Utrustning för anestesi, respiration och återupplivning

Kommittébeteckning: SIS/TK 329 (Anestesi- och respiratorutrustning)
Källa: CEN
Svarsdatum: den 6 aug 2019
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This device-specific standard specifies requirements for low flow nasal cannulae, used in both home care and hospital environments for the administration of oxygen therapy.

This document does not include requirements to prevent the proliferation of fire within the tubing but does specify a user-detachable connection that can be used to fit a fire-activated oxygen shut-off device such as that specified in
ISO 19211.

Kommittébeteckning: SIS/TK 329 (Anestesi- och respiratorutrustning)
Källa: CEN
Svarsdatum: den 28 aug 2019
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ISO 18190:2016 Clause 1 is replaced by:

This document specifies minimum performance and safety requirements for air entrainment devices used for delivery of designated oxygen concentrations to patients and includes 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 a fixed to deliver a single oxygen concentration or adjustable, to deliver a range of oxygen concentration outputs.

It 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, etc.