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BS EN ISO 23402-3:2024

$102.76

Dentistry. Portable dental equipment for use in non-permanent healthcare environment – Portable suction equipment

Published By Publication Date Number of Pages
BSI 2024 22
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This document specifies terminology, classification, requirements and test methods for portable suction equipment primarily intended to be used by dental professionals in non-permanent healthcare environments. This document applies to portable suction equipment incorporated in a portable dental unit and free-standing portable suction equipment. The requirements in this document focus on portability. This document specifies requirements for information to be supplied by the manufacturer on the performance, operation and maintenance of portable suction equipment designed and constructed to be transported for use in non-permanent healthcare environments. This document also specifies requirements for the instructions to be supplied by the manufacturer on assembling, disassembling and packing for human transport between non-permanent healthcare environments. This document does not apply to stationary dental equipment, wearable equipment (such as headlamps and loupes), mobile dental equipment or portable dental equipment that is not intended to be used in non-permanent healthcare environments or not designed to be disassembled, folded or packed for human transport between non-permanent healthcare environments. Also, requirements for stationary dental equipment that can be installed in a dental mobile medical facility (e.g. vehicular or containerized mobile dental clinic) are not considered in this document. This document specifies requirements for portable suction equipment used to provide reduced pressure and flow at the cannula connector. This document does not apply to portable suction equipment used for life support or for scavenging halogenated anaesthetic gases.

PDF Catalog

PDF Pages PDF Title
2 undefined
4 European foreword
Endorsement notice
7 Foreword
8 Introduction
9 1 Scope
2 Normative references
10 3 Terms and definitions
11 4 Classification
4.1 Applicable classifications
4.2 Classification according to the degree of integration and location
4.2.1 General
4.2.2 Type A: Fully integrated
4.2.3 Type B: Remote
4.2.4 Type C: Standalone
4.3 Classification according to air flow rate
12 5 Requirements
5.1 General
5.2 Protection against electric shock
5.3 Safety requirements
5.4 Electromagnetic compatibility
13 5.5 Utility requirements
5.5.1 Compressed air supply
5.5.2 Suction waste container
5.6 Operational requirements
5.6.1 General
5.6.2 Cleaning
5.7 Characterization of portable suction equipment flow rate performance
5.8 Maximum suction pressure
14 5.9 Amalgam separator
5.10 Bacterial filter
6 Sampling
7 Measurement and test methods
7.1 General
7.1.1 General provisions for tests
7.1.2 Reference conditions (air flow rates)
7.1.3 Atmospheric conditions
15 7.1.4 Other conditions
7.2 Performance tests
7.2.1 Measurement of flow rate performance
7.2.2 Measurement of maximum suction pressure of portable suction equipment types A and C
7.2.3 Measurement of maximum suction pressure of type B portable suction equipment
16 7.2.4 Measures to prevent excessive suction pressure
7.3 Bacterial filters
7.4 Visual inspection
7.4.1 Visual inspection equipment
7.4.2 Visual inspection of documentation
7.5 Resistance to solutions for the cleaning process
7.5.1 Principle
7.5.2 Test specimens
7.5.3 Test conditions
17 7.5.4 Solution(s) for the cleaning process
7.5.5 Immersion procedure
18 7.5.6 Inspection
8 Information supplied by the manufacturer
8.1 General
8.2 Instructions for use
19 8.3 Technical description
20 9 Marking
9.1 General
9.2 Marking on the outside of electrically operated portable suction equipment
9.3 Marking of packaging
10 Packaging
21 Bibliography
BS EN ISO 23402-3:2024
$102.76