BS EN ISO 5361:2016
$198.66
Anaesthetic and respiratory equipment. Tracheal tubes and connectors
| Published By | Publication Date | Number of Pages |
| BSI | 2016 | 56 |
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 4 | European foreword |
| 6 | Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC Table ZA.1 — Correspondence between this International Standard and Annex I of Directive 93/42/EEC [OJ L 169] |
| 11 | Foreword |
| 12 | Introduction |
| 14 | 1 Scope 2 Normative references |
| 15 | 3 Terms and definitions |
| 18 | 4 *General requirements for tracheal tubes and tracheal tube connectors 4.1 Risk assessment |
| 19 | 4.2 Safety 5 Specific requirements for tracheal tubes and tracheal tube connectors 5.1 Size designation 5.2 Dimensions 5.2.1 Tracheal tubes |
| 23 | 5.2.2 Tracheal tube connectors |
| 26 | 5.3 *Materials 5.4 Tracheal tube bevel 5.5 *Tracheal tube cuffs |
| 27 | 5.6 Inflating system for cuffs 5.7 Curvature of the tube |
| 29 | 5.8 *Radiopaque marker 5.9 *Kink resistance |
| 30 | 6 Additional requirement for tracheal tubes with a Murphy eye 6.1 Size of the Murphy eye 6.2 Location of the Murphy eye 6.3 Resistance to kinking or collapse of the Murphy eye 6.4 Surface characteristics of the Murphy eye 7 Requirements for tracheal tubes with tracheal tube connectors supplied sterile 7.1 Sterility assurance |
| 31 | 7.2 Packaging for tracheal tubes and tracheal tube connectors supplied sterile 8 Marking 8.1 Use of symbols 8.2 Marking on the tracheal tube |
| 32 | 8.3 Marking on the tracheal tube individual pack or any insert |
| 34 | 8.4 Marking on tracheal tube connectors |
| 35 | Annex A (informative) Rationale |
| 39 | Annex B (normative) Determination of cuff diameter |
| 40 | Annex C (normative) Test method for cuffed tube collapse |
| 43 | Annex D (normative) *Test method for cuff herniation |
| 45 | Annex E (informative) Guidance on design of tracheal tube connectors |
| 46 | Annex F (informative) Hazard identification for risk assessment |
| 49 | Annex G (normative) *Test method for tracheal seal |
| 52 | Annex H (normative) Test method to determine kink resistance |
| 54 | Bibliography |
