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BS EN ISO 10079-4:2021

BS EN ISO 10079-4:2021

$167.15

Medical suction equipment – General requirements

Published By Publication Date Number of Pages
BSI 2021 44
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This document specifies general requirements for medical suction equipment that are common to all parts of the ISO 10079 series .

This document is not applicable to the following:

  1. end-pieces such as suction catheters, drains, curettes, Yankauer suckers and suction tips;

  2. syringes;

  3. dental suction equipment;

  4. anaesthetic gas scavenging systems;

  5. laboratory suction;

  6. autotransfusion systems;

  7. mucus extractors including neonatal mucus extractors;

  8. suction equipment where the collection container is downstream of the vacuum pump;

  9. ventouse (obstetric) equipment;

  10. suction equipment marked for endoscopic use only; and

  11. plume evacuation systems.

PDF Catalog

PDF Pages PDF Title
2 undefined
7 Foreword
8 Introduction
9 1 Scope
2 Normative references
10 3 Terms and definitions
12 4 General requirements
4.1 Risk management
13 4.2 Usability
4.3 Clinical studies
4.4 Biophysical or modelling research
4.5 Test methods
5 Materials
5.1 Natural rubber latex
14 5.2 Cleaning, disinfection and sterilization
6 Design requirements
6.1 General
6.2 Collection containers
6.2.1 Capacity
15 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
16 6.4 Suction tubing and intermediate tubing
6.5 Vacuum level indicators
17 6.6 Environmental conditions for transport and storage
18 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
19 7.3 Noise
7.4 Air leakage
7.5 Vacuum levels and free air flows
7.6 Accuracy
20 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
21 8.5 Collection container capacity
9 Information supplied by the manufacturer
9.1 General
22 9.2 Symbols
9.3 Marking
23 9.4 Instructions for use
25 Annex A (informative) Rationale
27 Annex B (normative) Test methods
42 Annex C (informative) Schematic of medical suction equipment
43 Bibliography

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BS EN ISO 10079-4:2021
$167.15