oSIST prEN ISO 23402-1:2025

SLOVENSKI STANDARD
01-maj-2025
Zobozdravstvo - Prenosna dentalna oprema za začasno zdravstveno oskrbo - 1.
del: Splošne zahteve (ISO/DIS 23402-1:2025)
Dentistry - Portable dental equipment for use in non-permanent healthcare environment -
Part 1: General requirements (ISO/DIS 23402-1:2025)
Zahnheilkunde - Tragbare dentale Ausrüstung zur Anwendung in nicht-dauerhaften
Gesundheitseinrichtungen - Teil 1: Allgemeine Anforderungen (ISO/DIS 23402-1:2025)
Médecine bucco-dentaire - Équipement dentaire portatif destiné à être utilisé dans un
environnement de soins non permanent - Partie 1: Prescriptions générales (ISO/DIS
23402-1:2025)
Ta slovenski standard je istoveten z: prEN ISO 23402-1
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 23402-1
ISO/TC 106/SC 6
Dentistry — Portable dental
Secretariat: DIN
equipment for use in non‐
Voting begins on:
permanent healthcare
2025-03-28
environment —
Voting terminates on:
2025-06-20
Part 1:
General requirements
Médecine bucco-dentaire — Matériel dentaire portatif utilisable
dans des environnements de soins de santé non permanents —
Partie 1: Exigences générales
ICS: 11.060.20
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
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This document is circulated as received from the committee secretariat.
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Reference number
ISO/DIS 23402-1:2025(en)
DRAFT
ISO/DIS 23402-1:2025(en)
International
Standard
ISO/DIS 23402-1
ISO/TC 106/SC 6
Dentistry — Portable dental
Secretariat: DIN
equipment for use in non‐
Voting begins on:
permanent healthcare
environment —
Voting terminates on:
Part 1:
General requirements
Médecine bucco-dentaire — Matériel dentaire portatif utilisable
dans des environnements de soins de santé non permanents —
Partie 1: Exigences générales
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 2025
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
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Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 23402-1:2025(en)
ii
ISO/DIS 23402‐1:2025(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 .3
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 .4
5.2.1 General .4
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 Assembly and disassembly requirements .5
5.4 Utility requirements .5
5.5 Operational requirements .6
5.5.1 Ambient operating conditions .6
5.5.2 Usability .6
5.5.3 Reprocessing of external surfaces .6
5.5.4 Foreign object and liquid ingress .6
6 Sampling . 6
7 Measurement and test methods . 7
7.1 Visual inspection of the equipment .7
7.2 Visual inspection of the documentation .7
8 Manufacturer's instructions . 7
8.1 General .7
8.2 Instructions for use .7
8.3 Technical description.8
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 60601‐1:2005, IEC 60601‐
1:2005/AMD 1:2021 and IEC 60601‐1:2005/AMD 2 . 9
Bibliography .11

iii
ISO/DIS 23402‐1:2025(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 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)
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 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:
— Update of 5.2.7, 5.2.8 and 5.2.9 to specify requirements for portable dental equipment classified for
limited outdoor exposure and limited carrying distance as well as for equipment classified for rugged
outdoor exposure and extended carrying distance;
— Addition of 5.5.4, Foreign body and liquid ingress;
— Addition of e) and f) in 8.3 to include classification level for drop height and classification level for rough
road transport distance;
— General editorial updates.
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/DIS 23402‐1:2025(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 programs, particularly at external/off-site locations
(including dentistry, dental hygiene, dental assisting).
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 (such as 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 may
not be practical and is to 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.
This document is one in a series with the objective of standardizing requirements for portable dental
equipment for use in non-permanent healthcare environments.

v
DRAFT International Standard ISO/DIS 23402‐1:2025(en)
Dentistry — Portable dental equipment for use in non‐
permanent healthcare environment —
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.
Portable dental equipment within the scope of this document includes 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 (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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) a
...