Overview
EN ISO 5359:2014 (ISO 5359:2014) specifies safety, design and testing requirements for low-pressure hose assemblies for use with medical gases in anaesthetic and respiratory equipment. It covers hose assemblies for gases including oxygen, nitrous oxide, medical air, helium, carbon dioxide, xenon, oxygen‑enriched air, specified gas mixtures, air and nitrogen for driving surgical tools, and vacuum. The standard applies to assemblies operating up to 1 400 kPa and vacuum systems not exceeding 60 kPa absolute. It does not define connector dimensions/allocation, coaxial hoses for driving tools, or prescribe specific intended uses.
Key topics and technical requirements
- Scope & limits - gases covered; maximum pressure and vacuum ratings; exclusions (connectors, coaxial hoses, intended uses).
- Risk management & usability - requirements for safety assessment, usability considerations and clinical investigation where applicable.
- Materials & leaching - material selection and provisions addressing leaching of substances (e.g., phthalates) are included.
- Design & construction - mechanical design, colour coding and marking, and constructional requirements to reduce cross‑connection risks.
- Test methods - prescribed tests include: pressure drop, leakage, gas specificity, mechanical strength, deformation under pressure, resistance to occlusion, and durability of markings and colour coding.
- Marking, colour coding & packaging - labelling, gas‑specific colour coding, packaging and manufacturer information to support safe identification and use.
- Manufacturer information - required documentation and user information to accompany hose assemblies.
- Regulatory alignment - Annex ZA maps the standard to essential requirements of EU Directive 93/42/EEC (Medical Device Directive).
Applications and users
EN ISO 5359:2014 is used by:
- Manufacturers of medical hose assemblies and accessories to design, test and certify products for medical gas service.
- Medical device designers & system integrators who specify safe connections between equipment and fixed medical gas pipelines.
- Testing laboratories performing conformity and mechanical tests (leakage, pressure, occlusion resistance, durability).
- Hospitals, procurement and maintenance teams that select, inspect and maintain hoses to reduce cross‑connection and contamination risks.
- Regulatory and conformity assessment bodies assessing compliance with medical device directives.
Related standards
- ISO 18082 - addresses connector dimensions and allocation (connector details excluded from ISO 5359).
- ISO 15001 - referenced for gas‑specific safety aspects.
- EU Directive 93/42/EEC - Annex ZA links this standard to Medical Device Directive requirements.
EN ISO 5359:2014 is essential for anyone involved in the safe design, testing, procurement or regulation of low‑pressure medical gas hose assemblies.