prBAS EN ISO 23402-3:2025
Dentistry - Portable dental equipment for use in non-permanent healthcare environment - Part 3: Portable suction equipment
Opšte informacije
Status:Projekt
Broj stranica:20
Metoda usvajanja:Proglašavanje
Jezik:engleski
Izdanje:1.
Datum realizacije:22.10.2024
Predviđeni datum naredne faze:12.03.2025
Tehnički komitet:BAS/TC 25, Zaštita zdravlja
Direktive:
2017/745, Uredba (EU) o medicinskim sredstvima
ICS:
11.060.20, Zubarska oprema
Apstrakt
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.
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EN ISO 23402-3:2024, identičan
ISO 23402-3:2024, identičan
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