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BS EN ISO 10079-4:2021 Medical suction equipment - General requirements, 2021
- undefined
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 General requirements
- 4.1 Risk management
- 4.2 Usability
- 4.3 Clinical studies
- 4.4 Biophysical or modelling research
- 4.5 Test methods
- 5 Materials
- 5.1 Natural rubber latex
- 5.2 Cleaning, disinfection and sterilization
- 6 Design requirements
- 6.1 General
- 6.2 Collection containers
- 6.2.1 Capacity
- 6.2.2 Strength
- 6.3 Connections
- 6.3.1 Tubing connectors
- 6.3.2 Collection container inlet ports
- 6.3.3 Collection container exhaust ports
- 6.4 Suction tubing and intermediate tubing
- 6.5 Vacuum level indicators
- 6.6 Environmental conditions for transport and storage
- 7 Performance requirements
- 7.1 Operating position
- 7.2 Protection devices
- 7.2.1 Contamination protection
- 7.2.2 Overfill protection devices
- 7.2.3 Pressure protection
- 7.3 Noise
- 7.4 Air leakage
- 7.5 Vacuum levels and free air flows
- 7.6 Accuracy
- 7.7 Pharyngeal suction equipment
- 8 Additional/alternative requirements for suction equipment, suction tubing and intermediate tubing designed for field use or transport use
- 8.1 Physical requirements
- 8.2 Strength
- 8.3 Stability
- 8.4 Environmental conditions during operation
- 8.5 Collection container capacity
- 9 Information supplied by the manufacturer
- 9.1 General
- 9.2 Symbols
- 9.3 Marking
- 9.4 Instructions for use
- Annex A (informative) Rationale
- Annex B (normative) Test methods
- Annex C (informative) Schematic of medical suction equipment
- Bibliography [Go to Page]
