BS EN ISO 5366:2016
$167.15
Anaesthetic and respiratory equipment. Tracheostomy tubes and connectors
| Published By | Publication Date | Number of Pages |
| BSI | 2016 | 40 |
This International Standard specifies requirements for adult and paediatric tracheostomy tubes and connectors. Such tubes are primarily designed for patients who require anaesthesia, artificial ventilation or other respiratory support.
This International Standard is also applicable to specialized tracheostomy tubes that share common attributes, for example, those without a connector at the machine end intended for spontaneously breathing patients and those with reinforced walls or tubes made of metal or tubes with shoulders, tapering tubes, tubes with provision for suctioning or monitoring or delivery of drugs or other gases.
Flammability of tracheostomy tubes is a well recognized hazard (for example, when electrosurgical units or lasers are used with flammable anaesthetic agents in oxidant-enriched atmospheres) that is addressed by appropriate clinical management and is outside the scope of this International Standard.
NOTE ISO/TR 11991 gives guidance on avoidance of airway fires.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 4 | Contents Page |
| 5 | European foreword Endorsement notice |
| 9 | Foreword |
| 10 | Introduction |
| 12 | 1 *Scope 2 Normative references 3 Terms and definitions |
| 14 | 4 *General requirements for tracheostomy tubes and connectors |
| 15 | 5 Materials 6 Design requirements for tracheostomy tubes and connectors 6.1 General design requirements 6.2 Size designation and dimensions 6.2.1 *Designated size |
| 16 | 6.2.2 Outside dimension 6.2.3 Nominal length 6.3 Design 6.3.1 Connector |
| 17 | 6.3.2 Neck plate 6.3.3 Inner tube |
| 18 | 6.3.4 *Cuffs 6.3.5 Inflating tubes for cuffs 6.3.6 Cuff inflation indicator 6.3.7 *Inflating tube |
| 19 | 6.3.8 Patient end 6.3.9 Introducer 6.3.10 *Radiopaque marker 6.3.11 *Kink resistance 7 Requirements for tracheostomy tubes supplied sterile 7.1 Sterility assurance |
| 20 | 7.2 Packaging for tracheostomy tubes supplied sterile 8 Information supplied by the manufacturer 8.1 General 8.2 Marking of neck-plate 8.3 Marking on the inflation indicator |
| 21 | 8.4 Marking of tracheostomy tube connectors 8.5 Additional labelling of unit packs 8.6 Labelling of inner tube unit packs 8.7 Labelling of tracheostomy tube inserts |
| 23 | Annex A (informative) Rationale |
| 25 | Annex B (normative) Test method for the security of attachment of a fitted connector and neck-plate to the tracheostomy tube |
| 27 | Annex C (normative) Test method for determining the diameter of the cuff |
| 28 | Annex D (normative) Test method for cuff herniation |
| 30 | Annex E (normative) Test method for determining kink resistance |
| 32 | Annex F (informative) Guidance on materials and design |
| 33 | Annex G (informative) Hazard identification for risk assessment |
| 36 | Bibliography |
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BS EN ISO 5366:2016 – TC:2020 Edition
Tracked Changes. Anaesthetic and respiratory equipment. Tracheostomy tubes and connectors Published By Publication Date Number…
