Overview
ISO 23372:2022 - Anaesthetic and respiratory equipment - Air entrainment devices - specifies minimum performance, safety and information requirements for air entrainment devices (commonly known as venturi masks) used to deliver designated oxygen concentrations to patients. The standard defines required delivered oxygen concentration ranges, a test method (Annex A) to verify mixture accuracy, marking and labelling rules, and recommended optional colour coding to help users identify set oxygen concentrations. Devices that are integral to other medical devices (e.g., ventilators, humidifiers, nebulizers) are excluded.
Key Topics and Requirements
- Delivered oxygen concentration: Tableed designated concentrations (e.g., 24 %, 28 %, 31 %, 35 %, 40 %, 50 %, 60 %) with acceptable minimum/maximum output ranges for each designation and corresponding example colour codes.
- Test method (Annex A): Controlled oxygen flow through the device with sampling via a T-piece and measurement by a pre-calibrated oxygen analyser. Key test conditions include ambient correction to 22 ± 2 °C, 101.3 kPa and 50 ± 5 % RH. Instrumentation requirements include a flowmeter accuracy of ±2.5 % and an oxygen analyser accuracy of ±0.1 %.
- Design and connectors:
- Oxygen inlet: R2 small-bore socket per ISO 80369-2.
- Outlet connector: 22 mm socket per ISO 5356-1.
- Devices must operate with a flow-control device complying with ISO 15002 and be capable of delivering at least 15 L/min when connected to respiratory therapy tubing.
- Materials and biocompatibility: Breathing gas pathways must meet biocompatibility evaluation per ISO 18562-1.
- Marking & instructions:
- Devices must be marked with the designated oxygen concentration and recommended flow in characters at least 2.5 mm high.
- Adjustable devices must indicate each designated concentration and the direction to increase oxygen.
- Instructions must include flow-to-output tables/graphs and min/max input flows; adjustable devices must warn to monitor patient oxygenation (e.g., pulse oximetry).
Applications and Who Uses This Standard
- Manufacturers of air entrainment devices and delivery systems use ISO 23372:2022 to design, test and label products that reliably deliver specified oxygen concentrations.
- Test laboratories and conformity assessment bodies apply the Annex A test method for verification and certification.
- Clinical engineering teams, procurement managers and healthcare providers use this standard to select compliant venturi masks or air entrainment outlets and ensure safe oxygen therapy.
- Regulators and notified bodies reference it for product approval and market surveillance.
Related Standards
Keywords: ISO 23372:2022, air entrainment devices, venturi mask, oxygen concentration, test method, marking, colour coding, anaesthetic and respiratory equipment.