ISO 23402-3:2024
Dentistry — Portable dental equipment for use in non‐permanent healthcare environment — Part 3: Portable suction equipment
Dentistry — Portable dental equipment for use in non‐permanent healthcare environment — Part 3: Portable suction equipment
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 13
- Дата публикации:
- 22 апреля 2024 г.
- Издание:
- ISO IS 23402 edition 1 version 1
- ICS:
- 11.060.20
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.
Abstract
Overview
ISO 23402-3:2024 is an international standard developed by ISO for the dental sector, titled Dentistry - Portable dental equipment for use in non-permanent healthcare environment - Part 3: Portable suction equipment. This standard addresses the specialized requirements for portable suction equipment designed for dental professionals operating in temporary or mobile healthcare settings, such as field clinics, humanitarian missions, disaster zones, and outreach programs. Focusing on equipment that can be easily transported, assembled, disassembled, and safely operated, ISO 23402-3:2024 aims to ensure both user safety and reliable performance across diverse environments.
Key Topics
- Terminology & Classification: Defines standard terms and classifies portable dental suction devices by integration level, location, and minimum air flow rates. This facilitates clear communication between manufacturers, purchasers, and users.
- General & Safety Requirements: Outlines criteria for electrical safety, protection against shock, and adherence to relevant international electro-technical and safety standards depending on usage location (within or outside the patient environment).
- Electromagnetic Compatibility (EMC): Specifies EMC requirements to minimize risk of interference in sensitive dental environments.
- Operational Performance: Addresses required characteristics including flow rate, suction pressure limits, integration of bacteria filters, amalgam separators, and the ability to purge water prior to transport.
- Testing & Verification: Provides standardized methods for performance measurement and conformity, such as normalized flow rates and suction pressure testing.
- Cleaning, Disinfection, and Maintenance: Requires manufacturer-supplied instructions for cleaning, ensuring material compatibility with cleaning agents, and safe handling during assembly, disassembly, and transport.
- Manufacturer’s Information: Specifies required technical and operational data, packaging, and marking, to facilitate correct usage and maintenance.
Applications
Portable dental suction equipment standardized under ISO 23402-3:2024 is essential for:
- Mobile Dental Units: Devices incorporated within transportable dental units for use in temporary clinics and field hospitals.
- Standalone Portable Suction Devices: Independent suction equipment that can be carried to various sites and used alongside other portable dental instruments.
- Humanitarian and Disaster Response: Ensuring rapid deployment and reliable operation of dental services in non-permanent healthcare settings.
- Remote and Rural Care: Supporting dental procedures in locations lacking fixed clinical infrastructure.
These standards help manufacturers design products suited for easy transport and reassembly, while giving users-dental professionals and support staff-guidance on safe operation, effective cleaning, and clear labeling. This helps minimize infection risks, ensures reliability in challenging conditions, and harmonizes product expectations globally.
Related Standards
ISO 23402-3:2024 is part of a broader family of standards and is closely linked to:
- ISO 23402-1:2020 – General requirements for portable dental equipment in non-permanent environments
- ISO 1942 – Dentistry vocabulary
- ISO 7494-2 – Stationary dental unit and chair systems (air, water, suction, wastewater)
- ISO 9687 – Graphical symbols for dental equipment
- ISO 11143 – Dental amalgam separators
- ISO 29463-1:2017 – High efficiency filters (bacterial/particulate filtration efficiency)
- IEC 60601-1, IEC 60335-1 – Electrical and general safety requirements
- IEC 61000-6-2/6-3 – EMC immunity and emission standards
By adhering to ISO 23402-3:2024 and related standards, manufacturers and operators support safe, consistent, and effective dental care services in mobile and temporary healthcare environments worldwide.
Технические детали
- Технический комитет
- ISO/TC 106/SC 6 - Dental equipment
- SKU
- ISO 23402-3:2024
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