Overview
ISO 19211:2024 - Anaesthetic and respiratory equipment - Fire-activated oxygen shut-off devices for use during oxygen therapy - specifies safety, design, material, performance, testing and information requirements for devices that automatically stop oxygen flow in respiratory therapy tubing when activated by fire. The standard focuses on device behaviour, biocompatibility, oxygen compatibility and verifiable test methods (see Annex B). Note: these devices are not suitable for oxygen therapy systems with flows in excess of 20 l/min.
Key technical topics and requirements
- Scope and purpose: Defines requirements for fire-activated oxygen shut-off devices (FAOSOD) used in oxygen therapy tubing to minimise fire severity at the patient interface.
- Materials & biocompatibility: Gas-path materials must meet ISO 18562-1 for breathing gas pathways; materials in contact with oxygen must be oxygen-compatible and corrosion resistant.
- Connectors & mechanical strength:
- User-detachable inlet: R2 socket (small-bore connector per ISO 80369-2).
- User-detachable outlet: R2 cone (ISO 80369-2).
- Inlet/outlet must resist axial force of (50 ± 1.5) N and torque of (5 ± 0.5) Nm for ≥1 min.
- Flow and leakage limits:
- Resistance to flow: ≤ 0.9 kPa at 4 ± 0.2 l/min.
- Leakage under maximum static pressure (900 ± 10 kPa): ≤ 10 ml/min.
- Leakage under normal use pressure (20 ± 0.5 kPa): ≤ 1 ml/min.
- Activation performance:
- Must activate across the manufacturer‑specified range of flows and oxygen concentrations.
- Once activated, oxygen flow in recommended tubing must be reduced to ≤ 10 ml/min at static pressures of (600 ± 10) kPa and (20 ± 1) kPa.
- Environmental & home‑use conditions: Devices must meet IEC 60601-1-11 environmental requirements where applicable.
- Documentation & testing: Manufacturer information, instructions for use, packaging, sterile supply requirements and test methods are specified; Annex B contains normative test procedures and Annex C shows typical arrangements.
Practical applications & users
- Device manufacturers designing FAOSODs or integrating them into oxygen therapy systems.
- Medical device engineers and product safety teams ensuring oxygen compatibility and mechanical robustness.
- Test laboratories and conformity assessors performing the normative tests in Annex B.
- Hospital procurement, clinical engineers and risk managers evaluating device selection to reduce oxygen‑enriched fire risk in clinical and home-care settings.
- Regulators and standards compliance teams referencing harmonized requirements that take precedence over conflicting clauses in ISO 18190.
Related standards (referenced)
- ISO 18562-1 (biocompatibility of breathing gas pathways)
- ISO 80369-2 (small-bore connectors for respiratory applications)
- ISO 18190 (general airway device requirements) - device‑specific requirements in ISO 19211 take precedence where conflicting
- IEC 60601-1-11 (home healthcare environmental requirements)
Keywords: ISO 19211:2024, fire-activated oxygen shut-off devices, oxygen therapy, respiratory therapy tubing, FAOSOD, ISO 80369-2, ISO 18562-1, device testing, medical device standards.
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