BS EN ISO 5366:2016 – TC:2020 Edition
$217.84
Tracked Changes. Anaesthetic and respiratory equipment. Tracheostomy tubes and connectors
| Published By | Publication Date | Number of Pages |
| BSI | 2020 | 86 |
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 50 | Contents Page |
| 51 | European foreword Endorsement notice |
| 55 | Foreword |
| 56 | Introduction |
| 58 | 1 *Scope 2 Normative references 3 Terms and definitions |
| 60 | 4 *General requirements for tracheostomy tubes and connectors |
| 61 | 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 |
| 62 | 6.2.2 Outside dimension 6.2.3 Nominal length 6.3 Design 6.3.1 Connector |
| 63 | 6.3.2 Neck plate 6.3.3 Inner tube |
| 64 | 6.3.4 *Cuffs 6.3.5 Inflating tubes for cuffs 6.3.6 Cuff inflation indicator 6.3.7 *Inflating tube |
| 65 | 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 |
| 66 | 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 |
| 67 | 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 |
| 69 | Annex A (informative) Rationale |
| 71 | Annex B (normative) Test method for the security of attachment of a fitted connector and neck-plate to the tracheostomy tube |
| 73 | Annex C (normative) Test method for determining the diameter of the cuff |
| 74 | Annex D (normative) Test method for cuff herniation |
| 76 | Annex E (normative) Test method for determining kink resistance |
| 78 | Annex F (informative) Guidance on materials and design |
| 79 | Annex G (informative) Hazard identification for risk assessment |
| 82 | Bibliography |
