Overview
ISO 23371:2022 - Anaesthetic and respiratory equipment - Cuff pressure indication, control and regulation devices - defines essential performance and safety requirements for devices that indicate, control or regulate the intracuff pressure of airway cuffs (e.g., tracheal tubes, tracheostomy tubes, supralaryngeal airways). The standard covers stand‑alone cuff pressure indicators, integrated indicators with inflation mechanisms (syringes, pumps) and automatic cuff pressure regulators, and applies whether these devices are standalone or integrated into larger systems (ventilators, anaesthesia workstations).
Key topics and requirements
- Scope and purpose: Ensure safe cuff inflation to protect airway mucosa and reduce risks such as ischemia, nerve injury, micro‑aspiration and ventilator‑associated pneumonia.
- Metrological requirements:
- Devices may display numerical values or non‑numerical visual indicators.
- Numerical indicators must return to zero (atmospheric pressure) when disconnected.
- Accuracy: indicated value must be within ±2 cmH2O or ±10% (whichever is greater) under steady‑state conditions; hysteresis effects included.
- Connectors and compatibility:
- Outlet connector to the inflating tube: male Luer compliant with ISO 80369‑7, with means to prevent connection to Luer‑lock.
- Inlet connectors must be sealable and compatible with male Luer connections.
- Integrated and automatic systems:
- Integrated cuff inflation devices can be manual or electrically powered.
- Automatic cuff pressure regulators with alarms must follow IEC 60601‑1‑8 alarm levels: alarm if pressure deviates more than ±10% plus ±2 hPa for longer than 180 s; visual and audible medium priority alarm required.
- Electrically powered devices must signal power/battery failures.
- Design, materials, packaging and labelling: Conform to general airway device requirements (ISO 18190), include instructions for use, marking and sterile packaging controls where applicable.
- Testing and alternatives: Manufacturers may use validated alternative test methods if equivalent safety is demonstrated.
Applications and users
- Who uses this standard:
- Medical device manufacturers designing cuff pressure indicators, integrated inflation devices or automatic regulators.
- Clinical engineers, procurement teams and quality/regulatory professionals assessing equipment compliance.
- Test laboratories and conformity assessment bodies.
- Anesthesia departments and critical care units seeking to select safe cuff management devices.
- Practical benefits:
- Improves patient safety by standardizing accuracy, connector safety and alarm behaviour.
- Facilitates interoperability with ventilators and anaesthesia workstations.
- Supports clinical practice guidelines that recommend objective cuff pressure monitoring.
Related standards
- ISO 18190:2016 - General requirements for airways and related equipment
- ISO 80369‑7:2021 - Small‑bore connectors - Part 7 (Luer compatibility)
- IEC 60601‑1‑8 - Medical electrical equipment - Alarm systems
Keywords: ISO 23371:2022, cuff pressure indicator, intracuff pressure, cuff pressure regulation, anaesthetic and respiratory equipment, tracheal tube cuff, ventilator integration.