oSIST prEN ISO 23402-2:2026

Dentistry - Portable dental equipment for use in non-permanent healthcare environments - Part 2: Portable dental units (ISO/DIS 23402-2:2026)

This document provides terms, classifications, requirements and testing of portable dental equipment for use primarily by dental professionals in nonclinical settings. Part 1 of this document specifies terms, classifications, general requirements, and test methods. Specific requirements for certain types of portable dental equipment for use in nonclinical environments will be set forth in subsequent parts of this document.
This document does not apply to fixed dental equipment, wearable equipment (such as head lamps and loops), mobile dental equipment, or portable dental equipment that is not designed to be used or disassembled in nonclinical environments. In addition, this document does not include requirements for fixed dental equipment (e.g., portable dental clinics for vehicles or containers) that can be installed in dental mobile medical facilities.

Zahnheilkunde - Tragbare dentale Ausrüstung zur Anwendung in nicht-dauerhaften Gesundheitseinrichtungen - Teil 2: Tragbare dentale Einheiten (ISO/DIS 23402-2:2026)

Médecine bucco-dentaire - Matériel dentaire portatif utilisable dans des environnements de soins de santé non permanents - Partie 2: Units dentaires portatifs (ISO/DIS 23402-2:2026)

Zobozdravstvo - Prenosna dentalna oprema za začasno zdravstveno oskrbo - 2. del: Prenosne dentalne enote (ISO/DIS 23402-2:2026)

Ta dokument določa izraze, klasifikacije, zahteve in preskušanje prenosne zobozdravstvene opreme, namenjene predvsem uporabi zobozdravstvenih strokovnjakov v nekliničnih okoljih. Prvi del tega dokumenta določa izraze, klasifikacije, splošne zahteve in preskusne metode. Posebne zahteve za določene vrste prenosne zobozdravstvene opreme za uporabo v nekliničnih okoljih bodo določene v naslednjih delih tega dokumenta.
Ta dokument se ne uporablja za fiksno zobozdravstveno opremo, nosljivo opremo (kot so naglavne svetilke in lupe), mobilno zobozdravstveno opremo ali prenosno zobozdravstveno opremo, ki ni zasnovana za uporabo ali razstavljanje v nekliničnih okoljih. Poleg tega ta dokument ne vključuje zahtev za fiksno zobozdravstveno opremo (npr. prenosne zobozdravstvene klinike za vozila ali kontejnerje), ki jo je mogoče namestiti v mobilne medicinske zobozdravstvene objekte.

General Information

• Status: Not Published
• Public Enquiry End Date: 29-Jun-2026
• ICS: 11.060.20 - Dental equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 04-May-2026
• Due Date: 21-Sep-2026
• Ref Project: prEN ISO 23402-2 - Dentistry - Portable dental equipment for use in non‐permanent healthcare environments - Part 2: Portable dental units (ISO/DIS 23402-2:2026)

Relations

• Referred By: SIST EN ISO 15875-5:2026 - Plastics piping systems for hot and cold water installations - Crosslinked polyethylene (PE-X) - Part 5: Fitness for purpose of the system (ISO 15875-5:2025)
• Effective Date: 28-Jan-2026

Overview

oSIST prEN ISO 23402-2:2026:2026 is a draft international standard developed by CEN and ISO for dentistry portable dental equipment, with a focus on portable dental units designed for use in non-permanent healthcare environments. Standardized by ISO/TC 106/SC 6, this document specifies terminology, classification, requirements, and test methods applicable to portable dental units that are intended to be easily transported and set up by dental professionals outside of traditional clinical settings.

The scope of oSIST prEN ISO 23402-2:2026:2026 covers only those portable dental units that are designed to be moved and used in temporary healthcare locations. The standard does not apply to stationary, mobile, or wearable dental equipment, nor to equipment designed only for fixed or vehicular installations.

Key Topics

• Classification: The standard classifies portable dental units based on the integration of their utilities:
  • Fully integrated (built-in compressor, water, suction)
  • Partially integrated (some utilities built-in, some external)
  • Non-integrated (utilities must be provided externally)
• Core Requirements:
  • Technical and performance specifications for connections to dental handpieces and motors
  • Standards for dental water and air systems, including filtration, backflow prevention, and water/wastewater handling
  • Suction system configurations, including requirements for filters, separators, and connectors
  • Instructions for cleaning, maintenance, and operation aimed at infection control and safe use
• Testing & Conformity:
  • Provides standardized test methods for equipment performance, safety, and compatibility with other dental components
  • Requires manufacturers to document test reports, technical descriptions, and marking/packaging in line with specified criteria
• Documentation & Marking:
  • Detailed guidelines for manufacturers on required operating instructions, technical data, and proper labeling for safe deployment in temporary locations

Applications

This standard is essential for manufacturers, suppliers, and dental professionals involved in:

• Field Dentistry: Portable dental units compliant with this standard support dentists working in remote, underserved, or emergency environments, such as outreach programs, disaster response, and military field missions.
• Community and Mobile Health Clinics: The requirements ensure that dental care can be delivered reliably and hygienically in school programs, care homes, and short-term installations where traditional dental offices are not available.
• Regulatory Compliance: Following this standard supports product approvals in international markets, ensuring safety, compatibility, and standardization of portable dental equipment across regions.
• Procurement and Quality Assurance: Institutions and health agencies can use ISO 23402-2:2026 to define specifications, evaluate products, and ensure consistent equipment performance in non-permanent setups.

Related Standards

• ISO 23402-1: General requirements for portable dental equipment used in non-permanent healthcare environments, providing foundational definitions and general testing procedures.
• ISO 23402-3: Specific requirements for portable dental suction equipment.
• ISO 1942: Dentistry vocabulary, defining key terms used throughout related dental equipment standards.
• ISO 7494-1: General requirements for stationary dental units and dental patient chairs.
• ISO 7494-2: Requirements on air, water, suction, and wastewater systems in dental equipment.
• ISO 2151: Acoustics standards concerning noise test codes for compressors and vacuum pumps.

Staying compliant with oSIST prEN ISO 23402-2:2026:2026 ensures optimal safety, portability, and performance for dental units used in all types of temporary healthcare settings-supporting improved oral health services wherever they are needed most.

Standards Content (Sample)

SLOVENSKI STANDARD
01-junij-2026
Zobozdravstvo - Prenosna dentalna oprema za začasno zdravstveno oskrbo - 2.
del: Prenosne dentalne enote (ISO/DIS 23402-2:2026)
Dentistry - Portable dental equipment for use in non-permanent healthcare environments
- Part 2: Portable dental units (ISO/DIS 23402-2:2026)
Zahnheilkunde - Tragbare dentale Ausrüstung zur Anwendung in nicht-dauerhaften
Gesundheitseinrichtungen - Teil 2: Tragbare dentale Einheiten (ISO/DIS 23402-2:2026)
Médecine bucco-dentaire - Matériel dentaire portatif utilisable dans des environnements
de soins de santé non permanents - Partie 2: Units dentaires portatifs (ISO/DIS 23402-
2:2026)
Ta slovenski standard je istoveten z: prEN ISO 23402-2
ICS:
11.060.20 Zobotehnična oprema Dental equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT
International
Standard
ISO/DIS 23402-2
ISO/TC 106/SC 6
Dentistry — Portable dental
Secretariat: DIN
equipment for use in non‐
Voting begins on:
permanent healthcare
2026-04-24
environments —
Voting terminates on:
2026-07-17
Part 2:
Portable dental units
ICS: 11.060.20
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Reference number
ISO/DIS 23402-2:2026(en)
DRAFT
ISO/DIS 23402-2:2026(en)
International
Standard
ISO/DIS 23402-2
ISO/TC 106/SC 6
Dentistry — Portable dental
Secretariat: DIN
equipment for use in non‐
Voting begins on:
permanent healthcare
environments —
Voting terminates on:
Part 2:
Portable dental units
ICS: 11.060.20
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2026
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
ISO copyright office
RECIPIENTS OF THIS DRAFT ARE INVITED
CP 401 • Ch. de Blandonnet 8
TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
Phone: [phone]
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: [e-mail]
Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 23402-2:2026(en)
ii
ISO/DIS 23402‐2:2026(en)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification . 2
4.1 General .2
4.2 Classification of portable dental unit according to the integration of utility .2
5 Requirements . 2
5.1 General .2
5.2 Connections from the portable dental unit to dental handpieces and motors .2
5.2.1 General .2
5.2.2 Multifunction handpiece .2
5.2.3 Handpiece and motor .3
5.3 Dental unit water delivery system .3
5.3.1 Incoming water .3
5.3.2 Materials used for construction of procedural water systems within the
portable dental unit .3
5.3.3 Water and wastewater removal prior to transport or storage .3
5.3.4 Backflow prevention device for portable dental units connected to the external
drinking water supply .3
5.3.5 Particle filter .3
5.4 Dental air system .3
5.4.1 Incoming dental air .3
5.4.2 Particle filters .3
5.4.3 Bacterial filters .4
5.4.4 Condensate drain .4
5.4.5 Sound pressure level of compressed air source equipment .4
5.5 Portable dental unit suction system .4
5.5.1 Maximum static suction pressure .4
5.5.2 Suction pressure head loss .4
5.5.3 Air separator .4
5.5.4 Solids filter .4
5.5.5 Portable dental unit suction source connection point.4
5.5.6 Portable dental units with integrated suction source equipment. .5
5.5.7 Configuration of cannula connectors and cannula .5
5.5.8 Operating hoses with cannula connectors .5
5.6 Cleaning of suction lines and components .5
5.7 Test report .5
6 Sampling . 5
7 Test methods . 6
7.1 General provisions for tests .6
7.2 Visual inspection .6
7.2.1 Visual inspection of equipment .6
7.2.2 Visual inspection of documentation .6
8 Manufacturer's instructions . 6
8.1 General .6
8.2 Instructions for use .6
8.3 Technical description.6
9 Marking . . 7
10 Packaging. 7

iii
ISO/DIS 23402‐2:2026(en)
Annex A (informative) Test report . 8

iv
ISO/DIS 23402‐2:2026(en)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
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in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
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This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 6, Dental
equipment, in collaboration with the European Committee for Standardization (CEN) Technical Committee
CEN/TC 55, Dentistry, in accordance with the Agreement on technical cooperation between ISO and CEN
(Vienna Agreement).
A list of all parts in the ISO 23402 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s natio
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