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

SIST EN ISO 23402-1:2026 is the Slovenian adoption of EN ISO 23402-1:2026, which carries ISO 23402-1:2026 for dentistry. It specifies general requirements and test methods for portable dental equipment used in non-permanent healthcare environments, so manufacturers, test labs, and buyers can judge whether the equipment is fit for temporary, field, or other non-permanent care settings.

What does SIST EN ISO 23402-1:2026 specify?

SIST EN ISO 23402-1:2026 covers portable dental equipment that is designed and constructed to be transported for use in non-permanent healthcare environments. The document is aimed at equipment such as portable dental units, portable patient chairs, portable operator’s stools, portable operating lights, portable suction source equipment, portable air compressors, and similar portable dental equipment.

The scope also makes clear what is outside its coverage: stationary dental equipment, wearable equipment such as headlamps and loupes, mobile dental equipment, and portable equipment that is not intended for non-permanent healthcare environments or not designed to be disassembled, folded, or packed for human transport between such environments.

The document is organised into clauses on scope, normative references, terms and definitions, classification, requirements, sampling, test methods, manufacturer’s instructions, marking, and packaging, followed by Annex A and a bibliography. Annex A gives applicable testing methodology from IEC 60601-1.

What are the key requirements of SIST EN ISO 23402-1:2026?

SIST EN ISO 23402-1:2026 is built around classification, transport performance, operating conditions, and information supplied by the manufacturer. In practice, this means the equipment has to be defined clearly, tested as transported, and accompanied by usable instructions and marking.

Classification drives the rest of the document

Clause 4 classifies portable dental equipment by electrically operated characteristics, intended use environment, supply source, and exposure during transport. The intended use environment is either indoor use or outdoor use, and the transport exposure is either limited outdoor exposure and limited carrying distance, or rugged outdoor exposure and prolonged carrying distance.

This matters because the chosen classification determines the transport tests, ingress protection expectations, and the information that must appear in the technical description.

Transport performance has to match the way the equipment is carried

Clause 5.2 requires the equipment, including any storage case or transport case, to meet transport requirements in the packed-for-transport condition. The equipment must have grips or other handling features suitable for the intended number of carriers, which makes manual handling part of the design, not an afterthought.

A module carried by one person must not exceed 20 kg, and if several people are intended to carry it, the mass per person must still stay within that limit. For indoor-use equipment, each transport module must fit through a 0.8 m by 1.9 m door, which is a practical check for movement through buildings.

Transport tests focus on real handling risks

Clause 5.2 also requires the packed equipment to withstand environmental exposure, impact, free-fall drop, and vibration. The test conditions come from ISO 4180:2019, with the manufacturer selecting the relevant classification levels for drop height, rough road transport distance, and speed at impact.

For equipment classified for rugged outdoor exposure and prolonged carrying distance, the document requires more stringent transport classifications than for limited outdoor exposure. In practice, that means the manufacturer has to state the intended transport severity and prove the packaging and equipment can survive it.

Ingress protection depends on transport and use environment

Clause 5.2.9 covers foreign object and liquid ingress during transport, and Clause 5.4.4 covers the same risk when the equipment is unpacked and set up for use. For indoor use, the enclosure for each equipment module must conform to IP21; for outdoor use, it must conform to IP55.

This matters because portable dental equipment may move through weather, dust, splashes, or rough handling, and the enclosure has to protect parts that could malfunction or create risk.

Operating conditions and usability must be documented

Clause 5.3 requires the manufacturer to state electrical mains supply requirements where applicable, including voltage, frequency, and power, and to state safety requirements for the power source. If the equipment uses batteries, the battery type must be specified.

Clause 5.4 requires the equipment to operate within the ambient conditions stated by the manufacturer, and it applies the usability requirements of IEC 62366-1. The standard also asks the manufacturer to address poor usability risks linked to identification, marking, and documents, which is important when equipment is assembled, transported, and used by different people in different locations.

Surfaces, hygiene, and documentation matter in field use

Clause 5.4.3 requires instructions for processing external surfaces and connection interfaces, including suitable chemical agents and warnings about agents that can damage the equipment. Materials used for external and touchable surfaces, including the transport case where relevant, must tolerate cleaning and disinfection without deterioration or discoloration when tested to ISO 21530.

This is practical for infection control because portable equipment is handled more often, moved more often, and used in less controlled environments than fixed clinical equipment.

Marking, packaging, and instructions must support safe use

Clauses 8 to 10 require durable printed instructions, downloadable electronic instructions, marking on the equipment, marking on packaging, and packaging that prevents damage during anticipated transport. Clause 9 ties equipment marking to ISO 9687 and ISO 15223-1, so symbols and labels stay understandable and consistent.

What terms does SIST EN ISO 23402-1:2026 define?

SIST EN ISO 23402-1:2026 uses a small set of key terms to separate portable field equipment from other dental equipment.

• Dental equipment - furniture, machines, apparatus, and accessories made for dentistry or associated procedures.
• Portable dental equipment - transportable dental equipment intended to be moved from one location to another while being carried by one or more persons.
• Non-permanent healthcare environment - a setting used temporarily to provide dental or medical treatment.
• Transport case - a packaging container used both for transport and for protecting the portable dental equipment.
• Externally supplied source - a supply source that must be connected during use, such as mains power, water, or compressed air.
• Self-contained source - an internal supply source, such as a battery, compressor, suction source, or water reservoir, that does not need an external connection during use.

Who uses SIST EN ISO 23402-1:2026?

SIST EN ISO 23402-1:2026 is used by manufacturers designing portable dental equipment, test laboratories checking transport and enclosure performance, and quality or regulatory teams writing technical files and product specifications. Buyers and procurement teams use it to define what they expect from equipment intended for field clinics, temporary treatment rooms, or other non-permanent healthcare settings.

It is also relevant to dental professionals and organizations working in military field environments, humanitarian aid clinics, public health outreach, patient residences, long-term care facilities, prisons, schools, and workplaces.

What changed in SIST EN ISO 23402-1:2026 from the previous edition?

SIST EN ISO 23402-1:2026 supersedes SIST EN ISO 23402-1:2020. The second edition states these main changes:

• Clause 5.2.6, 5.2.7, and 5.2.8 were updated so impact, drop, and vibration depend on the classification for exposure during transport.
• Clause 5.4.4 was added.
• Clause 8.3 gained items e), f), and g) for drop height class, rough road transport distance class, and speed at impact class.
• Editorial updates were made.

Which standards are used with SIST EN ISO 23402-1:2026?

SIST EN ISO 23402-1:2026 refers to several standards that support vocabulary, transport testing, marking, cleaning, usability, electrical safety, and enclosure protection.

• ISO 1942 - provides dental vocabulary used for terms and definitions.
• ISO 4180:2019 - provides transport-package test schedules and the drop, vibration, and impact methods referenced in Clause 5.
• ISO 9687 - provides graphical symbols for dental equipment.
• ISO 15223-1 - provides symbols used with manufacturer-supplied information.
• ISO 21530 - provides the method for checking resistance of equipment surfaces to chemical disinfectants.
• IEC 60601-1 - provides general requirements for basic safety and essential performance where electrical safety is relevant.
• IEC 62366-1 - provides the usability engineering approach used for risks linked to identification, marking, and documents.
• IEC 80601-2-60 - provides particular requirements for the basic safety and essential performance of dental equipment.
• IEC 60529:1989+AMD 1:1999+AMD2:2013 - provides the IP Code used for ingress protection levels such as IP21 and IP55.

The document also points to subsequent parts of the ISO 23402 series for particular requirements for specific types of portable dental equipment.

What does the SIST EN ISO 23402-1:2026 document contain?

SIST EN ISO 23402-1:2026 contains classification rules, transport and use requirements, visual inspection methods, and manufacturer-information requirements. Clause 4 defines how to classify the equipment, while Clause 5 sets the main performance expectations for carrying, transport, exposure, usability, and hygiene-related surface processing.

Clauses 7 to 10 cover how conformity is checked, what instructions the manufacturer must provide, how the equipment and packaging must be marked, and how the equipment must be packaged for delivery. Annex A lists the IEC 60601-1 test methods that are often applicable, which helps when the equipment has electrical or patient-environment aspects that need safety verification.

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
...