NEN EN ISO 5366-1 : 2009

1 Scope
2 Normative references
3 Terms and definitions
4 Size designation and dimensions
5 Materials
6 Design and finish
7 Requirements for tracheostomy tubes supplied sterile
8 Marking and labelling
Annexes
A Test method for the security of attachment of connector
  and neck-plate to tracheostomy tube
  A.1 Principle
  A.2 Apparatus
  A.3 Procedure
  A.4 Expression of results
B Test method for determining the resting diameter of the cuff
  B.1 Principle
  B.2 Apparatus
  B.3 Procedure
  B.4 Expression of results
C Guidance on materials and design
  C.1 Materials
  C.2 Design
Bibliography

Defines 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.