This part of ISO 5366 specifies requirements for tracheostomy tubes made of plastics materials and/or rubber having inside diameters of 6,5 mm or greater. Such tubes are primarily designed for patients who require anaesthesia, artificial ventilation or other respiratory support, but need not be restricted to these uses.
This part of ISO 5366 is not applicable to specialized tubes, and does not address flammability of tracheostomy tubes.
BS EN ISO 5366-1:2009 Referenced Document
EN 556:1994 Sterilization of Medical Devices - Requirements for Medical Devices to Be Labelled `Sterile'
ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process*， 2018-08-01 Update
ISO 11607 Packaging for terminally sterilized medical devices
ISO 4135 Anaesthesiology — Vocabulary*， 2022-01-19 Update
ISO 5356-1 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets*， 2015-03-01 Update
ISO 5361 Anaesthetic and respiratory equipment — Tracheal tubes and connectors*， 2023-01-17 Update
ISO 594-1 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment; Part 1 : General requirements
BS EN ISO 5366-1:2009 history
2016BS EN ISO 5366:2016 Anaesthetic and respiratory equipment. Tracheostomy tubes and connectors
2009BS EN ISO 5366-1:2009 Anaesthetic and respiratory equipment - Tracheostomy tubes - TPart 1: Tubes and connectors for use in adults (ISO 5366-1:2000)