SIST EN ISO 23402-1:2026

• Abstract:

  This document specifies general requirements and test methods for portable dental equipment for use in non-permanent healthcare environments.; This document applies to portable dental units, portable patient chairs, portable operator’s stools, portable operating lights, portable suction source equipment, portable air compressors and other portable dental equipment in instances where these devices are designed and constructed to be transported for use in non-permanent healthcare environments.; NOTE Particular requirements for specific types of portable dental equipment for use in non-permanent healthcare environments are specified in subsequent parts of this document.; This document does not apply to stationary dental equipment, wearable equipment (e.g. 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. 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.

• Status: Published
• Public Enquiry End Date: 30-May-2025
• Publication Date: 19-Aug-2026
• ICS: 11.060.20 - Dental equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 30-Jul-2026
• Due Date: 04-Oct-2026
• Completion Date: 20-Aug-2026
• Ref Project: EN ISO 23402-1:2026 - Dentistry - Portable dental equipment for use in non‐permanent healthcare environments - Part 1: General requirements (ISO 23402-1:2026)

• Replaces: SIST EN ISO 23402-1:2020 - Dentistry - Portable dental equipment for use in non‐permanent healthcare environment - Part 1: General requirements (ISO 23402-1:2020)
• Effective Date: 01-Sep-2026

Overview

SIST EN ISO 23402-1:2026 - "Dentistry - Portable dental equipment for use in non‐permanent healthcare environments - Part 1: General requirements" - sets out the essential general requirements and test methods for portable dental equipment designed for temporary or non-permanent healthcare settings. Developed by the Slovenian Institute for Standardization (SIST), this international standard serves as a critical reference for device manufacturers, healthcare providers, and organizations involved in mobile, field-based, and outreach dental services.

The standard applies to a broad range of portable dental devices, including:

• Portable dental units
• Portable patient chairs and operator’s stools
• Portable operating lights
• Portable suction source equipment
• Portable air compressors
• Other portable dental devices intended for transportable use

Stationary dental equipment, wearable devices (such as headlamps and loupes), and mobile medical facility devices are excluded.

Key Topics

SIST EN ISO 23402-1:2026 focuses on the following key areas to ensure the safe and effective use of portable dental equipment:

• Transport and Handling Requirements: Specifies requirements for device portability, maximum weight and dimensions, grip/handling features, and how equipment should withstand transport, including impact, vibration, and environmental exposure.
• Use Environment Classification: Details equipment classification for indoor versus outdoor deployment, including settings with limited or rugged environmental protection.
• Supply Source Classification: Differentiates between devices using self-contained sources (batteries, water reservoirs) and those requiring external supplies.
• Ingress Protection: Outlines standards for resistance to foreign object and liquid ingress (e.g., IP21 for limited exposure and IP55 for rugged use).
• Assembly and Maintenance: Mandates design for safe, efficient assembly and disassembly, as well as clear maintenance instructions.
• Operational Safety and Usability: Includes basic electrical safety, usability engineering, and surface reprocessing to prevent contamination and ensure proper infection control.
• Test Methods: Covers visual inspections and performance tests to verify compliance with the requirements.

Applications

The requirements of ISO 23402-1:2026 are directly relevant to:

• Manufacturers: Ensuring portable dental equipment is designed and tested for reliable operation in diverse and often challenging environments.
• Healthcare Providers: Selecting suitable portable dental equipment for use in temporary clinics, home care, aged care facilities, schools, prisons, military field operations, and humanitarian missions.
• Regulators and Procurement Bodies: Assessing compliance and safety of portable dental devices based on international benchmarks.
• Disaster Response and Public Health: Deploying dental care solutions rapidly in emergency or underserved areas.

By adhering to these requirements, organizations can enhance patient safety, minimize risk, and maintain equipment integrity across a range of non-permanent healthcare environments.

Related Standards

SIST EN ISO 23402-1:2026 references and aligns with several related international standards, including:

• IEC 60529: Degrees of protection provided by enclosures (IP Code)
• IEC 60601-1: Medical electrical equipment - General requirements for basic safety and essential performance
• IEC 62366-1: Usability engineering for medical devices
• IEC 80601-2-60: Safety of dental electrical equipment
• ISO 4180: Packaging performance test schedules
• ISO 9687: Graphical symbols for dental equipment
• ISO 15223-1: Information symbols for medical device manufacturer’s instructions
• ISO 21530: Chemical disinfectant resistance of dental surfaces

Compliance with SIST EN ISO 23402-1:2026 ensures that portable dental equipment meets recognized safety, usability, and durability criteria, supporting the delivery of dental care wherever it is needed most.

SLOVENSKI STANDARD
01-september-2026
Nadomešča:
SIST EN ISO 23402-1:2020
Zobozdravstvo - Prenosna dentalna oprema za začasno zdravstveno oskrbo - 1.
del: Splošne zahteve (ISO 23402-1:2026)
Dentistry - Portable dental equipment for use in non-permanent healthcare environments
- Part 1: General requirements (ISO 23402-1:2026)
Zahnheilkunde - Tragbare dentale Ausrüstung zur Anwendung in nicht-dauerhaften
Gesundheitseinrichtungen - Teil 1: Allgemeine Anforderungen (ISO 23402-1:2026)
Médecine bucco-dentaire - Équipement dentaire portatif destiné à être utilisé dans un
environnement de soins non permanent - Partie 1: Prescriptions générales (ISO 23402-
1:2026)
Ta slovenski standard je istoveten z: EN ISO 23402-1:2026
ICS:
11.060.20 Zobotehnična oprema Dental equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 23402-1
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2026
EUROPÄISCHE NORM
ICS 11.060.20 Supersedes EN ISO 23402-1:2020
English Version
Dentistry - Portable dental equipment for use in non-
permanent healthcare environments - Part 1: General
requirements (ISO 23402-1:2026)
Médecine bucco-dentaire - Matériel dentaire portatif Zahnheilkunde - Tragbare dentale Ausrüstung zur
utilisable dans des environnements de soins de santé Anwendung in nicht-dauerhaften
non permanents - Partie 1: Exigences générales (ISO Gesundheitseinrichtungen - Teil 1: Allgemeine
23402-1:2026) Anforderungen (ISO 23402-1:2026)
This European Standard was approved by CEN on 17 May 2026.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2026 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 23402-1:2026 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 23402-1:2026) has been prepared by Technical Committee ISO/TC 106
"Dentistry" in collaboration with Technical Committee CEN/TC 55 “Dentistry” the secretariat of which
is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by January 2027, and conflicting national standards shall
be withdrawn at the latest by January 2027.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 23402-1:2020.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 23402-1:2026 has been approved by CEN as EN ISO 23402-1:2026 without any
modification.
International
Standard
ISO 23402-1
Second edition
Dentistry — Portable dental
2026-07
equipment for use in non‐
permanent healthcare
environments —
Part 1:
General requirements
Médecine bucco-dentaire — Matériel dentaire portatif utilisable
dans des environnements de soins de santé non permanents —
Partie 1: Exigences générales
Reference number
ISO 23402-1:2026(en) © ISO 2026

ISO 23402‐1:2026(en)
© ISO 2026
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ISO 23402‐1:2026(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Classification . 2
4.1 General .2
4.2 For electrically operated devices .2
4.3 According to intended use environment .2
4.4 According to supply sources.3
4.5 According to exposure during transport .3
5 Requirements . 3
5.1 General .3
5.2 Transport requirements .3
5.2.1 General .3
5.2.2 Grips or other handling features .4
5.2.3 Maximum mass .4
5.2.4 Maximum dimensions .4
5.2.5 Environmental exposure .4
5.2.6 Impact .4
5.2.7 Drop .4
5.2.8 Vibration .5
5.2.9 Foreign object and liquid ingress during transport .5
5.3 Utility requirements .5
5.4 Operational requirements .5
5.4.1 Ambient operating conditions .5
5.4.2 Usability .5
5.4.3 Processing of external surfaces .6
5.4.4 Foreign object and liquid ingress .6
6 Sampling . 6
7 Measurement and test methods . 6
7.1 Visual inspection of the equipment .6
7.2 Visual inspection of the documentation .6
8 Manufacturer's instructions . 7
8.1 General .7
8.2 Instructions for use .7
8.3 Technical description.7
9 Marking . . 8
9.1 Marking on the equipment .8
9.2 Marking of packaging .8
10 Packaging. 8
Annex A (informative) Applicable testing methodology from IEC 60601‐1 . 9
Bibliography .10

iii
ISO 23402‐1:2026(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
ISO technical committees. Each member body interested in a subject for which a technical committee
has been established has the right to be represented on that committee. International organizations,
governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely
with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO document 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)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO [had/had not] received notice of
(a) patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
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).
This second edition cancels and replaces the first edition (ISO 23402-1:2020), which has been technically
revised.
The main changes are as follows:
— 5.2.6, 5.2.7 and 5.2.8 have been updated to specify requirements for impact, drop and vibration according
to the classification for exposure during transport;
— 5.4.4 has been added;
— 8.3, list item e), 8.3, list item f) and 8.3, list item g) have been added to include classification level for drop
height and classification level for rough road transport distance;
— general editorial updates have been made.
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 national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

iv
ISO 23402‐1:2026(en)
Introduction
Transportable dental equipment is used by dental professionals to provide care to patients in a variety of
settings. Because the intended use applications and intended means for transporting such equipment vary
considerably, a wide variety of transportable dental equipment is commercially available. For example,
certain transportable equipment is designed and constructed to be carried or rolled on its own wheels
between rooms within a healthcare facility, while other transportable dental equipment is made to be folded
and packed to carry over terrain which can be rugged and used in transient dental care settings which can
have only limited shelter and utility services.
Transportable equipment that can be moved from one location to another while being carried by one or
more persons is referred to as portable equipment. The term "portable equipment" applies to equipment
that can be carried from room to room in a given facility or to remote parts of the world. This document
focuses on portable dental equipment which is specifically designed and constructed to be transported
between non-clinical environments and used by dental professionals to provide dental care in such settings,
including temporary field clinics.
Such portable dental equipment for use in non-permanent healthcare environments enables dental
professionals to provide a high standard of care to patients who do not have access to, or are not able
to, travel to traditional health care facilities. Settings in which this equipment is commonly used include
military field environments, humanitarian aid field clinics, public health outreach clinics, patient residences,
long-term care facilities, prisons, schools and workplaces.
A number of trends in health care have driven increased utilization of portable dental equipment in non-
permanent healthcare environments. Military forces use portable dental equipment in support of mobilized
forces or for humanitarian outreach. A variety of government and non-government organizations are
increasingly providing humanitarian dental care to underserved populations and populations affected
by disasters. Civilian health care workers are also increasingly providing dental services to a growing
population who are simply unable to visit traditional dental clinics due to age, disability or income. Academic
and research bodies regularly conduct dental education programmes (e.g. dentistry, dental hygiene and
dental assisting), particularly at external/off-site locations.
The transport and end-use conditions for portable dental equipment used in non-permanent healthcare
environments drive certain unique requirements which generally do not apply to portable, mobile or
stationary dental equipment used in traditional dental clinics or hospitals. Because portable equipment
used in non-permanent healthcare environments is intended to be moved between venues, and in some
cases carried over rugged terrain or in inclement conditions, it needs to be designed and constructed to
be safely transported by humans without damage, be efficiently assembled and disassembled, and deliver
reliable service at the point of use. Special consideration is given to the austerity of the environment in which
the equipment can be used and the availability and quality of utility supplies (e.g. electrical power, water,
compressed air). In order for the equipment to be sufficiently portable and capable of operating in extreme
conditions, certain requirements for dental equipment intended for use in traditional clinical settings can be
impractical and should be reconsidered for portable dental equipment for use in non-permanent healthcare
environments. There can also be unique safety and infection control concerns to consider.
The ISO 23402 series aims to standardize requirements for portable dental equipment for use in non-
permanent healthcare environments.

v
International Standard ISO 23402‐1:2026(en)
Dentistry — Portable dental equipment for use in non‐
permanent healthcare environments —
Part 1:
General requirements
1 Scope
This document specifies general requirements and test methods for portable dental equipment for use in
non-permanent healthcare environments.
This document applies to portable dental units, portable patient chairs, portable operator’s stools, portable
operating lights, portable suction source equipment, portable air compressors and other portable dental
equip
...