BS EN ISO 5366-1:2009

BS EN ISO 5366-1:2009 Anaesthetic and respiratory equipment. Tracheostomy tubes. Tubes and connectors for use in adults

BS EN ISO 5366-1 specifies requirements for tracheostomy tubes made of plastics materials and/or rubber having inside diameters of 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 BS ISO 5366 is not applicable to specialized tubes, and does not address flammability of tracheostomy tubes.

Contents of BS EN ISO 5366-1:

• Scope
• Normative references
• Terms and definitions
• Size designation and dimensions
• Materials
• Design and finish
• Requirements for tracheostomy tubes supplied sterile
• Marking and labelling
• Test method for the security of attachment of connector and neck-plate to tracheostomy tube
• Principle
• Apparatus
• Procedure
• Expression of results
• Test method for determining the resting diameter of the cuff
• Principle
• Apparatus
• Procedure B.4 Expression of results
• Guidance on materials and design
• Materials
• Design
• Bibliography