60.60 Standard published May 25, 2022
CEN
CEN/TC 215 Respiratory and anaesthetic equipment
European Norm
11.040.10 Anaesthetic, respiratory and reanimation equipment
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).
WITHDRAWN
EN 13544-3:2001+A1:2009
PUBLISHED
EN ISO 23372:2022
60.60
Standard published
May 25, 2022