BS EN ISO 8836:2014
$167.15
Suction catheters for use in the respiratory tract
| Published By | Publication Date | Number of Pages |
| BSI | 2014 | 40 |
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 4 | Foreword |
| 5 | Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC |
| 10 | Foreword |
| 11 | Introduction |
| 12 | 1 Scope 2 Normative references |
| 13 | 3 Terms and definitions |
| 16 | 4 *General requirements for open and closed suction catheters 4.1 Risk management |
| 17 | 4.2 Safety 5 Specific requirements for open and closed suction catheters 5.1 Size and length designations 5.2 *Dimensions |
| 18 | 6 Materials |
| 19 | 7 *Design 7.1 Lumen of the suction catheter 7.2 Suction catheter tip 7.3 *Suction catheter connector |
| 21 | 7.4 Additional requirements for closed suction catheters |
| 23 | 8 Performance requirements 8.1 Security of construction 8.2 Shaft performance |
| 24 | 8.3 *Vacuum control device performance 8.4 *Leakage 8.5 *Resistance to flow 8.6 *Radiopacity 9 Requirements for suction catheters supplied sterile 9.1 Sterility assurance |
| 25 | 9.2 Packaging of suction catheters supplied sterile 10 Marking 10.1 Marking on suction catheters |
| 26 | 10.2 Use of symbols |
| 27 | 10.3 Labelling of individual packs 10.4 Labelling of shelf/multi-unit packs |
| 29 | Annex A (informative) Rationale |
| 32 | Annex B (normative) Test method for security of attachment |
| 33 | Annex C (normative) Measurement of residual vacuum |
| 35 | Annex D (normative) Method of testing leakage |
| 36 | Annex E (informative) Hazard identification for risk assessment |
| 38 | Bibliography |
