ISO 23372:2022 PDF

Scope: This document specifies minimum performance and safety requirements for air entrainment devices used for delivery of designated oxygen concentrations to patients. It provides a test method to check the accuracy of the oxygen concentration in the air/oxygen mixture generated by the air entrainment devices. Air entrainment devices can be fixed to deliver a single oxygen concentration or adjustable, to deliver a range of oxygen concentration outputs. This document also specifies marking requirements and recommends an optional system of colour coding to assist the user in identifying the designated oxygen concentration. This document does not cover air entrainment devices which are integral with medical devices specified in other standards (e.g. emergency lung ventilators, humidifiers, nebulizers).

ISO 23372:2022 Referenced Document

ISO 15002 Flow control devices for connection to a medical gas supply system*， 2023-08-31 Update
ISO 18190:2016 Anaesthetic and respiratory equipment - General requirements for airways and related equipment
ISO 18562-1 Biocompatibility evaluation of breathing gas pathways in healthcare applications*， 2024-03-01 Update
ISO 20417 Medical devices — Information to be supplied by the manufacturer
ISO 5356-1 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets

2022 ISO 23372:2022 Anaesthetic and respiratory equipment — Air entrainment devices