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.
Directives related to this standards.
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
IN_DEVELOPMENT
prSSH EN ISO 23402-3:2024
40.20
DIS ballot initiated: 12 weeks
Feb 10, 2025
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