Overview
EN ISO 23372:2022 - Anaesthetic and respiratory equipment: Air entrainment devices specifies minimum performance, safety and information requirements for air entrainment (Venturi) devices used to deliver designated oxygen concentrations to patients. Published by CEN as the European adoption of ISO 23372:2022, the standard replaces the earlier EN 13544-3 series and defines functional tests (Annex A) to verify the accuracy of the delivered air/oxygen mixture. It covers both fixed- and adjustable-output devices but excludes air entrainment devices that are integral to other medical equipment (e.g., ventilators, humidifiers, nebulizers).
Key topics and requirements
- Performance and accuracy
- Test method (Annex A) to verify delivered oxygen concentration vs. declared values.
- Specified delivered ranges for designated concentrations (examples: 24% → 23–25%, 28% → 27–29%, 31% → 30–32%, 35% → 33–37%, 40% → 38–42%, 50% → 47–53%, 60% → 56–64%).
- Design and connectors
- Oxygen inlet: R2 small-bore connector per ISO 80369-2.
- Outlet: 22 mm socket per ISO 5356-1.
- Devices must operate with flow-control devices meeting ISO 15002, capable of delivering at least 15 L/min when connected to respiratory therapy tubing.
- Materials and biocompatibility
- Breathing-gas pathway materials must meet biocompatibility evaluation per ISO 18562-1.
- Marking and information
- Markings required: designated oxygen concentration and recommended flow (characters ≥ 2.5 mm).
- Optional colour-coding system recommended to aid identification (Pantone examples provided in the standard).
- Manufacturer information and instructions must comply with ISO 20417.
- Mechanical and safety checks
- Requirements for air inlet attachments (must not affect performance, obscure markings, or detach under specified tensile load - 5 ± 0.5 N for 60 s).
Applications and users
- Who uses this standard
- Medical device manufacturers and design engineers producing Venturi/air entrainment devices.
- Test laboratories and conformity assessors performing performance and safety verification.
- Clinical procurement teams, hospital biomedical engineers, and respiratory therapists who need assurance of device accuracy and compatibility.
- Regulatory bodies reviewing device compliance for market access in CEN/ISO jurisdictions.
- Practical value
- Ensures consistent delivery of designated oxygen concentrations in oxygen therapy.
- Improves device interoperability (connectors, flow requirements) and clinical safety through standard marking and testing.
Related standards
- ISO 18190 - General requirements for airways and related equipment
- ISO 15002 - Flow-metering devices
- ISO 5356-1 - Conical connectors, 22 mm
- ISO 80369-2 - Small-bore connectors for respiratory applications
- ISO 18562-1 - Biocompatibility of breathing gas pathways
- ISO 20417 - Manufacturer information for medical devices
Keywords: EN ISO 23372:2022, air entrainment devices, Venturi mask, oxygen concentration, medical device standard, anaesthetic and respiratory equipment, CEN, ISO 23372:2022.