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BS EN ISO 8836:2020 Suction catheters for use in the respiratory tract, 2020
- undefined
- European foreword
- Endorsement notice
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 *General requirements
- 5 Materials
- 6 Design requirements
- 6.1 General
- 6.2 Size designations and dimensions
- 6.3 Suction catheter tip
- 6.4 *Suction catheter connector
- 6.5 Additional requirements for closed suction catheters
- 6.5.1 General design
- 6.5.2 Closed suction catheter manifold and connectors
- 6.5.3 Protective sleeve
- 6.5.4 *Suction control device
- 6.5.5 Flushing system
- 6.5.6 T-piece port
- 6.6 Performance requirements
- 6.6.1 Security of construction
- 6.6.2 Shaft performance
- 6.6.3 Suction control device performance
- 6.6.4 *Leakage
- 6.6.5 *Resistance to flow
- 7 Requirements for suction catheters supplied sterile
- 8 Packaging
- 9 Information supplied by the manufacturer
- 9.1 General
- 9.2 Marking
- 9.3 Instructions for use
- Annex A (informative) Rationale
- Annex B (normative) Test method for security of attachment
- Annex C (normative) Measurement of residual vacuum
- Annex D (normative) *Method of testing leakage
- Annex E (informative) Hazard identification for risk assessment
- Bibliography [Go to Page]
