Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Size designation and dimensions
4.1 Designation of size of tube
4.2 Outside diameter
4.3 Length
4.4 Angle
5 Materials
6 Design and finish
6.1 Machine end
6.2 Paediatric tracheostomy tube connector
6.3 Inner tube
6.4 Neck-plate
6.5 Cuff
6.6 Inflating tubes for cuffs
6.7 Patient end
6.8 Introducer
7 Requirements for tracheostomy tubes supplied sterile
7.1 Sterility assurance
7.2 Packaging for tracheostomy tubes supplied sterile
8 Marking
8.1 Marking of tracheostomy tube
8.2 Marking of tracheostomy tube connectors
8.3 Marking of unit packs
9 Adaptor
Annex A (normative) - Test for security of attachment of
permanently attached connector, if provided, and
neck-plate to tracheostomy tube
A.1 Principle
A.2 Apparatus
A.3 Procedure
A.4 Expression of results
Annex B (normative) - Test method for determining the
resting diameter of the cuff
B.1 Principle
B.2 Apparatus
B.3 Procedure
B.4 Expression of results
Annex C (informative) - Guidance on materials and design
C.1 Materials
C.2 Design
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements of EU
Directive 93/42/EEC Medical devices
Bibliography