Overview
EN ISO 18777-2:2025 - "Transportable liquid oxygen systems for medical use - Part 2: Particular requirements for portable units" (approved by CEN November 2025) specifies safety, design and performance requirements unique to portable units used in transportable liquid oxygen systems for home-care medical use. Portable units are lightweight devices carried by patients, refilled from a base unit via a transfilling device, and intended for unsupervised use during daily activities.
Key topics and technical requirements
- Filling port connector: Portable units shall have a standardized filling port connector to ensure compatibility with base-unit transfilling devices and safe liquid oxygen transfer. Connector details (example essential dimensions) include: Øa 16.00 mm ± 0.05 mm, minimum b = 17.0 mm, c = 3.0 mm ± 0.5 mm, spring tension 20–45 N. The connector must be non-user detachable (not removable without tools).
- Maximum mass: Filled portable units (including recommended or integral conserving device) shall weigh less than 4 kg to support portability.
- Conserving devices: Oxygen-conserving devices fitted to portable units shall conform to ISO 80601-2-67 (requirements for oxygen-conserving equipment).
- Mechanical strength and durability: Units must maintain required performance after a 1 m drop onto a hard surface (worst-case orientation). Carrying straps and connections shall withstand a load equal to 2 × the filled mass.
- Position-of-use safety: Portable units shall include an audible alarm that activates when the unit is placed in a position posing a spillage risk.
- Other covered aspects: Design and construction requirements, evaporation rate, marking, instructions for use, and manufacturer-supplied information. Test methods and verification procedures are provided in Annex A (normative).
Practical applications
- Develop compliant portable liquid oxygen units: design engineers and manufacturers use this standard to ensure safe, interoperable components (e.g., filling ports, conserving devices).
- Conformity testing and certification: test laboratories and conformity assessors follow the prescribed tests (drop, connector compatibility, strap load, weighing) to verify compliance.
- Procurement and clinical use: healthcare providers, home-care suppliers and purchasing authorities can specify EN ISO 18777-2:2025 to ensure safe, user-friendly portable oxygen solutions.
- Technical documentation and labeling: instructive content, marking and user instructions aligned with the standard improve patient safety and regulatory acceptance.
Who should use this standard
- Medical device manufacturers and product designers
- Test laboratories and certification bodies
- Respiratory equipment suppliers and home healthcare providers
- Regulatory agencies and procurement teams
Related standards
Keywords: EN ISO 18777-2:2025, transportable liquid oxygen systems, portable units, filling port connector, oxygen-conserving device, portable oxygen, home-care oxygen, transfilling device, ISO 18777-1.
