Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General Requirements for
TRACHEOSTOMY TUBES and connectors
5 Materials
6 Design requirements for TRACHEOSTOMY TUBES
and connectors
7 Requirements for TRACHEOSTOMY TUBES
supplied sterile
8 Marking and labelling
Annex A (informative) - Rationale
Annex B (normative) - Test method for the security
of attachment of a fitted connector and
PLATE to the TRACHEOSTOMY TUBE
Annex C (normative) - Test method for determining
the diameter of the CUFF
Annex D (normative) - Test method for CUFF herniation
Annex E (normative) - Test method for leakage past
the CUFF
Annex F (normative) - Test method for determining
kink resistance
Annex G (informative) - Guidance on materials and design
Annex H (informative) - Hazard identification for risk assessment
Bibliography
Annex ZA (informative) - Relationship between this
document and the Essential Requirements
EU Directive 93/42/EEC