I.S. EN ISO 5366:2016
Current
The latest, up-to-date edition.
Anaestheticandrespiratoryequipment - Tracheostomy tubesandconnectors (ISO 5366:2016)
Hardcopy , PDF
English
13-11-2016
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
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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