EN ISO 5366:2016
Current
The latest, up-to-date edition.
Anaesthetic and respiratory equipment - Tracheostomy tubes and connectors (ISO 5366:2016)
26-10-2016
European foreword
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 Information supplied by the manufacturer
Annex A (informative) - Rationale
Annex B (normative) - Test method for the security of
attachment of a fitted connector and NECK-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 determining kink
resistance
Annex F (informative) - Guidance on materials and design
Annex G (informative) - Hazard identification for
risk assessment
Bibliography
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