Overview
ISO 23368:2022 - "Anaesthetic and respiratory equipment - Low-flow nasal cannulae for oxygen therapy" specifies safety, design and performance requirements for low-flow nasal cannulae used in home care and hospital settings. It covers device definition (flows ≤6 l/min), materials, biological safety of gas pathways, sterility, packaging and required information from manufacturers. The standard does not mandate fire-propagation prevention in tubing but requires a user‑detachable connection that can accept a fire‑activated oxygen shut‑off device.
Key topics and technical requirements
- Definition and scope
- Low‑flow nasal cannulae designed for oxygen therapy (≤6 l/min); devices must operate normally up to 15 l/min.
- Materials and biocompatibility
- Gas pathways must be assessed for biological safety per ISO 18562‑1.
- Design and layout
- Cannulae can be integral with therapy tubing (minimum 1.8 m) or user‑detachable with an inlet connector within 100 mm of the bifurcation (or within 500 mm if not bifurcated).
- Inlet connector
- User‑detachable inlet connectors must use an R2 respiratory small‑bore socket connector complying with ISO 80369‑2 to reduce misconnection risk.
- Integral inlet connectors must withstand an internal static pressure test of (200 ± 10) kPa for 30 s on a specified test nipple.
- Flow resistance and performance
- Therapy tubing resistance: ≤ 0.9 kPa/m at specified flows (4 l/min adult, 3 l/min paediatric, 2 l/min neonatal).
- Headset resistance: ≤ 10 kPa at the same flows.
- Flow reduction on semicircular bend must be ≤ 25% (Annex A test methods).
- Mechanical security
- Connectors must resist static axial disconnection force (40 ± 1.5) N; nasal prongs must resist (50 ± 1.5) N (Annex B).
- Sterility, packaging, manufacturer information
- Requirements referenced to ISO 18190 for sterility, packaging and labeling expectations.
Applications and users
- Manufacturers and designers of oxygen therapy interfaces (product development and compliance).
- Regulatory and quality teams verifying conformity for market access.
- Test laboratories conducting resistance, pressure and pull‑off testing using Annex A/B methods.
- Healthcare procurement, clinical engineers and respiratory therapists evaluating device compatibility and safety for home care and hospital oxygen therapy.
- Risk managers implementing fire‑safety measures (via compatible user‑detachable connectors for oxygen shut‑off devices).
Related standards
- ISO 18190 - General requirements for airways and related equipment
- ISO 18562‑1 - Biocompatibility evaluation of breathing gas pathways
- ISO 80369‑2 - Small‑bore connectors for respiratory applications
- ISO 4135 - Vocabulary for anaesthetic and respiratory equipment
Keywords: ISO 23368:2022, low‑flow nasal cannulae, oxygen therapy, home care oxygen, inlet connector, resistance to flow, R2 connector, ISO 80369‑2, biocompatibility.
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