Overview
EN ISO 23371:2022 - Anaesthetic and respiratory equipment: Cuff pressure indication, control and regulation devices (ISO 23371:2022) specifies essential performance and safety requirements for devices that indicate, inflate/deflate, control or automatically regulate the intracuff pressure of airway devices (tracheal tubes, tracheostomy tubes, supralaryngeal airways). The standard applies to stand‑alone cuff pressure indicators and those integrated into other medical systems (e.g. ventilators, anaesthesia workstations), and to devices that combine pressure indication with an inflation method (syringe, pump) or automatic pressure maintenance.
Key topics and requirements
- Scope and definitions: Clear definitions for cuff, airway device, cuff inflation device, cuff pressure indicator and automatic cuff pressure regulator.
- General performance & safety: Essential performance criteria for reliable intracuff pressure measurement and control to reduce harm from over‑ or under‑inflation.
- Metrological requirements: Accuracy, repeatability and traceability expectations for pressure indication (metrological specifics are defined in the standard).
- Design and connectors: Requirements for safe mechanical design, compatible connectors and integration with airway devices and patient circuits.
- Integrated and automatic regulators: Guidance for devices that maintain cuff pressure automatically or combine indication with inflation/deflation mechanisms.
- Mechanical strength and sterile supply: Tests for durability, strength and requirements where devices are supplied sterile.
- Packaging, marking and documentation: Mandatory manufacturer information, labeling, instructions for use and packaging requirements to ensure safe clinical use.
- Testing and alternative methods: Provisions for test methods and acceptable alternative verification approaches.
Practical applications and users
- Medical device manufacturers developing cuff pressure indicators, automatic cuff regulators, or integrating cuff pressure functions into ventilators and anaesthesia workstations.
- Clinical engineering, procurement and conformity assessment teams using the standard for design validation, regulatory compliance and product selection.
- Hospitals and critical care clinicians (ICU, anaesthesia, emergency medicine) using devices to reduce risks such as mucosal ischemia, aspiration and ventilator‑associated pneumonia by maintaining appropriate cuff pressures.
- Notified bodies and regulators assessing device safety and performance for market approval.
Related standards
- ISO 18190 - General requirements for airways and related equipment (referenced normative).
- ISO 80369‑7 - Small‑bore connectors for healthcare (connector safety).
- IEC 60601‑1‑8 - Alarm systems for medical electrical equipment (where applicable).
EN ISO 23371:2022 is essential for anyone designing, evaluating or procuring cuff pressure devices to ensure safe, accurate intracuff pressure control and compliance with international safety expectations.