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ISO 5366:2016

Anaesthetic and respiratory equipment — Tracheostomy tubes and connectors

Sep 30, 2016

General information

90.93     Dec 21, 2022

ISO

ISO/TC 121/SC 2

International Standard

11.040.10  

English   French  

Buying

Published

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Scope

ISO 5366:2016 specifies requirements for adult and paediatric tracheostomy tubes and connectors. Such tubes are primarily designed for patients who require anaesthesia, artificial ventilation or other respiratory support.
ISO 5366:2016 is also applicable to specialized tracheostomy tubes that share common attributes, for example, those without a connector at the machine end intended for spontaneously breathing patients and those with reinforced walls or tubes made of metal or tubes with shoulders, tapering tubes, tubes with provision for suctioning or monitoring or delivery of drugs or other gases.
Flammability of tracheostomy tubes is a well recognized hazard (for example, when electrosurgical units or lasers are used with flammable anaesthetic agents in oxidant-enriched atmospheres) that is addressed by appropriate clinical management and is outside the scope of this International Standard.
NOTE ISO/TR 11991 gives guidance on avoidance of airway fires.

Life cycle

PREVIOUSLY

ABANDON
ISO/DIS 5366-1

ABANDON
ISO/DIS 5366-3

NOW

PUBLISHED
ISO 5366:2016
90.93 Standard confirmed
Dec 21, 2022

National adoptions

Anaesthetic and respiratory equipment - Tracheostomy tubes and connectors (ISO 5366:2016)

60.60   Standard published

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