CAN/CSA-ISO 5366:18 (R2023)
Anaesthetic and respiratory equipment — Tracheostomy tubes and connectors (Adopted ISO 5366:2016, first edition, 2016-10-01)
This is the first edition of CAN/CSA-ISO 5366, Anaesthetic and respiratory equipment — Tracheostomy tubes and connectors, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 5366 (first edition, 2016-10-01). It replaces CAN/CSA-ISO 5366-1:14, Anaesthetic and respiratory equipment — Tracheostomy tubes — Part 1: Tubes and connectors for use in adults (adopted ISO 5366-1:2001) and CAN/CSA-ISO 5366-3:14, Anaesthetic and respiratory equipment — Tracheostomy tubes — Part 3: Paediatric tracheostomy tubes (adopted ISO 5366-3:2001).
For brevity, this Standard will be referred to as “CAN/CSA-ISO 5366” throughout.
This Standard was reviewed for Canadian adoption by the CSA Technical Committee on Perioperative Safety, under the jurisdiction of the CSA Strategic Steering Committee on Health Care Technology & Systems, and has been formally approved by the Technical Committee.
This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group.
This International Standard 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.
This International Standard 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.