose assemblies are safe, reliable and compatible with clinical environments. Typical applications include:

• Patient breathing circuits and anaesthesia machine connections
• Connections for medical gas delivery to equipment and instruments
• Vacuum and driving‑gas hoses for surgical tools (non‑coaxial types)

Who should use this standard

• Medical device manufacturers of hoses, connectors and assemblies
• Biomedical engineers and hospital procurement teams specifying safe components
• Test laboratories performing conformity and performance testing
• Regulatory authorities and conformity assessors
• Standards and quality managers in healthcare equipment supply chains

Related standards

Relevant references cited in ISO 5359:2014 include ISO 14971 (risk management), ISO 15001 (oxygen compatibility) and ISO 9170‑1 (terminal units for medical gas pipelines) as well as connector standards covering DISS, NIST and SIS systems.

Keywords: ISO 5359:2014, low‑pressure hose assemblies, medical gases, anaesthetic equipment, gas‑specific connectors, leakage testing, pressure drop, colour coding.