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BS EN ISO 10079-1:2015:2016 Edition

BS EN ISO 10079-1:2015:2016 Edition

$167.15

Medical suction equipment – Electrically powered suction equipment

Published By Publication Date Number of Pages
BSI 2016 42
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PDF Catalog

PDF Pages PDF Title
11 1 Scope
2 Normative references
12 3 Terms and definitions
14 4 General requirements
4.1 Risk management
15 4.2 Usability
4.3 Clinical investigation
4.4 Biophysical or modelling research
4.5 Test methods
5 Cleaning, disinfection and sterilization
16 6 Design requirements
6.1 Collection container
6.1.1 General
6.1.2 Container capacity
6.1.3 Container strength
6.2 Connections
6.2.1 Tubing connectors for collection containers
17 6.2.2 Inlet port
6.2.3 Exhaust port
6.3 Suction tubing
6.4 Vacuum level indicators
18 6.5 Spillage on electrical suction equipment
7 Operational requirements
7.1 Ease of operation
7.2 Dismantling and reassembly
7.3 Mechanical shock
7.4 Stability
19 7.5 Protective devices
7.5.1 Contamination protection
7.5.2 Overfill protection devices
7.5.3 Pressure protection
7.6 Noise
7.6.1 Low vacuum/low flowrate equipment
7.6.2 Suction equipment other than that specified in 7.6.1
20 7.7 Air leakage
7.7.1 Collection containers for general use
7.7.2 Collection containers for thoracic drainage
8 Physical requirements for suction equipment for field use
8.1 (*) Dimensions
8.2 Mass
9 Performance requirements for vacuum level and flowrate
9.1 High vacuum/high flowrate equipment
21 9.2 Medium vacuum equipment
9.3 Low vacuum/low flowrate equipment
9.4 Low vacuum/high flowrate equipment
9.5 Thoracic drainage equipment for adults
9.6 Intermittent vacuum equipment
9.7 Vacuum regulators with fixed setting
22 9.8 Vacuum regulators with variable setting
9.9 Equipment intended for pharyngeal suction
9.10 Battery powered transportable suction equipment
9.11 Interruption of the power supply
10 (*) Resistance to environment of suction equipment for field and/or transport use
10.1 Operating conditions
10.2 Storage
23 11 Information to be supplied by the manufacturer (labelling and instructions for use)
11.1 Information supplied by the manufacturer shall comply with EN 1041.
11.3 Labelling of equipment
24 11.4 Instructions for use
26 Annex A (normative) Test methods
37 Annex B (informative) Rationale statement
38 Annex C (informative) Lumen size and its effect on flowrate
39 Annex D (informative) Schematic of suction equipment
40 Bibliography

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BS EN ISO 10079-1:2015
$167.15