Overview
EN ISO 19211:2025 (identical to ISO 19211:2024) specifies safety and performance requirements for fire‑activated oxygen shut‑off devices used during oxygen therapy. These devices are intended to stop the flow of oxygen in respiratory therapy tubing when activated by fire, reducing the severity and propagation of fires at the patient interface. The standard applies to devices for typical respiratory tubing configurations and explicitly excludes systems with oxygen flows above 20 l/min.
Key topics and technical requirements
- Scope and applicability
- Defines the function of fire‑activated oxygen shut‑off devices (FAOSOD) and limits use to oxygen systems ≤ 20 l/min.
- Clarifies that use of FAOSOD in medical devices is not mandated by the standard.
- Materials and biocompatibility
- Requirements for materials in gas pathways and biological assessment aligned with ISO 18562 series.
- Oxygen compatibility to avoid ignition or degradation.
- Design and performance
- Design requirements for inlet/outlet connectors, resistance to flow, and prevention of inadvertent disassembly.
- Limits on leakage to atmosphere under static and normal-use conditions.
- Activation characteristics that reliably stop oxygen flow when exposed to fire.
- Testing and verification
- Device‑specific test methods are provided (see Annex B) for performance validation.
- Annex A gives rationale for specific clauses and Annex C shows typical device arrangements.
- Packaging, sterilization and information
- Requirements for packaging and protection during storage/transport.
- Provisions for sterile supply where applicable and mandatory manufacturer information/instructions for use.
- Standards precedence
- Device-specific requirements override any conflicting requirements in the general airway devices standard (ISO 18190); common requirements from ISO 18190 are removed here.
Applications and users
- Primary users
- Medical device manufacturers and designers of respiratory therapy accessories.
- Clinical engineers, hospital procurement teams, and infection control specialists.
- Testing laboratories, conformity assessment bodies, and notified bodies.
- Practical uses
- Integration into oxygen therapy circuits to reduce fire risk at patient interfaces (masks, cannulas, ventilator circuits).
- Risk mitigation in hospitals, homecare oxygen therapy, and transport settings (subject to flow limit).
Related standards
- ISO 17256 - respiratory therapy tubing
- ISO 18190 - general requirements for airway devices (superseded in conflict by EN ISO 19211)
- ISO 18562 series - biocompatibility of breathing gas pathways
- ISO 80369-2 - small-bore connectors for respiratory applications
Keywords: EN ISO 19211:2025, fire-activated oxygen shut-off devices, oxygen therapy, respiratory therapy tubing, ISO 19211:2024, medical device standard, oxygen shut-off, ISO 18190, ISO 17256.